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Forskolin-induced Swelling in Intestinal Organoids: An In Vitro Assay for Assessing Drug Response in Cystic Fibrosis Patients
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Predicting intestinal precipitation--a case example for a basic BCS class II drug.

Sara Carlert1, Anna Pålsson, Gunilla Hanisch

  • 1Department of Pharmacy, Uppsala University, Box 580, 75123 Uppsala, Sweden.

Pharmaceutical Research
|August 19, 2010
PubMed
Summary

Simple in vitro methods overestimate intestinal drug precipitation in humans. This study highlights the need to incorporate hydrodynamic factors for accurate in vivo prediction of drug crystallization for oral formulations.

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Area of Science:

  • Pharmacokinetics and Drug Metabolism
  • Physical Pharmacy and Drug Delivery
  • Computational Pharmaceutics

Background:

  • Accurate prediction of drug precipitation in the human intestine is crucial for oral drug formulation development.
  • Basic BCS class II drugs often exhibit low aqueous solubility, making them prone to precipitation.
  • In vitro and in silico models are increasingly used to predict in vivo drug behavior.

Purpose of the Study:

  • To evaluate the predictive accuracy of in vitro and in vitro/in silico methods for in vivo intestinal precipitation of basic BCS class II drugs.
  • To compare in vitro precipitation predictions with actual human pharmacokinetic data.
  • To identify limitations in current methods for predicting drug crystallization in the gastrointestinal tract.

Main Methods:

  • Investigated the precipitation rate of AZD0865 (pKa=6.1, log K(D)=4.2) in vitro using simulated intestinal fluid.
  • Employed a theoretical model to calculate in vitro crystallization rates.
  • Estimated in vivo human intestinal precipitation by analyzing pharmacokinetic data from clinical studies at various doses.

Main Results:

  • In vitro models consistently predicted rapid precipitation of AZD0865, with a predicted half-life of less than 20 minutes at the highest dose.
  • Human pharmacokinetic data showed a dose-proportional increase in drug plasma exposure, indicating no significant in vivo precipitation.
  • The theoretical model predicted negligible precipitation within the expected range of in vivo intestinal concentrations.

Conclusions:

  • Simple in vitro methods tend to overpredict intestinal crystalline precipitation for orally administered basic drugs in humans.
  • Hydrodynamic conditions in the human intestine are a critical factor that requires better integration into predictive models.
  • Improved in vitro and in silico methodologies are needed to accurately forecast in vivo drug precipitation and optimize oral dosage forms.