Pharmacological properties : תכונות פרמקולוגיות

Pharmacodynamic Properties

5.1 Pharmacodynamic Properties
Pharmacotherapeutic group: Multienzymes (amylase, lipase, protease), ATC code: A09A A02
Creon 25000 contains porcine pancreatin formulated as enteric-coated (acid-resistant) minimicrospheres within gelatine capsules. The capsules dissolve rapidly in the stomach releasing plenty of minimicrospheres, a multi-dose principle which is designed to achieve good mixing with the chyme, emptying from the stomach together with the chyme and after release, good distribution of enzymes within the chyme.
When the minimicrospheres reach the small intestine the coating rapidly disintegrates (at pH>5.5) to release enzymes with lipolytic, amylolytic and proteolytic activity to ensure the digestion of fats, starches and proteins. The products of pancreatic digestion are then either absorbed directly, or following further hydrolysis by intestinal enzymes.

Clinical efficacy:
Overall 30 studies investigating the efficacy of Creon ( Creon capsules with 10000, 25000 or 40000 Ph.Eur units of lipase and creon 5000) in patients with pancreatic exocrine insufficiency have been conducted. Ten of these were placebo controlled studies performed in patients with cystic fibrosis, chronic pancreatitis or post-surgical conditions.
In all randomized, placebo-controlled, efficacy studies, the pre-defined primary objective was to show superiority of Creon over placebo on the primary efficacy parameter, the coefficient of fat absorption (CFA).
The coefficient of fat absorption determines the percentage of fat that is absorbed into the body taking into account fat intake and fecal fat excretion. In the placebo- controlled PEI studies, the mean CFA (%,mean ± SD) was higher with Creon treatment (83.0%± 12.6%) as compared to placebo (62.6%± 21.8%.). The median treatment duration was 7 days on both treatments. In all studies, irrespective of the design, the mean CFA (%) at the end of the treatment period with Creon was similar to the mean CFA values for Creon in the placebo-controlled studies.
In all performed studies, irrespective of etiology, an improvement was also shown in disease specific symptomatology (stool frequency, stool consistency, flatulence).

Paediatric population:
In cystic fibrosis (CF) the efficacy of Creon was demonstrated in 288 paediatric patients covering an age range from newborns to adolescents. In all studies, the mean end-of-treatment CFA values exceeded 80% on Creon comparably in all paediatric age groups.

Pharmacokinetic Properties

5.2                  Pharmacokinetic Properties

Pharmacokinetic data are not available as the enzymes act locally in the gastro-intestinal tract.
After exerting their action, the enzymes are digested themselves in the intestine.