[Importance of dissolution profile in stability tests]

Acta Pharm Hung. 2007;77(2):132-41.
[Article in Hungarian]

Abstract

The aim of stability testing lies in its possibility of revealing all the effects that may influence the quality, efficacy and safety of a pharmaceutical preparation. The stability of a dosage form means that the release of the active ingredients remains unchanged or within specific limits. The manner of stability testing is regulated by guidelines, which consist of -- besides the regular tests of the active ingredient and the degradation products, the concerning impurities, the water content, the hardness -- the dissolution tests. Most physical changes influence the drug release in vivo, which can -- in vitro -- be followed by dissolution.

Publication types

  • English Abstract

MeSH terms

  • Drug Stability
  • Pharmaceutical Preparations / standards*
  • Safety
  • Solubility
  • Water / chemistry*

Substances

  • Pharmaceutical Preparations
  • Water