Study of PEG-Filstim acute toxicity

Authors

  • V. L. Karbovskyy LLC “PP “BIOFARMA”
  • I. A. Shevchuk LLC “PP “BIOFARMA”
  • I. A. Shevchuk LLC “PP “BIOFARMA”
  • O. V. Kurkina LLC “PP “BIOFARMA”
  • O. V. Kurkina LLC “PP “BIOFARMA”
  • T. Ye. Makovska Main Military Medical Hospital
  • T. Ye. Makovska Main Military Medical Hospital

DOI:

https://doi.org/10.24959/ubphj.17.110

Keywords:

fìlgrastim, pegfìlgrastim, neutropenia, acute toxicity, PEG-Fìlstim

Abstract

Topicality. Neutropenia is the most common hematological complication of chemotherapy in oncology patients. Thus, the development and implementation of pegylated forms of filgrastim into clinical practice is an important step in addressing the issue of neutropenia prevention and its complications.

Aim. To study PEG-Filstim acute toxicity.

Materials and methods. Experiments were determined in 20 white mature adult rats of both sexes with a weight of 170-230 g and 20 white mature adult mice of both sexes with a weight of 17-23 g in a single subcutaneous administration of PEG-Filstim at a dose of 10 mg/kg. The drug impact evaluation was carried out according to the following parameters: a) lethality; b) toxicity manifestations evaluation; c) changes in body weight; d) macroscopy of internal organs, weight coefficients of internal organs for rats (Day 14).

Results and discussion. Single subcutaneous administration of PEG-Filstim causes no deaths of rats or mice, doesn’t impact on body weight gain, integrative rates of functional state of laboratory animals and relative weight of internal organs, thus, there is no significant toxicity of this drug.

Conclusions. Therefore, the results of the conducted studies show, that LD50 for PEG-Filstim in subcutaneous administration in rats and mice is in beyond the dose of 10 mg/kg. According to toxicology classification of substances, PEG-Filstim falls into Class II of toxicity – highly toxic substances.

Author Biographies

V. L. Karbovskyy, LLC “PP “BIOFARMA”

PhD, Deputy Director for Science and Technology, LLC “PP “BIOFARMA”

I. A. Shevchuk, LLC “PP “BIOFARMA”

PhD, Head of R&D Department, LLC “PP “BIOFARMA”

I. A. Shevchuk, LLC “PP “BIOFARMA”

PhD, Head of R&D Department, LLC “PP “BIOFARMA”

O. V. Kurkina, LLC “PP “BIOFARMA”

PhD, Authorized Person of Quality LLC “BIOFARMA PLASMA”

O. V. Kurkina, LLC “PP “BIOFARMA”

PhD, Authorized Person of Quality LLC “BIOFARMA PLASMA”

T. Ye. Makovska, Main Military Medical Hospital

cardiologist, Main Military Medical Hospital

T. Ye. Makovska, Main Military Medical Hospital

cardiologist, Main Military Medical Hospital

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Published

2017-06-16

Issue

Section

Pharmacology and biochemistry