Abstract
The objective of this study was replacing an in vivo bioequivalence study by generating suitable in vitro data in order to get generic marketing authorisation. Solubility and permeability of sotalol hydrochloride were determined thereby achieving classification of this compound according to the biopharmaceutical classification system. In addition comparative investigation of in vitro dissolution properties of different Sota-saar ® formulations and the reference product provided satisfying justification to waive in vivo bioavailability (BA)/bioequivalence (BE) studies. The investigations on solubility were performed considering the highest dose strength in aqueous media (250 ml) with pH conditions between pH 1.0 and 7.5. Permeability was studied using the human colorectal carcinoma cell line Caco-2. In vitro as well as in vivo data suggest high permeability of the drug compound through the intestinal membrane. Thus, evaluation of solubility and permeability allow sotalol hydrochloride to be classified as biopharmaceutics classification system class I drug. In vitro dissolution profiles demonstrate comparable rapid dissolution (more than 85% in 15 min) for test and reference products. Summarizing, relevant prerequisites are fulfilled to waive BA/BE studies.
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
More From: European Journal of Pharmaceutics and Biopharmaceutics
Disclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.