N.A. Kovyazina, V.I. Reshetnikov, E.V. Funkner

This article is devoted to the concept of formulating rational composition and technology of tableted baсteriophages. The development of algorithm for creating a highly rational tablet dosage form of baсteriophages as a delivery system of the small intestine is highly important nowadays, because baсteriophages - viruses of bacteria are inactivated under the influence of various technological factors. As a result of information retrieval and systematic research for obtaining composition and technology of the gastro-resistant tablets «Sekstaphage» without shell, a new methodological approach has been worked out, which consists of: the requirements for the initial phage (polyvalent, complex, highly purified and phages adaptation to modern pathogens); studying the effects of excipients on the lytic activity of the bacteriophage components; selecting stabilizer of phages activity and excipients based on physiological characteristics of the interaction between phage and the patient (fillers providing the potential gastric resistant tablets, calcium ions facilitating the introduction of the phage into the cell after adsorption and sorbents for detoxifying in case of bacteria massive destruction); studying the influence of technological factors (the ratio of liquid phage and filler, the order of introduction of liquid bacteriophage in to semi-finished product) on the stability of the bacteriophage components; optimizing technological parameters: the type of tableting (obtaining tablets by drying tableting mass, using the method of direct compression, or tableting with a preliminary granulation); the type of drying (vacuum, air and freeze). The proposed algorithm of formulating rational composition and technology of tableted bacteriophages allows us scientifically to create tableted dosage forms of phages.