Abstract
Human saliva is a biological fluid of great importance in the field of dissolution testing. However, until now, no consensus has been reached on its key characteristics relevant to dissolution testing. As a result, it is difficult to select or develop an in vitro dissolution medium to best represent human saliva. In this study, the pH, buffer capacity, surface tension, viscosity and flow rate of both unstimulated (US) and stimulated (SS) human saliva were investigated in order to provide a platform of reference for future dissolution studies using simulated salivary fluids. Age and gender related differences in a sample size of 30 participants for each parameter were investigated. Significant differences were established between US and SS for all characteristics except surface tension. Therefore, the requirement for using two simulated salivary fluids should be considered when developing an oral dissolution model.
Highlights
The oral cavity as a dissolution site is often overlooked due to rapid oral transit as conventional dosage forms are swallowed
stimulated saliva (SS) was shown to have a lower viscosity, and a statistically significant difference in viscosity was observed between US and SS at every shear rate recorded with p < 0.0001 (Wilcoxon matched pairs test)
Since we found no significant difference between US and SS, it is likely that the surface active components of human saliva remain approximately constant, regardless of the stimulation state
Summary
The oral cavity as a dissolution site is often overlooked due to rapid oral transit as conventional dosage forms are swallowed. Conventional oral formulations such as tablets and capsules are of limited application in the paediatric and geriatric population and alternative oral dosage forms which reside in the mouth for a significant time are increasing in popularity [1]. Adult dosage forms which can be taken ‘‘on the move’’, without the co-administration of water are gaining interest [2]. Many alternative formulations, such as oral films, sublingual and buccal tablets and orally disintegrating tablets rely on dissolution or disintegration in saliva. There is no consensus on the key characteristics of human saliva which may affect dissolution, and as a result, it is difficult to select or develop an in vitro dissolution
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