Minimizing agglomeration of drug particle coating material during storage to stabilze disintegration times of pharmaceutical products

Pharmaceutical compositions comprising: 65-85% w/w active pharmaceutical ingredient (API) particles; 15-30% w/w coating material encapsulating the API particles; and 3-15% w/w matrix surrounding the coated API particles. The pharmaceutical composition comprises a disintegration time rate of less tha...

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Hauptverfasser: Craig Wheadon, Simon Andrew Martyn Howes, Rosaleen McLaughlin, Jonathon Whitehouse
Format: Patent
Sprache:eng
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Zusammenfassung:Pharmaceutical compositions comprising: 65-85% w/w active pharmaceutical ingredient (API) particles; 15-30% w/w coating material encapsulating the API particles; and 3-15% w/w matrix surrounding the coated API particles. The pharmaceutical composition comprises a disintegration time rate of less than 10 seconds for at least six months under storage conditions of at least 25°C and at least 60 % relative humidity. Also described are methods of forming the pharmaceutical compositions by: coating API particles with a coating material comprising deformable components; applying mechanical stress to deform the deformable components; coating with silica; applying mechanical stress to embed the silica on the coated API particles; sieving to remove excess coating material; mixing the particles into a matrix solution/suspension; and dosing into a mold. The coating material preferably comprises a wax such as carbauba wax, candelilla wax, or synthetic wax. The matrix preferably comprises a matrix former such as gelatin, and a structure former such as mannitol.