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

Urziya Alimova; Аssyl Boshkayeva; Nurgan Tussupova; Roza Omarova; Galiya Ibadullayeva; Zuriyadda Sakipova; Yernar Dzhadranov; Kurakbai Zharimbetov; Eduard Bissenbaev; Ubaidulla Datkhayev

doi:doi:10.11648/j.cmr.20160502.12

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

Urziya Alimova, Аssyl Boshkayeva, Nurgan Tussupova, Roza Omarova, Galiya Ibadullayeva, Zuriyadda Sakipova, Yernar Dzhadranov, Kurakbai Zharimbetov, Eduard Bissenbaev, Ubaidulla Datkhayev

Published in Clinical Medicine Research (Volume 5, Issue 2)

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.

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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

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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Plain Text BibTeX RIS

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

Copy | Download

@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}
}

Copy | Download

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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