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Related Experiment Videos

Solid-state characterization of nifedipine solid dispersions.

Sudha R Vippagunta1, Karin A Maul, Siva Tallavajhala

  • 1Department of Pharmaceutics, College of Pharmacy, University of Minnesota, Weaver-Densford Hall, 308 Harvard Street S.E., Minneapolis, MN 55455-0343, USA.

International Journal of Pharmaceutics
|March 14, 2002
PubMed
Summary

This study developed a stable nifedipine solid dispersion using Pluronic F68 and Gelucire 50/13, significantly enhancing nifedipine dissolution rates compared to the pure drug.

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Drug Delivery Systems

Background:

  • Nifedipine is a widely used calcium channel blocker with poor aqueous solubility, limiting its oral bioavailability.
  • Solid dispersions are an effective strategy to enhance the dissolution and bioavailability of poorly soluble drugs.

Purpose of the Study:

  • To characterize the solid-state properties and stability of a nifedipine solid dispersion system.
  • To evaluate the impact of Pluronic F68 and Gelucire 50/13 on nifedipine's physical state and dissolution behavior.

Main Methods:

  • Powder X-ray diffractometry (PXRD), differential scanning calorimetry (DSC), and diffuse reflectance infrared Fourier transform spectroscopy (DRIFTS) were used for characterization.
  • Water uptake was determined by weight gain under varying relative humidity (RH) and temperature conditions.

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  • Dissolution rates were assessed using USP Apparatus 2, comparing the solid dispersion to pure nifedipine.

    • Main Results:

    • Quantitative PXRD indicated a saturation solubility of 2.1-3.0% w/w nifedipine in the polymer matrix, with an excess of crystalline nifedipine present.
    • The solid dispersion showed significantly higher water uptake at 75% RH/45°C compared to 65% RH/25°C.
    • Over 8 weeks, the solid dispersion maintained its physical stability, with no changes in crystallinity or intermolecular interactions observed.
    • Nifedipine release from the solid dispersion was markedly faster (46.2% in 20 min) than from the pure drug (1.2% in 20 min).

    Conclusions:

    • The developed nifedipine solid dispersion system exhibits enhanced dissolution rates compared to the pure drug.
    • The solid dispersion demonstrates good physical stability over an 8-week period under tested storage conditions.
    • This formulation holds potential for improving nifedipine's therapeutic efficacy through enhanced drug delivery.