TỐI ƯU HÓA CÔNG THỨC BÀO CHẾ VIÊN NÉN PHÓNG THÍCH KÉO DÀI INDAPAMID 1,5 MG ĐẠT TƯƠNG ĐƯƠNG IN VITRO VỚI THUỐC ĐỐI CHỨNG

Abstract

Background: Hypertension is a growing health concern worldwide. As a chronic condition, it necessitates ongoing management through daily pharmacotherapy. Indapamide is a widely utilized antihypertensive agent belonging to the sulfonamide class, known for its diuretic effects. Indapamide is effective in lowering blood pressure; however, it possesses a short half-life, requiring patients to take multiple doses daily. This frequent dosing schedule often leads to poor patient adherence and suboptimal treatment outcomes. An extended-release (ER) tablet formulation of indapamide offers a promising solution to these challenges. By slowly releasing the drug over an extended period, ER formulations can maintain therapeutic drug levels in the bloodstream, thereby providing consistent blood pressure control over 24 hours. This reduces the need for frequent dosing, enhances patient compliance, and improves overall treatment efficacy. Additionally, the ER formulation can help mitigate the diuretic effects associated with indapamide. Currently, there is no domestically produced generic version of indapamide in an extended-release form available on the market. The development of such a formulation could provide a cost-effective and accessible treatment option for patients with hypertension. Objectives: Research using BCPharsoft software to optimize the amount of adhesive excipients and excipients to control drug release at the time points of 2h, 4h, 8h, 12h, and 16h so that they are equivalent in vitro with control drugs Materials and methods: Investigation of the dissolution of Natrilix®SR 1.5 mg control tablets and optimization of the formula of indapamide 1.5 mg extendedrelease tablets. Results: The optimal formula containing 30.5% HPMC K15M and 4.47% Povidon K30 has the same dissolution values as the reference drug, with f2 values greater than 50 in three dissolution media (pH buffers 1.2, 4.5, and 6.8). Conclusions: The formulation of indapamide 1.5 mg extended-release tablets has been optimized to achieve in vitro equivalents, aiming at the production and development of generic drugs.