Elucidation of the mechanism of amorphization and dissolution of bad glass former as a function of drug-polymer interaction and preparation method

Project/agreement No.

lzp-2024/1-0037

Project funding

300 000.00 EUR

Project manager

Valentyn Mohylyuk

Project realization

01.01.2025. - 31.12.2027.

Aim

The aim of the project is to investigate the amorphization and dissolution mechanism of a poor glass former as a function of drug and polymer interactions and preparation method. The drug sample naproxen is a poorly soluble medication and a poor glass former (worst-case scenario).

Description

The project will study the impact of polymer and solvent properties (solubility parameters, interaction with drugs, molecular weight, rheological properties, and glass transition temperature) on the stability of high drug-loaded ASD solids, thermodynamic and kinetic stabilization. The effect of manufacturing methods (liquid layer coating and electrospinning), process parameter settings on the obtained ASD solids and their physical stability, as well as a comparison of both methods, will be investigated. The impact of ASD composition (polymer type and drug load), manufacturing method, and polymer dissolution rate on the in vitro dissolution profile of the drug under simulated gastric and intestinal conditions, drug and polymer release, as well as critical parameters such as the congruence limit, will be examined. Algorithms will be proposed to tailor the main properties of the manufactured ASD, including the dissolution profile.

The project is interdisciplinary. It includes the following research areas: pharmacy, materials engineering, polymer chemistry, and physics. The project results will include three publications, three conference theses, and a Latvian patent.