Preserving functionally-coated API particles produced by solventless mixing processes in aqueous suspension
AssigneeCatalent U.K. Swindon Zydis Limited
InventorsRosaleen Mclaughlin, Adam Parker, Jonathon Whitehouse
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Abstract
Provided are pharmaceutical compositions and methods for preparing pharmaceutical compositions that preserve the coating of coated API particles in a pharmaceutical suspension. Pharmaceutical compositions include coated active pharmaceutical ingredient (API) particles comprising: an API particle; a first coating comprising one or more deformed components coating the API particle; a second coating comprising silica surrounding and/or partially or fully embedded into the first coating, a matrix former, and a structure former.
Claims17
A pharmaceutical composition comprising:
- a coated API particle comprising;
- a first coating comprising a wax;
- and
- a second coating comprising silica partially embedded in and/or embedded in the wax,
- wherein the coated API particle comprises 0.5-2.5% w/w silica and the silica produces a slower dissolution profile for the API as compared to API without silica.
A pharmaceutical composition comprising:
- coated API particles comprising:
- an API particle;
- a first coating comprising a wax;
- and
- a second coating comprising silica partially embedded in and/or embedded in the wax, wherein the coated API particle comprises 0.5-2.5% w/w silica and the silica produces a slower dissolution profile for the API as compared to API without silica,
- wherein the pharmaceutical composition is prepared by mixing the coated API particles into a matrix solution/suspension to form a pharmaceutical suspension, and dosing the pharmaceutical suspension comprising the coated API particles into molds.
Dependencies are inferred from the claim text.