Разработка и регистрация лекарственных средств (Dec 2023)
Study of the Effect of Matrix-forming Polymers on the Release Rate of Sodium 4,4'-(propanediamido)dibenzoate from Tablets
Abstract
Introduction. Wet granulation technology is a process of directed particle aggregation of powder materials to obtain required properties of tablet masses and, as a consequence, to achieve satisfactory characteristics of tablets. In this addition, as a result of wet granulation technology, if special excipients are used, it becomes possible to control the rate and kinetics of release of active pharmaceutical substances from tablets to achieve the desired therapeutic effect.Aim. To study the effect of matrix-forming components included in the composition of mixtures for granulation on the rate of release of sodium 4,4'-(propanediamido)dibenzoate from tablets.Materials and methods. The original substance sodium 4,4'-(propanediamido)dibenzoate, as well as a number of excipients, which included polymers used for prolonged-release dosage forms, lubricant – sodium stearyl fumarate, as well as pore-forming agents – PVP and MCC, were the objects of the study. The key parameters of tablets and dissolution kinetics were studied in accordance with the requirements of State Pharmacopoeia of the Russian Federation XIV edition and Pharmacopeia of the Eurasian Economic Union.Result and discussion. Prolonged release was achieved for all tablets, but more than 90 % of the substance was released after 12 hours in tablets containing ethylcellulose as a matrix-forming polymer. The release of APS from tablets of this formulation was the most prolonged.Сonclusion. The effect of matrix-forming components included in the composition of mixtures for granulation on the rate of release of 4,4'-(propanediamido)sodium dibenzoate from tablets has been studied. The most uniform and complete release of ASF from tablets in which the matrix-forming polymer is ethylcellulose in the amount of 27.7 %.
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