Methodological aspects of the acid hemodialysis concentrates development

Abstract

The aim of this paper is to develop a scientifically based methodology for the development of acid concentrates in order to perform purposefully organized research on the implementation of these concentrates into industrial manufacture. Material and Methods. Methodological concept of acid concentrates development. The objects of the study are liquid acid concentrates for hemodialysis containing sodium chloride, potassium chloride, calcium chloride hexahydrate, magnesium chloride hexahydrate, acetic acid and glucose. Methods of the study included bibliosemantic analysis, systematization of theoretical and practical material, and generalization of data. Results and Discussion. The methodology of the development of acid concentrates for hemodialysis is substantiated. To ensure the effectiveness and safety of the concentrates, it is necessary to theoretically and experimentally justify all pharmaceutical factors that affect the quality of the concentrates (active substances, solvent, technological processes, and packaging materials). The methodology of development of acid concentrates consists of the following stages of research: information retrieval, technological, analytical, and biological. The methodological concept is based on the implementation of the combination of marketing, technological, pharmacotechnological, physicochemical, chemical. and biopharmaceutical studies that ensure compliance of the developed products with medical, biological and pharmaceutical requirements for quality and safety of concentrates for renal replacement therapy. Conclusion.The authors developed and substantiated the methodology and drew up a plan of experimental research on the elaboration of the acid concentrates for renal replacement therapy in order to organize their industrial manufacture. Keywords: chronic kidney disease, methodology of pharmaceutical development, concentrates for hemodialysis