A kioldódási profil jelentosége a stabilitási vizsgálatokban

Translated title of the contribution: Importance of dissolution profile in stability tests

Lengyel Miléna, Dredán Judit, Shafir Gal, Klebovich Imre, Antal István

Research output: Contribution to journalArticle

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.

Translated title of the contributionImportance of dissolution profile in stability tests
Original languageHungarian
Pages (from-to)132-141
Number of pages10
JournalActa pharmaceutica Hungarica
Volume77
Issue number2
Publication statusPublished - Aug 24 2007

ASJC Scopus subject areas

  • Pharmaceutical Science

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