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Related Experiment Videos

Osmotic drug delivery using swellable-core technology.

A G Thombre1, L E Appel, M B Chidlaw

  • 1Pfizer Global R&D, Groton Laboratories, Eastern Point Road, Groton, CT 06340, USA. Avinash_G_Thombre@groton.pfizer.com

Journal of Controlled Release : Official Journal of the Controlled Release Society
|December 20, 2003
PubMed
Summary

Swellable-core technology (SCT) offers reliable drug delivery to the GI tract. In vitro and in vivo studies confirmed predictable drug release from various SCT formulations, regardless of core design or drug properties.

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Area of Science:

  • Pharmaceutical Technology
  • Drug Delivery Systems
  • Gastrointestinal Therapeutics

Background:

  • Swellable-core technology (SCT) utilizes osmotic pressure and polymer swelling for controlled drug release.
  • Reliable and reproducible drug delivery to the gastrointestinal (GI) tract remains a significant challenge.

Purpose of the Study:

  • To evaluate the in vitro and in vivo performance of swellable-core technology (SCT) formulations.
  • To assess the impact of different SCT core configurations on drug release kinetics.

Main Methods:

  • Formulation of two model drugs (tenidap, sildenafil) into four SCT core configurations: homogeneous-core, tablet-in-tablet (TNT), bilayer, and trilayer.
  • In vitro dissolution studies to determine drug release rates and extents.
  • In vivo pharmacokinetic and tablet-recovery studies in beagle dogs.

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Main Results:

  • Drug release rate was largely independent of core configuration, though homogeneous-core showed lower release extent under non-sink conditions.
  • Release rate was influenced by coating thickness and permeability, but not drug loading or delivery port characteristics.
  • Similar release profiles were observed for tenidap and sildenafil, despite differing physicochemical properties.
  • In vivo drug release closely matched in vitro predictions.

Conclusions:

  • Swellable-core technology (SCT) provides a robust platform for predictable oral drug delivery.
  • Core configuration has a limited impact on drug release kinetics within SCT systems.
  • SCT demonstrates versatility in accommodating drugs with diverse physicochemical properties for consistent GI tract delivery.