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

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Hydroxy propyl β-cyclodextrin complexation of promethazine hydrochloride for the formulation of fast dissolving sublingual film: in vitro and in vivo evaluation

Journal of Pharmaceutical Investigation : Volume 44

Journal of Pharmaceutical Investigation : Volume 43

Journal of Pharmaceutical Investigation : Volume 42

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

Content Provider	Springer Nature Link
Author	Patel, Hetal Ghayal, Aakash Shah, Shailesh Mishra, Ashish
Copyright Year	2014
Abstract	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 3$^{3}$ Box–Behnken design. Percentage drug release at given time (Q$_{3}$, Q$_{6}$, Q$_{12}$) 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.
Starting Page	51
Ending Page	63
Page Count	13
File Format	PDF
ISSN	20935552
Journal	Journal of Pharmaceutical Investigation
Volume Number	45
Issue Number	1
e-ISSN	20936214
Language	English
Publisher	Springer Netherlands
Publisher Date	2014-07-02
Publisher Place	Dordrecht
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Box–Behnken design Dicalcium phosphate dihydrate Sustained release Co-processed excipient Glyceryl monostearate Biomedicine general
Content Type	Text
Resource Type	Article
Subject	Pharmaceutical Science

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