Journal of Bioequivalence & Bioavailability

The bioequivalence of Citicoline 500mg film tablet

6^th World Congress on Bioavailability & Bioequivalence: BA/BE Studies Summit

August 17-19, 2015 Chicago, USA

Onursal Saglam

Scientific Tracks Abstracts: J Bioequiv Availab

Abstract:

Citicoline is an essential intermediate in the synthesis of structural phospholipids of cell membrane. Citicoline is also related
to acetylcholine metabolism (cholinergic action). Exogenously administered citicoline promotes rapid repair of injured cells
in brain ischemia with two leading mechanisms: i) direct repair of neuronal membranes ii) reduced generation of free fatty acids.
Also, citicoline down-regulates phospholipases to avert apoptotic and necrotic cell death. Animal and clinical studies indicate the
potential of Citicoline to improve cognitive deficits, stroke rehabilitation, brain and spinal cord injuries, neurological diseases, and
eye conditions. Citicoline is metabolized in the gut wall and liver. The by-products of exogenous citicoline formed by hydrolysis in the
intestinal wall are choline and cytidine. Following absorption, choline and cytidine are dispersed throughout the body, enter systemic
circulation and cross the blood-brain barrier for re-synthesis into citicoline in the brain. However, in humans, plasma cytidine is
converted to uridine, its circulating form, which is transformed in the brain to uridine diphosphate. The aim of the study was to
evaluate the pharmacokinetics of citicoline for determining the bioequivalence, only a few methods have been publish which were
only describing choline which is active metabolite of citicoline those were so far to be successful. The blood sampling was started from
-48 h for the clinical trial. The most feasible method was to determine the uridine levels and do base line correction for PK variables.
At the end of study, the Cmax, AUC0-t and tmax had been achieved successfully.

Biography :

Onursal Saglam has a Graduate degree from Department of Mathematics of Middle East Tech University in 1996. He had special project at Computer Sciences and
Statistics. He had worked for Turkish Pharmacist Association and participated in a number of IT project as Project Leader. He started to work in Novagenix as IT Manager
and now he is Deputy General Manager. During his work he has participated over 550 BA/BE studies.