Development of postcompressional textural tests to evaluate the mechanical properties of medicated chewing gum tablets with high drug loadings

Abstract

There is a growing interest in utilizing medicated chewing gums for drug delivery, especially those made using directly compressible gum bases, such as Health in gum. Directly compressing a gum base with high amounts of solid drug powder, however, poses a challenge as it may result in compressed compacts with hybrid properties between a chewing gum and a hard tablet. Currently, official Pharmacopeias do not specify a testing procedure for the estimation of the mechanical and textural properties of chewing gum tablets. To fill in the knowledge gap, we demonstrated in the present study how complementing a single-bite (knife) test with a modified two-bite test could be used to discriminate between chewing gums and hard tablets that were prepared by directly compressing Health in gum base with increasing concentration of curcumin powder in the blend. By utilizing these two tests, it was possible to identify clear demarcations between conventional tablets and chewing gums. In this study, we found that a 10% load by weight is the upper limit for curcumin loading in a binary blend with Health in gum to maintain the mastication properties of the compacts, which become brittle tablets at 30% load.

Impact of Compression Force on Mechanical, Textural, Release and Chewing Perception Properties of Compressible Medicated Chewing Gums

“…Four MCG batches compressed at different force values, i.e., 5, 7, 10, and 15 kN (100 dosage units in each one), were obtained. The values of 5, 10, and 15 kN compression force was chosen based on similar formulation studies [12,[21][22][23], and 7 kN-taking into account the recommendation of HiG ® manufacturer for production of compressible MCGs [12].…”

“…Indeed, 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].…”

“…However, currently, there are no official requirements on the mechanical (textural) properties of MCGs, while these characteristics are responsible for the chewiness and thus would affect the release behavior, as well as patient adherence and compliance to the treatment. In view of this, several techniques have been proposed for mechanical testing of MCGs, and texture profile analysis is among them [10,12,13,16].…”

In Vitro Performance Testing of Medicated Chewing Gums

“…In addition, the manufacturing processes (melting/ extrusion, direct compression) differ from those applied for other solid dosage forms (4,6). The resulting chewing gums manufactured by direct compression are also referred to as chewing gum tablets due to the production process, and the gum-forming behaviour is highly affected by the drug loading (7,8). In the literature, a clear differentiation is needed for chewing gum, chewable tablets, and chewable gels.…”