Comparison of the Design Space of Products with Different Initial Saturation

J Pharm Sci. 2022 Mar;111(3):717-726. doi: 10.1016/j.xphs.2021.09.034. Epub 2021 Sep 26.

Abstract

Vacuum freeze-drying is a promising technology widely used in pharmaceuticals. Preparing products with prebuilt porosity has attracted considerable attention due to its potential in shortening process duration. However, the design space for the primary drying of initially unsaturated products remains unclear. A novel index, average power, was proposed in this paper to represents the collapse risk. And a multiphase model was employed in this paper to build the design space for the products with initial voids. The simulation results show that both the drying time and average power show higher sensitivity to the temperature variation than pressure. In addition, the initial saturation has significant impacts on the design space, with small initial saturation resulting in vast design space and vice versa, which implies that small initial saturation is more beneficial for the actual production. This paper would be helpful for the development of freeze-drying.

Keywords: Design space; Freeze drying; Mathematical model; Prebuilt porosity.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Computer Simulation
  • Desiccation*
  • Freeze Drying / methods
  • Temperature