U.S. patent application number 12/772649 was filed with the patent office on 2011-11-03 for mixing cap and container system for improved delivery of perishable liquid mixtures.
Invention is credited to Brooke LIGON.
Application Number | 20110266170 12/772649 |
Document ID | / |
Family ID | 44857420 |
Filed Date | 2011-11-03 |
United States Patent
Application |
20110266170 |
Kind Code |
A1 |
LIGON; Brooke |
November 3, 2011 |
MIXING CAP AND CONTAINER SYSTEM FOR IMPROVED DELIVERY OF PERISHABLE
LIQUID MIXTURES
Abstract
System and compositions for preparing and delivering perishable
liquid mixtures comprising at least one active ingredient. The
system comprises vessels having novel barriers for segregating
solvent liquids from active ingredients prior to preparation. Novel
liquid mixtures having therapeutic properties are also
disclosed.
Inventors: |
LIGON; Brooke; (US) |
Family ID: |
44857420 |
Appl. No.: |
12/772649 |
Filed: |
May 3, 2010 |
Current U.S.
Class: |
206/219 |
Current CPC
Class: |
B65D 81/3211 20130101;
B65D 51/2807 20130101 |
Class at
Publication: |
206/219 |
International
Class: |
B65D 25/00 20060101
B65D025/00 |
Claims
1. A system for preparing and dispensing perishable liquids
comprising: a vessel having a container portion fitted with a
removable cap, said container suitably adapted to contain a solvent
liquid, and said cap containing at least one active ingredient and
having a soluble barrier to retain said active ingredient within
said cap, wherein at least one said active ingredient is GABA.
2. The perishable liquid delivery system of claim 1 further
comprising a solvent liquid contained within the container portion,
wherein the proportion of said active ingredient to said solvent
liquid is between 5 mg/ml and 50 mg/ml.
3. The perishable liquid delivery system of claim 1 wherein said
system further comprises a co-optimizer.
4. The perishable liquid delivery system of claim 3 wherein said
co-optimizer is synergistic to the physiologic function of said
active ingredient.
5. The perishable liquid delivery system of claim 1 wherein said
container portion of said vessel contains a volume of solvent
liquid in specific proportion to the amount of said active
ingredient.
6. The perishable liquid delivery system of claim 5 wherein said
vessel comprises a co-optimizer synergistic to the physiologic
function of said active ingredient.
7. The perishable liquid delivery system of claim 1 wherein said
active ingredient is in powder, liquid, or gel form.
8. The perishable liquid delivery system of claim 1 wherein said
vessel comprises an insoluble barrier adhered to the vessel between
said container portion and said soluble barrier.
9. The perishable liquid delivery system of claim 8 wherein said
cap comprises internal threads and said insoluble barrier is
adhered substantially inside and beyond the internal threads of
said cap.
10. The perishable liquid delivery system of claim 8 wherein said
insoluble barrier is adhered to said container portion, thereby
functioning as a sealing means to prevent solvent liquid contained
within said container portion from exiting said container
portion.
11. The perishable liquid delivery system of claim 1 wherein said
soluble barrier comprises at least one said active ingredient.
12. A device for preparing and dispensing at least one active
ingredient comprising: a cap suitably adapted to be removably
fitted to a container, said cap containing at least one active
ingredient and having a soluble barrier to retain said active
ingredient within said cap, said container suitably adapted to
contain a solvent liquid, wherein at least one said active
ingredient is GABA.
13. The active ingredient dispensing device of claim 12 wherein
said active ingredient is in powder, liquid, or gel form.
14. The active ingredient dispensing device of claim 12 wherein
said vessel comprises an insoluble barrier adhered to the cap such
that the insoluble barrier separates the soluble barrier from the
container.
15. The active ingredient dispensing device of claim 14 wherein
said cap comprises internal threads and said insoluble barrier is
adhered substantially inside and beyond the internal threads of
said cap.
16. The active ingredient dispensing device of claim 12 wherein
said soluble barrier comprises at least one said active
ingredient.
17. The active ingredient dispensing device of claim 12 wherein
said device further comprises a co-optimizer.
18. The active ingredient dispensing device of claim 17 wherein
said co-optimizer is synergistic to the physiologic function of
said active ingredient.
Description
CROSS REFERENCE TO RELATED APPLICATION
[0001] This application claims priority to a provisional
application, U.S. Ser. No. 61/174,199, filed Apr. 30, 2009,
entitled Mixing Cap And Container System For Improved Delivery Of
Perishable Liquid Mixtures, by Ligon, Brooke, which is hereby
incorporated by reference.
BACKGROUND OF THE INVENTION
[0002] 1. Technical Field
[0003] The present invention relates generally to preparing and
delivering perishable liquid mixtures. More particularly, the
present invention relates to systems for mixing or compounding
biologically active ingredients at or near the time of use.
[0004] 2. Description of Prior Art
[0005] Vitamins, nutraceuticals, and other dietary supplements are
frequently packaged as liquid mixtures. Likewise, common methods
for delivering ingestible therapeutics often involve combining
active ingredients with suitable liquid carriers. Since many active
ingredients begin to degrade shortly after contact with liquid,
their intended beneficial effects may significantly diminish before
being ingested.
[0006] The pH, temperature, solvent type, exposure to light and
air, ionic strength, and storage time of a mixture are understood
to affect the stability of active ingredients. In general, the
longer a labile ingredient exists in a liquid mixture, the less
effective it becomes. Amino acid related dietary supplements and
peptide based therapeutic agents are especially prone to degrading.
If contaminated with bacteria or other microorganisms, the
contaminants are likely to multiply, possibly making the mixture
toxic or more rapidly diminishing the potency of active
ingredients. To counter the degradation process, liquid mixtures
are often refrigerated. Solutions containing degradable agents also
commonly include stabilizers and preservatives. While these
countermeasures are usually successful at reducing degradation they
are difficult to accomplish and undesirable in many circumstances.
Refrigeration is costly and may be ineffective at maintaining
perishable mixtures at cold temperatures throughout their
manufacturing and distribution processes. Similarly, regularly
ingesting stabilizers and preservatives is prohibitive and thus
products with such additives are generally less appealing to
consumers when more healthful alternatives exist.
[0007] Other alternative and supplemental techniques have been
developed to reduce the degradation of active ingredients in
perishable liquid mixtures. When the loss of biological activity
can be accurately calculated, a greater proportion of active
ingredient may be provided in a product to compensate. This
strategy may be satisfactory when the cost of active ingredient is
minimal and the character and quantity of degradation products are
readily tolerated. However, large concentrations of degradation
products may noticeably precipitate or change the overall
beneficial and appealing properties of the product. Some perishable
liquid mixtures are lyophilized and later reconstituted immediately
prior to use. Reconstitution often requires measuring a suitable
amount of solvent and combining it with a lyophilized ingredient.
More convenient systems provide premeasured amounts of liquid for
combining with the lyophilized portion. In addition to the added
processing cost, spilling or contaminating the active ingredients
or diluent is an undesirable risk of lyophilized liquid delivery
devices.
[0008] To improve upon these shortcomings, various devices have
been invented for segregating premeasured amounts of liquid and dry
or powdered ingredients until time for mixing. A popular approach
involves breaking off or displacing a perforated structural barrier
which functions as an ingredient chamber bottom inside the
segregating device. As an example, U.S. Pat. No. 6,644,471
describes a device containing dry ingredients for inserting into
the neck of a bottle. The device segregates powdered ingredients
from liquid in the bottle until steps are taken to break a plunger
mechanism free. As with many of these devices, the dry ingredient
enters the liquid mixture accompanied by the discarded plunger.
[0009] An improvement over devices which dispose of components in
the liquid mixture, U.S. Pat. No. 7,032,745 discloses a device for
fitting inside the neck of a bottle in which a plastic ingredient
chamber bottom is used as a penetrable barrier. The barrier is
perforated along its perimeter except for a segment which functions
as a hinge. When the cap is manipulated to rupture the barrier, an
opening is created which allows the ingredients to fall. However,
the barrier remains attached to the device along its un-perforated
edge and thus only the ingredients combine with the liquid. Devices
which employ easily penetrable foil or paper barriers are generally
similar in function.
[0010] U.S. Pat. No. 7,464,811 avoids the problem of contaminating
mixtures with discarded barrier parts by employing a cap having an
ingredient chamber and multiple apertures. In a one position the
apertures are covered and liquid is prevented from reaching the
ingredients. In a second position, the apertures are opened so that
ingredients and liquid may pass through the apertures to mix.
[0011] Although potentially feasible as perishable mixture delivery
systems in limited circumstances, the previous devices have failed
to become widely accepted. Aside from the hazard of ingesting
discarded components, devices with small ports or openings are
prone to clogging as dry ingredient and liquid are mixed.
Furthermore, manufacturing multipart mechanisms capable of reliably
penetrating barriers in otherwise sealed containers is relatively
expensive, particularly as a result of the necessary moving
parts.
[0012] A more economical and reliable approach incorporates a
peelable paper, plastic, or foil barrier as is present in common
beverage containers. An example of a device employing such
technology to deliver liquid mixtures is U.S. patent application
Ser. No. 10/819,731 which includes multiple embodiments of a simply
designed and easily manufactured cap. The innermost portion of the
cap holds enhancement ingredients protected by a fluid soluble
seal. One embodiment includes a tabbed and peelable fluid insoluble
seal. The insoluble seal is described and depicted as being
disposed on the outer surface of the cap, over its opening, for
purposes of sealing off the cap and preventing tampering. To
prepare a liquid mixture, the fluid insoluble seal is peeled away
and the cap is attached to a suitable container at least partially
filled with fluid. Then the container is shaken until the soluble
seal, enhancement, and fluid are mixed. While this device is
contemplated for mixing and delivering ingredients such as
flavorings or vitamins, it may be unsuitable for pharmaceutical
applications since the quality and quantity of solvent fluid cannot
be completely controlled.
[0013] While perishable liquid mixtures may be prepared and
delivered advantageously by the preceding inventions, each is
significantly limited. Therefore, there is a need for a simple,
economical, and easy to use perishable liquid mixture delivery
system capable of preventing spills and contamination while
maximizing the properties of its active ingredients.
SUMMARY OF THE INVENTION
[0014] Accordingly, an aspect of the present invention is directed
to a system for improving the preparation and delivery of
perishable liquid mixtures which overcomes the disadvantages of
devices in the prior art. More specifically, the structure and
operative features of the invention described herein provides for
the reliable preparation and delivery of perishable liquids in a
vessel which is easily manufactured at minimal cost. Further still,
the invention disclosed herein provides an economical means for
delivering safe and accurate doses of nutraceutic and pharmaceutic
agents with minimum degradation products and extended shelf life.
In a further aspect of the invention, methods are disclosed for
delivering safe and economical perishable liquid mixtures according
the system described herein. In yet a further aspect of the
invention, specific therapeutic mixtures are disclosed for delivery
with the systems and methods described as well as by conventional
means.
[0015] One aspect of the system includes a vessel having a
container portion and a removable cap. The container portion
includes a neck and a rim and is generally positioned toward the
bottom of the vessel relative to the cap. The cap has a closed end
and an open container portion end. The cap is structured with an
ingredient chamber to hold a precise quantity of active ingredient
therein. The active ingredient is confined within the ingredient
chamber by various means including one or more removable barriers
disposed between the active ingredient and the container portion
end of the cap. At least one of the barriers is in close proximity
to the active ingredient and soluble in the solvent liquid. The
soluble barrier is adhered, compacted, tightly fitted, or otherwise
secured to its position in the cap, covering the ingredient
chamber. The cap and barriers fully enclose the active ingredient
and prevent the active ingredient from being spilled or
contaminated while the cap is removed or manipulated during
preparation of the perishable liquid mixture.
[0016] The container portion of the vessel holds a volume of
solvent liquid capable of disrupting the active ingredient along
with the soluble barrier, thereby removing them from their
positions in the cap. Once removed, the active ingredient and the
soluble barrier are incorporated with the solvent liquid. The
active ingredient, solvent liquid, and soluble barrier are present
in such proportion that when combined, the resulting perishable
liquid mixture is substantially uniform and may easily be delivered
by the vessel for ingestion. Furthermore, the active ingredient,
solvent liquid, and soluble barrier are in such proportion that the
biological activity of the active ingredient is sufficient to
provide a desired physiological effect.
[0017] Preferably, the system vessel also comprises one or more
insoluble barriers resistant to the solvent liquid. The insoluble
barrier is adhered to the rim of the container portion as a sealing
means or disposed inside the removable cap such that the insoluble
barrier prevents the solvent liquid from contacting the soluble
barrier until the insoluble barrier is removed. In either case, the
insoluble barrier preferably includes an easily grasped tab to help
remove the insoluble barrier from the system vessel. When the
system vessel includes an insoluble barrier adhered to the rim of
the container portion, it thereby prevents the solvent liquid from
exiting the container portion and protects against spills or
contamination. When the system vessel includes an insoluble barrier
within the cap in close proximity to the soluble barrier, the
insoluble barrier is adhered to a corresponding sealing surface
provided in the cap and functions with the cap to completely
enclose the soluble barrier and active ingredients. In preferred
embodiments, the insoluble barrier is one of only two barriers in
the vessel; the other being the soluble barrier positioned in the
cap. Optionally, the system vessel comprises a soluble barrier
accompanied by two insoluble barriers, one adhered to the cap and
another adhered to the container portion.
[0018] In alternate embodiments of the invention, active ingredient
is made firm or incorporated into the material of a soluble barrier
such that the active ingredient is retained within the ingredient
chamber of the cap without need for a separate soluble barrier.
Unless manufactured with a container portion having solvent liquid
these embodiments are may be provided without an insoluble
barrier.
[0019] In yet other alternate embodiments of the invention the
vessel does not incorporate a container portion, but rather the cap
is suitably adapted to be attached to a standard container. In such
embodiments the cap may comprise threads formed into its open end
such that said threads may be engaged with standard threads formed
onto the neck of a container.
[0020] The system is generally operated by first readying the
vessel for preparing the mixture. The vessel is readied by removing
the cap and peeling away all insoluble barriers to expose the
soluble barrier and open the container portion. The container
portion is filled with solvent liquid if such liquid is not already
present. Once the solvent liquid is present and the soluble barrier
is exposed, the cap is reattached to the container portion and the
vessel is inverted or otherwise agitated until the solvent liquid
ruptures the soluble barrier. Thereafter, the vessel is further
agitated to substantially dissolve or mix the active ingredient
with the solvent liquid. When substantially mixed together the
active ingredient and liquid produces a perishable liquid mixture
to be ingested by humans or animals in need.
[0021] It is to be understood that the foregoing and following
description of the invention is intended to be illustrative and
exemplary rather than restrictive of the invention as claimed.
These and other aspects, advantages, and features of the invention
will become apparent to those skilled in the art after review of
the entire specification, accompanying figures, and claims
incorporated herein.
BRIEF DESCRIPTION OF THE DRAWINGS
[0022] FIG. 1 is a perspective view of the invention depicting the
cap and upper container portion components of the system.
[0023] FIG. 2 is a perspective view of the invention depicting
major components of the system and vessel.
[0024] FIG. 3 is a side perspective view of the removable cap with
active ingredients and barriers in place.
[0025] FIG. 4 is a side perspective view of the invention depicting
a loaded cap and corresponding upper container portion neck
according to a preferred embodiment of the invention.
[0026] FIG. 5A is a side perspective view of the invention
depicting the system before active ingredients have been mixed with
solvent liquid.
[0027] FIG. 5B is a side perspective view of the invention
depicting the system after active ingredients have been mixed with
solvent liquid.
DETAILED DESCRIPTION
[0028] Various terms relating to the compositions and methods of
the present invention are used herein above and throughout the
specification and claims.
[0029] As used herein, "active ingredient" 310 includes reference
to substances recognized or intended to have a specific
nutraceutical or pharmacological effect.
[0030] The term "co-optimizer" includes reference to substances
which, when combined with active ingredient 310, improve the
recognized or intended biological activity of the active ingredient
310.
[0031] The term "GABA" includes reference to gamma-aminobutyric
acid in various degrees of purity including feed, food, or
pharmaceutical grades.
[0032] The term "insoluble barrier" 240 as used herein includes
reference to a barrier means which is substantially resistant and
impenetrable to the solvent liquid 320 such that when the insoluble
barrier 240 is sealably disposed between the solvent liquid 320 and
the active ingredient 310, the solvent liquid 320 remains isolated
from the active ingredient 310 despite prolonged contact of the
solvent liquid 320 with the insoluble barrier 240.
[0033] The term "less than normal insulin production" as used
herein refers to a deficient level of insulin production, such that
a human or animal patient or subject will have a fasting blood
glucose measurement which is at least periodically outside of the
acceptable normal range.
[0034] The term "perishable liquid mixtures" 300 as used herein
includes reference to liquid mixtures having at least one active
ingredient 310 in a solvent liquid 320 and which can be ingested by
pouring the mixture 300 from the container portion 210 of the
system 100. Perishable liquid mixtures 300 as used herein are
intended to include solutions, suspensions, colloidal dispersions,
and emulsions.
[0035] The term "perishable liquid mixture delivery system" 100 or
also synonymously "system" 100 as used herein includes reference to
the vessel 200, barriers 240,230, active ingredients 310, and other
substances contained therein.
[0036] The term "solvent liquid" 320 refers to liquid in the
container portion 210 of the vessel 200 for combination with the
active ingredient 310. The solvent liquid 320 is capable of
disrupting the structure of the soluble barrier 230 and mixing with
the soluble barrier 230 and active ingredient 310. The solvent
liquid 320 may be present in the system 100 as manufactured or
added to the container portion 210 of the vessel 200 at any time
prior to preparation of the perishable liquid mixture 300.
[0037] The term "soluble barrier" 230 as used herein refers to
ingestible material attached within the recess 222 of the cap 220
which is generally soluble in the solvent liquid 320. The soluble
barrier 230 generally encloses active ingredients 310 in the
ingredient chamber 224 of the cap 220 but may in certain
embodiments consist, in part, of active ingredients 310 such that
no other active ingredient 310 is present in the vessel 200. In
such certain embodiments it should be understood that dissolving
the soluble barrier 230 will impart adequate desired function of
the active ingredient 310 to the perishable liquid mixture 300.
[0038] The term "sealing means" as used herein refers to an
insoluble barrier 240 or other means which functions to prevent
solvent liquid 320 from exiting the container portion 210 of the
vessel 200.
[0039] The term "vessel" 200 as used herein generally includes the
container portion 210, removable cap 220, and any structural
features contained therein.
[0040] A major aspect of the invention includes embodiments of a
perishable liquid mixture delivery system 100 for preparing liquid
drinks for general consumption as well as for compounding and
delivering human and veterinary pharmaceuticals. The perishable
mixture delivery system 100 of the present invention is disposed
and structured to avoid contamination and be easily operated
without complicated instructions or training. In all applications,
the system 100 of the present invention provides a means for
assembling perishable liquid mixtures 300 immediately prior to
ingestion, thereby maximizing the properties and characteristics of
the active ingredient 310 for the greatest nutritional,
nutraceutical, or pharmacological effect. Furthermore, the delivery
system 100 of the present invention optimally maintains the
physical, chemical, and microbiological stability of active
ingredients 310 with minimal need for preservatives, freeze drying,
refrigeration, or the like, or expensive to manufacture components.
Therefore, the system 100 may be used to combine suitable solvent
liquids 320 with active ingredients 310 and deliver the resulting
perishable liquid mixtures 300 more safely, efficiently, and
economically than previous perishable mixture delivery devices.
[0041] Reference will now be made to presently preferred
embodiments of the invention, examples of which are illustrated in
the accompanying drawings.
[0042] Referring to FIG. 1, a perishable liquid mixture delivery
system 100 in accordance with exemplary embodiments of the present
invention is described. As illustrated, the delivery system 100
comprises a vessel 200 having a substantially hollow container
portion 210 adapted to be filled with solvent liquid 320 and a
removable cap 220. The cap 220 and container portion 210 are
coupled together by external threads 216 on the neck 212 of the
container portion 210. Said threads 216 correspond in the usual
manner to internal threads 226 disposed within the recess 222 of
the removable cap 220. However, other suitable fastening means may
be used to join the cap 220 and container portion 210 of the vessel
200. The cap 220 further includes an ingredient chamber 224 wherein
active ingredient 310 is maintained separately from the solvent
liquid 320 until it is desired that the perishable liquid mixture
300 be prepared or compounded. Preferably, the active ingredient
310 is in powder or granulated form. However, the active ingredient
310 may also be packed solid, held together with filler or binder
or the like, or may be present substantially as a liquid or a gel.
Said ingredient chamber 224 is of sufficient size and in proportion
to the volume of solvent liquid 320 held the container portion 210
such that when the solvent liquid 320 and the active ingredient 310
are combined, the resulting perishable liquid mixture 300 will be
biological active.
[0043] The vessel 200 of the perishable liquid mixture delivery
system 100 further comprises one or more removable barriers 230,240
(FIG. 1) which functions to isolate the active ingredient 310 from
the solvent liquid 320. At least one of the removable barriers 240
is effectively resistant to being disintegrated by the solvent
liquid 320, and performs as an insoluble barrier 240 which remains
in its position in the vessel 200 until it is peeled away or
otherwise manually removed. Depending upon the properties of
solvent liquid 320, the insoluble barrier 240 can be made from
foil, plastic, wax paper or the like and adhered to the vessel 200
according to conventional beverage bottling methods well known to
persons skilled in the art.
[0044] The insoluble barrier 240 must be sealably attached to a
corresponding sealing surface 228 of the vessel 200 to prevent the
solvent liquid 320 from contacting the active ingredient 310. In a
preferred exemplary embodiment of the system 100 as depicted in
FIG. 2, the insoluble barrier 240 is adhered to the rim 214 of the
neck 212 of the container portion 210, thereby functioning as a
sealing means and preventing the solvent liquid 320 from exiting
the container portion 210. Optionally, and as in a preferred
exemplary embodiment of the system 100 as depicted in FIG. 3, the
insoluble barrier 240 may be disposed at other locations in the
vessel 200 including but not limited to a designated sealing
surface 228 within the recess 222 of the cap 220 in such a manner
that the insoluble barrier 240 is disposed over and seals the
ingredient chamber 224 from the solvent liquid 320. As is depicted
in FIG. 3, if the insoluble barrier 240 is adhered to the cap 220
rather than the container portion 210 and the container portion 210
is without a sealing means, it is critical that the vessel 200
include a contact shoulder 229 or similarly functioning feature to
sealably contact the rim 214 of the container portion 210 and
prevent liquid from leaking outside the vessel 200 when the system
100 is shaken or inverted.
[0045] In preferred exemplary embodiments, the insoluble barrier
240 includes a tab 242 which is easily grasped so that the
insoluble barrier 240 may be peeled away from its position in the
vessel 200, prior to the preparation of the perishable liquid
mixture 300. Also in preferred embodiments, the vessel 200 includes
a soluble barrier 230 in close proximity to the active ingredient
310. The soluble barrier 230 is easily removed by the solvent
liquid 320 and combines with the perishable liquid mixture 300 when
dissolved. Referring now to FIG. 4, the soluble barrier 230 is
retained within or adhered to the cap 220 such that it contains the
active ingredient 310 inside the ingredient chamber 224 until the
soluble barrier 230 is disintegrated by the solvent liquid 320.
Furthermore, the soluble barrier 230 allows the cap 220 to be
inverted or otherwise manipulated while separated from the
container portion 210 without the risk of spilling or contaminating
the active ingredient 310.
[0046] The soluble barrier 230 may be made from combinations of
nontoxic and ingestible solid or semi-solid material able to be
disintegrated by the solvent liquid 320. Some examples of such
materials include cellulose, agar, gelatin, polyvinyl alcohol,
calcium phosphate, calcium carbonate, alginate, sorbitol, mannitol,
lactose, glucose, sucrose, or starch. Preferably, the soluble
barrier 230 material chosen is rapidly disintegrated in aqueous
solution and therefore functional with most common liquid
beverages. Numerous instructive texts cover the application of such
materials. Incorporated herein by reference as an example is Peter
A. Williams, Handbook of Industrial Water Soluble Polymers,
(1.sup.st ed., Blackwell 2007).
[0047] In the exemplary embodiment as depicted in FIG. 4,
sufficient active ingredient 310 to affect a desired result is held
within the ingredient chamber 224 proximate to the central axis
portion of the removable cap 220. The cap 220 includes internal
threads 226 to mate with the external threads 216 of container
portion 210 of the system 100. The active ingredient 310 is
granulated and completely covered by a soluble barrier 230 adhered
to the open end of the ingredient chamber 224. The cap 220 also
includes an insoluble barrier 240 disposed over the soluble barrier
230 and sealably adhered to a circular sealing surface 228 within
the cap 220. The container portion 210 includes a volume of solvent
liquid 320 in correct functional proportion to the active
ingredient 310. Also included in the recess 222 of the cap 220 and
outside the ingredient chamber 224 is a contact shoulder 229 around
the internal perimeter of the cap 220 for sealing with the rim 214
of the container portion 210. Thus, when the cap 220 is tightened
to the container portion 210, the seal between the contact shoulder
229 and rim 214 prevents solvent liquid 320 from leaving the vessel
200. Optionally, the insoluble barrier 240 is larger in diameter
than the sealing surface 228 and continues outward radially from
the central axis of the cap 220 to be disposed between the contact
shoulder 229 and the rim 214 such that when the cap 220 is combined
with the container portion 210, the insoluble barrier 240 functions
also as a sealing means to confine the solvent liquid 320 to the
container portion 210 of the vessel 200. As depicted in FIG. 4, the
insoluble barrier 240 is substantially round and includes a thin
plastic tab 242 for pulling the insoluble barrier 240 free of the
cap 220. Preferably the tab 242 is disposed outward from the
central axis of the cap 220 and wound between the threads 216,226
of the vessel 200 during manufacture to avoid being made wet by the
solvent liquid 320. When threaded together, the cap 220 and
container portion 210 are also connected with a tamper evident band
250.
[0048] In accordance with the present invention, active ingredient
310 may optionally be in liquid form. Depending upon the nature of
the active ingredient 310, adaptation of the system 100 for such
purposes may require added depth or other fortification to the
soluble barrier 230. Preferably, the liquid of the active
ingredient 310 is immiscible with and relatively ineffective at
disintegrating the soluble barrier 230 such that the soluble
barrier 230 remains intact until it is disrupted by the solvent
liquid 320 held in the container portion 210 of the system 100.
[0049] In a further optional embodiment, the active ingredient 310
is compacted, gelled, combined with soluble barrier 230 materials
or binder, or otherwise made firm so that the active ingredient 310
will function significantly as the soluble barrier 230. More
specifically, in such embodiments the active ingredient 310 is
retained in or adhered to the ingredient chamber 224 and remains
disposed therein until removed by contact with the solvent liquid
320. In such optional embodiments, the active ingredient 310 laden
soluble barrier 230 may be covered by an insoluble barrier 240
which is manually removed. Said insoluble barrier 240 may be
accompanied by a second insoluble barrier 240 disposed on the
container portion 210 of the vessel 200 or may be the only
insoluble barrier 240 of the system 100. In all such embodiments,
the active ingredient 310 remains ingestible and substantially
nontoxic despite being made firm to function as the soluble barrier
230.
[0050] In still another preferred embodiment of the present
invention, the system 100 lacks a container portion 210 but
includes an active ingredient 310 laden cap 220 compatible with a
popular liquid drink product such as bottled water, electrolyte
beverage, soda, fruit juice, or the like. In this and similar
embodiments, the liquid drink product and cap 220 are fitted to one
another to function together as a perishable liquid mixture
delivery system 100. Referring now to the exemplary embodiment in
FIG. 3, the cap 220 includes internal threads 226 corresponding to
external threads of a common liquid beverage container. Said cap
220 also includes an active ingredient 310 covered by a soluble
barrier 230 which may be disintegrated by the solvent liquid 320 in
said common liquid beverage container in accordance with the
present invention. Said cap 220 further includes an insoluble
barrier 240 between the internal threads 226 of the cap 220 and the
ingredient chamber 224 which is easily removed to expose the
soluble barrier 230. Optionally, said soluble barrier 230 may be
made especially robust and protected from mishaps during handling,
shipping, and storage by appropriate packaging. In such optional
embodiments said soluble barrier 230, once fitted to said common
liquid beverage container, may be protected from solvent liquid 320
by an insoluble barrier 240 inherent to and typical of such drink
products.
[0051] Referring generally now to all embodiments, components of
the vessel 200 may be constructed of glass, metal, plastic, paper,
and other materials using common existing technology. Similarly,
numerous embodiments of the system 100 including its related
barriers 240,230 may be manufactured using packaging processes,
materials, and methods well known to persons in the consumer
beverage, nutritional supplement, and pharmaceutical packaging
fields. Examples of readily available guides containing such
information include: Philip D. Rufe, Fundamentals of Manufacturing,
(2d ed., SME 2001); Geoff A. Giles, Handbook of Beverage Packaging,
(1.sup.st ed., Wiley-Blackwell 1999); Philip R. Ashurst, Chemistry
and Technology of Soft Drinks and Fruit Juices, (2d ed., Blackwell
2005); Dorothy A. G. Senior, Nick Dege, Technology of Bottled
Water, (2d ed., Blackwell 2005); and George F. Chrader, Ahmad K
Elshennawy, Lawrence E. Doyle, Manufacturing Process and Materials,
(4.sup.th ed., SME 2000) which are herein incorporated by
reference.
[0052] In a further aspect of the invention, methods are provided
for delivering perishable liquid mixtures 300 in accordance with
the perishable liquid mixture delivery system 100 described herein.
The structural and operative features of the system 100 of the
present invention allow for preparation and delivery which is
unique and distinguishable from known or conventional mixture
delivery steps. Moreover, by utilizing a self contained system 100
or, optionally, a protected soluble barrier 230, the operator is
afforded an easy, reliable, and relatively foolproof method for
delivering perishable liquid mixtures 300 under the most
challenging environments.
[0053] Perishable liquid mixtures 300 prepared, compounded, or
otherwise combined by the system 100 may include solutions,
suspensions, emulsions, or colloidal dispersions. If delivered as a
nutraceutical or pharmaceutical, the perishable liquid mixture 300
produces desired physiologic effects.
[0054] Referring now to FIGS. 5A and 5B, a perishable liquid
mixture 300 may be prepared by positioning the vessel 200 upright
and turning the cap 220 sufficiently with respect to the container
portion 210 so that the cap 220 and container portion 210 are
substantially disconnected. With the insoluble barrier 240 evident
in the recess 222 of the cap 220, the tab 242 is pulled until the
insoluble barrier 240 is completely removed, thereby exposing the
soluble barrier 230. Next, the cap 220 is reattached to the
container portion 210 and the vessel 200 is shaken until the
soluble barrier 230 is disrupted and active ingredients 310 are
mixed with the solvent liquid 320. Once the active ingredient 310
is adequately integrated with the solvent liquid 320, the cap 220
is again removed to deliver the resulting perishable liquid mixture
300. In a preferred embodiment, the cap 220 includes a valve means
whereby the cap 220 may remain in place as the perishable liquid
mixture 300 is ingested. In any case, the perishable liquid mixture
300 is preferably ingested shortly after preparation to maximize
its beneficial effects.
[0055] Referring again to the exemplary embodiment of FIG. 3,
wherein the cap 220 is intended to be fitted with a liquid drink
product to function together as the system 100, the perishable
liquid mixture 300 is prepared by first removing the insoluble
barrier 240 disposed between the soluble barrier 230 and the
internal threads 226 well inside the recess 222 of the system 100
cap 220. Next, with the soluble barrier 230 exposed, the cap 220 is
joined to an opened drink product having adequate solvent liquid
320 volume and external threads compatible with the cap 220 threads
226. The vessel 200 is then shaken or inverted to disintegrate the
soluble barrier 230 and combine the active ingredient 310 with
solvent liquid 320. Agitation of the vessel 200 should continue
until the active ingredient 310 and soluble barrier 230 are
substantially evenly distributed throughout the solvent liquid 320.
The resulting liquid mixture 300 is delivered immediately by simply
removing the cap 220 and drinking the entire contents of the
container portion 210. Optionally, the contents may be ingested
periodically within a time frame akin to the expected stability of
the mixture 300.
[0056] In yet a further aspect of the invention, perishable liquid
mixtures 300 are provided for delivery by the system 100. Such
perishable liquid mixtures 300 comprise active ingredients 310
labile in solution or liquid carriers and include nutritional
supplements such as creatine, GABA, and melatonin; as well as
recognized therapeutic pharmacological agents such as antibiotics,
analgesics, antiemetics, peptide hormones, anti-inflammatories
(such as glucosteroids or non-steroidal anti-inflamatories,
neurotransmitters like dopamine and dopamine agonists).
[0057] More specifically, a perishable liquid mixture 300 is
provided having beneficial therapeutic effect for persons and
animals deficient in homeostatic insulin production.
[0058] By way of example, a preferred embodiment of the present
invention includes the preparation and delivery of a perishable
liquid mixture 300 comprising gamma-aminobutyric acid (GABA) as its
active ingredient 310. The GABA may be isolated and purified as
feed, food, nutraceutical or pharmaceutical grade for combination
with a suitable solvent liquid 320, according to the nature of the
patient or subject ingesting the mixture 300. The solvent liquid
320 may be any ingestible liquid suitable for mixing with GABA,
including but not limited to potable water. The solvent liquid 320
may be water alone, or may also include flavorings, other
nutrients, or co-optimizers. The GABA containing perishable liquid
mixture 300 may be prepared and delivered according to the system
100 of the present invention or may be mixed and delivered
according to conventional methods. In any case, the GABA should be
mixed with solvent liquid 320 immediately prior to or near the time
of consumption in order to maximize its beneficial effect. The GABA
mixture 300 may be ingested all at once or in small portions
throughout an extended period of time.
[0059] To be therapeutically effective, GABA is administered to
patients or subjects in doses of between 0.6 and 60 milligrams per
kilogram of body weight. GABA is significantly soluble in water,
therefore practical proportions of GABA active ingredients 310 to
aqueous solvent liquids 320 are between 5 and 50 milligrams per
milliliter, depending on the type and amounts of other solutes also
present.
[0060] The procedures set forth below are used for administering
GABA for therapeutic effect in diabetic canine subjects having less
than normal insulin production.
Example 1
Preparation and Delivery of Gaba to Canine Subjects Deficient in
Insulin Production Using the System 100 of the Invention Herein
[0061] The procedure comprises three basic steps: 1) GABA is
provided in an ingredient chamber 224 of a perishable liquid
delivery system 100, separate from a proportional volume of potable
water also contained within the system 100; 2) a GABA perishable
liquid mixture 300 is prepared by i) first removing the cap 220 and
peeling away the insoluble barriers 240, and ii) the GABA is then
dissolved by reattaching the cap 220 and inverting the container
portion 210 according to the invention described herein; and 3) the
resultant mixture 300 is then delivered to the subject after once
again removing the cap 220.
[0062] A. Loading of the Perishable Mixture Delivery Container
Portion 210.
[0063] A vessel 200 is provided having a threaded 216 container
portion 210 and corresponding cap 220. The cap 220 includes threads
226, an ingredient chamber 224, a sealing surface 228, and a
contact shoulder 229.
[0064] Approximately 750 grams of GABA processed to approximately
99% purity is mixed with 500 grams of acacia gum binder and
compacted into the active ingredient chamber 224 of the inverted
cap 220 to act as a soluble barrier 230, according to the invention
described in the specification herein. The chamber 224 is then
covered by an insoluble barrier 240 of paper reinforced foil
adhered to a sealing surface 228 of the cap 220 with warmed gelatin
and allowed to cool. The container portion 210 of the delivery
system 100 is filled with approximately 100-300 mls. of filtered
potable water substantially free of microorganisms and pyrogens.
Under essentially sterile conditions, an additional foil and paper
barrier 240 prepared with warm gelatin is applied over the opening
of the container portion 210 and allowed to cool. The cap 220 is
joined to the container portion 210 and tightened.
[0065] B. Preparing the Perishable Liquid Mixture 300.
[0066] At or near the time that the subject is to ingest a dose of
GABA, the cap 220 is removed from the container portion 210 and
both insoluble barriers 240 are removed. The cap 220 is then
reattached to the container portion 210 and shaken gently until the
soluble barrier 230 containing GABA is substantially dissolved.
[0067] C. Delivering the Perishable Liquid Mixture 300.
[0068] A canine subject in need of treatment for diabetes is
confined in an environment having no access to water other than
from a designated dish. The mixture 300 is delivered by removing
the cap 220 from the container portion 210 of the system 100 and
pouring the mixture 300 into the dish. The subject is prevented
from spilling the mixture 300 and observed until substantially all
of the mixture 300 is ingested.
Example 2
Preparation and Delivery of Gaba to Canine Subjects Deficient in
Insulin Production Using Conventional Means
[0069] METHODS: GABA (99% pure from Sigma-Aldrich) at a dose of 30
mg/kg was brought into solution in 200 milliliters of water daily
so that the diabetic, insulin dependent canine test subject
consumed the dose within approximately four hours, based on average
consumption of water observed by owners. Fasting blood glucose and
fructosamine were monitored once a month. Each canine subject
served as its own control, with monitoring of blood glucose and
fructosamine off treatment recorded the first two months followed
by monitoring while on GABA therapy.
[0070] RESULTS: Insulin dependent test subjects began to
demonstrate improved glycemic control within two weeks of consuming
GABA diluted in water, observations continued over four months with
continued improvement in glycemic control over that period. The
fasting blood glucose in the first test subject declined by 49.6%
after two months of treatment. Fasting blood glucose in the second
test subject also declined by 50% after two months of treatment.
Similarly, both subjects demonstrated significantly lower
concentrations of blood fructosamine as a result of treatment with
GABA.
[0071] In preferred embodiments of perishable liquid mixtures 300
in accordance with the invention, active ingredients 310 are
accompanied by co-optimizers to improve the biological activity of
the active ingredient 310. Co-optimizers may include any substance
which improves the effectiveness of the active ingredient 310 and
comprise proteins, peptides, amino acids, vitamins, and recognized
organic and inorganic cofactors. The co-optimizer is dissolved in a
solvent fluid 320 and separated from active ingredients 310 in a
perishable liquid mixture system 100. Optionally, the co-optimizer
is in dry form and mixed directly with the active ingredient
310.
[0072] In a particular preferred embodiment, GABA is combined with
water as a solvent liquid 320. The water incorporates niacinamide
(or nicotineamide, or nicotinic acid amide) as a co-optimizer
synergistic with GABA. Together in the perishable liquid mixture
300 the GABA and niacinamide (or nicotineamide, or nicotinic acid
amide) are therapeutic for an absence or deficit of insulin in
diabetic patients or subjects. The GABA and co-optimizer may be
delivered by a perishable liquid mixture delivery system 100
according to the invention herein or may be delivered by more
conventional means.
[0073] As with all the embodiments of the invention, systems 100
incorporating active ingredients 310, solvent liquids 320, and
co-optimizers are manufactured and packaged using good
manufacturing practices. In particular, active ingredients 310,
solvent liquids 320, and co-optimizers are manufactured as
substantially sterile and pathogen and pyrogen free. Depending on
the combination of co-optimizer and solvent liquid 320,
preservatives such as citric acid, sodium citrate, methylparaben or
antioxidants and amino acids may be used. Similarly, common
stabilizers such as dextran, albumin, glycerol, inositol, polyvinyl
alcohol, mannitol, and maltose, may be necessary to maintain the
physical, chemical, and biological properties of co-optimizers
present in the solvent liquid 320.
[0074] What has been described and illustrated herein is a
preferred embodiment of the invention along with some it its
variations. The terms, descriptions and figures used herein are set
forth by way of illustration only and are not meant as limitations.
Those skilled in the art will recognize that many variations are
possible within the spirit and scope of the invention in which all
terms are meant in their broadest, reasonable sense unless
otherwise indicated. Any headings utilized within the description
are for convenience only and have no legal or limiting effect.
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