Sustained release pharmaceutical composition and preparation method thereof
AssigneeAnxo Pharmaceutical Co., Ltd.
InventorsChen-Ming HUANG, Li-Chuan CHUANG, Chih-Hung LI
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Abstract
Provided is a method for preparation of a sustained released pharmaceutical composition, wherein an active ingredient and a cellulose derivative dissolved in a lower alkyl alcohol solvent are processed with granulation such that the PEO does not need to be processed with granulation or sizing to achieve uniform drug distribution. Besides, the specific range of the viscosity of the cellulose derivate provides better uniformity to the sustained release pharmaceutical composition derived from the above preparation method.
Claims20
A method for preparation of a sustained release pharmaceutical composition, comprising steps of:
- mixing and granulating an active ingredient, a lower alkyl alcohol solvent having a concentration not lower than 80% (w/v) and a cellulose derivate to obtain multiple granulated powders;
- drying the multiple granulated powders to remove the lower alkyl alcohol solvent;
- mixing the dried multiple granulated powders, polyalkylene oxide and a lubricant to form a mixture which is uniform;
- compressing and tableting the mixture to obtain a sustained release pharmaceutical composition.
A sustained release pharmaceutical composition consisting of:
- an active ingredient;
- a cellulose derivate having viscosity from 50 mPa·s to 100,000 mPa·s and being hard to dissolve in a lower alkyl alcohol solvent having the concentration not lower than 80% (w/v);
- the lower alkyl alcohol solvent having the concentration not lower than 80% (w/v) in an amount of less than 5% in weight (wt %) based on the total weight of the sustained release pharmaceutical composition;
- a polyalkylene oxide having an average molecular weight above 500,000 Da;
- and
- a lubricant.
Dependencies are inferred from the claim text.