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Oluwatoyin A Adeleke1,2, Saba Abedin3

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Summary

This study establishes key quality control parameters for gummy formulations, essential for ensuring consistent, safe, and effective oral drug delivery. The findings provide crucial reference points for pharmaceutical development and quality assessment.

Keywords:
pharmaceutical analysispharmaceutical gummiesquality controlquality standardstexture analysis

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Drug Delivery

Background:

  • Gummy formulations offer advantages over traditional dosage forms, including improved patient compliance and ease of administration.
  • Despite their growing popularity for drug delivery, standardized quality control parameters for gummy formulations are lacking.
  • Ensuring consistent quality is vital for pharmaceutical products to be stable, safe, and therapeutically effective.

Purpose of the Study:

  • To investigate and quantify key physicochemical and micromechanical properties of gummy formulations.
  • To identify potential specification limits for evaluating the quality of gummy dosage forms.
  • To contribute to the standardization of quality control strategies for oral drug delivery gummies.

Main Methods:

  • Six brands of non-medicinal gummy products were analyzed.
  • Physicochemical properties including adhesiveness, adhesive force, chewiness, cohesiveness, hardness, springiness, resilience, matrix firmness, rupture force, moisture content, weight uniformity, and intraoral dissolution pH were quantified.
  • Micromechanical characteristics were assessed to determine their suitability as quality indicators.

Main Results:

  • A range of values for key parameters were determined: adhesiveness (0.009-0.028 mJ), adhesive force (0.009-0.055 N), chewiness (2.780-6.753 N), cohesiveness (0.910-0.990), hardness (2.984-7.453 N), springiness (0.960-1.000), resilience (0.388-0.572), matrix firmness (2.653-6.753 N), rupture force (5.315-29.016 N), moisture content (<5%), weight uniformity (<2.5 g; <7.5% deviation), and intraoral dissolution pH (3.5-6.8).
  • These quantified parameters demonstrate variability across different gummy brands.
  • The study identified specific measurable parameters that can serve as potential quality benchmarks.

Conclusions:

  • The quantified physicochemical and micromechanical properties provide a foundation for establishing quality control specifications for gummy formulations.
  • These findings can guide the development of standardized testing methods for gummy dosage forms.
  • This research supports the advancement of reliable oral drug delivery systems utilizing gummy matrices.