Optimization of Meloxicam Solid Dispersion Formulations for Dissolution Enhancement and Storage Stability Using 3³...

Area of Science:

• Pharmaceutical Sciences
• Materials Science

Background:

• Meloxicam (MX) exhibits poor aqueous solubility, limiting its oral bioavailability.
• Solid dispersions are a promising strategy to enhance the dissolution rate of poorly soluble drugs.

Purpose of the Study:

• To formulate and optimize meloxicam solid dispersions using response-surface-methodology (RSM).
• To investigate the effects of drug loading, carrier ratio, and preparation method on meloxicam dissolution.
• To characterize the optimized formulation for its physical properties and stability.

Main Methods:

• A 3^3 full factorial design with 27 formulations was employed.
• Factors studied included meloxicam loading, Soluplus®/Poloxamer-407 ratio, and preparation method (physical mixture, fusion, hot-melt extrusion).
• Optimization was guided by RSM, with characterization using DSC, XRD, PLM, and in vitro dissolution studies.

Main Results:

• Hot-melt extrusion (HME) yielded the highest meloxicam dissolution rates compared to fusion (FM) and physical mixture (PM).
• Decreasing meloxicam loading and increasing Soluplus® in the carrier ratio enhanced dissolution.
• The optimized formulation demonstrated rapid dissolution (Q10min = 89.09%) and confirmed the amorphous state of meloxicam.

Conclusions:

• RSM is effective for optimizing meloxicam solid dispersions.
• HME is a superior technique for enhancing meloxicam dissolution.
• The optimized formulation offers improved dissolution characteristics for meloxicam delivery.