Shakir, R., Al-Nima, A., Alfaris, S., Hamid, O. (2025). Evaluation of Hydrotropic Freeze Dried Systems for Meloxicam Solubility Enhancement. , 22(3), 155-164. doi: 10.33899/iraqij.p.2025.160298.1152
Rasha Khalid Shakir; Amina Mudhafar Al-Nima; Shahad Myasar Alfaris; Omar A Hamid. "Evaluation of Hydrotropic Freeze Dried Systems for Meloxicam Solubility Enhancement". , 22, 3, 2025, 155-164. doi: 10.33899/iraqij.p.2025.160298.1152
Shakir, R., Al-Nima, A., Alfaris, S., Hamid, O. (2025). 'Evaluation of Hydrotropic Freeze Dried Systems for Meloxicam Solubility Enhancement', , 22(3), pp. 155-164. doi: 10.33899/iraqij.p.2025.160298.1152
Shakir, R., Al-Nima, A., Alfaris, S., Hamid, O. Evaluation of Hydrotropic Freeze Dried Systems for Meloxicam Solubility Enhancement. , 2025; 22(3): 155-164. doi: 10.33899/iraqij.p.2025.160298.1152

Evaluation of Hydrotropic Freeze Dried Systems for Meloxicam Solubility Enhancement

Iraqi Journal of Pharmacy
Article 5, Volume 22, Issue 3, September 2025, Pages 155-164    PDF (897.71 K)
Document Type: Research Paper
DOI: 10.33899/iraqij.p.2025.160298.1152
Authors
Rasha Khalid Shakir; Amina Mudhafar Al-Nima* ; Shahad Myasar Alfaris; Omar A Hamid
Department of Pharmaceutics, College of Pharmacy, University of Mosul, Mosul, Iraq
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 MX’s 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 40.4±2.9% release compared to 18.6±1.9% 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.
Keywords
Meloxicam; Lyophilization; Hydrotropic agents; Carbomer-934; Poloxamer-188
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