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엔잘루타마이드의 용해도 개선을 위한 고형의 자가나노유화 약물전달시스템
이수민(Su Min Lee),이정균(Jeong Gyun Lee),윤서완(Seo Wan Yun),김경수(Kyeong Soo Kim) 대한약학회 2022 약학회지 Vol.66 No.6
The objective of this study was to develop a novel enzalutamide-loaded solidified self-nanoemulsifying drug delivery system formulation with enhanced solubility and dissolution rate. Various oil and surfactant were screened, then Medium Chain Triglyceride oil and Polysorbate 80 and Labrafil M2125CS were selected as oil and a surfactant. Pseudoternary phase diagram was constructed to detect the nanoemulsion zone. Among the SNEDDS formulations tested, SNEDDS consisted of MCT oil (oil), Polysorbate 80 (surfactant) and Labrafil M2125CS (co-surfactant) at a weight ratio of 20:70:10. The SNEDDS produced the emulsion droplet size 18.66±0.88 nm. Spray drying technique was used to convert the selected enzalutamide-loaded SNEDDS into solid SNEDDS with inert carrier such as silicon dioxide. Enzlautamide-loaded solid SNEDDS was characterized by scanning electron microscopy, transmission electron microscopy, powder X-ray diffractometry, dynamic light scattering, saturation solubility and in vitro dissolution study. The S-SNEDDS produced an emulsion droplet size of 15.37±0.49 nm and there was no change in particle size between with or without drug. SEM and PXRD results suggested that enzalutamide existed in amorphous form in enzalutamide-loaded solid SNEDDS. In addition, enzalutamide-loaded solid SNEDDS increased saturation solubility 42-fold and dissolution rates 23- fold compared to crystalline enzalutamide. Therefore, the solid SNEDDS could be a potential nano-sized drug delivery system for poorly water-soluble drug enzalutamide.
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용해도가 개선된 엔잘루타마이드 고체분산체 함유 정제의 개발
이정균(Jeong Gyun Lee),이수민(Su Min Lee),윤서완(Seo Wan Yun),김경수(Kyeong Soo Kim) 대한약학회 2022 약학회지 Vol.66 No.5
The objective of this study was to develop a novel enzalutamide tablet formulation with enhanced solubility and bioavailability, and inhibited recrystallization. Kollidon VA64 was selected as a soluble polymer for preparing enzalutamide solid dispersions. Solid dispersions with different enzalutamide to Kollidon VA64 weight ratios were prepared via solvent evaporation method. The enzalutamide solid dispersion consisting of enzalutamide and Kollidon VA64 at a weight ratio of 1:1, exhibited an excellent dissolution rate and potent inhibition of recrystallization. Enzalutamide solid dispersions were characterized by scanning electron microscopy, powder X-ray diffractometry, differential scanning calorimetry, and in vitro dissolution studies. The 1:1 solid dispersion exhibited excellent productivity, an elevated dissolution rate, and recrystallization inhibition. Therefore, enzalutamide solid dispersion loaded tablets were prepared and their dissolution was evaluated compared to a commercial product (Xtandi® soft capsule). The selected tablet formulation containing enzalutamide solid dispersion exhibited a higher dissolution rate in pH 1.0 solution than did the Xtandi® soft capsule, and prevented recrystallization of the enzalutamide. This research suggests that enzalutamide-containing solid dispersion tablets could be the most effective method to date for improving the dosing compliance of Xtandi® soft capsules, improving the dissolution rate of enzalutamide, and preventing recrystallization.
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