Patent ID: 8679533
Filing Date: 2014-03-25
Classification: A61K,A61P

Abstract:
1. An orally deliverable pharmaceutical once daily sustained release composition comprising about 0.1 to about 10 mg of pramipexole dihydrochloride monohydrate a starch in an amount of about 25% to about 75% by weight, a hydrophilic polymer in an amount of about 20% to about 70% by weight, wherein said pramipexole is dispersed in hydrophilic polymer and starch, and said hydrophilic polymer functions to provide sustained release of said pramipexole, said composition exhibiting at least one of (a) an in vitro release profile wherein on average no more than about 20% of the pramipexole is dissolved within 2 hours after placement of the composition in a standard dissolution test conducted according to USP24 using Apparatus 1 with a spindle rotation speed of 100 rpm and a dissolution medium of 0.05M phosphate buffer, pH 6.8, at 37° C.; and (b) an in vivo pramipexole absorption profile following single dose oral administration to healthy adult humans wherein the time to reach a mean of 20% absorption is greater than about 2 hours and/or the time to reach a mean of 40% absorption is greater than about 4 hours wherein said composition comprises a full daily dose contained in a single dose unit, further wherein said composition, when administered once daily, exhibits a bioavailability substantially equivalent to an equal daily dose of an immediate-release pramipexole dihydrochloride reference formulation administered three times a day.