Research of Stability of “Exkair” Tablets by the Method of Long-Term Storage

Abstract

The raised standard requirements regulated by the State Pharmacopoeia and the Analytical Normative Document (AND) are imposed to quality of the medicines applied in medical practice of the Republic of Kazakhstan. One of the main requirements imposed to quality of medicines is stability. The specification of test of stability of the tablets "Exkair" reflecting an assessment of physical and chemical properties of tablets and the list of indicators of quality according to requirements of the project of the AND is developed for expression of this concept. Determination of stability of tablets was carried out in the mode (long-term/real time testing) of long-term tests: temperature of natural storage - 25±2°C, relative humidity - (60±5)%. The indicators of quality of tablets included in the specification of stability on HP "Exkair" with reduction of test conditions and techniques of definition are presented. Results of test of stability of tablets confirm structure of a preparation: active substances - extract from the rhizomes of Acorus Calamus (0.009 g), extract of flowers of the Calendula officinalis (0.003 g); auxiliary substances - ascorbic acid (0.005 g), calcium stearate (0.006 g), sugar powder (0.517 g), aerosil (0.0015 g). On the basis of these test the assessment of quality of tablets with establishment of numerical values of parameters including period of storage is carried out. Period of storage of medicine established experimentally by the method of long-term storage under natural conditions within 2 years in packing regulated by the draft of the Analytical Normative Document (AND). Initial period of storage of the tablets "Exkair" makes 2 years. In this research period of storage of ready medicine was determined irrespective of expiration dates of the main substance (extract from the rhizomes of Acorus Calamus and extract of flowers of the Calendula officinalis).