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.