Tailored ASD destabilization - Balancing shelf life stability and dissolution performance with hydroxypropyl cellulose.

ABSTRACT: Amorphous solid dispersion (ASD) formulations are preferred enabling formulations for poorly water soluble active pharmaceutical ingredients (API) as they reliably enhance the dissolution behavior and solubility. Balancing a high stability against unwanted transformations such as crystallization and amorphous phase separation during storage on the one hand and optimizing the dissolution behavior of the formulation (high supersaturation and maintenance for long time) on the other hand are essential during formulation development. This study assessed the potential of ternary ASDs (one API and two polymers) containing the polymers hydroxypropyl cellulose together with poly(vinylpyrrolidone-co-vinyl acetate) (PVP VA64) or hydroxypropyl cellulose acetate succinate to stabilize the amorph

SUBMITTER: Luebbert C 

PROVIDER: S-EPMC10314205 | biostudies-literature | 2023 Dec

REPOSITORIES: biostudies-literature