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Application of spherical silicate to prepare solid dispersion dosage forms with aqueous polymers.

Kentaro Nagane1, Susumu Kimura2, Koji Ukai2

  • 1Pharmaceutical Science and Technologies, Eisai Co., Ltd., 1 Kawashima takehaya-machi, Kakamigahara, Gifu 501-6195, Japan; Department of Pharmaceutical Engineering, School of Pharmacy, Aichi Gakuin University, 1-100 Kusumoto, Chikusaku, Nagoya, Aichi 464-8650, Japan.

International Journal of Pharmaceutics
|July 23, 2015
PubMed
Summary

This study developed a novel nifedipine (NP) solid dispersion using porous silicate micro beads and a copolymer. This method enhances drug supersaturation and improves powder flowability for easier manufacturing.

Keywords:
NifedipineSilicate sphereSolid dispersionVinylpyrrolidone/vinyl acetate copolymerWurster-type fluidized bed granulator

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science

Background:

  • Nifedipine (NP) is a drug with poor aqueous solubility, limiting its therapeutic efficacy.
  • Developing stable solid dispersions is crucial for improving NP bioavailability.
  • Conventional methods like spray drying can result in poor powder characteristics.

Purpose of the Study:

  • To prepare and characterize nifedipine solid dispersions using porous silicate micro beads (MB) and vinylpyrrolidone/vinyl acetate copolymer (PVP/VA).
  • To evaluate the dissolution properties and powder characteristics of the developed solid dispersion.
  • To compare the proposed method with conventional spray-dried solid dispersions.

Main Methods:

  • Utilized a Wurster-type fluidized bed granulator for coating MB with NP and PVP/VA.
  • Characterized the morphology and powder properties of the resulting solid dispersion.
  • Performed dissolution tests to assess drug release and supersaturation.

Main Results:

  • The developed solid dispersion maintained nifedipine supersaturation during dissolution.
  • The morphology of the micro beads was preserved after the coating process.
  • The powder flowability of the proposed solid dispersion was significantly superior to spray-dried formulations.

Conclusions:

  • The proposed method offers a simple and scalable approach for preparing nifedipine solid dispersions.
  • This technique enhances drug dissolution and improves powder handling properties, facilitating downstream manufacturing.
  • The use of porous silicate micro beads with PVP/VA presents a promising strategy for improving nifedipine delivery.