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Journal of Pharmaceutical Investigation

, Volume 45, Issue 1, pp 51–63 | Cite as

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

  • Hetal PatelEmail author
  • Aakash Ghayal
  • Ashish Mishra
  • Shailesh Shah
Research Article
  • 137 Downloads

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 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.

Keywords

Co-processed excipient Sustained release Box–Behnken design Glyceryl monostearate Dicalcium phosphate dihydrate 

Abbreviations

DCPD

Dicalcium phosphate dihydrate

GMS

Glyceryl monostearate

PVP

Polyvinyl pyrrolidone

DSC

Differential scanning calorimetry

Notes

Acknowledgments

This article dose not contain any studies with human and animal subjects performed by any of the authors. All authors (H. Patel, A. Ghayal, A. Mishra, and S. Shah) declare that they have no conflict of interest. The authors are thankful to Cadila Healthcare limited, Ahmedabad (India) for providing gift sample of tramadol hydrochloride.

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Copyright information

© The Korean Society of Pharmaceutical Sciences and Technology 2014

Authors and Affiliations

  • Hetal Patel
    • 1
    Email author
  • Aakash Ghayal
    • 1
  • Ashish Mishra
    • 1
  • Shailesh Shah
    • 1
  1. 1.Department of Pharmaceutics, Maliba Pharmacy CollegeUka Tarsadia UniversityBardoli, SuratIndia

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