DELAYED RELEASE COMPOSITIONS OF DULOXETINE

摘要

A delayed release dosage form comprising core comprising duloxetine or its pharmaceutically acceptable salts or derivatives thereof, optionally, other pharmaceutically acceptable excipient(s) thereof; intermediate layer; and enteric layer; wherein the dosage form comprises one/more dissolution enhancer(s), wherein the enteric layer comprises one/more enteric polymers other than hydroxypropylmethyl acetate succinate. A process of preparing a delayed release dosage comprising mixing pharmaceutically acceptable excipients with duloxetine or its pharmaceutically acceptable derivatives thereof; granulating the product of previous step compressing the granulate formed in previous step to form core, coating said core with intermediate layer followed by coating with one/more enteric polymers and optional finishing coating. A delayed release dosage form comprising: core comprising duloxetine or its pharmaceutically acceptable derivative thereof, intermediate layer and enteric layer comprising one/more enteric polymers other than hydroxypropylmethyl acetate succinate; wherein dosage form contains one/more dissolution enhancer(s) and has improved dissolution.