Selection of flavoring agents and primary packaging for the combined oral solution named «Maglycimet»

Abstract

Aim. The main aim of research is selection of flavoring agents and primary packaging for a combined oral solution named «Maglycimet» based on theoretical and experimental. The solution consists of magnesium aspartate, magnesium glutamate, glycine and methylcobalamin.Methods. During the studying organoleptic, physicochemical and pharmaco-technological methods were used according to the requirements of the State Pharmacopoeia of Ukraine and the European Pharmacopoeia. Results. We investigated a series of the obtained solution with various corrective agents and their concentrations in order to give the medicine pleasant organoleptic characteristics. In the course of research next sweeteners were used: sodium cyclamate with concentrations 0.05-0.15 %; saccharin sodium with concentrations 0.05-0.15 %; saccharin sodium and sorbitol in such ratios: 0.1 and 5 %, 0.1 and 8.5 %, 0.15 and 10 %; sucrose with concentrations 20-30 %. Studies were performed using methods of A.I. Tentsova and I.A. Egorov in three separate stages. At the first stage 12 series of solution with different sweeteners were obtained. Four of them were selected to the second stage. At the third stage the best one was chosen according to the evaluation of volunteers group. It turned out to be saccharin sodium with concentration 0.1 %. The following flavoring agents were also investigated: «cherry», «raspberry», and «peach» with concentrations from 0.1 to 1.0 %. As a result of the research it was determined that the sample with the «cherry» flavoring agent with concentration 0.6 % had the best taste. 100 ml vials of orange glass and polyethylene terephthalate (two types) allowed for utilization in Ukraine were investigated as primary packaging. After 3, 6, 9, 12 and 18 months of solution storage in bottles monitoring of the main quality indicators was made. It was established that all types of packaging did not cause changes in the main indicators of the solution quality, beyond the design of quality control methods. This allows us to recommend all types of test vials.Conclusions. Sweetener saccharin sodium with concentration 0.1 % and a flavoring agent «cherry» with concentration of 0.6 % were chosen for the combined oral solution named «Maglycimet» based on the theoretical and experimental studies. Next types of bottles are recommended as a primary packaging: from orange glass and polyethylene terephthalate (two types)