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Formulation optimization of controlled release diclofenac sodium microspheres using factorial design
1Department of Pharmaceutics and Pharmaceutical Technology, L.M. College of Pharmacy, Navrangpura, Ahmedabad, India.
Summary
Diclofenac sodium microspheres were developed for controlled release. Optimized preparation involved lower stirring speed, higher CaCl2 concentration, and increased heavy liquid paraffin for reduced adverse effects.
Area of Science:
- Pharmaceutical Technology
- Materials Science
Background:
- Diclofenac sodium's oral administration can cause adverse effects.
- Controlled release systems offer a strategy to mitigate these side effects.
- Microspheres are a viable formulation for controlled drug delivery.
Purpose of the Study:
- To develop diclofenac sodium-loaded microspheres using sodium alginate.
- To investigate the influence of preparation variables on drug release kinetics.
- To optimize microsphere formulation for controlled diclofenac sodium release.
Main Methods:
- Sodium alginate microspheres loaded with diclofenac sodium were prepared.
- A 3(3) full factorial design was employed to study stirring speed, CaCl2 concentration, and liquid paraffin composition.
- Drug release (t80) was analyzed using multiple linear regression and response surface plots.
Main Results:
- Lower stirring speed, higher CaCl2 concentration, and increased heavy liquid paraffin percentage favored controlled drug release.
- Significant interactions (X1X2, X2X3) influenced the 80% drug dissolution time (t80).
- Anomalous diffusion kinetics governed the drug release mechanism.
Conclusions:
- Optimized formulation parameters enable controlled release of diclofenac sodium from alginate microspheres.
- The developed model accurately predicts drug release profiles.
- This approach can reduce diclofenac sodium's adverse effects via controlled oral delivery.