Advances in drug release investigations: Trends and developments for dissolution test media

Kakuk, Melinda and Farkas, Dóra and Antal, István and Kállai-Szabó, Nikolett (2020) Advances in drug release investigations: Trends and developments for dissolution test media. ACTA PHARMACEUTICA HUNGARICA, 90 (4). pp. 155-169. ISSN 0001-6659

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Abstract

Dissolution research started more than a century ago in the field of physical chemistry and went through several significant developments since. Yet, the explicit attention in drug-related dissolution has only started growing in the 1950s, after the researchers realized that drug release from orally administered solid pharmaceutical formulations significantly influences the bioavailability. Researches show that solubility and permeability of the drugs are key factors in the correlation between the in vitro examination and the in vivo determinations (IVIVC). This review aims to summarize the most relevant developments in chronological order, ranging from simple disintegration studies to biorelevant methods. Biorelevant methods can be used to recognize the effects of food on dissolution, as well as to identify solubility limitations and stability issues. The development of a biologically relevant dissolution method for oral dosage forms needs to take the physiological conditions of the gastrointestinal (GI) tract into account that may influence the drug dissolution. This review presents the simplest dissolution media, the composition of biorelevant media simulating gastrointestinal fluids, and the latest updates of the field.

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