Evaluation of Hydrotropic Freeze Dried Systems for Meloxicam Solubility Enhancement

Section: Research Paper
Issue
Vol. 22 No. 3 (2025): Volume 22 Issue 3
Published
Sep 1, 2025
Pages
155-164

Abstract

Background: The low solubility of Meloxicam (MX) necessitates preformulation strategies like hydrotropism to enhance it solubility and dissolution rate. Oral dispersible tablets (ODTs) give an alternative for patients with difficulty in swallowing, improving compliance and bypassing the first-pass effect. Many ODT manufacturing techniques, including lyophilization, aims to optimize MXs therapeutic performance. Methods: Five physical mixtures were prepared in five different ratios of MX to excipients (HPMC-E15, glycine, sodium benzoate, poloxamer-188 and mannitol). Comparative solubility analysis of (MX) was also conducted using different concentrations of different hydrotropic agents (sodium benzoate, sodium acetate, and urea). MX ODTs were prepared via lyophilization using mannitol as the matrix former and glycine as a protectant. The optimal formulation was selected and enhanced with a hydrotropic agent to improve MX solubility. Tablets were evaluated for physical properties, disintegration, dissolution, and drug content uniformity to ensure pharmacopeial compliance. In addition to FTIR and DSC tests which were conducted on the selected (MX) oral dispersible tablet formulation. Results: Solubility analysis identified sodium benzoate (30% m/v) as an effective hydrotropic agent for (MX) solubilization, facilitating the formulation of lyophilized tablets. After multiple trials incorporating HPMC-E15, Carbomer-934, Poloxamer-188, and mannitol as a diluent, three formulations (F5, F9, and F10) exhibited acceptable characteristics post-lyophilization. Among them, F5 (HPMC-E15 3%, Poloxamer-188 1%) demonstrated superior performance and was subsequently modified to F11 by incorporating 30% sodium benzoate to assess its impact on MX dissolution. One-way ANOVA of the drug release profile at 2 minutes indicated a significant enhancement, with F11 achieving 40.42.9% release compared to 18.61.9% for F5. Conclusion: The F11 demonstrated an enhanced dissolution rate, indicating the positive effect of the hydrotropic agent (sodium benzoate) on the solubility of MX.

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Authors

Amina Mudhafar Al-Nima

Department of Pharmaceutics, College of Pharmacy, University of Mosul, Mosul, Iraq

ORCID
Rasha Khalid Shakir

Department of Pharmaceutics, College of Pharmacy, University of Mosul, Mosul, Iraq

ORCID
Shahad Myasar Alfaris

Department of Pharmaceutics, College of Pharmacy, University of Mosul, Mosul, Iraq

ORCID
Omar A Hamid

Department of Pharmaceutics, College of Pharmacy, University of Mosul, Mosul, Iraq

ORCID

Identifiers

https://doi.org/10.33899/iraqij.p.2025.160298.1152
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How to Cite

Mudhafar Al-Nima, A., Khalid Shakir, R., Myasar Alfaris, S., & A Hamid, O. (2025). Evaluation of Hydrotropic Freeze Dried Systems for Meloxicam Solubility Enhancement. Iraqi Journal of Pharmacy, 22(3), 155–164. https://doi.org/10.33899/iraqij.p.2025.160298.1152