Preview

Drug development & registration

Advanced search

DEVELOPMENT OF THE COMPOSITION AND TECHNOLOGY FOR THE PREPARATION OF THE DRAGEE WITH IZONIAZIDE AND OILOXACIN

Abstract

A composition and a technological scheme for the preparation of the combined dragees, containing isoniazid and ofloxacin, were developed. The parameters of the quality of the developed dragees, were studied. The shelf life of the dragee with isoniazid and ofloxacin has been established, when stored 2 years, in glass-massed banks with a screw mouth closed with plastic caps in a dry, dark place at a temperature of 20-25 °C.

About the Authors

Yu. V. Shikova
Bashkir State Medical University of the Ministry of Healthcare of the Russian Federation
Russian Federation


O. E. Zaytseva
Bashkir State Medical University of the Ministry of Healthcare of the Russian Federation
Russian Federation


A. R. Kadyrov
Bashkir State Medical University of the Ministry of Healthcare of the Russian Federation
Russian Federation


E. V. Simonyan
South-Urals State Medical University of the Ministry of Healthcare of the Russian Federation
Russian Federation


T. A. Lihoded
Bashkir State Medical University of the Ministry of Healthcare of the Russian Federation
Russian Federation


References

1. Global tuberculosis report 2016 / World Health Organization. URL: http://www.who.int/tb/publications/global_report/gtbr2016_executive_summary_ru.pdf?ua=1 (дата обращения 26.08.2017).

2. C.M. Denkinger, M. Pai, D.W. Dowdy. Do we need to detect isoniazid resistance in addition to rifampicin resistance in diagnostic tests for tuberculosis? // PLoS One. 2014. V. 9(1).

3. G. Ramachandran, S. Swaminathan. Safety and tolerability profile of second-line anti-tuberculosis medications // Drug Saf. 2015. V. 38(3). P. 253-269.

4. H.W. Lee, J.K. Lee, E. Kim, J.J. Yim, C.H. Lee. The effectiveness and safety of fluoroquinolone-containing regimen as a first- line treatment for drug-sensitive pulmonary tuberculosis: a systematic review and meta-analysis // PLoS One. 2016. V. 11(7).

5. L.E. Ziganshina, A.F. Titarenko, G.R. Davies. Fluoroquinolones for treating tuberculosis (presumed drug-sensitive) // Cochrane Database Syst Rev. 2013. V. (6).

6. E.A. Kendall, S. Shrestha, T. Cohen, E. Nuermberger, K.E. Dooley, L. Gonzalez-Angulo, G.J. Churchyard, P. Nahid, M.L. Rich, C. Bansbach, T. Forissier, C. Lienhardt, D.W. Dowdy. Priority-setting for novel drug regimens to treat tuberculosis: an epidemiologic model // PLoS Med. 2017. V. 14(1).

7. J.A. Caminero, G. Sotgiu, A. Zumla, G.B. Migliori. Best drug treatment for multidrug-resistant and extensively drug-resistant tuberculosis // Lancet Infect Dis. 2010. V. 10(9). P. 621-629.

8. S. Thee, A.J. Garcia-Prats, P.R. Donald, A.C. Hesseling, H.S. Schaaf. Fluoroquinolones for the treatment of tuberculosis in children // Tuberculosis (Edinb). 2015. V. 95(3). P. 229-245.

9. B. Blomberg, S. Spinaci, B. Fourie, R. Laing. The rationale for recommending fixed-dose combination tablets for treatment of tuberculosis // Bull World Health Organ. 2001. V. 79(1). P. 61-68.

10. R. Panchagnula, S. Agrawal, Y. Ashokraj, M. Varma, K. Sateesh, V. Bhardwaj, S. Bedi, I. Gulati, J. Parmar, C.L. Kaul, B. Blomberg, B. Fourie, G. Roscigno, R. Wire, R. Laing, P. Evans, T. Moore. Fixed dose combinations for tuberculosis: Lessons learned from clinical, formulation and regulatory perspective // Methods Find Exp Clin Pharmacol. 2004. V. 26(9). P. 703-721.

11. C.S. Gautam, L. Saha. Fixed dose drug combinations (FDCs): rational or irrational: a view point // Br J Clin Pharmacol. 2008. V. 65(5). P. 795-796.

12. R. Taneja, A.J. Garcia-Prats, J. Furin, H.K. Maheshwari. Paediatric formulations of second-line anti-tuberculosis medications: challenges and considerations // Int J Tuberc Lung Dis. 2015. V. 19(12). P. 61-68.

13. C.R. Gallardo, D. Rigau Comas, A. Valderrama Rodríguez, M. Roqué i Figuls, L.A. Parker, J. Caylà, X. Bonfill Cosp. Fixeddose combinations of drugs versus single-drug formulations for treating pulmonary tuberculosis // Cochrane Database Syst Rev. 2016. V. (5).

14. G. Sgaragli, M. Frosini, S. Saponara, F. Corelli. Human Tuberculosis. III. Current and Prospective Approaches in Anti-Tubercular Therapy // Curr Med Chem. 2016. V. 23(21). P. 2245-2274.

15. G. Brigden, J.L. Castro, L. Ditiu, G. Grey, D. Hanna, M. Low, M.P. Matsoso, G. Perry, M. Spigelman, S. Swaminathan, E. Torreele, S. Wong. Tuberculosis and antimicrobial resistance - new models of research and development needed // Bull World Health Organ. 2017. V. 95(5). P. 315.

16. C. Lienhardt, P. Nahid, M.L. Rich, C. Bansbach, E.A. Kendall, G. Churchyard, L. González-Angulo, L. D’Ambrosio, G.B. Migliori, M. Raviglione. Target regimen profiles for treatment of tuberculosis: a WHO document // Eur Respir J. 2017. V. 49(1).

17. Ю.В. Шикова, С.Н. Ивакина, А.Р. Кадыров, Е.В. Елова, О.Е. Зайцева, Т.А. Лиходед. Анализ ассортимента лекарственных препаратов для выявления и разработки нового комбинированного противотуберкулезного препарата // Медицинский вестник Башкортостана. 2016. Т. 11. № 5(65). С. 56-60.

18. Изониазид // Регистр лекарственных средств России. URL: https://www.rlsnet.ru/mnn_index_id_627.htm (дата обращения 26.08.2017).

19. Офлоксацин // Государственный реестр лекарственных средств. URL: http://grls.rosminzdrav.ru (дата обращения 26.08.2017).

20. ОФС.1.4.2.0014.15. Растворение для твердых дозированных лекарственных форм // Государственная фармакопея Российской Федерации. XIII изд. URL: http://pharmacopoeia.ru/gosudarstvennaya-farmakopeya-xiii-online-gf-13-online/ (дата обращения 14.07.2017).

21. Патент РФ № 2622754. Драже с изониазидом и офлоксацином для лечения туберкулеза / Ю.В. Шикова, А.Р. Кадыров, В.А. Лиходед, В.В. Плечев, Е.В. Елова, О.Е. Зайцева, Е.В. Симонян. - № 2016117627/16; опубл. 19.06.2017; Бюл. № 17.


Review

For citations:


Shikova Yu.V., Zaytseva O.E., Kadyrov A.R., Simonyan E.V., Lihoded T.A. DEVELOPMENT OF THE COMPOSITION AND TECHNOLOGY FOR THE PREPARATION OF THE DRAGEE WITH IZONIAZIDE AND OILOXACIN. Drug development & registration. 2018;(1):40-44. (In Russ.)

Views: 793


Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 License.


ISSN 2305-2066 (Print)
ISSN 2658-5049 (Online)