Bioavailability of ambroxol sustained release preparations. Part II: Single and multiple oral dose studies in man.
The bioavailability of a new ambroxol sustained release preparation (75 mg) based on a dialyzing membrane for controlled release was studied in healthy volunteers after single and multiple oral dose in comparison with a standard sustained release formulation in a cross-over study under carefully controlled conditions. Plasma concentrations of ambroxol were measured by means of a HPLC method. Based on AUC data both preparations are found to be bioequivalent, but show different plasma concentration profiles. The test preparation showed a more pronounced sustained release profile than the reference preparation (single dose) resulting in significantly higher steady state plasma levels.
Janssen
T J
TJ
Farma Reseach B.V., Nijmegen, The Netherlands.
Guelen
P J
PJ
Vree
T B
TB
Botterblom
M H
MH
Valducci
R
R
D000328:Adult; D000551:Ambroxol / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D001964:Bromhexine / Q000031:analogs & derivatives*; D003692:Delayed-Action Preparations; D005260:Female; D006801:Humans; D008297:Male; D013056:Spectrophotometry, Ultraviolet
D003692:Delayed-Action Preparations; D000551:Ambroxol; D001964:Bromhexine