STABLE FORMULATION OF ACECLOFENAC AND THIOCOLCHICOSIDE TABLETS

The present study relates to the stable fixed dose combination comprising of Aceclofenac as a glycolic acid ester of Diclofenac is having analgesic and anti-inflammatory action and Thiocolchicoside, as a glycosulfurated analogue of colchicine which is well known centrally acting muscle relaxant in unit dosage form and to the preparation method thereof. Aceclofenac is very susceptible to decomposition under hydrolytic, oxidative stress and exposure to light. The major degradation product identified was diclofenac, which was detected as an impurity in the formulation. Many of the marketed formulation of Aceclofenac tablets having problem of high content of diclofenac impurity. Diclofenac having more gastrointestinal adverse effects such as gastritis, gastrointestinal haemorrhage, haemorrhagic diarrhoea, gastrointestinal ulcer than that of Aceclofenac. It was challenge to develop Aceclofenac tablet formulation having diclofenac impurity within compendial limit. The compatibilty of Aceclofenac with various tableting excipients was investigated physically and by means of Differential Scanning Calorimetry (DSC). Aceclofenac alone and with other excipients in 1:1 binary mixtures were investigated before and after accelerated storage. An interaction was observed between Aceclofenac and magnesium stearate. It was also observed that conversion of Aceclofenac to diclofenac was decreased when used in combination of Thiocolchicoside by using specific method of manufacture. Hydroxypropyl cellulose as a binder also play important role to prevent the conversion of Aceclofenac to diclofenac.