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

Received: 16 February 2016     Accepted: 13 April 2016     Published: 26 April 2016
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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).

Published in Clinical Medicine Research (Volume 5, Issue 2)
DOI 10.11648/j.cmr.20160502.12
Page(s) 13-19
Creative Commons

This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited.

Copyright

Copyright © The Author(s), 2016. Published by Science Publishing Group

Keywords

Extracts, Tablets, Stability, Quality of Drugs, Storage, Provisional Analytical Normative Document (PAND)

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.
Cite This Article
  • APA Style

    Urziya Alimova, Аssyl Boshkayeva, Nurgan Tussupova, Roza Omarova, Galiya Ibadullayeva, et al. (2016). Research of Stability of “Exkair” Tablets by the Method of Long-Term Storage. Clinical Medicine Research, 5(2), 13-19. https://doi.org/10.11648/j.cmr.20160502.12

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    ACS Style

    Urziya Alimova; Аssyl Boshkayeva; Nurgan Tussupova; Roza Omarova; Galiya Ibadullayeva, et al. Research of Stability of “Exkair” Tablets by the Method of Long-Term Storage. Clin. Med. Res. 2016, 5(2), 13-19. doi: 10.11648/j.cmr.20160502.12

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    AMA Style

    Urziya Alimova, Аssyl Boshkayeva, Nurgan Tussupova, Roza Omarova, Galiya Ibadullayeva, et al. Research of Stability of “Exkair” Tablets by the Method of Long-Term Storage. Clin Med Res. 2016;5(2):13-19. doi: 10.11648/j.cmr.20160502.12

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  • @article{10.11648/j.cmr.20160502.12,
      author = {Urziya Alimova and Аssyl Boshkayeva and Nurgan Tussupova and Roza Omarova and Galiya Ibadullayeva and Zuriyadda Sakipova and Yernar Dzhadranov and Kurakbai Zharimbetov and Eduard Bissenbaev and Ubaidulla Datkhayev},
      title = {Research of Stability of “Exkair” Tablets by the Method of Long-Term Storage},
      journal = {Clinical Medicine Research},
      volume = {5},
      number = {2},
      pages = {13-19},
      doi = {10.11648/j.cmr.20160502.12},
      url = {https://doi.org/10.11648/j.cmr.20160502.12},
      eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.cmr.20160502.12},
      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).},
     year = {2016}
    }
    

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  • TY  - JOUR
    T1  - Research of Stability of “Exkair” Tablets by the Method of Long-Term Storage
    AU  - Urziya Alimova
    AU  - Аssyl Boshkayeva
    AU  - Nurgan Tussupova
    AU  - Roza Omarova
    AU  - Galiya Ibadullayeva
    AU  - Zuriyadda Sakipova
    AU  - Yernar Dzhadranov
    AU  - Kurakbai Zharimbetov
    AU  - Eduard Bissenbaev
    AU  - Ubaidulla Datkhayev
    Y1  - 2016/04/26
    PY  - 2016
    N1  - https://doi.org/10.11648/j.cmr.20160502.12
    DO  - 10.11648/j.cmr.20160502.12
    T2  - Clinical Medicine Research
    JF  - Clinical Medicine Research
    JO  - Clinical Medicine Research
    SP  - 13
    EP  - 19
    PB  - Science Publishing Group
    SN  - 2326-9057
    UR  - https://doi.org/10.11648/j.cmr.20160502.12
    AB  - 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).
    VL  - 5
    IS  - 2
    ER  - 

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Author Information
  • Asfendiyarov Kazakh National Medical University, Almaty, Republic of Kazakhstan

  • Asfendiyarov Kazakh National Medical University, Almaty, Republic of Kazakhstan

  • Asfendiyarov Kazakh National Medical University, Almaty, Republic of Kazakhstan

  • Asfendiyarov Kazakh National Medical University, Almaty, Republic of Kazakhstan

  • Asfendiyarov Kazakh National Medical University, Almaty, Republic of Kazakhstan

  • Asfendiyarov Kazakh National Medical University, Almaty, Republic of Kazakhstan

  • Asfendiyarov Kazakh National Medical University, Almaty, Republic of Kazakhstan

  • Asfendiyarov Kazakh National Medical University, Almaty, Republic of Kazakhstan

  • Asfendiyarov Kazakh National Medical University, Almaty, Republic of Kazakhstan

  • Asfendiyarov Kazakh National Medical University, Almaty, Republic of Kazakhstan

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