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Formulation performance and processability window for manufacturing a dual-polymer amorphous solid dispersion via
T R Hörmann1, N Jäger2, A Funke3
1Institute for Process and Particle Engineering, Graz University of Technology, Inffeldgasse 13/3, 8010 Graz, Austria.
International Journal of Pharmaceutics
|October 17, 2018
Summary
This study optimized amorphous solid dispersions (ASDs) of nimodipine (NMD) using HPMC E5 and Eudragit E for hot-melt extrusion. A specific polymer ratio ensures physical stability and rapid drug release, crucial for effective drug delivery.
Area of Science:
- Pharmaceutical Technology
- Materials Science
- Drug Delivery
Background:
- Poorly soluble drugs like nimodipine (NMD) require advanced formulations for effective delivery.
- Amorphous solid dispersions (ASDs) are a promising strategy to enhance drug solubility and bioavailability.
- Hot-melt extrusion (HME) is a scalable technique for producing ASDs.
Purpose of the Study:
- To identify a formulation window for nimodipine (NMD) amorphous solid dispersions (ASDs) using a dual-polymer system (HPMC E5 and Eudragit E).
- To achieve desired functional ASD performance, including physical stability and immediate drug release.
- To ensure processability in hot-melt extrusion (HME) and strand pelletization.
Main Methods:
- Preparation of ternary ASD formulations with varying polymer ratios and NMD content (10-30% w/w).
- Evaluation using vacuum compression molding (VCM) and benchtop extrusion for sample preparation.
- Miscibility, phase behavior, Fourier-transform infrared spectroscopy (FTIR), and dissolution rate studies.
Main Results:
- ASD formulations were phase-separated but physically stable. NMD predominantly solubilized in Eudragit E, with evidence of hydrogen bonding.
- Processability was limited at high Eudragit E content due to low glass transition temperature and melt instability.
- HPMC E5 provided mechanical robustness, while Eudragit E enhanced dissolution rates. A formulation window of 1:2-2:3 Eudragit E:HPMC was identified.
Conclusions:
- A feasible formulation window for NMD ASDs was identified, balancing physical stability, dissolution enhancement, and processability.
- Eudragit E acts as a dissolution enhancer and stabilizer, while HPMC E5 ensures mechanical integrity during processing.
- Shear stress during HME significantly influences the performance of HPMC-based ASDs, highlighting the importance of optimized processing.
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