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        Formulation development of directly compressible co-processed excipient for sustained release of tramadol hydrochloride

        Hetal Patel,Aakash Ghayal,Ashish Mishra,Shailesh Shah 한국약제학회 2015 Journal of Pharmaceutical Investigation Vol.45 No.1

        The objective of present investigation was toprepare and evaluate directly compressible co-processedexcipient for sustained release tablets. Tramadol hydrochloridewas selected as a model drug. Percentage ofglyceryl monostearate, proportion of dicalcium phosphatedihydrate with respect to glyceryl monostearate and concentrationof polyvinyl pyrrolidone (PVP K30) wereselected as independent variables in 3³ Box–Behnkendesign. Percentage drug release at given time (Q3, Q6, Q12)and Carr’s index were selected as dependent variables. Glyceryl monostearate and dicalcium phosphate dihydrateblend was granulated with PVP K30 and passed through 30mesh sieve to prepare co-processed excipient. This wasevaluated for percentage fines, Carr’s index, particle sizedistribution and granular friability index. Drug was mixedwith co-processed excipient and sustained release tabletswere prepared and evaluated. Regression analysis wascarried out to evolve full and refined models. Contour plotswere presented for graphical expression of the results. Themechanism of drug release from all batches followed Fickiandiffusion. Optimized batch was found to be stable for3 months at accelerated conditions (40 ˚C/75 % RH). Itcan be concluded that multifunctional directly compressibleco-processed excipient of glyceryl monostearate anddicalcium phosphate dihydrate can successfully be used tosustain the release of highly water soluble drugs.

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