Evaluation of the use of Göttingen minipigs to predict food effects on the oral absorption of drugs in humans

TY - JOUR

T1 - Evaluation of the use of Göttingen minipigs to predict food effects on the oral absorption of drugs in humans

AU - Christiansen, Martin Lau

AU - Müllertz, Anette

AU - Garmer, Mats

AU - Kristensen, Jakob

AU - Jacobsen, Jette

AU - Abrahamsson, Bertil

AU - Holm, Rene

N1 - © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.

PY - 2015/1

Y1 - 2015/1

N2 - This study investigated the oral absorption of drugs in minipigs to predict food effects in man. The protocol was based on a previously described model in dogs and further investigated the food source (i.e., US FDA breakfast or a nutritional drink) and food quantities. Two poorly soluble compounds were investigated [pravastatin (negative food effect) and atazanavir (positive food effect)] in Göttingen minipigs after seven different food regimens. The gastric emptying rate was evaluated by coadministration of acetaminophen. In short, the results demonstrated longer gastric emptying times in minipigs when compared with humans, within a range from 2.3 to 8.4 h dependent on the food regimen. There were no significant differences in drug absorption between fed and fasted state for the two compounds. The study showed that the dog protocol could not be transferred directly to minipigs, but needs further investigation and adjustments in order to get a valid model using Göttingen minipigs for the evaluation of food effects on drug absorption in humans.

AB - This study investigated the oral absorption of drugs in minipigs to predict food effects in man. The protocol was based on a previously described model in dogs and further investigated the food source (i.e., US FDA breakfast or a nutritional drink) and food quantities. Two poorly soluble compounds were investigated [pravastatin (negative food effect) and atazanavir (positive food effect)] in Göttingen minipigs after seven different food regimens. The gastric emptying rate was evaluated by coadministration of acetaminophen. In short, the results demonstrated longer gastric emptying times in minipigs when compared with humans, within a range from 2.3 to 8.4 h dependent on the food regimen. There were no significant differences in drug absorption between fed and fasted state for the two compounds. The study showed that the dog protocol could not be transferred directly to minipigs, but needs further investigation and adjustments in order to get a valid model using Göttingen minipigs for the evaluation of food effects on drug absorption in humans.

U2 - 10.1002/jps.24270

DO - 10.1002/jps.24270

M3 - Journal article

C2 - 25417837

SN - 0022-3549

VL - 104

SP - 135

EP - 143

JO - Journal of Pharmaceutical Sciences

JF - Journal of Pharmaceutical Sciences

IS - 1

ER -