Critical parameters of the production process of oromucosal drug for the treatment of helminthiases in children

Abstract

Introduction. Troches are very popular in children due to their high compliance, pleasing organoleptic characteristics and easiness of administration. Nevertheless, the expanding range of drugs in this dosage form still lack anthelmintic products.  In order to introduce the new anthelminthic drug in the form of chewable troches under the conditional name “Albenpast”, there were conducted the studies over selection the optimal gel-forming agent and flavorings as correctors of taste characteristics. The purpose of this work is to develop the technology of chewable troches under the conditional name “Albenpast” and to establish the critical points of the production process. Materials & methods. As the objects of research the pure substances (albendazole, gelatin, glycerol, purified water, glucose syrup, fructose, citric acid, fruit flavoring, food coloring) and samples of troches on their basis were used. The research methods used are reflected in the State pharmacopoeia of Ukraine. Results & discussion. Research was conducted against the chewable troches “Albenpast” to the composition of the components of which the patent is claimed. Compositions of troches 1 and 2 differ in the type of sweetness flavoring: 1 contains glucose syrup, 2 contains fructose. Composition 2 is offered for the use in children who need to control the level of glucose.  The production process offered includes 9 stages with critical points in 2, 3, 4, 5 and 7. Additionally, for each stage the possible types of quality control are described. The further quality control of the obtained by the offered technology samples of chewable troches showed their full correspondence with the requirements of SPhU. Conclusion. The technological process of production of chewable troches is offered and the technological scheme of their production is given. Critical parameters of the production process and their values are identified and described. The results of the quality evaluation of obtained chewable troches according to the main quality indicators in accordance with the requirements of SPhU are presented.