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Biowaiver Extension Potential and IVIVC for BCS Class II Drugs by Formulation Design: Case Study for Cyclosporine Self-microemulsifying Formulation
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  • Biowaiver Extension Potential and IVIVC for BCS Class II Drugs by Formulation Design: Case Study for Cyclosporine Self-microemulsifying Formulation
  • Biowaiver Extension Potential and IVIVC for BCS Class II Drugs by Formulation Design: Case Study for Cyclosporine Self-microemulsifying Formulation
저자명
Yang. Su-Geun
간행물명
Archives of pharmacal research : a publication of the Pharmaceutical Society of Korea
권/호정보
2010년|33권 11호|pp.1835-1842 (8 pages)
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대한약학회
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정기간행물|ENG|
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이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
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기타언어초록

The objective of this work was to suggest the biowaiver potential of biopharmaceutical classification system (BCS) Class II drugs in self-microemulsifying drug delivery systems (SMEDDS) which are known to increase the solubility, dissolution and oral absorption of water-insoluble drugs. Cyclosporine was selected as a representative BCS Class II drug. New generic candidate of cyclosporine SMEDDS (test) was applied for the study with brand SMEDDS (reference I) and cyclosporine self-emulsifying drug delivery systems (SEDDS, reference II). Solubility and dissolution of cyclosporine from SMEDDS were critically enhanced, which were the similar behaviors with BCS class I drug. The test showed the identical dissolution rate and the equivalent bioavailability (0.34, 0.42 and 0.68 of p values for $AUC_{0{ ightarrow}24h}$, $C_{max}$ and $T_{max}$, respectively) with the reference I. Based on the results, level A in vitro-in vivo correlation (IVIVC) was established from these two SMEDDS formulations. This study serves as a good example for speculating the biowaiver extension potential of BCS Class II drugs specifically in solubilizing formulation such as SMEDDS.