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, I. Klebovich, I. Antal

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.

Original languageHungarian
Pages (from-to)132-141
Number of pages10
JournalActa Pharmaceutica Hungarica
Volume77
Issue number2
Publication statusPublished - 2007

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Hardness Tests
Dosage Forms
Guidelines
Safety
Water
Pharmaceutical Preparations
Drug Liberation
In Vitro Techniques

ASJC Scopus subject areas

  • Pharmaceutical Science

Cite this

A kioldódási profil jelentosége a stabilitási vizsgálatokban. / Miléna, Lengyel; Judit, Dredán; Gal, Shafir; Klebovich, I.; Antal, I.

In: Acta Pharmaceutica Hungarica, Vol. 77, No. 2, 2007, p. 132-141.

Research output: Contribution to journalArticle

Miléna, Lengyel ; Judit, Dredán ; Gal, Shafir ; Klebovich, I. ; Antal, I. / A kioldódási profil jelentosége a stabilitási vizsgálatokban. In: Acta Pharmaceutica Hungarica. 2007 ; Vol. 77, No. 2. pp. 132-141.
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