| 摘要 |
The present disclosure relates to delivery systems and methods for increasing the bioavailability and increasing the absorption rate by monolithic enteric capsule administration to humans of active ingredients compared to the bioavailability of active ingredients enterically coated for modified release or gastric protection, particularly acid sensitive active ingredients such as esomeprazole, omeprazole, and other proton pump inhibitors, systems for delivering active pharmaceutical ingredients to humans or animals via monolithic enteric capsules, and improved methods of treating gastrointestinal disorders with such methods and delivery systems. |
| 主权项 |
1. An enteric drug delivery system comprising: a monolithic enteric hard capsule filled with the active pharmaceutical ingredient, wherein the active pharmaceutical ingredient has not been enterically coated for modified release or gastric protection, wherein less than about 10% of the active pharmaceutical ingredient is released from the monolithic enteric capsule after about 2 hours in a pH of about 1.2, wherein at least about 80% of the active pharmaceutical ingredient is released from the monolithic enteric capsule after about 30 min at pH of about 6.8, and wherein more than about 95% of the active ingredient is released in the intestine; wherein the active pharmaceutical ingredient is a proton pump inhibitor selected from the group consisting of dexlanzoprazole, esomeprazole, ilaprazole, leminoprazole, lanzoprazole, omeprazole, pantoprazole, paripiprazole, rabeprazole, tenatoprazole and combinations, pharmaceutically acceptable salts, derivatives, and enantiomers thereof. |
