In vivo predictive release methods for medicated chewing gums

Abstract

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.

Concentration in Saliva and Antibacterial Effect of Xylitol Chewing Gum: In Vivo and In Vitro Study

“…The sampling technique, stimulated and unstimulated saliva, was postulated as the reason of the bimodal fashion release concentration [7]. In this study, the second peak was observed at the end of the chewing period; chewing saliva stimulation is reduced after 5 min and this may have influenced the presence of the bimodal release concentration; as reported in literature, the highest salivary concentration of drugs (fluoride, nicotine, etc) released from gums was detected between 5 and 10 min from the beginning of use [26][27][28][29].…”

In Vitro Performance Testing of Medicated Chewing Gums

“…For the jaw distance, a higher release was revealed with decreasing distance for both devices in the following order; apparatus A: 0.7 < 0.5 < 0.3 mm; apparatus B: 1.8 < 1.6 < 1.4 mm (Fig. 2) (26). In the case of apparatus B, a high chewing frequency in combination with high twisting angles cannot be used, due to a limited rotation speed of the upper piston (27).…”

“…The parameters of in vitro testing devices -chewing frequency, twisting angle of the jaws, and jaw distance -can be modified while the temperature is usually kept at 37 °C ± 0.5 °C (14). A general recommendation for adjustments of the release test devices is given by Gajendran et al (26). In principle, faster drug release was observed when the frequency increased from 40 to 60 strokes per minute.…”

Phenolics release kinetics in sugared and sugar‐free chewing gums: microencapsulated pomegranate peel extract usage

“…The consistency of oral processing (chewing, swallowing) can be affected by the texture of the chewing gum (Blee et al ., ). Therefore, it is possible that the release properties of bioactive compounds may alter depending on these mechanical effects (Haahr et al ., ; Gajendran et al ., ).…”

“…The consistency of oral processing (chewing, swallowing) can be affected by the texture of the chewing gum (Blee et al, 2011). Therefore, it is possible that the release properties of bioactive compounds may alter depending on these mechanical effects (Haahr et al, 2004;Gajendran et al, 2012). Main textural quality parameters for chewing gums such as hardness, adhesiveness, springiness, cohesiveness, chewiness and resilience were determined (Table 3).…”