삼투압을 이용한 과립의 제조와 약물의 방출 특성에 관한 연구

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 water swellable seed layer, drug layer, and drug release controlled membrane layer and manufactured by fluidized bed coater. Granule size, membrane thickness, membrane composition, osmotic agent amount, channeling agent type and amount, drug solubility and dissolution test condition have an effect on drug release from osmotic granule system. Drug release increased as granule size and membrane thickness decreased. Also, drug release increased as channeling agent, osmotic agent, drug solubility and dissolution test paddle speed increased. Drug release increased as hydrophilic composition in membrane increased. And porosity for drug release was differed by the type of channeling agent. 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.