Preview

Regulatory Research and Medicine Evaluation

Advanced search

The possibility of using laser methods for the quality control of highly diluted liquid pharmaceuticals

Abstract

Processing of interferon gamma antibodies, which involves gradual reduction of the concentration, induces the formation of deuterium-stabilized giant heterophase clusters (GHCs) of water characterized by the specific size spectrum and kinetics of formation/decay. An investigation into the formation/decay kinetics of GHCs of water by a 2D light scattering method using topological descriptors allows distinction between various dilutions of protein nanoparticles, in particular interferon gamma antibodies, and similar dilutions of glycine buffer (control). The possibility of analytical control of highly diluted pharmaceuticals is currently under discussion. The method may therefore find potential applications in the manufacturing control of ultrahighly diluted pharmaceuticals and express quality analysis.

About the Authors

A. V. Syroeshkin
Peoples’ Friendship University of Russia, Medical Institute
Russian Federation


T. V. Pleteneva
Peoples’ Friendship University of Russia, Medical Institute
Russian Federation


M. A. Morozova
Peoples’ Friendship University of Russia, Medical Institute
Russian Federation


E. V. Uspenskaya
Peoples’ Friendship University of Russia, Medical Institute
Russian Federation


O. V. Titorovich
Peoples’ Friendship University of Russia, Medical Institute
Russian Federation


E. V. Lesnikov
Russian Metrological Institute of Technical Physics and Radio Engineering
Russian Federation


V. I. Dobrovolsky
Russian Metrological Institute of Technical Physics and Radio Engineering
Russian Federation


References

1. European Pharmacopoeia. 8th ed. EDQM; 2014 [cited 2015 January 14]. Available from: http://online.edqm.eu/entry.htm.

2. Epshtein OI. Phenomenon of release activity and the hypothesis of «spatial» homeostasis. Uspehi fiziologicheskih nauk 2013; 44(3): 54–76 (in Russian).

3. Vasiliev AN, Sergeeva SA, Kachanova MV, et al. Application of ultrafine doses of antibodies to gamma-interferon in the treatment and prevention of viral infections. Antibiotiki i himioterapiya 2008; 53(3–4): 32–5 (in Russian).

4. Ulyantsev AS, Uspenskaya EV, Pleteneva TV, et al. Rapid method of determining the authenticity of aqueous solutions of drugs. Himiko- farmatsevticheskiy zhurnal 2009; 43(12): 47–51 (in Russian).

5. Syroeshkin AV, Smirnov AN, Goncharuk VV, et al. Water as a heterogeneous structure. Electronic journal «Issledovano v Rossii» 2006; 88: 843–54. Available from: http://www.sci-journal.ru/articles/2006/088.pdf (in Russian).

6. Goncharuk VV, Lapshin VB, Burdeinaya TN, et al. Physicochemical properties and biological activity of the water depleted of heavy isotopes. J Water Chem Technol. 2011; 33(1): 8–13.

7. Epshtein OI, Shtark MB, Kolyadko TM. Method of treating a pathological syndrome and a pharmaceutical agent. US Patent, ¹ 8535664 B2; 2013.

8. Epshtein OI, Kolyadko TM, Shtark MB. A method of treating a pathological syndrome and drug. Patent RF, ¹ 2181297 RU; 2002 (in Russian).

9. Syroeshkin AV, Smirnov AN, Goncharuk VV, et al. Water as a heterogeneous structure. Electronic journal «Issledovano v Rossii» 2006; 88: 843–54. Available from: http://www.sci-journal.ru/articles/2006/088.pdf (in Russian).

10. Syroeshkin AV, Popov PI, Grebennikova TV, et al. Laser diffraction for standartization of heterogeneous pharmaceutical preparations. J Pharm Biomed Anal. 2005; 37(5): 927–30.

11. Popov PI, Syroeshkin AV. Vidan. RF Certificate of official registration of the computer program,¹ 2005612135; 2005 (in Russian).

12. Syroeshkin AV, Stepanova NA, Popov PI, et al. Prognostication of toxicity of a group of chemical compounds comprising anti-tuberculosis medicines by the quantitative structure-activity correlation method. Forensic Med Exam 2009; (4): 210–7.

13. Epshtein OI. Extremely small doses (history of research). Moscow: RAMN; 2008 (in Russian).

14. Uspenskaya EV, Syroeshkin AV, Smirnov AN, et al. The structure of water and laser rapid methods for determining authenticity. Farmatsiya 2007; (5): 21–3 (in Russian).

15. Malyuchenko NV, Tonevitsky AG, Savvateev MN, et al. The study of the structural features of proteins intermittent-contact method of atomic force microscopy. Biofizika 2003; 48(5): 830–6 (in Russian).

16. Bhattacharya A, Prajapati R, Chatterjee S, et al. Concentration-dependent reversible self-oligomerization of serum albumins through intermolecular -sheet formation. Langmuir 2014; 30(49): 14894–904.

17. Chikramane PS, Kalita D, Suresh AK, et al. Why extreme dilutions reach non-zero asymptotes: A nanoparticulate hypothesis based on froth flotation. Langmuir 2012; 28: 15864–75.

18. Smirnov AN, Syroeshkin AV. Supramolecular water complexes. Rossiyskiy himicheskiy zhurnal 2004; 48(2): 125–35 (in Russian).

19. Kurihara K, Tamura M, Shohda K, et al. Self-reproduction of supramolecular giant vesicles combined with the amplification of encapsulated DNA. Nature Chemistry 2011; (3): 775–81.

20. Chernikov FR, Sorokin VN, Olenev AL, et al. The method for determining the quality of homeopathic medicinal products and devices for its implementation. Patent RF,¹ 2112976 RU; 1998 (in Russian).


Review

For citations:


Syroeshkin A.V., Pleteneva T.V., Morozova M.A., Uspenskaya E.V., Titorovich O.V., Lesnikov E.V., Dobrovolsky V.I. The possibility of using laser methods for the quality control of highly diluted liquid pharmaceuticals. The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. 2016;(3):31-36. (In Russ.)

Views: 637


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


ISSN 3034-3062 (Print)
ISSN 3034-3453 (Online)