Using the thermal methods of analysis in selecting the optimal production techniques for tablets based on ademetionine 1,4-butanedisulfonate substance

Abstract

When developing tablets on the base of ademetionine 1.4-butandionsulfonat substance it is difficult to obtain a stable product, as substance is hygroscopic, and its quantity in the tablet is 90% by weight of the core.
 The aim of our work was the choice of conditions which would assure the safety of physical and chemical properties of the substance in the production process and allowed to get quality product.
 Tablet mass was prepared by dry mixing, controlling the relative humidity in the range from 15 to 50% and a temperature from 15 to 25 °C. Studies were carried out by differential scanning calorimetry and the method for determining the weight of moisture. The results were compared with those obtained in studies for comparing drug Geptral (Abbott SpA, Italy).
 As a result of studies was found that study samples number 1 and number 2 are as close as possible to their thermodynamic properties to the comparing drug. However, achieving a relative humidity of 15% is costly compared with values reaching 20%. Thus in the case of serial production is sufficient to create the following conditions: relative humidity not above 20%, the temperature +20,0 ± 2,0 °C.