Physicochemical characterization of meloxicam-mannitol binary systems.

Area of Science:

• Pharmaceutical Sciences
• Drug Delivery Systems
• Materials Science

Background:

• Drug dissolution is a critical challenge in formulation development.
• Meloxicam (ME), an anti-inflammatory drug, exhibits poor water solubility, hindering its efficacy.
• Improving meloxicam's dissolution rate is essential for effective oral drug delivery.

Purpose of the Study:

• To enhance the dissolution rate of meloxicam (ME) in capsule formulations.
• To investigate the use of mannitol as a carrier for meloxicam.
• To explore different preparation methods, including physical mixtures and melt techniques.

Main Methods:

• Utilized mannitol as a carrier in various ratios with meloxicam (ME).
• Prepared physical mixtures and melt forms of meloxicam-mannitol systems.
• Employed Differential Scanning Calorimetry (DSC) and X-ray diffractometry (XRD) for system characterization.
• Applied Multivariate Curve Resolution (MCR) for interpreting XRD data.

Main Results:

• The amount of mannitol and meloxicam particle size were key factors influencing dissolution rate.
• Melt technology, utilizing a 10:1 ratio of mannitol to meloxicam (ME) with an average particle size of 6 micrometers, yielded optimal dissolution.
• Physical mixtures showed insufficient interaction (adhesion) between mannitol and meloxicam for effective dissolution.
• Melt technology resulted in the formation of mixed crystals, enhancing meloxicam dissolution.

Conclusions:

• Melt technology is a superior method for improving meloxicam dissolution compared to physical mixtures.
• Optimized meloxicam-mannitol ratios and particle sizes are crucial for enhanced drug release.
• The study demonstrates a novel application of MCR for interpreting XRD data in pharmaceutical systems.