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

Project title: Elucidation of the mechanism of amorphization and dissolution of bad glass former as a function of drug-polymer interaction and preparation method
Project contract number: lzp-2024/1-0037
Project implementation time: 01.01.2025 – 31.12.2027
Project beneficiary: Riga Stradiņš University (RSU); Project manager: Valentyn Mohylyuk
Project partner: University of Latvia (LU)
LU structural unit implementing the project: Institute of Atomic Physics and Spectroscopy, FST, LU
Research manager at University of Latvia: Dr. Roman Viter (Laboratory of Optical Biosensors and Functional Nanomaterials)
Funding for University of Latvia: 140 001 EUR

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

Description:
This fundamental interdisciplinary project is aimed at investigating the mechanism of amorphization and dissolution of bad glass former as a function of the drug-polymer interaction and preparation method. The model drug naproxen is a poorly soluble drug and a bad glass former (worst-case scenario). The effect of polymer and solvent properties (solubility parameters, interaction with drug, molecular weight, rheological properties, and glass transition temperature) on the solid-state stability of high drug-loaded ASD, thermodynamic and kinetic stabilization will be investigated. The effect of the manufacturing method (fluid bed coating and electrospinning), process parameters settings on the resulting solid-state of ASDs and their physical stability, as well as a comparison of the two methods, will be investigated. The effect of ASD composition (polymer type and drug load), manufacturing method, and dissolution rate of the polymer on the in-vitro drug dissolution profile in stomach- and intestine-mimicking conditions, release of drug and polymer, as well as critical parameters such as the limit of congruence, will be investigated. Algorithms for tailoring the main properties of fabricated ASD, including the dissolution profile, will be proposed. The project is interdisciplinary; it involves the following research areas: pharmaceuticals, material engineering, polymer chemistry, and physics

Expected results:
•    Original scientific articles published in high-level Q1 or Q2 journals – 3
•    Intellectual property registered in Latvia – 1
•    Project application submitted to the Latvian Research and Development Project Competition – 1
•    Other project results (e.g., data sets, etc.) – 4
•    Participation in international scientific conferences – 2
•    Participation in national scientific conferences

Project Team - Laboratory of Optical Biosensors and Functional Nanomaterials:
•    Roman Viter roman.viter@lu.lv 
•    Agris Bērziņš agris.berzins@lu.lv 
•    Iryna Tepliakova iryna.tepliakova@lu.lv 
•    Viktor Zabolotnii viktor.zabolotnii@lu.lv 
•    Aleksandrs Kapralovs aleksandrs.kapralovs@lu.lv 
•    Ruslans Kačanovs ruslans.kacanovs@lu.lv