Formulation, Optimization and Evaluation of Meloxicam Loaded Transdermal Emulgel Using Design of Experiments

Abstract

The present research paper summarizes the formulation, optimization and evaluation of a meloxicam-loaded transdermal emulgel intended to improve topical delivery of a poorly water-soluble non-steroidal anti-inflammatory drug. Meloxicam was characterized by organoleptic evaluation, melting point, solubility, UV spectrophotometry, Fourier transform infrared spectroscopy and differential scanning calorimetry. Oil-in-water emulgels were prepared with liquid paraffin, Tween 80, Carbopol 934, dimethyl sulfoxide, preservatives and triethanolamine. A Design of Experiments approach was used to study the effect of Carbopol 934, Tween 80 and DMSO on viscosity, spreadability and in-vitro drug release. The optimized formulation (F9) showed smooth white appearance, excellent homogeneity, skin-compatible pH of 6.5, spreadability value of 16, viscosity of 27,000 cP, drug content of 96% and 95% cumulative drug release at 8 h. Stability results after 3 months showed no change in appearance, minor pH change from 6.4 to 6.6, minimal viscosity reduction from 27,000 to 26,800 cP and drug content retention from 95.86% to 95.34%. The statistical model was significant for viscosity and spreadability, with Carbopol 934 being the dominant influencing factor. Overall, the developed meloxicam emulgel demonstrated acceptable physicochemical properties, sustained drug release and good short-term stability, indicating its potential as a topical/transdermal drug delivery system.

Introduction

The study focuses on the development and evaluation of a meloxicam emulgel formulation designed for improved topical/transdermal drug delivery. Emulgels are used because they combine the advantages of emulsions (better solubilization of lipophilic drugs) and gels (better stability, spreadability, and patient acceptability). Meloxicam, a poorly water-soluble NSAID with anti-inflammatory and analgesic activity, was selected as the model drug due to its suitability for topical delivery systems.

Formulation and methodology

The emulgel was prepared using Carbopol 934 as the gelling agent, Tween 80 as the emulsifier, liquid paraffin as the oil phase, and DMSO as a penetration enhancer, along with preservatives and other excipients. A factorial Design of Experiments (DoE) approach was used to optimize formulation variables such as Carbopol concentration, Tween 80, and DMSO, with responses including viscosity, spreadability, and drug release.

Preformulation studies confirmed that meloxicam is poorly water-soluble but highly soluble in organic and co-solvent systems, supporting its inclusion in an emulgel system. Compatibility studies using FTIR and DSC showed no significant drug–excipient interactions.

Key results

• Meloxicam showed:
  • Melting point consistent with literature (254–258°C)
  • λmax at 360 nm for UV analysis
• DoE optimization demonstrated:
  • Viscosity range: 10,000–27,000 cP
  • Spreadability range: 6–16
  • Improved drug release in optimized formulations (notably F9)
• Statistical analysis indicated significant influence of formulation variables on rheological and release properties, particularly interaction effects.

Conclusion

The results demonstrate that the emulgel system is suitable for incorporation of meloxicam. Low aqueous solubility confirmed the need for a biphasic vehicle, while solubility in propylene glycol and moderate oil-phase solubility supported the formulation strategy. FTIR and DSC studies indicated compatibility between meloxicam and excipients, a prerequisite for stable semisolid formulation development.Carbopol 934 played the most important role in controlling the rheological profile. Increased Carbopol concentration produced higher viscosity and also influenced spreadability. Tween 80 and DMSO contributed to emulsion stabilization and drug release, but their statistical effects were less pronounced than Carbopol in the observed design. The optimized F9 formulation achieved the best combination of homogeneity, viscosity, spreadability, drug content and in-vitro drug release. The in-vitro release profile of F9 reached 95% by 8 h, indicating sustained release from the gel matrix. Stability observations showed that the formulation remained smooth, homogeneous and chemically acceptable after 3 months, with minimal changes in pH, viscosity and assay. These data indicate the potential of meloxicam emulgel as a topical/transdermal dosage form with improved patient acceptability and controlled release characteristics. A meloxicam-loaded transdermal emulgel was successfully formulated and optimized using a Design of Experiments approach. The optimized formulation F9 showed excellent homogeneity, suitable pH, high viscosity, good spreadability, 96% drug content and 95% drug release at 8 h. Compatibility studies supported the absence of major drug-excipient interaction. Stability studies showed no physical instability and acceptable drug retention after 3 months. The study concludes that meloxicam emulgel is a promising topical/transdermal delivery system for sustained drug release and improved application properties.

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Copyright

Copyright © 2026 Abhijit Mehatre, Dr. Vaishali Kate. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.