Gastric Transit and Pharmacodynamics of a Two-Millimeter Enteric-Coated Pancreatin Microsphere Preparation in Patients with Chronic Pancreatitis

It has been suggested that enteric-coatedpancreatin microsphere (ECPM) preparations with spheresizes larger than 1.7 mm pass through the stomach at aslower rate than a meal and therefore may be less efficacious in restoring pancreatic enzymeactivity than preparations with smaller sphere sizes.The aim of this study was to investigate the gastrictransit profile of a 2-mm ECPM preparation in relation to that of a solid meal and to simultaneouslymeasure enzyme activities in eight patients withpancreatic exocrine insufficiency due to chronicpancreatitis. Gastric transit was assessed bydouble-isotope scintigraphy. A pancake was labeled with^99mTc. A 2-mm ECPM preparation was labeledwith ¹⁷¹Er. Intraluminal pancreatic enzymeactivities were assessed during a 6-hr period with thecholesteryl-[¹⁴C]octanoate breath test (for carboxyl ester lipaseactivity) and the N -benzoyl-L-tyrosyl-p aminobenzoicacid/p-aminosalicylic acid (NBT-PABA/PAS) test (forchymotrypsin activity). The ECPM preparation passedthrough the stomach more rapidly (median 24 min) thanthe pancake (median 52 min, P < 0.05). During ECPMtherapy, mean cumulative ¹⁴CO₂outputs rose significantly from 30% to 70% (P <0.05), but remained below outcomes in healthy volunteers. Mean cumulative plasmaPABA concentrations rose significantly from 46% to 87%(P < 0.05) and were not significantly different fromoutcomes in healthy volunteers. In chronic pancreatitis, a 2-mm ECPM preparation does not pass throughthe stomach more slowly than a solid meal, but in factfaster. Digestion of ester lipids and proteins showed animprovement to subnormal and normal levels,respectively.