Abstract

A RESEARCH ON FORMULATION AND EVALUATION OF FLOATING MICROSPHERES OF TOLPERISONE HYDROCHLORIDE

Manisha Kumari*, Prasanjit Paul and Dr. Nitin Kumar

ABSTRACT

Tolperisone HCl, a centrally acting muscle relaxant. Tolperisone HCl with its shorter half life, of 1.5- 2.5 hours, high first pass metabolism with frequent dosing characteristics makes it suitable candidate for development of oral controlled release dosage form. Nine formulations of drug loaded microspheres using three different polymeric combinations and ratio were prepared by emulsion solvent evaporation technique. The various polymer used in the formulations were Ethyl cellulose, Eudragit RS100 & Eudragit S100 (all hydrophobic). Average particle size ranged from 56.68 μm to 87.50 μm. Percentage yield ranged from 77.28 to 90.22% and drug entrapment efficiency ranges from 69.12 to 82.64%. Percentage drug loading was found to be satisfactory. Kinetics study showed that drug release follows first order kinetics. Batch F4 shows best dissolution profile because of highest similarity factor f2 (f2=75.62) among all the batches (which ranged from 51.74 to 75.62). FTIR study confirmed the stable character of Tolperisone HCl in formulations. Scanning electron microscopy revealed that the microspheres were spherical. Nine different formulations (F1 to F9) of Tolperisone HCl loaded microspheres were prepared using various polymeric combinations with a view for the sustained delivery of the drug over a time period of 12 hours.

Keywords: Floating microspheres, Gastro retentive drug delivery system, Emulsion solvent evaporation technique, Muscle relaxant.