Research for the selection of taste corrigents, filter materials and primary packaging for oral solution with magnesium salts

Abstract

The aim. Theoretically and experimentally, justify the choice of excipients for a combined oral solution with organic magnesium salts. Determine the compatibility of filter materials of three types. Select single-dose primary packaging for the developed oral solution and confirm its suitability during the relevant studies. Materials and methods. Organoleptic, physicochemical, and pharmaco-technological methods were used in the investigation. All methods meet the requirements of the State Pharmacopoeia of Ukraine and the European Pharmacopoeia. Organoleptic methods indicated the taste of the medicinal speciality behind the methods of O.I. Tentsova and I.A. Egorov. Physicochemical methods were used to determine pH, colour, density, and quantitative amount of active pharmaceutical ingredients. Pharmaco-technological methods were used to determine the properties of filter materials and primary packaging. Results. A sweetener and a flavouring agent for an oral solution with magnesium salts were selected based on the research. Saccharin sodium was selected as a sweetener in the amount of 0.15 %. «Cherry» in the amount of 0.4 % and «caramel» in the amount of 0.2 % were selected as flavouring agents. As a result of experiments, the suitability of filter materials made of сapron, nylon and polyethersulfone was proven. This is determined by the constancy of the main quality indicators of the drug 24, 48 and 72 hours after filtration. The suitability of the single-dose primary packaging in the process of storing the oral solution has been studied and proven. In the work, polymer ampoules of the «Moplen EP 2S 12 B» brand and the «Purell HP 371P» brand were used. The conducted research allows us to create a competitive domestic drug that will be technologically simple and convenient in administration and will also be distinguished by relatively low raw material costs and production. Conclusions. Based on theoretical and experimental studies, auxiliary substances, such as sweeteners and flavouring agents, were selected for the combined magnesium-containing drug. The suitability of filter materials for the combined oral solution was investigated and confirmed. The suitability of single-dose primary packaging of two types was selected and experimentally proven