Abstract: The invention relates to a double chamber container for holding and combining two separate components, at least one of which is liquid, comprising a cylindrical body (15) with a closure (20, 60) at each of the two ends (5, 70) of the body (15), an upper closure (60) at the liquid component end and a lower closure (20) at the solid component end, and a separating stopper (40) in the cylindrical body (15) as a seal between the two chambers (30, 50), the separating stopper (40) having a height H and the upper closure (60) at the liquid component end being movable by the application of pressure, and comprising on its underside a hollow needle (45) with a length L having at least one opening (42) which is provided at the end opposite the tip, where H <L.

Abstract: The present invention relates to an apparatus for determining the shear sensitivity of particles in solutions and methods of determining the respective shear velocities or the respective shear stress.

Abstract: The invention therefore relates to protein-containing powders, wherein the proportion of phenylalanine is at least 30% (w/w), or at least 40% (w/w). It has been shown that phenylalanine-containing powders, particularly after spray drying, are very suitable in terms of their aerodynamic characteristics and protein stabilisation for preparing powders or protein compositions with improved aerodynamic properties. The main component is phenylalanine and the optional further component is an excipient which has good water-solubility compared with phenylalanine, preferably a sugar or a polyol.

Abstract: The invention relates to the controlled crystallisation of powders, particularly spray-dried powders, for improving the flowability and the aerodynamic characteristics thereof and a method of reducing the electrostatics of a powder.

Abstract: The present invention relates to spray-dried amorphous powders which contain a pharmaceutical active substance and a matrix-forming agent, preferably a polymer, sugar or sugar alcohol in an amount of ?20-60% (w/w). The powders have a moisture content which is less than 1.2% (w/w), preferably less than 1% (w/w). The present invention also relates to special methods of preparing such powders and methods of administering them by inhalation.

Abstract: A double chamber container for holding and combining a solid lyophilizate and a liquid reconstituting medium, comprising a cylindrical body (15) with a closure (20, 60) at each of the two ends (5, 70), an upper displaceable closure at the reconstituting medium end, and a lower closure (20) at the lyophilizate end, a separating stopper (40) that can be pushed in the cylindrical body (15) and act as a seal between the upper chamber (50) and the lower chamber 30), and a bypass (35) arranged underneath the separating stopper (40), with a length L that is preferably greater than the height H of the separating stopper (40), wherein at the upper end (70) in the wall of the cylindrical body (15) or in the separating stopper (40) means (75, 45) are provided that allow partial connection of the interior of the cylindrical body (15) to the environment during the lyophilization.

Abstract: Double chamber container for holding and combining, e.g., a lyophilizate and a liquid reconstitution medium, comprising an integral cylindrical body (15) with a closure (20, 60) at each of the two ends (5, 70), an upper movable closure (60) to the side of the reconstitution medium and a lower closure (20) to the side of the lyophilizate, a separating stopper (40) that can be moved in the cylindrical body (15) as a seal between the upper chamber (50) and the lower chamber (30), a bypass (35), arranged below the separating stopper (40), having a length L greater than the height H of the separating stopper (40), wherein at the lower end (5) in the wall of the cylindrical body (15) or in the lower stopper (20) there are provided means (21, 25, 28) that allow connection of the interior of the cylindrical body (15) to the environment during the lyophilization.

Abstract: The invention relates to a double chamber container for holding and combining two separate components, at least one of which is liquid, comprising a cylindrical body (15) with a closure (20, 60) at each end (5, 70), of which the closure (60) at the end of a chamber containing the liquid component (50) can be pushed, and a separating stopper (40) which can only be pushed by increased pressure, which is mounted in the cylindrical body (15), which defines the volume of the chamber (30, 50) mounted above and below, as a seal between the two chambers (30, 50), with an opening (42) running therethrough along its longitudinal axis, said opening having an upper part (42a) to the side of the chamber containing the liquid component (50) that is closed off in fluid-tight manner by a shaped member that is movable by gentle to moderate pressure (45).

Abstract: The invention relates to a double chamber container for holding and combining two separate components, at least one of which is liquid, comprising a cylindrical body (15) with a closure (20, 60) at each of the two ends (5, 70) of the body (15), an upper closure (60) at the liquid component end and a lower closure (20) at the solid component end, and a separating stopper (40) in the cylindrical body (15) as a seal between the two chambers (30, 50), the separating stopper (40) having a height H and the upper closure (60) at the liquid component end being movable by the application of pressure, and comprising on its underside a hollow needle (45) with a length L having at least one opening (42) which is provided at the end opposite the tip, where H<L.

Abstract: The present invention relates to compositions, preferably powdered compositions such as spray-dried or freeze-dried powders, containing an antibody or and antibody derivative 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 those which contain lactosucrose or a combination of glucosyl and maltosyl sucrose.

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 powders, preferably spray-dried powders, which contain a pharmaceutical active substance and low-molecular dextran as excipient. Also disclosed are processes for preparing such powders and methods of administering them by inhalation.

Abstract: The present invention relates to a continuous low pressure extrusion process for preparing liposomes, processes for preparing complexes consisting of correspondingly prepared liposomes and nucleic acid molecules (lipoplexes), processes for the stable storage of corresponding lipoplexes, and correspondingly prepared liposomes and lipoplexes.