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Use of a Mutilumen Catheter to Assess the Bioavailability of an Enteric- Coated High-Buffered Pancrelipase Formulation in Patients with Exocrine Pancreatic Insufficiency

Author(s): Lisa M. Gangarosa | Ahsan N. Rizwan | Ryan Criste | Noelia Nebot | Kristina K. Wolf | Kim L. R. Brouwer

Journal: Journal of Bioequivalence & Bioavailability
ISSN 0975-0851

Volume: 3;
Issue: 2;
Start page: 026;
Date: 2011;
Original page

Keywords: Exocrine pancreatic insufficiency | Cystic fibrosis | Enteric coated high buffered pancrelipase | Intraduodenal | Aspiration | Catheter

Treatment of exocrine pancreatic insufficiency (EPI) secondary to conditions including cystic fibrosis or chronicpancreatitis requires exogenous supplementation with a specially formulated pancreatic enzyme product (PEP). TheFDA has mandated that the intestinal bioavailability of these preparations be evaluated in vivo in patients.This pilot clinical study examined the feasibility of using a multi-lumen catheter with an occluding balloon tomeasure changes in intraduodenal enzyme concentrations following oral administration of a PEP.In this two arm cross-over study, patients with mild-severe EPI were administered enteric coated (EC) highbufferedpancrelipase or placebo capsules with a liquid Lundh meal. Gastric and duodenal samples were aspiratedat 15-minute intervals over 3 hours in each treatment arm. The concentrations of three pancreatic enzymes (lipase,amylase, and protease) were measured in the collected fluids. The maximum concentration (Cmax), and area underthe duodenal enzyme concentration vs. time profile (AUC) were determined.Comparison of enzyme concentrations between placebo and treatment phases demonstrated appreciableincreases in all three enzymes in the subject with cystic fibrosis (CF+), but only a modest increase in the subject withmild-to-moderate EPI (CF-). During the EC-high-buffered pancrelipase+meal phase, the fold increase in the Cmax oflipase, amylase, and protease concentrations compared to the placebo+meal phase in subject CF- were 0.96, 1.65,and 1.64, respectively. In subject CF+, who had severe pancreatic enzyme insufficiency, the fold increase in theAUC of lipase, amylase and protease concentrations compared to the placebo+ meal phase was 66.1, 15.9, and651, respectively. Time to peak concentration occurred earlier during the active treatment phase. In both subjectsand both treatments a peak duodenal pH of 8 was measured.The catheter employed in this study can be used to determine bioavailability of PEPs in severe EPI in a singledaypretreatment vs. post treatment setting (NCT00744250).
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