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Novel mathematical method for quantitative expression of deviation from the higuchi model.

M C Gohel1, M K Panchal, V V Jogani

  • 1Department of Pharmaceutics, L.M. College of Pharmacy, P.O. Box. No. 4011, Navrangpura, Ahmedabad-380009, India. mukeshgohel@hotmail.com

AAPS Pharmscitech
|January 20, 2004
PubMed
Summary

A new mathematical method quantifies drug release deviations from ideal Higuchi kinetics using area under the curve (AUC) calculations. This approach aids in comparing drug formulations during development and quality control.

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery Systems
  • Mathematical Modeling

Background:

  • Higuchi's kinetics are crucial for predicting drug release from transdermal systems and implants.
  • Evaluating deviations from ideal release profiles is essential for formulation development and quality control.
  • Existing methods may lack precision in quantifying minor deviations in complex release patterns.

Purpose of the Study:

  • To develop a simple mathematical method for quantifying deviations from ideal Higuchi drug release profiles.
  • To validate the method using real-world dosage forms and compare it with established kinetic models.
  • To establish a tool for comparative analysis of drug release performance in pharmaceutical research and development.

Main Methods:

  • Developed a method based on Area Under the Curve (AUC) calculation using the trapezoidal rule to quantify release profile deviations.

Related Experiment Videos

  • Applied the method to diltiazem HCl tablets and diclofenac sodium microspheres designed for 12-hour release.
  • Utilized zero-order, first-order, Higuchi's, Hixson-Crowell's, and Weibull's models to describe and select the best-fit drug release kinetics based on goodness-of-fit tests.

    • Main Results:

    • The Higuchi model best described the release kinetics for both diltiazem HCl tablets and diclofenac sodium microspheres.
    • The developed mathematical method quantified release profile deviations, showing less than 16% deviation for tablets and less than 11% for microspheres from the ideal Higuchi profile.
    • The method demonstrated applicability for both incomplete and complete drug release scenarios and can be adapted for various release durations (6, 18, 24 hours).

    Conclusions:

    • The proposed AUC-based mathematical method provides a precise way to assess deviations from ideal Higuchi drug release.
    • This method is versatile and applicable to various modified-release formulations, aiding in comparative product analysis.
    • The technique supports research and development, quality control, and product promotion by enabling objective performance comparisons.