Formulation and evaluation of slow releasing mouth dissolving films from Emblica officinalis fruit for prevention of dental caries

Abstract

Intercepting dental caries with natural material based drug delivery systems is a novel method against chemical based formulations as the latter possess several disadvantages. The purpose of this study is to formulate antibacterial, slow releasing mouth dissolving films from Emblica officinalis aqueous extract which is active against Streptococcus mutans, the primary pathogen causing dental caries. Emblica officinalis aqueous extract was prepared by decoction method and gallic acid, a polyphenol responsible for antibacterial activity was qualified using ultra frequency liquid chromatography. Minimum inhibitory concentration of extract was found to be 5%. This dose was incorporated in hydroxpropyl methyl cellulose polymer with excipients using solvent casting method. Four different formulations were prepared by varying polymer-excipient ratio along with placebo films. All four formulations were checked for mechanical properties out of which one of the formulations (F4) showed optimal properties which was used for further studies. The films were made slow releasing with 30 min dissolution time and 14.53 min disintegration time which is statistically significant (p<0.05). Aqueous suspension of films containing 5% extract showed antibacterial activity with 20 mm zone of inhibition and toxicologically were non-hematotoxic (less than 5% haemolysis) and non-teratogenic. Hence, this in vitro study concludes that Emblica officinalis aqueous extract is a natural antibacterial source which can be used in formulating slow releasing mouth dissolving films which are better over chemical formulations like mouth washes as stay-in-mouth time of these films are extended ensuring good antibacterial activity with extended local bioavailability with no drug like feel within oral cavity.