摘要:
The present invention relates to a coating system, in particular to a coating system for articles where plastic materials slide against flexible rubber materials. The coating system is a silicone oil based coating having a viscosity of at least 200,000 centistokes, i.e. a high viscosity coating. The coating comprises in a preferred embodiment a silicone oil based block or graft copolymer, or segmented copolymer. Further the invention relates to a process of producing a component of an article coated as described above, comprising adding the coating material to the component material prior to molding and subsequently molding the component from the mixture, or molding the component from the component material and subsequently applying the coating material to the at least one surface of the component, as well as an article coated with a silicone oil based coating as defined above. Such an article is preferably a medical article, such as a container or an injection cylinder and a stopper. The coatings according to the present invention are especially suited to use for permanently coating internal surfaces of containers equipped with stoppers for storage and administration of liquid protein preparations. The coatings providing low friction between the two components, such as a container wall and a rubber stopper, result in high-precision dosing. The described coatings are particularly useful for coating containers for storage and administration of liquid protein solutions, such as insulin formulations.
摘要:
The present invention relates to a medical article for containing a pharmaceutical protein preparation comprising at least a first component and a second component, having at least one surface coated with a coating to reduce the friction between the two components and to reduce the protein adsorption to the coating. The coating is a hydrophilic coating whereby the hydrophilicity of the surface of the coating as measured by the water contact angle is below 90°, and the long term static friction forces between the first and the second component are below 14 N. The coatings according to the present invention are especially suited for permanently coating in ternal surfaces of containers equipped with stoppers for storage and administration of liquid protein preparations, such as insulin preparations. The coating is preferably a silicon-containing coating, such as a poly(dialkyl siloxane) oil or copolymer. The invention further relates to a process of producing a component of a medical article coated as described above, comprising adding the coating material to the component material prior to molding and subsequently molding the component from the mixture, or molding the component from the component material and subsequently applying the coating material to the at least one surface of the component, and hydrophilizing the coating material prior to the molding or after the molding. Also the invention relates to a coating as defined above for articles having at least a first component and a second component.
摘要:
A medicament container for storing a liquid medicament, such as insulin, comprises a wall with at least two opposite portions made of a polymer material having a light transmission at 400 nm of at least 25%, a glass transition temperature above 50° C., and a density of 0.95 g/cm3 or more. The polymer material comprises at least 70% by weight of a copolymer material composed of aliphatic cyclic or bicyclic hydrocarbons with 5 to 7 membered ring or rings and ethylene or propylene. The container is substantially inert to the medicament and, because it is either transparent or at least includes at least two opposed transparent portions, it is possible visually to inspect the contents of the container to make sure that the medicament has not crystalized or polymerized. The walls of the container provide a good barrier against m-cresol/phenol/benzyl alcohol preservatives and water.
摘要翻译:用于储存诸如胰岛素的液体药物的药物容器包括具有至少两个相对部分的壁,所述至少两个相对部分由聚合物材料制成,所述聚合物材料在400nm处的透光率至少为25%,玻璃化转变温度高于50℃, 且密度为0.95g / cm 3以上。 聚合物材料包含至少70重量%的由具有5至7元环或环的脂族环或双环烃和乙烯或丙烯组成的共聚物材料。 容器对药物基本上是惰性的,并且由于其是透明的或至少包括至少两个相对的透明部分,所以可以在目视上检查容器的内容物以确保药物未结晶化或聚合。 容器壁提供了对间甲酚/苯酚/苯甲醇防腐剂和水的良好屏障。
摘要:
A medicaments, container for storing a liquid medicament comprising one or more active medicaments, water and at least one preservative has a preferably cylindrical wall defining an interior space for such liquid medicament. The wall includes at least two opposed portions composed of a polymer material with a thickness of between 0.3 mm and 3 mm, a light transmission at 400 nm of 25% or more measured through the opposed container wall portions when the container is filled with water, using a standard spectrophotometer and air as reference. The polymer wall portions are of a material comprising at least 70% by weight of a linear optionally branched polyolefin material, the olefin monomer being selected from ethylene, propylene, butylene or a mixture thereof The polyolefin material has a crystallinity above 35% by weight, measured by differential scanning calorimetry, by cutting pieces from the container walls and heating them in an aluminum pan from 10.degree. C. to 270.degree. C. at the scanning rate of 10.degree. C./min, recording and integrating the melting endotherms, and using the value of 209 J/g for 100% crystalline polypropylene as a reference.
摘要:
The present invention relates to a medication delivery device comprising a cartridge assembly, a dosing assembly and optionally a needle assembly. The cartridge assembly comprises a cartridge having a stopper adapted to receive a plunger means. Furthermore, the cartridge assembly has one end sealed with a pierceable sealing, said end comprising coupling means for engaging a needle assembly, and another end comprising coupling means for engaging the dosing assembly. At least one of the coupling means of the cartridge assembly is unitarily moulded with the cartridge. The dosing assembly comprises a plunger means and has coupling means for engaging the cartridge assembly. The cartridge assembly and the dosing assembly are coupled together for delivering selected doses of medication. The cartridge is preferably moulded from a plastic material, such as a transparent material, and may be housed in a cartridge housing for protection of the cartridge. The coupling means may be selected from threaded locks, snap locks, hinged locks, or bajonet locks. The medication delivery device is especially suitable for delivering insulin, growth hormone or other medicines.
摘要:
A sensor package is provided comprising an implantable sensor having an electrode area and an electric contact area, the package comprising a shielding packaging enclosing at least the electrode area of the sensor while exposing the electric contact area. The sensor package fascilitates handling of the implantable sensor and provides for the possibility of sterilising the electric contact area leaving the electrode area protected.
摘要:
The present invention relates to a transfer device for transferring medicament from a medicament container to a syringe with a needle. The transfer device is arranged for transferring accurate dosages of insulin, growth hormone or other medicaments. The accuracy is ensured by the device comprising means for mounting a syringe to the device, the needle piercing a sealing of the device. Opposite the sealing a piston is arranged, said piston being non-releasable engaged with the piston driver during transfer of the medicament. Thereby the piston is not erroneously drawn from the piston driver, which would otherwise lead to incorrect dosing. Furthermore, the device comprises dosing means including the piston driver.
摘要:
The present invention relates to a drug delivery system, comprising a reservoir from which set doses are apportioned, a dose setting mechanism by which the relative position of two elements is changed by a distance proportional to a set dose, and a push button by activation of which an element is moved a distance corresponding to the distance proportional to the set dose, further comprises a working cylinder having an open end into which a plunger fits, and a closed end at which an inlet and an outlet port connect the space beneath the plunger with an inlet communicating with the reservoir and an outlet communicating with a drug delivery member, respectively. Valves means at the inlet and outlet control the passages from the reservoir to the working cylinder and from the working cylinder to the drug delivery member, respectively. The cylinder with the plunger, and the injection member are independently exchangeable, disposable parts.
摘要:
Solid pharmaceutical compositions for parenteral injection comprising a binder and at least one therapeutic agent. The pharmaceutical composition has the strength to be injected directly with the need of using cannulas or the like.
摘要:
Solid pharmaceutical compositions and methods of making and administering for parenteral injection comprising a binder and at least one therapeutic agent. The pharmaceutical composition has the strength to be injected directly with the need of using cannulas or the like.