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. Our Solution: The PED Device
Delivers enzymes to infants receiving overnight supplemental feedings via a gastrostomy tube (G-tube)
Uses Creon brand microspheres suspended in fluid delivery vehicle, Ora-Plus
The vehicle-microsphere mixture is continuously pumped into the G-tube, where it will be combined with the formula via a ‘Y’ connector, and then enter the stomach

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

7. Past Work: Researched pancreatic enzymes function
Assessed the current methods of obtaining the necessary pancreatic enzymes
Met with pharmacist pediatric nurse for advice and recommendations
Tested microsphere stability in the fluid delivery vehicle
Decided on the Creon Brand microspheres and the Ora-Plus suspending vehicle

8. Current Work:
Determining the minimum fluid vehicle volume necessary for overnight enzyme delivery
Investigating the capabilities of available pumps, both injection and peristaltic
Integrate pump fittings with connectors to gastrostomy tube (G-Tube)

9. Future Work:
Ensuring that all tubing and connectors work together and efficiently in the device
Design-Safe Analysis
Obtain funding from Solvay Pharmaceutical to improve the current crude PED model