TW470643B - A sevoflurane-containing article and methods for storing sevoflurane - Google Patents

Abstract

A pharmaceutical product. The pharmaceutical product includes a container constructed from a material containing one or more of polypropylene, polyethylene, and ionomeric resins. The container defines an interior space. A volume of a fluoroether-containing inhalation anesthetic is contained in the interior space defined by the container.

Description

470643 V. Description of the Invention (l) This application is a partial supplement to the US patent application filed on January 9, 1998, ^ 0 9/004, 792, and dated January 22, 998, to 22, • c. Supplemented by Shan Qiuyi's U.S. Patent Application Series 0 9/0 04, 876. BACKGROUND OF THE INVENTION The present invention relates to a method for the use of inhaled anesthetics, such as narcotics, to capture inhalants. In particular, the present invention is directed to a container composed of a substance that provides an obstacle to the transmission through the container wall and does not interact with the inhaled anesthetic substance contained in the container. Reacting fluoroether inhaled anesthesia methyl) ethyl ether), ether), isoflurane (1-alkane (2, 2-digas-1, (desf1urane)) (2 packed in glass made of drunk effect, but The current possible interaction is generally believed to be due to the reverse degradation of the acid with a vain acceptable group (-C-〇-C ~ F), which can lead to the loading of these fluorine materials containing silica glass with its container wall. And prevent other agents such as sevoflurane (fluorofluorenyl-2, 2, 2 rat — (trifluoroanflurane (2-chloro-1,1,2, trifluoroethyldifluorinyl-2,2 , 2-difluoroethyldifluorofluorenyl group), methoxy i 1-difluoroethyl methyl ether), and fluoroether-difluorofluorenyl group 1,2'2,2-tetrafluoroethyl ether ), Generally in a container. Although these fluoroether agents show excellent hemp found that under certain conditions these fluoroether agents have a glass capacity ^, thus promoting the degradation of fluoroether agents. Such interactions; The material is caused by the presence of Lewis acid. The electron pair that is not shared by Louis is based on the alpha fluorine scale that can interact with the fluoroether agent. These fluoroether agents produce decomposition products such as hydrofluoric acid in the presence of Lewis acid _ The glass material used by the agent is called丨 丨 Type I glass. This is calcium hydroxide, sodium hydroxide, and alumina. Π 丨 Type: Hinders vapor transmission, thus preventing the fluoroether agent from passing there and flying into it. But broken materials such as 111 Inside glass

Page 6 470643 V. Description of the invention (2) '" --------, ^ 3 The oxidized queen lutein has the effect of Lewis acid when it is directly exposed to the fluoroether agent, thus promoting the degradation of the agent. Such a drop, such as hydrofluoric acid, will corrode the glass thinner "h ^ 1 Newton's decomposition product + chemical late + Yu Weng w glassware's inner surface, so there is more oxygen in some $, Ii 'further promotes the degradation of bonding compounds. Structural degradation products may destroy the junction of glass containers. People have worked hard to inhibit the reaction of glass with various chemical agents. Use ^ 1 I understand that there are on the surface of the glass container; it is unacceptable in many uses. In addition, the glass container also has concerns about breaking. = During holding or falling or other strong forces, broken will cause 11 Anesthetics that are exposed to the contents of glass containers evaporate quickly. If the glass contains: Ether M, the adjacent parts must be broken: 3 or the patient in the ward retreats. Daggers are like the efforts made by the operating room to avoid breakage. It is cold outside the glass bottle with polyethylene (PVC) or synthetic thermoplastic resin such as the product of contact with ε (J Nemours and ^ 叩叩 叩), which is an attempt to increase the cost of the container, and = Smeared 'can't overcome the above It will happen when Yingli is loaded with inhaled anesthetic containing vanilla. Niu Jiechi uses the + +, ^ device based on this principle to store, transport dry, and transport by volume other than C3%. And transport inhaled anesthetics' to avoid the above heartbreaking

470643 5r clearly explains (3) the disadvantages of the device. The preferred material does not contain Lewis acid, which promotes the degradation of inhaled anesthetics, has sufficient barriers to prevent vapors from entering or exiting, and can increase the resistance to container breakage compared to glass containers. SUMMARY OF THE INVENTION The present invention is directed to a pharmaceutical product. The product includes a container made of a substance containing one or more polypropylene, polyethylene, and ionomer resin. This container defines an internal space in which a volume of fluoroether-containing inhaled anaesthetic | J is provided. In a specific embodiment, the present invention is directed to a pharmaceutical product, wherein a container defining an internal space has an internal surface adjacent to the internal space. The inner surface of the container is made of a substance containing one or more kinds of polypropylene, polyethylene, and ionomer resin. A volume of fluoroether-containing inhalation anesthetic is contained in the inner space of the container. The invention is also directed to a method of storing inhaled anesthetics. This method includes the step of providing a predetermined volume of fluoroether-containing inhalation anesthetic. A container is also provided which is composed of a substance containing one or more polypropylene, polyethylene, and ionomer resins. This container defines the interior space. A predetermined volume of inhaled anesthetic containing fluoroether is placed in the inner space of the container. In a specific embodiment of the method of the present invention, a predetermined volume of a fluoroether-containing inhalation anesthetic is provided. In addition, a container is provided that has an inner surface defining an inner space. The inner surface of the container is made of a substance containing one or more kinds of polypropylene, polyethylene, and ionomer resin. A predetermined volume of inhaled anesthetic containing fluoroether is placed in the inner space of the container. Brief illustration

Page 8 470643 V. Description of the invention (4) For a more complete understanding of the present invention, reference may be made to the following detailed description and accompanying drawings, wherein: FIG. 1 is a cross-sectional view of a pharmaceutical product manufactured according to the present invention. Detailed description of the invention The pharmaceutical products made according to the invention are generally shown in Figs. The medicinal product 10 includes a container 12 having an inner surface 14. The inner surface 14 surrounds the inner space 16 inside the container 12. The inhalation anesthetic 18 is contained in the internal space 16 of the container 12. In a preferred embodiment of the invention, the inhaled anesthetic 18 is a fluoroether compound. The fluoroether-containing inhalation anesthetics used in connection with the present invention include, but are not limited to, sevoflurane, enflurane, isoflurane, triflurane, and desflurane. The inhalation anesthetic 18 is a liquid and may include a liquid phase, a vapor phase, or a liquid phase and a vapor phase. The inhalation anesthetic 18 shown in Fig. 1 is a liquid phase. The purpose of the container 1 2 is to hold the inhaled anesthetic 18. In the specific embodiment shown in FIG. 1 of the present invention, the container 12 is bottle-shaped. However, it should be understood that the container 12 may have various configurations and volumes without departing from the spirit and scope of the present invention. For example, the container 12 may be in the configuration of a ship containing a large volume (eg, tens or hundreds of liters) of inhaled anesthetic 18. The cross section of such a ship may be square, spherical or oval without departing from the scope of the invention. The container 12 is preferably made of a material that minimizes the transmission of vapors into and out of the container 12, so that the amount of inhaled anesthetic 18 released from the internal space 16 of the container 12 is minimized, and thus the external of the container 12 The environment enters the internal space 16 and thus enters the vapor transmission of the inhaled anesthetic 18, such as water vapor transmission, to a minimum. The container 12 is also preferably composed of a material that does not promote degradation of the inhaled anesthetic 18. this

Page 9 470643

Description of the invention (5) _ In addition, the container 12 is preferably composed of materials that are stored and broken. During the cycle and the use of the container 1 2 will not now find 'contained by polyethylene extract _ used for inhalation anesthesia pads; containers made of materials are in use, and strength characteristics ... so this hinder' chemical interactions have many acid esters Species :: i molecular weight, six # solution to 'polyvinyl naphthalene is not the same. This kind of polymer can be divided into :: · 物 is and ^ blend. It is now known that, compared with the compound, the poly (ethylene) _. P sentence polymer, /, polymer, compared to the compound, can provide vapor transport: ^ polymer and copolymer and blending will understand that a certain polynaphthalic acid Vinegar Homopolymer. However, according to the present invention, the prerequisite is that the 苴 g J ester copolymer and blend can be used to have suitable transmission obstacles, such as inhalation of anesthetic and water vapor, and the anesthetic 18 has no interaction. ',,, and pieces are characterized by their required strength and resistance to inhalation and vapor containment. . f Taxi I, so there is no danger of degradation of the package. Inhalation anesthesia agent of Gu, Gu Yi, and Deflurane has occurred. Polyethylene which can be used in the present invention __

HiPERTUFTM 90 〇〇〇〇 poly # t ;;, an example of monomethyl ester material is a product name), a poly / Yue Ji February February (She11 Chemical Company's commercial formic acid vinegar.-General artist Senna ;; formic acid vinegar The basic 2,6 dimethylnaphthalene diS is also inseparable from the present invention gg φ & to the use of other polyethylene naphthalenedicarboxylic acid in the range described in the scope of the present invention. The container 12 is composed of a layer of material

O: \ 57 \ 57230.PTD Page 10 V. Description of Invention (6) Success. That is, the thickness of the container 12 is substantially ~ ^ In the example, as mentioned above, the container 丨 2 is made of containing B— =. Here, the structure is specifically implemented. In another embodiment of the present invention, the term “multi-layer” means to include (i) a multi-layer layer consisting of a layer and a layer. The two less layers here are composed of different materials, which are the materials of the stomach, which are the same or have different functional characteristics. I, chemical and structural properties are not aligned with each other to form a single layer; (丨 丨 古The middle layers are combined together (iii) lined materials, which are coated with different materials; any of the materials described above are made of concrete; and (b) the inner surface 14 of the upper U is preferably composed of 〒 In specific embodiments, the container should be understood to be composed of a material containing fluorine-containing fenene succinate-acetate. Containing polyethylene! Dimethyl ester, the surface 14 of the container that is in contact with :: 5 is preferably gas. Degradation of inhaled anesthetics may be reduced: the two most impediments to the characteristics and at the same time containing ::: again-in the specific embodiment, '$ 器 12 is composed of polyprenyl ^. In the preferred embodiment is used Polycyclopentyl pentene. Cz ", an example of a polymethyl fluorene thin material is sold by Daikyo Resin. '疋 is manufactured by Dai kyo / Pharma-Gummi / West Croup. By: Κίΐίpent豨 Material. Or 'inner surface 14 Α container of pentene. In a specific embodiment, the underwear surface 14 may be in the form of M Λ 疋, α, 丄, and the like: (i) different materials, such as glass, which are defined by glass, are lined with lining; or (丨 1) in different materials The defined body is coated with Tu 111) —multi-layered materials, as discussed above for polyethylene storage—Tian Yueyue.

Page 11 V. Description of the invention (7) In the second embodiment of the present invention, "a material of propylene, polyethylene, and ionomer resin": by ::, the inner surface 14 of the poly 12 is made of poly Propylene, polyethylene, and ion = 疋, capacity 15 DuPont SURLYN ionomer resin structure ^ God "liquid bond resin 11-the word means the heat of ionic crosslinking, polymer. Two pounds: body In the embodiment, the inner surface 14 may be such that σ; the body defined by glass is built with a lining; or (仏 = in different materials, such as Cai Dijia 所) i: ... the material of the layer 'as discussed above In the second solution, various known techniques can be used in the container 12. Table f :: The better technique can be used to construct the materials used in the container 12. (11) The cold lollies to be applied to the container 12 ΛΛ depends on the coating material. For example, if the glass material structure A is removed, the container 12 can be heated to at least the melting point of the main coating material to be coated to make the inner surface of the container 12 repeat. The coating C on the heated container 12, for example by atomizing the surface. Then the container is cooled to the coating material So that the coating can be judged as follows: $ & leave it out · point surface ". $ 复 物 枓 forms an early-breaking film or layer, which is shown in Figure 1 of the inner surface *, and the container 12 defines the opening α 2 〇. The opening 2 〇 can be used for the container 12 and use t / use μ / ㈤ J _ filled with crying 1 9 fine from βπ ~ then use 12 inside the contents, so that the outer can be closed when needed The opening 20 'closes the suction port 20a in the container 12, and the compound is taken out. As shown in FIG. 1, in the specific embodiment of the present invention, IL is clear ::. But it should be *, the opening 20 may There are various configurations without leaving the cover. 22 is the edge 4, -p

〇-A57 \ 57230.PTO Page 12 470643 丨 V. Description of Invention (8), Private j 1 6盍 22 can be composed of various known materials. Preferably, however, the lid 2 2 疋 is made of a material that minimizes the π transfer and a material that minimizes the degradation of the inhaled anesthetic agent 6. In a preferred embodiment of the present invention, the cover 22 has an inner surface 24 'This inner surface is made of polyethylene-containing material. Another embodiment of the present invention makes 97 objects called polypropylene-containing, polyethylene-containing, And / or away, the inner surface 24 of the second and second parts is made of vapor barrier characteristics of the material enough to reduce water vapor, and the material is composed, and the material delivery is minimized. In another embodiment of the present invention, the second aspect is: the transmission of the sword through it. The inner surface 24 is made of a polymethylpentene-containing progenitor: the upper cover 22 and / or its bamboo. She added that the cover 22 and / or its inner surface 24 may be made of polypropylene, and it should be understood that the old diphosphonate, polyfluorenylpentene, ionomer ethylene, polyethylene. As discussed in the discussion of the container 12, the cover 22: 2 ^, and mixtures thereof may be multilayered. The raw shell can be homogeneous, and the lid 22 and the container 12 can be constructed to form a container and a lid that can be screwed on the lid. It is well known. The lid 22 and the container are on it. This type is easy for a person skilled in the art to understand. These specific examples include, but are not limited to, moss that can be fastened on the container, other specific implementation caps, or those that are attached to the container by a known mechanism such as a collar. In a preferred embodiment, the lid 22 and the container 2 are removed from the container 12 of the present invention without forming the lid 22 or the container 12. The required volume is taken out to cause harm, so that the opening 20 can be closed with the lid 22. After the anesthetic 18, the container 12 also happens to include a twelve vessel 12 which does not form part of the present invention. Knives, features, such as' Rong Ye Zhi 8 delivered from container 12 to

Page 13 470643 V. Description of the invention (9) Configuration of anesthesia vaporizer. As issued to G r a b e n k 〇 r t of Yi Shu Shi 5, 5 0 5, 23 6 disclosed. ~ A method for manufacturing a container for use in the present invention is known. Example The polyethylene f-diphosphonate must be dried to about 0 before use, which is now known to be suitable for the physical properties of container 12 and lid 22. Used in this condensation ^. The preferred method for the humidity device 1 2 and the cover 22 is to spray-stretch-blow (丨 111) '6 (: 1: 丨 〇11-51 ^ 61 : 仏 -131〇 \ 〇 成 ^ Known materials for Technical Laboratory, Inc. of Tokyo 〖^ ° A〇KI Machine is particularly useful for this type of molding. Injection made of polyethylene zero two apan into the mold, Then move to the blowing table in the material container of $: 曱 Jun ester. Then heat this container in batches in a convection oven; ^ makeup, blowing to form it has been found that The degree of crystallinity of the material can not be achieved by single blow molding. The use of fire can increase this addition and form a barrier to vapor transmission, thereby enhancing the vapor barrier of the flame-increasing material with a crystallinity of 7 ^ `` 0 ''. Crystallization The increase of the degree also reduces the amount of material used for the container 1 2 which is the return of the formate (based on the weight to achieve the required container strength) and the total weight of the trough 1 2. The strength of the container during the load, storage and use of a large load 7 = can make the container in the lowest transport. For example, when the container 1 2 in transport or storage ^ ± When the container is broken up, or the box of the container 12-one stacked B ± 4 shall be stacked one by one. It should be noted that from annealed polyethylene ^, a larger container is required to have a stronger container. The glass container of the same strength is made of light π monoacetate material, which is not easy to break, and the manufacturing cost is also relatively high. The glass of the same weight of the driver is low. The lighter container weight also reduces the glass container with the same characteristics. π The cost for the construction of the wheel. In addition, 470643 V. Description of the invention (10) This type of container is also not an inventor's step. This ether's anflurane (desfurane), specifically, the acyl ester material structure 12 The inner surface 14 is described by multilayer polyethylene. The agent 16 of the present invention is placed in another container of inhaled anesthesia and various sevoflurane, (desf1urane), that is, the container 1 2 is formed, and the polymer can be provided with the container 1 2 The inner surface of the product is fluorinated ether. The inhaled anesthesia in the square ether of the present invention is a variety of sevoflurane, such as glass container, which includes inhaled isoflurane, which provides a fluorine puzzle. On it's can diacetate side The method also includes a clear method defined by the agent 16. This fluorofluoride also provides a homogeneous material that defines the internal methylpentane. This point has been achieved by inhaling the anesthetic device with a predetermined volume of fluorine containing anesthetic agent 16 6 According to the above-mentioned medical treatment, the polyethylene t in the internal space is composed of a container 12 and the inner volume includes a predetermined volume of the internal space of the inner space embodiment of the isoflurane-absorbing isoflurane. A is based on the above-mentioned production space, and is Exist in the capacity characteristics, or the above. The inhaling fluoroether of this hair agent 16 can be-and get the fluoroether drug product structure, and it is composed of the diformate homogeneous material surface 14 Fluorine, which provides pre-anesthetized oxyflurane, is composed of a polycontainer 12 and an inner layer is defined by a multi-layer polyamine method. The inhalation of anesthesia or multi-component containing polyethylene is an existing feature. Yu's aspiration volume of 16 can reach the fluorine container 12 based on the surface of pentene 1 4 fluorenyl includes the internal degradation. Intoxicant U Heptafluoride 1 2. Allen-TTt is contained in a container or is anesthetized with fluorine containing one or shout. On a specific material, the fluorinated olefin containing a predetermined volume of space is a one-or-bond method. In another specific embodiment, a predetermined volume of agent 16 is provided. This fluoroether-containing inhalation anesthetic 丨 6 can be female fluoroether, isoflurane, triflurane, and fluorine

Page 15 V. Description of the invention (11) (desf1urane) In other words, the container 1 2 ene, polyethylene, and the internal surface of the container 12 are made of multiple layers. The method also includes defining the interior of the container. . A container 12 constructed from the above product is also provided. A specific defined internal space 16 ′ is composed of a material containing-or a plurality of polypropylene and ionomer resins, wherein the material is on the surface 14 and may have the characteristics of a container 丨 2 homogeneous material, or the inner surface 14 of the material, This is already as described above. A predetermined volume of the fluoroether-containing inhalation anesthetic agent of the present invention is placed in a container space. The trough 1 2 and its inner surface 4 can be made of one or more of the above materials at each hair outlet 20, and the environment includes the extraction of diene and storage of two or more esters. And the liquid prepared in this way is provided by the polypropylene polymethyl container 1 2 in the formate-containing step, and the method has been performed here. A specific embodiment of the method is provided in the container 2 to communicate with the parent. In each hair-or polypropylene, poly 'and polymethylpentene, the cover 22 can be formed as such', polyethylene, and the material of the ion-bonded pentene. The method of defining the opening is specific and specific. The artist will attach the patents attached here. The container 12 can be bounded by the space 16 and the container method is specifically implemented. The cover made of ionic key tree material 2 2 The inner surface is made of 2 4 resin and polyethylene. The method of the present invention also includes an example to explain the understanding of the present invention. It can also determine the steps of opening the outer ring of 1 2 and reducing the fat and polyethylene. It is the essence of the present invention disclosed in the scope of

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Claims (1)

4706_ ： f | I _88105523_ Zhinian / (Month and Day Amendment _) 6. Application for patent scope 1. An inhalation anesthetic product comprising: a container containing a material selected from the group consisting of polyethylene naphthalate ), Consisting of polymethylpentane, polypropylene, polyethylene, ionomer resin compounds, and mixtures thereof, the container defines an internal space; and a sevoflurane having a volume, which is defined in the container, defines 2. The product according to item 1 of the scope of patent application, wherein the container defines an opening which provides liquid communication between the internal space of the container and the external environment of the container. The ether article also includes a lid which is configured to close the opening defined by the container. The lid contains materials selected from the group consisting of polypropylene, polyethylene, ionomer resin, polyethylene naphthalate, and polymethylene Compounds based on pentene and mixtures thereof. 3. The product according to item 1 of the scope of patent application, wherein the container defines an opening which provides the internal space of the container and the container. For liquid communication between the external environment, the sevoflurane-containing article further includes a cover with an inner surface, the cover is configured to close the opening defined by the container, and the inner surface of the cover is Material composition including polypropylene, polyethylene, polyethylene naphthalate, polypentylpentene, ionomer resin compounds and mixtures thereof 4. An inhalation anesthetic product comprising: A container having an inner surface adjacent to the inner space, the inner surface being composed of a material selected from the group consisting of polyethylene naphthalate, polymethylpentene, polypropylene, polyethylene, ionomer resin compounds, and mixtures thereof Material composition; and O: \ 57 \ 57230.ptc Page 1 2001.06.12.018 470643 _Case No. 88105523_p Year 『Month』 Amendment _ Sixth, the scope of patent application There is a volume of sevoflurane in this container. 5. The product according to item 4 of the scope of patent application, wherein the container defines an opening which provides liquid communication between the internal space of the container and the external environment of the container. The sevoflurane-containing article also includes A lid configured to close an opening defined by the container. The lid contains materials selected from compounds including polypropylene, polyethylene, ionomer resin, polyethylene naphthalate, and polypentylpentene. And its mixture. 6. The product according to item 4 of the scope of patent application, wherein the container defines an opening which provides liquid communication between the internal space of the container and the external environment of the container. The object containing hepta-II ether also includes A lid having an inner surface configured to close the opening defined by the container, the inner surface of the lid is made of a material selected from the group consisting of polypropylene, polyethylene, polyethylene naphthalate, and poly Lithylpentene, a compound of ionomer resin and its mixture. 7. A method for storing sevoflurane, the method comprising the steps of: providing a predetermined volume of sevoflurane; providing a container defining an internal space, the container being made of a material containing polyethylene naphthalate, Material composition of methylpentane, polypropylene, polyethylene, ionic resin compounds and mixtures thereof; and placing the predetermined volume of the sevoflurane in an internal space defined by the container. 8. The method for storing sevoflurane according to item 7 of the scope of patent application, wherein the container defines an opening that provides liquid communication between the internal space defined by the container and the external environment of the container, the Method package O: \ 57 \ 57230.ptc Page 2 2001.06.12.019 470643 _ Case No. 88105523_ ^ year month month amendment _ 6. The steps included in the scope of the patent application are: to provide a structure to close the opening defined by the container A lid made of a material containing a compound selected from the group consisting of polypropylene, polyethylene, polyethylene naphthalate, polypentyl pentene, ionomer resin, and a mixture thereof; and the container closed by the lid The opening defined. 9. The method for storing sevoflurane according to item 7 of the scope of patent application, wherein the container defines an opening that provides liquid communication between the internal space defined by the container and the external environment of the container, the The method further includes the steps of: providing a lid constituting to close the opening defined by the container, and the inner surface of the lid is made of a material selected from the group consisting of polypropylene, polyethylene, polyethylene naphthalate, and polymethyl A material consisting of a pentene, a compound of an ionomer resin, and a mixture thereof; and closing the opening defined by the container with the lid. 1 0. A method for storing sevoflurane, the method comprising the steps of: providing a predetermined volume of sevoflurane; providing a container defining an internal space, an inner wall of the container being adjacent to the internal space defined by the container, the The inner wall of the container is composed of a material selected from the group consisting of polyethylene dinaphthalene, polypentyl pentene, polypropylene, polyethylene, ionomer resin compounds, and mixtures thereof; and the predetermined volume of heptafluoro The ether is placed in the interior space defined by the container. 1 1. A method for storing sevoflurane according to item 10 of the scope of patent application, which O: \ 57 \ 57230.ptc Page 3, 2001.06.12.020 470643 _ Case No. 88105523_ ^ year month month amendment _ VI. In the scope of the patent application, the container defines its opening, and the opening provides the interior defined by the container For the liquid communication between the space and the external environment of the container, the method further comprises the steps of: providing a cover constituting to close the opening defined by the container, the cover is made of , Polyethylene naphthalate, polypentyl pentene, an ion-bonded resin compound, and a mixture thereof; and the lid is used to close the opening defined by the container. 1 2. The method for storing sevoflurane according to item 10 of the scope of patent application, wherein the container defines an opening which provides liquid communication between the internal space defined by the container and the external environment of the container The method further comprises the steps of: providing a lid configured to close the opening defined by the container, and the inner surface of the lid is made of a material selected from the group consisting of polypropylene, polyethylene, polyethylene naphthalate, and polymethyl A material consisting of a dipentyl, an ion-bonding resin compound and a mixture thereof; and closing the opening defined by the container with the lid. O: \ 57 \ 57230.ptc Page 4 2001.06.12.021