Conducting biological tests in the development of self-emulsifying drug delivery systems with simvastatin

Authors

DOI:

https://doi.org/10.15587/2519-4852.2023.295450

Keywords:

self-emulsifying drug delivery systems, increased activity, improved solubility, simvastatin, biological tests

Abstract

The aim of the study was to compare the hypolipidemic activity of the developed self-emulsifying drug delivery systems with simvastatin with reference samples of the substance and the finished drug product of industrial production.

Materials and methods. The substance of simvastatin (India, s. DK40-2005021, 99.09 %, introduced into the composition of self-emulsifying compositions based on castor oil (Ukraine), polyethylene glycol 40 hydrogenated castor oil (India), Tween 80 (Ukraine), glycerol monostearate (Gustav Heess GmbH, Germany) or polyethylene glycol 100 stearate (ERCA, Italy). Reference samples were Simvastatin-Sandoz (Salutas Pharma, Germany, series LX5161) and simvastatin in pure form.

The experimental animals were Syrian hamsters aged 2 months. Hyperlipidemia was modeled by means of an alimentary load. To assess the state of lipid metabolism in animals, the content of triacylglycerols, total cholesterol, low-density lipoprotein and high-density lipoprotein in the blood serum was determined by colorimetric enzymatic methods using the appropriate standard reagent kits "Triacylglycerols F" HP022.02, "Cholesterol F" HP026.02, "Cholesterol-LDL F" HP026.05 and "Cholesterol-HDL F" HP026.04 (LLC SPE "Filicit-Diagnostics", Ukraine) on a semi-automatic biochemical analyzer MapLab Plus (BSI, Italy).

Results. The reference samples had similar dose-dependent efficacy parameters. At the same time, the test samples, also having similar dose-dependent effects, in absolute terms at the maximum concentration reduced the amount of low-density lipoprotein and total cholesterol more effectively than the reference samples. When using the test samples in their average concentration, the level of triglycerols was significantly reduced, which is rather a concomitant effect of simvastatin.

Conclusions. The improvement of the overall efficacy of simvastatin when it is introduced into self-emulsifying drug delivery systems has been proved, which is associated with the modification of pharmacokinetic parameters by improving the solubility of the substance in the aqueous environment of the gastrointestinal tract

Author Biographies

Liubov Bodnar, National University of Pharmacy

Postgraduate Student

Department of Pharmaceutical Technology of Drugs

Dmytro Lytkin, National University of Pharmacy

PhD

Educational and Scientific Institute of Applied Pharmacy

Nataliia Polovko, National University of Pharmacy

Doctor of Pharmaceutical Sciences, Professor

Department of Pharmaceutical Technology of Drugs

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Conducting biological tests in the development of self-emulsifying drug delivery systems with simvastatin

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Published

2023-12-31

How to Cite

Bodnar, L., Lytkin, D., & Polovko, N. (2023). Conducting biological tests in the development of self-emulsifying drug delivery systems with simvastatin. ScienceRise: Pharmaceutical Science, (6(46), 64–69. https://doi.org/10.15587/2519-4852.2023.295450

Issue

No. 6(46) (2023)

Section

Pharmaceutical Science

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Copyright (c) 2023 Liubov Bodnar, Dmytro Lytkin, Nataliia Polovko

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