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<p>The solid-state characterization of milled and unmilled mesalamine (MES) was investigated using different analytical techniques such as bulk properties, Fourier transform infrared spectroscopy (FT-IR), differential scanning calorimetry, contact angle, field emission scanning electron microscopy (FE-SEM), and powder X-ray diffraction studies. Saturation solubility studies and powder dissolution studies were carried out in 0.1 N HCl, acetate, and phosphate buffers of different species with molarity ranges of 5, 50, 100, and 200&#xa0;mM. The temperature-dependent solubility studies of MES were carried out and computed with theoretical values obtained from the Jain and Yalkowsky equation and modified Van’t Hoff equation. The milling of MES changed the crystal morphology (needle to plate-like crystal) and was confirmed using different techniques. The bulk properties of MES were better than milled MES. The solubility studies revealed the significant effect of temperature, pH, buffer, and molarity on the solubility of MES. The extent of dissolution at 30&#xa0;min was 2.3 folds higher with milled MES compared to the MES. The highest solubility of MES was achieved with Na<sub>2</sub>HPO<sub>4</sub>/KH<sub>2</sub>PO<sub>4</sub> buffer across the molarity range of 5&#xa0;mM to 200&#xa0;mM. The solubility and dissolution data revealed that NaH<sub>2</sub>PO<sub>4</sub>/NaOH with 50&#xa0;mM as a dissolution media could be useful for optimizing the formulation during product development.</p>

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Effect of solid-state characteristics and buffers on the solubility and dissolution behaviors of mesalamine

  • 期刊论文

  • 发表日期：

    2025年5月21日

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  • Sonam Sharma,
  • Sakshi Anil Kunjir,
  • Prajakta Raosaheb Pathare,
  • Jyoti Deoriya,
  • Abhisek Sahoo,
  • Rajkumar Malayandi

摘要

The solid-state characterization of milled and unmilled mesalamine (MES) was investigated using different analytical techniques such as bulk properties, Fourier transform infrared spectroscopy (FT-IR), differential scanning calorimetry, contact angle, field emission scanning electron microscopy (FE-SEM), and powder X-ray diffraction studies. Saturation solubility studies and powder dissolution studies were carried out in 0.1 N HCl, acetate, and phosphate buffers of different species with molarity ranges of 5, 50, 100, and 200 mM. The temperature-dependent solubility studies of MES were carried out and computed with theoretical values obtained from the Jain and Yalkowsky equation and modified Van’t Hoff equation. The milling of MES changed the crystal morphology (needle to plate-like crystal) and was confirmed using different techniques. The bulk properties of MES were better than milled MES. The solubility studies revealed the significant effect of temperature, pH, buffer, and molarity on the solubility of MES. The extent of dissolution at 30 min was 2.3 folds higher with milled MES compared to the MES. The highest solubility of MES was achieved with Na2HPO4/KH2PO4 buffer across the molarity range of 5 mM to 200 mM. The solubility and dissolution data revealed that NaH2PO4/NaOH with 50 mM as a dissolution media could be useful for optimizing the formulation during product development.