U.S. patent application number 09/987335 was filed with the patent office on 2003-05-15 for cups and container assemblies for storing and dispensing liquid pharmaceutical formulations.
Invention is credited to Zinnbauer, Gerald.
Application Number | 20030089718 09/987335 |
Document ID | / |
Family ID | 25533191 |
Filed Date | 2003-05-15 |
United States Patent
Application |
20030089718 |
Kind Code |
A1 |
Zinnbauer, Gerald |
May 15, 2003 |
Cups and container assemblies for storing and dispensing liquid
pharmaceutical formulations
Abstract
The present invention provides cups for storing and dispensing
liquids, such as liquid pharmaceutical formulations, having a bowl
with an open top and a curved inner surface with an annular base
extending from a bottom portion of the bowl, and a rim
circumscribing the upper portion of the bowl. The present invention
also provides unit dose container assemblies including cups
according to the present invention and lids enclosing the open top,
and container package assemblies for storing and dispensing liquid
pharmaceutical formulations.
Inventors: |
Zinnbauer, Gerald;
(Cornelius, NC) |
Correspondence
Address: |
DICKSTEIN SHAPIRO MORIN & OSHINSKY LLP
2101 L STREET NW
WASHINGTON
DC
20037-1526
US
|
Family ID: |
25533191 |
Appl. No.: |
09/987335 |
Filed: |
November 14, 2001 |
Current U.S.
Class: |
220/359.2 ;
220/359.3; 220/608; 220/633 |
Current CPC
Class: |
B65D 1/26 20130101; A61J
7/0046 20130101; B65D 25/2897 20130101; B65D 25/24 20130101 |
Class at
Publication: |
220/359.2 ;
220/359.3; 220/608; 220/633 |
International
Class: |
B65D 041/00; B65D
025/24 |
Claims
What is claimed is:
1. A cup for dispensing a liquid comprising: a bowl having an open
top, a curved bottom portion which is concave on at least a portion
of its inner surface, and an annular wall forming an upper sidewall
for said cup; an annular base circumscribing the bottom portion of
said bowl and forming a lower sidewall for said cup; and an annular
rim circumscribing the open top of said bowl and having a top
surface extending outward from the upper sidewall of the cup.
2. The cup of claim 1 further comprising a lid removably affixed to
the rim and enclosing the open top.
3. The cup of claim 1 wherein the inner surface of said bowl
comprises a material selected from the group consisting of high
density polyethylene, polypropylene, and cylic olefin copolymer
barrier material.
4. The cup of claim 1 wherein said cup is formed by injection
molding.
5. The cup of claim 1 wherein said annular rim has a rounded
edge.
6. The cup of claim 1 wherein said annular base extends beyond the
bottom of said bowl.
7. The cup of claim 1 wherein said annular base is cylindrical.
8. The cup of claim 1 wherein said annular base is
frustoconical.
9. The cup of claim 1 wherein said annular base has a lateral hip
extension.
10. The cup of claim 1 wherein said rim comprises a reverse draft
angle.
11. The cup of claim 1 wherein said rim comprises a step.
12. The cup of claim 1 wherein said rim top surface meets said bowl
inner surface at an angle.
13. The cup of claim 1 further comprising a step between the top of
said rim and the inner surface of said bowl.
14. The cup of claim 1 wherein said concave bowl bottom portion is
hemispherical.
15. The cup of claim 2 wherein said lid is a flexible, disposable
lid.
16. The cup of claim 2 wherein said lid comprises a laminate.
17. The cup of claim 2 wherein said lid comprises a tab for
facilitating removal of the lid.
18. The cup of claim 2 wherein said lid comprises a label.
19. The cup of claim 1 further comprising a stacking vane affixed
to the inner surface of the bowl.
20. The cup of claim 1 wherein the upper sidewall further comprises
a gripping surface.
21. The cup of claim 1 further comprising a liquid pharmaceutical
formulation present within the bowl of said cup.
22. The cup of claim 21 wherein said liquid pharmaceutical
formulation is indicated for oral administration.
23. The cup of claim 21 wherein said liquid pharmaceutical
formulation is present in a unit dose amount.
24. The cup of claim 21 wherein said liquid pharmaceutical
formulation is selected from the group consisting of solutions,
syrups, and suspensions.
25. The cup of claim 21 wherein the liquid pharmaceutical
formulation is a suspension.
26. The cup of claim 21 wherein the liquid pharmaceutical
formulation comprises a pharmaceutically active ingredient selected
from the group consisting of lactulose, nystatin, phenytoin,
sulfatrim, ibuprofen, and megestrol acetate.
27. A package assembly for storing and dispensing a liquid
pharmaceutical formulation comprising the cup of claim 1 and a
reservoir containing a liquid pharmaceutical formulation.
Description
FIELD OF THE INVENTION
[0001] The field of this invention is cups and containers for
storing and dispensing liquid pharmaceutical formulations.
BACKGROUND OF THE INVENTION
[0002] Liquid pharmaceutical formulations, such as oral syrups, are
typically stored or contained in bottles, with individual doses
being dispensed by pouring a portion of the stored syrup into a
spoon or measuring cup from which the patient then drinks. The
spoon or cup is then rinsed or washed to remove medicine adhering
to the inner surface, so the spoon or cup can be reused in the
future. The bottle containing the remaining undispensed formula is
then closed and stored until another dose is to be administered.
This cycle of dispensing and storing is typically repeated until
all of the formulation has been used, too little remains in the
bottle to be useful as an effective dose, or the formula remaining
in the bottle has become contaminated, has expired, or has
otherwise become unsuitable for safe or effective use as a
medicament.
[0003] Currently marketed measuring cups, which are often cups or
caps provided or sold with the bottle as a separate part of the
packaging, are typically manufactured by vacuum-formation. In such
a process, a thin sheet of plastic, typically a styrene, is laid
over an open mold or female half. The thin plastic sheet is heated,
then vacuumed into or over the mold, forming the cup. Cups formed
by such methods typically have common characteristics, including,
among others, a flat bottom, rounded outer edges which contribute
to instability, and a lack of durability. Markings are frequently
added to a sidewall of the cup to serve as a target demarcation to
guide the patient or treatment provider in administering a dose of
the liquid pharmaceutical formulation.
[0004] Various vacuum-formed cups are known in the art for
dispensing oral liquid pharmaceutical formulations. However, the
vacuum-forming process has limitations which impact on the
properties and usefulness of the resulting cup. For instance, the
choice of material available for use in the process is limited, and
typically results in weak or thin-walled products. The cups are
also typically flat-bottomed with inner edges that, along with the
material used, result in adherence of the liquid to the inner
surface and therefore incomplete or inadequate dispensation of the
liquid formulation. The flat bottom of a vacuum-formed cup can be
made larger to enhance its stability. However, enlarging the bottom
results in diminished evacuation efficiency. The vacuum-forming
process moreover is not optimal for producing cups with consistent
or precise volumes. Such inconsistency and imprecision can result
in inaccurate doses of medicine.
[0005] In addition to vacuum-formation of plastic cups, other
materials such as pliable metals have been bent into shape to
produce cups. Metal cups have many of the same or similar
limitations as those produced by vacuum-formation. Metal can easily
dent or become misshapen, resulting in inaccurate cup volume, and
thus inaccurate dosing. As with vacuum-formed cups, metal, flat
bottomed cups also do not adequately release liquid formulations
upon dispensing. Moreover, typical use of any of the prior art cups
provides excessive opportunity for human error. Because a patient
or treatment provider allocates a unit dose, typically by
attempting to hit the target demarcation included on the cup,
spillage or under- or over-shooting the mark is common, if not
likely. Moreover, reuse of the same cup can lead to contamination
of the medicine remaining in the storage bottle from which the dose
is poured.
[0006] It should therefore be appreciated that there is currently a
need for a device which overcomes these limitations. In particular,
there is a need for a stable, durable device for containing and
delivering a liquid pharmaceutical formulation with precision and
efficiency of evacuation, and particularly a cup which can store
and accurately dispense a unit dose of such formulation.
SUMMARY OF THE INVENTION
[0007] The present invention provides devices, including cups and
container assemblies, for storing and dispensing liquid
pharmaceutical formulations which have numerous advantages over the
prior art. The present invention provides a durable cup which has a
smooth inner surface so as to reduce or eliminate adherence of the
pharmaceutical formulation when the cup is inverted or the
formulation is otherwise dispensed.
[0008] Cups according to the invention include a bowl, an annular
base and a rim. The bowl has an open top, a curved bottom which is
concave on at least a portion of its inner surface, and an annular
wall which forms an upper sidewall for the cup. An annular base
circumscribes the concave bottom of the bowl and forms a lower
sidewall for the cup. The cups include an annular rim
circumscribing the open top of the bowl. The rim has a top surface
extending outward from the upper sidewall of the cup. In another
embodiment the cups further include a lid removably affixed to the
rim and enclosing the open top. The cup has a concave inner surface
of the bowl that is without edges and sufficiently smooth to
prevent a liquid from adhering to the inner surface when the liquid
is dispensed. Such an inner surface may be injected molded from
materials such as high density polyethylene, polypropylene, and
cylic olefin copolymer barrier material.
[0009] As used herein, "dispersed," "dispensing" and modifications
thereof refer to manipulation of the open cup's position so as to
allow the liquid to be poured from the cup. Typically, dispensing
occurs by tilting or inverting the open cup so that a patient can
drink a liquid pharmaceutical formulation.
[0010] The cups of the present invention can be used as unit dose
cups for storing and dispensing a unit dose of a pharmaceutical
formulation, and can also be used as measuring and dispensing cups
either alone or packaged together with another container, which
contains a liquid pharmaceutical formulation. As used herein, "unit
dose" refers to an amount predetermined to be an effective single
dose for the intended patient. When the cups of the present
invention are employed as unit dose cups they are provided enclosed
with a removable lid, thus providing for long term storage and
protection of the pharmaceutical formulation contents from
environmental conditions.
[0011] Additional features and advantages of the invention will be
set forth in the description and figures which follow and will be
apparent from the description or may be learned by practice of the
invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] FIG. 1A is a perspective view of a cup in accordance with
the present invention. FIG. 1B is a side elevational view of the
cup of FIG. 1A. FIG. 1C is a vertical cross sectional view of the
cup.
[0013] FIG. 2 depicts an alternate embodiment of a cup of the
present invention in perspective view, FIG. 2A, and vertical cross
sectional view, FIG. 2B.
[0014] FIGS. 3A-D illustrate various embodiments and features of
rims of cups in accordance with the present invention.
[0015] FIG. 4 depicts the top inner edge of an alternate embodiment
of a cup in accordance with the present invention.
[0016] FIG. 5 depicts an alternate configuration of the annular
base of a cup in accordance with the invention.
[0017] FIG. 6 depicts another alternate configuration of the
annular base of a cup in accordance with the invention.
DETAILED DESCRIPTION OF THE INVENTION
[0018] Reference will now be made in detail to embodiments of the
invention, which serve to explain the principles of the invention.
It is to be understood that application of the teachings of the
present invention to a specific problem or environment will be
within the capabilities of one having ordinary skill in the art in
light of the teachings contained herein.
[0019] The present invention provides devices, including cups and
containers, for dispensing a liquid, including a liquid
pharmaceutical formulation. The devices have a bowl with an open or
a sealingly closeable top and a curved bottom which is concave on
its inner surface. The devices are composed of a material which
renders the concave inner surface sufficiently smooth to prevent
liquid contents, such as pharmaceutical suspension and syrup
formulations, from adhering to the surface when dispensed. The
devices of the invention are particularly useful with viscous syrup
and suspension formulations, but can also be used with solutions
and any other liquid pharmaceutical or other liquid product.
[0020] The cups according to the invention include an annular base
circumscribing the outer surface of the bowl's bottom. The cups can
also have a rim circumscribing the open top. The rim includes a top
surface extending outward from the top inner edge of the cup.
[0021] The present invention further provides unit dose cups for
storing and dispensing a liquid pharmaceutical formulation. Unit
dose cups according to the invention have an open top and a curved,
for example, a hemispherical, bottom which is concave on its inner
surface. The unit dose cups can include a foil, plastic, laminate
or other suitable material for sealingly enclosing the open
top.
[0022] The cups of the present invention are composed of a material
which renders the cup's inner surface sufficiently smooth and slick
to prevent the liquid contents from adhering to the cup when
dispensed. Such a material preferably has a small molecular
structure and prevents liquids from intermingling on a molecular
basis. Cups according to the invention may be manufactured by any
suitable method, including vacuum forming, injection molding, or
any combination of the two. A preferred manufacturing method is
injection molding to obtain smooth surfaces and high compressive
strength. In the injection molding process a mold, typically with
two halves, is set together with a space between them which
corresponds to the shape of the object to be formed. Plastic or
other suitable material is forced into the space through an
opening. The material then hardens and the halves are separated,
releasing the formed object. The injection molding process may use
molds suitable for straight draw molding or molds with side action.
Preferred materials for composing cups according to the invention
are high density polyethylene or polypropylene. Alternatively, a
cyclic olefin copolymer (COC) barrier material may be used. The cup
may be of a color or shade which visually identifies or
distinguishes the cup. The cup may be transparent or opaque.
[0023] The liquid contained or measured within the cup will
typically be a liquid pharmaceutical formulation present in a unit
dose amount. The liquid pharmaceutical formulation may be indicated
for oral administration and may be, for example, a solution, syrup,
or a suspension. The liquid pharmaceutical formulation is typically
a suspension, but may be any other liquid, including any other
liquid suitable for ingesting a pharmaceutically active product.
Various pharmaceutical products for use in accordance with the
present invention include, by way of example only, oral
formulations containing lactulose, nystatin, phenytoin, sulfatrim,
ibuprofen, or megestrol acetate, together with a pharmaceutically
acceptable carrier.
[0024] Various embodiments according to present invention will now
be described with reference to the accompanying drawings, wherein
like reference numerals correspond to like components. Referring to
FIGS. 1 and 2, the illustrated cup includes a bowl 2 having a
smooth concave inner surface, which may be hemispherical or
non-spherical. The inner surface does not include any sharp edges,
which are typically present with prior art flat bottom cups. The
bowl 2 is supported by an annular base 7, which provides a stable
resting platform or surface for the cup. The sidewall of the bowl
forms an upper sidewall 17 for the cup, while the base 7 forms the
lower sidewall 19 of the cup. The lower sidewall 19 extends even
with, or preferably beyond, the outer bottom portion 21 of the bowl
so that the cup can stably rest on the table, shelf, hospital tray,
or other surface.
[0025] The angle 20 between the annular base and the table, shelf
or other horizontal surface can be 90.degree., resulting from a
cylindrical base, or any other suitable angle, such as from a
conical or frustoconical base. The angle 18 between the upper and
lower sidewalls 17, 19 is typically less than or equal to
180.degree. and, may be about 120.degree. to 150.degree., for
example. The angle 18 may be, but need not be, gradual or rounded
to form a smooth outer surface, so long as the concave inner
surface of the cup does not contain any corners or angles where
residual liquid contents might otherwise adhere after the bulk
liquid is dispensed.
[0026] The bowl 2 and annular base 7 can be manufactured with any
suitable dimensions selected depending on the dosage or other end
use application of the cup. The bowl 2 will typically be wider,
i.e., have a larger maximum diameter, than the annular base 7. The
ratio of height to diameter for the bowl 2 may be, for example, in
the range of about 1.5:1 to 1:1. The height of the base 7 is
preferably just sufficient to raise the bottom 21 of the bowl 2 off
of the table, shelf, or other surface. The ratio of height to
diameter of the base 7 may be, for example, about 1:3 to 1:5.
[0027] The upper 17 and lower 19 portions of the sidewall 1 can
provide for improved stability and grip. The raised gripping
surface or ribs 3 shown in the embodiment illustrated in FIG. 1
provide additional grip enhancement. FIG. 2 illustrates an
alternate configuration for gripping surfaces 3. Numerous other
configurations of gripping surfaces can be used in accordance with
the present invention. A gripping surface may encircle the cup
entirely or only partially and may be rounded or have defined
edges. The gripping surface may be molded or formed as part of the
cup or may be affixed to the cup after the molding or forming
process. The gripping surface may be textured to enhance friction
between the user's fingers and the cup sidewall.
[0028] The concave shape of the inner surface of the bowl 2
promotes evacuation of the cup's contents in that it preferably
includes no internal corners or edges. The concave configuration
may be of a variety of shapes and dimensions including, by way of
example only, those yielding hemispherical or hemi-oblong shapes.
The shape of the inner surface may be one in which a pure or 100%
radius is achieved. Numerous materials can be used to render the
cup's inner surface sufficiently smooth to further prevent or
minimize any residual liquid contents from adhering to it when
dispensed. These materials include, by way of example only, high
density polyethylene and polypropylene.
[0029] In the illustrated embodiments, the cups also include a rim
4, with a top surface 6, and an outer edge which forms a rounded
continuous surface 5. This rim configuration can facilitate removal
of an optional flexible, disposable lid 13, as shown in FIG. 3D.
Lid 13 may contain a label indicating on its surface unit dose
quantity and other characteristics of the cup's contents. Lid 13
may be a laminate having a paper layer and a foil underside with a
seal that adheres to the cup's rim 4. The lid may alternately be a
rigid lid. Suitable lids may be opaque or transparent and may
contain a tab or other grip for facilitating removal. Various
suitable processes for affixing lid 13 include, by way of example,
the use of perforated labels on a roller, blowing the lid onto the
cup, or a "pick and place" method in which a robotic arm places the
lid onto the cup.
[0030] The rim's rounded edge shape also serves to eliminate the
hazards to a patient's lips associated with rougher edges. The top
surface 6 of the rim will typically have a relatively small
dimension to aid in keeping the surface clean and dispensing the
contents.
[0031] Referring now to FIG. 3A, the outer edge of the rim may be
manufactured with a reverse draft angle 15 to facilitate removal of
the cup from an injection mold. The angle 15 is preferably greater
than or equal to 0.degree. and more preferably, between about
1.degree. and 45.degree..
[0032] FIG. 3B shows a parting line 14 which may occur during a
molding process at the point where two molds meet. A phenomenon
known as flash may occur if the two molds do not fit together
precisely. Flash can result in sharp, irregular edges and occurs
when liquid squirts between the ill-fitting molds. In one
embodiment of the present invention, a step 16, illustrated in FIG.
3B, is included at the parting line to reduce or eliminate the
occurrence of flash.
[0033] FIGS. 3A and 3C illustrate the top edge 8 of the cup of a
preferred embodiment of the invention. Top edge 8 occurs where the
surface 6 of the rim meets the inner surface of the upper sidewall
17 of the cup. The sharp demarcation created by the surface of the
rim and the inner surface of the cup provides for enhanced content
removal with a minimum of residue spilling on and clinging to the
top surface of the rim during dispensing of the cup's contents. In
an alternate embodiment, the edge 8 may include a step as shown in
FIG. 4. This configuration helps to prevent liquid contents from
spilling out upon lid removal by allowing the liquid to drain back
into the cup.
[0034] FIGS. 5 and 6 illustrate embodiments having alternate
annular base configurations 7. In the embodiment illustrated in
FIG. 5, the annular base is frustaconic, with the angle 18 formed
by upper sidewall 17 and lower sidewall 19 being less than
180.degree. and angle 20 being greater than 90.degree.. The
configuration illustrated in FIG. 5 can be achieved via an
injection molding process by using a mold with movement or side
action. A straight draw mold may be used in the manufacture of cups
having annular base configurations in which angle 20 is about
90.degree..
[0035] The alternate embodiment illustrated in FIG. 6 includes a
base 7 which includes a lateral hip extension 22 at its top which
extends outward from sidewall 1 of the cup. Hip extension 22 may be
substantially horizontal or may extend slightly upward or
downward.
[0036] Numerous alternative base configurations may be used in
accordance with the present invention. Such configurations include,
by way of example only, bases having multiple concentric annular
portions. In configurations with multiple concentric annular base
portions, each individual portion may be at the same or at a
different angle in relation to a horizontal surface. Any of the
bases suitable for use in the present invention may be friction
enhanced on its bottom surface 23. Such friction enhancement may be
a texture or other suitable enhancement produced during the
manufacturing process of the cup. Alternatively, the friction
enhancement may be a surface affixed to the base after the cup is
molded or formed. The annular base 7, preferably has a rectangular
lower edge 23, which promotes stability for the cup to remain
upright when placed on a surface such as a hospital tray, shelf, or
table during use or storage, or while the cup is being filled, or a
lid is being affixed during production. In the embodiment
illustrated in FIG. 2B, the outer sidewall 1, formed in part by the
annular base, provides for superior strength against radial
compression 9.
[0037] The upper portion 17 of the outer sidewall also allows for
the inclusion of a conspicuously placed marking 11, if desired. The
marking may be a design, a symbol, a word or group of words, or
other graphic marking, including a measurement scale for
determining the liquid volume of the cup's contents. The space
provided on the outer surface of the cup's bottom 12 may
accommodate additional markings or writing. The markings may be
raised. Markings can be used in marketing the product or
identifying its origin.
[0038] The embodiment illustrated in FIG. 2B includes optional
stacking vanes 10. These stacking vanes allow a plurality of cups
to be stacked with minimal distance between them to improve packing
efficiency and accommodate space limitations.
[0039] The above description and examples are illustrative of
alternative embodiments which achieve the objects, features, and
advantages of the present invention, and it is not intended that
the present invention be limited thereto.
* * * * *