U.S. patent application number 11/621440 was filed with the patent office on 2007-08-16 for container for compositions containing cefdinir.
Invention is credited to Shyamala C. Jayaraman, Daniel W. Kim, Chetan P. Pujara.
Application Number | 20070187405 11/621440 |
Document ID | / |
Family ID | 38093343 |
Filed Date | 2007-08-16 |
United States Patent
Application |
20070187405 |
Kind Code |
A1 |
Pujara; Chetan P. ; et
al. |
August 16, 2007 |
CONTAINER FOR COMPOSITIONS CONTAINING CEFDINIR
Abstract
Plastic containers for storage and preservation of compositions
comprising cefdinir are disclosed.
Inventors: |
Pujara; Chetan P.; (Gurnee,
IL) ; Kim; Daniel W.; (Chicago, IL) ;
Jayaraman; Shyamala C.; (Gurnee, IL) |
Correspondence
Address: |
ROBERT DEBERARDINE;ABBOTT LABORATORIES
100 ABBOTT PARK ROAD
DEPT. 377/AP6A
ABBOTT PARK
IL
60064-6008
US
|
Family ID: |
38093343 |
Appl. No.: |
11/621440 |
Filed: |
January 9, 2007 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60761199 |
Jan 23, 2006 |
|
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Current U.S.
Class: |
220/200 |
Current CPC
Class: |
A61J 1/00 20130101; A61K
9/145 20130101 |
Class at
Publication: |
220/200 |
International
Class: |
B65B 7/16 20060101
B65B007/16 |
Claims
1. A plastic container having a closure device for storing and
preserving compositions comprising sodium benzoate and cefdinir,
wherein the percentage of the sodium benzoate or the cefdinir
remains substantially unchanged over time.
2. The plastic container of claim 1, wherein the cefdinir therein
is cefdinir powder for reconstituted suspension.
3. A plastic container having a closure device for storing and
preserving compositions comprising sodium benzoate and cefdinir,
wherein the cefdinir remains at least at about 90% of its original
theoretical amount or the sodium benzoate remains at least at about
80% of its original theoretical amount.
4. The plastic container of claim 3, wherein the cefdinir therein
is cefdinir powder for reconstituted suspension.
5. A plastic container having a closure device for storing and
preserving pharmaceutical compositions comprising sodium benzoate
and cefdinir, wherein, after 24 months, the cefdinir remains at
least at about 90% of its original theoretical amount or the sodium
benzoate remains at least at about 80% of its original theoretical
amount.
6. The plastic container of claim 5, wherein the cefdinir therein
is cefdinir powder for reconstituted suspension.
7. A polyethylene naphthylate container having a closure device for
storing and preserving pharmaceutical compositions comprising
sodium benzoate and cefdinir.
8. The plastic container of claim 7, wherein the cefdinir therein
is cefdinir powder for reconstituted suspension.
9. A polyethylene naphthylate container having a closure device for
storing and preserving pharmaceutical compositions comprising
sodium benzoate and cefdinir, wherein the cefdinir remains at least
at about 90% of its original theoretical amount or the sodium
benzoate remains at least at about 80% of its original theoretical
amount.
10. The polyethylene naphthylate container of claim 9, wherein the
cefdinir therein is cefdinir powder for reconstituted
suspension.
11. A polyethylene naphthylate container having a closure device
for storing and preserving pharmaceutical compositions comprising
sodium benzoate and cefdinir, wherein, after 24 months, the
cefdinir remains at least at about 90% of its original theoretical
amount or the sodium benzoate remains at least at about 80% of its
original theoretical amount.
12. The polyethylene naphthylate container of claim 11, wherein the
cefdinir therein is cefdinir powder for reconstituted
suspension.
13. A cyclic olefin copolymer container having a closure device for
storing and preserving pharmaceutical compositions comprising
sodium benzoate and cefdinir.
14. The cyclic olefin copolymer container of claim 13, wherein the
cefdinir therein is cefdinir powder for reconstituted
suspension.
15. A cyclic olefin copolymer container having a closure device for
storing and preserving pharmaceutical compositions comprising
sodium benzoate and cefdinir, wherein the cefdinir remains at least
at about 90% of its original theoretical amount or the sodium
benzoate remains at least at about 80% of its original theoretical
amount.
16. The cyclic olefin copolymer container of claim 15, wherein the
cefdinir therein is cefdinir powder for reconstituted
suspension.
17. A cyclic olefin copolymer container having a closure device for
storing and preserving pharmaceutical compositions comprising
sodium benzoate and cefdinir, wherein, after 24 months, the
cefdinir remains at least at about 90% of its original theoretical
amount or the sodium benzoate remains at least at about 80% of its
original theoretical amount.
18. The cyclic olefin copolymer container of claim 17, wherein the
cefdinir therein is cefdinir powder for reconstituted
suspension.
19. A plastic container having a closure device for storing and
preserving compositions comprising sodium benzoate and cefdinir,
wherein the percentage of the sodium benzoate and the cefdinir
remains substantially unchanged over time.
20. The plastic container of claim 19, wherein the cefdinir therein
is cefdinir powder for reconstituted suspension.
21. A plastic container having a closure device for storing and
preserving compositions comprising sodium benzoate and cefdinir,
wherein the cefdinir remains at least at about 90% of its original
theoretical amount and the sodium benzoate remains at least at
about 80% of its original theoretical amount.
22. The plastic container of claim 21, wherein the cefdinir therein
is cefdinir powder for reconstituted suspension.
23. A plastic container having a closure device for storing and
preserving pharmaceutical compositions comprising sodium benzoate
and cefdinir, wherein, after 24 months, the cefdinir remains at
least at about 90% of its original theoretical amount and the
sodium benzoate remains at least at about 80% of its original
theoretical amount.
24. The plastic container of claim 23, wherein the cefdinir therein
is cefdinir powder for reconstituted suspension.
25. A polyethylene naphthylate container having a closure device
for storing and preserving pharmaceutical compositions comprising
sodium benzoate and cefdinir.
26. The polyethylene naphthylate container of claim 25, wherein the
cefdinir therein is cefdinir powder for reconstituted
suspension.
27. A polyethylene naphthylate container having a closure device
for storing and preserving pharmaceutical compositions comprising
sodium benzoate and cefdinir, wherein the cefdinir remains at least
at about 90% of its original theoretical amount and the sodium
benzoate remains at least at about 80% of its original theoretical
amount.
28. The polyethylene naphthylate container of claim 27, wherein the
cefdinir therein is cefdinir powder for reconstituted
suspension.
29. A polyethylene naphthylate container having a closure device
for storing and preserving pharmaceutical compositions comprising
sodium benzoate and cefdinir, wherein, after 24 months, the
cefdinir remains at least at about 90% of its original theoretical
amount and the sodium benzoate remains at least at about 80% of its
original theoretical amount.
30. The polyethylene naphthylate container of claim 29, wherein the
cefdinir therein is cefdinir powder for reconstituted
suspension.
31. A cyclic olefin copolymer container having a closure device for
storing and preserving pharmaceutical compositions comprising
sodium benzoate and cefdinir.
32. The cyclic olefin copolymer container of claim 31, wherein the
cefdinir therein is cefdinir powder for reconstituted
suspension.
33. A cyclic olefin copolymer container having a closure device for
storing and preserving pharmaceutical compositions comprising
sodium benzoate and cefdinir, wherein the cefdinir remains at least
at about 90% of its original theoretical amount and the sodium
benzoate remains at least at about 80% of its original theoretical
amount.
34. The cyclic olefin copolymer container of claim 33, wherein the
cefdinir therein is cefdinir powder for reconstituted
suspension.
35. A cyclic olefin copolymer container having a closure device for
storing and preserving pharmaceutical compositions comprising
sodium benzoate and cefdinir, wherein, after 24 months, the
cefdinir remains at least at about 90% of its original theoretical
amount and the sodium benzoate remains at least at about 80% of its
original theoretical amount.
36. The cyclic olefin copolymer container of claim 35, wherein the
cefdinir therein is cefdinir powder for reconstituted suspension.
Description
[0001] This application claims priority to U.S. Provisional Patent
Application No. 60/761,199, filed Jan. 23, 2006.
FIELD OF THE INVENTION
[0002] This invention pertains to plastic containers for storage
and preservation of compositions comprising cefdinir.
BACKGROUND OF THE INVENTION
[0003] Cefdinir, an antibiotic available as capsules and powder for
reconstituted suspension, is transported and stored in glass
containers. To improve safety and handling of cefdinir, there is an
existing need in the therapeutic arts for a less breakable
container in which the cefdinir may be transported and stored.
BRIEF DESCRIPTION OF THE FIGURES
[0004] FIG. 1 shows the effect of plastic type on cefdinir amount
over time.
[0005] FIG. 2 shows the effect of plastic type on sodium benzoate
amount over time.
[0006] FIG. 3 shows a preferred shape for a plastic container.
SUMMARY OF THE INVENTION
[0007] One embodiment of this invention pertains to a plastic
container having a closure device for storing and preserving
compositions comprising sodium benzoate and cefdinir, wherein the
percentage of the sodium benzoate or the cefdinir remains
substantially unchanged over time.
[0008] Another embodiment pertains to a plastic container having a
closure device for storing and preserving compositions comprising
sodium benzoate and cefdinir, wherein the percentage of the sodium
benzoate and the cefdinir remains substantially unchanged over
time.
DETAILED DESCRIPTION OF THE INVENTION
[0009] This invention pertains to plastic containers for storage
and preservation of compositions comprising cefdinir.
[0010] One embodiment of this invention pertains to a plastic
container having a closure device for storing and preserving
compositions comprising sodium benzoate and cefdinir, wherein the
percentage of the sodium benzoate or the cefdinir remains
substantially unchanged over time.
[0011] Another embodiment pertains to a plastic container having a
closure device for storing and preserving compositions comprising
sodium benzoate and cefdinir, wherein the cefdinir remains at least
at about 90% of its original theoretical amount or sodium benzoate
remains at least at about 80% of its original theoretical
amount.
[0012] Still another embodiment pertains to a plastic container
having a closure device for storing and preserving pharmaceutical
compositions comprising sodium benzoate and cefdinir, wherein,
after 24 months, the cefdinir remains at least at about 90% of its
original theoretical amount or the sodium benzoate remains at least
at about 80% of its original theoretical amount.
[0013] Still another embodiment pertains to a polyethylene
naphthylate container having a closure device for storing and
preserving pharmaceutical compositions comprising sodium benzoate
and cefdinir.
[0014] Still another embodiment pertains to a polyethylene
naphthylate container having a closure device for storing and
preserving pharmaceutical compositions comprising sodium benzoate
and cefdinir, wherein the cefdinir remains at least at about 90% of
its original theoretical amount or the sodium benzoate remains at
least at about 80% of its original theoretical amount.
[0015] Still another embodiment pertains to a polyethylene
naphthylate container having a closure device for storing and
preserving pharmaceutical compositions comprising sodium benzoate
and cefdinir, wherein, after 24 months, the cefdinir remains at
least at about 90% of its original theoretical amount or the sodium
benzoate remains at least at about 80% of its original theoretical
amount.
[0016] Still another embodiment pertains to a cyclic olefin
copolymer container having a closure device for storing and
preserving pharmaceutical compositions comprising sodium benzoate
and cefdinir.
[0017] Still another embodiment pertains to a cyclic olefin
copolymer container having a closure device for storing and
preserving pharmaceutical compositions comprising sodium benzoate
and cefdinir, wherein the cefdinir remains at least at about 90% of
its original theoretical amount or the sodium benzoate remains at
least at about 80% of its original theoretical amount.
[0018] Still another embodiment pertains to a cyclic olefin
copolymer container having a closure device for storing and
preserving pharmaceutical compositions comprising sodium benzoate
and cefdinir, wherein, after 24 months, the cefdinir remains at
least at about 90% of its original theoretical amount or the sodium
benzoate remains at least at about 80% of its original theoretical
amount.
[0019] Still another embodiment pertains to a plastic container
having a closure device for storing and preserving compositions
comprising sodium benzoate and cefdinir, wherein the percentage of
the sodium benzoate and the cefdinir remains substantially
unchanged over time.
[0020] Still another embodiment pertains to a plastic container
having a closure device for storing and preserving compositions
comprising sodium benzoate and cefdinir, wherein the cefdinir
remains at least at about 90% of its original theoretical amount
and the sodium benzoate remains at least at about 80% of its
original theoretical amount.
[0021] Still another embodiment pertains to a plastic container
having a closure device for storing and preserving pharmaceutical
compositions comprising sodium benzoate and cefdinir, wherein,
after 24 months, the cefdinir remains at least at about 90% of its
original theoretical amount and the sodium benzoate remains at
least at about 80% of its original theoretical amount.
[0022] Still another embodiment pertains to a polyethylene
naphthylate container having a closure device for storing and
preserving pharmaceutical compositions comprising sodium benzoate
and cefdinir.
[0023] Still another embodiment pertains to a polyethylene
naphthylate container having a closure device for storing and
preserving pharmaceutical compositions comprising sodium benzoate
and cefdinir, wherein the cefdinir remains at least at about 90% of
its original theoretical amount and the sodium benzoate remains at
least at about 80% of its original theoretical amount.
[0024] Still another embodiment pertains to a polyethylene
naphthylate container having a closure device for storing and
preserving pharmaceutical compositions comprising sodium benzoate
and cefdinir, wherein, after 24 months, the cefdinir remains at
least at about 90% of its original theoretical amount and the
sodium benzoate remains at least at about 80% of its original
theoretical amount.
[0025] Still another embodiment pertains to a cyclic olefin
copolymer container having a closure device for storing and
preserving pharmaceutical compositions comprising sodium benzoate
and cefdinir.
[0026] Still another embodiment pertains to a cyclic olefin
copolymer container having a closure device for storing and
preserving pharmaceutical compositions comprising sodium benzoate
and cefdinir, wherein the cefdinir remains at least at about 90% of
its original theoretical amount and the sodium benzoate remains at
least at about 80% of its original theoretical amount.
[0027] Still another embodiment pertains to a cyclic olefin
copolymer container having a closure device for storing and
preserving pharmaceutical compositions comprising sodium benzoate
and cefdinir, wherein, after 24 months, the cefdinir remains at
least at about 90% of its original theoretical amount and the
sodium benzoate remains at least at about 80% of its original
theoretical amount.
[0028] The term "substantially unchanged," as used herein in
reference to cefdinir, means remains at least at about 90% of its
original theoretical amount, preferably at least at about 95% of
its original theoretical amount, more preferably at least at about
98% of its original theoretical amount, most preferably at least at
about 99% of its original theoretical amount.
[0029] The term "substantially unchanged," as used herein in
reference to sodium benzoate, means remains at least at about 80%
of its original theoretical amount, preferably at least at about
90% of its original theoretical amount, more preferably at least at
about 95% of its original theoretical amount, most preferably at
least at about 99% of its original theoretical amount.
[0030] The cefdinir of this invention may be in a physical form
such as powders, pellets or granules. In a preferred embodiment for
the practice of this invention the cefdinir is in powder form for
reconstitution in suspension.
[0031] The amount of cefdinir in a sample removed from a container,
based on a formula composition for its label indication (its
original theoretical amount), is typically between about 90% and
100% of its original theoretical amount.
[0032] For example, for a teaspoon of a composition comprising
cefdinir powder for reconstituted suspension with a label
indication that claims that 250 mg of cefdinir will be in that
teaspoon, the amount of cefdinir in that teaspoon may be about 90%
to about 100% of the 250 mg.
[0033] FIG. 3 shows a plastic container 1, provided with a
conventional closure device 2, that is useful for storing and
preserving compositions comprising sodium benzoate and cefdinir 3.
It is meant to be understood that the container 1 shown in FIG. 3
is a preferred embodiment for the practice of this invention and
that a container of any shape for storing and preserving
pharmaceutical compositions comprising cefdinir can be made from a
plastic in which the percentage of the cefdinir in the compositions
remains substantially constant over time.
[0034] In a study with HDPE and triple layer bottles (PET/COC/PET),
it was noted that a substantial reduction in the amount of sodium
benzoate and original theoretical amounts of cefdinir occurred over
time. It was also noted that the reduction of the original
theoretical amounts of cefdinir in the composition accelerated when
the amount of sodium benzoate in the same composition dropped to
below about 90% of its original amount.
[0035] A rapid screening study was designed to evaluate plastics
that might cause reduction in the amount of sodium benzoate. The
plastics tested are shown in TABLE 1. TABLE-US-00001 TABLE 1
Plastic Abbreviation Cyclic Olefin Copolymer 8007 D-61 COC Ethylene
Chlorotrifluoroethylene E-CTFE Fluorinated ethylenepropylene FEP
High-density Polyethylene 5502 BN HDPE Polyethylene naphthylate
75-3177 PEN Polyethylene terphthalate 79921 PET
Polyphenylenesulfide Fotran 9320C0 PPS Polypropylene FT120WB PP
Polystyrene 3510 PS Polyvinyl chloride PVC
[0036] Based on the results of this study, shown in TABLE 2, PEN
and COC were chosen for further evaluation. TABLE-US-00002 TABLE 2
Plastic Beads % Loss After 1 Week % Loss After 2 Weeks PEN 6.5 13.8
PPS 4.0 17.7 polystyrene 11.9 18.0 COC 11.5 19.8 PET 10.2 20.3
polypropylene 14.4 20.3 HDPE 22.9 22.3 PVC 15.9 24.9 control (1)
-1.3 0.4 control (2) 7.8 17.4 % loss are w/w percentages (1)
without beads and without salt solution and (2) without beads and
with salt solution
[0037] Bottles made from PEN and COC were charged with active
granulation and placed on an accelerated stability study at
25.degree. C./60% relative humidity for 24 months along with glass
bottles that served as controls. The contents of the bottles were
tested at pre-determined time points for cefdinir and sodium
benzoate concentration.
[0038] As shown in FIG. 1, results from the stability study
indicate that the assay values of cefdinir were greater than 90%
for the glass, PEN and COC bottles. The sodium benzoate values for
the glass, PEN and COC bottles also remained substantially constant
over the duration of the study.
[0039] Additionally, bottles made from E-CTFE and FEP were charged
with active granulation and placed on an accelerated stability
study at 40.degree. C./75% relative humidity for 6 months along
with glass bottles that served as controls. The contents of the
bottles were tested at pre-determined time points for cefdinir and
sodium benzoate concentration. Results from this stability study
indicated that the assay values for the glass, E-CTFE and FEP
bottles remained substantially constant over the duration of the
study.
[0040] The foregoing is meant to illustrate the invention but not
to limit it. Variations and changes obvious to one skilled in the
art are intended to be within the scope of the invention as defined
in the claims.
* * * * *