Artificial stomach for the analyze in targeted development of complex hard pharmaceutic forms

Main applicant: Lek farmacevtska družba d.d., Razvojni center Slovenija

Development partner: Fakulteta za strojništvo, Univerza v Ljubljani and Fakulteta za farmacijo, Univerza v Ljubljani

A key milestone in the development process of generic medicines is to prove the bioequivalence (BE) with reference (original) products. Bioequivalence studies on humans are timely and costly. For this reason it is of key importance to guarantee the success of such studies. In a cooperation between Lek, Faculty of Mechanical engineering and Faculty of Pharmacy from the University of Ljubljana, a technically complex simulator of the digestive tract known as »artificial stomach« has been developed. The essence and the benefit of this device is the ability to simulating stomach contact on real scale. This allows testing of generic and reference medicines under bioequivalence conditions. This method significantly increases the possibilities of successful bioequivalent studies of complex products.