HRP20000521A2 - Container for an inhalation anesthetic - Google Patents

Container for an inhalation anesthetic Download PDF

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HRP20000521A2
HRP20000521A2 HR20000521A HRP20000521A HRP20000521A2 HR P20000521 A2 HRP20000521 A2 HR P20000521A2 HR 20000521 A HR20000521 A HR 20000521A HR P20000521 A HRP20000521 A HR P20000521A HR P20000521 A2 HRP20000521 A2 HR P20000521A2
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Croatia
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container
cap
mentioned
inhalation anesthetic
internal space
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HR20000521A
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Croatian (hr)
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Mary
Steven
Keith
Joan Garapolo
David Loffredo
Rajagopalan Raghavan
George
Patrick Rice
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Abbott Lab Chad 0377 Ap6D 2
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Priority claimed from US09/205,460 external-priority patent/US6162443A/en
Application filed by Abbott Lab Chad 0377 Ap6D 2 filed Critical Abbott Lab Chad 0377 Ap6D 2
Publication of HRP20000521A2 publication Critical patent/HRP20000521A2/en
Publication of HRP20000521B1 publication Critical patent/HRP20000521B1/en

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Description

Pozadina izuma Background of the invention

Predloženi izum odnosi se na posudu za inhalacijski anestetik i na metodu za pohranjivanje inhalacijskog anestetika. Posebno, predloženi izum odnosi se na posudu izrađenu od materijala koji čini pregradu za prolaz pare kroz stijenku posude i koja ne reagira s inhalacijskim anestetikom koji se nalazi u njoj. The proposed invention relates to a container for an inhalation anesthetic and to a method for storing an inhalation anesthetic. In particular, the proposed invention relates to a container made of a material that forms a partition for the passage of steam through the wall of the container and that does not react with the inhalation anesthetic contained therein.

Fluoreterska inhalacijska anestetička sredstva, kao sevofluran (fluormetil-2,2,2-trifluor-1-(trifluormetil)etil eter), enfluran (2-klor-1,1,2-trifluoretil difluormetil eter), izofluran (1-klor-2,2, 2-trifluoretil difluormetil eter), metoksifluran (2,2-diklor-1,1-difluoretil metil eter) i desfluran (2-difluormetil 1,2,2,2-tetrafluoretil eter) se tipično distribuiraju u posudama izrađenim iz stakla. lako se je pokazalo da su ta fluoreterska sredstva odlična anestetička sredstva, nađeno je da, pod određenim uvjetima, fluoretersko sredstvo i staklo mogu djelovati jedno na drugo, potičući time degradaciju fluoreterskog sredstva. Vjeruje se da je ta interakcija posljedica prisutnosti Lewisovih kiselina u materijalu sadržanom u staklu. Lewisove kiseline imaju praznu orbitalu koja može prihvatiti nepodijeljeni elektronski par i time stvoriti potencijalnu stranu za reakciju s alfa fluoreterskom skupinom (-C-O-C-F) fluoreterskog sredstva. Degradacija tog fluoreterskog sredstva u prisutnosti Lewisove kiseline može imati za posljedicu stvaranje proizvoda degradacije, kao što je fluorovodična kiselina. Fluorether inhalation anesthetic agents, such as sevoflurane (fluoromethyl-2,2,2-trifluoro-1-(trifluoromethyl)ethyl ether), enflurane (2-chloro-1,1,2-trifluoroethyl difluoromethyl ether), isoflurane (1-chloro- 2,2,2-trifluoroethyl difluoromethyl ether), methoxyflurane (2,2-dichloro-1,1-difluoroethyl methyl ether), and desflurane (2-difluoromethyl 1,2,2,2-tetrafluoroethyl ether) are typically dispensed in containers made of from glass. these fluoroether agents were easily shown to be excellent anesthetic agents, it was found that, under certain conditions, the fluoroether agent and glass could interact with each other, thereby promoting the degradation of the fluoroether agent. This interaction is believed to be due to the presence of Lewis acids in the material contained in the glass. Lewis acids have an empty orbital that can accept a lone electron pair and thereby create a potential site for reaction with the alpha fluoroether group (-C-O-C-F) of the fluoroether agent. Degradation of this fluoroether agent in the presence of a Lewis acid can result in the formation of degradation products such as hydrofluoric acid.

Stakleni materijal, koji se zasada koristi za izradu posuda za ta fluoreterska sredstva, navodi se kao staklo tipa III. Taj materijal sadrži silicijev dioksid, kalcijev hidroksid i aluminijev oksid. Staklo tipa III čini pregradu za prolaz para kroz stijenku posude, čime se sprečava prolaz fluoreterskog sredstva kroz posudu i sprečava se prolaz drugih para u posudu. Međutim, aluminijev oksid, koji se nalazi u staklenom materijalu, kao što je staklo tipa III, kad se izravno izloži fluoreterskom sredstvu, ima sklonost da djeluje kao Lewisova kiselina, čime pospješuje degradaciju fluoreterskog sredstva. Proizvodi degradacije, nastali ovom degradacijom, npr. fluorovodična kiselina, mogu nagristi unutarnju površinu staklene posude, čime se izlažu dodatne količine aluminijevog oksida fluoreterskom spoju i time se pospješuje daljnju degradaciju fluoreterskog spoja. U nekim slučajevima, dobiveni proizvodi degradacije mogu ugroziti strukturnu cjelovitost staklene posude. The glass material currently used to make containers for these fluoroether agents is referred to as type III glass. This material contains silicon dioxide, calcium hydroxide and aluminum oxide. Type III glass forms a partition for the passage of vapor through the vessel wall, thus preventing the passage of the fluoroether agent through the vessel and preventing the passage of other vapors into the vessel. However, alumina present in a glass material such as type III glass, when directly exposed to a fluoroether agent, has a tendency to act as a Lewis acid, thereby promoting the degradation of the fluoroether agent. Degradation products, formed by this degradation, eg hydrofluoric acid, can corrode the inner surface of the glass container, which exposes additional amounts of aluminum oxide to the fluoroether compound and thus promotes further degradation of the fluoroether compound. In some cases, the resulting degradation products can compromise the structural integrity of the glass vessel.

Uloženi su napori da se spriječi reaktivnost stakla prema raznim kemikalijama. Na primjer, nađeno je da će u nekim slučajevima staklo obrađeno sa sumporom zaštititi stakleni materijal. Međutim, treba imati na umu da u mnogim aplikacijama prisutnost sumpora na površini staklene posude nije prihvatljiva. Efforts have been made to prevent the reactivity of the glass towards various chemicals. For example, it has been found that in some cases, glass treated with sulfur will protect the glass material. However, it should be noted that in many applications the presence of sulfur on the surface of the glass vessel is not acceptable.

Osim toga, staklene posude predstavljaju lomljivu stvar. Na primjer, staklene posude se mogu slomiti kad padnu ili kad se na neki drugi način izlože dovoljnoj sili, ili pri upotrebi ili tijekom transporta ili rukovanja. Takovi lomovi mogu uzrokovati da se medicinsko i slučajno osoblje izloži sadržajima staklene posude. U tom pogledu, inhalacijska anestetička sredstva brzo isparavaju. Stoga, dakle, ako se u staklenoj posudi nalazi inhalacijski anestetik kao sevofluran, zbog loma posude može biti potrebna evakuacija područja koje se nalazi neposredno oko slomljene posude, npr. operacijske prostorije ili medicinskog osoblja. In addition, glass containers are a fragile thing. For example, glass containers may break when dropped or otherwise subjected to sufficient force, or during use or during transport or handling. Such breakages can cause medical and incidental personnel to be exposed to the contents of the glass container. In this respect, inhalational anesthetic agents evaporate quickly. Therefore, if an inhalational anesthetic such as sevoflurane is contained in a glass container, breakage of the container may require evacuation of the area immediately surrounding the broken container, eg the operating room or medical personnel.

Napori usmjereni na probleme lomljenja, tipično su uključivali prevlake od polivinil klorida (PVC) ili od sintetičke termoplastične smole kao što je Surlyn® (registrirani trgovački naziv proizvoda tvrtke E. I. Du Pont De Nemours & Company) na vanjskoj strani, odnosno na površinama stakla koje ne dolaze u dodir s proizvodom. Ti su napori povisili cijenu posuda, estetski su nepovoljni i nisu prevladali gore spomenute probleme koji se odnose na degradaciju do koje može doći kad se staklo upotrijebi za posude u kojima se nalaze inhalacijska anestetička sredstva koja sadrže fluoreter. Efforts to address breakage problems have typically involved coatings of polyvinyl chloride (PVC) or a synthetic thermoplastic resin such as Surlyn® (a registered trade name of E. I. Du Pont De Nemours & Company) on the exterior, i.e., surfaces of the glass that do not come into contact with the product. These efforts have increased the cost of the containers, are aesthetically unfavorable, and have not overcome the aforementioned problems related to degradation that can occur when glass is used for containers containing inhalation anesthetic agents containing fluoroether.

Iz tog razloga poželjno je osigurati posudu izrađenu od materijala različitog od stakla, čime bi se izbjegli gore spomenuti nedostaci stakla pri pohranjivanju, transportu i davanju inhalacijskih anestetika. Prednosni materijal ne sadrži Lewisove kiseline koje mogu pospješiti degradaciju inhalacijskog anestetičkog sredstva, i koje, u usporedbi sa staklenim posudama, osiguravaju dovoljnu pregradu za prolaz para u i iz posude i povećavaju otpor posude prema lomu. For this reason, it is desirable to provide a container made of a material different from glass, which would avoid the aforementioned disadvantages of glass when storing, transporting and administering inhalation anesthetics. The carrier material does not contain Lewis acids that can promote the degradation of the inhalation anesthetic agent, and which, compared to glass containers, provide a sufficient barrier for the passage of vapor in and out of the container and increase the container's resistance to breakage.

Kratki opis izuma Brief description of the invention

Predloženi izum odnosi se na farmaceutski proizvod. Proizvod se sastoji od posude izrađene od materijala koji sadrži jedan ili više spojeva iz skupine koju čine polipropilen, polietilen i ionomerne smole. Posuda omeđuje unutarnji prostor u kojem se nalazi volumen inhalacijskog anestetika koji sadrži fluoreter. The proposed invention relates to a pharmaceutical product. The product consists of a container made of a material containing one or more compounds from the group consisting of polypropylene, polyethylene and ionomer resins. The container encloses an internal space containing a volume of inhalation anesthetic containing fluoroether.

U alternativnoj izvedbi, predloženi izum odnosi se na farmaceutski proizvod u kojem posuda, koja omeđuje unutarnji prostor, ima unutarnju površinu koja graniči s unutarnjim prostorom. Unutarnja površina posude je izrađena od materijala koji sadrži jedan ili više spojeva iz skupine koju čine polipropilen, polietilen i ionomerne smole. Volumen fluoretera, koji sadrži inhalacijski anestetik, nalazi se u unutarnjem prostoru posude. In an alternative embodiment, the proposed invention relates to a pharmaceutical product in which the container, which delimits the interior space, has an interior surface bordering the interior space. The inner surface of the container is made of a material that contains one or more compounds from the group consisting of polypropylene, polyethylene and ionomer resins. The volume of fluorether, which contains the inhalation anesthetic, is located in the inner space of the container.

Predloženi izum odnosi se, nadalje, na metodu za pohranjivanje inhalacijskog anestetika. Metoda uključuje stupanj pripravljanje prethodno određenog volumena inhalacijskog anestetika koji sadrži fluoreter. Također je predviđena posuda, pri čemu je posuda izrađena od materijala koji sadrži jedan ili više spojeva iz skupine koju čine polipropilen, polietilen i ionomerne smole. Posuda omeđuje unutarnji prostor. Prethodno određen volumen inhalacijskog anestetika koji sadrži fluoreter nalazi se u unutarnjem prostoru posude. The proposed invention also relates to a method for storing an inhalation anesthetic. The method includes the step of preparing a predetermined volume of inhalation anesthetic containing fluoroether. A container is also provided, wherein the container is made of a material containing one or more compounds from the group consisting of polypropylene, polyethylene and ionomer resins. The container delimits the interior space. A predetermined volume of inhalation anesthetic containing fluoroether is located in the inner space of the container.

U alternativnoj izvedbi metode prema predloženom izumu, predviđen je prethodno određen volumen inhalacijskog anestetika koji sadrži fluoreter. K tome, predviđena je posuda s unutarnjom površinom koja omeđuje unutarnji prostor. Unutarnja površina posude izrađena je od materijala koji sadrži jedan ili više spojeva iz skupine koju čine polipropilen, polietilen i ionomerne smole. Prethodno određen volumen inhalacijskog anestetika koji sadrži fluoreter nalazi se u unutarnjem prostoru posude. In an alternative embodiment of the method according to the proposed invention, a predetermined volume of inhalation anesthetic containing fluoroether is provided. In addition, a container with an inner surface that delimits the inner space is provided. The inner surface of the container is made of a material that contains one or more compounds from the group consisting of polypropylene, polyethylene and ionomer resins. A predetermined volume of inhalation anesthetic containing fluoroether is located in the inner space of the container.

Kratki opis crteža Brief description of the drawing

Za potpunije razumijevanja predloženog izuma, slijedeći opis u pojedinostima može se usporediti s priloženim crtežom pri čemu slika 1 prikazuje poprečni presjek farmaceutskog proizvoda konstruiranog u skladu s predloženim izumom. For a more complete understanding of the proposed invention, the following detailed description may be compared with the accompanying drawing wherein Figure 1 shows a cross-sectional view of a pharmaceutical product constructed in accordance with the proposed invention.

Opis izuma u pojedinostima Description of the invention in detail

Farmaceutski proizvod izrađen u skladu s predloženim izumom na slici 1 općenito je označen s 10. Farmaceutski proizvod 10 sastoji se od posude 12 koja ima unutarnju površinu 14. Unutarnja površina 14 omeđuje unutarnji prostor 16 koji se nalazi unutar posude 12. Inhalacijski anestetik 18 nalazi se u unutarnjem prostoru 16 posude 12. U prednosnoj izvedbi predloženog izuma, inhalacijski anestetik 18 sadrži fluoreterski spoj. Inhalacijski anestetik koji sadrži fluoreter i koji se upotrebljava u svezi s predloženim izumom uključuje, ali nije nužno ograničen na sevofluran, enfluran, izofluran, metoksifluran i desfluran. Inhalacijski anestetik 18 je tekućina, i može uključiti tekuću fazu, fazu pare ili oboje, tekuću i fazu pare. Slika 1 prikazuje inhalacijski anestetik 18 u tekućoj fazi. A pharmaceutical product made in accordance with the proposed invention in Figure 1 is generally designated 10. The pharmaceutical product 10 consists of a container 12 having an interior surface 14. The interior surface 14 defines an interior space 16 located within the container 12. Inhalation anesthetic 18 is located in the inner space 16 of the vessel 12. In a preferred embodiment of the proposed invention, the inhalation anesthetic 18 contains a fluoroether compound. Fluorether-containing inhalation anesthetics used in connection with the present invention include, but are not necessarily limited to, sevoflurane, enflurane, isoflurane, methoxyflurane, and desflurane. Inhalation anesthetic 18 is a liquid, and may include a liquid phase, a vapor phase, or both, a liquid and a vapor phase. Figure 1 shows inhalation anesthetic 18 in the liquid phase.

Svrha posude 12 je da se u njoj drži inhalacijski anestetik 18. U izvedbi predloženog izuma prikazanoj na slici 1, posuda 12 ima oblik boce. Međutim, jasno je da posuda 12 može imati razne oblike i volumene, čime se ne udaljava od smisla i svrhe predloženog izuma. Na primjer, posuda 12 može biti oblikovana kao transportna posuda za veliki volumen (npr. 10 ili 100 litara) inhalacijskog anestetika 18. Takove transportne posude mogu imati pravokutni, okrugli ili dugoljasti presjek, čime se ne udaljava od predviđene svrhe izuma. The purpose of the container 12 is to hold the inhalation anesthetic 18 in it. In the embodiment of the proposed invention shown in Figure 1, the container 12 has the shape of a bottle. However, it is clear that the container 12 can have various shapes and volumes, which does not deviate from the meaning and purpose of the proposed invention. For example, the container 12 can be shaped as a transport container for a large volume (eg 10 or 100 liters) of inhalation anesthetic 18. Such transport containers can have a rectangular, round or oblong section, which does not deviate from the intended purpose of the invention.

Posuda 12 izrađena je od materijala koji prolaz pare u i iz posude 12 smanjuje na minimalnu količinu, čime se do minimuma smanjuje količinu inhalacijskog anestetika 18 koji se oslobodi iz unutarnjeg prostora 16 posude 12, a time se na minimum smanjuje i količinu pare, npr. vodene pare koja prođe iz vanjske okoline posude 12 u unutarnji prostor 16, i time, dakle u inhalacijski anestetik 18. Posuda 12 također je prednosno izrađena od materijala koji ne pospješuje degradaciju inhalacijskog anestetika 18. K tome, posuda 12 izrađena je ponajprije od materijala koji do minimuma smanjuje mogućnost loma posude 12 tijekom skladištenja, transporta i upotrebe. The container 12 is made of a material that reduces the passage of steam in and out of the container 12 to a minimum amount, thereby reducing to a minimum the amount of inhalation anesthetic 18 that is released from the inner space 16 of the container 12, and thus also reducing the amount of steam to a minimum, e.g. water of steam that passes from the outer environment of the container 12 into the inner space 16, and thus into the inhalation anesthetic 18. The container 12 is also preferably made of a material that does not promote the degradation of the inhalation anesthetic 18. In addition, the container 12 is preferably made of a material that minimizes the possibility of container 12 breakage during storage, transport and use.

Nađeno je da, pri upotrebi inhalacijskih anestetika 18, posude izrađene od materijala koji sadrži polietilen naftalat osiguravaju željenu pregradu na paru, kemijsku interakciju i karakteristike čvrstoće. Stručnjaku je jasno da postoji mnogo tipova polietilen naftalatnih polimera s različitom molekulskom masom, dodacima i sadržajem naftalata. Ti se polimeri mogu kategorizirati u tri odvojene skupine; to su naime homopolieri, kopolimeri i smjese. Nađeno je da polietilen naftalatni homopolimeri osiguravaju više pregrade za prolaz pare u usporedbi s kopolimerima i smjesama. Iz tog razloga povoljno je da materijal iz kojeg je izrađena posuda 12 predloženog izuma sadrži polietilen naftalat homopolimer. Međutim, jasno je da se u svezi s predloženim izumom mogu upotrijebiti određeni kopolimeri i smjese polietilen naftalata, pod uvjetom da oni osiguravaju dovoljnu pregradu za prolaz para, npr. para inhalacijskog anestetika i vodene pare, i pod uvjetom da oni osiguravaju dovoljnu čvrstoću i ne-reaktivnost s inhalacijskim anestetikom 18. It has been found that, when using inhalation anesthetics 18 , containers made of material containing polyethylene naphthalate provide the desired vapor barrier, chemical interaction, and strength characteristics. It is clear to the person skilled in the art that there are many types of polyethylene naphthalate polymers with different molecular weights, additives and naphthalate content. These polymers can be categorized into three separate groups; namely, homopolymers, copolymers and mixtures. Polyethylene naphthalate homopolymers were found to provide higher vapor barriers compared to copolymers and blends. For this reason, it is advantageous that the material from which the container 12 of the proposed invention is made contains polyethylene naphthalate homopolymer. However, it is clear that certain polyethylene naphthalate copolymers and blends may be used in connection with the present invention, provided that they provide a sufficient barrier to the passage of vapors, e.g., inhalation anesthetic vapor and water vapor, and provided that they provide sufficient strength and do not -reactivity with inhalation anesthetic 18.

Osim željenih pregradnih svojstava za vodenu paru, materijali koji sadrže polietilen naftalat, polietilen naftalat ne sadrži Lewisove kiseline i stoga ne donose nikakvo pospješivanje degradacije inhalacijskog anestetika koji sadrži fluoreter i koji se nalazi u posudi izrađenoj iz njega. In addition to the desired water vapor barrier properties, materials containing polyethylene naphthalate, polyethylene naphthalate do not contain Lewis acids and therefore do not promote the degradation of a fluoroether-containing inhalation anesthetic contained in a container made from it.

Primjer polietilen naftalatnog materijala, koji se može upotrijebiti u svezi s predloženim izumom, je HiPERTUFTM 90000 poliesterska smole (trgovački naziv proizvoda tvrtke Shell Chemical Company), polietilen naftalat na osnovi 2,6-dimetil naftalata. Stručnjaku je jasno da se mogu upotrijebiti i drugi polietilen naftalati bez udaljavanja od smisla izuma prikazanog dalje u priloženim patentnim zahtjevima. An example of a polyethylene naphthalate material that can be used in connection with the present invention is HiPERTUF™ 90000 polyester resin (trade name of Shell Chemical Company), a polyethylene naphthalate based on 2,6-dimethyl naphthalate. It is clear to the person skilled in the art that other polyethylene naphthalates can also be used without departing from the scope of the invention shown further in the appended patent claims.

U prvoj izvedbi predloženog izuma, posuda 12 izrađena je od jednoslojnog materijala. To jest, debljina posude 12 je uglavnom homogena. U toj izvedbi, kako je gore spomenuto, posuda 12 izrađena je od materijala koji sadrži polietilen naftalat. In the first embodiment of the proposed invention, the vessel 12 is made of a single-layer material. That is, the thickness of the container 12 is generally homogeneous. In this embodiment, as mentioned above, the container 12 is made of a material containing polyethylene naphthalate.

U alternativnoj izvedbi predloženog izuma, posuda 12 je višeslojna. Kako se ovdje rabi, smatra se da pojam višeslojno uključuje (i) materijale sastavljene od više nego jednog sloja, pri čemu su barem dva sloja izrađena od različitih materijala, tj. materijala koji su kemijski ili strukturno različiti, ili ti materijali imaju različita svojstva, pri čemu su slojevi povezani jedan na drugi ili su drugačije poravnati jedan s drugim tako da tvore jedinstvenu plohu; (ii) materijali koji imaju prevlaku od drugačijeg materijala; (iii) materijali koji sadrže povezani sloj, pri čemu je sloj izrađen od drugačijeg materijala; i (iv) poznate inačice gore opisanih. U alternativnoj izvedbi predloženog izuma, unutarnja površina 14 posude 12 izrađena je ponajprije od materijala koji sadrži polietilen naftalat. Jasno je da površina posude 14, koja je u dodiru s inhalacijskim anestetikom koji sadrži fluoreter i koji se nalazi u njoj, sadrži ponajprije polietilen naftalat, da bi se time osigurale željene značajke u smislu pregrade za paru i da se istovremeno smanji moguću degradaciju inhalacijskog anestetika koji sadrži fluoreter. In an alternative embodiment of the proposed invention, the vessel 12 is multi-layered. As used herein, the term multilayer is considered to include (i) materials composed of more than one layer, where at least two layers are made of different materials, i.e., materials that are chemically or structurally different, or those materials have different properties, wherein the layers are connected to each other or are otherwise aligned with each other so as to form a single surface; (ii) materials that have a coating of a different material; (iii) materials containing a bonded layer, wherein the layer is made of a different material; and (iv) known versions of those described above. In an alternative embodiment of the proposed invention, the inner surface 14 of the container 12 is primarily made of a material containing polyethylene naphthalate. It is clear that the surface of the vessel 14, which is in contact with the inhalation anesthetic containing fluoroether and which is contained therein, preferably contains polyethylene naphthalate, in order to provide the desired properties in terms of a vapor barrier and at the same time to reduce the possible degradation of the inhalation anesthetic containing fluoroether.

U alternativnoj izvedbi predloženog izuma, posuda 12 je izrađena od materijala koji sadrži polimetilpenten. U prednosnoj izvedbi upotrebljava se policiklometilpenten. Primjer polimetilpentenskog materijala upotrijebljenog u svezi s predloženim izumom je “Daikyo Resin CZ” koji proizvodi i prodaje tvrtka Daikyo/Pharma-Gummi/West Group. To je policiklometilpentenski materijal. Alternativno, unutarnja površina 14 posude 12 izrađena je od materijala koji sadrži polimetilpenten. U toj alternativnoj izvedbi, unutarnja površina 14 može imati oblik (i) sloja stavljenog unutar tijela omeđenog s drugačijim materijalom, npr. staklom; ili (ii) prevlaka nanesena na tijelo omeđeno s drugačijim materijalom; ili (iii) sloj višeslojnog materijala, kako je gore spomenuto s svezi s polietilen naftalatom. In an alternative embodiment of the proposed invention, the container 12 is made of a material containing polymethylpentene. In a preferred embodiment, polycyclomethylpentene is used. An example of a polymethylpentene material used in connection with the proposed invention is "Daikyo Resin CZ" manufactured and sold by Daikyo/Pharma-Gummi/West Group. It is a polycyclomethylpentene material. Alternatively, the inner surface 14 of the container 12 is made of a material containing polymethylpentene. In this alternative embodiment, the inner surface 14 may take the form of (i) a layer placed inside the body bounded with a different material, eg glass; or (ii) a coating applied to a body bounded with a different material; or (iii) a layer of multilayer material, as mentioned above in connection with polyethylene naphthalate.

U drugoj alternativnoj izvedbi predloženog izuma, posuda 12 izrađena je od materijala koji sadrži jedan ili više spojeva iz skupine koju čine polipropilen, polietilen i ionomerne smole. Alternativno, unutarnja površina 14 posude 12 izrađena je od materijala koji sadrži jedan ili više spojeva iz skupine koju čine polipropilen, polietilen i ionomerne smole, kao što je Surlyn® ionomerna smola koju proizvodi tvrtka DuPont. Kako se ovdje rabi, pojam “ionomerna smola” odnosi se na termoplastični polimer koji je unakrsno povezan ionski. U toj alternativnoj izvedbi, unutarnja površina 14 može imati oblik (i) sloja stavljenog unutar tijela omeđenog s drugačijim materijalom, npr. staklom; ili (ii) prevlaka nanesena na tijelo omeđeno s drugačijim materijalom; ili (iii) jedan sloj višeslojnog materijala, kako je gore spomenuto u svezi s polietilen naftalatom. In another alternative embodiment of the proposed invention, the vessel 12 is made of a material containing one or more compounds from the group consisting of polypropylene, polyethylene and ionomer resins. Alternatively, the inner surface 14 of the container 12 is made of a material containing one or more compounds from the group consisting of polypropylene, polyethylene and ionomer resins, such as Surlyn® ionomer resin manufactured by DuPont. As used herein, the term "ionomeric resin" refers to a thermoplastic polymer that is ionically cross-linked. In this alternative embodiment, the inner surface 14 may take the form of (i) a layer placed inside the body bounded with a different material, eg glass; or (ii) a coating applied to a body bounded with a different material; or (iii) one layer of multilayer material, as mentioned above in connection with polyethylene naphthalate.

Stručnjaku je jasno da se prevlaku može nanijeti na unutarnju površinu posude 12 primjenom raznih poznatih postupaka. Prednosni postupak ovisit će o (i) materijalu iz kojeg je izrađena posuda; i (ii) materijalu prevlake koju se nanosi na posudu 12. Na primjer, ako je posuda 12 izrađena od poznatog staklenog materijala, prevlaka se može nanijeti na unutarnju površinu posude grijanjem posude 12 barem do tališta materijala prevlake koji će se na nju nanijeti. Materijal prevlake se zatim nanese na vruću posudu 12 primjenom raznih poznatih postupaka, npr. prskanjem atomiziranog materijala prevlake na unutarnju površinu. Posudu 12 se zatim pusti ohladiti na temperaturu ispod tališta materijala prevlake, čime se uzrokuje da materijal prevlake oblikuje jednostruki, neprekinuti film ili sloj, tj. unutarnju površinu 14. It is clear to one skilled in the art that the coating can be applied to the inner surface of the container 12 using various known methods. The preferred procedure will depend on (i) the material from which the container is made; and (ii) the coating material applied to the container 12. For example, if the container 12 is made of a known glass material, the coating can be applied to the inner surface of the container by heating the container 12 to at least the melting point of the coating material to be applied thereto. The coating material is then applied to the hot pan 12 using a variety of known methods, eg by spraying the atomized coating material onto the inner surface. The vessel 12 is then allowed to cool to a temperature below the melting point of the coating material, thereby causing the coating material to form a single, continuous film or layer, i.e., the inner surface 14.

Kako je prikazano na slici 1, posuda 12 omeđuje otvor 20. Otvor 20 olakšava punjenje posude 12 i omogućuje pristup do sadržaja u posudi, čime je omogućeno da se sadržaj izvadi iz posude 12 kad je potrebno. U izvedbi predloženog izuma prikazanoj na slici 1, otvor 20 čine usta boce. Međutim, jasno je da otvor 20 može imati razne poznate konfiguracije bez udaljavanja od svrhe predloženog izuma. As shown in Figure 1, the container 12 defines an opening 20. The opening 20 facilitates the filling of the container 12 and provides access to the contents of the container, thereby enabling the contents to be removed from the container 12 when necessary. In the embodiment of the proposed invention shown in Figure 1, the opening 20 is formed by the mouth of the bottle. However, it is clear that the opening 20 can have various known configurations without departing from the purpose of the proposed invention.

Kapica 22 konstruirana je tako da protočno začepi otvor 20, i time protočno zatvarajući inhalacijski anestetik 16 u posudi. Kapica 22 može biti izrađena od raznih poznatih materijala. Međutim, kapica je prednosno izrađena od materijala koji na minimum smanjuje prolaz para kroz nju i na minimum smanjuje moguću degradaciju inhalacijskog anestetika 16. U prednosnoj izvedbi predloženog izuma, kapica 22 je izrađena od materijala koji sadrži polietilen naftalat. U alternativnoj izvedbi predloženog izuma, kapica 22 ima unutarnju površinu 24 koja je izrađena od materijala koji sadrži polietilen naftalat. U drugoj alternativnoj izvedbi predloženog izuma, kapica 22 i/ili njena unutarnja površina, izrađena je od materijala koji sadrži spoj iz skupine koju čine polipropilen, polietilen i/ili ionomerni materijal koji ima pregradna svojstva za paru dovoljna da se na minimum smanji prolaz vodene pare i para inhalacijskog anestetika kroz nju. Također u drugoj, alternativnoj izvedbi predloženog izuma, kapica 22 i/ili njena unutarnja površina izrađena je od materijala koji sadrži polimetilpenten. Ukratko, jasno je da kapica 22 i/ili njena unutarnja površina 24 može biti izrađena od polipropilena, polietilena, polietilen naftalata, polimetilpentena, ionomernih smola i njihovih kombinacija. Kako je gore spomenuto u svezi s posudom 12, kapica 22 može biti homogena ili može biti višeslojne naravi. The cap 22 is designed to flow-seal the opening 20, thereby flow-sealing the inhalation anesthetic 16 in the container. The cap 22 can be made of various known materials. However, the cap is preferably made of a material that minimizes the passage of steam through it and minimizes possible degradation of the inhalation anesthetic 16. In a preferred embodiment of the proposed invention, the cap 22 is made of a material containing polyethylene naphthalate. In an alternative embodiment of the proposed invention, the cap 22 has an inner surface 24 that is made of a material containing polyethylene naphthalate. In another alternative embodiment of the proposed invention, the cap 22 and/or its inner surface is made of a material that contains a compound from the group consisting of polypropylene, polyethylene and/or an ionomer material that has vapor barrier properties sufficient to minimize the passage of water vapor and inhalation anesthetic vapor through it. Also in another, alternative embodiment of the proposed invention, the cap 22 and/or its inner surface is made of a material containing polymethylpentene. In summary, it is clear that the cap 22 and/or its inner surface 24 can be made of polypropylene, polyethylene, polyethylene naphthalate, polymethylpentene, ionomer resins, and combinations thereof. As mentioned above in connection with the container 12, the cap 22 can be homogeneous or it can be multi-layered in nature.

Kapica 22 i posuda 12 mogu biti izrađene tako da se kapica 22 može učvrstiti na posudu pomoću navoja. Posude i kapice tog tipa su dobro poznate. Također su moguće alternativne izvedbe kapice 22 i posude 12 i stručnjak za dotično područje će ih odmah prepoznati. Takove alternativne izvedbe uključuju, ali nisu nužno ograničene samo na kapice koje se mogu nabiti na posude, kapice koje se mogu učvrstiti lijepljenjem na posude i kapice koje se mogu učvrstiti pomoću poznatih mehaničkih naprava, npr. metalnih prstenova. U prednosnoj izvedbi predloženog izuma, kapica 22 i posuda 12 konfigurirane su tako da se kapica 22 može skinuti s posude 12 bez trajnog oštećenja bilo kapice 22 ili posude 12, čime se omogućuje korisniku da ponovno zatvori otvor 20 s kapicom 22 nakon što je iz posude 12 izvadio željeni volumen inhalacijskog anestetika 18. The cap 22 and the container 12 can be made so that the cap 22 can be secured to the container by means of threads. Bowls and caps of this type are well known. Alternative designs of cap 22 and container 12 are also possible and will be readily recognized by one skilled in the art. Such alternative embodiments include, but are not necessarily limited to caps that can be pressed onto containers, caps that can be secured by gluing to containers, and caps that can be secured by means of known mechanical devices, eg, metal rings. In a preferred embodiment of the present invention, the cap 22 and the container 12 are configured so that the cap 22 can be removed from the container 12 without permanently damaging either the cap 22 or the container 12, thereby allowing the user to reseal the opening 20 with the cap 22 after being removed from the container 12 removed the desired volume of inhalation anesthetic 18.

Posuda 12 može uključiti dodatne elemente koji ne čine dio predloženog izuma. Na primjer, posuda 12 može biti konfigurirana tako da uključuje sistem za dovođenje inhalacijskog anestetika 18 iz posude 12 u uređaj za isparavanje anestetika. U.S. patent br. 5,505,236, Grabenkort, opisuje takav sistem. The container 12 may include additional elements that do not form part of the proposed invention. For example, the vessel 12 may be configured to include a system for delivering the inhalation anesthetic 18 from the vessel 12 to the anesthetic vaporizer. LOUSE. patent no. 5,505,236, Grabenkort, describes such a system.

Metode za izradu posuda tipa upotrijebljenog u predloženom izumu su poznate u struci. Na primjer, poznato je da se prije prerade polietilen naftalat mora osušiti do razine vlage od približno 0,005% da bi se dobila optimalna fizička svojstva posude 12 i kapice 22. Prednosna metoda za proizvodnju posuda 12 i kapica 12 koje se upotrebljavaju u svezi s predloženim izumom uključuje prešanje s injekcijskim rasteznim puhanjem materijala koji sadrži polietilen naftalat. Za provedbu tog postupka prešanja mogu se posebno upotrijebiti strojevi koje proizvodi tvrtka AOKI Technical Laboratory, Inc. of Tokyo. Materijal koji sadrži polietilen naftalat injekcijski se preša u predkalupu koji se zatim prenosi u stanicu za puhanje, gdje se rasteže i napuhuje tako da se oblikuje posudu. Zatim se posude šaržno griju u kale u konvekcijskoj peći. Methods for making containers of the type used in the proposed invention are known in the art. For example, it is known that prior to processing polyethylene naphthalate must be dried to a moisture level of approximately 0.005% in order to obtain the optimum physical properties of the container 12 and cap 22. A preferred method for manufacturing the containers 12 and caps 12 used in connection with the present invention involves injection stretch blow molding of material containing polyethylene naphthalate. Machines manufactured by AOKI Technical Laboratory, Inc. can be specially used to carry out this pressing process. of Tokyo. The material containing polyethylene naphthalate is injection molded into a pre-mold which is then transferred to a blow station, where it is stretched and inflated to form the container. Then the containers are heated in batches in a convection oven.

Nađeno je da kaljenje materijala koji sadrži polietilen naftalat povisuje stupanj kristalizacije u materijalu do razine koja se ne može postići samo postupkom prešanja s puhanjem. Povećana kristalizacija ima za posljedicu veća pregradna svojstva za prolaz pare, čime se pojačavaju pregradna svojstva prema pari posude 12 izrađene od kaljenog materijala koji sadrži polietilen naftalat. Povišena kristalizacija također povisuje ukupnu masu posude (12) (računano nakon težini potrebnoj da se dobije čvrstoću odabrane posude) i količinu potrebnog materijala da se dobije čvrstoću materijala za posudu 12. Povećana čvrstoća posude omogućuje da posuda izdrži veća opterećenja tijekom transporta, skladištenja i upotrebe, čime se na minimum smanjuju lomovi posude. Na primjer, veća čvrstoća posude poželjna je kad se posude 12 stavljaju jedna povrh druge, što se može desiti kad se posude 12, kutije ili palete posuda 12 slažu za transport ili skladištenje. Treba napomenuti da posuda izrađena od materijala koji sadrži kaljeni polietilen naftalat ima masu manju od staklene posude usporedivih karakteristika čvrstoće, manje je sklona lomu nego staklena posuda slične težine i cijena njene izrade je manja nego staklene posude sličnih karakteristika. Manja težina posude također smanjuje troškove povezane s transportom takovih posuda. Tempering a material containing polyethylene naphthalate has been found to increase the degree of crystallization in the material to a level that cannot be achieved by blow molding alone. The increased crystallization results in greater barrier properties for the passage of steam, thereby enhancing the barrier properties against steam of the container 12 made of hardened material containing polyethylene naphthalate. Increased crystallization also increases the total mass of the container (12) (calculated after the weight required to obtain the strength of the selected container) and the amount of material required to obtain the material strength of the container 12. The increased strength of the container allows the container to withstand greater loads during transport, storage and use , which minimizes vessel breakage. For example, greater container strength is desirable when containers 12 are stacked on top of each other, which may occur when containers 12, boxes, or pallets of containers 12 are stacked for shipping or storage. It should be noted that a vessel made of material containing hardened polyethylene naphthalate has a lower mass than a glass vessel of comparable strength characteristics, is less prone to breakage than a glass vessel of similar weight, and the cost of its manufacture is lower than glass vessels of similar characteristics. The lower weight of the container also reduces the costs associated with the transport of such containers.

Metoda predloženog izuma uključuje stupanj priprave prethodno određenog volumena inhalacijskog anestetika 16 koji sadrži fluoreter. Inhalacijski anestetik 16 koji sadrži fluoreter može biti jedan ili više od slijedećih anestetika: sevofluran, enfluran, izofluran, metoksifluran i desfluran. Također je predviđena posuda 12 konstruirana u skladu s gore opisanim farmaceutskim proizvodom. Posebno, posuda 12 omeđuje unutarnji prostor i izrađena je od materijala koji sadrži polietilen naftalat, pri čemu je polietilen naftalat prisutan na unutarnjoj površini 14 posude 12, bilo kao rezultat homogenih svojstava posude 12, ili kao rezultat unutarnje površine 14 višeslojnog materijala izrađenog od polietilen naftalata, kako je gore spomenuto. Metoda predloženog izuma uključuje, nadalje, stupanj stavljanja prethodno određenog volumena inhalacijskog anestetika 16 koji sadrži fluoreter u unutarnji prostor omeđen s posudom. The method of the proposed invention includes the step of preparing a predetermined volume of inhalation anesthetic 16 containing fluoroether. Inhalation anesthetic 16 containing fluoroether can be one or more of the following anesthetics: sevoflurane, enflurane, isoflurane, methoxyflurane and desflurane. Also provided is a container 12 constructed in accordance with the pharmaceutical product described above. In particular, the container 12 delimits the interior space and is made of a material containing polyethylene naphthalate, wherein the polyethylene naphthalate is present on the inner surface 14 of the container 12, either as a result of the homogeneous properties of the container 12, or as a result of the inner surface 14 of a multilayer material made of polyethylene naphthalate , as mentioned above. The method of the proposed invention further includes the step of placing a predetermined volume of inhalation anesthetic 16 containing fluoroether into the interior space bounded by the vessel.

U alternativnoj izvedbi metode predloženog izuma, predviđen je prethodno određen volumen inhalacijskog anestetika 16 koji sadrži fluoreter. Inhalacijski anestetik 16 koji sadrži fluoreter može biti jedan ili više od slijedećih anestetika: sevofluran, enfluran, izofluran, metoksifluran i desfluran. Također je data posuda izrađena u skladu s gore opisanim proizvodom. Posebno, posuda 12 omeđuje unutarnji prostor i izrađena je od materijala koji sadrži polimetilpenten, pri čemu je polimetilpenten prisutan na unutarnjoj površini 14 posude 12 bilo kao rezultat svojstva homogenosti materijala posude 12 ili kao rezultat unutarnje površine 14 od višeslojnog materijala sastavljenog od polimetilpentena, kako je gore spomenuto. Metoda nadalje uključuje stupanj stavljanja prethodno određenog volumena inhalacijskog anestetika koji sadrži fluoreter u unutarnji prostor omeđen s posudom. In an alternative embodiment of the method of the proposed invention, a predetermined volume of inhalation anesthetic 16 containing fluoroether is provided. Inhalation anesthetic 16 containing fluoroether can be one or more of the following anesthetics: sevoflurane, enflurane, isoflurane, methoxyflurane and desflurane. Also, this container is made in accordance with the product described above. In particular, the container 12 delimits the interior space and is made of a material containing polymethylpentene, wherein the polymethylpentene is present on the inner surface 14 of the container 12 either as a result of the homogeneity property of the material of the container 12 or as a result of the inner surface 14 being made of a multi-layered material composed of polymethylpentene, as mentioned above. The method further includes the step of placing a predetermined volume of inhalation anesthetic containing fluoroether into the interior space bounded by the vessel.

U drugoj alternativnoj izvedbi metode predloženog izuma, predviđen je prethodno određen volumen inhalacijskog anestetika 16 koji sadrži fluoreter. Inhalacijski anestetik 16 koji sadrži fluoreter može biti jedan ili više od slijedećih anestetika: sevofluran, enfluran, izofluran, metoksifluran i desfluran. Predviđena je posuda 12 izrađena u skladu s gore opisanim proizvodom. Posebno, posuda 12 omeđuje unutarnji prostor 16 i izrađena je od materijala koji sadrži jedan ili više spojeva iz skupine koju čine polipropilen, polietilen i ionomerne smole, pri čemu je (su) naveden(i) materijal(i) prisutan (prisutni) na unutarnjoj površini 14 posude 12 bilo kao rezultat svojstva homogenosti materijala posude 12 ili kao rezultat unutarnje površine 14 od višeslojnog materijala sastavljenog od jednog od navedenih materijala, kako je gore spomenuto. Metoda nadalje uključuje stupanj stavljanja prethodno određenog volumena inhalacijskog anestetika 16 koji sadrži fluoreter u unutarnji prostor omeđen s posudom. In another alternative embodiment of the method of the proposed invention, a predetermined volume of inhalation anesthetic 16 containing fluoroether is provided. Inhalation anesthetic 16 containing fluoroether can be one or more of the following anesthetics: sevoflurane, enflurane, isoflurane, methoxyflurane and desflurane. A container 12 made in accordance with the product described above is provided. In particular, the container 12 delimits the inner space 16 and is made of a material containing one or more compounds from the group consisting of polypropylene, polyethylene and ionomer resins, wherein the specified material(s) is (are) present on the inner surface 14 of the container 12 either as a result of the homogeneity property of the material of the container 12 or as a result of the inner surface 14 being made of a multilayer material composed of one of the aforementioned materials, as mentioned above. The method further includes the step of placing a predetermined volume of inhalation anesthetic 16 containing fluoroether into the interior space bounded by the vessel.

Jasno je da posuda 12 i njena unutrašnjost 14 mogu biti izrađene iz više od jednog gore spomenutog materijala. It is clear that the container 12 and its interior 14 can be made of more than one material mentioned above.

U svakoj izvedbi metode predloženog izuma, u posudi 12 može biti izrađen omeđen otvor 20, pri čemu otvor 20 osigurava protočnu vezu između unutarnjeg prostora 16 posude 12 i vanjske okoline posude 12. Svaka izvedba predloženog izuma može nadalje uključiti stupanj stavljanje kapice 22 izrađene od materijala koji sadrži jedan ili više spojeva iz skupine koju čine polipropilen, polietilen, ionomerne smole, polietilen naftalat i polimetilpenten. Alternativno, kapica može biti izrađena tako da je njena unutarnja površina 24 izrađena od materijala koji sadrži jedan ili više spojeva iz skupine koju čine polipropilen, polietilen, ionomerne smole, polietilen naftalat i polimetilpenten. Metoda predloženog izuma uključuje nadalje stupanj zatvaranja otvora omeđenog s posudom 12 s kapicom 22. In each embodiment of the method of the proposed invention, a limited opening 20 can be made in the container 12, wherein the opening 20 provides a flow connection between the internal space 16 of the container 12 and the external environment of the container 12. Each embodiment of the proposed invention can further include the step of placing a cap 22 made of material which contains one or more compounds from the group consisting of polypropylene, polyethylene, ionomer resins, polyethylene naphthalate and polymethylpentene. Alternatively, the cap can be made so that its inner surface 24 is made of a material containing one or more compounds from the group consisting of polypropylene, polyethylene, ionomer resins, polyethylene naphthalate and polymethylpentene. The method of the proposed invention further includes the step of closing the opening defined by the container 12 with the cap 22.

Iako je farmaceutski proizvod i metoda predloženog izuma ovdje opisana s obzirom na određene prednosne izvedbe, stručnjaku je jasno da se mogu učiniti razne modifikacije izuma bez udaljavanja smisla i svrhe ovdje opisanog izuma, kako je zahtjevan u priloženim patentnim zahtjevima. Although the pharmaceutical product and method of the proposed invention is described herein with respect to certain preferred embodiments, it is clear to one skilled in the art that various modifications of the invention may be made without departing from the spirit and purpose of the invention described herein, as required in the appended claims.

Claims (17)

1. Proizvod s inhalacijskim anestetikom, naznačen time, da se sastoji od: - posude izrađene od materijala koji uključuje spoj odabran iz skupine koju čine polietilen naftalat, polimetilpenten, polipropilen, polietilen, ionomerne smole i njihove kombinacije, pri čemu spomenuta posuda omeđuje unutarnji prostor konstruiran tako da se u njemu, izvan tijela pacijenta, nalazi inhalacijski anestetik; i - volumena sevoflurana koji se nalazi u spomenutom unutarnjem prostoru omeđenom sa spomenutom posudom.1. A product with an inhalation anesthetic, characterized by the fact that it consists of: - containers made of materials that include a compound selected from the group consisting of polyethylene naphthalate, polymethylpentene, polypropylene, polyethylene, ionomer resins and their combinations, wherein said container delimits an internal space constructed so that, outside the patient's body, inhalation anesthetic is located in it; and - the volume of sevoflurane located in the mentioned internal space bounded by the mentioned vessel. 2. Proizvod s inhalacijskim anestetikom prema zahtjevu 1, naznačen time, da spomenuta posuda ima omeđeni otvor, pri čemu otvor omogućuje protočnu vezu između unutarnjeg prostora omeđenog sa spomenutom posudom i vanjske okoline spomenute posude, i pri čemu spomenuti proizvod s inhalacijskim anestetikom nadalje uključuje kapicu, koja kapica je izrađena tako da zatvara spomenuti otvor omeđen u spomenutoj posudi, i spomenuta kapica izrađena je od materijala koji uključuje spoj odabran iz skupine koju čine polipropilen, polietilen, polietilen naftalat, polimetilpenten, ionomerne smole i njihove kombinacije.2. An inhalation anesthetic product according to claim 1, characterized in that said container has a limited opening, wherein the opening enables a flow connection between the internal space bounded by said container and the external environment of said container, and wherein said inhalation anesthetic product further includes a cap , which cap is made to close said opening defined in said container, and said cap is made of a material that includes a compound selected from the group consisting of polypropylene, polyethylene, polyethylene naphthalate, polymethylpentene, ionomer resins, and combinations thereof. 3. Proizvod s inhalacijskim anestetikom prema zahtjevu 1, naznačen time, da spomenuta posuda ima omeđeni otvor, pri čemu otvor omogućuje protočnu vezu između unutarnjeg prostora omeđenog sa spomenutom posudom i vanjske okoline spomenute posude, i pri čemu spomenuti proizvod s inhalacijskim anestetikom nadalje uključuje kapicu, koja kapica je izrađena tako da zatvara spomenuti otvor omeđen u spomenutoj posudi, pri čemu je unutarnja površina spomenute kapice izrađena od materijala koji uključuje spoj odabran iz skupine koju čine polipropilen, polietilen, polietilen naftalat, polimetilpenten, ionomerne smole i njihove kombinacije.3. An inhalation anesthetic product according to claim 1, characterized in that said container has a limited opening, wherein the opening enables a flow connection between the internal space bounded by said container and the external environment of said container, and wherein said inhalation anesthetic product further includes a cap , which cap is made to close said opening defined in said container, wherein the inner surface of said cap is made of a material that includes a compound selected from the group consisting of polypropylene, polyethylene, polyethylene naphthalate, polymethylpentene, ionomer resins and combinations thereof. 4. Proizvod s inhalacijskim anestetikom, naznačen time, da se sastoji od posude koja omeđuje unutarnji prostor konstruiran tako da se u njemu, a izvan tijela pacijenta, nalazi inhalacijski anestetik, pri čemu posuda ima unutarnju površinu koja graniči s unutarnjim prostorom, i spomenuta unutarnja površina izrađena je od materijala koji uključuje spoj odabran iz skupine koju čine polietilen naftalat, polimetilpenten, polipropilen, polietilen, ionomerne smole i njihove kombinacije, i volumena sevoflurana koji se nalazi u spomenutoj posudi.4. A product with an inhalation anesthetic, characterized by the fact that it consists of a container delimiting an internal space constructed so that an inhalation anesthetic can be found in it, and outside the patient's body, wherein the container has an internal surface bordering the internal space, and said internal the surface is made of a material that includes a compound selected from the group consisting of polyethylene naphthalate, polymethylpentene, polypropylene, polyethylene, ionomer resins and combinations thereof, and the volume of sevoflurane contained in said vessel. 5. Proizvod s inhalacijskim anestetikom prema zahtjevu 4, naznačen time, da spomenuta posuda ima omeđeni otvor, pri čemu otvor omogućuje protočnu vezu između unutarnjeg prostora omeđenog sa spomenutom posudom i vanjske okoline spomenute posude, i pri čemu spomenuti proizvod s inhalacijskim anestetikom nadalje uključuje kapicu, koja kapica je izrađena tako da zatvara spomenuti otvor omeđen u spomenutoj posudi, i spomenuta kapica izrađena je od materijala koji uključuje spoj odabran iz skupine koju čine polipropilen, polietilen, polietilen naftalat, polimetilpenten, ionomerne smole i njihove kombinacije.5. An inhalation anesthetic product according to claim 4, characterized in that said container has a limited opening, wherein the opening enables a flow connection between the internal space bounded by said container and the external environment of said container, and wherein said inhalation anesthetic product further includes a cap , which cap is made to close said opening defined in said container, and said cap is made of a material that includes a compound selected from the group consisting of polypropylene, polyethylene, polyethylene naphthalate, polymethylpentene, ionomer resins, and combinations thereof. 6. Proizvod s inhalacijskim anestetikom prema zahtjevu 4, naznačen time, da spomenuta posuda ima omeđeni otvor, pri čemu otvor omogućuje protočnu vezu između unutarnjeg prostora omeđenog sa spomenutom posudom i vanjske okoline spomenute posude, i pri čemu spomenuti proizvod s inhalacijskim anestetikom nadalje uključuje kapicu, koja kapica ima unutarnju površinu, spomenuta kapica izrađena je tako da zatvara spomenuti otvor omeđen u spomenutoj posudi, i spomenuta unutarnja površina te kapice izrađena je od materijala koji uključuje spoj odabran iz skupine koju čine polipropilen, polietilen, polietilen naftalat, polimetilpenten, ionomerne smole i njihove kombinacije.6. An inhalation anesthetic product according to claim 4, characterized in that said container has a limited opening, wherein the opening enables a flow connection between the internal space bounded by said container and the external environment of said container, and wherein said inhalation anesthetic product further includes a cap , which cap has an inner surface, said cap is made to close said opening defined in said container, and said inner surface of said cap is made of a material that includes a compound selected from the group consisting of polypropylene, polyethylene, polyethylene naphthalate, polymethylpentene, ionomer resins and their combinations. 7. Postupak za pohranjivanje inhalacijskog anestetika izvan tijela pacijenta, naznačena time, da uključuje stupnjeve: - pripravljanje prethodno određenog volumena sevoflurana; - pripravljanje posude koja omeđuje unutarnji prostor, pri čemu je spomenuta posuda izrađena od materijala koji uključuje spoj odabran iz skupine koju čine polietilen naftalat, polimetilpenten, polipropilen, polietilen, ionomerne smole i njihove kombinacije; i - stavljanje prethodno određenog volumena sevoflurana u spomenuti unutarnji prostor omeđen sa spomenutom posudom.7. A method for storing an inhalation anesthetic outside the patient's body, characterized in that it includes the steps: - preparation of a previously determined volume of sevoflurane; - preparation of a container that delimits the interior space, wherein said container is made of a material that includes a compound selected from the group consisting of polyethylene naphthalate, polymethylpentene, polypropylene, polyethylene, ionomer resins and their combinations; and - putting a previously determined volume of sevoflurane into the mentioned inner space bordered by the mentioned vessel. 8. Postupak za pohranjivanje anestetičkog sredstva prema zahtjevu 7, naznačena time, da spomenuta posuda ima omeđeni otvor, pri čemu otvor omogućuje protočnu vezu između unutarnjeg prostora omeđenog sa spomenutom posudom i vanjske okoline spomenute posude, i pri čemu spomenuta metoda uključuje nadalje stupnjeve: - pripravljanje kapice, koja kapica je izrađena tako da zatvara spomenuti otvor omeđen u spomenutoj posudi, i - spomenuta kapica izrađena je od materijala koji uključuje spoj odabran iz skupine koju čine polipropilen, polietilen, polietilen naftalat, polimetilpenten, ionomerne smole i njihove kombinacije; i - zatvaranje spomenutog otvora u spomenutoj posudi sa spomenutom kapicom.8. A method for storing an anesthetic agent according to claim 7, characterized in that said container has a limited opening, wherein the opening enables a flow connection between the internal space bounded by said container and the external environment of said container, and wherein said method further includes the steps: - preparation of the cap, which cap is made in such a way as to close the said opening defined in the said container, i - the mentioned cap is made of a material that includes a compound selected from the group consisting of polypropylene, polyethylene, polyethylene naphthalate, polymethylpentene, ionomer resins and their combinations; and - closing the mentioned opening in the mentioned container with the mentioned cap. 9. Postupak za pohranjivanje anestetičkog sredstva prema zahtjevu 7, naznačena time, da spomenuta posuda ima omeđeni otvor, pri čemu taj otvor omogućuje protočnu vezu između unutarnjeg prostora omeđenog sa spomenutom posudom i vanjske okoline spomenute posude, i pri čemu spomenuta metoda uključuje nadalje stupnjeve: - pripravljanje kapice, koja kapica je izrađena tako da zatvara spomenuti otvor omeđen u spomenutoj posudi, i spomenuta kapica ima unutarnju površinu izrađenu od materijala koji uključuje spoj odabran iz skupine koju čine polipropilen, polietilen, polietilen naftalat, polimetilpenten, ionomerne smole i njihove kombinacije; i - zatvaranje spomenutog otvora u spomenutoj posudi sa spomenutom kapicom.9. A method for storing an anesthetic agent according to claim 7, characterized in that said container has a limited opening, wherein said opening enables a flow connection between the internal space bounded by said container and the external environment of said container, and wherein said method further includes the steps: - preparing a cap, which cap is made to close said opening defined in said container, and said cap has an inner surface made of a material that includes a compound selected from the group consisting of polypropylene, polyethylene, polyethylene naphthalate, polymethylpentene, ionomer resins and combinations thereof; and - closing the mentioned opening in the mentioned container with the mentioned cap. 10. Postupak za pohranjivanje inhalacijskog anestetika, naznačena time, da spomenuta metoda uključuje stupnjeve: - pripravljanje prethodno određenog volumena sevoflurana; - pripravljanje posude koja omeđuje unutarnji prostor, pri čemu spomenuta posuda ima unutarnju stijenku koja graniči s unutarnjim prostorom omeđenim sa spomenutom posudom, i spomenuta unutarnja stijenke spomenute posude izrađena je od materijala koji uključuje spoj odabran iz skupine koju čine polietilen naftalat, polimetilpenten, polipropilen, polietilen, ionomerne smole i njihove kombinacije; i - stavljanje prethodno određenog volumena spomenutog inhalacijskog anestetika koji sadrži fluoreter u spomenuti unutarnji prostor omeđen sa spomenutom posudom.10. Method for storing inhalation anesthetic, characterized in that said method includes steps: - preparation of a previously determined volume of sevoflurane; - preparation of a container that delimits the inner space, wherein said container has an inner wall that borders the inner space bounded by said container, and said inner wall of said container is made of a material that includes a compound selected from the group consisting of polyethylene naphthalate, polymethylpentene, polypropylene, polyethylene, ionomer resins and their combinations; and - placing a previously determined volume of the mentioned inhalation anesthetic containing fluorether in the mentioned internal space bordered by the mentioned vessel. 11. Postupak za pohranjivanje anestetičkog sredstva prema zahtjevu 10, naznačena time, da spomenuta posuda ima omeđeni otvor, pri čemu taj otvor omogućuje protočnu vezu između unutarnjeg prostora omeđenog sa spomenutom posudom i vanjske okoline spomenute posude, i pri čemu spomenuta metoda uključuje nadalje stupnjeve: - pripravljanje kapice, koja kapica je izrađena tako da zatvara spomenuti otvor omeđen u spomenutoj posudi, i spomenuta kapica izrađena je od materijala koji uključuje spoj odabran iz skupine koju čine polipropilen, polietilen, polietilen naftalat, polimetilpenten, ionomerne smole i njihove kombinacije; i - zatvaranje spomenutog otvora u spomenutoj posudi sa spomenutom kapicom.11. A method for storing an anesthetic agent according to claim 10, characterized in that said container has a limited opening, wherein said opening enables a flow connection between the internal space bounded by said container and the external environment of said container, and wherein said method further includes the steps: - preparation of a cap, which cap is made so as to close said opening defined in said container, and said cap is made of a material that includes a compound selected from the group consisting of polypropylene, polyethylene, polyethylene naphthalate, polymethylpentene, ionomer resins and combinations thereof; and - closing the mentioned opening in the mentioned container with the mentioned cap. 12. Postupak za pohranjivanje anestetičkog sredstva prema zahtjevu 10, naznačena time, da spomenuta posuda ima omeđeni otvor, pri čemu taj otvor omogućuje protočnu vezu između unutarnjeg prostora omeđenog sa spomenutom posudom i vanjske okoline spomenute posude, i pri čemu spomenuta metoda uključuje nadalje stupnjeve: - pripravljanje kapice, koja kapica je izrađena tako da zatvara spomenuti otvor omeđen u spomenutoj posudi, i spomenuta kapica ima unutarnju površinu izrađenu od materijala koji uključuje spoj odabran iz skupine koju čine polipropilen, polietilen, polietilen naftalat, polimetilpenten, ionomerne smole i njihove kombinacije; i - zatvaranje spomenutog otvora u spomenutoj posudi sa spomenutom kapicom.12. A method for storing an anesthetic agent according to claim 10, characterized in that said container has a limited opening, wherein said opening enables a flow connection between the internal space bounded by said container and the external environment of said container, and wherein said method further includes the steps: - preparing a cap, which cap is made to close said opening defined in said container, and said cap has an inner surface made of a material that includes a compound selected from the group consisting of polypropylene, polyethylene, polyethylene naphthalate, polymethylpentene, ionomer resins and combinations thereof; and - closing the mentioned opening in the mentioned container with the mentioned cap. 13. Proizvod s inhalacijskim anestetikom, naznačen time, da uključuje: - posudu izrađenu od materijala koji uključuje polietilen naftalat, pri čemu posuda omeđuje unutarnji prostor izrađen tako da se u njemu, izvan tijela pacijenta, nalazi inhalacijski anestetik; i - volumen sevoflurana koji se nalazi u spomenutom unutarnjem prostoru omeđenom sa spomenutom posudom.13. A product with an inhalation anesthetic, characterized in that it includes: - a container made of a material that includes polyethylene naphthalate, whereby the container delimits an internal space made so that, outside the patient's body, there is an inhalation anesthetic; and - the volume of sevoflurane located in the mentioned internal space bounded by the mentioned container. 14. Proizvod s inhalacijskim anestetikom, naznačen time, da uključuje: - posudu izrađenu od materijala koji uključuje polimetilpenten, pri čemu posuda omeđuje unutarnji prostor izrađen tako da se u njemu, izvan tijela pacijenta, nalazi inhalacijski anestetik; i - volumen sevoflurana koji se nalazi u spomenutom unutarnjem prostoru omeđenom sa spomenutom posudom.14. A product with an inhalation anesthetic, characterized in that it includes: - a container made of a material that includes polymethylpentene, whereby the container delimits an internal space made so that, outside the patient's body, there is an inhalation anesthetic; and - the volume of sevoflurane located in the mentioned internal space bounded by the mentioned vessel. 15. Proizvod s inhalacijskim anestetikom, naznačen time, da uključuje: - posudu izrađenu od materijala koji uključuje polipropilen, pri čemu posuda omeđuje unutarnji prostor izrađen tako da se u njemu, izvan tijela pacijenta, nalazi inhalacijski anestetik; i - volumen sevoflurana koji se nalazi u spomenutom unutarnjem prostoru omeđenom sa spomenutom posudom.15. A product with an inhalation anesthetic, characterized in that it includes: - a container made of a material that includes polypropylene, whereby the container delimits an internal space made so that, outside the patient's body, inhalation anesthetic is located in it; and - the volume of sevoflurane located in the mentioned internal space bounded by the mentioned vessel. 16. Proizvod s inhalacijskim anestetikom, naznačen time, da uključuje: - posudu izrađenu od materijala koji uključuje polietilen, pri čemu posuda omeđuje unutarnji prostor izrađen tako da se u njemu, izvan tijela pacijenta, nalazi inhalacijski anestetik; i - volumen sevoflurana koji se nalazi u spomenutom unutarnjem prostoru omeđenom sa spomenutom posudom.16. A product with an inhalation anesthetic, characterized in that it includes: - a container made of a material that includes polyethylene, whereby the container delimits an internal space made so that, outside the patient's body, there is an inhalation anesthetic; and - the volume of sevoflurane located in the mentioned internal space bounded by the mentioned vessel. 17. Proizvod s inhalacijskim anestetikom, naznačen time, da uključuje: - posudu izrađenu od materijala koji uključuje ionomerne smole, pri čemu posuda omeđuje unutarnji prostor izrađen tako da se u njemu, izvan tijela pacijenta, nalazi inhalacijski anestetik; i - volumen sevoflurana koji se nalazi u spomenutom unutarnjem prostoru omeđenom sa spomenutom posudom.17. A product with an inhalation anesthetic, characterized in that it includes: - a container made of a material that includes ionomer resins, whereby the container delimits an internal space made so that, outside the patient's body, there is an inhalation anesthetic; and - the volume of sevoflurane located in the mentioned internal space bounded by the mentioned vessel.
HR20000521A 1998-01-09 1999-01-08 Container for an inhalation anesthetic HRP20000521B1 (en)

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