Development of in situ gel for artificial saliva and satisfaction study

Abstract

Xerostomia, the subjective complaint about the dry mouth, may lead to the difficulty in daily living including speaking, swallowing, taste acuity and sleeping. Patients are often advised to drink water or chew ice to moisturize the oral cavity and also recommended to use stimulant or saliva substitute, such as sour candies, chewing gum and artificial saliva. In Thailand, there is no artificial saliva products available in the market and this makes it difficult to access the artificial saliva. Hence, artificial saliva have been developed in the form of solution in many hospitals to dispense for xerostomia patients in the hospitals. Because of its bad taste and short duration of action, patients did not cooperate to use such products. In this study, in situ gel-forming artificial saliva containing gellan gum and hydroxyethyl cellulose was developed. Physical stability of in situ gel-forming artificial saliva was investigated. The stable formulations were investigated for gelation time and mucoadhesion of in situ gel-forming artificial saliva on porcine buccal mucosa. The highest mucoadhesive formulation was selected for satisfaction study in 15 volunteers with dry mouth.

The result found that in situ gel-forming artificial saliva containing 0.1% and 0.15%w/v of gellan gum and 0.15% and 0.3% of HEC were stable. The concentration of gellan gum affected the gelation time of in situ gel-forming artificial saliva, by increasing gellan gum concentration decreases gelation time. The in situ gel-forming artificial saliva, which contained 0.15%w/v of gellan gum and 0.3%w/v of HEC had the highest mucoadhesive property and was selected for satisfaction study. The clinical outcome showed that use of this in situ gel-forming artificial saliva could reduce dryness of mouth and almost volunteers were satisfied with this formulation.