Vorobyeva V.M. 1
Polukhin D.G. 1
Kraft L.A. 1
Kudrikova L.E. 1
Motin Y.G. 1
1 The Altai State Medical University
Methodological approach to pharmaceutical development enables to optimize the studies for drug making. Thus, the experimental theoretical substantiation of the algorithm-scheme of the development of medicines for the local treatment of burns of the esophagus was made. At the information search stage the need for drugs proposed for development was identified and the goal, the objectives of the study, the requirements to drugs were stated. In the research phase the optimization of the qualitative and quantitative composition was performed, the rational technology was developed and the quality rating was determined. The choice of drug concentration was made according to its entering the digestive tract. The powder for suspension was selected as a rational dosage form, the technology was developed and the peculiarities of the packaging and storage were defined. At the stage of standardization and pharmacological trials the criteria for assessing the quality of dry suspensions were specified, HPLC methods for quantitative determination of metronidazole, prednisolone, lidocaine hydrochloride, methyluracil were validated, the projects of normative documents and laboratory regulations for Premeltop and Remeltop drugs and their pharmacological evaluation were made. Algorithm-scheme is used as the basis of the methodology of medicine development to treat the burns of the esophagus.