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The Development of an Age-Appropriate Fixed Dose Combination for Tuberculosis Using Physiologically-Based

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A new physiologically-based biopharmaceutics model (PBBM) was developed to predict tuberculosis drug exposure in children. The model confirmed the safety and efficacy of a new dispersible tablet formulation for pediatric use.

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PBBMefficacyformulationmodelingpediatricssafetysimulationtuberculosis

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Area of Science:

  • Pharmacokinetics and Biopharmaceutics
  • Pediatric Drug Development
  • Computational Modeling

Background:

  • Tuberculosis (TB) treatment maintenance relies on isoniazid (INH) and rifampicin (RIF).
  • Brazil lacks a reference drug for pediatric TB maintenance therapy.
  • A new age-appropriate dispersible tablet formulation for INH and RIF was developed for all pediatric age groups.

Purpose of the Study:

  • To develop and validate a physiologically-based biopharmaceutics model (PBBM) to predict drug exposure.
  • To link in vitro performance of a new pediatric TB dispersible tablet to in vivo pharmacokinetic (PK) data.
  • To assess the safety and efficacy of the new formulation in children.

Main Methods:

  • Physico-chemical and biopharmaceutical properties of INH and RIF were utilized.
  • A PBBM was developed in GastroPlus™, incorporating mechanistic metabolic clearance and formulation disintegration/dissolution data.
  • Model validation was performed using literature and in-house clinical data.

Main Results:

  • The PBBM successfully predicted drug exposure for children across various age groups and dosing regimens.
  • Probabilistic models of efficacy and safety were combined with real-world pediatric data.
  • The model-predicted systemic exposure correlated with clinical outcomes.

Conclusions:

  • The developed PBBM accurately predicts pharmacokinetic profiles for pediatric TB treatment.
  • The new dispersible tablet formulation and dosing regimen are predicted to be safe and effective for children.
  • This model supports the use of age-appropriate formulations in pediatric drug development.