USING THE SeDeM-ODT METHOD FOR THE DEVELOPMENT OF GK-2 TABLETS DISPERSED IN THE ORAL CAVITY

Abstract

Introduction. The SeDeM-ODT method is a relatively new method based on expert judgment and pie charts, which reflect 15 main parameters of the suitability of a dosage form for direct compression and dispersibility in the oral cavity.The purpose of the research presented in this article is to study the pharmaceutical substance (API) GK-2 (bis- (N-monosuccinyl-L-glutamyl-L-lysine)hexamethyleneamide) using the SeDeM-method, to determine the direction for the correction of technological properties using excipients and to develop using the presented methods of the composition of tablets GK-2, dispersible in the oral cavity.Materials and methods. Preparation of tablets – manual hydraulic press PRG-50; method for determining flowability (GPM.1.4.2.0016.15, GP XIV, volume 2) – bulk density analyzer (ERWEKA SVM 221), GTB flowability tester (ERWEKA, Germany); crushing strength of tablets (GPM.1.4.1.0011.15, GP XIV, volume 2) – strength analyzer TBF 1000 CopleyScientific® (Great Britain); method for determining disintegration (GPM.1.4.2.0013.15, GP XIV edition, volume 2) – PTZ-S disintegration tester (Pharma Test, Germany); weight loss on drying (GPM.1.2.1.0010.15, GP XIV edition, volume 1) – moisture analyzer Sartorius MA-35 (Sartorius AG, Germany); determination of fractional composition – a vibrating sieve with pore sizes: 850, 600, 425, 300 and 250 microns, is used to determine the particle size distribution; tablet abrasion tester (GPM.1.4.2.0004.15, GP XIV edition, volume 2) – tablet abrasion tester PTF 30 ERA (Pharma Test, Germany); Optical microscopy (GPM.1.2.1.0009.15, GP XIV edition, volume I) – microscope Nicon, Eclipse E 200; digital camera Nicon Ds-Ri2. The data were processed using the SeDeM and SeDeM-ODT methods.Results. Model formulations have been developed containing various types of co-process fillers and a sliding excipient, which have been studied using the main pharmaceutical-technological methods and optical microscopy. Based on the data obtained, SeDeM-ODT diagrams were constructed, in which the parameters were converted into “radii”, reflecting the degree of acceptability for each technological characteristic. In addition, the following factors were calculated from the pie charts: volumetric parameter, compressibility coefficient, flowability parameter, stability coefficient, dosage coefficient, dispersibility coefficient, as well as the index of good pressing, the parametric index and the parametric index of the profile.Conclusion. As a result of the data obtained, the most optimal composition was selected that was acceptable for all the factors under consideration and had the highest values of the parametric index.