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US 2019/0054024 A1Published application
Solid Dosage Forms
AssigneesHumanwell Pharmaceutical US, Yichang Humanwell Pharmaceutical Co., Ltd.
InventorsJun Yang, Yunqi Wu, Dunxi Chen, Cuiying Zhang, Yuping Yang, Longmei Qu, Lie Li, Jie Li, Wentao Du, Yigang Fu
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Abstract
A solid pharmaceutical dosage form having drug-loaded particles and methods of making.
Claims25
A solid pharmaceutical dosage form comprising a plurality of drug-loaded particles wherein the drug-loaded particles comprise a core comprising a hydrophilic or gelling polymer and a drug-load applied to the core wherein the drug-load comprises a drug and a binder.
A process for preparing a solid dosage form comprising steps of:
- (i) preparing a drug-loading solution, suspension, or dispersion comprising a drug, a binder, a solvent comprising water and optionally at least one additional pharmaceutical excipient;
- (ii) spraying the drug-loading solution, suspension, or dispersion onto particles of a first hydrophilic polymer to form drug-loaded particles wherein the particles of the first hydrophilic polymer have an average particle size of about 25 μm to 800 μm and the particles of the first hydrophilic polymer are selected from the group consisting of:
- (a) alkyl substituted celluloses having a viscosity within the range of about 100 to about 11,000 centipoise as a 2% aqueous solution at 20° C., (b) polyethylene oxide having an approximate molecular weight of 100,000 Daltons to about 10,000,000 Daltons or (c) a combination of (a) and (b);
- (iii) drying the drug-loaded particles;
- (iv) optionally blending the drug-loaded particles with an extra-granular composition to form a final blend;
- and
- (v) forming the drug-loaded particles into a dosage form.
4 more elements
Dependencies are inferred from the claim text.