ABSTRACT
BACKGROUND AND OBJECTIVES: In clinical practice, the need sometimes arises to administer pancreatic enzyme replacement therapy via gastrostomy tube (G-tube) by mixing the pellets contained in the capsules with soft food. The objective of this study was to identify G-tubes that allow administration of pancrelipase gastro-resistant pellets without clogging, sticking, pellet damage or loss of enteric coating integrity. METHODS: In this in vitro study, CREON® (pancrelipase) Delayed-Release Capsules were opened and the pellets sprinkled onto a small amount of baby food of pH <4.5 (applesauce and bananas manufactured by both Gerber and Beech-Nut). The mixture was stirred gently and after 15 minutes poured into a 35 mL syringe and pushed slowly (~15 mL in 10-15 seconds) through a G-tube. Pellets were collected and the tube flushed with water. G-tubes were inspected visually for clogging/sticking and damage to pellets was assessed. If there was none with all four foods, pellet integrity (gastric resistance and lipase activity) was assessed by an in vitro dissolution method with a 2-hour gastric simulation step. The activity required to confirm integrity was ≥80% of actual US Pharmacopeia lipase activity per capsule. G-tubes initially tested were Kimberly-Clark MIC Bolus® size 14 French (Fr) and upwards and Kimberly-Clark MIC-KEY® 14 Fr and upwards. Following successful testing, assessment of Bard® Tri-Funnel 18 Fr and Bard® Button 18 Fr G-tubes was carried out. RESULTS: Based on the absence of clogging, sticking and visible damage to pellets, and the maintenance of pellet integrity, administration of CREON® pancrelipase pellets was feasible through the following G-tubes: Kimberly-Clark MIC Bolus® size 18 Fr, Kimberly-Clark MIC-KEY® 16 Fr, Bard® Tri-Funnel 18 Fr and Bard® Button 18 Fr. Lipase activity met the predetermined specification and was ≥90% for all four tubes and all four foods, with no differences versus untreated pellets (i.e. pellets not mixed with baby food or pushed through a G-tube). These data apply to all CREON® pancrelipase capsule formulations, regardless of their strength in lipase units, as pellet composition, size and quality are identical. CONCLUSION: CREON® pancrelipase pellets can be mixed with baby food of pH <4.5 and administered via the following G-tubes without clogging, sticking or visible pellet damage, and with no loss of gastric resistance or lipase activity: Kimberly-Clark MIC Bolus® size 18 Fr and larger, Kimberly-Clark MIC-KEY® 16 Fr and larger, Bard® Tri-Funnel 18 Fr and larger and Bard® Button 18 Fr and larger.
