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Various dissolution methods are utilized to assess a drug’s dissolution rate, including the flow-through cell, paddle-over-disk, cylinder, and reciprocating disk methods.The flow-through cell apparatus (USP (United States Pharmacopeia) method 4) comprises a reservoir for the dissolution medium and a pump that propels the medium through the cell containing the test sample. This method is crucial for assessing modified-release dosage forms with minimally soluble active ingredients,...
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In Vitro Dissolution as a Tool for Formulation Selection: Telmisartan Two-Step IVIVC.

Alejandro Ruiz Picazo1, Ma Teresa Martinez-Martinez1, Sarin Colón-Useche1,2

  • 1Engineering: Pharmacokinetics and Pharmaceutical Technology Area , Miguel Hernandez University , Alicante 03550 , Spain.

Molecular Pharmaceutics
|May 11, 2018
PubMed
Summary

This study developed an in vitro-in vivo correlation (IVIVC) for telmisartan formulations. A biopredictive dissolution test using USP IV apparatus accurately predicted in vivo performance, aiding formulation selection for bioequivalence trials.

Keywords:
BCSIVIVCbioequivalencein vivo predictive dissolutiontelmisartan

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Area of Science:

  • Pharmacokinetics and Drug Formulation
  • Biopharmaceutics and Drug Delivery
  • Analytical Chemistry

Background:

  • Telmisartan is a Biopharmaceutic Classification System (BCS) class II compound, exhibiting low solubility and high permeability.
  • In vitro-in vivo correlation (IVIVC) is crucial for predicting drug product performance and reducing the need for extensive bioequivalence (BE) studies.
  • Developing a reliable IVIVC for immediate-release formulations can streamline drug development and quality control.

Purpose of the Study:

  • To develop an exploratory two-step level A IVIVC for telmisartan oral immediate-release formulations.
  • To identify a biopredictive in vitro dissolution test that accurately reflects in vivo absorption characteristics.
  • To establish a risk-analysis tool for formulation selection in future BE trials.

Main Methods:

  • Telmisartan solubility and permeability were assessed to confirm BCS class II status.
  • Plasma profiles from BE studies were analyzed using reference scaling and deconvolution (Loo-Riegelman) to determine fraction absorbed (fa).
  • In vitro dissolution studies were conducted using USP II and USP IV apparatus under various conditions, with f2 similarity factor used to compare models and Levy plots for time scaling.

Main Results:

  • One generic telmisartan formulation (X2) demonstrated in vivo bioequivalence, while others (X1, Y1) did not meet acceptance criteria for Cmax.
  • The most biopredictive dissolution conditions involved the USP IV apparatus with a flow rate of 8 mL/min and a three-step pH change (1.2, 4.5, 6.8) with 0.05% Tween 80.
  • This optimized in vitro method successfully reflected in vivo formulation differences and predicted BE outcomes.

Conclusions:

  • A robust, biopredictive dissolution test for telmisartan immediate-release formulations was successfully developed.
  • The established IVIVC model can serve as a valuable tool for predicting in vivo performance and guiding formulation development.
  • This approach can potentially reduce the number of costly and time-consuming bioequivalence studies required during drug product registration.