Packaging materials for formulations containing 2-pyrrolidone derivatives

Abstract

Packaging materials substantially lacking adsorptive and absorptive properties for 2-pyrrolidone derivatives are provided. The packaged products described herein provide for retention of the 2-pyrrolidone derivative within the formulation thereby maintaining the integrity of such formulations. Packaged products are useful for ophthalmic, otic, and nasal applications. Ophthalmic application includes therapeutic uses and contact lens care uses.

Description

[0001]This application claims priority to U.S. Provisional Application, U.S. Ser. No. 60 / 854,320 filed Oct. 24, 2006.FIELD OF THE INVENTION[0002]The present invention relates to the field of packaging materials that maintain the integrity of formulations comprising 2-pyrrolidone derivative compounds.BACKGROUND OF THE INVENTION[0003]Traditional glass containers and vials are generally considered inert to aqueous-based pharmaceutical formulations. The chemical inertness of glass renders it a desirable material for containing and distributing such formulations; however, glass is breakable, difficult to handle, and inconvenient for patient use. Molded polymer containers are frequently an acceptable substitute for packaging liquid formulations for distribution and use, particularly containers made from polymers such as low or high density polyethylene (LDPE or HDPE), polypropylene (PP), or polyethylene terephthalate (PETE).[0004]Any inappropriate chemical or physical interaction between ...

AI Technical Summary

Benefits of technology

[0013]A method of minimizing absorption and adsorption of a 5-(R1)-N-(R2)-2-pyrrolidone compound to a container material therefor is an embodiment of the invention. The method comprises packaging a 5-(R1)-N-(R2)-2-pyrrolidone-containing formulation in a container made from a polyethylene terephthalate, a fluoropolymer, or a polystyrene; or packaging a 5-(R1)-N-(R2)-2-pyrrolidone-containing formulation in a container having an inner lining; the inner lining made from a material substantially lacking absorptive and adsorptive properties for the 5-(R1)-N-(R2)-2-pyrrolidone; and the container other than the inner lining is made from a polypropylene or a polyethylene. For the 5-(R1)-N-(R2)-2-pyrrolidone-containing formulation, R1 is H, methyl or ethyl, and R2 is C6-C12 straight-chain, branched, substituted or unsubstituted alkyl, oxyalkyl, amidoalkyl, hydroxyalkyl, alkenyl, alkynyl, cycloalkyl, alkylcycloalkyl, or alkylaryl.

Problems solved by technology

In the process of packaging such formulations, the present inventors unexpectedly discovered that certain types of common packaging material adsorb or absorb the 2-pyrrolidone derivative, thus removing it from the formulation and rendering the formulation ineffective for its intended purpose.

In particular, the present inventors have discovered that low density polyethylene (LDPE), a common and generally desirable packaging material due to its flexibility, is ineffective for packaging 2-pyrrolidone derivative-containing formulations.

Further, polypropylene (PP) packaging material was also found to be ineffective.