CONTAINER FOR COMPOSITIONS CONTAINING CEFDINIR

Description

This application claims priority to U.S. Provisional Patent Application No. 60/761,199, filed Jan. 23, 2006.

FIELD OF THE INVENTION

This invention pertains to plastic containers for storage and preservation of compositions comprising cefdinir.

BACKGROUND OF THE INVENTION

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

FIG. 1 shows the effect of plastic type on cefdinir amount over time.

FIG. 2 shows the effect of plastic type on sodium benzoate amount over time.

FIG. 3 shows a preferred shape for a plastic container.

SUMMARY OF THE INVENTION

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.

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

This invention pertains to plastic containers for storage and preservation of compositions comprising cefdinir.

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.

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.

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.

Still another embodiment pertains to a polyethylene naphthylate container having a closure device for storing and preserving pharmaceutical compositions comprising sodium benzoate and cefdinir.

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.

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.

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.

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.

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.

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.

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.

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.

Still another embodiment pertains to a polyethylene naphthylate container having a closure device for storing and preserving pharmaceutical compositions comprising sodium benzoate and cefdinir.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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 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

Based on the results of this study, shown in TABLE 2, PEN and COC were chosen for further evaluation.

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

Bottles made from PEN and COC were charged with active granulation and placed on an accelerated stability study at 25° 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.

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.

Additionally, bottles made from E-CTFE and FEP were charged with active granulation and placed on an accelerated stability study at 40° 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.

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.