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Developing a Formulation Strategy Coupled with PBPK Modeling and Simulation for the Weakly Basic Drug Albendazole.

Harsh Shah1, Kushal Shah2, Bhavin Gajera3

  • 1Invagen, A Cipla Subsidiary, Hauppauge, NY 11788, USA.

Pharmaceutics
|April 28, 2023
PubMed
Summary

Albendazole absorption is limited by poor solubility. Physiologically based pharmacokinetic modeling revealed that increasing solubility and reducing precipitation enhance albendazole sulfoxide bioavailability.

Keywords:
PBPK modelingSimcyp™absorption modelingformulation developmentmodel transfer experimentparameter sensitivityprecipitation kineticssupersaturation

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Area of Science:

  • Pharmacokinetics and Drug Metabolism
  • Pharmaceutical Sciences
  • Computational Modeling

Background:

  • Albendazole (ABZ) is a crucial antiparasitic agent with limited oral bioavailability due to poor aqueous solubility and extensive first-pass metabolism.
  • Its active metabolite, albendazole sulfoxide (ABZ_SO), is the primary contributor to therapeutic efficacy, but its systemic exposure is dissolution-rate limited.
  • Understanding formulation impacts on ABZ absorption is critical for optimizing drug delivery.

Purpose of the Study:

  • To utilize physiologically based pharmacokinetic (PBPK) modeling to identify key formulation parameters influencing albendazole sulfoxide (ABZ_SO) oral bioavailability.
  • To investigate the impact of in vitro parameters such as pH solubility, precipitation kinetics, and particle size on ABZ absorption and ABZ_SO exposure.
  • To guide the development of advanced formulations for improved ABZ_SO systemic exposure.

Main Methods:

  • Development of a PBPK model for ABZ and ABZ_SO using the Simcyp™ Simulator, integrating data from in vitro experiments.
  • In vitro characterization including pH-dependent solubility, precipitation kinetics, particle size distribution, and biorelevant solubility studies.
  • Sensitivity analyses to evaluate the influence of physiological and formulation variables on ABZ_SO systemic exposure.

Main Results:

  • PBPK model simulations indicated that elevated gastric pH significantly diminishes ABZ absorption and subsequent ABZ_SO systemic exposure.
  • Reducing particle size below 50 µm did not yield significant improvements in ABZ bioavailability.
  • Enhanced ABZ_SO systemic exposure was predicted through strategies that increase drug solubility or supersaturation and mitigate ABZ precipitation in the intestine.

Conclusions:

  • PBPK modeling provides a robust platform for dissecting the complex factors governing ABZ oral bioavailability.
  • Formulation strategies focusing on enhancing solubility and controlling precipitation are essential for improving ABZ_SO therapeutic efficacy.
  • This study offers valuable insights for designing next-generation albendazole formulations with superior pharmacokinetic profiles.