Use of Biomarkers in Pharmacokinetics Studies of Medicinal Products of Natural Origin

Косман, В. М.; Фаустова, Н.М.; Karlina, M. V.; Makarov, Valery G.; Макарова, М.Н.

doi:10.30895/1991-2919-2021-11-1-24-35

Cited by 2 publications

(2 citation statements)

References 23 publications

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“…Such approaches may be proposed on the knowledge of the mechanism of action, the point of application, the pharmacodynamics response of a drug under study. A biomarker approach may be effective for individual compounds (including synthetic peptides) and complex mixtures, endogenous or rapidly metabolizing compounds when it is difficult or impossible to analyze them with classical chromatographic methods [34,35]. The biomarker choice is not a simple task and if it is possible to create or adapt a commercially available reagent kit (for the enzyme immunoassay method, for example) it will be preferable to solve a particular analytical problem.…”

Section: Discussionmentioning

confidence: 99%

“…Thus, animals were kept alive and returned to the stock population after the experiment. This case is one more example of the pilot study's importance in bioethical, design and analysis aspects for such analytes and analytical approaches in the same way as we mentioned previously [35,37]. The main study covered all important aspects that are necessary to characterize the original drug pharmacokinetics [5,10].…”

Section: Discussionmentioning

confidence: 99%

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Pharmacokinetics of new analgesic tridecapeptide with an octaarginine vector investigated after original analytical approach

Косман¹,

Фаустова²,

Karlina³

et al. 2022

Лабораторные животные для научных исследований

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A new analgesic tridecapeptide (TDP) with an octaarginine vector has been proposed for clinical use in chronic pain syndrome. The work investigated the pharmacokinetic properties of TDP in the form for oral administration. The special analytical approach was proposed because classical chromatography methods are low-powerful for peptide quantification in biological matrices. The study was conducted on male rats and rabbits with a single oral administration of the drug in three doses, a single intravenous administration in one dose and multiple administrations to rats in one dose. To determine the TDP concentration in blood plasma, tissues, and excretes, an enzyme immunoassay with a commercially available reagent kit for a similar target analyte (Elisa kit for 1-Deamino 8D-Arginine Vasopressin) was developed and partially validated. Pharmacokinetic parameters were calculated using the non-compartment method of statistical moments. The pharmacokinetics of TDP was found to be linear after a single administration in the dose range of 10-50 mg/kg for rats and 5-25 mg/kg for rabbits. The absolute bioavailability of the TDP after oral via intravenous administration in rats and rabbits were about 8-16%. The active substance was intensively distributed to muscles, liver and spleen; the lowest tissue distribution was detected in the kidneys. TDP was excreted with urine in trace amounts (about 0.2%), with feces -about 1.2%; repeated administration did not lead to its accumulation. The pharmacokinetics parameters of the new analgesic tridecapeptide were evaluated after the original analy tical approach. The final study included all main areas necessary to characterize the original drug pharmacokinetics.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Pharmacokinetics of new analgesic tridecapeptide with an octaarginine vector investigated after original analytical approach

Косман¹,

Фаустова²,

Karlina³

et al. 2022

Лабораторные животные для научных исследований

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Study of pharmacokinetic of new peptide drug 1-deamino-arginine-vasotocin for hypernatremia correction

Косман¹,

Фаустова²,

Karlina³

et al. 2022

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Introduction: The pharmacokinetics studies are some of the necessary parts of the drugs preclinical investigations. Pharmacokinetic properties of new peptide drug 1-deamino-arginine-vasotocin (dAVT) in the form of an injection solution for intravenous and intramuscular administration for hypernatremia correction were investigated. Materials and methods: The study was carried out on male rats and rabbits with a single intravenous administration of the drug in three doses, a single intramuscular administration in one dose and multiple administration to rats in one dose. To determine natriiuretic peptide concentration in blood plasma, tissues, and excretes, assays based on a sodium level change measurement using a biochemical analyzer have been developed and validated. Pharmacokinetic parameters were calculated by the model-independent method of statistical moments. Results and discussion: The pharmacokinetics of the drug was found to be linear after a single administration of dAVT drug in the dose range 3–10 μg/kg for rats and rabbits. The relative bioavailability of dAVT after intramuscular and intravenous administrations was more than 30%. After a biomarker content change, the active substance was intensively distributed into highly vascularized organs (spleen), the organs that provide metabolism and subsequent excretion (liver and kidneys), whereas it hardly reached moderately and weakly vascularized tissues (muscles, omentum). Less than 10% dAVT was excreted with urine; no dAVT was determined in feces; and repeated administration did not lead to its cumulation. Conclusion: Pharmacokinetics parameters of new nonapeptide drug 1-deamino-arginine-vasotocin were evaluated after original analytical biomarker approach. The study included all main areas necessary to characterize the original drug pharmacokinetic.

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Use of Biomarkers in Pharmacokinetics Studies of Medicinal Products of Natural Origin

Cited by 2 publications

References 23 publications

Pharmacokinetics of new analgesic tridecapeptide with an octaarginine vector investigated after original analytical approach

Pharmacokinetics of new analgesic tridecapeptide with an octaarginine vector investigated after original analytical approach

Study of pharmacokinetic of new peptide drug 1-deamino-arginine-vasotocin for hypernatremia correction

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