Formulation and dissolution kinetics study of hydrophilic matrix tablets with tramadol hydrochloride and different co-processed dry binders

Eur J Pharm Sci. 2016 Dec 1:95:36-45. doi: 10.1016/j.ejps.2016.08.002. Epub 2016 Aug 3.

Abstract

The aim of this study is to present the possibility of using of co-processed dry binders for formulation of matrix tablets with drug controlled release. Hydrophilic matrix tablets with tramadol hydrochloride, hypromellose and different co-processed dry binders were prepared by direct compression method. Hypromelloses Methocel™ K4M Premium CR or Methocel™ K100M Premium CR were used as controlled release agents and Prosolv® SMCC 90 or Disintequik™ MCC 25 were used as co-processed dry binders. Homogeneity of the tablets was evaluated using scanning electron microscopy and energy dispersive X-ray microanalysis. The release of tramadol hydrochloride from prepared formulations was studied by dissolution test method. The dissolution profiles obtained were evaluated by non-linear regression analysis, release rate constants and other kinetic parameters were determined. It was found that matrix tablets based on Prosolv® SMCC 90 and Methocel™ Premium CR cannot control the tramadol release effectively for >12h and tablets containing Disintequik™ MCC 25 and Methocel™ Premium CR >8h.

Keywords: Co-processed dry binders; Dissolution kinetics; Hypromellose; Matrix tablets; Tramadol hydrochloride.

MeSH terms

  • Chemistry, Pharmaceutical / methods*
  • Drug Liberation
  • Hydrophobic and Hydrophilic Interactions*
  • Hypromellose Derivatives / chemistry*
  • Hypromellose Derivatives / pharmacokinetics*
  • Solubility
  • Tablets
  • Tramadol / chemistry*
  • Tramadol / pharmacokinetics*

Substances

  • Tablets
  • Tramadol
  • Hypromellose Derivatives