Pharmacology
doi: 10.25005/2074-0581-2020-22-1-106-111
DEVELOPMENT OF THE COMPOSITION AND TECHNOLOGY OF COATED TABLETS WITH RHEUM CORDATUM LOSINSK. EXTRACT

G.T. Zhumashova, Z.B. Sakipova

School of Pharmacy, S.D. Asfendiyarov Kazakh National Medical University, Almaty, Republic of Kazakhstan

Objective: Development of a rational composition, optimal technology, standardization criteria for tablets with Rheum cordatum extract, establishing the stability of the composition and storage conditions.

Methods: As an active pharmaceutical substance, a standardized extract of Rheum cordatum was used. Pharmacopoeial excipients for the production of tablet mass are magnesium hydroxycarbonate, croscarmellose sodium, microcrystalline cellulose, Plasdone S-630, magnesium aluminum metasilicate, calcium stearate, purified water and film coating Opadry 85F18422 White. To obtain tablets qualified equipment was used in the technological process: a tablet mass mixer, a rotary tablet press, highly efficient film coating equipment, a packaging machine / blister machine. When developing the tablets, we were guided by the «Quality by design» concept of medicines, based on ICH guidelines: ICH Q11 «Development and manufacture of medicinal substances», ICH Q8 «Pharmaceutical Development» and ICH Q10 «Pharmaceutical Quality System». Standard pharmacopoeial research methods were used.

Results: 50 experimental mass models for tableting have been developed in the variants of combining excipients and active substance in an effective single dose of 300 mg. Only 4 models of the core tablets obtained met the selection criteria (abrasion, crush resistance, disintegration, and dissolution). The optimal tableting method using wet granulation is substantiated, which makes it possible to obtain tablets of the proper pharmacopoeial quality and the following composition: soft rhubarb root extract, magnesium hydroxycarbonate, croscarmellose sodium, microcrystalline cellulose 102, Plasdone S-630, magnesium aluminum metasilicate, calcium stearate. To coat the obtained tablet cores, the following film coating composition was selected: Opadry 85F18422 White, consisting of polyvinyl alcohol, titanium dioxide E 171, macrogol 4000 and talc.

Conclusion: The pharmaceutical development of coated tablets with an extract of Rheum cordatum has been done. The rational composition and optimal technology for producing tablet cores coated with a film coating of Opadry 85F18422 White were established. The quality of the obtained tablets was evaluated, the stability of the composition for 9 months was studied, the results of quality indicators are within acceptable standards, and research in this direction is going on.

Keywords: Extract, coated tablets, pharmaceutical development, composition, technology, stability.

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References
  1. Tabin Sh, Gupta RC, Bansal G, Kamili AN. Comparative HPLC analysis of emodin, aloe emodin and rhein in Rheum emodi of wild and in vitro raised plants. Journal of Pharmacognosy and Phytochemistry. 2016;5(2):121-30.
  2. Gao LL, Xu XD, Nang HJ, Yang JS, Chen SL. Chemical constituents in Rheum tanguticum. Chin Tradit Herb Drugs. 2011;42(3):443-6.
  3. Wang AQ, Li JL, Li JS. Chemical constituents of Rheum emodi. Chin Tradit Herb Drugs. 2010;41(3):343-6.
  4. Zhang C, Li L, Xiao YY, Tian GF, Chen DD, Wang Y, et al. Two new anthraquinone glycosides from the roots of Rheum palmatum. J Asian Nat Prod Res. 2010;12(12):1026-32.
  5. Li QQ, Li JS, Lu Y, Huang GX, Yan LJ. Spectroscopy to study potential cytotoxicity of aloe-emodin. J Tosicol. 2010;24(4):285-7.
  6. Chang YC, Lai TY, Yu CS, Chen HY, Yang JS, Chueh FS, et al. Emodin induces apoptotic death in murine myelomonocytic leukemia WEHI-3 cells in vitro and enhances phagocytosis in leukemia mice in vivo. Evid Based Complement Alternat Med. 2011;2011:523596.
  7. Li XH, Qi Y, Cai RL, Li M, Wang XY, Peng C. Effect of lipopolysaccharide-induced expression of inducible nitric oxide synthase by aloe-emodin in RAW 264.7 cells. Chin Pharmacol Bull. 2010;26(4):488-92.
  8. Liu Q, Zhang XL, Tao RY, Niu YJ, Chen XG, Tian JY, et al. Rhein, an inhibitor of adipocyte differentiation and adipogenesis. J Asian Nat Prod Res. 2011;13(8):714-23.
  9. Ashok Kumar R, Rajkumar V, Guha G. Antioxidant and anti-cancer potentials of Rheum emodi rhizome extracts. Evid Based Complement Alternat Med. 2011;2011:697986. Available from: https://doi.org/10.1093/ecam/neq048.
  10. Grudzinskaya LM, Gemedzhieva NG, Nelina NV, Karzhaubekova JJ. Annotirovannyy spisok lekarstvennykh rasteniy Kazakhstana [Annotated list of medicinal plants of Kazakhstan]. Almaty, RK: 2014. p. 111-5.
  11. Alyautdin RN. Farmakologiya [Pharmacology]. Moscow, RF: GEOTAR-Media; 2010. 608 p.
  12. Chueshov VI, Gladukh EV, Sayko IV. Tekhnologiya lekarstv promyshlennogo proizvodstva. Chast’ 2 [Manufacturing technology of drugs. Part 2]. Vinnitsa, Ukraine: Nova Kniga; 2014. 696 p.
  13. Gosudarstvennaya farmakopeya Respubliki Kazakhstan. T. 2 [The State Pharmacopoeia of the Republic of Kazakhstan. Vol. 2]. Almaty, RK: Zhibek Zholy; 2009. 804 p.
  14. Zhumashova GT, Sakipova ZB, Sayakova GM, Jankulov DM. A marketing analysis of the Kazakhstani pharmaceutical market of laxatives. Vestnik Kazakhskogo Natsional’nogo meditsinskogo universıteta. 2018;1:310-8.
  15. European pharmacopoeia. Eighth edition. Vol. 1. Strasbourg, France: Council of Europe; 2013. 1456 p.

Authors' information:

Zhumashova Gulsim Tokanovna
PhD Student of specialty Pharmacy, S.D. Asfendiyarov Kazakh National Medical University
ORCID ID: 0000-0002-5997-0584
E-mail: g.zhumashova@mail.ru

Sakipova Zuriyadda Bektemirovna
Doctor of Pharmaceutical Sciences, Full Professor, Dean of the School of Pharmacy, S.D. Asfendiyarov Kazakh National Medical University
ORCID ID: 0000-0003-4477-4051
E-mail: sakipova.zb@gmail.com

Information about support in the form of grants, equipment, medications

The authors did not receive financial support from manufacturers of medicines and medical equipment

Conflicts of interest: No conflict

Address for correspondence:

Zhumashova Gulsim Tokanovna
PhD Student of specialty Pharmacy, S.D. Asfendiyarov Kazakh National Medical University

050012, Republic of Kazakhstan, Almaty, Bogenbai Batyr Str., 151, Campus № 2

Tel.: +7 (777) 9636147

E-mail: g.zhumashova@mail.ru

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