다중층 과립을 이용한 난용성 약물의 방출 제어

Abstract

Osmotic granule system which is one of the drug delivery systems has been developed to improve manufacturing process and other problems of tablet osmotic systems. It consists of a water swellable seed layer, drug layer, and membrane controlling drug release and manufactured by fluidized bed coaing method. The osmotic multi-layered granules composed of sugar, various excipients, such as hydroxypropyl cellulose (HPC), lactose, fructose, cellulose acetate (CA), and Eudragitⓡ have been successfuly developed for purpose delivering Nifedipine(ND). ND tablet dosage forms of Adalatⓡ (Bayer) are commercialized systems. Hydrophilc swelling agnet, Granule size, solubilizer, membrane composition, and hydrophilic channeling agent had an effect on drug release from osmotic granule system. Drug release increased as granule size. Also, drug release increased as channeling agent, drug solubility. Drug release increased as hydrophilic composition in membrane increased. From these results, we assured that osmotic granule can be fabricated by fluidized bed coating methods, and the appropriate release profile could be controlled by these factors.