FORMULATION AND EVALUATION OF ACECLOFENAC LOADED MICROSPONGE

Pharmaceutical

The objective of present work was to prepare microsponges of drug aceclofenac. Preformulation testing is the first step in the rational step in the development of dosage forms of a substance. The drug aceclofenac powder was examined for its organoleptic properties found it was observed that it was off white, bitter, crystalline odorless powder. When tested for its solubility in various solvents, it was determined that drug sample was sparingly soluble in water and soluble in 0.1 HCl, methanol, ethanol and Buffer 6.8 pH etc. melting point observed 150-153OC. The partition coefficient was determined as 0.29 ± 0.06. Aceclofenac solution was scanned in the U.V. range of 200-400 nm using systronics, UV Visible spectrophotometer. The spectrophotometric method of analysis of Aceclofenac at max 275.8 nm was found to be reproducible and highly sensitive. The standard curves were prepared in Buffer 6.8 pH at max 275.8nm. The IR spectrum of drug substance was authenticated using FT-IR spectroscopy. Drug and polymer compatibility study reveals that there is no interference between drug and polymer thus can be used for further formulation and evaluation purposes. The microsponges containing Aceclofenac were fabricated by quasi emulsion solvent diffusion method using an inner phase comprising Eudragit S 100 and dibutyl phthalate (1%w/v) dissolved in 7 ml of dichloromethane. Dibutyl phthalate was added to improve the plasticity of the polymer. General parameters of evaluations were observed as Yield (39.66 ± 0.47 to 75.25 ± 0.02), % Drug Content (31.78 ± 0.02 to 45.28 ± 0.01), % Encapsulation Efficiency (91.30 ± 0.04 to 96.56 ± 0.02) and Mean Particle size (98.3 ± 1.02 to 107.6 ± 1.05). SEM Photomicrographs revealed that formulated aceclofenac microsponges were spherical and sponge. In-vitro Release of drug from Aceclofenac microsponges reveals that formulations F-5 and F-6 have release above 90%. Formulated microsponges preparation incorporated in gels in fixed amount. That gel formulations were evaluated and found all formulations were clear, odourless, washable, homogeneous, and free from grittiness and also no phase separation found. Drug stability concerns about drug product safety, efficacy, and quality, found it to appropriate. The percentage drug loss from the formulations was used as a measure of storage stability. It can be concluded that for better stability, the formulations should be stored at low temperature in refrigerator.

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