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Pharmacokinetic Models: Comparison and Selection Criterion01:26

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Physiological and compartmental models are valuable tools used in studying biological systems. These models rely on differential equations to maintain mass balance within the system, ensuring an accurate representation of the dynamic processes at play.
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Identification of Pharmaceuticals in The Aquatic Environment Using HPLC-ESI-Q-TOF-MS and Elimination of Erythromycin Through Photo-Induced Degradation
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A photochemical kinetic model for solid dosage forms.

Thiago C Carvalho1, Thomas E La Cruz2, Jose E Tábora2

  • 1Drug Product Science & Technology, Bristol-Myers Squibb, Co., One Squibb Dr., New Brunswick, NJ 08901, USA.

European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V
|August 24, 2017
PubMed
Summary
This summary is machine-generated.

This study introduces a mathematical model for solid-state pharmaceutical photodegradation under polychromatic light. The model accurately predicts degradation, showing light attenuation limits effective exposure in powder beds.

Keywords:
Bulk APIConfirmatory studiesForced degradation studiesICH Q1BModelingOral solidsPhotostability studies

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Area of Science:

  • Pharmaceutical Sciences
  • Chemical Kinetics
  • Photochemistry

Background:

  • Photodegradation models for pharmaceuticals in solution are common.
  • Solid-state photodegradation models, especially under polychromatic light, are less developed.

Purpose of the Study:

  • Develop a mathematical model for solid-state photodegradation of pharmaceutical powders.
  • Incorporate optical phenomena and powder properties into the model.
  • Assess photostability risk and inform control strategies.

Main Methods:

  • Adapted solution-phase kinetic models for solid-state conditions.
  • Applied Beer-Lambert law for light attenuation, including scattering and density effects.
  • Validated the model with drug substance and intermediates under various light conditions.

Main Results:

  • The model reasonably predicted photodegradation under white and yellow light (5-11 kLux).
  • Photoreaction reciprocity law was observed.
  • Significant light attenuation occurred beyond 500μm depth; 100μm depth showed near-complete degradation in 10 days.

Conclusions:

  • The developed model effectively simulates solid-state photodegradation in pharmaceutical powders.
  • Light penetration depth is a critical factor, limiting degradation in thicker layers.
  • The model aids in assessing photostability and defining manufacturing control strategies.