화학공학소재연구정보센터
홈 로그인 로그아웃 연락처 사이트맵
Polymer(Korea), Vol.35, No.4, 277-283, July, 2011
Export Citation
플라스돈 S-630과 함께 분무건조된 모델 난용성 약물로서 프란루카스트의 pH 용해도 특성 및 용출률 개선
pH Solubility Properties and Improved Dissolution of Pranlukast as an Poorly Water-soluble Model Drug Prepared by Spray-drying with Plasdone S-630
조원형, 이영현, 송병주, 유석철, 임동균, 강길선†
  • 전북대학교 BIN 융합공학과 ＆ 고분자ᆞ나노공학과
Won Hyung Cho, Young Hyun Lee, Byung Joo Song, Seok Cheol Yoo, Dong Kyun Lim, and Gilson Khang†
  • Department of BIN Fusion Tech & Department of PolymerㆍNano Sci. Tech., Chonbuk Nat'l Univ., 664-14 Dukjin, Jeonju 561-756, Korea
E-mail:
초록
고체분산체는 난용성 약물의 용출률 개선을 위한 방법으로 주로 사용된다. 난용성 약물인 프란루카스트를 플라스돈 S-630과 함께 분무건조하여 고체분산체를 제조하였다. pH에 따른 프란루카스트 용해도 실험을 실시하여 높은 pH에서 약물의 용해도가 높게 나왔다. 입도 분석으로 고체분산체 내의 약물의 크기가 나노 크기로 작아진 것을 확인하였다. 표면전위를 측정하여 고체분산체가 음전하를 가지고 있는 것을 확인하였다. 주사전자현미경으로 고체분산체의 표면이 구형임을 확인하였고, 시차주사열량계와 X-선 회절 분석법을 통해 고체분산체가 무정형임을 확인하였다. 고체분산체의 용출특성을 알아보기 위해 인공장액(pH 6.8)에서 용출거동을 확인하였고, 대조실험을 위해 시판제인 오논®캡슐을 사용하였다. 이 결과로 분무건조를 통한 고체분산체의 제조를 통해 난용성 약물의 용출특성을 확인하였고, 경구용 약제 학적 형태를 가질 수 있는 것을 확인하였다.
Solid dispersion is mainly used for improved dissolution of poorly water-soluble drugs. Solid dispersion of pranlukast was prepared by spray-drying with plasdone S-630. When pH of water was high, pranlukast was highly soluble in the solubility experiment of solid dispersions with varying pH. The particle size of pranlukast particles in solid dispersions was measured to be in nanometers scale based on particle size analysis. Zeta-potential analysis confirmed the negative charge of solid dispersion. SEM was used to observe the surface of solid dispersion, which confirmed spherical morphology, DSC and XRD confirmed the amorphous nature of solid dispersions. The in vitro test was carried out to find improved dissolution rate of pranlukast solid dispersion in simulated juice gastric and a controlled experiment was carried out to compare pranlukast solid dispersions with a conventional drug (Onon®). These results showed the dissolution properties of pranlukast solid dispersions prepared by spray drying proper for the oral pharmaceutical formulation.
Keywords:solid dispersion;poorly water-soluble drug;solubility;plasdone S-630.
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