Immediate release pharmaceutical composition of tizanidine

US10813916B2 · kind B2 · utility

Assignee

• Jubilant Generics Limited · IN

Inventors

• Pankaj Soni · Noida, IN
• Rashmi Panda · Dublin, US
• Ganesh Vinayak Gat · Pune, IN
• Dinesh Kumar · Chandigarh, IN
• Kamal S. Mehta · Noida, IN
• Ravikumar Nithiyanandam · Viralimalai, IN

Key dates

• Filing date: May 27, 2016
• Grant date: Oct 27, 2020
• Expiry date: Mar 19, 2037

Classification

• Technology area (CPC A): Human Necessities
• CPC primary: A61K9/4866
• WIPO field: Pharmaceuticals
• WIPO sector: Chemistry

Abstract

The present invention relates to an immediate release solid oral pharmaceutical composition comprising an effective amount of Tizanidine or its pharmaceutically acceptable salts, esters, solvates, polymorphs, stereoisomers or mixtures thereof. The solid oral dosage form comprises one or more methacrylic acid copolymers or its derivatives and is bioequivalent to the commercially available counterpart (ZANAFLEX® capsule) after oral administration. The invention also relates to a process for preparation of a pharmaceutical capsule dosage form comprising an effective amount of Tizanidine Hydrochloride wherein, the dosage form comprises methacrylic acid copolymer or its derivatives.