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Understanding the Effects of Associated Factors in the Development of Microsponge-Based Drug Delivery: a Statistical
Shibam Karmakar1, Sourav Poddar2, Jasmina Khanam3
1Department of Pharmaceutical Technology, Jadavpur University, Kolkata, India.
AAPS Pharmscitech
|September 16, 2022
Summary
This study optimized drug-loaded microsponge formulations using design of experiments and response surface methodology. The developed method ensures reproducible, stable, and reliable drug delivery with high yield and entrapment efficiency.
Area of Science:
- Pharmaceutical Sciences
- Drug Delivery Systems
- Formulation Development
Background:
- Developing stable and reproducible drug formulations is crucial for effective therapy.
- Microsponge technology offers potential for controlled drug release and improved therapeutic outcomes.
- Optimizing formulation parameters is essential to minimize batch-to-batch variability and ensure product quality.
Purpose of the Study:
- To prepare and characterize drug-loaded microsponge formulations.
- To optimize the formulation process using design of experiments (DoE) and response surface methodology (RSM).
- To ensure the reproducibility, stability, and reliability of the developed microsponge formulation.
Main Methods:
- Utilized Quality by Design (QbD) principles and DoE for formulation optimization.
- Employed a quasi-emulsion solvent evaporation method for microsponge preparation.
- Analyzed critical process attributes (CPAs) like particle size, yield, and drug entrapment efficiency.
Main Results:
- Achieved high drug entrapment efficiency (77.69-94.38%) and product yield (76.91-96.38%).
- Optimized formulation yielded ~96% yield, 347 µm particle size, and ~93.55% entrapment efficiency.
- Demonstrated a constant drug release rate over 8 hours with 75% drug release.
Conclusions:
- The QbD-driven approach successfully optimized drug-loaded microsponge formulation.
- The developed method is reproducible, stable, and reliable for scalable manufacturing.
- Microsponge formulations show promise for controlled drug delivery with consistent performance.
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