New scale-down methodology from commercial to lab scale to optimize plant-derived soft gel capsule formulations on a commercial scale |
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Authors: | Sana Oishi Shin-ichiro Kimura Shuji Noguchi Mio Kondo Yosuke Kondo Yoshiyuki Shimokawa Yasunori Iwao Shigeru Itai |
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Institution: | 1. School of Pharmaceutical Sciences, University of Shizuoka, 52-1 Yada, Suruga-ku, Shizuoka 422-8526, Japan;2. Faculty of Pharmaceutical Sciences, Toho University, 2-2-1 Miyama, Funabashi, Chiba 274-8510, Japan;3. Fuji Capsule Co., Ltd., 4242-1 Kitayama, Fujinomiya, Shizuoka 418-0112, Japan |
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Abstract: | A new scale-down methodology from commercial rotary die scale to laboratory scale was developed to optimize a plant-derived soft gel capsule formulation and eventually manufacture superior soft gel capsules on a commercial scale, in order to reduce the time and cost for formulation development. Animal-derived and plant-derived soft gel film sheets were prepared using an applicator on a laboratory scale and their physicochemical properties, such as tensile strength, Young’s modulus, and adhesive strength, were evaluated. The tensile strength of the animal-derived and plant-derived soft gel film sheets was 11.7?MPa and 4.41?MPa, respectively. The Young’s modulus of the animal-derived and plant-derived soft gel film sheets was 169?MPa and 17.8?MPa, respectively, and both sheets showed a similar adhesion strength of approximately 4.5–10?MPa. Using a D-optimal mixture design, plant-derived soft gel film sheets were prepared and optimized by varying their composition, including variations in the mass of κ-carrageenan, ι-carrageenan, oxidized starch and heat-treated starch. The physicochemical properties of the sheets were evaluated to determine the optimal formulation. Finally, plant-derived soft gel capsules were manufactured using the rotary die method and the prepared soft gel capsules showed equivalent or superior physical properties compared with pre-existing soft gel capsules. Therefore, we successfully developed a new scale-down methodology to optimize the formulation of plant-derived soft gel capsules on a commercial scale. |
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Keywords: | DoE design of experiment MCT medium chain triglyceride Soft gel capsule Scale-down methodology Rotary die method Design of experiment Gelatin Carrageenan |
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