New scale-down methodology from commercial to lab scale to optimize plant-derived soft gel capsule formulations on a commercial scale

Int J Pharm. 2018 Jan 15;535(1-2):371-378. doi: 10.1016/j.ijpharm.2017.11.029. Epub 2017 Nov 14.

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.

Keywords: Carrageenan; Design of experiment; Gelatin; Rotary die method; Scale-down methodology; Soft gel capsule.

MeSH terms

  • Adhesiveness
  • Capsules / chemistry*
  • Carrageenan / chemistry
  • Drug Compounding
  • Elastic Modulus
  • Gels / chemistry*
  • Tensile Strength

Substances

  • Capsules
  • Gels
  • Carrageenan