Gastric retentive pharmaceutical compositions for treatment and prevention of CNS disorders

摘要

The present disclosure is directed to methods and compositions for ameliorating, preventing and treating central nervous system (CNS) disorders. The invention aims to treat subjects suffering from, susceptible to, or diagnosed with CNS disorders, and in particular, to treating patients suffering from those disorders which are associated with neurotransmitter system dysfunction.

主权项

1. A method for treating a subject suffering from a movement disorder, comprising orally administering to said subject an extended release dosage form comprising a polymer matrix,
wherein the polymer matrix comprises at least one hydrophilic polymer wherein the at least one hydrophilic polymer is present in the polymer matrix in an amount ranging from 20 wt % to 60 wt % and the at least one hydrophilic polymer comprises polyethylene oxide) having a molecular weight of about 900,000 Daltons to 2,000,000 Daltons,
wherein a first dose of levodopa and a first dose of carbidopa are dispersed in the polymer matrix, andwherein the polymer matrix swells upon imbibition of fluid to a size sufficient for gastric retention in the gastrointestinal tract of the subject in a fed mode,wherein not more than 40% of the first dose of levodopa and not more than 40% of the first dose of carbidopa are released from the dosage form within about the first hour after administration, andwherein at least 80% of the first dose of levodopa and at least 80% of the first dose of carbidopa are released from the dosage form during a period of about 8 hours after oral administration.