Boehringer Mannheim Gmbh

Roche Diagnostics Gmbh

Hoffmann-la Roche Inc.

Heidelberg Pharma Holding Gmbh

Heinrich Woog

Werner Gruber

Gerhard Winter

Rolf-Dieter Gabel

Fritz Demmer

Hans-Jorg Markl

Rainer Rudolph

Uwe Michaelis

Werner Rothe

Walter Preis

Alexander Wirl

Werner Heller

Stephan Fischer

Ulrich Kohnert

Bernhard Pichler

Markus Mattern

Georg Kallmeyer

J&ouml;rn M&ouml;ckel

Christian Klessen

Hans-J&ouml;rg Markl

Jorn Mockel

Frtiz Demmer

Joern Moeckel

The invention concerns lyophilized pharmaceutical preparations of monoclonal or polyclonal antibodies which contain a sugar or an amino sugar, an amino acid and a surfactant as stabilizers. In addition the invention concerns a process for the production of this stable lyophilizate as well as the use of a sugar or amino sugar, an amino acid and a surfactant as stabilizers for therapeutic or diagnostic agents containing antibodies.

Stable lyophilized pharmaceutical preparations of monoclonal or polyclonal antibodies

The present invention relates to a rapid and readily reproducible process for stabilizing biologically active substances by combining the biologically active substance witha a stabilizingmixture and drying the resulting mixture into a dry, amorphous product by means of convection drying. The invention also relates to the amorphous, microscopically homogeneous products which are obtained by this process, are in the form of powders and have a uniform geometric, in particular spherical, shape. The invention furthermore relates to the use of substance mixtures for stabilizing biologically active material, in particular proteins by means of spray drying.

Method of stabilizing biologically active substances

Ready-to-use, aqueous injection solutions containing carvedilol (1-(9H-carbazolyl-4-yloxy)-3-&lsqb;&lsqb;(2-(2-methoxyphenoxy)ethyl&rsqb;-amino&rsqb;-2-propanol) or its pharmacologically harmless salts which are stable in storage and are well tolerated by veins are disclosed.

Stabilized carvedilol injection solution

The invention relates to a solid pharmaceutical form of administration containing a diphosphonic acid or a physiologically compatible salt thereof as the active substance, wherein the active substance is present in granulate form, optionally together with pharmaceutical adjuvants in the inner phase, and the outer phase contains a lubricant in the form of less than 5% by weight of stearic acid relative to the total weight of the form of administration.

Pharmaceutical composition containing diphosphonic acid or salt thereof

The present invention concerns solid instant-release forms of administration (IR form of administration) comprising therapeutic active substances or active substance concentrates in particular lipid conjugates of nucleosides which have gel-forming properties in aqueous media as well as processes for their production.

Solid instant-release forms of administration and process for producing the same

The present invention relates to a process for the preparation of bisphonate-containing pharmaceutical compositions for oral administration wherein the active substance is wet-granulated in a fluidized-bed granulator and the wet granulate is dried in the fluidised bed granulator. The dried granulate is further processed to produce desired dosage forms.

Process for making bisphosphonate compositions

The present invention concerns a process for the production of well-tolerated, preserved injection or infusion solutions containing human protein.

Process for the production of pharmaceutical preparations containing human protein for infusion or injection purposes

Oral pharmaceutical preparation containing ibandronat

Aqueous pharmaceutical preparations of G-CSF are disclosed that are stable on storage and a buffer selected from the group consisting of a salt of citrate, maleate, a combination of phosphate and citrate, and arginine; and at least one surfactant.

Growing community of inventors

Laudenbach, Germany

Heinrich Woog