In vitro dissolution and release kinetics of multisource ciprofloxacin 500 mg tablets in West Gondar, Ethiopia: Implications for interchangeability and regulatory oversight

by Tewodros Denekew Haile, Ayenew Ashenef, Chilot Abiyu Demeke, Yeniewa Kerie Anagaw, Abibo Wondie Mekonen, Minichil Chanie Worku, Asnakew Mulaw Beirhun, Yesuneh Tefera Mekasha, Melaku Getahun Feleke Background In vitro dissolution is a critical quality control test in pharmaceutical development, used to measure the rate and extent at which an active pharmaceutical ingredient (API) is released from solid dosage forms, such as tablets, into solution under standardized conditions. It serves as a predictive tool for in vivo drug behavior, providing insights into drug release mechanisms and ensuring the development of robust, effective, and consistent products.

Despite its importance, data on dissolution performance remain limited for certain drugs. As a rapid, reliable, and cost-effective method to estimate drug absorption, this study focused on evaluating the dissolution profiles of different brands of ciprofloxacin 500 mg tablets and applying kinetic modeling to support regulatory decision-making.

Methods Twenty samples of ciprofloxacin 500 mg tablets were collected from retail outlets in six selected sites of the West Gondar Zone including Humera, Mai Kadra, Metema, Gendawuha, Kokit, and Midregenet towns between January and July 2022.