Dr. Falk Pharma Gmbh

Markus Proels

Rudolf Wilhelm

Roland Greinwald

Ralph Mueller

Tanju Nacak

Erik Fischer

Heidi Waenerlund Poulsen

Ansgar Boegershausen

Disclosed is an optimized pharmaceutical formulation for the treatment of inflammatory conditions of the esophagus. A pharmaceutical formulation in the form of an orodispersible effervescent tablet is stable, easy to produce, and can be used without dissolving same in a liquid. It is not necessary to drink anything with the tablet as this would reduce the time that the budesonide solution remains in the affected regions of the esophagus. The effervescent tablet of the invention surprisingly resulted in an unexpectedly high rate of histological remission in patients with active eosinophilic esophagitis.

Optimized pharmaceutical formulation for the treatment of inflammatory conditions of the esophagus

An optimized pharmaceutical formulation for the treatment of inflammatory diseases of the colon is disclosed, wherein the pharmaceutical formulation is a capsule containing pellets, which capsule is suitable for oral administration and delivers the active substance in a targeted manner to the site of action, namely the colon. This is achieved by a complex and multiple coating of pellets, which permit a modified release of active substance. The release of the active substance is at its maximum only in the colon, with at the same time low blood plasma levels. The results of the pharmaceutical tests concerning in vitro release are corroborated by the results in pharmaco-kinetic and clinical studies and the clinical efficacy demonstrated by these. The formulation according to the invention has a very good medicinal safety.

Pellets having a multi-layer structure for delayed release of the active substance in the distal colon

The present invention relates to a pure polymorph of Nor-UDCA or Bis-nor-UDCA, or of a pharmaceutically acceptable salt thereof. The invention further provides a pharmaceutical composition comprising the polymorph of the invention, and a method for preparing the polymorph. The invention includes the pharmaceutical use of the polymorph or of the pharmaceutical composition of the invention.

Optimized synthesis of pure, non-polymorphic, crystalline bile acids with defined particle size

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Freiburg/Breisgau, Germany

Markus Proels