MODIFIED RELEASE FORMULATION AND METHODS OF USE
First Claim
1. A modified release pharmaceutical formulation, comprising:
- about 30-70% N-(2-amino-4-(fluorobenzylamino)-phenyl)carbamic acid ethyl ester (retigabine), or a pharmaceutically acceptable salt, solvate or hydrate thereof;
about 5-30% of a drug delivery matrix comprising hydroxypropylmethylcellulose (HPMC); and
an enteric polymer,said pharmaceutical formulation producing a sustained plasma concentration of said retigabine following administration to a subject for 4-20 hours longer than the time required for in vitro release of 80% of said retigabine.
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Accused Products
Abstract
A modified release pharmaceutical formulation includes about 30-70% N-(2-amino-4-(fluorobenzylamino)-phenyl)carbamic acid ethyl ester (retigabine), or a pharmaceutically acceptable salt, solvate or hydrate thereof, about 5-30% of a drug delivery matrix including hydroxypropylmethylcellulose (HPMC), and an enteric polymer. The pharmaceutical formulation produces a sustained plasma concentration of retigabine following administration to a subject for 4-20 hours longer than the time required for in vitro release of 80% of retigabine. The plasma concentration vs. time profile of this formulation is substantially flat over an extended period lasting for about 4 hours to about 36 hours. A method of treating a disorder characterized by nervous system hyperexcitability includes administering to a subject an effective amount of these pharmaceutical formulations.
61 Citations
21 Claims
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1. A modified release pharmaceutical formulation, comprising:
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about 30-70% N-(2-amino-4-(fluorobenzylamino)-phenyl)carbamic acid ethyl ester (retigabine), or a pharmaceutically acceptable salt, solvate or hydrate thereof; about 5-30% of a drug delivery matrix comprising hydroxypropylmethylcellulose (HPMC); and an enteric polymer, said pharmaceutical formulation producing a sustained plasma concentration of said retigabine following administration to a subject for 4-20 hours longer than the time required for in vitro release of 80% of said retigabine. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21)
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Specification