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The Influence of Chitosan on the Oral Bioavailability of Acyclovir—a Comparative Bioavailability Study in Humans
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The Influence of Chitosan on the Oral Bioavailability of Acyclovir—a Comparative Bioavailability Study in Humans
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Journal Article
The Influence of Chitosan on the Oral Bioavailability of Acyclovir—a Comparative Bioavailability Study in Humans
2015
Overview
ABSTRACT
Purpose
The effects of chitosan hydrochloride on the oral absorption of acyclovir in humans were studied to confirm the absorption enhancing effects reported for
in vitro
and rat studies, respectively.
Methods
A controlled, open-label, randomized, 3-phase study was conducted in 12 healthy human volunteers. Zovirax 200 mg dispersible tablets co-administered with doses of 400 and 1000 mg chitosan HCl were compared with Zovirax only.
Results
The expected increased absorption of acyclovir was not observed. On the contrary, mean area under the plasma concentration-time curve (AUC0-12 h) and maximal plasma concentration (C
max
) decreased following concomitant chitosan intake (1402
versus
1017 and 982.0 ng∙h/ml and 373
versus
208 and 235 ng/ml, respectively). In addition, T
max
increased significantly in presence of 1000 mg of chitosan from 1 to 2 h.
Conclusions
The results of this study in human volunteers did not confirm an absorption enhancing effect of chitosan. Reference values were comparable to literature data, whereas addition of chitosan resulted in significant opposite effects on C
max
, T
max
and AUC. Additional studies are needed to investigate the cause of the discrepancy. The observed variability and complex potential interactions may complicate the use of chitosan HCl in oral pharmaceutical formulations.
Publisher
Springer US,Springer Nature B.V
Subject
Acyclovir - administration & dosage
/ Acyclovir - pharmacokinetics
/ Adult
/ Antiviral Agents - administration & dosage
/ Antiviral Agents - pharmacokinetics
/ Biomedical and Life Sciences
/ Biomedical Engineering and Bioengineering
/ Chromatography, High Pressure Liquid
/ Data Interpretation, Statistical
/ Female
/ Humans
/ Male
/ Pharmacy
