THE CHOICE OF EXCIPIENTS FOR OBTAINING THE GLYCLINE WITH THIOTRIAZOLINE SUBLINGUAL TABLETS BY DIRECT COMPRESSION METHOD Notification 2. Study of the influence of excipients on the pharmaco-technological characteristics of the tablets
DOI:
https://doi.org/10.11603/2312-0967.2020.2.11193Keywords:
glycine, thiotriazoline, tablets, excipients, direct compression method, mathematical planning of the experimentAbstract
The aim of the work: selection of excipients for producing sublingual tablets (glycine with thiotriazoline) by direct compression, studying their effect on the compression process, appearance, uniformity of mass, friability, resistance to cruching abrasion, hardness, disintegration time and the organoleptic properties of the tablets.
Materials and methods. The following materials were used in studies: glycine (Shiiiazhuana lirona Pharmaceutical Co., Ltd., China); thiotriazoline (State Enterprise "Chemical reagents Plant" of the Scientific and Technological Complex of the Institute of Single Crystals of the National Academy of Sciences of Ukraine), certified excipients by both domestic and foreign manufacturers.
Tablets of glycine and thiotriazoline were prepared by direct compression method. The tablets were pressed using a laboratory tableting press 6000S (Belarus) with a punch diameter of 10 mm.
Results and Discussions. The Greek-Latin square 4x4 was used to study the four qualitative factors. The appearance, the uniformity of mass, the resistance of tablets of glycine with thiotriazoline to crushing, the friability using the PHARMA TEST AG Siemensstrasse 5 D-63512 Hainburg (Germany), disintegration time of tablets on the ERWEKA ZTx20, organoleptic properties were studied. According to the results of the experimental studies, the analysis of variance of the experimental data was carried out and conclusions were drawn about the influence of the studied factors on the quality rating of tablets of glycine with thiotriazoline.
Conclusion. As a result of our studies, we studied the effect of four groups of excipients on the process of pressing, appearance, uniformity of mass, friability, resistance to cruching abrasion, hardness, disintegration time, organoleptic characteristics of sublingual tablets of glycine with thiotriazoline, which were obtained by direct pressing. The analysis of variance of the results made it possible to choose the optimal excipients that meet all the pharmacological requirements for the tablet dosage form of the State Pharmacopoeia of Ukraine.
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