ISSN: A/F

“Comparison of Nifedipine/Polyvinylpyrrolidone Amorphous Solid Dispersions Miscibility at Various Temperatures”

Abstract

The miscibility of Nifedipine/Polyvinylpyrrolidone (NIF/PVP) amorphous solid dispersions (ASDs) is crucial for predicting crystallization resistance and stability. This study evaluates the effectiveness of rheological and solid-state nuclear magnetic resonance (ssNMR) methods for determining miscibility at different temperatures. Specifically, it examines whether rheological methods are reliable at high temperatures (175°C) and ssNMR at low temperatures (-20°C), their consistency in results, the impact of molecular weight on miscibility, and the implications for stability prediction. Experimental data confirm that rheological analysis provides accurate miscibility assessment at elevated temperatures, while ssNMR is precise at lower temperatures. The findings demonstrate consistency between these methods, establish molecular weight as a significant factor in miscibility determination, and highlight the importance of accurate miscibility measurement for predicting ASD stability. These insights contribute to improving methodologies for evaluating ASD stability, addressing existing research gaps, and enhancing pharmaceutical formulation strategies.

References

  1. Hancock, B. C., & Zografi, G. (1997). Characteristics and significance of the amorphous state in pharmaceutical systems. Journal of Pharmaceutical Sciences, 86(1), 1-12.
  2. Taylor, L. S., & Zhang, G. G. Z. (2016). Physical chemistry of amorphous pharmaceutical solids. Journal of Pharmaceutical and Biomedical Analysis, 147, 170-178.
  3. Newman, A., Engers, D., Bates, S., Ivanisevic, I., Kelly, R. C., & Zografi, G. (2008). Characterization of amorphous API: Polymer mixtures using X-ray powder diffraction and solid-state NMR. Journal of Pharmaceutical Sciences, 97(11), 4840-4856.
  4. Van den Mooter, G. (2012). The use of amorphous solid dispersions: A formulation strategy to overcome poor solubility and dissolution rate. Drug Discovery Today: Technologies, 9(2), e79-e85.
  5. Yu, L. (2001). Amorphous pharmaceutical solids: Preparation, characterization and stabilization. Advanced Drug Delivery Reviews, 48(1), 27-42.
  6. Marsac, P. J., Shamblin, S. L., & Taylor, L. S. (2006). Theoretical and practical approaches for prediction of drug-polymer miscibility and solubility. Pharmaceutical Research, 23(10), 2417-2426.
  7. Baird, J. A., & Taylor, L. S. (2012). Evaluation of amorphous solid dispersion properties using thermal, spectroscopic, and rheological characterization techniques. Molecular Pharmaceutics, 9(12), 3209-3218.
  8. Chokshi, R. J., Zia, H., & Sandhu, H. K. (2005). Improving the dissolution rate of poorly water-soluble drugs by solid dispersions and complexation methods. Drug Development and Industrial Pharmacy, 31(1), 25-34.
  9. Ting, J. M., Porter, W. W., Mecca, J. M., Bates, F. S., & Lodge, T. P. (2015). Advances in polymer-based drug solubilization. Molecular Pharmaceutics, 12(9), 3023-3034.
  10. Baghel, S., Cathcart, H., & O'Reilly, N. J. (2016). Polymeric amorphous solid dispersions: A review of formulation considerations, characterization, and stabilization. Advanced Drug Delivery Reviews, 100, 116-125.
Download PDF

How to Cite

Vishwash Singh, (2025-03-06 12:19:17.627). “Comparison of Nifedipine/Polyvinylpyrrolidone Amorphous Solid Dispersions Miscibility at Various Temperatures”. JANOLI International Journal of Pharmaceuticals and Chemicals, Volume t8VTiGjctuTvNUTp50bc, Issue 1.