Journal of Bioequivalence & Bioavailability

Kim L. R. Brouwer

Publications

• Research Article
  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): Ahsan N. Rizwan, Ryan Criste, Noelia Nebot, Kristina K. Wolf, Kim L. R. Brouwer and Lisa M. GangarosaAhsan N. Rizwan, Ryan Criste, Noelia Nebot, Kristina K. Wolf, Kim L. R. Brouwer and Lisa M. Gangarosa
  
  Treatment of exocrine pancreatic insufficiency (EPI) secondary to conditions including cystic fibrosis or chronic pancreatitis requires exogenous supplementation with a specially formulated pancreatic enzyme product (PEP). The FDA 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 to measure 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) highbuffered pancrelipase or placebo capsules with a liquid Lundh meal. Gastric and duodenal samples were aspirated at 15-minute intervals over 3 hours in each treatment arm. The concentrations of three pancreatic enzymes (lipase, amylase, and prot.. View More»
  DOI: 10.4172/jbb.1000053

  Abstract PDF