NGHIÊN CỨU BÀO CHẾ VIÊN NANG CHỨA ESOMEPRAZOL 20MG DẠNG HẠT BAO TAN TRONG RUỘT

Abstract

Objectives: Preparation of capsules containing esomeprazole delayed release pellet. Materials and methods: The materials were esomeprazole with polymer Eudragit^®L30D-55. Survey the active coating layer (alcohol: water ratio, PEG 6000 weight, talc weight, dry matter content), survey the insulation layer (alcohol: water ratio, PEG 6000 weight, dry matter content), survey the soluble layer in the intestine (TiO₂ weight, the weight gain of the intestinal layer) to the pellet process to determine the solubility in hydrochloric acid 0,1N in 2 hours was more than 10% and in phosphate buffer medium pH 6.8 for 30 minutes not less than 80%. Results: In the active coating layer, the alcohol: water ratio was 3:1, the weight of PEG 6000 was 2,1g, the weight of talc was 2,1g and the dry matter content was 8%. In the insulating layer, the alcohol: water ratio was 3:1, the weight of PEG 6000 was 1,2g and the dry matter content was 6%.In the intestinal soluble coating with TiO₂ weight of 1g, the weight gain of the intestinal soluble coating was 30%. Conclusion: Has prepared capsules containing esomeprazole delayed release pellets form to meet the standards of USP43.