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Rate-programmed drug delivery systems release drugs in a controlled manner to maintain therapeutic levels. Three main designs include reservoir, matrix, and hybrid systems.Reservoir systems consist of a drug core enclosed within a membrane that controls drug release. In non-swelling reservoir systems, polymers like ethyl cellulose or polymethacrylates are used. These do not hydrate in aqueous media and control release through membrane thickness, porosity, or insolubility. This type includes...

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Evaluating tamsulosin hydrochloride-released microparticles prepared using single-step matrix coating.

Atsushi Maeda1, Tatsuki Shinoda, Naoki Ito

  • 1Pharmaceutical Research and Technology Labs, Astellas Pharma Inc., 180 Ozumi, Yaizu, Shizuoka 425-0072, Japan. atsushi.maeda@jp.astellas.com

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Researchers developed sustained-release tamsulosin hydrochloride microparticles for orally disintegrating tablets. The optimal formulation demonstrated comparable in vitro and in vivo performance to a commercial product.

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Area of Science:

  • Pharmaceutical Technology
  • Drug Delivery Systems

Background:

  • Tamsulosin hydrochloride is commonly formulated for sustained release.
  • Orally disintegrating tablets (ODTs) offer improved patient compliance.
  • Developing effective sustained-release formulations for ODTs is crucial.

Purpose of the Study:

  • To determine the optimal composition of microparticles for sustained-release tamsulosin hydrochloride in ODTs.
  • To evaluate the in vitro drug release and in vivo absorption of these microparticles.
  • To compare the performance against a commercial product (Harnal® pellets).

Main Methods:

  • Microparticles were prepared using a fluidized bed coating process with Aquacoat® and Eudragit® NE30D dispersions on microcrystalline cellulose cores.
  • Formulation composition was optimized for sustained drug release.
  • In vitro drug release studies and in vivo absorption studies were conducted.
  • Drug release kinetics were analyzed using the Higuchi model.

Main Results:

  • Spherical microparticles with approximately 200 μm diameter were produced.
  • The optimal ratio of Aquacoat® to Eudragit® NE30D was determined to be 9:1.
  • In vitro drug release profiles were similar to Harnal® pellets and followed Fickian diffusion (Higuchi model up to 80% release).
  • In vivo absorption properties were comparable to Harnal® pellets, showing a linear correlation between in vitro and in vivo release.

Conclusions:

  • A single-step coating process successfully produced tamsulosin hydrochloride microparticles with sustained-release properties.
  • The developed microparticles demonstrated comparable performance to the commercial product, Harnal® pellets.
  • This formulation is suitable for use in orally disintegrating tablets requiring sustained drug delivery.