Naslov
Developing in vitro release tests for semisolid dosage forms containing dexpanthenol and metronidazol

Autori
Bujan, Vlasta ; Štanfel, Danijela ; Kamhi Saršon, Silvia

Vrsta, podvrsta i kategorija rada
Sažeci sa skupova, sažetak, ostalo

Izvornik
Book of Abstracts 5. Croatian congress on pharmacy / - , 2015, 174-174

Skup
5. Croatian congress on pharmacy

Mjesto i datum
Rovinj, Hrvatska, 21.05.2015. - 24.05.2015

Vrsta sudjelovanja
Poster

Vrsta recenzije
Međunarodna recenzija

Ključne riječi
in vitro release ; dexpanthenol ; metronidazol ; semisolid

Sažetak
Semisolid dosage forms are complex formulations which include cream, ointment, gel and lotion. Their drug release is a reflection of physical and chemical properties and depends largely on formulation and manufacuring proces. In vitro release test is useful performance test for semisolid dosage forms in assessment of product sameness after postaproval changes. Level 2 changes of formulation composition were introduced in two differrent formulations ; dexpanthenol cream and metronidazol cream. According to Food and Drug Association (FDA) Guidance for Industry: Scale-Up and Postapproval Changes (SUPAC-SS) manufacturer should provide in vitro release documentation with comparison of release rate for prechange and postchange formulation. Therefore, it was necessary to develop reliable methods to determinate in vitro release rate. Starting point was choosing receptor media for each active ingredient in their respective dosage form by analysing their solubility in different solvents. After selecting adequate receptor media (phosphate buffer pH 5.8 for dexpanthenol cream, deionized water for metronidazole cream), other key parameters such as stiring rate, porous membrane and sample weight were selected by runing screening tests. Tests were performed in dissolution apparatus Varian VK7010 with on-line autosamper Varian VK8000, using immersion cells with variable depth reservoir. Assay of dexpanthenol and metronidazole was determinated with validated high performance liquid chromatography (HPLC) methods. After method development, release rate of prechange lot was compared with release rate of postchange lot and Mann-Whitney U test was used to calculate the 90% confidance interval for both drug products. Results have shown that in vitro release rates of prechange and postchange formulation of dexpanthenol cream and prechange and postchange formulation of metronidazol cream are within 90% confidence interval, therefore their equivalence was proven. In conclusion, conforming to SUPAC-SS guidance and U.S. Phamacopeia (USP), two methods for release testing of dexpanthenol cream and metronidazol cream were successfully developed for products that have undergone postapproval changes, furthermore their equivalence in relation to prechange lot was proven.

Izvorni jezik
Engleski

Znanstvena područja
Kemija, Farmacija

POVEZANOST RADA