Product Performance Test for Medicated Chewing Gums

Gajendran, Jayachandar; Kraemer, Johannes; Knudsen, S.

doi:10.14227/dt170310p15

Cited by 12 publications

(17 citation statements)

References 11 publications

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“…However, in many instances, the compendial apparatus is not suitable for testing the product performance in vitro owing to the nature and type of dosage form and the physiological site intended for release .…”

Section: Introductionmentioning

confidence: 99%

“…Like any other dosage form, many product quality tests have been employed for medicated chewing gum formulations. The importance and the type of product quality tests have already been discussed . Besides product quality tests, drug release tests can provide useful information about the characteristics of the product itself, which includes, but is not limited to, the influence of composition of the gum and other excipients on drug release, a main tool required primarily during product screening, development and prediction of product performance in vivo .…”

Section: Introductionmentioning

confidence: 99%

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In vivo predictive release methods for medicated chewing gums

Gajendran

Kraemer²,

Langguth

2012

Biopharm & Drug Disp

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Understanding the performance of a drug product in vivo plays a key role in the development of meaningful in vitro drug release methodology. In case of functional chewing gums, the mode and the mechanism of release and the site of application differ significantly from other conventional solid oral dosage forms and require a special consideration to extract meaningful information from clinical studies. In the current study, suitable drug release methodology was developed to predict the in vivo performance of an investigated chewing gum product. Different parameters of the drug release testing apparatus described in the Ph. Eur. and Pharmeuropa were evaluated. Drug release data indicate that the parameters, chewing distance, chewing frequency and twisting motion, affect the drug release. Higher drug release was observed when the frequency was changed from 40 chews/min to 60 chews/min for apparatus A and B, as was the case for the twisting motion when changed from 20º to 40º for apparatus B. As far as the chewing distance is concerned, the release rate was in the following order; apparatus A: 0.3 mm > 0.5 mm > 0.7 mm; apparatus B: 1.4 mm > 1.6 mm > 1.8 mm. A suitable apparatus set-up for in vitro release testing was identified. The method will be useful for the establishment of in vitro in vivo correlations (IVIVC) for medicated chewing gums. Interchangeability of the apparatus for a product is not generally recommended without prior knowledge of the performance of the product, as the construction and principle of operation for the apparatus differ considerably.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

In vivo predictive release methods for medicated chewing gums

Gajendran

Kraemer²,

Langguth

2012

Biopharm & Drug Disp

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“…The chewing activity of the patient and oral health of mouth cavity also influences the drug release. Because of these reasons, apparatus consisted of following parameter was considered for the release of gum formulations which simulated human chewing behavior [14]. In vitro drug release of diphenhydramine hydrochloride chewing gum was performed by using dissolution test apparatus of medicated chewing gum based on European Pharmacopoeia at 40 mL dissolution medium of pH 6.0 phosphate buffer maintained at temperature 37±0.5 o C [15].…”

Section: Drug Release Studymentioning

confidence: 99%

Formulation of Eco-friendly Medicated Chewing Gum to Prevent Motion Sickness

Shete¹,

Muniswamy²,

Pandit³

et al. 2015

AAPS PharmSciTech

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ABSTRACT. An attempt was made to formulate medicated chewing gum to prevent motion sickness using natural gum base for faster onset of action and easy administration, anywhere and anytime, without access to water. To avoid the discard issue of gum cud, natural gum base of Triticum aestivum (wheat grain) was explored because of its biodegradable and biocompatible nature and easy availability. Prolamin, extracted from wheat, showed good chewing capacity, elasticity, high water retention capacity, antifungal activity, and compatibility with the drug. Formulations were prepared based on a two-factor and three-level factorial design. Amount of calcium carbonate (texturizer) and gum base were selected as independent variables. Elasticity and drug release were considered as the dependent variables. All batches were evaluated for the content uniformity, elasticity study, texture study, in vitro drug release study, and chewiness study. Results revealed that medicated chewing gum containing 80 mg of calcium carbonate and 500 mg of gum base showed good elasticity and more than 90% drug release within 16 min. Thus, this study suggested that both good elasticity and chew ability and abundant availability of wheat grain can act as a potential gum base for medicated chewing gum.

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“…Drug release tests for medicated chewing gums have been developed using compendial apparatus. As for conventional oral products, the compendial apparatus allow, among other things, the determination of the influence of composition and the manufacturing process of the gums on drug release (7,8).…”

Section: Medicated Gumsmentioning

confidence: 99%