Boehringer Ingelheim Pharma Gmbh & Co Kg

Boehringer Ingelheim International Gmbh

Stefan Bassarab

Patrick Garidel

Wolfgang Friess

Torsten Schultz-Fademrecht

Karoline Bechtold-Peters

Richard Fuhrherr

Andreas Langer

Markus Hemminger

Ingo Michael Presser

Alexander Bauer

Nicole Denkinger

Hans-Joachim Kern

Hans-Hoachim Kern

Double chamber container for holding and combining, e.g., a lyophilizate and a liquid reconstitution medium, comprising

Dual chamber container for lyophilization, process for the filling up and use thereof

A double chamber container for holding and combining a solid lyophilizate and a liquid reconstituting medium, comprising a cylindrical body with a closure at each of the two ends, an upper displaceable closure at the reconstituting medium end, and a lower closure at the lyophilizate end, a separating stopper that can be pushed in the cylindrical body and act as a seal between the upper chamber and the lower chamber, and a bypass arranged underneath the separating stopper, with a length L that is preferably greater than the height H of the separating stopper, wherein at the upper end in the wall of the cylindrical body or in the separating stopper means are provided that allow partial connection of the interior of the cylindrical body to the environment during the lyophilization.

Dual chamber container and process for its filling up

The present invention concerns powders containing a pharmaceutical active substance and a combination of excipients comprising at least one 1,4 O-linked saccharose derivative selected from the compounds: 1,4 O-linked D-Gal-saccharose (lactosucrose), 1,4 O-linked D-Glu-saccharose (glucosyl sucrose), or 1,4 O-linked Glu-Glu-saccharose (maltosyl sucrose) in combination with at least one further excipient. The other excipient is preferably an amino acid, a peptide and/or a mono-, di- and/or oligosaccharide, wherein the oligosaccharide may be a second 1,4 O-linked saccharose derivative, provided that this is different from the first.

Powder comprising new compositions of oligosaccharides and methods for their preparation

The present invention relates to a spray-dried powder and method for its manufacture. A spray dried powder containing a pharmaceutical active substance and one or more 1,4 O-linked saccharose derivatives chosen from the compounds: 1,4 O-linked D-gal-saccharose (lactosucrose), 1,4 O-linked D-glu-saccharose (glucosyl sucrose) or 1,4 O-linked glu-glu-saccharose (maltosyl sucrose). Preferred combinations are such that they contain glucosyl and maltosyl sucrose.

Spray-dried powder comprising at least one 1,4 O-linked saccharose-derivative and methods for their preparation

Disclosed are applications of oligosaccharides/oligosaccharide mixtures for the production and stabilization of pharmaceutical compositions, chiefly powders, that contain antibodies or antibody derivatives as pharmaceutical active substance. The production of powders is accomplished through spray drying or freeze drying. Also disclosed are the corresponding antibody-containing powders as well as processes for their production.

1,4 O-linked saccharose derivatives for stabilization of antibodies or antibody derivatives

Growing community of inventors

Biberach, Germany

Stefan Bassarab