Developing the design of triturate tablet machine

Authors

  • Владислав Юрійович Шибецький National Technical University of Ukraine "Kyiv Polytechnic Institute" Pobedy, 37, Kyiv, Ukraine, 03056, Ukraine https://orcid.org/0000-0001-5482-0838
  • Вадим Миколайович Поводзинський National Technical University of Ukraine "Kyiv Polytechnic Institute" Pobedy, 37, Kyiv, Ukraine, 03056, Ukraine https://orcid.org/0000-0002-9591-909X

DOI:

https://doi.org/10.15587/2312-8372.2014.25303

Keywords:

medicine, triturate tablets, tablet machine, liophilicity, wet granulation

Abstract

Producing medicines that meet the requirements of current legislation requires equipment that is designed, operated and repaired under conditions of Good manufacturing practice. For implementing this prerequisite, correct formulation of source data and technical design specification is needed.

Producing solid dosage forms is realized in a typical technological process, where wet granulation and drying of the obtained molding compound is a significant part of production. Creating tablet machine for producing molded (triturate) tablets needs taking into account the specificity of the finished products and improving the technological process at combining several operations. In this paper, modern concept of technical specification in designing triturate tablet machine and its design, which takes into account achievements in pharmaceutical engineering and provides even distribution of ingredients, sterility and liophilicity are developed. The design of the developed triturate tablet machine allows significantly change the concept of producing molded tablets and creates modern principles in the wider use of this type of solid forms for technologies of sterile and non-sterile medicines.

Author Biographies

Владислав Юрійович Шибецький, National Technical University of Ukraine "Kyiv Polytechnic Institute" Pobedy, 37, Kyiv, Ukraine, 03056

Assistant of the department of biotechnology and engineering

Вадим Миколайович Поводзинський, National Technical University of Ukraine "Kyiv Polytechnic Institute" Pobedy, 37, Kyiv, Ukraine, 03056

Ph.D., Associate Professor

Department of Bioengineering and Engineering

References

  1. Sharp, J. Good Pharmaceutical Manufacturing Practice: Rationale and Compliance [Text] / J. Sharp. — CRC Press, 2005. — 503 p.
  2. Федотов, А. Е. Основы GMP: производство лекарственных средств [Текст] / А. Е. Федотов. — М.: АСИНКОМ, 2012. — 583 с.
  3. Никитюк, В. Г. Оборудование на фармацевтическом предприятии. Проектирование и приемка — основные аспекты [Текст] / В. Г. Никитюк, Т. Н. Шакина // Фармацевтическая отрасль. — 2012. — № 2(31). — С. 30–38.
  4. Current Good Manufacturing Practice for Finish Pharmaceutical [Text] / Code of Federal Regulation Title 21 (CFR 21). — Part 211. — 2011. — P. 142–163.
  5. Хаджиева, З. Д. Технологические аспекты использования вспомогательных веществ в производстве лекарственных препаратов [Текст] / З. Д. Хаджиева, А. В. Кузнецов, Д. В. Бирюкова // Фундаментальные исследования. — 2012. — № 5(2). — С. 436–440.
  6. Jonat, S. Investigation of compacted hydrophilic and hydrophobic colloidal silicondioxides as glidants for pharmaceutical excipients [Text] / S. Jonat, S. Hasenzahl, M. Drechsler, P. Albers, K. W. Wagner, P. C. Schmidt // Powder Technology. — 2004. — № 1–2. — P. 31—43.
  7. Laich, Т. Versuche zur Direkttablettierung pflanzlicher Trockenextrakte unter Verwendung eines inter-nen und eines externen Schmiersystems [Text] / Т. Laich, M. Reher, Т. Kissel, G. M. Voss // Pharm. Ind. — 1995. — № 11. — Р. 950—958.
  8. Miertus, S. Electrostatic interaction of a solute with a continuum. A direct utilization of ab-initio molecular potentials for the prevision of solvent effects [Text] / S. Miertus, E. Scrocco, J. Tomasi // Chem. Phys. — 1981. — Vol. 55. — P. 117–129.
  9. Федосеева, А. А. Представление технологического процесса производства таблетированных лекарственных препаратов с помощью блок схемы и временних сетей Петри [Текст] / А. А. Федосеева // Радіоелектронні і комп’ютерні системи. — 2013. — № 5(64). — С. 385–389.
  10. Александров, Б. С. Методы гранулирования фармацевтических материалов и их влияние на свойства гранулятов и таблеток [Текст] / Б. С. Александрова // Хим.-фарм. пром.: Обзорн. информ. ЦБНТИ Минмедпром. — 1VT. — 1976. — № 9. — 22 с.
  11. Белоусов, В. А. Основные закономерности прессования химико-фармацевтических порошков [Текст] / В. А. Белоусов // Хим.-фармац. журн. — 1979. — № 5. — С. 49–55.
  12. Miyamoto, Y. Optimization of the granulation process for designing tablets [Теxt] / Y. Miyamoto, A. Ryu, S. Sugawara, M. Miyajima // Chem Pharm Bull. — 1998. — Vol. 46, № 9. — P. 1432–1437.
  13. Бродский, Ю. А. Технологическое вибрационное оборудование для фармацевтической промышленности [Текст] / Ю. А. Бродский, М. И. Одинокий // Хим.-фармац. журн. — 1999. — Т. 33, № 7. — С. 44–48.
  14. Sharp, J. (2005). Good Pharmaceutical Manufacturing Practice: Rationale and Compliance. CRC Press, 503.
  15. Fedotov, A. E. (2012). Basics of GMP: production of drugs. Moscow: ASINKOM, 583.
  16. Nikitiuk, V. G., Shakin, T. N. (2012). Equipment for pharmaceutical enterprise. Designing and acceptance — the main aspects. Pharmaceutical industry, 2(31), 30–38.
  17. Current Good Manufacturing Practice for Finish Pharmaceutical. (2011). Code of Federal Regulation Title 21 (CFR 21), Part 211, 142–163.
  18. Hadjieva, Z. D., Kuznetsov, A. V., Biryukova, D. V. (2012). Technological aspects of the use of auxiliary substances in the production of drugs. Scientific Journal «Fundamental research», № 5(2), 436–440.
  19. Jonat, S., Hasenzahl, S., Drechsler, M., Albers, P., Wagner, K. W., Schmidt, P. C. (2004). Investigation of compacted hydrophilic and hydrophobic colloidal silicondioxides as glidants for pharmaceutical excipients. Powder Technology, 1(2), 31–43.
  20. Laich, Т., Reher, M., Kissel, Т., Voss, G. M. (1995). Versuche zur Direkttablettierung pflanzlicher Trockenextrakte unter Verwendung eines inter-nen und eines externen Schmiersystems. Pharm. Ind., 11, 950–958.
  21. Miertus, S., Scrocco, E., Tomasi, J. (1981). Electrostatic interaction of a solute with a continuum. A direct utilization of ab-initio molecular potentials for the prevision of solvent effects. Chem.Phys, 55, 117–129.
  22. Fedoseyeva, A. A. (2013). Submission of technological process the production of medicines using flowcharts and timed Petri nets. Radio electronic and computer systems, 5(64), 385–389.
  23. Alexandrov, B. S. (1976). Methods of granulation of pharmaceutical materials and their influence on the properties of granules and tablets. Chem-Pharm. ind.: Panoramic. Inform, CBNTI Minmedprom, 9, 22.
  24. Belousov, V. A. (1979). Basic laws of pressing chemical-pharmaceutical powders. Chem.-pharmacy Journal, 5, 49–55.
  25. Miyamoto, Y., Ryu, A., Sugawara, S., Miyajima, M. (1998). Optimization of the granulation process for designing tablets. Chem Pharm Bull., 46(9), 1432–1437.
  26. Brodsky, Y. A., Lonely, M. I. (1999). Vibration technological equipment for the pharmaceutical industry. Chem.-pharmacy Journal, 33(7), 44–48.

Published

2014-06-24

How to Cite

Шибецький, В. Ю., & Поводзинський, В. М. (2014). Developing the design of triturate tablet machine. Technology Audit and Production Reserves, 3(4(17), 4–8. https://doi.org/10.15587/2312-8372.2014.25303

Issue

Section

Production reserves