Registration Number
0224U033461,
(0123U100824)
, R & D reports
Title
Determining the safety of the innovative analgesic propoxazepam in its chemical and biological interactions with other drugs in polytherapy
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2. Визначення хімічних та фізико-хімічних властивостей субстанції пропоксазепаму, необхідних для інтерпретації фармацевтичної взаємодії.
Head
Holovenko Mykola Ya., Доктор біологічних наук
Registration Date
27-12-2024
Organization
Physico-Chemical Institute O. Bogatsky National Academy of Sciences of Ukraine
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Experimental study of the possible interaction of propoxazepam with other drugs in the conditions of polytherapy in order to confirm the safety of the drug
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The conducted studies studied the interaction of propoxazepam at the pharmaceutical, pharmacokinetic and pharmacological levels. The absence of significant pharmaceutical interactions at the absorption stage was established. Propoxazepam is well tolerated after a single dose (5 mg), has rapid absorption and slow excretion. Oxidized metabolites and their glucuronides are excreted in the urine in a total amount of up to 10.5% of the administered dose, which indicates a high level of metabolism. According to the results of studies of inhibition of various isoforms of cytochrome CYP 450, propoxazepam can cause clinically significant interaction with substrates of CYP1A2, CYP2C8, CYP2C9, CYP2C19 and CYP2D6, however, after a single dose of the drug, concentrations that can cause inhibition of the activity of the studied enzymes are not reached. The possibility of adjusting the pharmacological effects of propoxazepam with flumazenil has been shown. In general, propoxazepam does not cause significant pharmacokinetic and pharmaceutical interactions with a single dose, although further studies are needed to assess the potential for inhibition of CYP enzymes and the impact on pharmacological effects with chronic use.
Product Description
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Artemenko Anatolii H.
Burenkova Nataliia O.
Valivodz Iryna P.
Holovenko Mykola Ya.
Kichova Mariia Ye.
Larionov Vitalii B.
Ohnichenko Liudmyla M.
Khromov Oleksandr I.
Tsapenko Zhanna М.
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2024-12-27
