Study On Enteric Coating Layer Formulation And Coating Process Of Doxycycline Hydrochloride Enteric Coated Pellets

• Main Authors: Li-Chung Hsiao, 蕭力中
• Other Authors: Chien-Chih Yu
• Format: Others
• Language: zh-TW
• Published: 2018
• Online Access: http://ndltd.ncl.edu.tw/handle/m434y2

碩士 === 中國醫藥大學 === 製藥碩士學位學程 === 106 === Coat hydrochloric acid doxycycline enteric-coated pellets with different dissolution characteristics enteric coating, HPMC-P and EUDRAGIT® L30D-55, in different coating process; identify their dissolution, roundness, and friability in 0.06M HCl solution and pH 5.5 buffer solution as well as impact of intense light, high temperature and high humidity on the product and its accelerated stability. Initial results suggest HPMC-P and EUDRAGIT® L30D-55 based products make no significant difference in acid and pH5.5 buffer solution in terms of dissolution. Particles coated by fluid bed granulation end up with better acid dissolution, roundness, and friability than their side granulation counterparts. We then take samples made by bed granulation and different formula for stability and puncture tests. Test results suggest EUDRAGIT® L30D-55 based pellets outperm the HPMC-P ones with respect to substance and concentration while maintaining the same good stability in environment of intense light, high temperature and high humidity as well as less than 2% dissolution in 0.06M HCl solution. EUDRAGIT® L30D-55 is then poised the optimum prescription. Coating EUDRAGIT® L30D-55 enteric material with fluid bed granulation is the best option in terms of reliable quality, lower costs and environment friendliness.