Design Characterization and Evaluation of Meloxicam Gel Prepared by Suspension and Solution Polymerization Using Solubility Parameter as the Basis for Development

摘要

Meloxicam gel was designed based on the matching of the solubility parameter (δ) of the drug with that of the polymer and subsequently with skin for improved dermal delivery of meloxicam. The δ of meloxicam (11.48 (cal/cm³)^0.5) determined by solubility measurement was matched statistically to the solubility parameter of monomers, n-vinyl-2-pyrrolidone, polyvinyl alcohol (PVA), hydroxyl ethyl methacrylate, ethylene glycol methacrylate (EGMA) determined by intrinsic viscosity measurement. Consequently gels were formulated by polymerization in selected solvent blend of water/ethyl acetate (20:80) in which the drug showed maximum solubility. Thus, F1–F16 formulations designed were evaluated for physicochemical properties, textural analysis, and in vitro drug release. On the basis of optimum characteristics, F2 (PVA, δ = 16.96 (cal/cm³)^0.5) and F8 (EGMA, δ = 18.35 (cal/cm³)^0.5) formulated by suspension polymerization were selected and subjected to skin irritation and topical anti-inflammatory studies. The formulation F8 demonstrated significant (p < 0.05) of anti-inflammatory activity in comparison to marketed piroxicam gel and was free from irritation.