Influence of a standard meal on the absorption of a controlled release pseudoephedrine suspension.
The influence of a standard meal on the extent and rate of absorption of pseudoephedrine from a liquid controlled release (CR) formulation (Pennkinetic System) was studied in 16 normal male volunteers. Equivalent single doses of an immediate release reference syrup (IR-Sudafed) and the CR suspension were each studied under both fasted and postprandial conditions. AUC results showed no significant influence of food or formulation, indicating that the CR formulation was absorbed to the same extent as the IR product under all conditions. CMAX and TMAX tabulations under fasted conditions indicated that the CR preparation peaked at a lower level at a later time. Food diminished IR CMAXs but the CR suspension's CMAXs and TMAXs were apparently unaffected by food. This study indicates that this CR pseudoephedrine suspension releases drug independently of food intake.
Graves
D A
DA
Pennwalt Pharmaceutical Division, Rochester, NY 14603.
Wecker
M T
MT
Meyer
M C
MC
Straughn
A B
AB
Amsel
L P
LP
Hinsvark
O N
ON
Bhargava
A K
AK
Rotenberg
K S
KS
D000293:Adolescent; D000328:Adult; D003692:Delayed-Action Preparations; D004809:Ephedrine / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics*; D005502:Food; D006801:Humans; D008297:Male
D003692:Delayed-Action Preparations; D004809:Ephedrine