FORMULATION AND EVALUATION OF LIQUID-FILLED HARD GELATIN CAPSULE OF DICLOFENAC POTASSIUM

Background Diclofenac Potassium is the potassium salt form of diclofenac, a benzene acetic acid derivate, and nonsteroidal anti-inflammatory drug (NSAID) with analgesic, antipyretic and anti-inflammatory activity. Aim: Therefore, the purpose of the present study was to formulate and evaluate liquid-filled hard gelatin capsules of diclofenac potassium. Methods: The liquid-filled soft gelatin capsules were prepared by using PEG 400, propylene glycol and water mixture under temp of 90⁰ C followed by adding PVA, Cremophore EL, Labrasol and in last diclofenac potassium was finally added to the mixture under stirring. The final formulation was filled in a hard gelatin capsule, and the hand band seal was performed. Physico-Chemical Evaluation: A total fifteen liquid-filled hard gelatin capsule formulations were prepared (F-1 to F-15) and evaluated for weight variation test, lock length, drug content, nephelometric turbidity units (NTU) and in-vitro release study. Results: The drug content ranged from 92.76±0.12 to 99.25 ±0.19. The results indicated that the drug content was uniform in all the formulations. The disintegration time ranges from 130 sec to 232 sec. In-vitro dissolution study shows % cumulative drug release ranging from 84.10±1.76 to 99.57±0.653. Optimized formulation F14 at 40± 2⁰C, 75 ± 5% RH was found to be stable up to 30 days. Conclusion: Hence liquid filled hard gelatin capsule of diclofenac potassium can be a potential alternative to available traditional oral drug delivery systems of diclofenac potassium to improve its bioavailability.