New scale-down methodology from commercial to lab scale to optimize plant-derived soft gel capsule formulations on a commercial scale
| Autor: | Yosuke Kondo, Sana Oishi, Kondo Mio, Shuji Noguchi, Yasunori Iwao, Shigeru Itai, Shin-ichiro Kimura, Shimokawa Yoshiyuki |
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| Rok vydání: | 2018 |
| Předmět: |
Materials science
business.product_category food.ingredient Starch Drug Compounding Pharmaceutical Science Modulus Capsules Nanotechnology 02 engineering and technology Carrageenan 030226 pharmacology & pharmacy Gelatin Soft gel capsule 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine food Elastic Modulus Tensile Strength Ultimate tensile strength Composite material Elastic modulus Commercial scale Adhesiveness 021001 nanoscience & nanotechnology chemistry Die (manufacturing) 0210 nano-technology business Gels |
| Zdroj: | International Journal of Pharmaceutics. 535:371-378 |
| ISSN: | 0378-5173 |
| DOI: | 10.1016/j.ijpharm.2017.11.029 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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