Abstract

Medicated chewing gums (MCGs) represent a beneficial platform for realizing drugs intended for dental prophylaxis and treatment. The present study aimed to investigate the impact of compression force on the mechanical, textural, release, and chewing perception characteristics of compressible MCGs with the combination of lysozyme hydrochloride (LH) and ascorbic acid (AsA). Four batches of MCGs were obtained on a laboratory single-punch tablet machine applying different forces, i.e., 5, 7, 10, and 15 kN, and evaluated by their geometrical parameters, mechanical resistance, surface and internal structure characteristics, texture profile, release behavior, and perception attributes during mastication. It was found that increasing compression force slightly affected resistance to crushing and friability of MCGs, but resulted in surface smoothing and formation of a thicker layer with highly compacted particle arrangement. According to the texture analysis, increasing compression force led to harder and more adhesive gums, indicating possible difficulties in chewing and, therefore, impairment of their consumer properties. Lower compression forces were also found to be preferable in terms of better drug release from the obtained chewing gums. The volunteers’ assessment showed that an increase of compression force led to significantly raising the initial hardness and crumbliness as well as to decreasing the rate of the integral gum mass formation during mastication, which may negatively affect perceptive sensations when using MCGs. Based on the results obtained, the optimal compressing force was selected to be 7 kN, which allows obtaining MCGs with good organoleptic, mechanical, textural, and release properties.

Highlights

  • In recent years, the pharmaceutical research field has shown a growing interest towards patient-friendly drug delivery systems

  • All batches of Medicated chewing gums (MCGs) compressed at 5, 7, 10, and 15 kN compression force values completely met the requirements of Ph.Eur. on resistance to crushing and friability tests; change in the compression force resulted in differences in textural, release, and chewing perception properties of the samples

  • The higher compression force led to harder gums, characterized by the less efficient release of active pharmaceutical ingredients (APIs) at the initial bite, and less crumbliness and faster merging into one gum mass during chewing

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Summary

Introduction

The pharmaceutical research field has shown a growing interest towards patient-friendly drug delivery systems One of those is medicated chewing gum (MCG). There are several brands of directly compressible gum bases currently available in the pharmaceutical excipient market that allow obtaining MCGs by a simple compression method using common tableting machines. Among such compressible gum bases, Health-in-Gum® produced by Cafosa (Spain) appears to be the most mentioned in the literature [11,12,13]. The present study focuses on the mechanical, textural, release, and chewing perception characteristics of MCGs with the mentioned active pharmaceutical ingredients (APIs) depending on the compression force applied in the manufacturing process

Materials
Preparation of Medicated Chewing Gums
Mechanical Resistance of MCGs
Surface and Internal Structure Characterization
Texture Profile Analysis
In Vitro Drug Release Study
Chewing Perception Assessment
Statistical Analysis
Results and Discussion
Comparative textural profile analysis of of MCGs with
Conclusions
Full Text
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