RESEARCH OF THE EXCIPIENTS EFFECT FOR POLYMER BASIS IN OCULAR INSERT DEVELOPMENT

Abstract

Abstract. The spread of ophthalmic infectious diseases around the world and uniformity of the market of dosage forms for their therapy generate an incentive for scientists to develop innovative drug forms, to create improved therapy for such diseases as uevitis, conjunctivitis, keratitis and blepharitis. There are two types of eye dosage forms on the market of the Russian Federation - drops and ointments, which have a short shelf life after the first application, a high risk of microbial infection and infection of a "healthy" eye. Based on these facts, the study aims to develop a solid extended dosed biodegradable ocular insert for use in ophthalmotherapy. This article is devoted to the peculiarities of influence of film forming agents of different nature, plasticizer and solubilizing agent (poloxamer) and their ratio on the biopharmaceutical properties of the polymeric base of ocular insert. Polymers of both natural and semi-synthetic nature (hydroxyethylcellulose, sodium alginate, xanthan and gellan gum) were used to create the polymeric basis. Placebo inserts were formed at room temperature in open space for three days. The test of the samples was carried out according to the parameters of description, elasticity, dissolution time, humidity, which include in the State Pharmacopeia XIV, and mucohedhesion, that is an important parameter for locally administering on mucosa, although it is not regulated in official documents. The series of experiments showed the optimum concentrations and ratios of the auxiliary substances used, namely 0.5% to 2.5% for film type manufacturers, 2% for plasticizers and 0.5% for poloxamers, respectively. The formulations that showed the best performance when evaluating the parameters were - sodium alginate 2.5%, glycerin 2%, poloxamer 0.5%, water purified up to 40.0; xanthan gum 0.4%, glycerin 2%, poloxamer 0.5%, water purified up to 40.0.have a wide variation in different age categories, which requires further study. on additional samples of children in the region.