Development and optimization of a novel sustained-release dextran tablet formulation for propranolol hydrochloride

Int J Pharm. 2006 Jul 6;317(1):32-9. doi: 10.1016/j.ijpharm.2006.02.049. Epub 2006 Apr 11.

Abstract

A novel oral controlled delivery system for propranolol hydrochloride (PPL) was developed and optimized. The in vitro dissolution profiles of sustained-release matrix tablets of racemic PPL were determined and compared with the United States Pharmacopeia (USP) tolerance specifications for Propranolol Hydrochloride Extended-Release Capsules. The influence of matrix forming agents (native dextran, hydroxypropyl methylcellulose (HPMC), cetyl alcohol) and binary mixtures of them on PPL release in vitro was investigated. A central composite design was applied to the optimization of a sustained-release tablet formulation. The sustained-release matrix tablets with good physical, mechanical and technological properties were obtained with a matrix excipient:PPL ratio of 60:40 (w/w), with a dextran:HPMC ratio of 4:1 (w/w) and with a cetyl alcohol amount of 15% (w/w). A comparative kinetic study of the present matrix tablets and commercial SUMIAL RETARD capsules (Spain) was established. The value for the similarity factor (f(2)=69.6) suggested that the dissolution profile of the present two sustained-release oral dosage forms are similar. Higuchi (diffusion) and Hixon-Crowell (erosion) kinetic profiles were achieved and this codependent mechanism of drug release was established.

Publication types

  • Comparative Study

MeSH terms

  • Capsules
  • Carboxymethylcellulose Sodium / chemistry
  • Chemistry, Pharmaceutical
  • Delayed-Action Preparations
  • Dextrans / chemistry*
  • Fatty Alcohols / chemistry
  • Hardness
  • Hypromellose Derivatives
  • Methylcellulose / analogs & derivatives*
  • Methylcellulose / chemistry
  • Propranolol / chemistry*
  • Solubility
  • Tablets

Substances

  • Capsules
  • Delayed-Action Preparations
  • Dextrans
  • Fatty Alcohols
  • Tablets
  • Hypromellose Derivatives
  • Methylcellulose
  • cetyl alcohol
  • Propranolol
  • Carboxymethylcellulose Sodium