The pharmacokinetic profile of a new 800-mg tablet of nonanimal chondroitin sulfate (CS) (MythocondroR©, 800-mgtablets, Gnosis S.p.A., Italy) was investigated vs an animal CS in healthy volunteers for a total period of 48 hours. After asingle 2400-mg dose of the test and the reference formulation,total CS,the compositional disaccharides (Di6S,Di4SandDi0S), and the overall charge density were quantified in plasma. The safety and tolerability profile after a singledose of this new nonanimal CS tablets was excellent. After baseline-corrected concentrations, an overall greater plasmaconcentration was observed after 24 hours of44% and after 48 hours of45% from administration of nonanimal whencompared to animal-derived CS. Moreover, nonanimal CS increases the specific sulfation in the 6-position ofN-acetyl-galactosamine in human plasma CS and, as a consequence, the overall charge density, reaching double values (0.91), after48 hours compared to bovine CS and to endogenous CS. In conclusion, nonanimal CS, possessing a lower molecularweight than an animal-derived sample, produces a greater CS concentration for a more prolonged period of time inplasma and an increase in charge density and specific 6-sulfation of endogenous plasma CS.

Oral bioavailability and pharmacokinetics of nonanimal chondroitin sulfate and its constituents in healthy male volunteers / N. Volpi, V. Mantovani, F. Galeotti, D. Bianchi, V. Straniero, E. Valoti, N. Miraglia. - In: CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT. - ISSN 2160-7648. - 8:3(2019 Apr), pp. 336-345.

Oral bioavailability and pharmacokinetics of nonanimal chondroitin sulfate and its constituents in healthy male volunteers

Straniero, Valentina;Valoti, Ermanno;
2019-04

Abstract

The pharmacokinetic profile of a new 800-mg tablet of nonanimal chondroitin sulfate (CS) (MythocondroR©, 800-mgtablets, Gnosis S.p.A., Italy) was investigated vs an animal CS in healthy volunteers for a total period of 48 hours. After asingle 2400-mg dose of the test and the reference formulation,total CS,the compositional disaccharides (Di6S,Di4SandDi0S), and the overall charge density were quantified in plasma. The safety and tolerability profile after a singledose of this new nonanimal CS tablets was excellent. After baseline-corrected concentrations, an overall greater plasmaconcentration was observed after 24 hours of44% and after 48 hours of45% from administration of nonanimal whencompared to animal-derived CS. Moreover, nonanimal CS increases the specific sulfation in the 6-position ofN-acetyl-galactosamine in human plasma CS and, as a consequence, the overall charge density, reaching double values (0.91), after48 hours compared to bovine CS and to endogenous CS. In conclusion, nonanimal CS, possessing a lower molecularweight than an animal-derived sample, produces a greater CS concentration for a more prolonged period of time inplasma and an increase in charge density and specific 6-sulfation of endogenous plasma CS.
biotechnological process, chondroitin sulfat; human plasma; oral absorption; pharmacokinetic
Settore CHIM/08 - Chimica Farmaceutica
24-lug-2018
CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/2434/583058
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