Preparation method for solid dispersions

Abstract

A method of preparation of a solid dispersion of a polyvinyl alcohol-polyethylene glycol graft copolymer (PVA-PEG graft co-polymer), such as Kollicoat IR with a BCS Class II drug or a BCS Class IV drug, whereby the method comprises: a) dissolving the polyvinyl alcohol-polyethylene glycol graft copolymer (PVA-PEG graft co-polymer) separately in a water/first alcohol mixture; and b) dissolving the BCS Class II drug or a BCS Class IV drug, in a mixture of a second alcohol with a non alcoholic organic solvent in which the compound has an high solubility; and c) mixing the both solutions to obtain a third solution with a total amount of solved solid of 1 to 15 g per 100 ml, and optionally having an acid, including inorganic acids including hydrohalic acids, e.g. hydrochloric or hydrobromic acid; sulfuric; nitric; phosphoric and the like acids; or organic acids including acetic, propanoic, hydroxyacetic, lactic, pyruvic, oxalic, malonic, succinic, maleic, fumaric, malic, tartaric, citric, methane-sulfonic, ethanesulfonic, benzenesulfonic, p-toluenesulfonic, cyclamic, salicylic, p-aminosalicylic, palmoic and the like acids in the mixture of both the solutions to achieve an acid pH; and d) spray drying the third solution.