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

  • Research Article
  • Theme: Advancements in Dissolution Testing of Oral and Non-Oral Formulations
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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.

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Author notes

  1. Brenda Espíndola, Francieli Furlan Bortolon and Juliana Munari Oliveira Pinto contributed equally to this work.

Authors and Affiliations

  1. Departamento de Ciências Farmacêuticas, Universidade Federal de Santa Catarina, Campus Reitor João David Ferreira Lima, Trindade, Florianópolis, Santa Catarina, 88040-970, Brazil

    Brenda Espíndola, Francieli Furlan Bortolon, Juliana Munari Oliveira Pinto, Bianca Ramos Pezzini & Hellen Karine Stulzer

Authors
  1. Brenda Espíndola
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  2. Francieli Furlan Bortolon
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  3. Juliana Munari Oliveira Pinto
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  4. Bianca Ramos Pezzini
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  5. Hellen Karine Stulzer
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Correspondence to Hellen Karine Stulzer.

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Guest Editor: Sandra Klein

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Espíndola, B., Bortolon, F.F., Pinto, J.M.O. et al. New Approach for the Application of USP Apparatus 3 in Dissolution Tests: Case Studies of Three Antihypertensive Immediate-Release Tablets. AAPS PharmSciTech 19, 2866–2874 (2018). https://doi.org/10.1208/s12249-018-1086-0

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