Abstract

EFFECT OF HYDROPHILIC DRUG RELEASE RETARDANTS ON MATRIX TABLETS OF ACECLOFENAC SODIUM FOR ORAL SUSTAINED DRUG DELIVERY

Manjanna K. M.*, Rajesh K.S., Shiva Kumar. B.

Abstract

The successful optimization and development of drug entity, design of dosage form then plays important role. Aceclofenac sodium a novel NSAID used in the treatment of rheumatoid arthritis, frequency of administration may cause certain GI-adverse effects. The purpose of the present research work was to develop sustained release matrix tablets of aceclofenac sodium by wet granulation technique using different concentrations of locust bean gum (LBG) and hydroxyl propyl methyl cellulose (HPMC-K15M) as rate controlling polymer matrices. The solubility studies of aceclofenac were conducted to select suitable dissolution media. The drug excipients mixtures were subjected to preformulation by FTIR, DSC and XRPD studies. The different in-process and finished product quality controlled tests of the formulations were evaluated. In-vitro drug release potential was estimated in simulated gastric fluid pH1.2 for initial 2h, mixed phosphate buffer pH6.8 up to 6 h and simulated intestinal pH 7.4 at end of 12h studies. While increasing the concentrations of polymers significantly affects physicochemical properties of tablets and found within the limits. The release of drug from the tablets in pH1.2 is negligible. Under neutral conditions the tablets will swell and the drug release depend on swelling and erosion process resulting optimum level of drug released in a sustained manner and exhibited Higuchi model kinetics. The entire process is feasible in an laboratory scale and demands pilot study.

Keywords: Aceclofenac sodium, Sustained release, Matrix tablets, HPMC, Locust bean gum, Higuchi Matrix Kinetics.