PREPARATION AND ASSESSMENT OF AMORPHOUS SOLID DISPERSIONS USING VARIOUS METHODOLOGIES

Abstract

Amorphous products and particularly amorphous solid dispersions are currently one of the most upcoming and widely used areas in the pharmaceutical field. This approach offers huge potential and advantageous features regarding the overall improvement of drug bioavailability. Presently, different manufacturing processes are being developed to produce amorphous solid dispersions with suitable robustness and reproducibility, ranging from solvent evaporation to melting processes. In the present paper, laboratorial and industrial scale processes were reviewed, and guidelines for a rationale selection of manufacturing processes were suggested. This would ensure an adequate development (laboratorial scale) and production according to the good manufacturing practices (GMP) (industrial scale) of amorphous solid dispersions, with further suggestions on the process validations and drug development pipeline.

Keywords: Solid dispersion, BCS Classification, Poor-water solubility, Bioavailability