Continuous Process for Manufacturing Immediate Release Pharmaceutical Granule Compositions of Poorly Soluble Drugs

Abstract

This invention relates to a continuous process for manufacturing a pharmaceutical granule composition comprising (i) from 0.5% to 20% by weight of at least one drug classifiable as Class II or Class IV of the Biopharmaceutical Classification System, (ii) a first excipient being a maltodextrin, and (iii) from 15% to 40% by weight of a second excipient being a polyethylene glycol having a weight number molecular weight between 300 and 5,000, said second excipient comprising a solid fraction and a liquid fraction, said pharmaceutical granule composition providing a drug release of at least 70% within 10 minutes in water. The process comprises the steps of: (a)homogenising a mixture comprising said drug (i), said first excipient (ii) and the solid fraction of said second excipient (iii), (b)feeding the mixture obtained in step (a) and the liquid fraction of said second excipient (iii) into an extruding means having one or more mixing zones and one or more transport zones, and (c)extruding the materials fed in step (b) while operating said extruding means at a temperature not above the melting temperature of the solid fraction of the second excipient until a pharmaceutical granule composition in obtained.