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SUMMARY

Substantiation of a QUALITY Target PROFILE FOR THE DEVELOPMENT OF COMBINED eye drops for glaucoma treatmentA.M.Yakubchuk, E.G. Fetisova, A.V.Dorovskyy, L.M. AndryukovaNationalPharmaceuticalUniversity, Kharkiv.The article contains the definition of an element of pharmaceutical development, namely, the quality target profile of combined eye drops for glaucoma treatment. The feasibility of the drug developing has been scientifically substantiated by the research results of current trends in the glaucoma treatment, one of which is a combination of drugs with different mechanisms of action.The quality target drug profile has been defined in relation to quality, safety and efficacy. It forms the basis for development planning and a better understanding of the drug and the process.Substantiation of quality target profile for combined eye drops with antyglaucomous actions has been conducted for all aspects that recommended by guidelines 42-3.0:2011 «Medicinal products. Pharmaceutical development (ICH Q8)» taking into account the characteristics of the dosage form, and set consistently: the alleged use in the clinical setting, route of administration, dosage form, delivery system; strength dose; system container / closure means; quality criteria of medicinal product designated for placing on the product market.It has been substantiated intended use in a clinical setting, route of administration and dosage form with the assistance of available scientific data, information and knowledge:- Active substance Timolol maleate - adrenergic agent, is most often used at the present date as part of hypotensive drugs; Taurine refers to the substances that stabilize adrenergic receptors and can change the pharmacological activity of adrenergic drugs;- Combined use of Timolol maleate and Taurine enhances the hypotensive effect by reducing production and increasing the outflow of aqueous humor, because of pharmacological synergy action of both drugs, which provides increased outflow of aqueous humor through the drainage system of the eye;- Eye drops continue to be the most common dosage form in ophthalmology, providing local application by instillation into the eye.Regarding potency doses: active substances selected for the development of combined eye drops are well known and used as part of eye drops (mono-drugs), their therapeutic concentrations are given in the references, and for the study selected concentration of 0.34% for timolol maleate and 4% - for taurine.Planning choice of container / closure means has been made taking into account, firstly, the market experience of primary packaging for finished mono drugs of timolol and taurine, secondly, available facilities of eye drops industrial production in various primary packaging types inUkraine. Given the number of appointed drug instillation for daily glaucoma treatment (1 drop), drops weight interval for domestic production drip (25-45 mg), and the shelf life of eye drops after opening the vial (1 month) the studies have been planned in the following types of primary packaging: glass containers with nominal capacity of 5 ml closed by rubber closures and pressurized by aluminum caps; low density polyethylene containers with a capacity of 1 ml and 5 ml made by Blow-Fill-Seal packaging system; assembly low density polyethylene containers with a capacity of 5 ml.Regarding the aspect of substantiation of the drug quality criteria: the regulated indicators and the biomedical requirements were the basis. The list of biomedical monitoring indicators consists of pH, osmolarity, viscosity, refractive index. 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