Optimizing Process Parameters for Controlled Drug Delivery: A Quality by Design (QbD) Approach in Naltrexone
P Lakshmikanth Reddy1, Sangeetha Shanmugasundaram2
1Department of Pharmaceutics, SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulathur, 603203, India.
AAPS Pharmscitech
|May 9, 2024
Summary
This study optimized naltrexone microsphere formulation using Quality by Design (QbD). The optimized microspheres demonstrated comparable in vivo and in vitro drug release profiles to the innovator product.
Area of Science:
- Pharmaceutical Technology
- Drug Delivery Systems
- Formulation Science
Background:
- Microsphere formulation presents manufacturing challenges in achieving desired quality attributes.
- Optimizing critical process parameters (CPPs) is crucial for consistent microsphere production.
Purpose of the Study:
- To optimize critical process parameters (CPPs) for naltrexone microspheres using Quality by Design (QbD).
- To evaluate in vivo and in vitro drug release profiles of the optimized naltrexone microspheres.
Main Methods:
- Quality by Design (QbD) methodology and Box-Behnken design were employed.
- Oil-in-water emulsion solvent extraction technique used for microsphere fabrication.
- Critical process parameters (CPPs) investigated: polymer concentration, phase ratio, and quench volume.
Main Results:
- Increased polymer concentration reduced particle size; reduced quench volume decreased burst release.
- Higher aqueous to organic phase ratio enhanced drug entrapment efficiency.
- An optimal formulation was identified with favorable characteristics.
Conclusions:
- The QbD approach successfully optimized naltrexone microsphere formulation.
- In vitro and in vivo drug release data integration provided a comprehensive understanding.
- This study offers guidance for developing generic naltrexone microsphere formulations.
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