Category: Formulation and Quality
Purpose: The objectives of this study was to assess the impact of manufacturing process conditions on the physicochemical properties like as MADG loading, solubility and release of monoacetyldiglyceride (MADG)-loaded solid self-nanoemulsifying drug delivery system (solid SNEDDS) for water insoluble oily drug.
Methods: MADG-loaded solid SNEDDSs were prepared by spray drying method using a SDS and calcium silicate. The effect of inlet temperature of 60, 80 and 100°C and feed solution composition at 0, 10, 50, 90, 100% ethanol solution on the physicochemical properties of spray dried MADG-loaded solid SNEDDSs were studied.
Results: The inlet temperature significantly affected water solubility of MADG. Moreover, the feed solution composition significantly affected water solubility and release rate and amount of MADG. MADG-loaded solid SNEDDS dried at 60°C and feed solution composition of 90% ethanol solution showed the best water solubility (3.27 ± 0.39 vs 0 µg/mL) and release (94.4 ± 1.6 vs 32.8 ± 7.4%, 60 min, distilled water with 2.5% SDS) of MADG as optimum product compared to commercial product (form: soft gelatin capsule). The developed MADG-loaded solid SNEDDS showed excellent emulsion droplet size (about 230 nm).
Conclusion: Thus, MADG-loaded solid SNEDDS made with optimum spray-drying condition at 60°C and feed solution composition of 90% ethanol solution had the best physicochemical properties.
Ji eun Choi– Cheonan-si, Ch'ungch'ong-namdo, Republic of Korea
Min-Jong Choi– Student, Department of Pharmaceutical Engineering, Dankook University, South Korea, Cheonan-si, Ch'ungch'ong-namdo, Republic of Korea
Yoo Jin Choi– Ansan, Kyonggi-do, Republic of Korea
Mi Ran Woo– Ansan-si, Kyonggi-do, Republic of Korea
Jung Suk Kim– Student, Hanyang University, Ansan-si, Kyonggi-do, Republic of Korea
Dong Shik Kim– Hanyang University, Ansan, Kyonggi-do, Republic of Korea
Han-Gon Choi– College of Pharmacy, Hanyang University, South Korea, Ansan-si, Kyonggi-do, Republic of Korea
Sung Giu Jin– Department of Pharmaceutical Engineering, Dankook University, South Korea, Cheonan-si, Ch'ungch'ong-namdo, Republic of Korea