ULTRASE®/ULTRASE® MT
Resists Acid For Targeted Delivery
Strong Acid Resistance2,3
In Vitro Lipase Activity of Various Pancreatic Enzyme Products After 2 Hours Exposure to Simulated Gastric Fluid2
Adapted from Kraisinger et al, J of Clinical Pharmacology, 1994.
Resistance of Enteric Coating to Simulated Gastric Juice: Residual Lipase Activity After Incubation of Products for 2 hours at pH 1.0*,3
Adapted from Kuhn et al, J Pediatr Pharmacol Ther, 2007.
Delivers High Lipase Activity to the Site of Action1,4
- Bioactive enzymes specifically formulated for delivery to the site of digestion1,4
- There is considerable patient to patient variation in mixing, gastric emptying and intestinal transit of food and pancreatin.5
- An earlier study reviewing the relationship of gastric emptying and enzyme sphere size showed that in 50% of subjects, 1.6mm spheres (the predicted optimal size) did not pass with food at the same time6
“The clinical efficacy of pancreatic enzymes in patients with CF is a function of the amount of biologically active enzyme that reaches the small intestine. This is a function of the content of the product, acid stability and the pH at which the coating dissolves and releases active enzyme.”2
- Kraisinger et al, J of Clinical Pharmacology, 1994
Pancrelipase capsules are contraindicated in patients known to be hypersensitive to pork protein. Pancrelipase capsules are contraindicated in patients with acute pancreatitis or with acute exacerbations of chronic pancreatic diseases. To protect enteric coating, minitablets must not be crushed or chewed.
* Graph depicts all products commercially available
REFERENCES
1. ULTRASE® /ULTRASE® MT (pancrelipase) Capsules Prescribing Information.
2. Kraisinger M, Hochhaus G, Stecenko A, et al. Clinical pharmacology of pancreatic enzymes in patients with cystic fibrosis and In Vitro performance of microencapsulated formulations. J. of Clinical Pharmacology 1994;34:158-166.
3. Kuhn RJ, Eyting S, Henniges F, Potthoff A. In Vitro comparison of physical parameters, enzyme activity, acid resistance, and pH dissolution characteristics of enteric-coated pancreatic enzyme preparations: implications for clinical variability and pharmacy substitution. J Pediatr Pharmacol Ther 2007; 12(2): 115-128.
4. Data on file, Axcan Pharma US, Inc.
5. Taylor CJ, Hillel PG, Ghosal S, et al. Gastric emptying and intestinal transit of pancreatic enzyme supplements in cystic fibrosis. Arch Dis Child 1999; 80: 149-152.
6. Meyer JH, Elashoff J, Porter-Fink V, et al. Human postprandial gastric emptying of 1-3 millimeter spheres. Gastroenterology 1988; 94:1315-1325.
7. Konstan MW, Liou TG, Strausbaugh S, et al. Efficacy and safety of ULTRASE® MT20 in treating pancreatic insufficiency in cystic fibrosis. Poster presented at: 2008 Digestive Disease Week; May 17-22, 2008; San Diego, CA.
8. Kalivianakis M, Minich DM, Bijleveld CM. Fat malabsorption in cystic fibrosis patients. Nutrition Research Newsletter 1999. Available at http://findarticles.com/p/articles/mi_m0887/is_4_18/ai_54466788. Accessed May 14, 2008.
9. Khan K, Schwarzenberg SJ. Gastrointestinal disease associated with cystic fibrosis. US Respiratory Disease 2007. Available at http://www.touchrespiratorydisease.com/gastrointestinal-disease-associated-witha7760- 1.html. Accessed May 14, 2008.
10. Wolters Kluwer TRx Report, April 2008.
11. FingerTip Formulary, Percent of Lives as of July 30, 2008.
12. Hendeles L. Letters to the editor: unapproved generic enzymes. J. of Pediatric Pharmacology and Therapeutics 2001;6:10-
