Patent ID: 7939104
Filing Date: 2011-05-10
Classification: A61K,A61P

Abstract:
1. A wet granulation method of preparing a pharmaceutical composition having improved solubility comprising a hydrophobic drug or pharmaceutically acceptable salt thereof and a compound having at least one carboxylic acid moiety, wherein the molar ratio of the compound having at least one carboxylic acid moiety to the hydrophobic drug or pharmaceutically acceptable salt thereof is from about 2:1 to about 10:1, said method comprising: (a) combining a compound having at least one carboxylic acid moiety with a solid hydrophobic drug or pharmaceutically acceptable salt thereof, and optionally one or more excipients, to form a premix; (b) adding a solvent, and optionally a surfactant, to the premix formed in step (a) to form a wet granulation; and (c) drying the wet granulation to form a pharmaceutical composition; wherein the hydrophobic drug or pharmaceutically acceptable salt thereof is selected from the group consisting of ziprasidone, raloxifene, paroxetine, glimepiride, anagrelide, modafinil, cabergoline, replaginide, glipizide, benzodiazepines, clofibrate, chlorpheniramine, dinitirate, digoxin, digitoxin, ergotamin tartate, estradiol, fenofibrate, griseofulvin, hydrochlorothiazide, hydrocortisone, isosorbide, medrogeston, oxyphenbutazone, prednisolone, prednisone, polythiazide, progensterone, spironolactone, tolbutamide, 10,11-dihydro-5H-dibenzo[a,d]cyclo-heptene-5-carboxamide, 5H-dibenzo[a,d]cycloheptene-5-carboxamide and mixtures thereof and wherein the hydrophobic drug or pharmaceutically acceptable salt thereof in the pharmaceutical composition exhibits a dissolution rate in a buffered aqueous medium at a pH of 7.5 and a temperature of 37° C. of at least about 35% over about 30 minutes after being combined therewith.