Romanian Society of Pharmaceutical Sciences
 

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OLANZAPINE TRANSFER INTO SHEEP’S MILK. AN ANIMAL MODEL

BIANCA-EUGENIA ŐSZ 1, AMELIA TERO-VESCAN 2*, MARIA DOGARU 1, SZENDE VANCEA 3, SILVIA IMRE 4, PAUL BOSA 1, CAMIL-EUGEN VARI 1

1.Department of Pharmacology and Clinical Pharmacy, University of Medicine and Pharmacy of Tîrgu Mureș, 38 Gheorghe Marinescu Street, 540139, Târgu Mureș, Romania
2 .Department of Pharmaceutical Biochemistry, Chemistry of environmental factors, University of Medicine and Pharmacy of Tîrgu Mureș, Târgu Mureș, Romania
3 .Department of Physical Chemistry, University of Medicine and Pharmacy of Tîrgu Mureș, Târgu Mureș, Romania
4 .Department of Analytical Chemistry and Drug Analysis, University of Medicine and Pharmacy of Tîrgu Mureș, Târgu Mureș, Romania

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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.