ISSN 0021-3454 (print version)
ISSN 2500-0381 (online version)
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vol 67 / February, 2024
Article

DOI 10.17586/0021-3454-2021-64-4-329-338

UDC 615.074; 544.773

MULTI-CHAMBER APPARATUS WITH A CONVEYOR MAGNETIC DRIVE FOR DETERMINING THE KINETICS OF DISSOLUTION OF PHARMACEUTICAL FORMS

L. Y. Vodneva
St. Petersburg State Chemical Pharmaceutical University, Department of Technical Mechanics and Engineering Graphics;


A. A. Vodnev
Petrolaser Ltd, Department of Innovation Developments; Head of the Department;


S. N. Lopaev
Petrolaser Ltd;


O. B. Korotkov
Petrolaser Ltd, Department of Innovation Developments;


V. A. Skorykh
St. Petersburg State Chemical Pharmaceutical University, ;


S. Y. Perepelkina
ITMO University, Saint Petersburg, 197101, Russian Federation; Associate Professor


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Abstract. It is obvious for both drug developers and manufacturers, that the solubility of various pharmaceutical forms is very important for the delivery of active substances; in addition, this characteristic is used in the standard method of quality control in production. Methods for testing the solubility of various pharmaceuticals require expensive, mostly imported, equipment with a small number of simultaneously used solution containers. The presented device for testing solubility uses the principle of magnetically activated mixing and contains twelve tanks (reservoirs) mounted in a thermostat. A moving magnetic field, generated either by the windings of electromagnets or by permanent magnets moving on a conveyor or on a disk along the tanks, affects the standard agitators with the dissolution medium located in each tank. In order to confirm the satisfactory coincidence of the physical and chemical processes occurring in all containers, the model of the device was created and tested for the simultaneous digestion of such samples as coated tablets and gelatin-based capsules. To check the obtained results, three types of buffer solutions and distilled water were used as a solvent liquid, and the method of comparing the luminescence intensity and measuring the acidity of the samples was used in the analysis of the dissolution kinetics. Good reproducibility of the measurement results showed similar parameters of digestion process provided by the device.
Keywords: pharm kinetic properties, delivery of remedy, multi-channel stirrer, targeted delivery, comparative dissolution kinetics test, biopharmaceutical equivalence, sustained release drugs

References:
  1. http://www.minpromtorg.gov.rU/ministry/strategic/sectoral/7/utverzhdennaya_strategiya_farma2020_231009.pdf. (in Russ.)
  2. http://www.accessdata.fda.gov/scripts/cder/dissolution/index.cfm. (in Russ.)
  3. Lindenberg M., Kopp S., Dressman J. European Journal of Pharmaceutics and Biopharmaceutics, 2004, vol. 58, рр. 265–278.
  4. Guidance for Industry. Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System, FDA, 2000.
  5. Shokhin I.E., Ramenskaya G.V., Vasilenko G.F., Malalshenko E.A. Pharmaceutical Chemistry Journal, 2011, no. 2(45), pp. 107–109.
  6. Shokhin I.E., Ramenskaya G.V., Kulinich Yu.I., Vasilenko G.F., Davydova K.S. Farmatsiya, 2010, no. 8(22), pp. 22–25. (in Russ.)
  7. Mironov A.N., Romodanovsky D.P., Niyazov R.R., Goryachev D.V. The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products, 2014, no. 2, pp. 3–8. (in Russ.)
  8. Emshanova S.V. Obespecheniye kachestva otechestvennykh lekarstvennykh sredstv (optimizatsiya tekhnologii i sovershenstvovaniye standartizatsii tabletirovannykh lekarstvennykh form (Quality Assurance of Domestic Medicines (Optimization of Technology and Improvement of Standardization of Tableted Dosage Forms)), Extended abstract of Doctor’s thesis, Moscow, 2007. (in Russ.)
  9. Sermukhamedova O.V., Sakipova Z.B. and Ibragimova L.N. 2nd International Conference and Expo on Drug Discovery & Designing, October 27–29, 2016 Rome, Italy, https://www.longdom.org/ proceedings/pharmaceutical-availability-of-capsules-of-sedative-profile-7880.html.
  10. Gryzlova A.S. XIII Mezhdunarodnaya nauchno-prakticheskaya konferentsiya molodykh uchenykh i spetsialistov organizatsiy v sfere sel'skokhozyaystvennykh nauk (XIII International Scientific and Practical Conference of Young Scientists and Specialists of Organizations in the Field of Agricultural Sciences), Abstracts of Papers, 2019, рр. 224–226. (in Russ.)
  11. Vodnev A.A., Bogdanov S.A. Thesis of 13 th Intern. Conf. on Trichinelasis, Changchun, China, 2011.