Bioavailability of paracetamol with/without caffeine in Egyptian patients with hepatitis C virus

Theodor Bilharz Research Institute

Bibliographic Information

Authors: El-Lakkany N.M.; Hendawy A.S.; Seif El-Din S.H.; Ashour A.A.; Atta R.; Abdel-Aziz A.-A.H.; Mansour A.M.; Botros S.S.

Journal: European Journal of Clinical Pharmacology

Publisher: Springer Verlag

Publication Date: 18 February 2016

Volume / Issue: Volume 72 / Issue 5

Pages: 573–582

ISSN: 316970

DOI: 10.1007/s00228-016-2025-1

Scopus: View on Scopus

PubMed: 26888096

Document Type: Article

Authors and Affiliations

El-Lakkany N.M., Department of Pharmacology, Theodor Bilharz Research Institute, Warak El-Hadar, Imbaba, P.O. Box 30, Giza, 12411, Egypt; Hendawy A.S., Department of Pharmacology, Theodor Bilharz Research Institute, Warak El-Hadar, Imbaba, P.O. Box 30, Giza, 12411, Egypt; Seif El-Din S.H., Department of Pharmacology, Theodor Bilharz Research Institute, Warak El-Hadar, Imbaba, P.O. Box 30, Giza, 12411, Egypt; Ashour A.A., Department of Pharmacology and Toxicology, Faculty of Pharmacy, Al-Azhar University, Nasr city, Cairo, Egypt; Atta R., Department of Hepatogastroenterology, Theodor Bilharz Research Institute, Warak El-Hadar, Imbaba, P.O. Box 30, Giza, 12411, Egypt; Abdel-Aziz A.-A.H., Department of Pharmacology and Toxicology, Faculty of Pharmacy, Al-Azhar University, Nasr city, Cairo, Egypt; Mansour A.M., Department of Pharmacology and Toxicology, Faculty of Pharmacy, Al-Azhar University, Nasr city, Cairo, Egypt; Botros S.S., Department of Pharmacology, Theodor Bilharz Research Institute, Warak El-Hadar, Imbaba, P.O. Box 30, Giza, 12411, Egypt

Abstract

Purpose: This study investigates the involvement of liver dysfunction in the modulation of paracetamol pharmacokinetic profile in genotype-4 HCV patients treated with either paracetamol alone (Para) or in combination with caffeine (Para-Caf). Methods: Twenty healthy volunteers and 20 Child-Pugh B HCV patients, each divided into two equal subgroups, were examined, whose liver/kidney functions were correlated with their main clinical manifestation. After an overnight fasting, healthy and hepatic subjects received either a single dose of Para (1000 mg paracetamol) or Para-Caf (1000 mg paracetamol/130 mg caffeine). Two milliliters of saliva samples were collected prior to and at different time-intervals after drug administration and analyzed using HPLC. Results: There was a noticeable increase in the mean concentration time profile of salivary paracetamol concentrations in hepatic patients, with concomitant decrease in paracetamol clearance (CLT), along with induction in the primary pharmacokinetic (PK) parameters, C max, AUC(0-8 h) and AUC(0-∞) (by about 95, 82, and 64 %, respectively, after treatment with Para, and 98, 96, and 101 %, respectively, after treatment with Para-Caf), when compared with the corresponding parameters in healthy subjects. Additionally, the healthy subjects treated with Para-Caf exhibited bioinequivalent increase in C max, K a, and t 1/2 with decrease in T max when compared with the healthy individuals treated with Para alone. A similar pattern was recorded in hepatic patients after addition of caffeine to paracetamol, with even augmented significant increase in K a and t 1/2 (by 100 and 32 %, respectively). Conclusions: Liver dysfunction modified the PK of paracetamol expressed as earlier effective paracetamol concentration, with obvious decrease in its clearance. Caffeine induced faster absorption (evidenced by shorter T max and higher K a) and prolonged t 1/2 of paracetamol, the effects that were more profound in hepatic patients. Further studies are needed to evaluate the influence of liver damage on paracetamol pharmacokinetics whenever repeated dosing is applied, to avoid possible drug accumulation. © 2016 Springer-Verlag Berlin Heidelberg.

Keywords

Absorption rate constant; Bioavailability; Caffeine; Child-Pugh B HCV patients; HPLC; Paracetamol; Acetaminophen; Adult; Aged; Analgesics; Arabs; Biological Availability; Female; Hepatitis C; Humans; Liver Diseases; Male; Middle Aged; Saliva; paracetamol plus caffeine; unclassified drug; analgesic agent; abdominal pain; area under the curve; Article; clinical article; controlled study; dizziness; drug absorption; drug bioavailability; drug blood level; drug clearance; drug half life; drug saliva level; Egyptian; Hepatitis C virus; human; liver dysfunction; maximum plasma concentration; priority journal; single drug dose; Arab; liver disease; metabolism; randomized controlled trial

Citation Information

Scopus Citations: 4

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