Preparation of artificial tears with in-situ gelling properties for the management of dry eye disease: efficient droplet administration by a 3D-printed device

Aims The present study was aimed at developing in-situ gelling artificial tear formulations and a three-dimensional (3D) printed administration aid.Materials and methods In-situ gelling formulations were prepared using gellan gum and hydroxypropyl methylcellulose (HPMC). Administration aid was developed by fused deposition modeling approach. Formulations were evaluated for physicochemical properties, sterility, in-vitro erythrocyte morphology assessment, disintegration, in-silico analysis, ex-vivo ocular surface retention, in-vivo ocular irritation and efficacy in dry eye disease model in rabbits. 3D printed device was evaluated for volume of dispensed droplets, usability, instillation success rate and acceptance by human participants.Results Prepared formulations exhibited acceptable physicochemical properties, sterility and did not irritate the rabbit eye. In-silico analysis suggested interactions between gellan gum, HPMC and ocular proteins (mucin, p-glycoprotein, OATP2A1). Formulations showed an ocular retention time of ~20–24 hours and disintegrated within the same timeframe. A two-fold increase was recorded in the Schirmer 1 test score of formulations treated rabbit eye than the untreated counterpart. A ~ 21% increase in the droplet volume was observed in the presence of administration aid. 3D printed aid facilitated instillation of formulations.Conclusions Schirmer 1 test scores increased following treatment with prepared formulations as compared to untreated counterparts. An administration aid was successfully engineered for dispensing prepared formulations.