(- / 0)

Recording date:

Duration:

Session:

Speaker:

Co-Authors:

Back

Abstract:

Keywords

Powders, Reconstitution, Formulation, Active Pharmaceutical Ingredients

Abstract

In this project, we investigate the underlying mechanisms governing the dissolution of active pharmaceutical ingredients (API) from a powder state. The API is dissolved either in water or an excipient solution. Here, a range of relevant APIs are characterized in terms of physicochemical characteristics  aiming to identify limiting factors in the reconstitution of the protein in solution.

Previous research performed by Lillford and Fryer (1998), Börjesson et al. (2016), and by Andersson (2020) has gone into the production and reconstitution of powders in the food industry, specifically the dairy industry. Here, reconstitution is shown to be limited by factors such as fish-eye formation and  poor imbibition of the powder into the liquid. These are both indicators of poor penetration of the liquid through the powder.

We look at dissolution of a range of pharmaceutically relevant API which are characterized in terms of e.g. powder particle size distributions, porosity, contact angle etc. to be able to identify limiting factors to the reconstitution. The aim of this is to find linkage between the characteristics of the API and  the dissolution, yielding quicker process with reduced variability, while also minimizing the potential stressing of the pharmaceutical molecules.

1

Figure 1: Principal drawing of a formulation process in the production of injectable drug products.

References

  • Andersson, I.-M. (2020) Functionality of Spray-Dried Whey Protein Powders - Surface Composition, Particle Morphology and Rehydration. LTH. Börjesson, E. et al. (2016) ‘Permeability of powder beds formed from spray dried dairy powders in relation to morphology data’, Powder Technology, 298, pp. 9–20. Available at: https://doi.org/10.1016/j.powtec.2016.05.006.
  • Lillford, P.J. and Fryer, P.J. (1998) ‘Food particles and the problems of hydration’, Chemical Engineering Research and Design, 76(7 A7), pp. 797–802. Available at: https://doi.org/10.1205/026387698525531.