Abstract: The present invention provides for a suspension formulation comprising a protein particle suspended in a non-aqueous vehicle, wherein the particle comprises a protein and a stabilizing agent, and wherein the residual water content of the suspended protein particle is less than 1.0 wt % based on total weight of the particle.

Abstract: A veterinary pharmaceutical composition, including at least one active veterinary pharmaceutical substance which is selected among gonadorelin and gonadorelin analogs as well as salts of gonadorelin and of the gonadorelin analogs, is provided. The composition includes a liposome-free matrix which delays the release of the active veterinary pharmaceutical substance from the composition, which matrix includes a basic material which is selected from the group consisting of natural and synthetic triglycerides, vegetable oils, diacylpropanediols, diacylbutanediols and mixtures of these substances, the veterinary pharmaceutical composition including no biodegradable polymer.

Abstract: A method for producing a polyglycerol nanogel is disclosed, the method comprising the following steps: Mixing an aqueous solution of first polyglycerol macromonomers, which are modified with a first reactive group, with an aqueous solution of second polyglycerol macromonomers, which are modified with a second reactive group, wherein the first reactive group and the second reactive group can react with each other forming a chemical bond; transferring the mixture into an organic non-solvent; and precipitation of a polyglycerol nanogel consisting of first polyglycerol macromonomers and second polyglycerol macromonomers which are covalently bound to each other. According to an aspect of the invention, the method is characterized in that the organic non-solvent is miscible with water and in that the method is carried out without adding surface-active substances.

Abstract: A veterinary pharmaceutical composition, including at least one active veterinary pharmaceutical substance which is selected among gonadorelin and gonadorelin analogs as well as salts of gonadorelin and of the gonadorelin analogs, is provided. The composition includes a liposome-free matrix which delays the release of the active veterinary pharmaceutical substance from the composition, which matrix includes a basic material which is selected from the group consisting of natural and synthetic triglycerides, vegetable oils, diacylpropanediols, diacylbutanediols and mixtures of these substances, the veterinary pharmaceutical composition including no biodegradable polymer.

Abstract: The invention provides a monitoring device (32) for a dryer (10) includes a means for sensing a physical parameter, such as temperature or strain, at a sensing locus within the dryer (10), for example at a vial (20). The sensing means comprises an optical sensing fiber (38) having at least one fiber Bragg grating (54). Moreover, the invention provides a dryer, in particular a freeze dryer (10), which is equipped with such monitoring device (32).

Abstract: A method for producing a polyglycerol nanogel is disclosed, the method comprising the following steps: Mixing an aqueous solution of first polyglycerol macromonomers, which are modified with a first reactive group, with an aqueous solution of second polyglycerol macromonomers, which are modified with a second reactive group, wherein the first reactive group and the second reactive group can react with each other forming a chemical bond; transferring the mixture into an organic non-solvent; and precipitation of a polyglycerol nanogel consisting of first polyglycerol macromonomers and second polyglycerol macromonomers which are covalently bound to each other. According to an aspect of the invention, the method is characterized in that the organic non-solvent is miscible with water and in that the method is carried out without adding surface-active substances.

Abstract: The invention provides a monitoring device (32) for a dryer (10) includes a means for sensing a physical parameter, such as temperature or strain, at a sensing locus within the dryer (10), for example at a vial (20). The sensing means comprises an optical sensing fiber (38) having at least one fiber Bragg grating (54). Moreover, the invention provides a dryer, in particular a freeze dryer (10), which is equipped with such monitoring device (32).

Abstract: The invention provides a monitoring device (32) for a dryer (10) includes a means for sensing a physical parameter, such as temperature or strain, at a sensing locus within the dryer (10), for example at a vial (20). The sensing means comprises an optical sensing fiber (38) having at least one fiber Bragg grating (54). Moreover, the invention provides a dryer, in particular a freeze dryer (10), which is equipped with such monitoring device (32).

Abstract: The invention provides a polymer based material comprising a water binding agent present in an amount sufficient to chemically and/or physically absorb and/or adsorb water to prevent degradation of the polymer. The invention also provides a polymer based material comprising a plasticizer or organic solvent as well as a multi-component material or composite including materials encompassing a second polymer and/or an active agent. The invention further provides a pharmaceutical composition comprising the aforesaid polymer based material, which can be used for treatment of bone, cartilage and/or periodontal defects.

Abstract: The present invention relates to a polymer based material comprising a water binding agent, whereas the water binding agent is present in an amount sufficient to chemically and/or physically absorb and/or adsorb water to prevent degradation of the polymer. It also relates to a polymer based material which comprises a plasticizer or organic solvent as well as a multi-component material or composite including materials encompassing a second polymer and/or an active agent. Furthermore it relates to a method for manufacturing the polymer comprising material and use of the material for the preparation of a pharmaceutical composition to be used for treatment of bone, cartilage and/or periodontal defects. The invention also encompasses a kit using the polymeric material.

Abstract: Disclosed are methods of making bioactive BMP-2 microparticles and methods of using the microparticles.

Abstract: The invention provides a monitoring device (32) for a dryer (10) includes a means for sensing a physical parameter, such as temperature or strain, at a sensing locus within the dryer (10), for example at a vial (20). The sensing means comprises an optical sensing fiber (38) having at least one fiber Bragg grating (54). Moreover, the invention provides a dryer, in particular a freeze dryer (10), which is equipped with such monitoring device (32).

Abstract: Disclosed are methods of making BMP-2 microparticles and methods of using the microparticles. These microparticles are prepared, for example, by mixing a solution containing BMP-2 with a second solution whose ionic concentration and pH results in the precipitation of the BMP-2.

Abstract: The invention relates to a method for stabilizing an aqueous protein solution against exogenous stress and to the use of a container for stabilizing an aqueous protein solution.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: The present invention relates to a polymer based material comprising a water binding agent, whereas the water binding agent is present in an amount sufficient to chemically and/or physically absorb and/or adsorb water to prevent degradation of the polymer. It also relates to a polymer based material which comprises a plasticizer or organic solvent as well as a multi-component material or composite including materials encompassing a second polymer and/or an active agent. Furthermore it relates to a method for manufacturing the polymer comprising material and use of the material for the preparation of a pharmaceutical composition to be used for treatment of bone, cartilage and/or periodontal defects. The invention also encompasses a kit using the polymeric material.

Abstract: An in-situ-hardening paste, containing an organic or inorganic filling material, a biodegradable polymer and a water soluble polymeric plasticizer was developed as a delivery system for an active agent with scaffold properties in the field of tissue regeneration. The hardened paste is sufficient mechanical stable to can be used as bone and cartilage replacement matrix. All components are full biocompatible, preferably bioresorbable and certified for parenteral application. The sustained release of peptides and proteins can be modulated by the composition and process design. The invention encompasses a pharmaceutical composition comprising the paste of the invention and relates to the use of said paste for the preparation of a pharmaceutical composition to be used for bone augmentation, for treating bone defects, for treating degenerative and traumatic disc disease, for treating bone dehiscence or to be used for sinus floor elevation.

Abstract: The invention relates to a method for stabilizing an aqueous protein solution against exogenous stress and to the use of a container for stabilizing an aqueous protein solution.