TY - JOUR AU - Logoyda, Liliya PY - 2019/02/09 Y2 - 2024/03/28 TI - In Vitro Dissolution Kinetics of Bisoprolol Tablets Under Biowaiver Conditions JF - Asian Journal of Pharmaceutics (AJP) JA - AJP VL - 13 IS - 01 SE - ORIGINAL ARTICLES DO - 10.22377/ajp.v13i01.3009 UR - https://asiapharmaceutics.info/index.php/ajp/article/view/3009 SP - AB - <p>Introduction: Biowaiver procedure, nowadays, is a trend of Modern Biopharmaceuticals. The biowaiver approach<br />based on Biopharmaceutical Classification System BCS is intended to replace bioequivalence in vivo studies.<br />Bisoprolol is a medicine most commonly used for heart diseases, the beta blocker family of medications, and is of<br />the β1-selective type. The Aim of the Study: The aim was to study the dissolution kinetics of bisoprolol tablets to<br />assess their equivalence under conditions in vitro according to the biowaiver. Methods: The study of dissolution<br />kinetics of drugs in the form of bisoprolol tablets has been carried out in accordance with the requirements of the<br />“biowaiver” procedure, the recommendations of the SPhU, and the WHO requirements to assess the possibility of<br />replacing the pharmacokinetic studies in vivo by tests in vitro. Results and Discussion: The possibility to use the<br />recommendations of the “biowaiver” procedure for the registration of generics bisoprolol tablets has been found.<br />The studies conducted have shown that bisoprolol can be referred to Class І of the BCS, i.e., substances with a<br />high biopharmaceutical solubility and a high penetration rate. It will allow conducting comparative studies in vitro<br />to confirm the equivalence of drugs. Conclusions: The evaluated bisoprolol drugs fulfill biowaiver criteria for<br />drugs containing BCS Class I active pharmaceutical ingredients. Both drugs are “rapidly dissolving,” both meet<br />the criteria of dissolution profile similarity, f2 (i.e., the dissolution profile of the test product is similar to that of<br />the reference product in pH 1.2, 4.5, and 6.8 buffers using the paddle method at 75 rpm), and both are considered<br />to be in vitro equivalent without in vivo evaluation.</p> ER -