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Development of Alcohol-Resistant Extended-Release Formulations: Regulatory Considerations and Formulation Strategies.

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This study developed extended-release (ER) formulations using polyvinyl acetate (PVAc) and polyvinylpyrrolidone (PVP-90) to prevent alcohol-induced dose dumping (ADD). Optimized formulations showed reduced ADD risk and maintained ER profiles, even after storage.

Keywords:
ADD guidelinealcohol resistencealcohol-induced dose dumping (ADD)polyvinyl acetate (PVAc) dispersionpolyvinylpyrrolidone (PVP) 90reservoir-type extended-release formulationsustained release coating

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery Systems

Background:

  • Alcohol-induced dose dumping (ADD) is a critical concern for modified-release formulations.
  • Polyvinyl acetate (PVAc) and polyvinylpyrrolidone (PVP-90) are polymers with potential for developing robust drug delivery systems.

Purpose of the Study:

  • To develop reservoir-type extended-release (ER) formulations resistant to alcohol-induced dose dumping (ADD).
  • To investigate the use of polyvinyl acetate (PVAc) and polyvinylpyrrolidone (PVP-90) in mitigating ADD.

Main Methods:

  • ER formulations were created using water-soluble and water-insoluble core diluents and binders.
  • Various PVAc with PVP-90 (3:1 w/w) coating levels were applied.
  • In vitro risk mitigation studies assessed polymer and film properties (viscosity, swelling, elasticity, breaking force) under alcohol exposure.

Main Results:

  • Formulations with L-PVP in the core showed no burst release in alcohol but had compromised ADD resistance at lower coating levels.
  • Higher PVP-90 concentrations in the core slowed disintegration; >15% prevented disintegration in 0.1N HCl with 40% alcohol.
  • The optimized formulation (25% PVP-90 core, PVAc with PVP-90 coating) minimized ADD risk and maintained ER release after 3 months of accelerated storage.

Conclusions:

  • Core and coating compositions are crucial for achieving ADD resistance in ER formulations.
  • Even formulations meeting current FDA guidelines may exhibit dose dumping, suggesting a need to review regulatory standards.
  • Harmonizing regulatory requirements between agencies like EMA and US FDA is necessary for relevant in vitro ADD assessment methods.