Development of a combined solution of pyrimidine nucleotides with vitamin B6

Abstract

Pyrimidine nucleotides, namely uridine monophosphate and cytidine monophosphate, play an important role in the cellular metabolism of nerve fibers. The combination of these nucleotides with pyridoxine hydrochloride (vitamin В6) in one dosage form will allow us to fully implement the strategy of the complex neurotropic pharmacotherapy in neuropathies of various origins. To develop a stable solution, an important step at the stage of the composition development is to study the compatibility of active substances (active pharmaceutical ingredients - APIs) in solution. Samples of binary solutions and solutions containing all active substances were prepared and examined. The API interaction was determined by various parameters – changes in color, transparency, рН, the total impurity content, etc. Based on a comprehensive study of the processes of the API dissolution the optimal pH limits of the solution required for the stable existence of a combination of substances with different pH values of the medium have been substantiated and experimentally confirmed. As a result of the research, the optimal pH value of the solution recommended is 4.0-4.8. In the composition of substances the amount of water can be in an adsorbed or crystallized, or combined form. This fact should be taken into account in order to correctly calculate the actual amounts of initial ingredients when preparing the solution. The nature of the water component of APIs was clarified when studying the phase composition of samples on a powder diffractometer. The studies conducted have allowed us to determine the directions of further research for developing the composition of an injection drug. This research is in choosing the optimal buffer system and excipients-antioxidants.