Application of Response Surface Methodology Using Face-centered Central Composite Design for Studying Long-Term...

Area of Science:

• Pharmaceutical Sciences
• Materials Science
• Chemical Engineering

Background:

• Post-approval stability studies are crucial for drug product lifecycle management.
• Alginate-gelatin beads offer a promising drug delivery system for gliclazide (GLZ).
• Evaluating long-term stability under various formulation conditions is essential.

Purpose of the Study:

• To assess the long-term stability of gliclazide (GLZ) alginate-gelatin beads using Design of Experiments (DoE).
• To identify optimal formulation variables for stable GLZ bead performance.
• To compare model-dependent and independent approaches for stability evaluation.

Main Methods:

• A three-factor, three-level face-centered DoE was employed.
• Formulation variables included GLZ%, alginate:gelatin ratio, and glutaraldehyde%.
• Drug release, particle size, FT-IR, and DSC were analyzed before and after storage.

Main Results:

• Formulations exhibited stable particle size and consistent GLZ release profiles post-storage.
• Factor effect relationships on drug release remained unchanged after storage.
• Optimized formulations (OP-1, OP-2) demonstrated excellent stability, with minor changes in GLZ crystallinity or polymorphic form.

Conclusions:

• DoE is a powerful tool for optimizing and predicting the long-term stability of GLZ alginate-gelatin beads.
• The developed formulations are suitable for post-approval lean-stability approaches.
• The study confirms the robustness of the alginate-gelatin bead system for gliclazide delivery.