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.

1 . A packaged product comprising:
 a formulation for ophthalmic, otic, or nasal use, the formulation comprising 5-(R 1 )-N-(R 2 )-2-pyrrolidone,
 wherein R 1  is H, methyl or ethyl, and 
 wherein R 2  is C 6 -C 12  straight-chain, branched, substituted or unsubstituted alkyl, oxyalkyl, amidoalkyl, hydroxyalkyl, alkenyl, alkynyl, cycloalkyl, alkylcycloalkyl, or alkylaryl; and 
   a container comprising a material substantially lacking absorptive and adsorptive properties for the 5-(R 1 )-N-(R 2 )-2-pyrrolidone,   wherein the formulation is packaged in the container.   
     
     
         2 . The packaged product of  claim 1  wherein the container consists essentially of the material substantially lacking absorptive and adsorptive properties for the 5-(R 1 )-N-(R 2 )-2-pyrrolidone. 
     
     
         3 . The packaged product of  claim 1 , wherein the container comprises an inner lining; the material of the inner lining substantially lacks absorptive and adsorptive properties for the 5-(R 1 )-N-(R 2 )-2-pyrrolidone; and the container other than the inner lining is made from a polypropylene or a polyethylene. 
     
     
         4 . The packaged product of  claim 1 , wherein the container further comprises a coating, wherein the coating is made of a gas impermeable laminate material. 
     
     
         5 . The packaged product of  claim 1 , wherein the material substantially lacking absorptive and adsorptive properties for the 5-(R 1 )-N-(R 2 )-2-pyrrolidone is selected from the group consisting of polyethylene terephthalate; a flouropolymer; and polystyrene. 
     
     
         6 . The packaged product of  claim 5  wherein the fluoropolymer is selected from the group consisting of polytetrafluoroethlyene; perfluoroalkoxy polymer; fluorinated ethylene propylene copolymer; and ethylenetetrafluoroethylene copolymer. 
     
     
         7 . The packaged product of  claim 5 , wherein the container has a coating of a gas impermeable material. 
     
     
         8 . The packaged product of  claim 7 , wherein the gas impermeable material is a metallic film. 
     
     
         9 . The packaged product of  claim 1 , wherein R 1  is H or methyl and R 2  is C 6 -C 12  straight-chain alkyl. 
     
     
         10 . The packaged product of  claim 9  wherein R 1  is H and R 2  is C 8  straight-chain alkyl such that the 5-(R 1 )-N-(R 2 )-2-pyrrolidone is N-octyl-2-pyrrolidone. 
     
     
         11 . The packaged product of  claim 9  wherein R 1  is H and R 2  is C 12  straight-chain alkyl such that the 5-(R 1 )-N-(R 2 )-2-pyrrolidone is N-dodecyl-2-pyrrolidone. 
     
     
         12 . The packaged product of  claim 1  wherein the formulation further comprises a micelle-forming surfactant at a concentration of less than about 0.3 wt/v %. 
     
     
         13 . A packaged product for ophthalmic, otic, or nasal use, comprising:
 a container made from a material consisting essentially of polyethylene terephthalate; and   a formulation comprising a 5-(R 1 )-N-(R 2 )-2-pyrrolidone,
 wherein R 1  is H, methyl or ethyl, and 
 wherein R 2  is C 6 -C 12  straight-chain, branched, substituted or unsubstituted alkyl, oxyalkyl, amidoalkyl, hydroxyalkyl, alkenyl, alkynyl, cycloalkyl, alkylcycloalkyl, or alkylaryl. 
   
     
     
         14 . A packaged product for ophthalmic, otic, or nasal use, comprising:
 a container made from a material consisting essentially of
 polytetrafluoroethlyene, perfluoroalkoxy polymer, fluorinated ethylene propylene copolymer, or ethylenetetrafluoroethylene copolymer; and 
   a formulation comprising a 5-(R 1 )-N-(R 2 )-2-pyrrolidone,
 wherein R 1  is H, methyl or ethyl, and 
 wherein R 2  is C 6 -C 12  straight-chain, branched, substituted or unsubstituted alkyl, oxyalkyl, amidoalkyl, hydroxyalkyl, alkenyl, alkynyl, cycloalkyl, alkylcycloalkyl, or alkylaryl. 
   
     
     
         15 . A method of minimizing absorption and adsorption of a 5-(R 1 )-N-(R 2 )-2-pyrrolidone compound to a container material therefor, comprising:
 packaging a 5-(R 1 )-N-(R 2 )-2-pyrrolidone-containing formulation in a container made from polyethylene terephthalate, a fluoropolymer, or polystyrene;   or   packaging a 5-(R 1 )-N-(R 2 )-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-(R 1 )-N-(R 2 )-2-pyrrolidone; and the container other than the inner lining is made from a polypropylene or a polyethylene;
 wherein R 1  is H, methyl or ethyl, and 
 wherein R 2  is C 6 -C 12  straight-chain, branched, substituted or unsubstituted alkyl, oxyalkyl, amidoalkyl, hydroxyalkyl, alkenyl, alkynyl, cycloalkyl, alkylcycloalkyl, or alkylaryl. 
   
     
     
         16 . The method of  claim 15 , wherein the container is made from a fluoropolymer and the fluoropolymer consists essentially of polytetrafluoroethylene, perfluoroalkoxy polymer; fluorinated ethylene propylene copolymer; or ethylenetetrafluoroethylene copolymer. 
     
     
         17 . The method of  claim 15 , wherein the container is made from polyethylene terephthalate. 
     
     
         18 . The method of  claim 15 , wherein the container is coated with a gas impermeable material and wherein the container has an inner lining and the inner lining is made from a soluble fluoropolymer. 
     
     
         19 . The method of  claim 15  wherein R 1  is H and R 2  is C 8  straight-chain alkyl such that the 5-(R 1 )-N-(R 2 )-2-pyrrolidone is N-octyl-2-pyrrolidone. 
     
     
         20 . The method of  claim 15 , wherein R 1  is H and R 2  is C 12  straight-chain alkyl such that the 5-(R 1 )-N-(R 2 )-2-pyrrolidone is N-dodecyl-2-pyrrolidone.