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Model-Based Equivalent Dose Optimization to Develop New Donepezil Patch Formulation.

Woojin Jung1, Heeyoon Jung1, Ngoc-Anh Thi Vu1

  • 1College of Pharmacy, Chungnam National University, Daejeon 34134, Korea.

Pharmaceutics
|February 26, 2022
PubMed
Summary
This summary is machine-generated.

A new pharmacokinetic model accurately describes donepezil oral and patch formulations. The donepezil patch offers a bioequivalent alternative to oral dosing, though formulation optimization is needed for clinical usability.

Keywords:
donepezilequivalent dose optimizationmodel-based approachestransdermal patch

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Area of Science:

  • Pharmacokinetics and Drug Development
  • Transdermal Drug Delivery Systems

Background:

  • Donepezil is commonly administered orally for Alzheimer's disease.
  • A transdermal patch formulation was developed to offer an alternative to oral donepezil.
  • Understanding the pharmacokinetic profiles of both formulations is crucial for dose compatibility.

Purpose of the Study:

  • To develop a population pharmacokinetic model for oral and transdermal donepezil formulations.
  • To investigate compatible doses between the oral and patch formulations.
  • To assess the bioequivalence of the donepezil patch compared to oral administration.

Main Methods:

  • Population pharmacokinetic modeling using NONMEM and R software.
  • Analysis of plasma donepezil levels via liquid chromatography/tandem mass spectrometry.
  • Bioequivalence testing using a 2x2 crossover design, evaluating AUC and Cmax.

Main Results:

  • A two-compartment model with two transit compartments accurately described donepezil pharmacokinetics for both oral and patch formulations.
  • The pharmacokinetic model was validated through visual predictive checks, goodness-of-fit plotting, and bootstrap methods.
  • A weekly donepezil patch dose of 114-146 mg was found to be bioequivalent to a daily 10 mg oral dose.

Conclusions:

  • A robust pharmacokinetic model for donepezil oral and transdermal delivery was successfully developed and validated.
  • The donepezil patch demonstrates bioequivalence to the oral formulation, providing a viable alternative.
  • Further formulation optimization is recommended to address the potentially large patch size for improved clinical usability.