Micro-Scale Vacuum Compression Molding as a Predictive Screening Tool of Protein Integrity for Potential Hot-Melt...

Area of Science:

• Pharmaceutical Technology
• Materials Science

Background:

• Hot-melt extrusion (HME) is crucial for solid protein formulations, enhancing stability and enabling long-term release.
• HME requires substantial material quantities, limiting its use for initial screening.

Purpose of the Study:

• Introduce vacuum compression molding (VCM) as a predictive screening tool for protein stability in HME.
• Identify suitable polymeric matrices for protein stabilization and extended-release dosage forms using minimal protein.
• Evaluate protein stability after thermal stress in VCM-processed formulations.

Main Methods:

• Investigated protein stability (lysozyme, BSA, human insulin) in polymers (PEG 20,000, PLGA, EVA) using VCM.
• Analyzed protein stability via differential scanning calorimetry (DSC), Fourier-transform infrared spectroscopy (FT-IR), and size exclusion chromatography (SEC).

Main Results:

• VCM provided insights into solid-state protein stabilization mechanisms.
• Demonstrated successful application of VCM for various protein-polymer combinations.
• Highlighted ethylene-vinyl acetate (EVA) as a promising polymer for protein stabilization and extended-release systems.

Conclusions:

• VCM is an effective screening tool for predicting protein stability in HME formulations.
• Identified EVA as a suitable matrix for solid-state protein stabilization and extended-release applications.
• VCM-processed stable protein-polymer mixtures can be further evaluated using HME for process-related stability.