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Small-Volume Dissolution Testing of Pediatric Mini-Tablets Using Miniaturized USP Apparatuses: Regulatory and

Stefanie Broocks1, Melanie Gebhardt1, Sandra Klein2

  • 1Department of Pharmacy, Institute of Biopharmaceutics and Pharmaceutical Technology, University of Greifswald, 3 Felix Hausdorff Street, 17489, Greifswald, Germany.

AAPS Pharmscitech
|November 26, 2025
PubMed

Insights

Mini-tablets (MTs) require specialized dissolution testing. A small-volume Reciprocating-Holder apparatus demonstrated superior sensitivity for evaluating extended-release (ER) mini-tablets compared to a Mini-Paddle system.

Area of Science:

  • Pharmaceutical Technology
  • Drug Delivery Systems
  • Analytical Chemistry

Background:

  • Mini-tablets (MTs) are crucial pediatric dosage forms, but lack standardized quality control (QC) methods, especially for extended-release (ER) formulations.
  • Existing QC methods may not adequately assess the performance of miniaturized drug delivery systems.

Purpose of the Study:

  • To evaluate two miniaturized dissolution apparatuses (Mini-Paddle and small-volume Reciprocating-Holder) for assessing ER MTs.
  • To determine the sensitivity and discriminatory power of these systems for pediatric drug products.

Main Methods:

  • Tested melatonin and sodium valproate ER MTs using Mini-Paddle (USP 2) and small-volume Reciprocating-Holder (USP 7) apparatuses.
  • Assessed drug release from individual and manipulated batches to evaluate method performance.

Main Results:

  • The Reciprocating-Holder apparatus provided sensitive, single-unit testing for both drug products, detecting batch variations.
  • The Mini-Paddle apparatus showed limitations with low-dose formulations, masking individual variability due to unit pooling.

Conclusions:

  • The small-volume Reciprocating-Holder is a promising tool for QC of ER MTs, offering superior sensitivity.
  • Standardized, miniaturized dissolution methods are urgently needed for regulatory acceptance and quality assurance of MTs.
Keywords:
extended releasemini paddlequality controlreciprocating holdersmall-volume dissolution testing

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