Compendial and non-compendial approaches to the development of in-vitro release methodologies for ketoprofen suppositories

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Article Title: Compendial and non-compendial approaches to the development of in-vitro release methodologies for ketoprofen suppositories
Authors: Nicoară A.C., Ardelean S., Lupuleasa D., Ciolan D.F., Miron D.S., Rădulescu F.Ș.
Affiliation: 1University of Medicine and Pharmacy „Carol Davila” Bucharest, Faculty of Pharmacy, Bucharest, Romania. 2 „Vasile Goldiș” Western University of Arad, Faculty of Pharmacy, Arad, Romania.
Abstract: The paper presents compendial and non-compendial approaches for the development of in-vitro release tests adapted to the composition and biopharmaceutical characteristics of suppositories containing 100 mg ketoprofen. 40 mesh and Palmieri baskets, as well as rotary dialysis adaptors were used on standard dissolution equipment. The role of the hydrodynamic conditions and design particularities was analyzed, emphasizing on the correspondence with the limiting steps of the in-vivo processes. The results confirmed that the discriminatory character is highly dependent on the experimental setup.
Keywords: ketoprofen, in-vitro release, USP apparatus 1, Palmieri baskets, rotary dialysis cells.
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*Correspondence: Dalia Simona Miron, University of Medicine and Pharmacy „Carol Davila” Bucharest, Faculty of Pharmacy, Department of Pharmaceutical Physics and Informatics, no.6 Traian Vuia St., 020956, Bucharest, Romania, Tel. +40-(21)-3180740, email: dalia_simona_m@yahoo.com.