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Multiple dose pharmacokinetics of caffeine administered in chewing gum to normal healthy volunteers.
Biopharm Drug Dispos. 2005 Dec; 26(9):403-9.BD

Abstract

The purpose of this study was to examine the pharmacokinetics of three doses of caffeine administered as Stay Alert chewing gum in a multiple dose regimen.

METHODS

A double-blind, parallel randomized, four-treatment study design was employed. The treatment groups were: 50, 100 and 200 mg caffeine and placebo. Subjects were 48 (n = 12 per group), healthy, non-smoking, males and females who had abstained from caffeine ingestion for at least 20 h prior to dosing, who were randomly assigned to the treatment groups. Caffeine was administered at 2,400, 0200 and 0400 h depending on the treatment group. Blood samples were collected pre-dose and at 5, 15, 30, 45, 60, 75, 90 and 105 min after each caffeine dose. Samples were also collected at 7.5, 8.5 and 18 h after the last dose of caffeine. Plasma caffeine levels were analysed by a validated UV-HPLC method.

RESULT

The mean T(max) after the third dosing ranged from 0.37 to 1.12 h. C(max) for 50, 100 and 200 mg was 2.69, 3.45 and 6.33 mg/l, respectively. AUC(inf) for 50, 100 and 200 mg group was 33.2, 46.94 and 86.94 mg/l * h, respectively. AUC(inf) values suggested a dose proportionate increase. Dose normalized C(max) and AUC(0-tau) values across doses were not significantly different, suggesting linearity was maintained after multiple doses of the Stay Alert chewing gum. There were no group related differences in elimination.

CONCLUSIONS

The results suggest that caffeine administered in the gum formulation (Stay Alert chewing gum) via a multiple dosing regimen provides an effective and convenient means of maintaining effective concentrations of caffeine that would in some operational scenarios be desirable for maintaining alertness and performance in sleep deprived individuals.

Authors+Show Affiliations

Pharmacokinetics-Biopharmaceutics Laboratory, Department of Pharmaceutical Sciences, School of Pharmacy, University of Maryland at Baltimore, AHB 540A, 100 Penn Street, 21201, USA.No affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

16158445

Citation

Syed, Shariq A., et al. "Multiple Dose Pharmacokinetics of Caffeine Administered in Chewing Gum to Normal Healthy Volunteers." Biopharmaceutics & Drug Disposition, vol. 26, no. 9, 2005, pp. 403-9.
Syed SA, Kamimori GH, Kelly W, et al. Multiple dose pharmacokinetics of caffeine administered in chewing gum to normal healthy volunteers. Biopharm Drug Dispos. 2005;26(9):403-9.
Syed, S. A., Kamimori, G. H., Kelly, W., & Eddington, N. D. (2005). Multiple dose pharmacokinetics of caffeine administered in chewing gum to normal healthy volunteers. Biopharmaceutics & Drug Disposition, 26(9), 403-9.
Syed SA, et al. Multiple Dose Pharmacokinetics of Caffeine Administered in Chewing Gum to Normal Healthy Volunteers. Biopharm Drug Dispos. 2005;26(9):403-9. PubMed PMID: 16158445.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Multiple dose pharmacokinetics of caffeine administered in chewing gum to normal healthy volunteers. AU - Syed,Shariq A, AU - Kamimori,Gary H, AU - Kelly,William, AU - Eddington,Natalie D, PY - 2005/9/15/pubmed PY - 2006/3/17/medline PY - 2005/9/15/entrez SP - 403 EP - 9 JF - Biopharmaceutics & drug disposition JO - Biopharm Drug Dispos VL - 26 IS - 9 N2 - UNLABELLED: The purpose of this study was to examine the pharmacokinetics of three doses of caffeine administered as Stay Alert chewing gum in a multiple dose regimen. METHODS: A double-blind, parallel randomized, four-treatment study design was employed. The treatment groups were: 50, 100 and 200 mg caffeine and placebo. Subjects were 48 (n = 12 per group), healthy, non-smoking, males and females who had abstained from caffeine ingestion for at least 20 h prior to dosing, who were randomly assigned to the treatment groups. Caffeine was administered at 2,400, 0200 and 0400 h depending on the treatment group. Blood samples were collected pre-dose and at 5, 15, 30, 45, 60, 75, 90 and 105 min after each caffeine dose. Samples were also collected at 7.5, 8.5 and 18 h after the last dose of caffeine. Plasma caffeine levels were analysed by a validated UV-HPLC method. RESULT: The mean T(max) after the third dosing ranged from 0.37 to 1.12 h. C(max) for 50, 100 and 200 mg was 2.69, 3.45 and 6.33 mg/l, respectively. AUC(inf) for 50, 100 and 200 mg group was 33.2, 46.94 and 86.94 mg/l * h, respectively. AUC(inf) values suggested a dose proportionate increase. Dose normalized C(max) and AUC(0-tau) values across doses were not significantly different, suggesting linearity was maintained after multiple doses of the Stay Alert chewing gum. There were no group related differences in elimination. CONCLUSIONS: The results suggest that caffeine administered in the gum formulation (Stay Alert chewing gum) via a multiple dosing regimen provides an effective and convenient means of maintaining effective concentrations of caffeine that would in some operational scenarios be desirable for maintaining alertness and performance in sleep deprived individuals. SN - 0142-2782 UR - https://www.unboundmedicine.com/medline/citation/16158445/Multiple_dose_pharmacokinetics_of_caffeine_administered_in_chewing_gum_to_normal_healthy_volunteers_ L2 - https://doi.org/10.1002/bdd.469 DB - PRIME DP - Unbound Medicine ER -