Research of Stability of “Exkair” Tablets by the Method of Long-Term Storage
Clinical Medicine Research
Volume 5, Issue 2, March 2016, Pages: 13-19
Received: Feb. 16, 2016; Accepted: Apr. 13, 2016; Published: Apr. 26, 2016
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Authors
Urziya Alimova, Asfendiyarov Kazakh National Medical University, Almaty, Republic of Kazakhstan
Аssyl Boshkayeva, Asfendiyarov Kazakh National Medical University, Almaty, Republic of Kazakhstan
Nurgan Tussupova, Asfendiyarov Kazakh National Medical University, Almaty, Republic of Kazakhstan
Roza Omarova, Asfendiyarov Kazakh National Medical University, Almaty, Republic of Kazakhstan
Galiya Ibadullayeva, Asfendiyarov Kazakh National Medical University, Almaty, Republic of Kazakhstan
Zuriyadda Sakipova, Asfendiyarov Kazakh National Medical University, Almaty, Republic of Kazakhstan
Yernar Dzhadranov, Asfendiyarov Kazakh National Medical University, Almaty, Republic of Kazakhstan
Kurakbai Zharimbetov, Asfendiyarov Kazakh National Medical University, Almaty, Republic of Kazakhstan
Eduard Bissenbaev, Asfendiyarov Kazakh National Medical University, Almaty, Republic of Kazakhstan
Ubaidulla Datkhayev, Asfendiyarov Kazakh National Medical University, Almaty, Republic of Kazakhstan
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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).
Keywords
Extracts, Tablets, Stability, Quality of Drugs, Storage, Provisional Analytical Normative Document (PAND)
To cite this article
Urziya Alimova, Аssyl Boshkayeva, Nurgan Tussupova, Roza Omarova, Galiya Ibadullayeva, Zuriyadda Sakipova, Yernar Dzhadranov, Kurakbai Zharimbetov, Eduard Bissenbaev, Ubaidulla Datkhayev, Research of Stability of “Exkair” Tablets by the Method of Long-Term Storage, Clinical Medicine Research. Vol. 5, No. 2, 2016, pp. 13-19. doi: 10.11648/j.cmr.20160502.12
Copyright
Copyright © 2016 Authors retain the copyright of this article.
This article is an open access article distributed under the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/) which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
References
[1]
CPMP / ICH /2736/ 99 corr (Q1A R) Stability testing guidelines: stability testing of new drug substances and products. Note for guidance on stability testing: stability testing of new drag substances and products (revision), 2000.
[2]
The harmonized guidelines of ICH Q1A "Studying of Stability of New Medicines"
[3]
The resolution of the government of the Republic of Kazakhstan of December 5, 2011 No. 1459 "About the approval of Rules of production and quality control, and also carrying out tests of stability and establishment of period of storage and repeated control of medicines, products of medical appointment and medical equipment".
[4]
Meshkovsky A. P. Appropriate practice of storage of medicines / A. P. Meshkovsky // Farmateka. 2000. - No. 3. – P. 27-30.
[5]
Meshkovsky A. P. Tests of stability and establishment of expiration dates of medicines // Farmateka 2000. No. 2. P. 25-38.
[6]
Management 42-3.4: 2004 Quality manuals. Medicines. Production of finished pharmaceutical products. — Kiev, Ministry of Health of Ukraine, 2004.
[7]
Management Ministry of Health of Ukraine 42-3.3:2004 "Quality manual. Medicines. Stability studying".
[8]
Management Ministry of Health of Ukraine 42-3.4:2004 "Quality manuals. Medicines. Production of finished pharmaceutical products".
[9]
Tulegenova A. U. The concept of efficiency and safety of medicines, the State Pharmacopoeia of the Republic of Kazakhstan // Pharmacy Kazakhstan. - 2007. – Р. 12-14.
[10]
Tulegenova A. U. Some aspects of the stability testing of medicines (message) // Pharmacy Kazakhstan. - 2006. - №3. – Р. 29-31.
[11]
Tulegenova A. U. Some aspects of the stability testing of medicines (message) // Pharmacy Kazakhstan. - 2006. - №4. – Р. 38-40.
[12]
Tulegenova A. U. Some aspects of the stability testing of medicines (message) // Pharmacy Kazakhstan. - 2006. - №5. – Р. 31-34.
[13]
Brian R. Mallhews. Regulatory Aspects of stability testing in Europe // Drug Develop and Industrial Pharmacy. - 1999. - Vol. 27(7). - P. 831-856.
[14]
The draft of Provisional Analytical Normative Document of the Republic of Kazakhstan (PAND) «Tablets from rhizome Acorus Calamus and from flower Calendula officinalis».
[15]
State Pharmacopoeia of Republic of Kazakhstan, Vol. I, “Tablets” Monograph.
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