A DOSAGE FORM WITH INCREASED STABILITY COMPRISING TAMSULOSIN AND FINASTERIDE

摘要

PURPOSE: A soft capsule formulation containing sustained release tamsulosin salts-containing granules and finasteride-containing powder is provided to ensure stability in a humid place. CONSTITUTION: A soft capsule formulation contains sustained release tamsulosin salts-containing granules and finasteride-containing powder. The amount of tamsulosin hydrochloride and finasteride is 0.1-0.8 mg and 1-5 mg, respectively. A method for manufacturing the sustained release tamsulosin particles comprises: a step of coating an inactive core with a drug and coating the upper end of the core with water-insoluble polymers of ethyl cellulose; a step of additionally coating the upper end with enteric polymers of methacrylic copolymer type C; and mixing sustained release particles without enteric coating and enteric sustained release particles. [Reference numerals] (AA) Drug elution(%) at 45 minutes; (BB) United States Pharmacopeia standard; (CC) Comparative embodiment 1; (DD) Embodiment 3; (EE) Time(months)