Alkhalaf M. Development of the composition and technology of sugar-lowering tablets with Zingiber officinale extract

The work is devoted to the development of a new drug with a dry extract of ginger in the form of tablets for the treatment of type 2 diabetes. According to pharmacological studies, a conditional therapeutic dose of dry ginger extract of 80 mg/kg, has been established, which has a pronounced hypoglycemic effect. Based on the obtained results, the content of dry ginger extract in one tablet was calculated as 300 mg. Based on the results of physicochemical and pharmacotechnological studies of ginger extract mixtures with modern diluents, GalenIQ 721 was chosen because it leads to improved flowability, disintegration, compaction, which indicates the feasibility of its incorporation into the solid dosage form. Using the analysis of variance, the optimal excipients have been selected in the composition of tablets with ginger extract: from the group of binders - Kollidon K 30, moisture regulator - Neusilin UFL 2 and lubricant - calcium stearate. Using a technique based on the theory of multi-vector optimization, the optimal amount of selected excipients has been established, which provided the necessary pharmacotechnological characteristics of tablets in accordance with the requirements of SPU. A rational technology of tablets for the treatment of type 2 diabetes has been developed and the main indicators of their quality have been studied. Methods of identification, assay of BAS in the extract, finished dosage form and "Dissolution" test have been developed, which are included in the draft QCM. The term and conditions of storage of the drug under the conditional name "Imbitab" - 2 years at a temperature of (25 ± 2) ºC in the primary strip - packaging of aluminum foil have been established. Antidiabetic properties and safety of the developed tablets "Imbitab" have been established.