Types of crystalline glucose for the preparation of solutions and tablet dosage forms

DOI: https://doi.org/10.29296/25419218-2020-05-04
Issue: 
5
Year: 
2020

L.S. Khvorova All-Russian Research Institute of Starch Products, Branch, V.M. Gorbatov Federal Research Center for Food Systems, Russian Academy of Sciences, 11, Nekrasov St., Kraskovo, Moscow Region 140051, Russian Federation

Crystalline glucose is used in the pharmaceutical industry to design a number of essential medicines. Currently, the world produces three main types of crystalline glucose (α-glucose in hydrated and anhydrous forms and β-glucose in anhydrous form), which differ in their physicochemical and technological properties. This fact should be decisive in the rational use of a specific form of glucose to obtain solutions or tablet dosage forms. It also affects the quality of medicines and the profitability of their production. For the preparation of infusion solutions, it is advisable to use the glucose types that have a high solubility, an insignificant content of impurities, whereas microbiological purity is guaranteed by the appropriate production technology with crystallization at temperatures above 55°C: these are anhydrous α- and β-glucoses. To obtain infusion solutions of glucose with sodium chloride, it is rational to use the pharmaceutical substance developed by the authors as a double compound of glucose with sodium chloride (DC), which contains glucose and sodium chloride in the single-crystal lattice with the chemical formula (C6H12O6)2·NaCl·H2O. The chemical composition of the product is similar to that of 2.5% glucose solution + 0.4% sodium chloride and is ideal for its preparation. To obtain the medicinal product 5% glucose solution + 0.9% sodium chloride, it is advisable to use the second version of the substance, which is additionally enriched with sodium chloride under production conditions. The product has a high solubility and microbiological purity. Hydrated glucose that has a lower solubility than the other types of glucose, but has a high moisture content of 9% and crystals as thin plates, readily amenable to the direct compression of tablets without additional moistening is recommended as a preferred substance for the preparation of tablet dosage forms.

Keywords: 
crystalline glucose
types
properties
use for the preparation of solutions and tablets

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