Pancreatic Enzyme Delivery (PED) Device

1. Pancreatic Enzyme Delivery (PED) Device Group Members: Todd Dhavale Erica Osadzinski Advisor: Dr. Dennis C. Stokes Associate Prof. Pediatrics Pulmonary Medicine

2. What is Cystic Fibrosis (CF)? • 40,000 cases in the United States alone • 2,000 children are born with CF every year • Inherited disease which causes exocrine (outward secreting) glands in the body to fail to function normally. • Mucus-producing exocrine glands often produce thick, sticky secretions which plug-up ducts and other passageways. • This occurs in the lungs and intestines and interferes with breathing and digestion. • CF is not curable at this time

3. Effects of Cystic Fibrosis on Digestion • Occurs in 8 out of 10 of all CF patients • Pancreatic enzymes do not reach intestinal tract • Malabsorption occurs • Patients do not gain weight --growth impairment • Therefore, above average caloric intake is needed along with supplemental enzymes • Our major concerns are these effects on infants with CF

4. The Current Situation • Currently infants receive no supplemental enzymes • Supplemental enzymes are packaged in “microspheres” which are enclosed in capsules which infants are unable to swallow • Microspheres are made to protect the enzymes in the acidic environment of the stomach • Microspheres release and activate the enzymes in the alkaline small intestine so absorption can occur • Thus, there is a need for a device that can administer the microspheres to infants simultaneously with the formula

5. Requested device parameters for infants and small children: • Eight hour night time feeding • Dr. Stokes prescribes: • 3-5 capsules (containing pancreatic enzyme microspheres) per night time feeding

6. Our Solution: The PED Device • Delivers enzymes to infants receiving overnight supplemental feedings via a gastrostomy tube (G-tube)

7. Components of the PED Device • Uses Creon brand microspheres suspended in fluid delivery vehicle, Ora-Plus

8. Components of the PED Device • The vehicle-microsphere mixture is continuously pumped into the G-tube • where it will be combined with the formula via a ‘Y’ connector, • then enter the stomach

9. Alternate Solutions??? • Pre-mixing microspheres in formula? • intact • crushed • Dry, Without Suspending Vehicle? • air • gravity deposit in formula

10. Implementing and testing our solution: • 1) Researched pancreatic enzymes function • 2) Assessed the current methods of obtaining the necessary pancreatic enzymes • 3) Met with pharmacist and pediatric nurse for advice and recommendations • 20-25mLlimit volume forOra-Plus

11. 4) Which Microspheres worked best? • Tested microsphere stability in the fluid delivery vehicle: • Pancrecarb MS-8 had too large of Microspheres • Pancrecarb MS-4 had the smallest Microspheres • But the Pancrecarb brand proved to be unstable in the Ora-Plus… • Thus these Microspheres broke down before reaching the stomach Creon Pancrecarb MS-4 Pancrecarb MS-8

12. 5) Our Choice: Creon Brand microspheres • Creon brand Microspheres are slightly larger than the smallest, Pancrecarb MS-4 • Creon proved to remain stable in the Ora-Plus for around 8 hours, (over-night) • Pancrecarb only remained stable for a mere 1 hour

13. 6) PED Pump Requirements • Need 20-25mL of fluid vehicle for overnight feeding • For 3-5 Creon 5 Capsules over 8 hour period: • 20 mL / 8 Hrs = 2.5 mL/Hr • 5 capsules / 20 mL = 1 capsule / 4 mL

14. 7) Which Pump works better? • Delivers the minimum fluid vehicle volume necessary for overnight enzyme delivery: • Syringe • Peristaltic • Our Choice: • SYRINGE PUMP • WHY?

15. 8) Other factors • Integrate pump fittings with connectors to gastrostomy tube (G-Tube) • DesignSafe Analysis

16. Future Work: • Improve the current crude PED model: • Solvay Pharmaceutical Funding? • Self-contained device • Out-Patient Use