Tropical Journal of Pharmaceutical Research

Original Research Article | OPEN ACCESS

Formulation and in Vitro Evaluation of Once Daily Sustained Release Formulation of Aceclofenac

Santanu Ghosh , B B Barik

University Department of Pharmaceutical Sciences, Utkal University, Bhubaneswar, Orissa.-751004, India;

For correspondence:- Santanu Ghosh Email: santanu97@rediffmail.com Tel:+919282118780

Received: 6 November 2009 Accepted: 26 March 2010 Published: 24 June 2010

Citation: Ghosh S, Barik BB. Formulation and in Vitro Evaluation of Once Daily Sustained Release Formulation of Aceclofenac. Trop J Pharm Res 2010; 9(3):265-273 doi: 10.4314/tjpr.v9i3.8

© 2010 The authors.
This is an Open Access article that uses a funding model which does not charge readers or their institutions for access and distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0) and the Budapest Open Access Initiative (http://www.budapestopenaccessinitiative.org/read), which permit unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited..

Abstract

Purpose: The objective of the study was to develop matrix tablets for oral controlled release of aceclofenac using ethyl cellulose, guar gum and various grades of cellulose polymers.

Methods: Possible drug-excipient interaction was evaluated by high performance liquid chromatography (HPLC) and Fourier infrared spectroscopy (FTIR). The tablets prepared were assessed for their physicochemical, in vitro drug release at pH1.2, 4.5, 6.8 and 7.5 and stability characteristics. Comparison with a ‘once daily’ commercial aceclofenac product was made in the in vitro studies.

Results: There was no interaction between aceclofenac and the polymers used as excipients. Furthermore, the physicochemical properties of the tablets were satisfactory. The release profile of one of the formulated aceclofenac tablets (F7), which contained hydroxypropyl methyl cellulose (HPMC K4M), was statistically similar (p < 0.05) to that of the commercial aceclofenac brand in all the dissolution media. The formulated products ware stable and showed no changes in physical appearance, drug content, or dissolution pattern after storage at 40 ^oC /75 %RH for 6 months.

Conclusion: The results indicate that it is feasible to achieve a stable ‘once daily’ sustained release aceclofenac tablet formulation by using HPMC K4M of 4000cps viscosity grade as matrix material.

Keywords: Aceclofenac, Sustained release, Matrix tablets, Cellulose polymers, Stability studies