There is on-going development of generic EU CTD Dossier of Pantoprazole, 40mg/vial, injectible form.
Dossier should be available in September 2007.
Development of this pharmaceutical is carried out according to EU-requirements in country without patent protection or with Bolar-provisions. There will be no sales in those countries where this offer would constitute an infringement of third parties intellectual proprietary rights.
Pantoprazole is a proton pump inhibitor (PPI) that suppresses the final step in gastric acid production by forming a covalent bond to two sites of the (H + ,K + )- ATPase enzyme system at the secretory surface of the gastric parietal cell. This effect is dose- related and leads to inhibition of both basal and stimulated gastric acid secretion irrespective of the stimulus. The binding to the (H + ,K + )- ATPase results in a duration of antisecretory effect that persists longer than 24 hours for all doses tested.
Pantoprazole is prepared as an enteric- coated tablet so that absorption of pantoprazole begins only after the tablet leaves the stomach. Peak serum concentration (Cmax) and area under the serum concentration time curve (AUC) increase in a manner proportional to oral and intravenous doses from 10 mg to 80 mg. Pantoprazole does not accumulate and its pharmacokinetics are unaltered with multiple daily dosing. Following oral or intravenous administration, the serum concentration of pantoprazole declines biexponentially with a terminal elimination half- life of approximately one hour. In extensive metabolizers (see Metabolism section) with normal liver function receiving an oral dose of the enteric- coated 40 mg pantoprazole tablet, the peak concentration (Cmax) is 2.5 µg/ mL, the time to reach the peak concentration (tmax) is 2.5 h and the total area under the plasma concentration versus time curve (AUC) is 4.8 µg· hr/ mL. When pantoprazole is given with food, its tmax is highly variable and may increase significantly. Following intravenous administration of pantoprazole to extensive metabolizers, its total clearance is 7.6- 14.0 L/ h and its apparent volume of distribution is 11.0- 23.6L.
More details at http://www.rxlist.com/cgi/generic3/protonix.htm
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