In vitro characterization and release study of Ambroxol hydrochloride matrix tablets prepared by direct compression

Pharm Dev Technol. 2012 Sep-Oct;17(5):562-73. doi: 10.3109/10837450.2011.557728. Epub 2011 Mar 23.

Abstract

A series of either hydrophilic or hydrophobic polymers were used to prepare controlled release Ambroxol hydrochloride (AMX) matrix tablets by direct compression. Both the compatibility and flow properties of AMX/polymer mixtures were investigated. The effect of the amount and type of polymer on the physical properties and in vitro drug release was studied and compared to commercially available Ambroxol(®) SR capsules. A kinetic study of the release profile of AMX from the prepared matrix tablets was performed. All excipients used in the study were compatible with the model drug. AMX/drug mixtures containing sodium alginate (NA) and hydroxypropylmethyl cellulose (HPMC) showed better flow properties than other polymers used in the study. The in vitro drug release studies showed that matrix tablets formulae containing 10% HPMC (S7) or a combination of 30% NA and 5% HPMC (Ah) exhibited a higher ability to control the release of AMX. The kinetic study revealed that a diffusion controlled mechanism prevailed except when carbopol was used. Formula Ah followed a non-fickian diffusion mechanism similar to Ambroxol(®) SR capsules. Both formulae S7 and Ah could be considered as potential candidates for formulation of AMX controlled release matrix tablets.

MeSH terms

  • Alginates / chemistry*
  • Ambroxol / administration & dosage*
  • Delayed-Action Preparations / chemistry*
  • Diffusion
  • Drug Compounding / methods
  • Expectorants / administration & dosage*
  • Glucuronic Acid / chemistry
  • Hexuronic Acids / chemistry
  • Hypromellose Derivatives
  • Kinetics
  • Methylcellulose / analogs & derivatives*
  • Methylcellulose / chemistry
  • Tablets

Substances

  • Alginates
  • Delayed-Action Preparations
  • Expectorants
  • Hexuronic Acids
  • Tablets
  • Ambroxol
  • Hypromellose Derivatives
  • Glucuronic Acid
  • Methylcellulose