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Methods and Findings
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Methods Find Exp Clin Pharmacol 2003, 25(7): 531
ISSN 0379-0355
Copyright 2003 Clarivate Analytics
CCC: 0379-0355
DOI: 10.1358/mf.2003.25.7.778092
 
 
Bioavailability of two new formulations of paracetamol, compared with three marketed formulations, in healthy volunteers
Sevilla-Tirado, F.J., Gonzalez-Vallejo, E.B., Leary, A.C., Breedt, H.J., Hyde, V.J., Fernandez-Hernando, N.
 
 
The aim of this study was to compare the main pharmacokinetic characteristics of two new paracetamol formulations, powder sachet and tablet, with that of three commercially available paracetamol formulations: two conventional solid tablets and one effervescent tablet. Twelve healthy volunteers participated in an open, single dose (paracetamol 1000 mg), randomized, five-way, crossover study. Formulations studied included: formulation A: 2 x 500 mg paracetamol tablets (Laboratorios Belmac S.A.); formulation B: 1 x 1000 mg paracetamol powder sachets (Laboratorios Belmac, S.A.); formulation C: 2 x 500 mg paracetamol film-coated tablets (Panadol(R), SmithKline Beecham); formulation D: 2 x 500 mg paracetamol tablets (Tylenol(R), McNeil); and formulation E: 1 x 1000 mg effervescent paracetamol tablets (Efferalgan(R), UPSA). The primary variables were area under the plasma concentration time curve extrapolated to infinity (AUC0-infinity), maximum plasma concentration (Cmax), and time to maximum plasma concentration (tmax). Mean AUC0-infinity ranged from 52.6 (B) to 56.3 mcg.h/ml (D); mean Cmax varied between 17.98 (C) and 20.73 mcg/ml (E); mean tmax ranged from 0.40 (E) to 0.88 h (C); and median t1/2 varied between 2.65 (C) and 2.81 h (A). Formulations A, B and E showed significantly shorter tmax than formulation C. The tmax and Cmax values found for formulations A and B were very similar to that found for E, an effervescent tablet formulation. In conclusion, the two new formulations of paracetamol tested in this study were absorbed rapidly after a single oral dose in healthy volunteers, similar to an effervescent paracetamol formulation and significantly faster than two ordinary commercialized paracetamol tablets.


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