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