Pancreatin EC Pellets
Pancreatin-Delayed Release Pellets-Suitable for 10,000, 25,000, 40,000 IU unit Capsules
Pancreatin is a pancreatic enzyme preparation (pancrelipase) consisting of lipase, protease, and amylase enzymes. It is used to treat exocrine pancreatic insufficiency (EPI).
- Complete technical package available for registrations in all regulated/semi-regulated markets.
This is a pancreatic enzyme preparation consisting of pancrelipase, an extract derived from porcine pancreatic glands.
Pancrelipase is a combination of lipase, protease, and amylase enzymes used to treat exocrine pancreatic insufficiency (EPI). Pancrelipase is a beige-white amorphous powder miscible in water and practically insoluble or insoluble in alcohol and ether.
Each delayed-release capsule for oral administration contains enteric-coated spheres (0.71–1.60 mm in diameter).
The active ingredient evaluated in clinical trials is lipase. The product is dosed by lipase units. Other active ingredients include protease and amylase.
Product contains the following inactive ingredients: cetyl alcohol, dimethicone, Hypromellose phthalate, polyethylene glycol, and triethyl citrate.
Additional Information
| Percentage | 70% (Bovine & Porcine), 10000 IU, 25000 IU, 36000IU, 40000IU |
|---|---|
| Release Type | Delayed Release |
| Target Formulations | Capsules |
| Routes of administration | Oral |
| Documentation Available: | DMF in CTD Format |
| Forms of PFI | Pellets/Micro pellets (for capsules) |
