DEVELOPMENT OF THE COMPOSITION AND TECHNOLOGY OF A COCKTAIL TEST SYSTEM FOR RATIONAL PHARMACOTHERAPY

Abstract

Cocktail test systems are being used for determination of individual activity of cytochrome P450 isoenzymes in a patient. The usage of test systems allows taking into account the phenotypic features of drug metabolism to prescribe the most effective drug therapy. Aim. Development of a test system in the form of a solid gelatin capsule containing microtablets of caffeine, efavirenz, flurbiprofen, metoprolol tartrate and evaluation of their technological properties. Development of a method for the determination of marker components of a "cocktail" formulation using the Proton NMR spectroscopy method. Materials and methods. Microtabletes containing caffeine, efavirenz, flurbiprofen (Molekula Limited, UK) and metoprolol tartrate (KONO Chem Co., LTD, China) were manufactured on a tablet press of the XSpress type (BOSCH, Germany), in one of the sockets of which a 12-punch press tool with a diameter of 2 mm matrix holes was inserted. The resulting microtablets passed pharmaceutical and technological tests for dosage forms in accordance with the Pharmacopoeia of the Russian Federation XIV edition. Finnipipette F1 mechanical pipettes were used to sample the solvent and analytic solution, and a Vortex 2 shaker, an ultrasonic water bath, a Minispin Plus centrifuge, benzoic acid, and DMSO-d6 were used for sample preparation. Results and discussion. A common solvent has been selected for all active substances of the test system. Conditions for the introduction of probe preparations into the filler substance of the sorbent have been selected. Tableting parameters have been worked out. Conclusion. As a result of the conducted research, the composition and production technology of a cocktail test system for rational pharmacotherapy have been developed. A technological scheme for obtaining microtablets of probe preparations has been developed. For a mixture of active substances, the conditions for quantitative analysis were selected using the Proton NMR spectroscopy method.