EFFECT OF POLYMER AND GAS FORMING AGENT ON FLOATING DRUG DELIVERY OF TRAMADOL HYDROCHLORIDE USING RESPONSE SURFACE METHODOLOGY: IN VITRO AND IN VIVO EVALUATION
Journal Title: International Journal of Pharmaceutical Applications - Year 2011, Vol 2, Issue 3
Abstract
Tramadol hydrochloride is a synthetic opioid used as a centrally acting analgesic and effective in both experimental and clinical pain. The half-life of the drug is about 5.5 hours and oral dose is 50 to 100 mg every 4 to 6 hours. To reduce the frequency of administration and to improve patient compliance, a sustained-release formulation of tramadol is desirable. The 32 full factorial design was employed for formulation of tramadol hydrochloride tablets. Sodium bicarbonate was incorporated as a gas-generating agent. The concentration of sodium bicarbonate required for optimum floating ability was finalised by 32 full factorial design along with HPMC K4M independent variable. Combination of polymers hydroxy propyl methyl cellulose (HPMC) grade K4M and hydroxy propyl cellulose (HPC) was used to achieve sustained release effect. The concentration of polymers was considered as the independent variables and dependent variables were floating time, drug content of formulation, and % drug release after 10 hours, swelling index and hardness of the tablets. The drug-excipient compatibility was studied with the help of Infrared-red spectroscopy. In vivo drug release pattern was studied using the X-ray radiographic technique. From the factorial batches, it was observed that formulation containing combination of 10% sodium bicarbonate and 10% citric acid shows optimum floating ability whereas the formulation containing 75 % HPMC K4M and 50% HPC shows optimum sustained drug release pattern with adequate floating. X ray study of the optimised formulations showed gastroretention for 6 hrs indicating successful floating GRDDS of tramadol HCl.
Authors and Affiliations
Swati C. Jagdale , Swapnil A. Ghorpade , Bhanudas S. Kuchekar , Aniruddha R. Chabukswar
Keywords
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