Budesonide alone or in combination with ursodeoxycholic acid in the therapy of cholestatic liver diseases

• US 5,858,998 A
• Filed: 09/30/1997
• Issued: 01/12/1999
• Est. Priority Date: 09/26/1997
• Status: Expired due to Term

• Current Assignee: Dr Falk Pharma GmbH
• Original Assignee: Dr Falk Pharma GmbH
• Inventors: Leuschner, Maria
• Primary Examiner(s): HENLEY III, RAYMOND J
• Application Number:
  US08/940,211
• Time in Patent Office: 469 Days
• Field of Search: 514/171
• US Class Current: 514/171
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/575 substituted in position 17 beta by a chain of three or more carbon atoms, e.g. cholane, cholestane, ergosterol, sitosterol
• CPC Class Codes: A61K 31/58 containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin digitoxin A61K31/7048

Abstract

According to the invention it was unexpectedly found that budesonide can be used for the treatment of cholestatic liver diseases such as PBC, PSC and AC. In particular budesonide is highly effective when administered together with ursodeoxycholic acid.

Claims

1. A pharmaceutical pack comprising a pharmaceutical composition comprising budesonide as pharmaceutically active agent and a pharmaceutical composition comprising ursodeoxycholic acid as pharmaceutically active agent for joined or timely shifted administration.

2. A pharmaceutical composition comprising budesonide and ursodeoxycholic acid.

3. A method for treating a cholestatic liver disease comprising administering to a human afflicted with cholestatic liver disease, an amount of budesonide effective to alleviate a symptom of the disease.

4. The method of claim 3 wherein the cholestatic liver disease is primary biliary cirrhosis.

5. The method of claim 3 wherein the cholestatic liver disease is primary sclerosing cholangitis.

6. The method of claim 3 wherein the cholestatic liver disease is autoimmune cholangitis.

7. A method for treating a cholestatic liver disease comprising administering to a human afflicted with cholestatic liver disease a combination of budesonide and ursodeoxycholic acid.

8. The method of claim 7 wherein the cholestatic liver disease is primary biliary cirrhosis.

9. The method of claim 7 wherein the cholestatic liver disease is primary sclerosing cholangitis.

10. The method of claim 7 wherein the cholestatic liver disease is autoimmune cholangitis.