Spray-dried amorphous solid dispersions and method for preparation
AssigneeMerck Patent GmbH
InventorsLena Mueller, Laura Halstenberg, Thomas Kipping, Nicole Di Gallo
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Abstract
The present invention relates to the use of polyvinyl alcohol for spray-drying to form an amorphous solid dispersion of an active pharmaceutical ingredient in a polyvinyl alcohol matrix. Furthermore, the invention relates to a process for producing an amorphous solid dispersion of an active pharmaceutical ingredient in a polyvinyl alcohol matrix by spray-drying.
Claims20
An amorphous solid dispersion comprising at least one active pharmaceutical ingredient in a polyvinyl alcohol matrix, wherein the amorphous solid dispersion is obtained by a spray-drying process using polyvinyl alcohol having a hydrolysis degree of 90% or lower.
Process for producing an amorphous solid dispersion of at least one active pharmaceutical ingredient in a polyvinyl alcohol matrix by spray-drying, comprising the steps of:
- a) preparing a feed solution comprising the at least one active pharmaceutical ingredient and at least one polyvinyl alcohol having a hydrolysis degree of 90% or lower, and
- b) spray-drying the feed solution.
Process for producing an amorphous solid dispersion of at least one active pharmaceutical ingredient in a polyvinyl alcohol matrix by three-fluid nozzle spray-drying, comprising the steps of:
- a) preparing a first feed solution comprising the at least one active pharmaceutical ingredient,
- b) preparing a second feed solution comprising a polyvinyl alcohol having a hydrolysis degree of 90% or lower, and
- c) spray-drying the first and second feed solution with a three-fluid nozzle.
Dependencies are inferred from the claim text.