The objective of present study was to formulate and evaluate gastro retentive extended release floating tablets of tramadol hydrochloride by direct compression technique. Tramadol hydrochloride is a non-steroidal anti-inflammatory drug used for osteoarthritis and for acute to chronic pain. Combination of hydrophilic polymers like hydroxyl propyl methyl cellulose (HPMCK4M, HPMC K15M and HPMC K100M) and polyethylene oxide (POLYOX WSR 303) are used as matrix retarding polymers for the preparation of gastro retentive extended release floating tablets. DSC and FTIR study indicated that there was no chemical interaction between drug and excipients. By varying the ratios of drug and polymer the formula was optimized for preparation of floating tablets. Pre and post compression parameters of all the formulations were within specified limits. Combination of HPMC K100M and POLYOX WSR 303 has shown better floating lag time and in-vitro release profiles. Among all formulations F14 with 20% HPMC K100M and 25% of POLYOX WSR 303 has shown in-vitro profiles upto 24 hrs with 98.63% drug release. Formulation F14 with 60:20 of sodium bicarbonate and citric acid shown floating lag time below 10 sec. Optimized formulation follows the first order release kinetics and dissolution data was analysed by korsmeyer-peppas model and it showed non fickian (anomalous) i.e. both swelling and diffusion release mechanism. Accelerated stability studies for 3 months indicated that tramadol hydrochloride was stable in floating tablets. Results of the present study indicated the suitability of hydrophilic polymers in the preparation of gastro retentive extended release floating tablets of tramadol hydrochloride.
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