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Related Experiment Videos

[Stability of nilvadipine solid dispersion tablet with non-packaging condition].

Noriyuki Hirasawa1, Sayoko Ishise, Hitomi Miyata

  • 1Research and Development Center, Nichi-iko Pharmaceutical Co., Ltd., 205-1 Shimoumezawa, Namerikawa 936-0857, Japan. n-hirasawa@nichiiko.co.jp

Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan
|February 11, 2004
PubMed
Summary

Nilvadipine (NIL) solid-dispersion tablets demonstrate excellent stability and dissolution, even when stored improperly. The drug remained over 99% stable and dissolved over 85% under stressed conditions, showing good pharmaceutical quality.

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Stability
  • Formulation Development

Context:

  • Investigating the stability of Nilvadipine (NIL) solid-dispersion tablets under non-ideal storage conditions.
  • Assessing the impact of elevated temperature, humidity, and light exposure on drug product quality.

Purpose:

  • To evaluate the dissolution, stability, and physical properties of NIL solid-dispersion tablets when stored contrary to packaging instructions.
  • To determine the robustness of the NIL formulation under accelerated stress testing.

Summary:

  • Nilvadipine solid-dispersion tablets maintained over 85% dissolution and >99% stability assay after storage at 40°C, 25°C, 75% RH, and light.
  • Powder X-ray diffraction confirmed Nilvadipine remained in its amorphous state.
  • Tablet hardness decreased over 3 months, indicating humidity had a greater impact than temperature on physical tablet characteristics.

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Impact:

  • Establishes the good stability profile of Nilvadipine solid-dispersion tablets, suggesting resilience in real-world storage scenarios.
  • Provides valuable data for pharmaceutical formulation and packaging guidelines for Nilvadipine.
  • Highlights the critical role of humidity control in maintaining tablet physical integrity.