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<p>Improving the solubility and bioavailability of poorly water-soluble drugs such as atorvastatin remains a critical challenge in pharmaceutical formulation. This study aims to enhance the physicochemical and micromeritic properties of atorvastatin through spherical co-agglomeration using polyethylene glycol (PEG) and polyvinylpyrrolidone (PVP) as hydrophilic polymers. Co-agglomerates were prepared and characterized using Powder X-ray Diffraction (PXRD), Differential Scanning Calorimetry (DSC), Fourier Transform Infrared Spectroscopy (FTIR), Scanning Electron Microscopy (SEM), and intrinsic dissolution testing at pH levels of 1.2 and 6.8. PXRD and DSC revealed reduced crystallinity, indicating partial amorphization in co-agglomerates. FTIR analysis confirmed the presence of intermolecular interactions between atorvastatin and the polymers. SEM images showed the formation of dense, spherical particles, while particle size distribution data revealed improved uniformity. Flowability tests demonstrated significant improvements in micromeritic properties, including a lower angle of repose and a lower compressibility index. Intrinsic dissolution rates in both media demonstrated a 1.7-fold increase compared to raw atorvastatin. These findings confirm that spherical co-agglomeration effectively enhances the wettability, dissolution, and manufacturability of atorvastatin. The study contributes to the development of optimized drug delivery systems and supports further exploration of polymer-based agglomeration techniques to enhance the oral bioavailability of hydrophobic drugs.</p>

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Amorphization and Micromeritic Optimization of Atorvastatin by PEG–PVP Mediated Spherical Agglomeration Approach

  • 期刊论文

  • 发表日期：

    2026年1月22日

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  • Indra Indra,
  • Viani Sukma Nur’aini,
  • Anindita Tri Kusuma Pratita

摘要

Improving the solubility and bioavailability of poorly water-soluble drugs such as atorvastatin remains a critical challenge in pharmaceutical formulation. This study aims to enhance the physicochemical and micromeritic properties of atorvastatin through spherical co-agglomeration using polyethylene glycol (PEG) and polyvinylpyrrolidone (PVP) as hydrophilic polymers. Co-agglomerates were prepared and characterized using Powder X-ray Diffraction (PXRD), Differential Scanning Calorimetry (DSC), Fourier Transform Infrared Spectroscopy (FTIR), Scanning Electron Microscopy (SEM), and intrinsic dissolution testing at pH levels of 1.2 and 6.8. PXRD and DSC revealed reduced crystallinity, indicating partial amorphization in co-agglomerates. FTIR analysis confirmed the presence of intermolecular interactions between atorvastatin and the polymers. SEM images showed the formation of dense, spherical particles, while particle size distribution data revealed improved uniformity. Flowability tests demonstrated significant improvements in micromeritic properties, including a lower angle of repose and a lower compressibility index. Intrinsic dissolution rates in both media demonstrated a 1.7-fold increase compared to raw atorvastatin. These findings confirm that spherical co-agglomeration effectively enhances the wettability, dissolution, and manufacturability of atorvastatin. The study contributes to the development of optimized drug delivery systems and supports further exploration of polymer-based agglomeration techniques to enhance the oral bioavailability of hydrophobic drugs.