PHARMACEUTICAL COMPOSITION COMPRISING PANCREATIN AND A LIPASE-CONTAINING COATING
The present invention relates to a pharmaceutical composition comprising pancreatin, which has a coating that contains a least one lipase. Preferably the at least one lipase is burlulipase. It also relates to a medicinal product comprising such a pharmaceutical composition. A method of producing such a pharmaceutical composition also forms part of the present invention.
1 . Pharmaceutical composition comprising pancreatin, having a coating that contains at least one lipase, wherein the pharmaceutical composition comprises a core which contains pancreatin onto which the coating is applied, characterised in that the at least one lipase used in the coating is a lipase different from the lipases present in the pancreatin.
2 . Pharmaceutical composition according to claim 1 , characterised in that the activity of the at least one lipase is stable against the in vitro simulated effect of gastric acid.
3 . Pharmaceutical composition according to any one of claim 1 or 2 , characterised in that the at least one lipase is a bacterial lipase.
4 . Pharmaceutical composition according to any one of claim 1 , 2 or 3 , characterised in that the at least one lipase is burlulipase.
5 . Pharmaceutical composition according to any one of claims 1 to 4 , more particularly according to claim 4 , characterised in that it does not have a gastric juice-resistant coating.
6 . Pharmaceutical composition according to any one of claims 1 to 5 , characterised in that it comprises a core that is selected from the group consisting of tablets, micro-tablets, fast disintegrating micro-tablets, granulates, pellets and powders.
7 . Pharmaceutical composition according to any one of claims 1 to 6 , characterised in that it comprises a core that is a fast disintegrating micro-tablet.
8 . Pharmaceutical composition according to any one of claims 1 to 7 , characterised in that the coating comprises burlulipase and a binding agent.
9 . Pharmaceutical composition according to any one of claims 1 to 8 , characterised in that the coating comprises burlulipase and hydroxypropyl methylcellulose
10 . Pharmaceutical composition according to any one of claims 1 to 9 , characterised in that in its coating it exhibits a lipolytic activity in the range from 10,000 to 500,000 TBU/g.
11 . Medicinal product comprising a composition according to any one of claims 1 to 10 .
12 . Medicinal product according to claim 11 for the prevention and/or treatment of digestive disorders.
13 . Medicinal product according to any one of claim 11 or 12 for the prevention and/or treatment of exocrine pancreatic insufficiency in patients with cystic fibrosis.
14 . Method of manufacturing a pharmaceutical composition according to any one of claims 1 to 10 , comprising the steps:
Provision of pancreatin,
Provision of a coating composition for the coating containing at least one lipase,
Coating of the pancreatin with the coating composition for the coating.
15 . Method according to claim 14 , characterised in that the pancreatin is provided in the form of a pancreatin-containing fast disintegrating micro-tablet and the coating composition for the coating is a solution of burlulipase, hydroxypropyl methylcellulose and possibly other auxiliary substances in water.