Development of a Self-Microemulsifying Solid Dosage Formulation for Enhanced Solubility and Stability of Meloxicam: A Comprehensive Study
Abstract
Meloxicam (MLX), a nonsteroidal anti-inflammatory drug belonging to the oxicam family, iscommonly used to alleviate inflammation and pain. However, MLX’s limited solubility and subsequent low bioavailability necessitate the development of innovative formulations. This study aimed to improve the dispersibility and stability of MLX by incorporating it into a self-microemulsifying liquid drug delivery system (SMLDDS) and subsequently converting it into a solid dosage form, specifically capsules. The liquid formulation, consisting of oleic acid oil (10%), Tween 80 (38.57%), propylene glycol (25.72%), and Transcutol P (25.72%), was transformed into a solid powder using an adsorbent mixture of Avicel PH 101, Avicel PH 102, and Aerosil 200. Among the self-microemulsifying capsules (SSMEDDS) developed, SSMEDDS-1 exhibited excellent flow properties, the highest drug content (99.96%), and rapid cumulative drug release (100% within 20 minutes). Characterization studies confirmed the absence of any drug-component interactions, as evidenced by characteristic peaks of meloxicam in Fourier-transform infrared spectroscopy (FTIR). X-ray powder diffraction (XPRD) and differential scanning calorimetry (DSC) analyses revealed the conversion of MLX from its crystalline to amorphous form, enhancing solubility and dissolution rate. A three-month stability test conducted at various temperatures demonstrated the formulation’s stability in terms of appearance, with minimal changes in drug content and consistent in vitro drug release profiles. This study presents a successful approach to enhance the solubility and stability of meloxicam through a self-microemulsifying solid dosage formulation. The optimized formulation offers potential benefits for improving the therapeutic efficacy and patient compliance of MLX, thereby advancing the field of drug delivery systems for poorly soluble drugs.
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