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Rational design of PLA-based ASDs for pharmaceutical 3D printing: Insights from phase diagram modeling
Alma Lucia Villela Zumaya1, Anton Iemtsev2, Michal Fulem2
1Faculty of Chemical Engineering, University of Chemistry and Technology, Prague, Technická 5, 166 28 Prague 6, Czech Republic.
Summary
Phase diagram modeling aids in selecting plasticizers for 3D-printed amorphous solid dispersions (ASDs). This approach predicts stability, guiding the development of personalized medicines with enhanced drug efficacy and shelf-life.
Area of Science:
- Pharmaceutical Sciences
- Materials Science
- Computational Chemistry
Background:
- 3D printing enables personalized medicine, with Poly(lactide) (PLA) as a key polymer.
- PLA's processability for 3D printing often necessitates plasticizers.
- Amorphous solid dispersions (ASDs) are crucial for enhancing drug solubility and bioavailability.
Purpose of the Study:
- To investigate phase diagram modeling for rational plasticizer selection in PLA-based ASDs.
- To assess the impact of plasticizers on the thermodynamic and kinetic stability of ASDs.
- To correlate predictive modeling with experimental validation for pharmaceutical 3D printing applications.
Main Methods:
- Conductor-like Screening Model for Real Solvents (COSMO-RS) for predicting thermodynamic stability (API solubility).
- Modeling glass transition temperatures to evaluate kinetic stability of ASDs.
- Experimental validation using differential scanning calorimetry and X-ray powder diffraction.
Main Results:
- Phase diagram modeling predicted thermodynamic instability for all formulations.
- Kinetic stability was predicted for formulations with no plasticizer or specific concentrations of triacetin (TA) and triethyl citrate (TEC).
- Experimental studies confirmed the model's predictions regarding physical stability over time.
Conclusions:
- Phase diagram modeling is a valuable tool for designing stable ASDs in pharmaceutical 3D printing.
- The study demonstrates a correlation between predicted phase behavior and experimental physical stability.
- This approach facilitates the rational selection of plasticizers for tailored drug delivery systems.
