Problems of scientific substantiation of extemporaneous formulations technologies and ways of its solution. P a r t І. Retrospective view on the unification aspects of extemporaneous formulations

  • A. S. Solovyev Shupyk National Medical Academy of Post-graduate Education, Kyiv
  • A. I. Tikhonov National University of Pharmacy, Kharkiv
  • T. G. Yarnykh National University of Pharmacy, Kharkiv
  • O. P. Gudzenko Lugansk State Medical University
  • O. A. Rukhmakova National University of Pharmacy, Kharkiv
Keywords: extemporaneous formulations, unification, historical aspects

Abstract

Extemporaneous formulations largely depend on practical experience and require constant analysis, the results of which should be reported to all the medical and pharmaceutical workers.

The aim of the work is a retrospective analysis of unification of extemporaneous formulations; study the current state of the regulatory framework of extemporaneous preparations technology. Studies were performed using archival information materials, literature data and materials from our studies using conventional empirical methods.

In order to unify the extemporaneous formulations in many countries, including Ukraine, are published official collections of medicinal prescriptions, the range of which is periodically reviewed and updated.

The first guide of extemporaneous formulations «List of medicinal formulas» containing 241 formulations was published in 1930. The first Soviet «Pharmaceutical Manual» was published in 1949; it contained the widely used medicines, known under certain conventional names.

In 1993, was organized a work to prepare the «Compendium of the dosage prescriptions», which contained 728 standardized prescriptions and was recommended by the Ministry of Health to the practical work (order No. 223 from 08. 12. 91).

Similar manuals were issued in other countries: «Pharmaceutical Formulas» (England, 1944), «Formulaire de Magistrale du Syndicat» (France, 1992), «Formules Magistrales» (APIC, 1994), «Formularium Nederlandse Apothekers» (Netherlands, 1967), etc.

Among modern informal publications in Ukraine refers published in 1999 «Handbook of extemporaneous formulations. Allopathy and homeopathy» edited by acad. A. I. Tikhonov. It was first compiled and systematized over 2,000 prescriptions of extemporaneous medicines.

In view of the introduction into the work of pharmacies requirements of Good Pharmaceutical Practice (GPP) in 2000 was published already 2-nd edition of this handbook «Extemporaneous formulations (technology, use)» in 4 parts. GPP requirements to the technology of non-sterile, sterile and aseptic medicines are described in the two methodical recommendations edited by acad. A. I. Tikhonov and prof. T. G. Yarnykh and approved by the Order of the Ministry of Public Health of Ukraine No. 391 from 03. 08. 2005.

In the aspect of improving the quality of extemporaneous drugs in Ukraine is conducted a work on the development of compositions and technologies of new extemporaneous formulations. It creates a series of newsletters, regulating their production process, and approved by the Ministry of Public Health of Ukraine.

Besides, technology of extemporaneous preparations is also contained in articles published by scientists in scientific and popular journals as well as in dissertations.

Thus, on the basis of this analysis it can be argued that the establishment of the regulatory framework of extemporaneous drugs technology enhances their quality, improving production activities of pharmacies, as well as improve the drug supply of the population in terms of individualized treatment of the patient.

References

1. Requirements for the manufacture of non-sterile medicinal products in pharmacies: Method. rivers 2nd form. / Ed. OI Tikhonova, TG Yarnyh. - K .: Ministry of Health of Ukraine, 2005. - 98 p.
2. Requirements for the manufacture of sterile and aseptic medicinal products in pharmacies: Method. rivers 2nd form. / Ed. OI Tikhonova, TG Yarnyh. - K .: Ministry of Health of Ukraine, 2005. - 76 p.
3. Vlasenko I.O. Extemporal production - visiting card of the classical pharmacy // Pharmacist-practitioner. - 2007. - No. 5. - P. 2-4.
4. Egorova S. N. Pharmacy manufacture: dosage forms, which do not have industrial analogues // New pharmacy. Effective management. - 2007. - No. 6. - P. 39-42.
5. Chekman I.S., Gorchakova N.O., Kava T.V., Kiselev O.G. Extemporal Formulation: An Effective Direction of Individualization of Treatment of Patients / Mat. science-practice conf. "Modern problems of the extemporaneous formulation", September 27-28, 2007 - Kharkiv: View of the NFUU, 2007. - P. 13-14.
6. Extemporal manufacturing of medicines in Ukraine: current state and prospects [Electronic resource]. - Mode of access: http://amm.net.ua/ekstemporalne-vigotovlennya-likiv.html
7. Syatina M. L., Popovich V. P., Babsky AA, Gluschenko O. M. Extemporal preparation of drugs: problems and ways of their solution / Mat. science-practice conf. "Modern problems of the extemporal formulation", September 27-28, 2007 - Kharkiv: View of the NFUU, 2007. - P. 15-16.
8. Gromovik B.P., Mokryanin SM, Tereshchuk S.I., Miroshnikova I.O. Prospects of the development of the pharmacy service of Ukraine in view of possible European integration // Pharmac. journ - 2007. - No. 1. - P. 3-9.
9. Yarnykh T.G., Tikhonov A.I., Garkavtseva O.A., Romanenko N.V. Principles of preparation of drugs in the conditions of pharmacies // Provizor. - 2009. - No. 21. - pp. 24-29.
10. Kaleniuk T. G., Belous S. B., Luta M. L., Czolij LF. Problems of making extemporal drugs. Mat. science-practice conf. "Modern problems of extemporal formulation", September 27-28, 2007 - Kharkiv: View of the NFUU, 2007. - P. 17-24.
11. Tikhonov A.I., Chernykh V.P., Budnikova T.N., Yarnykh T.G. Modern problems of preparation of extemporal drugs in pharmacies of Ukraine / Ibid. - Kharkiv: View of the NFUU, 2007. - P. 6-14.
12. Reference book of extemporal formulation / Ed. AI Tikhonova. - K .: Morion, 1999. - 496 pp.
13. Modern problems of extemporal formulation: Mat. science-practice conf. (Kharkiv, September 27-28, 2007). - Kharkiv: View of the NFUU, 2007. - 236 p.
14. Tikhonov AI, Yarnykh T. G. Normative-technological aspects of the preparation of extemporal drugs / Al. Vi-lea Congres Al Farmacistilor din Republica Moldova. Chisinau - 2009. - P. 69-71.
15. Tikhonov A.I., Yarnykh T.G. Current state and prospects of extemporaneous preparation of drugs in the conditions of pharmacies // Pharmac. journ - 2004. - No. 5. - P. 42-46.
16. Tikhonov O.I., Yarnykh T.G., Lukienko O.V. Improvement of normative base regulating the preparation of extemporal drugs / Actual questions of pharmaceutical and medical science and practice: Zb. sciences articles - Zaporozhye, 2006. - Vip. XV, T. 2. - P. 140-143.
17. Tikhonov A.I., Yarnykh T.G., Lukienko O.V. Research on the improvement of technology of extemporaneous drugs // Bulletin of Pharmacy. - 2005. - No. 3 (43). - P. 3-8.
18. Yarnykh TG, Gorova OA, Romanenko NN Requirements of Pharmacopoeia of USA and DFU for the manufacture of drugs in pharmacies // Prosazor - 2008. - No. 11. - P. 52-56.
19. British Pharmacopeia. - London: HMCO, 2009. - V. 1-4. - 10952 p.
20. Vail J., Naddeo AM, Kinget R. et al. Compounding Around the World // Inter. J. Pharm. Compounding - 2008. - N 2. - P. 102-115.
21. European Pharmacopeia. - suppl. 5.8. - Strasbourg: Council of Europe, 2004 - 2570 p.
22. Good Pharmacy Practice (GPP) in developing countries. Solemetary guidelines for stepwise implementation. - FIP Community Pharmacy Section, 1999.
23. Hinkle A. R., Newton G. D. Compounding in the Pharmacy curriculum: beyond the basics // Inter. J. Pharm. Compounding - 2004 - May, June. - P. 181.
24. Miller D. G. Legislative / Regulatory Update from the International Academy of Compounding Pharmacists // Ibid. - 2012. - V. 16, N 1. - P. 50-52.
25. United State Pharmacopeia. - XXIV ed. - Rockville: The United State Pharmacopeial, 2000 - 2569
26. Vogler S., Arts D., Habl C. Community Pharmacy in Europe: Lessons from Deregulation - case studies. - Vienna: Identic, 2006 - 13 pp.
Published
2019-02-12
How to Cite
Solovyev, A. S., Tikhonov, A. I., Yarnykh, T. G., Gudzenko, O. P., & Rukhmakova, O. A. (2019). Problems of scientific substantiation of extemporaneous formulations technologies and ways of its solution. P a r t І. Retrospective view on the unification aspects of extemporaneous formulations. Farmatsevtychnyi Zhurnal, (1), 3-21. Retrieved from https://pharmj.org.ua/index.php/journal/article/view/310
Section
Management, marketing and logistics

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