Development of multiple unit oral formulations for colon specific drug delivery

Abstract

The present thesis deals with the investigation carried out on the development of multiple-unit oral formulations for colon-specific drug delivery formulations with the objective of the release of API in the colonic region of GIT. The first chapter of the thesis gives a brief account on anatomy, physiology, the condition, prevalence of colon. The different strategies applied in formulating oral colonic drug delivery system was been discussed. The use of polymetha methacrylate in the system. Literature review of the prior investigation and developments for the delivery system is being mentioned. The second chapter deals with the scope and detailed objectives along with the plan of work. The detailed proposal of carrying the project is described. The pellets were formulated into capsules and tablets with emphasis to carry the API to the colonic region. The third chapter gives the details on the materials and methods of the study. The preformulation study related with organoleptic properties of API and polymers, development of in vitro dissolution method and compatibility studies by using DSC for the formulation. The experimental technique extrusion and spheronization used in the formulation of pellets, coating of pellets, characterization of pellets physically, in vitro and in vivo study are described in this chapter. The fourth chapter deals with the results inferred with the study and its discussions. A novel colonic drug delivery system was developed using multiple coating of aqueous polymethacrylates on core pellets containing API. These delivery system proved successful for site-specific colonic delivery. The delivery system can be easily manufactured on a large-scale in a reasonable processing from a regulatory viewpoint; all the ingredients comprising the delivery system are official. The thrust of this work was is the applicability of multiple coatings of polymethacrylates on formulated pellets for site-specific release in the ileocecal region and colon followed by sustained-release of a model API.