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AAPS PharmSciTech

, Volume 19, Issue 7, pp 2866–2874 | Cite as

New Approach for the Application of USP Apparatus 3 in Dissolution Tests: Case Studies of Three Antihypertensive Immediate-Release Tablets

  • Brenda Espíndola
  • Francieli Furlan Bortolon
  • Juliana Munari Oliveira Pinto
  • Bianca Ramos Pezzini
  • Hellen Karine Stulzer
Research Article Theme: Advancements in Dissolution Testing of Oral and Non-Oral Formulations
  • 96 Downloads
Part of the following topical collections:
  1. Theme: Advancements in Dissolution Testing of Oral and Non-Oral Formulations

Abstract

The USP Apparatus 3 is a compendial dissolution Apparatus that has been mainly used to assess the performance of modified-release drug products. However, this Apparatus can be applied to dissolution testing of immediate-release tablets as well, with several advantages such as lower consumption of dissolution media, reduced setup time in quality control routine, and minimized hydrodynamic issues. In this work, three immediate-release (IR) tablets containing antihypertensive drugs of different Biopharmaceutic Classification System (BCS) classes were evaluated in order to assess the possible interchangeability between the official dissolution method using typical USP Apparatus 1 or 2 and the proposed methods using USP Apparatus 3. Depending on the selection of the appropriate operational conditions, such as dip rate and sieve mesh size, it was observed that USP Apparatus 3 could provide similar dissolution profiles compared to USP Apparatus 1 or 2 to the drug products tested. In addition, USP Apparatus 3 avoided conning issues related to USP Apparatus 2. The successful application of USP Apparatus 3 in dissolution tests for IR drug products depends on the definition of specific test conditions for each product, considering all the equipment variables, as well as drug and formulation characteristics.

KEY WORDS

dissolution testing immediate-release tablets USP Apparatus 3 USP Apparatus 1 and 2 antihypertensive drugs 

Notes

Compliance with Ethical Standards

Conflict of Interest

The authors declare that they have no conflict of interest.

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Copyright information

© American Association of Pharmaceutical Scientists 2018

Authors and Affiliations

  • Brenda Espíndola
    • 1
  • Francieli Furlan Bortolon
    • 1
  • Juliana Munari Oliveira Pinto
    • 1
  • Bianca Ramos Pezzini
    • 1
  • Hellen Karine Stulzer
    • 1
  1. 1.Departamento de Ciências FarmacêuticasUniversidade Federal de Santa CatarinaFlorianópolisBrazil

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