Abstract: The present invention relates to a liquid pharmaceutical formulation, which is stable at room temperature, being essentially free of water, comprising a) at least one easily degradable active pharmaceutical ingredient, b) at least one pharmaceutically acceptable organic solvent and c) at least one pharmaceutically acceptable alkaline earth metal salt and its use in medicine.

Abstract: The present invention relates to a liquid pharmaceutical formulation, which is stable at room temperature, being essentially free of water, comprising a) at least one easily degradable active pharmaceutical ingredient, b) at least one pharmaceutically acceptable organic solvent and c) at least one pharmaceutically acceptable alkaline earth metal salt and its use in medicine.

Abstract: The present invention relates to a liquid pharmaceutical formulation, which is stable at room temperature, being essentially free of water, comprising a) at least one easily degradable active pharmaceutical ingredient, b) at least one pharmaceutically acceptable organic solvent and c) at least one pharmaceutically acceptable alkaline earth metal salt and its use in medicine.

Abstract: The invention relates to aqueous pharmaceutical compositions comprising the compound 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}-N-(methylsulfonyl) acetamide; glycine; polysorbate 20; and an aqueous phosphate buffer, wherein the relative amounts are as described in the description, wherein the pH of said pharmaceutical composition is between about 7 and 8; to lyophilized pharmaceutical compositions prepared from said aqueous compositions, and to reconstituted aqueous compositions thereof which are suitable for i.v. administration. The invention further relates to processes for the preparation of said compositions, and to their use for the treatment of diseases and disorders which are related to IP receptor.

Abstract: The present invention relates to stable aqueous formulations comprising at least 5 mg/mL CD-RAP and a charged amino acid, said amino acid preferably having a net charge at a pH between about 6 and 8. The ingredients of the formulation preferably provide stability over repeated freeze-thaw cycles. In a preferred aspect, the formulation is for use in therapy, preferably for use in the treatment of inflammatory disorders, preferably osteoarthritis. Furthermore, a kit comprising the formulation of the invention is provided.

Abstract: The present invention is directed to an improved lyophilization process wherein a plurality of vials is not in contact with the shelf of the lyophilization device. The present invention is further directed to lyophilization cake and intermediate cake obtainable according to the process of the invention.

Abstract: The present invention relates to stable aqueous formulations comprising at least 5 mg/mL CD-RAP and a charged amino acid, said amino acid preferably having a net charge at a pH between about 6 and 8. The ingredients of the formulation preferably provide stability over repeated freeze-thaw cycles. In a preferred aspect, the formulation is for use in therapy, preferably for use in the treatment of inflammatory disorders, preferably osteoarthritis.

Abstract: The present invention relates to dried reconstituted vesicle (DRV) compositions and water based formulations thereof, which contain one or more therapeutic agents (e.g. hydrophilic protein). More particularly, it relates to DRVs comprising at least one lipid and a fusion promoting agent which after reconstitution form large multilamellar liposomes encapsulating an active agent in an aqueous phase.

Abstract: The present invention relates to stable aqueous formulations comprising at least 5 mg/mL CD-RAP and a charged amino acid, said amino acid preferably having a net charge at a pH between about 6 and 8. The ingredients of the formulation preferably provide stability over repeated freeze-thaw cycles. In a preferred aspect, the formulation is for use in therapy, preferably for use in the treatment of inflammatory disorders, preferably osteoarthritis. Furthermore, a kit comprising the formulation of the invention is provided.

Abstract: The present invention relates to a spinal nucleus pulposus implant for use in the treatment of the intervertebral disc and in particular, to the use of a CD-RAP protein therefore.

Abstract: The present invention relates to a device having osteoinductive and osteoconductive properties in vivo comprising a carrier containing calcium phosphate and an osteoinductive protein, wherein the carrier is homogenously coated with the protein. Moreover, the present invention relates to a method for the production of a device having osteoinductive and osteoconductive properties in vivo. The invention encompasses a pharmaceutical composition comprising the device of the invention or a device which is obtainable by the method of the invention and relates to the use of the device 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. Finally, the invention relates to a kit comprising the device of the invention or a device which is obtainable by the method of the invention.

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 device having osteoinductive and osteoconductive properties in vivo comprising a carrier containing calcium phosphate and an osteoinductive protein, wherein the carrier is homogenously coated with the protein. Moreover, the present invention relates to a method for the production of a device having osteoinductive and osteoconductive properties in vivo. The invention encompasses a pharmaceutical composition comprising the device of the invention or a device which is obtainable by the method of the invention and relates to the use of the device 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. Finally, the invention relates to a kit comprising the device of the invention or a device which is obtainable by the method of the invention.

Abstract: The present invention relates to a method of coating of a device, preferably implants, with a substance comprising the steps of (a) contacting said device into a solution of said substrate or substance, and (b) drying said device while being submerged in said solution. The present invention also relates to a packaging container for a device, preferably an implant. Said packaging container being adapted such that said device is coatable within said packaging container. Moreover, the present invention relates to a method of coating the inner surfaces of a packaging container for a device, preferably implants, to be coated by a substance, comprising the steps of (a) siliconizing said inner surfaces of said container using a silicone emulsion, and (b) heat-curing to form a baked-in silicone layer on said inner surfaces of said container.

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: The present invention relates to a method for producing a device comprising the steps of (a) providing a solution comprising dissolved osteoinductive protein, (b) contacting the solution of the preceding step with a carrier containing a surface of metal or a metal alloy, (c) allowing coating of the surface of said carrier with said dissolved protein and (d) drying of the coated carrier obtained in step (c) wherein steps (b) to (d) are carried out under a reduced concentration of oxygen. The invention also encompasses a device obtainable by the method of the present invention. Moreover, the present invention relates to a pharmaceutical composition comprising the said device and to the use of the device for the preparation of a pharmaceutical composition to be used for an accelerated osseointegration and new bone formation. Finally, the present invention relates to a kit comprising the device of the present invention.

Abstract: The present invention relates to a method for producing a device comprising the steps of (a) providing a solution comprising dissolved osteoinductive protein, (b) contacting the solution of the preceding step with a carrier containing a surface of metal or a metal alloy, (c) allowing coating of the surface of said carrier with said dissolved protein and (d) drying of the coated carrier obtained in step (c) wherein steps (b) to (d) are carried out under a reduced concentration of oxygen. The invention also encompasses a device obtainable by the method of the present invention. Moreover, the present invention relates to a pharmaceutical composition comprising the said device and to the use of the device for the preparation of a pharmaceutical composition to be used for an accelerated osseointegration and new bone formation. Finally, the present invention relates to a kit comprising the device of the present invention.

Abstract: The present invention relates to a method for producing a device comprising the steps of (a) providing a solution comprising dissolved osteoinductive protein, (b) contacting the solution of the preceding step with a carrier containing a surface of metal or a metal alloy, (c) allowing coating of the surface of said carrier with said dissolved protein and (d) drying of the coated carrier obtained in step (c) wherein steps (b) to (d) are carried out under a reduced concentration of oxygen. The invention also encompasses a device obtainable by the method of the present invention. Moreover, the present invention relates to a pharmaceutical composition comprising the said device and to the use of the device for the preparation of a pharmaceutical composition to be used for an accelerated osseointegration and new bone formation. Finally, the present invention relates to a kit comprising the device of the present invention.

Abstract: The present invention relates to a material having osteoinductive and osteoconductive properties in vivo comprising a ceramic carrier, preferably containing calcium phosphate, and an active agent, preferably an osteoinductive protein/peptide or a drug, and a polymer, wherein the active agent is homogeneously coated on the carrier and within the polymer, which is preferably a degradable polymer. Said polymer modulates the release kinetic of the active agent and protects same from degradation to prolong the half-life in vivo. Moreover, the present invention relates to a method for the production of a material having osteoinductive and osteoconductive properties in vivo.

Abstract: The present invention relates to a spinal nucleus pulposus implant for use in the treatment of the intervertebral disc and in particular, to the use of a CD-RAP protein therefore.