Master of Engineering Science
Esomeprazole magnesium tri-hydrate (EMT) is a proton pump inhibitor, used for the treatment of gastric and duodenum ulcers. It is currently the best choice for the treatment of acid-related diseases, but it is extremely unstable in gastric acid and sensitive to wet, heat, light. It also will react with the enteric coating material used in this study. So enteric coating and sub coating is needed.
This study offers a new approach, dry powder coating technology, to achieve drug loading and enteric coating of EMT beads and capsules. Dry powder coating, a new type of solvent-less coating technology, can address most of the problems of solvent-based coating. This study consists of three parts. Firstly, achieve EMT-loaded beads, enteric coated EMT beads and enteric coated capsules filled with EMT-loaded beads by dry powder coating process. Secondly, the process conditions of the drug loading and enteric coating process were optimized. Thirdly, the process condition and coating results of EMT beads and EMT capsules were compared.
Results of SEM micrographs and drug release profiles showed both the enteric coated EMT beads and capsules successfully formed a smooth film and satisfied enteric release requirement. The dry powder coating was successfully shown to be a feasible strategy to achieve effective enteric delivery for EMT, as well as other alkali reacting active pharmaceutical ingredient (API). The best process conditions so far were achieved after the process conditions optimization.
Ge, Xiaojing, "Apply dry powder on drug loading and enteric coating of esomeprazole magnesium trihydrate beads and capsules" (2019). Electronic Thesis and Dissertation Repository. 6021.
Available for download on Wednesday, January 17, 2024