U.S. patent application number 13/976309 was filed with the patent office on 2014-02-13 for pouch, method of manufacturing a pouch and a method of dispensing a product from a pouch.
This patent application is currently assigned to ABBOTT LABORATORIES. The applicant listed for this patent is Terrence B. Mazer, Robert Alan Miller, JR., David C. Ulstad, Wilson George Zeitler. Invention is credited to Terrence B. Mazer, Robert Alan Miller, JR., David C. Ulstad, Wilson George Zeitler.
Application Number | 20140044381 13/976309 |
Document ID | / |
Family ID | 45509646 |
Filed Date | 2014-02-13 |
United States Patent
Application |
20140044381 |
Kind Code |
A1 |
Ulstad; David C. ; et
al. |
February 13, 2014 |
POUCH, METHOD OF MANUFACTURING A POUCH AND A METHOD OF DISPENSING A
PRODUCT FROM A POUCH
Abstract
A single-use pouch (10) for liquid product has a front panel
(12) and a back panel (14). The front and back panels at least in
part cooperatively define an interior space (15) of the pouch. The
interior space has a total liquid capacity. A volume of liquid
product is contained within the interior space. The volume of
liquid product is less than about 60% of the total liquid capacity
of the pouch.
Inventors: |
Ulstad; David C.; (Dublin,
OH) ; Miller, JR.; Robert Alan; (Westerville, OH)
; Mazer; Terrence B.; (New Albany, OH) ; Zeitler;
Wilson George; (Westerville, OH) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Ulstad; David C.
Miller, JR.; Robert Alan
Mazer; Terrence B.
Zeitler; Wilson George |
Dublin
Westerville
New Albany
Westerville |
OH
OH
OH
OH |
US
US
US
US |
|
|
Assignee: |
ABBOTT LABORATORIES
ABBOTT PARK
IL
|
Family ID: |
45509646 |
Appl. No.: |
13/976309 |
Filed: |
December 9, 2011 |
PCT Filed: |
December 9, 2011 |
PCT NO: |
PCT/US11/64247 |
371 Date: |
October 23, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61427526 |
Dec 28, 2010 |
|
|
|
Current U.S.
Class: |
383/207 |
Current CPC
Class: |
B31B 70/813 20170801;
B31B 70/84 20170801; B65B 2220/22 20130101; B65D 75/5811 20130101;
B31B 2155/00 20170801; B65D 5/6623 20130101; B31B 2160/10 20170801;
B65B 2220/18 20130101; B65D 81/3261 20130101; B65D 5/2057 20130101;
B31B 2155/0014 20170801; B65D 75/5861 20130101; B65B 9/20 20130101;
B65D 75/5827 20130101; B65D 5/48042 20130101; B65D 75/5866
20130101; B65D 5/5035 20130101; B65D 77/062 20130101 |
Class at
Publication: |
383/207 |
International
Class: |
B65D 75/58 20060101
B65D075/58 |
Claims
1-15. (canceled)
16. A single-use pouch comprising: a web folded to form a pouch
having a front panel, a back panel, a top edge, a bottom edge, and
two side edges, wherein the top edge, the bottom edge and one of
the two side edges are sealed, the other of the two side edges is a
fold line, and the front panel and the back panel define an
interior space; and a liquid product contained in the interior
space; wherein the interior space includes a body and a spout, one
side of the spout defined by the fold line, and the spout in fluid
communication with the body and through which the product is
dispensed from the pouch.
17. The single-use pouch of claim 16 wherein the fold line acts as
a channel to guide liquid product from the body towards an opening
at the end of the spout.
18. The single-use pouch of claim 16 wherein a width of the pouch
is at least three times a width of the spout.
19. The single-use pouch of claim 16 wherein the interior space
includes a transition portion connecting the spout and the body,
wherein the transition portion defines a travel path for the liquid
product, and the travel path is at an angle to the fold line.
20. The single-use pouch of claim 16 wherein at least one of the
front panel and the rear panel includes a line of weakness
positioned between the top edge and the body, and in a path
transverse to the spout.
21. The single-use pouch of claim 16 further comprising a gripping
portion positioned between the top edge and the body.
22. The single-use pouch of claim 21 wherein the gripping portion
includes a portion of the front panel sealed to a portion of the
back panel.
23. The single-use pouch of claim 22 wherein at least one of the
front panel and the rear panel includes a line of weakness
positioned entirely within the gripping portion.
24. The single-use pouch of claim 21 wherein the gripping portion
defines a side of the spout opposite the fold line.
25. The single-use pouch of claim 16 wherein the liquid product is
aseptically processed.
26. The single-use pouch of claim 16 wherein the liquid product is
a human milk fortifier.
27. The single-use pouch of claim 16 wherein the liquid product is
manually kneadable within the interior space.
28. The single-use pouch of claim 16 wherein the liquid product is
visible through at least one of the front panel and the back
panel.
29. The single-use pouch of claim 28 wherein indicia is printed on
the front panel and the back panel, and at least the majority of at
least one of the front panel and the back panel is transparent.
30. The single-use pouch of claim 16 wherein the web is a
multi-layer plastic laminate.
31. A single-use pouch comprising: a multi-layer plastic sheet
folded to form a pouch having a front panel, a back panel, a top
edge, a bottom edge, and two side edges, wherein the top edge, the
bottom edge and one of the two side edges are sealed, the other of
the two side edges is a fold line, and the front panel and the back
panel define an interior space; and an aseptically processed liquid
product contained in the interior space; wherein the interior space
includes a body and a spout, one side of the spout defined by the
fold line, and the spout in fluid communication with the body,
wherein the fold line acts as a channel to guide liquid product
from the body towards an opposite end of the spout.
32. The single-use pouch of claim 31 wherein at least one of the
front panel and the rear panel includes a line of weakness
positioned between the top edge and the body, and in a path
transverse to the spout.
33. The single-use pouch of claim 31 wherein the line of weakness
is positioned remotely from the spout.
34. The single-use pouch of claim 31 further comprising a gripping
portion positioned between the top edge and the body, the gripping
portion including a portion of the front panel sealed to a portion
of the back panel.
35. The single-use pouch of claim 34 wherein the gripping portion
defines a side of the spout opposite the fold line.
Description
[0001] This application claims priority to U.S. Provisional
Application No. 61/427,526, filed Dec. 28, 2010, the disclosure of
which is herein incorporated by reference in its entirety.
FIELD OF THE DISCLOSURE
[0002] The field of this disclosure relates generally to packaging
for liquid products and more particularly to a pouch for containing
and dispensing aseptically processed low acid concentrated liquid
(e.g., human milk fortifier), methods for manufacturing a
hermetically sealed pouch, methods for aseptically packaging the
human milk fortifier in the pouch, method for testing of seal
integrity of the pouch and methods of using the pouch to dispense
human milk fortifier.
BACKGROUND OF THE DISCLOSURE
[0003] Human milk is generally recognized as an ideal food source
for most infants due to its overall nutritional composition. It is
well known and generally accepted that human milk provides infants
with unique immunologic and developmental benefits as compared
generally to commercially available infant formulas.
[0004] For some infants, however, especially preterm infants, human
milk does not always meet their complete nutritional needs.
Although these infants still generally benefit from human milk, it
is often desirable to supplement their human milk feedings with
additional nutrients. Initially, preterm infants may grow more
rapidly than many of their term counterparts, and accelerated
growth often requires additional nutrition, which can be made
possible by the use of a human milk fortifier in combination with
human milk.
[0005] Human milk fortifiers described in literature and
commercially available have been formulated as reconstitutable
powders rather than liquids in order to minimize the volume
displacement of human milk by the fortifier. Powdered human milk
fortifiers, however, are not considered commercially sterile
therefore microbes can be present in powdered human milk fortifiers
and may grow once dispensed from the package into the human
milk.
[0006] More recently, liquid human milk fortifiers, and
specifically highly concentrated human milk fortifier liquids, have
received more attention as an alternative to powders. Although
these highly concentrated human milk fortifiers do generally
displace slightly more volume than powders, the liquids are
processed to be commercially sterile, which is not an option for
powders.
[0007] Hydrolyzed proteins are often desirable to utilize in human
milk fortifiers as they are generally more easily digested and
absorbed into the gut of a preterm infant as compared to
substantially intact proteins. Additionally, the hydrolyzed
proteins may be hypoallergenic such that they may not predispose
the infant to cow's milk allergies later in life. However, as
compared to intact proteins, extensively hydrolyzed proteins (i.e.,
proteins having a degree of hydrolysis of about 20% or more) tend
to have poor ability to form long term stable emulsions.
Additionally, the presence of high levels of insoluble minerals
such as calcium salts may also cause a number of stability issues
when used in combination with extensively hydrolyzed proteins. As
such, manufacturing long term stable liquid concentrated human milk
fortifiers including extensively hydrolyzed proteins have proven
difficult.
[0008] To combat this problem, many liquid human milk fortifiers
have been manufactured with stabilizers, such as carrageenan. The
stabilizers act to hold the nutrients and insolubles in solution
over time and thus improve long term stability of the product.
Although stabilizers, such as carrageenan, have generally proven to
retard precipitation of many ingredients in the liquid human milk
fortifier, these types of stabilizers are not permitted in infant
formulas and human milk fortifiers in many countries around the
world. When stabilizers cannot be used in highly concentrated human
milk fortifiers, it can be very difficult to produce a long term
stable highly concentrated human milk fortifier.
[0009] As such, there is a need for liquid human milk fortifiers
that are commercially sterile, do not require refrigeration, and
have relatively low acidity. In addition, there is a need for
packaging for liquid human milk fortifiers that is sufficiently
flexible to allow insitu mixing of the fortifier, and transparent
so that a user can visually observe the human milk fortifier to
ensure proper mixing has occurred before opening the packaging to
dispense the human milk fortifier. Moreover, the packaging should
be easy to use and should minimize the amount of residual human
milk fortifier remaining in the packaging after dosing.
BRIEF DESCRIPTION OF THE DISCLOSURE
[0010] In one aspect, a single-use pouch for liquid product
generally comprises a front panel and a back panel. The front and
back panels at least in part cooperatively define an interior space
of the pouch. The interior space has a total liquid capacity. A
volume of liquid product is contained within the interior space.
The volume of liquid product is less than about 50% of the total
liquid capacity of the pouch.
[0011] In another aspect, a single-use pouch for liquid product
generally comprises a front panel and a back panel. The front and
back panels at least in part cooperatively define an interior space
of the pouch. The interior space has a total liquid capacity. A
volume of liquid product and gas is contained within the interior
space. The volume of liquid product and gas is less than about 40%
of the total liquid capacity of the pouch.
[0012] In yet another aspect, a pouch generally comprises a front
panel and a back panel. The front and back panels at least in part
cooperatively define an interior space of the pouch. At least one
of the front panel and the back panel is made at least in part from
a flexible, transparent material. An aseptically processed liquid
product is contained within the interior space of the pouch and
visually observable through the at least one of the front panel and
the back panel.
[0013] In still another aspect, a method of packaging an aseptic
liquid product into a pouch generally comprises sterilizing both
sides of a flexible and transparent web of sheet material with a
sterilant. The web is drawn across forming shoulders, around
filling tubes, to create longitudinal pouch tubes. Two pouches are
formed, one from each lane. Each pouch is filled with an
aseptically processed liquid product.
[0014] In still yet another aspect, a method of dispensing a liquid
product from a pouch generally comprises obtaining a pouch having
an aseptically processed liquid product contained therein. At least
a portion of the pouch is transparent for allowing visual
observation of the liquid product contained therein. The pouch is
manually kneaded to mix the liquid product within the pouch. The
liquid product is visually observed through the transparent portion
of the pouch to determine if the liquid product has been
sufficiently mixed. The pouch is opened and the liquid product is
poured from the pouch.
[0015] In still a further aspect, a single-use pouch for product
generally comprises a body having a front panel and a back panel.
The front and back panels at least in part cooperatively define an
interior space of the pouch for containing the product. A spout is
in fluid communication with the interior space. Product is
dispensed from the pouch through the spout. The spout has a width
and the body has a width wherein the ratio of the width of the body
and the width of the spout is between about 3:1 and about 5:1.
[0016] In yet a further aspect, a secondary container for holding a
plurality of pouches generally comprises a base section and a lid
hingely attached to the base section for movement between a closed
position and an opened position. A pair of hold downs are disposed
adjacent opposite ends of the hinge.
[0017] In still another aspect, a secondary container for holding a
plurality of pouches generally comprises a base section and a lid
hingely attached to the base section for movement between a closed
position and an opened position. The base section includes a bottom
wall, at least one side wall extending up from the bottom wall, a
top wall, and an interior floor. The interior floor is tented along
its center line.
BRIEF DESCRIPTION OF THE DRAWINGS
[0018] FIG. 1 is a perspective of one suitable embodiment of a
pouch for containing and dispensing a liquid product, the pouch
being illustrated in a closed configuration;
[0019] FIG. 2 is a front elevation thereof;
[0020] FIG. 3 is a back elevation thereof;
[0021] FIG. 4 is a cross-section taken along line 4-4 of FIG.
2;
[0022] FIG. 5 is a cross-section taken along line 5-5 of FIG.
2;
[0023] FIG. 6 is a front elevation similar to FIG. 2 but
illustrating the pouch in an opened configuration;
[0024] FIG. 7A is an enlarged fragmentary cross-section taken along
line 7-7 of FIG. 3 illustrating one suitable laminate for forming
the pouch;
[0025] FIG. 7B is an enlarged fragmentary cross-section similar to
FIG. 7A but illustrating another suitable laminate for forming the
pouch
[0026] FIG. 8 is a front elevation of another suitable embodiment
of a pouch for containing and dispensing a liquid product, the
pouch being illustrated in a closed configuration;
[0027] FIG. 9 is a front elevation of another suitable embodiment
of a pouch for containing and dispensing a liquid product, the
pouch being illustrated in a closed configuration
[0028] FIG. 10 is a flow diagram illustrating one suitable
embodiment of a process for manufacturing the pouch and filling the
pouch with a liquid product;
[0029] FIGS. 11A-11C are schematics illustrating sequential aspects
of the process for manufacturing and filling the pouch;
[0030] FIG. 12 is a perspective of one suitable embodiment of a
secondary packaging for containing a plurality of the pouches;
[0031] FIG. 13 is a perspective illustrating the pouch in its
opened configuration and the liquid product contained therein being
dispensed into a nursing bottle containing human milk;
[0032] FIGS. 14A and 14B are side elevations of pouches similar to
the ones illustrated in FIGS. 2 and 9 except that the pouches seen
herein are opaque;
[0033] FIGS. 15A and 15B illustrate the pouch of FIG. 14A in the
process of being opened and being tilted as if the product
contained therein is being dispensed;
[0034] FIGS. 16A and 16B illustrate another suitable embodiment of
a secondary packaging for containing a plurality of the pouches
illustrating a lid of the packaging in a closed position and in an
opened position;
[0035] FIG. 17 is a front perspective view of the secondary
packaging of FIG. 12 with the lid closed;
[0036] FIG. 18 is another front perspective of the secondary
packaging of FIG. 12 with the lid closed;
[0037] FIG. 19 is a rear perspective of the secondary packaging of
FIG. 12 with the lid closed;
[0038] FIG. 20 is a front perspective of the secondary packaging of
FIG. 12 with the lid opened;
[0039] FIG. 21 is a side elevation of the secondary packaging of
FIG. 12 with the lid opened;
[0040] FIG. 22 is a schematic illustration of a plastic container
including a concentrated liquid human milk fortifier that does not
contain any OSA-modified corn starch or low acyl gellan gum;
[0041] FIG. 23 is a schematic illustration of a plastic container
including a concentrated liquid human milk fortifier that contains
OSA-modified corn starch but does not contain low acyl gellan
gum;
[0042] FIG. 24 is a schematic illustration of a plastic container
including a concentrated liquid human milk fortifier that contains
low acyl gellan gum but does not contain OSA-modified corn starch;
and
[0043] FIG. 25 is a schematic illustration of a plastic container
including a concentrated liquid human milk fortifier that contains
both OSA-modified corn starch and low acyl gellan gum.
[0044] Corresponding reference characters indicate corresponding
parts throughout the drawings.
DETAILED DESCRIPTION OF THE DRAWINGS
Pouch
[0045] FIGS. 1-5 of the drawings illustrate one embodiment of a
pouch, indicated generally at 10, suitable for packaging and
dispensing a liquid product, e.g., a liquid product intended for
human consumption. As used herein "liquid product" means a product
that is a flowable non-solid product including, for example but not
limited to, aqueous solutions, solutions having a determinable
viscosity, emulsions, colloids, pastes, gels, dispersions and other
flowable non-solid products so as to exclude solid products such as
bars and particulate products, such as powders.
[0046] As seen therein, the illustrated pouch 10 has a front panel
12 and a back panel 14 generally opposed to and sealingly engaged
with the front panel to at least in part define an interior space
15 sized and shaped for containing the product. The illustrated
pouch 10 comprises two side edges 16, 18, two end edges 20, 22, a
longitudinal axis LA, and a transverse axis TA. In the illustrated
embodiment, the pouch 10 is formed from a single-piece of sheet
material that has been folded about a longitudinal fold line. As
seen in FIGS. 2-5, the fold line forms one of the side edges 16 of
the pouch 10. The front panel 12 of the pouch 10 is joined to the
back panel 14 along the other side edge 18 and at the end edges 20,
22 along a plurality of seal lines 25, such as by heat sealing, to
seal the interior space 15 of the pouch. It is understood, however,
that the front panel 12 and back panel 14 of the pouch 10 may be
joined in other ways without departing from the scope of the
present invention (e.g., adhesive). It is also understood that the
pouch 10 could be formed from two separate panels that are sealed
together along both side edges 16, 18 and the end edges 20, 22. It
is also contemplated that the pouch 10 may include sidewalls (not
shown) intermediate the front panel 12 and the back panel 14
without departing from the scope of this invention.
[0047] With reference to FIGS. 2 and 3, the seal lines 25 include
end segments 25a, 25b disposed along the margins adjacent the end
edges 20, 22 of the pouch 10, respectively, to fluidly seal the
ends of the pouch. A side edge segment 25c is disposed adjacent one
of the side edges 18 (i.e., opposite the side edge 16 defined by
the fold line) and extends the longitudinal length of the pouch 10.
The side edge segment 25c intersects (or otherwise contacts) the
end segments 25a, 25b to define the interior space 15 of the pouch
10 and to seal the pouch in a fluid-tight manner. As seen in FIGS.
2 and 3, the seal lines 25 further comprise an inboard seal segment
25d that connects one of the end segments 25a (the upper seal
segment as viewed in FIGS. 2 and 3) to the side edge segment 25c.
In the illustrated embodiment, the inboard seal segment 25d
includes a longitudinal component 25d' extending downward from the
end segment 25a and a diagonal component 25d'' extending diagonally
from the longitudinal component to the side edge segment 25c. It is
understood, however, that the inboard seal segment 25d can have
different configurations (e.g., generally L-shaped) without
departing from the scope of this invention.
[0048] With reference still to FIGS. 2 and 3, the pouch 10 includes
a body 60, a spout 62, and a transition (or funnel) portion 64
connecting the body to the spout. The body 60 is the portion of the
pouch 10 below the lower extent of the diagonal component 25d'' of
the inboard seal segment 25d of the seal lines 25. The body 60 has
a height H1 and a width W1. In the illustrated embodiment, the
height H1 of the body 60 is approximately 75 mm and the width W1 of
the body is approximately 36 mm. It is understood that the body 60
can have heights and widths less than or greater than the exemplary
heights and widths provided herein. The spout 62 is defined by the
end segment 25a and the longitudinal component 25d' of the inboard
seal segment 25d of the seal lines 25. As seen in FIGS. 2-4, the
spout 62 includes the fold line defining one of the side edges 16
of the pouch 10. In use, the fold line acts as a channel and guides
the product along the fold line and towards an opening in the
spout. The spout 62 has a height H2 and a width W2. In the
illustrated embodiment, the height H2 of the spout 62 is
approximately 17 mm and the width W1 of the spout is approximately
10 mm. Thus, the illustrated body 60 of the pouch 10 has a width
ratio of about 3.6:1 with respect to the width of the spout 62.
That is, the body has a width that is about 3.6 times larger than
the width of the spout 62. It is understood that the spout 62 can
have heights and widths less than or greater than the exemplary
heights and widths provided herein. For example, the ratio of the
width of the body and the width of the spout may be between about
3:1 and about 5:1, such as, about 4:1.
[0049] The transition portion 64 is a portion of the pouch 10
disposed between the spout 62 and body 60, and includes the
diagonal component 25d'' of the inboard seal segment 25d of the
seal lines 25. In use, the diagonal component 25d'' of the inboard
seal segment 25d acts as a funnel-like surface to funnel the
product towards the spout. The transition portion 64 has a height
H3. In the illustrated embodiment, the height H3 of the transition
portion 64 is approximately 17 mm. The width of the transition
portion 64 reduces along its height as it extends from the body 60
to the spout 62. It is understood that the transition portion 64
can have heights and widths less than or greater than the exemplary
heights and widths provided herein.
[0050] In a sealed (broadly, closed) configuration of the pouch 10,
as illustrated in FIGS. 1-3, the product is sealingly enclosed in
the interior space 15 of the pouch. In one suitable embodiment, the
product is aseptically processed and sealed within the pouch 10 as
described in more detail below. The pouch 10 can be selectively
configured from the sealed configuration to an opened configuration
as illustrated in FIG. 6 to permit dispensing of the product from
the pouch. In one suitable embodiment, the product is a liquid and
can be poured from the pouch 10 through the spout 62. It is
understood, however, that the product can be any suitable, liquid
substance including a gel or a paste.
[0051] As illustrated in FIGS. 1-3, the pouch 10 has a first line
of weakness 30 formed on the front panel 12 of the pouch and a
second line of weakness 32 formed on the back panel 14 of the
pouch. The lines of weakness 30, 32 provide a path along which the
pouch 10 is more readily torn to open the pouch (i.e., configured
to the opened configuration). It is understood that the pouch 10
may have a line of weakness 30, 32 disposed on only one of the
front and back panels 12, 14, with the other panel being free of a
line of weakness and remain within the scope of this invention.
While the lines of weakness 30, 32 in the illustrated embodiment
are substantially equal in length, the lengths of the lines of
weakness 30, 32 can be different without departing from the scope
of this invention. Thus, the line of weakness 30 on the front panel
12 of the pouch 10 may be longer or shorter than the line of
weakness 32 on the back panel 14 of the pouch.
[0052] In the illustrated embodiment, the lines of weakness 30, 32
comprise score lines. The term "line of weakness" is used herein to
mean any defined (e.g., intended) structural feature that weakens
the pouch 10 along a predetermined path so that the pouch 10 is
more readily ruptured, or torn, upon application of a tearing force
along the line of weakness and is not limited to score lines. For
example, in other embodiments, the lines of weakness 30, 32 may
comprise a plurality of separation points, a score line, a
breakaway line or areas, a chain stitch, a thinning of the pouch
material, a plurality of aligned perforations (e.g., holes, slits,
apertures, voids, or the like) or other suitable line of weakness.
The lines of weakness 30, 32 may be formed by partial pressure
cutting, partial ultrasonic cutting, partial thermal deformation,
mechanical thinning, or other suitable techniques.
[0053] As mentioned, the lines of weakness 30, 32 provide a path of
low resistance along which the pouch 10 may be torn. However, the
level of resistance to tearing provided by the lines of weakness
30, 32 can be altered. Lowering the tear resistance would make the
pouch 10 easier to open. As a result, less force is needed to tear
the pouch 10 along the lines of weakness 30, 32. However, lowering
the tear resistance may increase the risk that the pouch 10 will
unintentionally tear apart or otherwise leak. On the other hand,
increasing the resistance of the lines of weakness 30, 32, would
require a greater force to tear the pouch 10 along the lines of
weakness. In addition, the lines of weakness 30, 32 can have
varying tear resistance along their length or a portion of their
length. In addition, the tear resistance of the line of weakness 30
in the front panel 12 of the pouch 10 may be equal to or different
than the tear resistance of the line of weakness 32 in the back
panel 14 of the pouch.
[0054] In the illustrated embodiment, the lines of weakness 30, 32
begin at the side edge 18 (e.g., the side edge not defined by the
fold line), extend through the side edge segment 25c of the seal
lines 25 and generally parallel to but spaced from one of the end
edges 20, and terminate within the longitudinal component 25d' of
the inboard seal segment 25d of the seal lines and generally
adjacent the spout 62. Accordingly, the product can be accessed by
tearing the pouch 10 along the lines of weakness 30, 32 as
illustrated in FIG. 6. The spout 62 is torn approximately in half
longitudinally during tearing of the lines of weakness 30, 32. It
is understood, however, that more or less of the spout 62 can be
torn away.
[0055] In the illustrated embodiment, the portion of the pouch 10
above the lines of weakness 30, 32 defines a gripping portion 66
suitable for manually grasping to facilitate opening of the pouch
10 by tearing along the lines of weakness 30, 32. In one suitable
embodiment, the gripping portion 66 is removed from the remainder
of the pouch 10 when the pouch is opened (i.e., when the pouch is
torn along the lines of weakness 30, 32). It is contemplated,
however, that the gripping portion 66 can remain connected to the
pouch 10 so long as the spout 62 is sufficiently open to allow the
product to flow out of the interior space 15 of the pouch.
[0056] The pouch 10 may be formed from any suitable material
including woven material, non-woven material, films, laminates, or
a combination thereof. For example, in one suitable embodiment, the
pouch 10 comprises a two layered laminate having an inner layer 50
and an outer layer 52 (FIG. 7A). In one particularly suitable
embodiment, the inner layer 50 is formed from a co-extrusion of
linear low density polyethylene (LLDPE) and ethylene vinyl alcohol
(EVOH), and the outer layer 52 from barrier coated polyethylene
terephthalate (PET). In another suitable embodiment, which is
illustrated in FIG. 7B, the pouch 10 comprises a three layered
laminate having an inner layer 50', an outer layer 52', and an
intermediate layer 54' disposed between the inner and outer layers
(FIG. 7B). In one particularly suitable embodiment, the inner layer
50' is formed from a co-extrusion of linear low density
polyethylene (LLDPE) and ethylene vinyl alcohol (EVOH), and the
outer layer 52' from barrier coated polyethylene terephthalate
(PET). The intermediate layer 54' is formed from one of aluminum
oxide coated PET, a silicon oxide coated PET, or ethylene vinyl
alcohol. As explained in more detail below, the pouch 10, in one
suitable embodiment, is formed from a non-metallic material. That
is, the pouch 10 is substantially free from metal. It is
understood, however, that the layers 50, 50', 52, 52', 54' can be
formed from any suitable materials without departing from some
aspects of this invention.
[0057] As seen in FIG. 7A, the layers 50, 52 of the two layer
laminate are bonded together using adhesive 51. It is understood,
however, that the layers 50, 52 can be bonded together using other
suitable techniques. As also seen in FIG. 7A, indicia 53 is printed
on an inner surface of the inner layer 50 (i.e., the surface that
faces and is bonded to the outer layer 52) using suitable ink. It
is understood, however, that the indicia 53 can be printed on
either surface of the outer layer 52.
[0058] In one suitable embodiment, at least a portion of the pouch
10 is generally transparent to permit visual observation of the
product contained therein. In the illustrated embodiment, for
example, the entire pouch 10 is generally transparent. In one
suitable embodiment, the inner surface of the inner layer 50 of
either the front panel 12 or the back panel 14 can be covered with
a white ink to render the front/back panel generally transparent.
It is understood, however, that less then the entire pouch can be
transparent. For example, the front panel 12 could be made from a
generally transparent material and the back panel 14 formed from a
translucent or opaque material, or vise versa. In another example,
the pouch 10 could include a longitudinally extending strip of
transparent material (e.g., to form a window) on either one of or
both the front and back panels 12, 14 of the pouch while the
remainder of the pouch is formed from a generally translucent or
opaque material. It is understood, that the pouch 10 can be formed
from generally opaque material as seen in FIGS. 14A and 14B without
departing from some aspects of this invention.
[0059] The pouch 10 illustrated in FIGS. 1-6 is suitably configured
for containing and dispensing a predetermined target dispensing
dosage, such as, approximately 5 ml. It is understood, however,
that the pouch 10 can be configured to hold any suitable target
dosage. For example, FIG. 8 illustrates a second embodiment of a
pouch 110 substantially similar to the pouch 10 of FIGS. 1-6 except
that the pouch of this second embodiment is smaller and designed to
hold a target dosage of approximately 2 ml. More specifically, the
pouch 110 has a shorter body 160 than the body 60 of the pouch 10
illustrated in FIGS. 1-6. Otherwise, the pouches 10, 110 are
substantially the same including, in one embodiment, being of the
same width for ease of manufacturing different sized pouches. In
another example, FIG. 9 illustrates a third embodiment of a pouch
210 substantially similar to the previous described pouch 10 of
FIGS. 1-6 except that the pouch of this embodiment is larger and
designed to hold a target dosage of approximately 80 ml. More
specifically, the pouch 210 has a longer body 260 than the body 60
of the pouch 10 illustrated in FIGS. 1-6. Otherwise, the pouches
10, 210 are substantially the same. Depending on the product and
the desired target dosage, it is understood that the pouch may be
sized and configured for generally any target dosage.
[0060] In one suitable embodiment, each of the pouches 10, 110, 210
is filled with a greater quantity of product as compared to its
intended target dispensing dosage to account for residual product
that remains within the pouch after use, such as, due to viscosity
and stickiness of the product. Testing of the pouch 10 illustrated
in FIGS. 1-6 determined that approximately 88 percent of the pouch
contents are typically dispensed during use. As a result, each of
the pouches 10, 110, 210 has an actual fill volume that is
approximately 12 percent greater than the target dispensing dosage.
Thus, the pouch 110 intended to have a 2 ml dosage (FIG. 8) has a
fill volume of approximately 2.27 ml. The pouch 10 intended to have
a 5 ml dosage (FIGS. 1-7) has a fill volume of approximately 5.69
ml. And the pouch 210 intended to have an 80 ml dosage size (FIG.
9) has a fill volume of approximately 90.91 ml. It is understood
that the pouches 10, 110, 210 can have other anticipated residual
rates (i.e., besides 88 percent) as a result of viscosity,
stickiness or other factors and thus other fill volumes without
departing from the scope of this invention.
[0061] Moreover, it is anticipated that each of the pouches 10,
110, 210 will have a distribution ratio within .+-.4 percent. That
is, the actual amount of product distributed from each of the
pouches 10, 110, 210 will be within 4 percent of the target dosage
for that pouch. Thus, the pouch 110 intended to have a 2 ml dosage
(FIG. 8) will actually dispense a quantity of product between about
1.92 ml and about 2.08 ml. The pouch 10 intended to have a 5 ml
dosage (FIGS. 1-7) will actually dispense a quantity of product
between about 4.8 ml and about 5.2 ml. And the pouch 210 intended
to have an 80 ml dosage (FIG. 9) will actually dispense a quantity
of product between about 76.8 ml and about 83.2 ml. It is
understood that the pouches 10, 110, 210 can have a different
distribution ratio (i.e., besides .+-.4 percent) without departing
from the scope of this invention.
[0062] Each of the pouches 10, 110, 210 is capable (e.g.,
sufficiently flexible) of being manually kneaded or otherwise
manipulated by a user to ready the product within the pouch before
opening the pouch. Thus, in one embodiment, the product can be
thoroughly mixed within the pouch 10, 110, 210 before the pouch is
opened and the product dispensed therefrom. In other embodiments
where the product is more gel-like, kneading also, or
alternatively, thins the product to render it easier to pour. In
one suitable embodiment, the front and back panels 12, 14 of the
pouch 10 contact each other during the kneading process under
relatively light, manual pressure and the product is able to move
freely throughout the interior space 15.
[0063] A qualitative kneadability study was performed on pouches
designed for a target dispensing dosage of about 5 ml. The pouches
had a total (e.g., maximum) liquid capacity of about 20 ml. In
Example 1, ten pouches were filled with a various amount of air
(broadly, a gas) and manually kneaded. The kneadability of the
pouch was rated as being easy, moderate, difficult or extremely
difficult. The amount of air and the results of the testing are
provided in the following Table. In Example 2, ten pouches were
filled with a various amount of liquid and manually kneaded. The
kneadability of the pouch was rated as being easy, moderate,
difficult or extremely difficult. The amount of liquid and the
results of the testing are provided in the following Table. In
Example 3, ten pouches were filled with various combinations of
liquid and air and manually kneaded. The kneadability of the pouch
was rated as being easy, moderate, difficult or extremely
difficult. The amount of liquid and air and the results of the
testing are provided in the following Table.
Example 1
TABLE-US-00001 [0064] Air Only Sample Air Volume (ml) Total Volume
Ease of Kneading 1 6 6 Easy 2 7 7 Easy 3 8 8 Easy 4 9 9 Easy 5 10
10 Easy 6 11.5 11.5 Moderate 7 16.5 16.5 Moderate 8 19 19 Moderate
9 22 22 Difficult 10 26.5 26.5 Extremely Difficult
Example 2
TABLE-US-00002 [0065] Liquid Only Sample Liquid Volume (ml) Total
Volume Ease of Kneading 1 4 4 Easy 2 5 5 Easy 3 6 6 Easy 4 7 7 Easy
5 8 8 Easy 6 9 9 Easy 7 10 10 Easy 8 12 12 Moderate 9 16 16
Difficult 10 20 20 Extremely Difficult
Example 3
TABLE-US-00003 [0066] Liquid + Air Air Volume (ml)/ Total Liquid
Vol = 5.56 ml % Air Volume Volume Ease of Kneading 1 0.6/10% 6.2
Easy 2 1.4/20% 7.0 Easy 3 2.4/30% 7.9 Easy 4 3.7/40% 9.3 Easy 5
5.6/50% 11.1 Easy 6 8.3/60% 13.9 Moderate 7 10.3/65% 15.9 Moderate
8 13/70% 18.5 Difficult 9 16.7/75% 22.2 Extremely Difficult 10
22.2/80% 27.8 Extremely Difficult
[0067] The intent of the kneadability study was to determine
suitable packaged volumes at which kneading of the product/pouch
becomes impractical (i.e., difficult or extremely difficult).
[0068] As seen above for Example 2, where no air is present the
amount of liquid within the pouch should be less than or equal to
about 50% of the total liquid capacity of the pouch. When the
amount of liquid in the pouch exceeded 50%, the kneadibility of the
pouch was reduced. In one suitable embodiment, the volume of liquid
in the pouch is between about 20% and about 50%, more suitably
between about 30% and about 40%, and even more suitably about 35%
of the total liquid capacity of the pouch.
[0069] As seen above for Example 3, the total volume taken up by
liquid and gas (e.g., air) within the pouch should be less than or
equal to about 50% of the total liquid capacity of the pouch. When
the combined volume of liquid and gas exceeds about 50%, the
kneadibility of the pouch is reduced. In one suitable embodiment,
the combined volume of liquid and gas in the pouch is between about
10% and about 50%, more suitably between about 20% and about 40% of
the total liquid capacity of the pouch.
Human Milk Fortifiers
[0070] Concentrated Liquid Human Milk Fortifier
[0071] In one suitable use, the pouch 10, 110, 210 can contain
liquid human milk fortifier capable of being poured directly from
the pouch into a container having human milk therein. It is
understood, however, that the pouch 10, 110, 210 can contain any
suitable product including other products intended for human
consumption. One suitable liquid human milk fortifier is a
concentrated liquid human milk fortifier comprising protein, fat,
carbohydrate OSA-modified starch and low acyl gellan gum. The
concentrated liquid human milk fortifier has a solids content of at
least about 20%, or even at least about 25%, including from about
25% to about 32%, and further including from about 29% to about
32%. The concentrated liquid human milk fortifier has a caloric
density of at least about 1.25 kcal/ml (37 kcal/fl oz), including
from about 1.4 kcal/ml (42 kcal/fl oz) to about 5 kcal/ml (149
kcal/fl oz), and also including from about 1.5 kcal/ml (44 kcal/fl
oz) to about 2.5 kcal/ml (74 kcal/fl oz), and also including from
about 1.9 kcal/ml (56 kcal/fl oz) to about 2.0 kcal/ml (59 kcal/fl
oz). The concentrated liquid human milk fortifiers is formulated to
provide fortified human milk having an osmolality of less than
about 400 mOsm/kg water, preferably from about 300 mOsm/kg water to
about 400 mOsm/kg water.
[0072] Extensively Hydrolyzed Casein Protein
[0073] The concentrated liquid human milk fortifier includes
hypoallergenic extensively hydrolyzed casein as a protein source.
The term "hypoallergenic" as used herein means that the
concentrated liquid human milk fortifier has a decreased tendency
to provoke an allergic reaction in a preterm or term infant as
compared to non-hypoallergenic fortifiers. Generally, the
concentrated liquid human milk fortifier includes at least about
35%, including at least about 50%, including at least about 60%,
including at least about 75%, including at least about 90% and
further including about 100% extensively hydrolyzed casein, by
total weight of protein in the concentrated human milk fortifier.
In one embodiment, the concentrated liquid human milk fortifier
includes 100% extensively hydrolyzed casein, by total weight of the
protein in the concentrated human milk fortifier. In this
embodiment, the concentrated liquid human milk fortifier is
hypoallergenic. In some other embodiments, the concentrated liquid
human milk fortifier will include from about 35% to 100%, including
from about 50% to 100%, further including from about 75% to 100%
extensively hydrolyzed casein, by total weight of protein in the
concentrated human milk fortifier. The concentrated liquid human
milk fortifier may optionally include other hypoallergenic or
non-hypoallergenic proteins in addition to the extensively
hydrolyzed casein protein.
[0074] Extensively hydrolyzed casein proteins suitable for use in
concentrated liquid human milk fortifiers include those having a
degree of hydrolysis of from about 20% to about 70%, including from
about 30% to about 60%, and further including from about 40% to
about 60%. Generally, the extensively hydrolyzed casein has a ratio
of total amino nitrogen (AN) to total nitrogen (TN) of from about
0.2 AN to 1.0 TN to about 0.4 AN to about 0.8 TN. Suitable
commercially available extensively hydrolyzed caseins will
generally have a protein level in the ingredient of from about 50%
to about 95%, including from about 70% to about 90%. One suitable
commercially available extensively hydrolyzed casein is Dellac
CE90, which is a spray dried powder casein hydrolysate (Friesland
Campina Domo, Amersfoort, The Netherlands).
[0075] Stabilizer System
[0076] The concentrated liquid human milk fortifier includes a
synergistic two component stabilizer system. The first component is
an octenyl succinic anhydride (OSA) modified corn starch. The
second component is a low acyl gellan gum. These two components act
in a synergistic manner to stabilize the concentrated liquid human
milk fortifier emulsion and retard the precipitation of nutrients
therefrom.
[0077] The OSA-modified corn starch is generally prepared by
esterifying a dextrinized, ungelatinized waxy corn starch with
1-octenyl succinic anhydride. Methods of this type are well known
in the art. One suitable commercially available OSA-modified corn
starch is N-CREAMER.TM. 46 (National Starch Food Innovation,
Bridgewater, N.J.). Without being bound to a particular theory, it
is believed that the OSA-modified corn starch adsorbs in the oil
and water interface thus preventing the oil droplets from
coalescence/aggregation by steric hinderance and charge repulsion.
The OSA-modified corn starch is present in the concentrated liquid
human milk fortifier in an amount of from about 0.1% to about 3.5%,
including from about 0.6% to about 2.0%, including from about 0.8%
to about 1.5%, and further including about 1.2% by weight of the
concentrated liquid human milk fortifier.
[0078] The low acyl gellan gum (also known as and commonly referred
to as deacylated gellan gum) may be a water-soluble polysaccharide
produced by fermentation of a pure culture of Sphingomonas elodea.
As used herein, "low acyl" means that the gellan gum has been
treated such that it forms firm, non-elastic, brittle gels, that
are heat stable, as compared to "high acyl" which forms soft, very
elastic, non-brittle gels. Without being bound to a particular
theory, it is believed that the low acyl gellan gum creates a three
dimensional gelled network of very small microgels that interact
with each other to provide a stable suspension. One suitable
commercially available low acyl gellan gum is Kelcogel F (CP Kelco
U.S. Inc., Atlanta Ga.).
[0079] The low acyl gellan gum is present in the concentrated
liquid human milk fortifier in an amount from greater than 125 ppm
to about 800 ppm, including from about 150 ppm to about 400 ppm,
including from about 200 ppm to about 300 ppm and further including
about 200 ppm.
[0080] Macronutrients
[0081] The concentrated liquid human milk fortifier comprises
carbohydrate, fat, and protein macronutrients of sufficient types
and amounts, that when used in combination with human milk (or
other infant feeding formula), they help meet the nutritional needs
of infants and especially premature infants. The concentration of
these macronutrients includes the ranges described hereinafter. The
term "infant" as used herein, refers generally to individuals less
than about 1 year of age, actual or corrected. The term "premature
infants" are used herein refers to those infants born at less than
37 weeks gestation, have a birth weight of less than 2500 gm, or
both.
[0082] Protein
[0083] The concentrated liquid human milk fortifier comprises a
protein suitable for use with infants, especially preterm infants,
at concentrations ranging from about 5% to about 50%, including
from about 20% to about 40%, including from about 5% to about 30%,
including from about 10% to about 25%, and also including from
about 15% to about 25%, on a dry weight basis. In some embodiments,
the protein may be at a concentration of less than 10%, on a dry
weight basis. The protein concentration may be from about 7 to
about 15 grams, including from about 9 to about 12 grams of protein
per 100 grams of final liquid product.
[0084] As noted above, the protein component of the concentrated
liquid human milk fortifier is at least partially comprised of
extensively hydrolyzed casein. In one particularly suitable
embodiment, the protein component of the concentrated human milk
fortifier is entirely comprised of extensively hydrolyzed casein.
In embodiments wherein additional proteins sources (i.e., one or
more protein sources in addition to the extensively hydrolyzed
protein source) are to be used in the concentrated liquid human
milk fortifier in addition to the extensively hydrolyzed casein
(i.e., the concentrated human milk fortifier protein component is
not 100% extensively hydrolyzed casein), the fortifier may still be
made hypoallergenic by including additional hypoallergenic proteins
such as soy protein hydrolysate, whey protein hydrolysate, rice
protein hydrolysate, potato protein hydrolysate, fish protein
hydrolysate, egg albumen hydrolysate, gelatin protein hydrolysate,
combinations of animal and vegetable protein hydrolysates, and
combinations thereof.
[0085] In this context, the terms "protein hydrolysates" or
"hydrolyzed protein" are used interchangeably herein and include
extensively hydrolyzed proteins, wherein the degree of hydrolysis
is most often at least about 20%, including from about 20% to about
80%, and also including from about 30% to about 80%, even more
preferably from about 40% to about 60%. The degree of hydrolysis is
the extent to which peptide bonds are broken by a hydrolysis
method. The degree of protein hydrolysis for purposes of
characterizing the extensively hydrolyzed protein component of
these embodiments is easily determined by one of ordinary skill in
the formulation arts by quantifying the amino nitrogen to total
nitrogen ratio (AN/TN) of the protein component of the selected
formulation. The amino nitrogen component is quantified by USP
titration methods for determining amino nitrogen content, while the
total nitrogen component is determined by the Tecator Kjeldahl
method, all of which are well known methods to one of ordinary
skill in the analytical chemistry art.
[0086] In other embodiments, the concentrated liquid human milk
fortifier, in addition to the extensively hydrolyzed protein, may
include an additional non-hypoallergenic protein source including
for example, partially hydrolyzed or non-hydrolyzed (intact)
protein, and can be derived from any known or otherwise suitable
source such as milk (e.g., casein, whey, lactose-free milk protein
isolates), animal (e.g., meat, fish), cereal (e.g., rice, corn),
vegetable (e.g., soy), or combinations thereof. The protein can
include, or be entirely or partially replaced by, free amino acids
known or otherwise suitable for use in nutritional products,
non-limiting examples of which include free amino acids including
L-alanine, L-arginine, L-asparagine, L-aspartic acid, L-carnitine,
L-cystine, L-glutamic acid, L-glutamine, glycine, L-histidine,
L-isoleucine, L-leucine, L-lysine, L-methionine, L-phenylalanine,
L-proline, L-serine, L-taurine, L-threonine, L-tryptophan,
L-tyrosine, L-valine, and combinations thereof.
[0087] Carbohydrate
[0088] The concentrated liquid human milk fortifier comprises a
carbohydrate suitable for use with infants, especially preterm
infants, at concentrations most typically ranging up to about 75%
by weight on a dry weight basis, including from about 10% to about
50%, and also including from about 20% to about 40%, by weight on a
dry weight basis. Carbohydrates suitable for use in the
concentrated liquid human milk fortifier include hydrolyzed or
intact, naturally and/or chemically modified, starches sourced from
corn, tapioca, rice or potato, in waxy or non-waxy forms. Other
non-limiting examples of suitable carbohydrate sources include
hydrolyzed cornstarch, maltodextrin (i.e. non-sweet, nutritive
polysaccharide having a DE value less than 20), corn maltodextrin,
glucose polymers, sucrose, corn syrup, corn syrup solids (i.e.,
polysaccharide having a DE value greater than 20), glucose, rice
syrup, fructose, high fructose corn syrup, indigestible
oligosaccharides such as fructooligosaccharides (FOS), galactose,
glycerol and combinations thereof. The carbohydrates may comprise
lactose or can be substantially free of lactose.
[0089] The concentrated liquid human milk fortifier may include a
non-reducing carbohydrate component, which may represent from about
10% to 100%, including from about 80% to 100%, and also including
100%, by weight of the total carbohydrate in the concentrated
liquid human milk fortifier. The selection of a non-reducing
carbohydrate may enhance the product stability and is generally
better tolerated by infants, especially premature infants.
Non-limiting examples of non-reducing carbohydrates include sucrose
or other carbohydrates that do not readily oxidize or react with
Tollen's, Benedict's, or Fehling's reagents. The concentrated
liquid human milk fortifier may have a carbohydrate component,
wherein the carbohydrate component comprises a mono- and/or
disaccharide such that at least about 50%, including from about 80%
to 100%, and also including 100%, of the mono- and/or disaccharide
is a non-reducing carbohydrate.
[0090] Fat
[0091] The concentrated liquid human milk fortifier comprises a fat
component suitable for use with infants, especially preterm
infants, at concentrations most typically ranging up to about 40%
by weight on a dry weight basis, including from about 10% to about
40%, and also including from about 15% to about 37%, and also
including from about 18% to about 30%, by weight on a dry weight
basis. Fats suitable for use in the concentrated liquid human milk
fortifier include coconut oil, soy oil, corn oil, olive oil,
safflower oil, high oleic safflower oil, MCT oil (medium chain
triglycerides), sunflower oil, high oleic sunflower oil, structured
triglycerides, palm and palm kernel oils, palm olein, canola oil,
marine oils, cottonseed oils, and combinations thereof.
[0092] Suitable fats for use in the concentrated liquid human milk
fortifier include emulsifiers to help the various fortifier
components readily disperse when combined with human milk.
Non-limiting examples of suitable emulsifiers include soya bean
lecithin, or fractions there of, polyoxyethylene stearate, mono and
di-glycerides, and combinations there of, polyoxyethylene sorbitan
monopalmitate, polyoxyethylene sorbitan monostearate, ammonium
phosphatides, polyoxyethylene sorbitan monolaurate, citric acid
esters of mono and diglycerides of fatty acids, tartaric acid
esters of mono and diglycerides of fatty acids, and combinations
thereof. Natural soy lecithin is especially useful in this respect.
The fat component of the concentrated liquid human milk fortifier
may therefore optionally include any emulsifier suitable for use in
infant nutritional products. Emulsifier concentrations in these
products may range up to about 10%, including from about 1% to
about 10%, even more typically from about 1.5% to about 5%, by
weight of the total fat component.
[0093] The concentrated liquid human milk fortifier also include
embodiments that comprise as part of the fat component one or more
of arachidonic acid, docosahexaenoic acid, or combinations thereof,
alone or in further combination with linoleic acid, linolenic acid,
or both.
[0094] The weight ratio of fat to protein in the concentrated
liquid human milk fortifier is at least about 0.9, including from
about 1 to about 5, and also including from about 2 to about 4.
These ratios may be helpful in further stabilizing the concentrated
liquid human milk fortifier.
[0095] Vitamins and Minerals
[0096] The concentrated liquid human milk fortifier may further
comprise any of a variety of vitamins, non-limiting examples of
which include vitamin A, vitamin D, vitamin E, vitamin K, thiamine,
riboflavin, pyridoxine, vitamin B12, niacin, folic acid,
pantothenic acid, biotin, vitamin C, choline, inositol, salts and
derivatives thereof, and combinations thereof. The concentrated
liquid human milk fortifier includes embodiments comprising per 100
kcal of fortifier solids one or more of the following: vitamin A
(from about 250 to about 6500 IU), vitamin D (from about 40 to
about 1200 IU), vitamin K, vitamin E (at least about 0.3 IU),
vitamin C (at least about 8 mg), thiamine, vitamin B12, niacin,
folic acid, pantothenic acid, biotin, choline (at least about 7
mg), and inositol (at least about 2 mg).
[0097] The concentrated liquid human milk fortifiers may also
further comprise any of a variety of minerals known or otherwise
suitable for use in infant or other nutritional formulas,
non-limiting examples of which include phosphorus, magnesium,
calcium as described hereinbefore, zinc, manganese, copper, iodine,
sodium, potassium, chloride, selenium, chromium, and combinations
thereof. The concentrated liquid human milk fortifier also includes
embodiments comprising per 100 kcal of the fortifier solids one or
more of the following: calcium (at least about 50 mg), phosphorus
(at least about 25 mg), magnesium (at least about 6 mg), iodine,
zinc (at least about 0.5 mg), copper, manganese, sodium (from about
20 to about 60 mg), potassium (from about 80 to about 200 mg),
chloride (from about 55 to about 150 mg) and selenium (at least
about 0.5 mcg).
[0098] Other Optional Ingredients
[0099] The concentrated liquid human milk fortifier may further
optionally comprise other ingredients that may modify the physical,
chemical, aesthetic or processing characteristics of the formulas
or serve as pharmaceutical or additional nutritional components
when used in the targeted population. Many such optional
ingredients are known for use in food and nutritional products,
including infant formulas, and may also be used in the concentrated
liquid human milk fortifiers, provided that such optional materials
are compatible with the essential materials described herein, are
safe and effective for their intended use, and do not otherwise
unduly impair the performance of the concentrated liquid human milk
fortifier. Non-limiting examples of such optional ingredients
include preservatives, anti-oxidants, various pharmaceuticals,
buffers, carotenoids, colorants, flavors, nucleotides and
nucleosides, thickening agents, prebiotics, probiotics, sialic
acid-containing materials, and other excipients or processing
aids.
Examples
Examples 1-4
[0100] The ingredients for the concentrated liquid human milk
fortifiers of Examples 1-4 are shown in the following table.
TABLE-US-00004 Ingredient (Per 1000 Kg) Example 1 Example 2 Example
3 Example 4 Water Q.S. Q.S. Q.S. Q.S. Casein Hydrolysate 108 Kg 108
Kg 125 Kg 150 Kg Maltodextrin 104 Kg 104 Kg 104 Kg 104 Kg MCT Oil
17.3 Kg 17.3 Kg 17.3 Kg 17.3 Kg Tricalcium Phosphate 16.0 Kg 16.0
Kg 16.0 Kg 16.0 Kg Soy Oil 10.4 Kg 10.4 Kg 10.4 Kg 10.4 Kg
OSA-Modified 12.0 Kg 10.0 Kg 35.0 Kg 6.0 Kg Corn Starch Coconut Oil
6.3 Kg 6.3 Kg 6.3 Kg 6.3 Kg Potassium Citrate 6.9 Kg 6.9 Kg 6.9 Kg
6.9 Kg Ascorbic Acid 2.9 Kg 2.9 Kg 2.9 Kg 2.9 Kg Magnesium Chloride
4.0 Kg 4.0 Kg 4.0 Kg 4.0 Kg M. Alpina Oil (ARA) 2.6 Kg 2.6 Kg 2.6
Kg 2.6 Kg Leucine 1.8 Kg 1.8 Kg 1.8 Kg 1.8 Kg C. Cohnii Oil (DHA)
2.1 Kg 2.1 Kg 2.1 Kg 2.1 Kg Potassium Chloride 1.1 Kg 1.1 Kg 1.1 Kg
1.1 Kg Tyrosine 1.4 Kg 1.4 Kg 1.4 Kg 1.4 Kg Distilled
Monoglycerides 800 g 800 g 800 g 800 g Mixed Carotenoid 551 g 551 g
551 g 551 g Premix M-Inositol 529 g 529 g 529 g 529 g Sodium
Chloride 861 g 861 g 861 g 861 g L-Carnitine 221 g 221 g 221 g 221
g Tryptophan 331 g 331 g 331 g 331 g Zinc Sulfate 309 g 309 g 309 g
309 g Niacinamide 320 g 320 g 320 g 320 g dl-Alpha-Tocopheryl 364 g
364 g 364 g 364 g Acetate Gellan gum 200 g 300 g 400 g 600 g
Ferrous Sulfate 106 g 106 g 106 g 106 g Choline Chloride 353 g 353
g 353 g 353 g Calcium Pantothenate 132 g 132 g 132 g 132 g Vitamin
A Palmitate 77 g 77 g 77 g 77 g Riboflavin 33 g 33 g 33 g 33 g
Vitamin D3 13 g 13 g 13 g 13 g Copper Sulfate 18 g 18 g 18 g 18 g
Pyridoxine 20 g 20 g 20 g 20 g Hydrochloride Thiamin Hydrochloride
24 g 24 g 24 g 24 g Folic Acid 3.3 g 3.3 g 3.3 g 3.3 g Biotin 2.5 g
2.5 g 2.5 g 2.5 g Manganese Sulfate 1.8 g 1.8 g 1.8 g 1.8 g
Phylloquinone 880 mg 880 mg 880 mg 880 mg Sodium Selenate 90 mg 90
mg 90 mg 90 mg Cyanocobalamin 88 mg 88 mg 88 mg 88 mg Potassium
Hydroxide Q.S. Q.S. Q.S. Q.S.
[0101] The concentrated liquid human milk fortifier is prepared by
solubilizing and combining/mixing ingredients into a homogeneous
aqueous mixture which is subjected to a sufficient thermal
treatment and aseptic filling to achieve long term physical and
microbial shelf stability. The term "shelf stability" as used
herein means that the concentrated liquid human milk fortifier is
resistant to separation and precipitation for time period after
manufacture of at least three months, and preferably at least six
months.
[0102] To begin the manufacturing process, macronutrients
(carbohydrate, protein, fat, and minerals) are combined in several
slurries together and with water. This blend is subjected to an
initial heat treatment and then tested to verify proper nutrient
levels. An intermediate aqueous carbohydrate-mineral (CHO-MIN)
slurry is prepared by heating appropriate amount of water to
140-160.degree. F. With agitation, the following soluble
ingredients are added: maltodextrin, potassium citrate, magnesium
chloride, potassium chloride, sodium chloride, and choline
chloride. The carbohydrate-mineral slurry is held at
130-150.degree. F. under agitation until added to the blend.
[0103] An intermediate oil slurry is prepared by heating MCT oil
and coconut oil to 150 to 170.degree. C. and then adding distilled
monoglycerides with agitation for a minimum of 10 minutes in order
to the ingredient to dissolve. Soy oil, vitamin A palmitate,
vitamin D3, di-alpha-tocopheryl-acetate, phylloquinone,
ARA-containing oil, DHA-containing oil, and carotenoid premix are
then added with agitation to the oil blend. Insoluble mineral
calcium source, and ultra micronized tricalcium phosphate is added
to the oil. Gellan gum and OSA-modified starch are then added to
the oil blend with proper agitation. The oil blend slurry is
maintained at 130-150.degree. F. under agitation until added to the
blend.
[0104] The blend is prepared by combining the ingredient water,
casein hydrolysate, all of the CHO-MIN slurry and whole oil blend
slurry. The blend is maintained at 120.degree. F. for a period of
time not to exceed two hours before further processing.
[0105] The blend is then homogenized using one or more in-line
homogenizers at pressures from 1000-4000 psig with or without a
second stage homogenization from 100-500 psig followed by heat
treatment using a UHTST (ultra-high temperature short time,
292-297.degree. F. for 5-15 seconds) process. After the appropriate
heat treatment, the batch is cooled in a plate cooler to
33-45.degree. F. and then transferred to a refrigerated holding
tank, where it is subjected to analytical testing.
[0106] The next step in the manufacturing process involves adding
vitamins, trace minerals, other ingredients, and water in order to
reach the final target total solids and vitamin/mineral contents.
The final batch is filled into a suitable container under aseptic
conditions or treated with a terminal sterilization process so the
product will be stable at room temperature for an extended
shelf-life. Additional detail on this process is provided in the
following paragraphs.
[0107] A trace mineral/vitamin/nutrient solution (STD1) is prepared
by heating water to 80-100.degree. F. and adding the following
ingredients with agitation: potassium citrate, ferrous sulfate,
zinc sulfate, copper sulfate, manganese sulfate, sodium selenate,
pyridoxine hydrochloride, riboflavin, thiamine hydrochloride,
cyanocobalamin, folic acid, calcium pantothenate, niacinamide,
biotin, m-inositol, nucleotide/choline premix, L-carnitine,
L-Leucine, and L-tyrosine.
[0108] A vitamin C solution (STD2) is prepared by adding ascorbic
acid to a water solution with agitation.
[0109] All STD1 and STD2 solutions are then added to the
refrigerated batch, with agitation. The appropriate amount of
ingredient dilution water is then added to the batch to achieve a
target total solids level of 29.0-32.0%. The final batch is then
subjected to appropriate thermal treatment and filled into a
suitable container (e.g., pouches 10, 110, 120) under aseptic
packaging conditions and processes. The term "aseptic packaging" as
used herein, unless otherwise specified, refers to the manufacture
of a packaged product without reliance upon "retort packaging",
wherein the nutritional liquid and package are sterilized
separately prior to filling, and then are combined under sterilized
or aseptic processing conditions to form a sterilized, aseptically
packaged, nutritional liquid product. The term "retort packaging"
as used herein, and unless otherwise specified, refers to the
common practice of filling a container, most typically a metal can
or other similar package, with a nutritional liquid and then
subjecting the liquid-filled package to the necessary heat
sterilization step, to form a sterilized, retort packaged,
nutritional liquid product.
Example 5
[0110] In Example 5, four separate concentrated liquid human milk
fortifiers were prepared and the overall stability in terms of
amount of phase separation (emulsion stability), sediment at the
bottom of the container, and creaming at the top of the liquid, of
each was evaluated at 24 hours after manufacture. Each of the four
tested concentrated liquid human milk fortifiers was based on the
concentrated liquid human milk fortifier of Example 2 above.
[0111] The first concentrated liquid human milk fortifier was
identical to that of Example 2 except that it did not contain any
OSA-modified corn starch and did not contain any low acyl gellan
gum. The second fortifier was identical to that of Example 2 except
that it did not contain any low acyl gellan gum. The third
fortifier was identical to that of Example 2 except that it did not
contain any OSA-modified corn starch. The fourth fortifier was
identical to that of Example 2. Each of the four fortifiers was
prepared in accordance with the manufacturing process of Examples
1-4.
[0112] Upon evaluation, the first fortifier (no OSA-modified corn
starch and no low acyl gellan gum) showed nearly complete phase
separation of the oil and water phases, and showed both heavy
creaming at the top of the liquid and heavy sediment at the bottom
of the container. See FIG. 22.
[0113] Upon evaluation, the second fortifier (no low acyl gellan
gum) showed both heavy creaming at the top of the liquid and heavy
sediment at the bottom of the container. See FIG. 23.
[0114] Upon evaluation, the third fortifier (no OSA-modified corn
starch) showed nearly complete phase separation of the oil phase
and the water phase. See FIG. 24.
[0115] Upon evaluation, the fourth fortifier (containing both
OSA-modified corn starch and low acyl gellan gum) showed no phase
separation, no creaming, and no sediment. See FIG. 25. The
stabilizing system of a combination of OSA-modified corn starch and
low acyl gellan gum showed a synergistic interaction and allowed
for the manufacture of physically stable concentrated liquid human
milk fortifier containing extensively hydrolyzed casein and a high
level of insoluble calcium salts without causing defects in
emulsion stability and sediment fall out.
[0116] Gelled Human Milk Fortifier
[0117] Another suitable human milk fortifier suitable for packaging
in the pouches 10, 110, 210 is a gelled human milk fortifier. The
gelled human milk fortifier generally comprises protein, fat, and
carbohydrate in a stable, concentrated gel that is shear thinning
and stabilizer-free. The term "gelled human milk fortifier" as used
herein means a human milk fortifier that is in the form of a
colloid in which the dispersed phase has combined with the
dispersion medium to produce a semisolid material, such as a jelly,
pudding or yogurt. A "gelled human milk fortifier" has a viscosity
at room temperature of greater than 800, 900 or even 1000 cps as
measured using a Brookfield Viscometer (spindle 61, 60 rpm, after
10 seconds of rotation). The term "shear thinning" as used herein
means an effect where viscosity decreases with increasing rate of
shear stress.
[0118] Various embodiments of the gelled human milk fortifiers can
be substantially free of any optional or selected essential
ingredient or feature described herein, provided that the remaining
gelled human milk fortifier still contains all of the required
ingredients or features as described herein. In this context, and
unless otherwise specified, the term "substantially free" means
that the selected gelled human milk fortifier contains less than a
functional amount of the optional ingredient, typically less than
0.1% by weight, and also including zero percent by weight of such
optional or selected essential ingredient. The gelled human milk
fortifiers can comprise, consist of, or consist essentially of the
essential elements, as well as any additional or optional
ingredients, components, or limitations described herein or
otherwise useful in the gelled human milk fortifier.
[0119] Product Form
[0120] The gelled human milk fortifier is shear thinning such that
they can easily be converted from the gelled form to a liquid form
by shaking and/or kneading prior to being poured from the pouch 10,
110, 210. Generally, the gelled human milk fortifier has a
viscosity of greater than 1000 cps at room temperature as measured
using a Brookfield Viscometer Model DVII (spindle 61, 60 rpm, after
10 seconds rotation). The gelled human milk fortifier has a shaken
viscosity, as defined herein, of from about 20 cps to about 200
cps, or even from about 20 cps to about 150 cps, or even from about
20 cps to about 100 cps, or even from about 20 cps to about 80 cps,
or even from about 50 cps to about 95 cps. Generally, as the gelled
human milk fortifier ages, the shaken viscosity will increase
slightly.
[0121] The gelled human milk fortifier has a gel strength, as
defined herein, of from about 25 grams to about 200 grams, or even
from about 50 grams to about 200 grams, or even from about 75 grams
to about 150 grams. The gelled human milk fortifier has a shaken
gel strength of less than 10, or even less than 5 or even zero. In
one suitable embodiment, the shaken gel strength is zero.
[0122] The gelled human milk fortifiers can be stabilizer free.
That is, they may be formulated to not include any stabilization
agent for keeping precipitation and/or settling from occurring in
the fortifier. By formulating the gelled human milk fortifier to be
stabilizer free, it becomes more acceptable worldwide.
Specifically, the gelled human milk fortifier can be formulated to
be carrageenan-free.
[0123] The gelled human milk fortifier is generally formulated to
have a caloric density of at least about 1.25 kcal/ml (37 kcal/fl
oz), including from about 1.4 kcal/ml (42 kcal/fl oz) to about 5
kcal/ml (149 kcal/fl oz), and also including from about 1.5 kcal/ml
(44 kcal/fl oz) to about 2.5 kcal/ml (74 kcal/fl oz), and also
including from about 1.9 kcal/ml (56 kcal/fl oz) to about 2.0
kcal/ml (59 kcal/fl oz). The gelled human milk fortifier is
preferably formulated to provide fortified human milk having an
osmolality of less than about 400 mOsm/kg water, preferably from
about 300 mOsm/kg water to about 400 mOsm/kg water.
[0124] Macronutrients
[0125] The gelled human milk fortifiers of the present disclosure
comprise carbohydrate, fat, and protein macronutrients of
sufficient types and amounts, that when used in combination with
human milk or other infant feeding formula, they help meet the
nutritional needs of the infant, especially the premature infant.
The concentration of these macronutrients in the various
embodiments of the present disclosure includes the ranges described
hereinafter.
[0126] Protein
[0127] The gelled human milk fortifier comprises a protein suitable
for use with infants, especially preterm infants, at concentrations
ranging from about 10% to about 30%, including from about 10% to
about 25%, and also including from about 15% to about 25%, on a dry
weight basis. In some embodiments, the protein may be at a
concentration of less than 10%.
[0128] In one suitable embodiment, the gelled human milk fortifier
is prepared by aseptic processing, which comprise the requisite
protein concentrations with a specific blend of casein and whey
protein. The blend includes from about 40% to about 80% by weight
of whey protein, including from about 50% to about 70% by weight
whey protein, including from about 55% to about 70% by weight whey
protein, and including from about 60% to about 70% by weight whey
protein, in combination with from about 20% to about 60% by weight
of casein protein, including from about 30% to about 50% by weight
of casein protein, including from about 20% to about 50% by weight
casein protein, including from about 20% to about 45% by weight
casein protein, including from about 20% to about 40% by weight
casein protein, including from about 20% to about 30% casein
protein. It has been found that these particular blends of whey
protein and casein protein provide for a suitable gelled human milk
fortifier that can be prepared by aseptic processing.
[0129] In some embodiments, in addition to the whey protein and
casein protein outlined above, the gelled human milk fortifier may
contain additional protein. Suitable additional protein may include
soy protein hydrolysate, casein protein hydrolysate, whey protein
hydrolysate, rice protein hydrolysate, potato protein hydrolysate,
fish protein hydrolysate, egg albumen hydrolysate, gelatin protein
hydrolysate, combinations of animal and vegetable protein
hydrolysates, and combinations thereof.
[0130] Proteins suitable for use in the gelled human milk fortifier
may include intact or hydrolyzed proteins, free amino acids, or
combinations thereof. Non-limiting examples of suitable proteins
include hydrolyzed, partially hydrolyzed or non-hydrolyzed protein,
and can be derived from any known or otherwise suitable source such
as milk (e.g., casein, whey, lactose-free milk protein isolates),
animal (e.g., meat, fish), cereal (e.g., rice, corn), vegetable
(e.g., soy), or combinations thereof. The protein can include, or
be entirely or partially replaced by, free amino acids known or
otherwise suitable for use in nutritional products, non-limiting
examples include L-alanine, L-arginine, L-asparagine, L-aspartic
acid, L-carnitine, L-cystine, L-glutamic acid, L-glutamine,
glycine, L-histidine, L-isoleucine, L-leucine, L-lysine,
L-methionine, L-phenylalanine, L-proline, L-serine, L-taurine,
L-threonine, L-tryptophan, L-tyrosine, L-valine, and combinations
thereof.
[0131] Carbohydrate
[0132] The gelled human milk fortifiers comprises a carbohydrate
suitable for use with infants, especially preterm infants, at
concentrations most typically ranging up to about 75% by weight on
a dry weight basis, including from about 10% to about 50%, and also
including from about 20% to about 40%, by weight on a dry weight
basis. Carbohydrates suitable for use in the gelled human milk
fortifiers include hydrolyzed or intact, naturally and/or
chemically modified, starches sourced from corn, tapioca, rice or
potato, in waxy or non-waxy forms. Other non-limiting examples of
suitable carbohydrate sources include hydrolyzed cornstarch,
maltodextrin (i.e. non-sweet, nutritive polysaccharide having a DE
value less than 20), corn maltodextrin, glucose polymers, sucrose,
corn syrup, corn syrup solids (i.e., polysaccharide having a DE
value greater than 20), glucose, rice syrup, fructose, high
fructose corn syrup, indigestible oligosaccharides such as
fructooligosaccharides (FOS), and combinations thereof. The
carbohydrates may comprise lactose or can be substantially free of
lactose.
[0133] One embodiment of the gelled human milk fortifier includes a
non-reducing carbohydrate component, which may represent from about
10% to 100%, including from about 80% to 100%, and also including
100%, by weight of the total carbohydrate. The selection of a
non-reducing carbohydrate may enhance the product stability and is
generally better tolerated by infants, especially premature
infants. Non-limiting examples of non-reducing carbohydrates
include sucrose or other carbohydrates that do not readily oxidize
or react with Tollen's, Benedict's, or Fehling's reagents. The
gelled human milk fortifier therefore includes embodiments
comprising a carbohydrate component, wherein the carbohydrate
component comprises a mono- and/or disaccharide such that at least
about 50%, including from about 80% to 100%, and also including
100%, of the mono- and/or disaccharide is a non-reducing
carbohydrate.
[0134] Fat
[0135] The gelled human milk fortifiers also comprises a fat
component suitable for use with infants, especially preterm
infants, at concentrations most typically ranging up to about 40%
by weight on a dry weight basis, including from about 10% to about
40%, and also including from about 15% to about 37%, and also
including from about 18% to about 30%, by weight on a dry weight
basis. Fats suitable for use in the gelled human milk fortifier may
include coconut oil, soy oil, corn oil, olive oil, safflower oil,
high oleic safflower oil, MCT oil (medium chain triglycerides),
sunflower oil, high oleic sunflower oil, structured triglycerides,
palm and palm kernel oils, palm olein, canola oil, marine oils,
cottonseed oils, and combinations thereof.
[0136] Suitable fats for use in the gelled human milk fortifier
include emulsifiers to help the various fortifier components
readily disperse when combined with human milk. Non-limiting
examples of suitable emulsifiers include soya bean lecithin,
polyoxythylene stearate, polyoxyethylene sorbitan mono-oleate,
polyoxyethylene sorbitan monopalmitate, polyoxyethylene sorbitan
monostearate, ammonium phosphatides, polyoxyethylene sorbitan
monolaurate, citric acid esters of mono and diglycerides of fatty
acids, tartaric acid esters of mono and diglycerides of fatty
acids, and combinations thereof. Natural soy lecithin is especially
useful in this respect. The fat component of the gelled human milk
fortifier may therefore optionally include any emulsifier suitable
for use in infant nutritional products. Emulsifier concentrations
in these products may range up to about 10%, including from about
1% to about 10%, even more typically from about 1.5% to about 5%,
by weight of the total fat component. The weight ratio of fat to
protein (fat:protein, by weight) in the human milk fortifier is at
least about 0.9, including from about 1 to about 5, and also
including from about 2 to about 4. These ratios may be helpful in
further stabilizing the gelled human milk fortifier.
[0137] The gelled human milk fortifier also include embodiments
that comprise, as part of the fat component, one or more of
arachidonic acid, docosahexaenoic acid, or combinations thereof,
alone or in further combination with linoleic acid, linolenic acid,
or both.
[0138] Vitamins and Minerals
[0139] The gelled human milk fortifier may further comprise any of
a variety of vitamins, non-limiting examples of which include
vitamin A, vitamin D, vitamin E, vitamin K, thiamine, riboflavin,
pyridoxine, vitamin B12, niacin, folic acid, pantothenic acid,
biotin, vitamin C, choline, inositol, salts and derivatives
thereof, and combinations thereof. The gelled human milk fortifier
includes embodiments comprising per 100 kcal of fortifier solids
one or more of the following: vitamin A (from about 250 to about
750 IU), vitamin D (from about 40 to about 100 IU), vitamin K,
vitamin E (at least about 0.3 IU), vitamin C (at least about 8 mg),
thiamine, vitamin B12, niacin, folic acid, pantothenic acid,
biotin, choline (at least about 7 mg), and inositol (at least about
2 mg).
[0140] The gelled human milk fortifier may also further comprise
any of a variety of minerals known or otherwise suitable for use in
infant or other nutritional formulas, non-limiting examples of
which include phosphorus, magnesium, calcium as described
hereinbefore, zinc, manganese, copper, iodine, sodium, potassium,
chloride, selenium, and combinations thereof. The gelled human milk
fortifier also include embodiments comprising per 100 kcal of the
fortifier solids one or more of the following: calcium (at least
about 50 mg), phosphorus (at least about 25 mg), magnesium (at
least about 6 mg), iodine, zinc (at least about 0.5 mg), copper,
manganese, sodium (from about 20 to about 60 mg), potassium (from
about 80 to about 200 mg), chloride (from about 55 to about 150 mg)
and selenium (at least about 0.5 mcg).
[0141] Other Optional Ingredients
[0142] The gelled human milk fortifier may further optionally
comprise other ingredients that may modify the physical, chemical,
aesthetic or processing characteristics of the formulas or serve as
pharmaceutical or additional nutritional components when used in
the targeted population. Many such optional ingredients are known
for use in food and nutritional products, including infant
formulas, and may also be used in the gelled human milk fortifiers
of the present disclosure, provided that such optional materials
are compatible with the essential materials described herein, are
safe and effective for their intended use, and do not otherwise
unduly impair product performance. Non-limiting examples of such
optional ingredients include preservatives, anti-oxidants, various
pharmaceuticals, buffers, carotenoids, colorants, flavors,
nucleotides and nucleosides, thickening agents, prebiotics,
probiotics, sialic acid-containing materials, and other excipients
or processing aids.
EXAMPLES
[0143] The following examples illustrate specific embodiments
and/or features of the gelled human milk fortifier. The examples
are given solely for the purpose of illustration as many variations
thereof are possible. All exemplified amounts are weight
percentages based upon the total weight of the formulation, unless
otherwise specified.
Example 1
[0144] In this Example, a gelled human milk fortifier is prepared
with the ingredients shown in the following table.
TABLE-US-00005 Qty. per Ingredients 32000 lb Water Q.S. Condensed
Skim Milk 5250 Kg Non-Fat Milk Solids 1365 Kg Corn Maltodextrin
1450 Kg Corn Syrup Solids 1388 Kg Medium Chain triglycerides 694 Kg
Whey Protein Concentrate 634 Kg Calcium Phosphate 271 Kg Ascorbic
Acid 152 Kg Magnesium Chloride 38.0 Kg Potassium Citrate 12.2 Kg
Sodium Chloride 12.1 Kg Soy Lecithin 8.84 Kg M-Inositol 7.98 Kg
Magnesium Phosphate 5.55 Kg M. Alpina Oil 5.35 Kg Niacinamide 4.35
Kg Alpha-Tocopheryl Acetate 4.21 Kg Zinc Sulfate 3.51 Kg C. Cohnii
Oil 3.45 Kg Choline Chloride 2.90 Kg Calcium Pantothenate 1.89 Kg
Potassium Phosphate 1.62 Kg Ferrous Sulfate 1.64 Kg Vitamin A
Palmitate 900 g Cupric Sulfate 678 g Riboflavin 572 g Thiamine
Hydrochloride 373 g Pyridoxine Hydrochloride 232 g Vitamin D3 152 g
Folic Acid 47.9 g Biotin 34.1 g Manganese Sulfate 23.2 g
Phylloquinone 11.6 g Cyanocobalamin 1.60 g Sodium Selenate 0.798 g
Calcium Carbonate as needed Sodium Citrate as needed Potassium
Hydroxide as needed
[0145] The gelled human milk fortifier is prepared by solubilizing
and combining ingredients into a homogeneous aqueous mixture which
is subjected to an adequate heat treatment to achieve long term
shelf stability. To begin the manufacturing process, the
ingredients that supply the macronutrients (carbohydrate, protein,
fat and minerals) are combined in multiple slurries together and
with water. This blend is subjected to an initial heat treatment
and then tested to verify proper nutrient levels. Additional detail
on this process is provided in the following paragraphs.
[0146] An intermediate aqueous carbohydrate-mineral slurry is
prepared by heating water to 60-66.degree. C. With agitation, the
following soluble minerals are added: magnesium chloride, potassium
citrate, sodium chloride, monopotassium phosphate and magnesium
phosphate. Once fully dissolved, corn maltodextrin and corn syrup
solids are added to the mineral solution. The carbohydrate-mineral
slurry is held at 54.degree. C. under low agitation until added to
the blend.
[0147] An intermediate oil and protein slurry is prepared by
heating MCT oil to 32-43.degree. C. and then adding DHA oil and AA
oil, with agitation. A soy lecithin emulsifier (8.84 kg) is added
with agitation to the heated oils and allowed to dissolve. Vitamin
A, vitamin D, and vitamin K, and natural vitamin E are then added
with agitation to the oil blend. Whey protein concentrate and
tricalcium phosphate are added to the oil. The oil and protein
slurry is maintained at 38.degree. C. under low agitation until
added to the blend.
[0148] An intermediate aqueous protein slurry is prepared by
heating ingredient water to 49-54.degree. C., and then adding whey
protein concentrate with moderate agitation. The aqueous protein
slurry is held at 52.degree. C. under low agitation until added to
the blend.
[0149] The blend is prepared by combining the carbohydrate-mineral
slurry with condensed skim milk and non-fat milk solids and then
adding the oil and protein slurry and the aqueous protein slurry.
After no less than five minutes, the blend pH is adjusted to
6.8-7.0 using a 1N KOH solution, and thereafter maintained at
52-60.degree. C., for a period of time not to exceed two hours
before further processing.
[0150] The pH adjusted blend is then homogenized using one or more
in-line homogenizers at pressures from 1000-4000 psig with or
without a second stage homogenization from 100-500 psig followed by
heat treatment using a HTST (high temperature short time,
74.degree. C. for 16 seconds). After the appropriate heat
treatment, the batch is cooled in a plate cooler to 1.0-5.0.degree.
C. and then transferred to a refrigerated holding tank, where it is
subjected to analytical testing.
[0151] The next step in the manufacturing process involves adding
vitamins, trace minerals and water to the target total solids. The
final batch is sterilized and filled into a suitable container
under aseptic conditions or treated with a terminal sterilization
process so the product will be stable at room temperature for an
extended shelf life. Additional detail on this process is provided
in the following paragraphs.
[0152] A trace mineral solution is prepared by heating water to
27-38.degree. C. and adding the following minerals with agitation:
potassium citrate, ferrous sulfate, zinc sulfate, cupric sulfate,
manganese sulfate, sodium selenate.
[0153] A water-soluble vitamin solution is prepared by heating
water to 27-38.degree. C. The following vitamins are added to the
water with agitation: choline chloride, niacinamide, riboflavin,
calcium pantothenate, pyridoxine hydrochloride, thiamine
hydrochloride, m-inositol, biotin, folic acid, and
cyanocobalamin.
[0154] A vitamin C solution is prepared by adding ascorbic acid to
1N KOH solution with agitation.
[0155] All three vitamin or mineral solutions are then added to the
refrigerated batch, with agitation. The appropriate amount of
ingredient dilution water is then added to the batch to achieve a
target total solids level of 32%, and the pH is adjusted to 7.0
with a 1N KOH solution.
Example 2
[0156] In this Example, the unshaken viscosity, shaken viscosity,
unshaken get strength and shaken gel strength of the human milk
fortifier prepared in Example 1 is tested at a sample aged three
months and a sample aged six months.
[0157] The viscosities were measured using a Brookfield Viscometer
Model DV11+ (spindle 61, 60 rpm, after 10 second of rotation). The
gel strengths were measure using a Stable Micro Systems TA.XT plus
Texture Analyzer (1 inch ball probe, 20 mm depth). For the shaken
samples, each sample was shaken vigorously by hand for five seconds
prior to testing.
[0158] The results of the viscosity measurements and gel strengths
are shown in the following Table.
TABLE-US-00006 Sample A Sample B (aged 3 months) (aged 6 months)
Unshaken Shaken Unshaken Shaken Viscosity >1000 cps 56 cps
>1000 cps 95 cps Gel Strength 78 g 0 g 133 g 0 g
[0159] As can be seen from the data in the Table, the unshaken
viscosities for both samples are greater than 1000 cps, while the
viscosities of both shaken samples are substantially less (56 cps
for 3 months and 95 cps for 6 months). This indicates that in
unshaken form, a gel is present whereas after shear is applied (by
shaking) the gel easily breaks for forms a liquid of relatively low
viscosity that could easily be poured from one of the pouches 10,
110, 210.
[0160] Additionally as can be seen from the data in the Table, the
unshaken gel strength for both samples is relatively high (78 grams
at 3 months and 133 grams at 6 months), while the gel strengths
after shaking for both samples is zero grams. This indicates that
after shaking, the gel has transformed into a liquid that could
easily be poured from one of the pouches 10, 110, 210.
Dose Pouches
[0161] The concentrated liquid human milk fortifier and the gel
human milk fortifier can be packaged in suitable unit dose pouches
(e.g., pouches 10, 110, 210). The term "unit dose" as used herein
refers to individual, single-use, pouches of concentrated human
milk fortifier containing a predetermined amount of human milk
fortifier that can be used in a preparation of a predetermined
amount of human milk. The unit dose pouches 10, 110, 210 are single
use containers that alone, or in combination with other unit dose
pouches, provide sufficient human milk fortifier to supplement
human milk for immediate use, e.g., preferably within 8-24 hours,
more preferably within 0-3 hours, of mixing with human milk.
[0162] The amount or volume of concentrated liquid human milk
fortifier or gel human milk fortifier in each unit dose pouch 10,
110, 210 includes those embodiments in which the package contains
an amount suitable to prepare an infant's feeding. In one suitable
embodiment, the unit dose pouches 10, 110, 210 typically contain
sufficient fortifier to provide from about 0.5 g to about 10 g of
fortifier solids, more typically from about 0.8 g to about 5.0 g of
fortifier solids, and even more typically from about 0.85 g to
about 2.0 g, of fortifier solids. The terms "fortifier solids" or
"total solids", unless otherwise specified, are used
interchangeably herein and refer to all material components of the
compositions of the present disclosure, less water.
[0163] The amount of fortified human milk prepared for a premature
infant, for example, typically ranges from 25 ml to 150 ml a day.
Consequently, in one suitable embodiment, a single unit dose is the
appropriate amount of fortifier solids to fortify a 25 ml
preparation. Multiple pouches 10, 110, 210 can be used to prepare
larger feeding volumes, especially for term infants.
[0164] Aseptic Packaging
[0165] The concentrated liquid human milk fortifier and the gel
human milk fortifier can be sterilized and aseptically packaged
into the pouches 10, 110, 210. The aseptic packaging can be
accomplished using any of a variety of techniques well known to
those of ordinary skill in the formulation art, so long as the
technique is sufficient to achieve long term shelf stability of the
fortifier. FIG. 10 is a flow diagram of one suitable process for
manufacturing a plurality of aseptically sterilized pouches 10,
110, 210 suitable for containing the concentrated liquid human milk
fortifier, the gel human milk fortifier, or any other suitable
aseptic product. While the following description of the aseptic
packaging process is provided with respect to the pouch 10
illustrated in FIGS. 1-6, it is understood that the pouches 110,
210 of FIGS. 8 and 9 can be processed in substantially the same
manner.
[0166] In this embodiment, a web of plastic sheeting (e.g., the two
layered laminate illustrated in FIG. 7A) is fed from a suitable web
feeding device 80 (e.g., unwound from a roll) to a web alignment
device 82 as indicated in the flow chart in FIG. 10. In one
suitable embodiment, the web has a width sufficient to make four
pairs of pouches 10 in side-by-side relationship (FIG. 11A-C). It
is understood, however, that the width of the web can be sufficient
to make more or fewer pairs of pouches 10 in side-by-side
relationship. From the web alignment device 82 and as indicated in
FIG. 10, the web is directed to a coding station 84 wherein the web
is laser coded (or otherwise printed) with indicia, e.g., batch
number, expiration date, current time and date. It is contemplated
that other indicia can be printed on the pouch 10 including, for
example, the manufacturer's name, the trade name of the product,
the generic name of the product, direction of use, nutritional
information of the product, and/or quantity of the product. The web
is then fed to a laser scoring station 86 wherein the web is scored
along three longitudinal lines (FIGS. 10 and 11A) to delineate the
four separate pairs of pouches.
[0167] The web next enters a sterilization station 88 wherein the
web passes through a peroxide bath, thereby sterilizing the entire
web, as both sides of the web are brought into direct contact with
a peroxide solution. It is contemplated that other sterilants
(e.g., oxonia) or forms of sterilization (e.g., UV light, electron
beam) can be used. Once the web has passed through the peroxide
bath, the web is dried by blowing sterile air thereon at a drying
station 90. While still in a sterile environment, the web is
directed to a web separation station 92 and a web folding station
94. More specifically, the web is separated into four lanes at the
web separation station 92 as it is pulled across respective forming
collars. Each of the four lanes is defined by segments of the web.
Each of the web segments are folded by the respective forming
collar. Thus, in the described embodiment, the four forming collars
both separate the web into segments and fold the segments. In other
words, the four forming collars collectively define both the web
separation station 92 and the web folding station 94. It is
understood, however, that the web separation station 92 and the web
folding station 94 can be separate, discrete stations. It is also
understood that the forming collars can be any suitable device(s)
capable of dividing the web into a plurality of web segments and
folding each of the web segments.
[0168] As illustrated in FIG. 11B, the respective forming collar
folds each of the side edges of the respective web segment inward
(i.e., in the direction of the arrows of FIG. 11B) toward the
longitudinal center line of the web segment at the folding station
94. As seen in FIG. 11B, each of the web segments are folded about
a fill pipe. After the web segment is folded longitudinally, each
of the web segments are longitudinally heat sealed at a
longitudinal seal station 96 wherein the overlying portion of the
web segment is bonded to the underlying portion of the web segment
along each of the side edges to form the side edge segments 25c of
the seal lines 25.
[0169] Next, each of the web segments is perforated along a
longitudinal perforation line located between the tubes of each of
the web segments at a longitudinal perforation station 97 (FIGS. 10
and 11B). Once each of the web segments move past a fill nozzle
disposed on the respective fill pipe, the web segments are directed
to a horizontal sealing station 99 wherein each of the web segments
are heat sealed to sealingly bond the overlying portion to the
underlying portion of the blank to form one of the end segments 25a
and the inboard seal segment 25d of the seal lines 25. As seen in
FIG. 11C, two pouches 10, which are separated by the perforated
center line, are formed from each of the web segments and the
respective fill nozzle is disposed within the interior space of the
pouch. The pouches 10 are then filled at a filling station 98
wherein both of the pouches of each of the four web segments are
filled with a predetermined amount of sterilized product. Next,
each of the pouches 10 is moved past the respective fill nozzle and
is heat sealed shut, which forms the other end segment 25b of the
seal lines 25, at the horizontal sealing station 99. The lines of
weakness 30, 32 for each of the pouches 10 are formed at a tear
notch and cutting station 302.
[0170] After the pouches 10 are filled with product and sealed,
they are transferred to weight and leak inspection stations 304
wherein each of the pouches 10 are weighed and checked for leakage.
Pouches 10 that pass inspection are incubated at an incubation
station 305 and tested for spoilage at a spoilage inspection
station 306. Then, pouches are packaged in pluralities into
suitable secondary packaging, e.g., opaque cardboard box 500, 500'
as illustrated in FIGS. 12, 16A and 16B at a secondary packaging
station 307. FIGS. 12,16A and 16B illustrate different embodiments
of suitable secondary packaging 500, 500' for the pouches 10.
Pouches 10 that fail inspection are discarded.
[0171] When the product is a liquid human milk fortifier (e.g., the
concentrated liquid human milk fortifier or the gelled human milk
fortifier described above), the product can be sterilized by heat
treatment via a high temperature short time (HTST) process or an
ultra high temperature (UHT) process to sufficiently reduce the
bioburden before the pouches 10 are filled. The above described
packaging process of a sterile product, allows some products (e.g.,
some embodiments of the concentrated liquid human milk fortifier
and the gelled human milk fortifier described above) to maintain
commercially sterility over an extended shelf-life without the need
for refrigeration even if the product is low acid (i.e., has a pH
greater than 4.6) and has water activity greater than 0.85.
[0172] In one embodiment, the liquid human milk fortifier is
photosensitive. That is, the vitamins in liquid human milk
fortifier will degrade more slowly when not exposed to light, and
conversely, will degrade more rapidly when exposed to light. When
the liquid human milk fortifier is photosensitive, the opaque
cardboard box 500 inhibits the pouches 10 container therein from
being exposed to light and thereby extends the shelf life of the
liquid human milk fortifier.
Leak Detection Inspection System
[0173] In one suitable inspection station 304, each of the pouches
10 are transferred through an in-line checkweigher were it is
weighed. Any pouch 10 having a weight outside an acceptable weight
range is rejected. The pouches 10 that pass the inline checkweigher
are aligned and conveyed into a high voltage leak detection (HVLD)
inspection system. In this system, the seal integrity of each of
the pouches 10 is non-destructively inspected by applying high
voltage to the sealed liquid-filled pouch. The system is designed
to conduct electric current through the pouch 10 and measure the
amount of current that passes through the pouch. A pouch 10 with a
leak (i.e., a faulty seal) will transfer more current to a ground
electric than a pouch having a seal with good integrity. The seals
of the pouch 10 act as an insulator to the liquid inside. Any pouch
10 that does not pass inspection (i.e., has a current above an
acceptable range) is automatically rejected.
[0174] More specifically, once the pouches 10 enter the high
voltage leak detection inspection system, they pass to a press that
applies a compression force to each of the pouches. The compression
force pushes liquid into any weak areas of the pouch body and/or
pouch seal. While compressed, each of the pouches 10 is conveyed
past a series of rollers and metal electrode brushes in the
inspection station wherein high voltage power is applied the
pouches. In one suitable configuration, the voltage is transferred
from an upper electrode positioned above the pouch through the
pouch 10 to ground electrode positioned beneath the pouch. In other
words, the pouch 10 completes the circuit between the upper
electrode and the ground electrode, which provides a measurable
volume of electric current through the pouch.
[0175] A pouch 10 with good seal integrity will provide a lower
voltage output as compared to a pouch with poor seal integrity,
which provides a higher voltage output. Thus, the high voltage leak
detection inspection machine determined if each of the pouches 10
is "good" or "bad" based on the measured voltage relative to a
voltage threshold, which is a pre-determined set point. If the
measured voltage is below the threshold, the pouch will be
transferred to an outfeed conveyor for subsequent secondary
packaging. If the measured voltage is above the threshold, the
pouch 10 will be transferred to a reject bin.
Secondary Container
[0176] In one suitable embodiment, the cardboard box 500 (broadly,
the secondary container) includes a generally rectangular base
section 502 and a lid 501 hingely attached to the base (FIGS. 12
and 17-21). The base section 502 and lid 501 are indicated
generally by their respective reference numbers. The base section
502 includes a bottom wall 504, four side walls 506 extending up
from the bottom wall, and a top wall 508. As seen in FIG. 21, the
top wall 508 of the base section 502 extends along only a portion
of a length of the box 500. For example, in the illustrated
embodiment, the box 500 has a length L of about 12 cm and the top
wall 508 has a length L' of 2.5 cm. It is understood that the box
500 and top wall 508 can have different lengths. It is also
understood that the ratio between the length of the box 500 and the
length of the top wall 508 can be different. It is further
understood that the box 500 can be shaped other than rectangular
and be constructed from other suitable materials (e.g.,
plastic).
[0177] The lid 501, which is formed integrally with the base
section 502, has an upper wall 510 and a pair of tapered sidewalls
503 extending downward from the upper wall. An end wall 505 extends
downward from the upper wall 510 and between the sidewalls 503. The
lid 501 is pivotally about a living hinge 507 between a closed
position (FIGS. 17-19) and an opened position (FIGS. 12, 20 and
21). The living hinge 507 is located between the top wall 508 of
the base section 502 and the upper wall 510 of the lid 501. In one
suitable embodiment, the weight of the lid 501 is sufficient to
bias the lid about the living hinge toward to the closed position.
The end wall 505 of the lid 501 includes a tab 511 adapted for
insertion into a slot 513 in one of the side walls (i.e., a front
wall) of the box 500 for holding the lid 501 in the closed
position. The tab 511 can be seen inserted into the slot 513 in
FIG. 17. It is understood that the lid 501 can be hingely attached
to the base section 502 in other suitable manners besides the
illustrated living hinge 507. It is further understood that the lid
501 can be formed separate from the base section 502 and attached
thereto.
[0178] A pair of hold-downs 509 are located adjacent the ends of
the living hinge 507 to provide rigidity and support to the box 500
about the living hinge. In the illustrated embodiment, each of the
hold-downs 509 are flaps that extend outward from the top wall of
the base section 502. Each of the flaps are folded about a pair of
fold-lines and inserted into an associated slot in one of the
sidewalls of the base section (FIG. 21). One of the fold-lines is
adjacent the top wall 508 of the base section 502 and the other is
adjacent the slot in the respective sidewall. Each of the flaps
includes a head portion (not shown) to inhibit the flap from being
pulled (or otherwise withdrawn) from the associated slot.
[0179] As seen in FIGS. 12 and 20, an interior floor 521 of the box
500 is tented or peaked along its center line 533. That is, the
interior floor 521 is highest at its center and slopes downward
toward each of its sides. In one suitable embodiment, the interior
floor 521 of the box 500 is defined by an insert that is formed
separate from the other components of the box and rest on top of
the bottom wall of the base section. It is, understood, however,
that the interior floor 521 can be formed integrally with another
component of the box 500, such as, the bottom wall of the base
section.
Method of Use
[0180] In use, a user removes a pair of the joined pouches 10 from
the cardboard box 500 of FIG. 12 (or the cardboard box 500' of
FIGS. 16A and 16B) and separates them by tearing along the
perforated center line that divides the two, joined pouches. Once
the pouches 10 are separated, the user inspects the contents of one
of the pouches through the transparent front and back panels to
determine if the product has separated or spoiled. If the product
has separated (or mixing is otherwise desired), the user can
manually knead (or otherwise manipulate) the product within the
pouch 10 as described above to thoroughly mix the product insitu.
Once the user observes that the product is thoroughly mixed, the
user manually grips the pouch 10 by its grip portion 66 and tears
the grip portion along the lines of weakness 30, 32 to completely
remove the grip portion from the pouch 10. In doing so, the user
opens the pouch 10 by tearing through the spout 62 to form the
spout opening 63 (FIGS. 6 and 15).
[0181] The product can be poured or squeezed from the pouch 10. In
one embodiment, the product is a consumable product that can be
consumed directly from the pouch 10. In another embodiment, the
product is a consumable product intended to be mixed with another
product. For example, if the product is a human milk fortifier
(e.g., the concentrated liquid human milk fortifier or the gelled
human milk fortifier described above), the human milk fortifier can
be dispensed directly into a container (e.g., infant bottle B)
containing human milk M (or other suitable infant formula) as
illustrated in FIG. 13. In such an embodiment, the resulting
fortified human milk or fortified infant formula is suitable for
oral feeding to an infant, including a premature infant.
General
[0182] All percentages, parts and ratios as used herein, are by
weight of the total composition, unless otherwise specified. All
such weights as they pertain to listed ingredients are based on the
active level and, therefore, do not include solvents or by-products
that may be included in commercially available materials, unless
otherwise specified.
[0183] Numerical ranges as used herein are intended to include
every number and subset of numbers within that range, whether
specifically disclosed or not. Further, these numerical ranges
should be construed as providing support for a claim directed to
any number or subset of numbers in that range. For example, a
disclosure of from 1 to 10 should be construed as supporting a
range of from 2 to 8, from 3 to 7, from 5 to 6, from 1 to 9, from
3.6 to 4.6, from 3.5 to 9.9, and so forth.
[0184] All references to singular characteristics or limitations of
the present disclosure shall include the corresponding plural
characteristic or limitation, and vice versa, unless otherwise
specified or clearly implied to the contrary by the context in
which the reference is made.
[0185] All combinations of method or process steps as used herein
can be performed in any order, unless otherwise specified or
clearly implied to the contrary by the context in which the
referenced combination is made.
[0186] When introducing elements of the present invention or the
preferred embodiment(s) thereof, the articles "a", "an", "the" and
"said" are intended to mean that there are one or more of the
elements. The terms "comprising", "including" and "having" are
intended to be inclusive and mean that there may be additional
elements other than the listed elements.
[0187] As various changes could be made in the above constructions
without departing from the scope of the invention, it is intended
that all matter contained in the above description or shown in the
accompanying drawings shall be interpreted as illustrative and not
in a limiting sense.
* * * * *