Дослідження з оптимізації складу та технології комбінованих таблеток бісопрололу фумарату з індапамідом

The aim. The study was focused on the development and optimization of a rational tablet formulation containing bisoprolol fumarate and indapamide by applying a response surface methodology to ensure the required pharmaco-technological and biopharmaceutical characteristics of the final dosage form. Materials and methods. The central composite design was used to establish the relation between independent variables, such as, quantity of PEG 6000, quantity of Prosolv EASYtab SP, quantity of Sachelac 80 and dependent variables, such as flowability, bulk density, tapped density, angle of repose, Carr’s index, uniformity of weight, friability, tablet hardness and disintegration time in order to obtain the optimal formulation using response surface methodology. Tablets were prepared by direct compression method. Quantitative determination of APIs in tablets was quantified by HPLC with UV detection at 220 nm. Results. After generating the polynomial equations that relate the dependent and independent variables, the process was optimized for five responses. It was found that the tablet contained 1% PEG 6000, 37% Prosolv EASYtab SP, and 37% Sachelac 80 was a better formulation in terms of hardness (89 N), uniformity of weight (1.1%), friability (0.20%) and rapid disintegration (2.3 min). The experimental values of the dissolution of optimized tablets showed 95.6% release of bisoprolol fumarate and 99.7% release of indapamide. The quantitative content of active ingredients (bisoprolol fumarate and indapamide) in the developed tablets meets the requirements of the State Pharmacopoeia of Ukraine. Conclusions. The study enabled the development of an optimized formulation and manufacturing process for combined bisoprolol fumarate and indapamide tablets, ensuring compliance with pharmaco-technological standards and demonstrating the applicability of response surface methodology for formulation design