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KMID : 0369820150450010051
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Jorunal of Korean Pharmaceutical Sciences
2015 Volume.45 No. 1 p.51 ~ p.63
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Formulation development of directly compressible co-processed excipient for sustained release of tramadol hydrochloride
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Patel Hetal
Ghayal Aakash
Mishra Ashish
Shah Shailesh
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Abstract
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The objective of present investigation was to prepare and evaluate directly compressible co-processed excipient for sustained release tablets. Tramadol hydrochloride was selected as a model drug. Percentage of glyceryl monostearate, proportion of dicalcium phosphate dihydrate with respect to glyceryl monostearate and concentration of polyvinyl pyrrolidone (PVP K30) were selected as independent variables in 33 Box?Behnken design. Percentage drug release at given time (Q3, Q6, Q12) and Carr’s index were selected as dependent variables. Glyceryl monostearate and dicalcium phosphate dihydrate blend was granulated with PVP K30 and passed through 30 mesh sieve to prepare co-processed excipient. This was evaluated for percentage fines, Carr’s index, particle size distribution and granular friability index. Drug was mixed with co-processed excipient and sustained release tablets were prepared and evaluated. Regression analysis was carried out to evolve full and refined models. Contour plots were presented for graphical expression of the results. The mechanism of drug release from all batches followed Fickian diffusion. Optimized batch was found to be stable for 3 months at accelerated conditions (40 °C/75 % RH). It can be concluded that multifunctional directly compressible co-processed excipient of glyceryl monostearate and dicalcium phosphate dihydrate can successfully be used to sustain the release of highly water soluble drugs.
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KEYWORD
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Co-processed excipient, Sustained release, Box?Behnken design, Glyceryl monostearate, Dicalcium phosphate dihydrate
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