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

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

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

4. The Current Situation n Currently infants receive no supplemental enzymes n Supplemental enzymes are packaged in “microspheres” which are enclosed in capsules which infants are unable to swallow n Microspheres are made to protect the enzymes in the acidic environment of the stomach n Microspheres release and activate the enzymes in the alkaline small intestine so absorption can occur n 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: n Eight hour night time feeding n Dr. Stokes prescribes: –3-5 capsules (containing pancreatic enzyme microspheres) per night time feeding

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

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

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

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

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

11. 4) Which Microspheres worked best? n 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… n Thus these Microspheres broke down before reaching the stomach Creon Pancrecarb MS-4 Pancrecarb MS-8

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

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

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

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

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