title: [Importance of dissolution profile in stability tests].
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.
authors.affiliation: Semmelweis Egyetem, Gyógyszerészeti Intézet, Budapest, Hogyes E u 7 --1092.
authors.forename: Miléna
authors.initials: M
authors.lastname: Lengyel
authors.forename: Judit
authors.initials: J
authors.lastname: Dredán
authors.forename: Gal
authors.initials: G
authors.lastname: Shafir
authors.forename: Imre
authors.initials: I
authors.lastname: Klebovich
authors.forename: István
authors.initials: I
authors.lastname: Antal
mesh_terms: D004355:Drug Stability; D004364:Pharmaceutical Preparations / Q000592:standards*; D012449:Safety; D012995:Solubility; D014867:Water / Q000737:chemistry*
chemical_list: D004364:Pharmaceutical Preparations; D014867:Water