title: A new rapidly absorbed paediatric paracetamol suspension. A six-way crossover pharmacokinetic study comparingthe rate and extent of paracetamol absorption from a new paracetamol suspension with two marketed paediatric formulations.
abstract: The objective of this study was to compare the rate and extent of paracetamol absorption from the new Paracetamol pediatric suspension (PPS) with two marketed paracetamol suspensions: Children's panadol (CP) and Panodil baby & infant (PBI). The study also assessed the effect on paracetamol absorption of light-calorie, low-fat food consumed 2 h before dosing. Twenty eight male adult volunteers received a single oral dose of 1000 mg of paracetamol from each of three treatments, in both fasted and fed states according to a randomized, single-center, open-label, six-way crossover study design. PPS was bioequivalent to both CP and PBI for AUC(0-10 h), AUC(0-inf) and C(max) in both fasted and fed state. However, PPS had greater rate of paracetamol absorption and a faster speed of onset. T(max) for PPS was significantly shorter than for PBI in both fasted (p = 0.0005) and fed state (p = 0.0001). Median T(max) for PPS was also 10 min shorter than CP in fasted state. Time to reach minimum effective concentration (MEC) for PPS was significantly shorter than CP and PBI. Early paracetamol exposure of PPS was significantly higher than that of the two existing paracetamol products. Food had a significant effect in the early exposure and onset of therapeutic level of paracetamol from PPS. AUC(0-30 min) was significantly higher and time to reach plasma paracetamol at MEC level was significantly shorter than in the fasted state.
authors.affiliation: MDS Pharma Services, Belfast, Northern Ireland.
authors.forename: Stephen
authors.initials: S
authors.lastname: Smith
authors.forename: Agron
authors.initials: A
authors.lastname: Collaku
authors.forename: Louise
authors.initials: L
authors.lastname: Heaslip
authors.forename: Yong
authors.initials: Y
authors.lastname: Yue
authors.forename: Yan-Yan
authors.initials: YY
authors.lastname: Starkey
authors.forename: Geoffrey
authors.initials: G
authors.lastname: Clarke
authors.forename: Nick
authors.initials: N
authors.lastname: Kronfeld
mesh_terms: D000042:Absorption / Q000502:physiology; D000082:Acetaminophen / Q000008:administration & dosage / Q000493:pharmacokinetics*; D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000367:Age Factors; D058633:Antipyretics / Q000008:administration & dosage / Q000493:pharmacokinetics*; D019540:Area Under Curve; D001682:Biological Availability; D002648:Child; D002675:Child, Preschool; D018592:Cross-Over Studies; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005215:Fasting; D018565:Food-Drug Interactions; D006801:Humans; D007223:Infant; D008297:Male; D013535:Suspensions / Q000008:administration & dosage / Q000493:pharmacokinetics*; D013810:Therapeutic Equivalency; D055815:Young Adult
chemical_list: D058633:Antipyretics; D013535:Suspensions; D000082:Acetaminophen