Design and characterization of Aceclofenac mouth dissolving tablets by effervescent formulation approach 

By Ravikumar, Sachin R. Patil, M. B. Patil, Mahesh S. Paschapur, Mahalaxmi R. 


Abstract

Aceclofenac is a novel non-steroidal anti-inflammatory drug (NSAID) having anti-inflammatory and analgesic properties and is widely used in the treatment of rheumatoid arthritis, osteoarthritis and ankylosing spondylitis. Difficulty in swallowing (dysphagia) is common among all age groups, especially in elderly and pediatrics. One of the major problems with this drug is its low solubility in biological fluids, which results into poor bioavailability after oral administration. Though aceclofenac is well absorbed after oral dosing, there is a first pass metabolism leading to a reduced bioavailability of the drug (40-50%). Therefore, the present investigation was concerned to develop Mouth dissolving tablets of aceclofenac by effervescent formulation approach to provide patient friendly dosage form. The effervescent excipient system not only aids rapid disintegration of tablets in the oral cavity but also masks the slight bitter taste of medicament. Sodium bicarbonate, heat treated Sodium bicarbonate, tartaric acid, sodium glycine carbonate and citric acid were used as effervescent agents and their ratio in the formulation was optimized. The study revealed that 10:8 ratio of heat treated Sodium bicarbonate and citric acid (F3) in the aceclofenac Mouth dissolving tablets gave a soothing fizz, excellent mouth feel, good palatability and quick dissolution profile. The optimized formulation (F3) was found to be stable during the stability studies conducted as per ICH guidelines, as it showed no significant changes (P<0.05) in the physicochemical properties, disintegration time and in vitro drug release. 

 

Key Words : Mouth dissolving tablets, effervescence, Aceclofenac, in vitro dissolution.

 

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