Delayed release compositions of duloxetine

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 enhan...

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Bibliographische Detailangaben
Hauptverfasser: SHRENIK ANNASAHEB KOLE, MAKARAND KRISHNAKUMAR AVACHAT, ASHOK KUMAR SAHOO
Format: Patent
Sprache:eng
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Zusammenfassung: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.