Formulation and Manufacturing Process Design for Pressure Sensitive Colon-Targeting Capsule as a Novel Lipoid Oral Drug Delivery System

摘要

We have developed pressure sensitive colon-targeting capsules (PSCTC), a novel oral drug delivery system with a unique mechanism, where the system releases loading medications from a thermo-sensitive hard fat following a mechanical destruction by change in a pressure with intestinal motility along the GI tract [1]. In the present work, we have modified the formulation of the capsule to improve the pressure sensitivity in the delivery function and designed the basic manufacturing process for the future scale-up production and have found that the combination of a compression molding followed by a pan coating should be an appropriate process for the PSCTC production. This paper will include the data on the PSCTC obtained through our recent in vitro and in vivo evaluation studies.