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 o C /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.