Xây dựng công thức màng bao bảo vệ viên nén 2 lớp amoxicillin và acid clavulanic giải phóng kéo dài

Abstract

A coating film was formulated for 2-layer extended release tablets of amoxicillin and clavulanic acid. The tablets were coated with hydroxypropyl methylcellulose (HPMC) E15, Eudragit EPO [poly(methacrylate-methylmethacrylate)], Eudragit E100, Opadry, and OpadryAMB [poly(vinylalcohol)-based formulation], HPMC E15 was selected as polymer, and combined with talc, stearic acid, PEG 6000 (20%; 10% and 15%, respectively calculared on the polymer). The coating weight gain of the obtained tablets was 4%. The film-coating showed good moisture-proof properties with a moisture absorption of 0.41% after 6 hours' exposition to the ambient humidity of 95%. Chemically, the obtained HPMC coated tablets were stable. The amoxicillin and clavulanic acid contents remained unchanged (105.1 and 102.2%, respectively) after 3 days of storage under natural ambient conditions.