Pancreatin EC Pellets
Pancreatin-Delayed Release Pellets-Suitable for 10000, 25000, 40000 iu unit Caps (Creon)
- Release pattern and comparative study done with innovator
- MKPPL product advantages include:
- Smaller size of pellets.
- Spherical shaped pellets compared to the innovator Creon.
- Higher drug loading possible to meet 50,000 iu lipase activity.
Offer complete technical package for registrations in all regulated/semi regulated markets.
CREON is a pancreatic enzyme preparation consisting of pancrelipase, an extract derived from porcine pancreatic glands. Pancrelipase contains multiple enzyme classes, including porcine-derived lipases, proteases, and amylases.
Pancrelipase is a beige-white amorphous powder. It is 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. CREON is dosed by lipase units.
Other active ingredients include protease and amylase.
CREON contains the following inactive ingredients: cetyl alcohol, dimethicone, Hypromellose phthalate, polyethylene glycol, and triethyl citrate.
3,000 USP units of lipase; 9,500 USP units of protease; 15,000 USP units of amylase delayed-release capsules have a white opaque cap with imprint “CREON 1203” and a white opaque body. The shells contain titanium dioxide and Hypromellose.
6,000 USP units of lipase; 19,000 USP units of protease; 30,000 USP units of amylase delayed-release capsules have a Swedish-orange opaque cap with imprint “CREON 1206” and a blue opaque body. The shells contain FD&C Blue No. 2, gelatin, red iron oxide, sodium lauryl sulfate, titanium dioxide, and yellow iron oxide.
12,000 USP units of lipase; 38,000 USP units of protease; 60,000 USP units of amylase delayed-release capsules have a brown opaque cap with imprint “CREON 1212” and a colorless transparent body. The shells contain black iron oxide, gelatin, red iron oxide, sodium lauryl sulfate, titanium dioxide, and yellow iron oxide.
24,000 USP units of lipase; 76,000 USP units of protease; 120,000 USP units of amylase delayed-release capsules have a Swedish-orange opaque cap with imprint “CREON 1224” and a colorless transparent body. The shells contain gelatin, red iron oxide, sodium lauryl sulfate, titanium dioxide, and yellow iron oxide.
36,000 USP units of lipase; 114,000 USP units of protease; 180,000 USP units of amylase delayed-release capsules have a blue opaque cap with imprint “CREON 1236” and a colorless transparent body. The shells contain gelatin, titanium dioxide, FD&C Blue No. 2 and sodium lauryl sulfate.
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) |
