No 1 (2013)
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FROM THE EDITOR
CURRENT REVIEWS
3-13 1091
Abstract
This review covers the pharmacokinetic characteristics of the various antisense oligonucleotide drugs. A comparison of the pharmacokinetics of drugs first and second generation. As well as the influence on the pharmacokinetics of the chemical modification of the molecule.
BIOEQUIVALENCE STUDIES
Bioequivalence study of tablet forms of risperidone, olanzapine and quetiapine in healthy volunteers
14-22 564
Abstract
This article presents the results of three studies of bioequivalence tablet forms of atypical antipsychotics risperidone, olanzapine, and quetiapine produced by JSC «Northern Star», Russia and the corresponding original drugs risperidone, olanzapine and quetiapine. Studies have been done by determining the concentrations of risperidone, olanzapine and quetiapine in the blood plasma of healthy volunteers after a single dose compared drugs inside an empty stomach open randomized crossover design in two stages, with two sequences medication. Plasma samples were analyzed by validated volunteers using HPLC with mass spectrometric detection. Analyzed for drugs following pharmacokinetic parameters were calculated: Сmax , AUC0-t , AUC0-? „ Сmax /AUC0-t TSmax , kel , T1/2. 90% confidence intervals relations for log-transformed values ??of AUC0-t, Cmax and Smax/AUC0-t study drugs risperidone were respectively 91,39-112,98%, 91,12-105,02%, 88,69-104,50% and the study drugs olanzapine 89,32-121,29%, 95,79-114,68%, 87,11-116,42% and in the study drugs quetiapine 93,24-115,84%, 90,03-120,80% and 92,96-108,33%. According to studies, it was concluded bioequivalence compared drugs risperidone, olanzapine and quetiapine.
23-26 747
Abstract
A simple, specific, sensitive and reproducible good method for quantitative determination of Levofloxacin in plasma using HPLC with UV-spectrophotometric detection. With this technique the pharmacokinetics and relative bioavailability of domestic generic of levofloxacin in 18 healthy volunteers after a single oral dose of 500 mg. Found that the drug being tested, levofloxacin (OOO «Ozone», Russia) is bioequivalent to the reference drugs Tavanic® («Sanofi Winthrop Industry», France).
Y. M. Budach,
O. E. Kurilo,
A. K. Sariev,
D. A. Abaimov,
M. V. Shiryaev,
E. Y. Styrova,
S. A. Altynbekov,
G. A. Dzholdygulov,
V. N. Seryakov,
K. S. Altynbekov
27-34 884
Abstract
Within the cross, a single, open, randomized study with 10 day washout period, the two sequences has been studied bioequivalence of tablet forms two bisoprolol 18 volunteers (10 mg dosage). Plasma samples were analyzed by a validated HPLC-MS/MS within 48 hours. For preparations analyzed following pharmacokinetic parameters were calculated: AUC0-t, Cmax, Tmax , Cmax /AUC. 90% confidence interval for log-transformed values for AUC0-t was 0.9142—1.0568 for Cmax —0,9371 —1,0473. The study concluded that comparable drugs were bioequivalence of bisoprolol.
PHARMACOKINETICS STUDIES
35-39 526
Abstract
The purpose of this study was to compare the pharmacokinetic and pharmacodynamic parameters of three formulations of a new drug on the basis of plasmid DNA pCIGF for regenerative gene therapy damage the surface of human tissues of various etiologies. Preclinical study of the pharmacological properties of the drug and drug safety carried out in mice, which was administered once and twice. Introduction of liquid and lyophilized forms of the drug was carried out by intramuscular injection, topically applied gel form. Analyzed various organs: brain, heart, blood, lung, liver, kidney, spleen, muscle for the presence of plasmid depending on the time after administration.
40-42 431
Abstract
In the study of excretion of the drug established that VMA-99-82 detected in the urine for at least 72 hours of the study. Renal clearance was 0.936 ml/hr, extrarenal — 666.04 ml/h by intravenous route of administration, 1.8 ml/hr and 1009.72 ml/h, respectively, by the oral route of administration. Superiority over the renal clearance extrarenal correlates with earlier data on the distribution of the compound VMA-99-82 in organs and tissues. The drug was determined in the kidney in low concentrations and by intravenous and oral routes of administration. Tissue availability was 0,452 and 0,413 in intravenous and oral routes of administration, respectively. Win unmodified substance elimination of the administered dose is less than 1%, and its amount in the feces is about 5 times lower than that in the urine. In this regard, we can assume an intense flow of processes of biotransformation.
ISSN 2587-7836 (Print)
ISSN 2686-8830 (Online)
ISSN 2686-8830 (Online)