CREATING LABORATORY TECHNOLOGY OF GENERIC EPIRUBICIN PHARMECEUTICAL DOSAGE FORM

O. L. Orlova; Орлова Ольга Львовна; A. P. Polozkova; Полозкова А. П.; N. A. Oborotova; Оборотова Н. А.; Z. S. Shprakh; Шпрах З. С.; M. P. Kiseleva; Киселева М. П.; L. M. Borisova; Борисова Л. М.; M. V. Dmitrieva; Дмитриева М. В.; Y. V. Rodionova; Родионова Ю. В.; S. V. Kohachevskaya; Копачевская С. В.; T. Y. Eskina; Еськина Т. Ю.; Z. S. Smirnova; Смирнова З. С.

doi:10.17650/1726-9784-2016-15-4-72-77

CREATING LABORATORY TECHNOLOGY OF GENERIC EPIRUBICIN PHARMECEUTICAL DOSAGE FORM

Authors: Orlova O.L.¹, Polozkova A.P.¹, Oborotova N.A.¹, Shprakh Z.S.¹, Kiseleva M.P.¹, Borisova L.M.¹, Dmitrieva M.V.¹, Rodionova Y.V.¹, Kohachevskaya S.V.¹, Eskina T.Y.¹, Smirnova Z.S.¹
Affiliations:
1. ФГБУ «Российский онкологический научный центр им. Н.Н. Блохина» Минздрава России
Issue: Vol 15, No 4 (2016)
Pages: 72-77
Section: ORIGINAL REPORTS
Published: 30.12.2016
URL: https://bioterapevt.abvpress.ru/jour/article/view/841
DOI: https://doi.org/10.17650/1726-9784-2016-15-4-72-77
ID: 841

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Abstract

Introduction. Governments around the world seek to reduce rapidly rising health care costs. Using the same high quality and often cheaper than the original brands, generics greatly reduces costs while providing an adequate quality of care. Therefore the development of generic medicines is an important task. The purpose of the study - the reproduction of the pharmaceutical dosage form for creation of national drug-generic epirubicin. Materials and methods. The study used a substance epirubicin (Ph. Eur current edition, Teva Pharmaceutical Industries Ltd., Israel); “Farmorubicin”, production “Pfizer Italia Srl” for “Pfizer Inc.”, Italy / US and excipients conforming to with relevant regulatory documents. Mice transplanted tumor: lymphocytic leukemia P388. Methods: technological, pharmaco-analytical, biological and pharmacological. Results. Pharmaceutical analysis of reproduced generic-drug “Epirubicin-RONC®” showed that itfully meets the requirements of manufacturer’s monograph. The results of “acute” toxicity study in rats and observations of the experimental animals within 30 days after a single administration suggest that both drugs have similar toxicological properties and are almost identical. Generic “Epirubicin RONC®” and “Farmorubicin” in lyophilized dosage form for injection 10.0 mg/vial, administered once, shows equal antitumor effect at two administration routes in mice with transplantable tumor: lymphocytic leukemia P-388. Conclusion. N.N. Blokhin Russian Cancer Research Center Ministry of Health of Russia has been reproduced generic - “Epirubi-cin-RONC®”, which is fully conform to the imported drug.

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дженерик, технология, токсичность, биологическая активность, generic, technology, toxicity, biological activity

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CREATING LABORATORY TECHNOLOGY OF GENERIC EPIRUBICIN PHARMECEUTICAL DOSAGE FORM

Full Text

Abstract

Keywords

About the authors

References

Supplementary files