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.
Claims30
A pharmaceutical composition comprising:
- an API particle;
- a first coating comprising one or more deformed components coating the API particle;
- a second coating comprising silica on top of the first coating;
- a matrix former;
- and
- a structure former.
A pharmaceutical composition comprising:
- coated API particles comprising:
- an API particle;
- a first coating comprising one or more deformed components;
- and
- a second coating comprising silica;
- a matrix former;
- and
- a structure former,
- wherein the pharmaceutical composition is prepared by mixing the coated API particles into a matrix solution/suspension comprising the matrix former and the structure former and a solvent to form a pharmaceutical suspension, and dosing the pharmaceutical suspension comprising the coated API particles into molds.
A method of preparing a pharmaceutical composition comprising:
- combining API particles with particles of a first coating material, wherein the first coating material comprises one or more deformable components;
- applying energy to the combination of API particles and the particles of the first coating material to form an ordered mixture of API particles comprising a discrete layer of the particles of the first coating material on a surface of the API particles;
- applying energy to the ordered mixture of API particles and particles of the first coating material to deform the one or more deformable components to form coated API particles, wherein the coated API particles comprise a continuous film of the first coating material surrounding each of the API particles;
- combining the coated API particles with particles of a second coating material;
- applying energy to the coated API particles with particles of the second coating material to at least partially embed the second coating material in the first coating material to form coated API particles comprising a second coating;
- and
- mixing the coated API particles comprising the second coating into a matrix solution/suspension to form a pharmaceutical suspension.
Dependencies are inferred from the claim text.