OLANZAPINE TRANSFER INTO SHEEP’S MILK. AN ANIMAL MODEL
BIANCA-EUGENIA ŐSZ1, AMELIA TERO-VESCAN2*, MARIA DOGARU1, SZENDE VANCEA3, SILVIA IMRE4, PAUL BOSA1, CAMIL-EUGEN VARI1
1Department of Pharmacology and Clinical Pharmacy, University of Medicine and Pharmacy of Tîrgu Mureș, 38 Gheorghe
Marinescu Street, 540139, Târgu Mureș, Romania
2Department of Pharmaceutical Biochemistry, Chemistry of environmental factors, University of Medicine and Pharmacy of
Tîrgu Mureș, Târgu Mureș, Romania
3Department of Physical Chemistry, University of Medicine and Pharmacy of Tîrgu Mureș, Târgu Mureș, Romania
4Department of Analytical Chemistry and Drug Analysis, University of Medicine and Pharmacy of Tîrgu Mureș, Târgu
Mureș, Romania
*corresponding author: amelia.tero.vescan@umftgm.ro
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Abstract:
A drug transfer into breast milk and inclusion in risk classes might be a cumbersome process, restricted by the small number
of clinical cases available, especially for drugs with limited or infrequent use. To assess the excretion of olanzapine into
breast milk we used a sheep animal model. Six sheep, with suckling lambs, were treated with 5 mg olanzapine daily, for 10
days, in order to reach steady state plasma concentration. Blood and milk samples were collected daily from the sheep, and
an additional blood sample was taken from lambs on the 10th day. AUC and Css min values from plasma and milk were
calculated to assess the milk/plasma ratio (M/P) and the relative infant dose (RD %) in order to compare these values with the
available data from the literature. The determined minimum plasma concentrations were lower than those reported in humans
for the same dose because of the pharmacokinetic differences between the two species, but the calculated M/P ratio values are
comparable to those reported in literature which make this animal model suitable to predict the drug transfer into the breast milk.

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