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Transitioning from a lab-scale PLGA microparticle formulation to pilot-scale manufacturing.
1Purdue University, Departments of Biomedical Engineering and Pharmaceutics, West Lafayette, IN 47907, USA.
Summary
Scaling up Poly(lactic-co-glycolic) acid (PLGA) microparticle manufacturing presents challenges. This study shows that controlling formulation and processing parameters allows for consistent drug release kinetics during scale-up of long-acting naltrexone microparticles.
Area of Science:
- Pharmaceutical Sciences
- Biomaterials Engineering
- Drug Delivery Systems
Background:
- Scaling up Poly(lactic-co-glycolic) acid (PLGA) microparticle manufacturing from benchtop to clinical batches is complex.
- Variations in formulation composition and processing parameters can significantly impact microparticle performance.
Purpose of the Study:
- To evaluate the in vitro and in vivo performance of a long-acting naltrexone formulation during manufacturing scale-up.
- To compare benchtop-scale and pilot-scale production using rotor-stator and in-line processes.
Main Methods:
- Physicochemical characterization (drug loading, residual solvent, morphology) of naltrexone microparticles.
- In vitro drug release studies.
- In vivo pharmacokinetic evaluation in a rat model.
Main Results:
- Morphological differences observed between benchtop and pilot-scale microparticles.
- Slight variations in in vitro release profiles noted.
- Similar in vivo pharmacokinetic profiles demonstrated for both scales.
Conclusions:
- Manufacturing scale-up of PLGA microparticles is achievable while maintaining consistent drug release kinetics.
- Careful control of formulation and processing parameters is crucial for successful scale-up.
