Abstract:
본 발명은 난용성 약물의 나노입자를 포함하는 분말의 제조방법, 그에 의해 제조된 분말 및 이를 포함하는 약학적 조성물에 관한 것이다. 본 발명의 제조방법 은 표면 안정화제의 존재 하에 나노입자화된 난용성 약물의 균질화된 분산 용액을 제공하는 단계, 균질화된 분산 용액과 수용성 분산제 용액을 혼합하는 단계, 및 결 과로서 얻어진 혼합 용액을 건조시켜 분말을 회수하는 단계를 포함한다. 본 발명의 제조방법에 의한 난용성 약물의 나노입자를 포함하는 분말은 수용 액에 재분산시 난용성 약물이 나노수준의 입자크기를 유지하면서,약물의 용해도와 용출속도가 증가하여 향상된 생체이용률을 나타내므로, 난용성 약물의 경구 투여 또는 비경구 투여를 목적으로 하는 제형 개발에 유용하게 활용될 수 있다.
Abstract:
PURPOSE: A method for manufacturing powder containing nanoparticles of insoluble drug is provided to maintain nanoscopic insoluble drug and enhance elusion rate and solubility of drug. CONSTITUTION: A method for manufacturing powder containing nanoparticles of insoluble drug comprises: a step of preparing homogenized dispersion solution of insoluble drug under the presence of surface stabilizer; a step of mixing homogenized dispersion agent and water soluble dispersion solution; and a step of drying mixture solution and collecting powder. The water soluble dispersion agent is gelatin, carrageenan, alginic acid, arabinoxylan, beta-glucan, guar gum, locust soybean gum, pectin, starch, casein, glucomannan, cyclodextrin, methylcellulose, chitosan, or gluten. A pharmaceutical composition contains powder containing nanoparticles of insoluble drug and pharmaceutically acceptable carrier.
Abstract:
A manufacturing method of powder including nano particles of insoluble drug is provided to maintain stability in case that insoluble drug is re-dispersed at aqueous solution, to be no side effect by impurity and to improve bio-availability. A manufacturing method of powder including nano particles of insoluble drug comprises steps of: adding particles of insoluble drug which is active component, a surface passivating agent and additional dispersion secondary particle in aqueous solution including dispersion secondary particle to aturation concentration; mixing, shattering and homogenizing the obtained dispersed solution; and centrifuging or filtering the homogenized dispersed solution and drying it and obtaining the powder from the dispersed solution.