(340b) Modeling Particle Formation in Spray Drying of Amorphous Solid Dispersions

Authors: 
Valente, P., Hovione FarmaCiência SA
Sousa, R., R&D Drug Product Development
Nakai, M., Hovione

line-height:150%"> " arial>In this presentation we present a mathematical model of the
various concurrent physical phenomena that a polymer solution with an Active
Pharmaceutical Ingredient (API) undergo prior to forming an amorphous solid
dispersion particle, such as atomization, co-solvent evaporative dynamics,
propensity for phase separation and shell formation.

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line-height:150%"> " arial>The numerical model is benchmarked against single-droplet
drying data obtained with a suspended droplet apparatus indicating that the
model captures, to a first approximation, the dominant physical phenomena (see
Figure 1).

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line-height:150%"> " arial>The motivation of the work is to support the development of
Amorphous Solid Dispersion powders of poorly water soluble APIs in hydrophilic
polymeric matrices which is a commonly used strategy to increase the solubility
and dissolution rate of oral-dosage forms. However, successful development of
amorphous solid dispersions for optimal performance and stability depends on both
the formulation (e.g. drug load, polymer system and surfactants) and on the
manufacturing technology/process conditions. Optimizing the formulation and the
process requires extensive laboratory work, which is often compromised by time
and cost constraints. Therefore, the ability to perform virtual experiments is
highly advantageous and cost-effective.

 

Figure 1: Model prediction (dashed-line) benchmarked
against experimental data (filled circles represent Temperature measurements,
whereas hollow circles represent droplet size).

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line-height:150%"> " arial>*Vulcanus in Japan-Europe program for supporting Mr.
Masahiro Nakai’s internship