Abstract
Orodispersible tablets (ODTs) offer rapid disintegration of the dosage form when placed on the tongue, which leads to fast release of the active pharmaceutical ingredient. Despite increased use in diverse patient populations, there have been numerous challenges associated with ODTs. One such concern is the lack of standardised assessment of disintegration behaviour. In the European Pharmacopoeia, ‘orodispersibles’ are defined as such if disintegration time is faster than 3 min. Common in vitro measurement methods only provide single time point data and have limited physiological accuracy. To determine more bio-predictive disintegration kinetics, a bench-top in vitro oral cavity model (OCM) was modified and piloted to assess disintegration of three ODTs of differing hardness. All ODTs disintegrated similarly within the OCM—surface breakdown/swelling, initial ‘wash away’ and final ‘wash away’. The distinct advantage presented within this pilot study using the OCM is the opportunity to ascertain disintegration behaviour profiles of ODTs by evaluating changes in the observable area during simulated oral processing. The model could be implemented as a decision-support tool during the early stages of the drug design process to improve acceptability and further understand ODT disintegration behaviour.
Highlights
Orodispersible tablets (ODTs) offer, among other advantages, rapid disintegration of the dosage form when placed on the tongue, which leads to fast release of the active pharmaceutical ingredient
If the unresolved questions on how to provide greater accuracy when measuring disintegration in relation to area can be answered, through further investigations and modifications of the oral cavity model (OCM), the findings presented will be of greater significance
Three ODTs of varying hardnesses were tested by two disintegration methodologies
Summary
Orodispersible tablets (ODTs) offer, among other advantages, rapid disintegration of the dosage form when placed on the tongue, which leads to fast release of the active pharmaceutical ingredient. This has led to the manufacture and licensing of ODTs to improve the effectiveness of treatment in numerous clinical conditions such as attention deficit hyperactivity disorder (ADHD) [1,2], epilepsy [3], pain [4], and psychiatric illnesses [5]. In the European Pharmacopoeia, dosage forms are defined as ‘orodispersible’ if disintegration time is faster than 3 min [11] when using the specified methodology and in vitro apparatus. Reasons include a lack of physiologically relevant media, which exhibits dosage forms to substantial fluid volumes and imprecise pressures as well as the absence of any information on disintegration kinetics over time
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