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AssigneeMerck Patent GmbH
InventorsThomas KIPPING, Finn BAUER, Nicole DI GALLO, Anja-Nadine KNUETTEL, Alessandro Giuseppe ELIA
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The present invention relates to a method for producing an amorphous solid dispersion of at least one active pharmaceutical ingredient in a polymer matrix. The Invention further relates to a pharmaceutical composition using polymers as an excipient and particularly to an improved pharmaceutical composition comprising polyvinyl alcohol grades with different degrees of hydrolysis, which is suitable to stabilize active pharmaceutical ingredients.
A method for producing an amorphous solid dispersion of at least one active pharmaceutical ingredient in a polymer matrix, wherein the polymer matrix comprises polyvinyl alcohol, comprising selecting a first polyvinyl alcohol having a first degree of hydrolysis, selecting a second polyvinyl alcohol having a second degree of hydrolysis which is lower than the first degree of hydrolysis, mixing the first polyvinyl alcohol, the second polyvinyl alcohol and the active pharmaceutical ingredient at a temperature above the glass transition temperature or melting temperature of the polymer matrix, thereby forming an amorphous solid dispersion of the active pharmaceutical ingredient.
A method for stabilizing the amorphous form of an active pharmaceutical ingredient in a polymer matrix comprising polyvinyl alcohol, said method comprising a step of mixing a first polyvinyl alcohol having a first degree of hydrolysis, a second polyvinyl alcohol having a second degree of hydrolysis which is lower than the first degree of hydrolysis and the active pharmaceutical ingredient at a temperature above the glass transition temperature or melting temperature of the polymer matrix, thereby forming an amorphous solid dispersion of the active pharmaceutical ingredient, whereas the weight ratio of the first PVA and the second PVA is between 1:1 and 1:10.
A method for stabilizing the amorphous form of an active pharmaceutical ingredient in an amorphous solid dispersion comprising
Dependencies are inferred from the claim text.