NGHIÊN CỨU SÀNG LỌC TRONG XÂY DỰNG CÔNG THỨC BÀO CHẾ VIÊN NÉN VERAPAMIL HYDROCLORID GIẢI PHÓNG KÉO DÀI
Tác giả: NGUYỄN THỊ THANH DUYÊN, NGUYỄN VĂN KHANG, PHẠM VĂN HÙNG, ĐÀM THANH XUÂN, LÊ NGỌC KHÁNH, TRƯƠNG HUY KHÔI
TÓM TẮT
Summary
This study aimed to prepare sustained-release tablets of 120 mg verapamil hydrochloride, which had a drug release profile meeting the requirement of the dissolution test in USP 42. The tablets were prepared by the wet granulation method, and the sustained-release matrix was formed using HPMC and sodium alginate. Various types and concentrations of HPMC were studied for the effect on drug release. Different concentrations of sodium alginate, PVP K30, and Avicel PH101 were also investigated. The results showed that the high molecular weight and high viscosity grade of HPMC made a more retarded drug release profile. Adding sodium alginate also reduced the dissolution rate of the drug. Sodium alginate is insoluble and does not swell at a low pH medium, therefore limiting the penetration of the water into the core. As a result, it reduced the dissolution and diffusion of the drug in the first hour. For the next 7 hours, sodium alginate slowly swelled and dissolved in pH 6.8 medium, thus contributing to drug release control. Avicel PH101 was used in different amounts, which increased the amount of drug release at 5 and 8 hours. Because of many micro-capillary channels in Avicel’s structure, water can deeply penetrate the tablets’ core, therefore increasing the amount of drug released. The preliminary formula was found out and had a release profile meeting the requirement of the USP 42.
Keywords: Sustained release, verapamil, tablets.
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