HUE027282T2 - Eljárás adagolókészülék elõállítására szer orális bevételéhez - Google Patents

Eljárás adagolókészülék elõállítására szer orális bevételéhez Download PDF

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Publication number
HUE027282T2
HUE027282T2 HUE07700757A HUE07700757A HUE027282T2 HU E027282 T2 HUE027282 T2 HU E027282T2 HU E07700757 A HUE07700757 A HU E07700757A HU E07700757 A HUE07700757 A HU E07700757A HU E027282 T2 HUE027282 T2 HU E027282T2
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Hungary
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agent
layers
layer
folded
sheet
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HUE07700757A
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English (en)
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Moshe Tsabari
Avner Balshey
Erez Yofe
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Intec Pharma Ltd
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Publication of HUE027282T2 publication Critical patent/HUE027282T2/hu

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/07Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use
    • A61J3/071Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use into the form of telescopically engaged two-piece capsules
    • A61J3/074Filling capsules; Related operations
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/07Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use
    • A61J3/071Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use into the form of telescopically engaged two-piece capsules
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/07Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use
    • A61J3/078Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use into the form of wafers or cachets
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
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    • A61K9/2072Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
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    • A61K9/4808Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
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    • B32B37/14Methods or apparatus for laminating, e.g. by curing or by ultrasonic bonding characterised by the properties of the layers
    • B32B37/16Methods or apparatus for laminating, e.g. by curing or by ultrasonic bonding characterised by the properties of the layers with all layers existing as coherent layers before laminating
    • B32B37/18Methods or apparatus for laminating, e.g. by curing or by ultrasonic bonding characterised by the properties of the layers with all layers existing as coherent layers before laminating involving the assembly of discrete sheets or panels only
    • B32B37/182Methods or apparatus for laminating, e.g. by curing or by ultrasonic bonding characterised by the properties of the layers with all layers existing as coherent layers before laminating involving the assembly of discrete sheets or panels only one or more of the layers being plastic
    • B32B37/185Laminating sheets, panels or inserts between two discrete plastic layers
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    • B32B37/00Methods or apparatus for laminating, e.g. by curing or by ultrasonic bonding
    • B32B37/14Methods or apparatus for laminating, e.g. by curing or by ultrasonic bonding characterised by the properties of the layers
    • B32B37/26Methods or apparatus for laminating, e.g. by curing or by ultrasonic bonding characterised by the properties of the layers with at least one layer which influences the bonding during the lamination process, e.g. release layers or pressure equalising layers
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B39/00Layout of apparatus or plants, e.g. modular laminating systems
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B7/00Layered products characterised by the relation between layers; Layered products characterised by the relative orientation of features between layers, or by the relative values of a measurable parameter between layers, i.e. products comprising layers having different physical, chemical or physicochemical properties; Layered products characterised by the interconnection of layers
    • B32B7/04Interconnection of layers
    • B32B7/12Interconnection of layers using interposed adhesives or interposed materials with bonding properties
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B63/00Auxiliary devices, not otherwise provided for, for operating on articles or materials to be packaged
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    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B7/00Closing containers or receptacles after filling
    • B65B7/16Closing semi-rigid or rigid containers or receptacles not deformed by, or not taking-up shape of, contents, e.g. boxes or cartons
    • B65B7/28Closing semi-rigid or rigid containers or receptacles not deformed by, or not taking-up shape of, contents, e.g. boxes or cartons by applying separate preformed closures, e.g. lids, covers
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29KINDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2105/00Condition, form or state of moulded material or of the material to be shaped
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    • B29KINDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
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    • B32B2307/00Properties of the layers or laminate
    • B32B2307/70Other properties
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    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
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    • Y10T156/00Adhesive bonding and miscellaneous chemical manufacture
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    • Y10T156/1002Methods of surface bonding and/or assembly therefor with permanent bending or reshaping or surface deformation of self sustaining lamina
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    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
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    • Y10T156/1051Methods of surface bonding and/or assembly therefor with permanent bending or reshaping or surface deformation of self sustaining lamina by folding

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  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Folding Of Thin Sheet-Like Materials, Special Discharging Devices, And Others (AREA)

Claims (8)

  1. Szabadalrtü igeaypontok
    1, Eljárás szer abagolé: készülék i^§2[k«lôâÈiMsâiæ oüris bevételre,: ássefy tartalmaz: 0) összesütkimk {41¾ egy vagy:több réteget {422,.423:. 424, 42b>, üardy tartalmaz egy rag* több âéyÿgstt szerrel vagy szert kibocsátó fomiuláciésval általában síkbeli összeállításba, hogy integrál? készüléket -432} akikrounk ki. (ri) össehííjtiak #203 m integrált adagoló készülékét {432}, hogy összehajtó?? integrált adagoló készüléke? (4S2) alakítsunk ki, amely első tengelyt határoz meg, ágy hogy az isszehaj&tí készüléknek ¢4112) egyre kisebb ráncai vasssak távolodva az első tengelytől, ügy, ixsgy egy részbe® keres? fee®sszí^tszéíeí adjon; és ílil) legalább részben kapszulázzuk {:430) a® összehajtott adagom készitlékt (48.2) egy alakra 1402}, amely alkaMss orális átlagolásra.
  2. 2. Az. L igénypont sxe.risi.ti eljárás, ahol a® egy vagy több réteg tartalmaz egy vagy több polimer anyagot, ahol az egy vagy több réteg íartahsksz egy jxillrnert vagy polimerek kombinációját, a polimer vagy polhnerek mindegyik réíegbgs lehetitek ugyanazok vagy különbözőek egy rrsásik rétegétől a készülékért beiül. % Az. I. vagy 2. igénypont szerinti eljárás, amely tartalmaz legalább egy rétege? szalag alakjában, asrsely aa egy vagy több réteg legalább egyikéhez kapcsolódik.
  3. 4. Aa 1-3. igénypontok bármelyike szerisrti eljárás, ahol az összeállítás tartalmazza az egy vagy több réteg integrációját laminál? készülék kialakítására.
  4. 5. Az 1-4. igénypontok bármelyike saerinti eljárás, amely tartalmazza két külső réteg összeállítását, amely első anyagból vatr és llrnkeiónális réteg: helbgl&iásat, a íuhkoíortális réteg tartalmaz legalább egy réteget, szalag alakjslbsm vagy több szalag: alakjában, amely második anyagból vas: és atstély tartalmazza « Szer vagy szer kilxtesáiő hmtonlációt. b. Az 1-5. igé&yfsMk bármelyiké szerinti öljáráís,: amely tartalmazza erősítő polimer kömpoxisió legalább egy rétegének: összeállítását, amelynek meebeníkal szilárdsága olyast, begy az adáfolő Mszülék kiktgíogatásakor, az erősítő jxdiraer kompíendő lehetővé les® a készülék mégísrtását lényégébe?? stet® összehajtott felépítésbe«. 7. A 3-6. igénypontok bármelyike szerinti eljárás, amely imtahasgí® leplább egy réteg összeállítását égy vagy több folytonos vagy nem fidytsmes szalag alakjában, amelynek vari egy vagy több rétege, asttely tarsaltíiazza a szesz vagy szeriMboesátdribrmsláeíét. & Az 1-7. .igéirypoKtrk hánttéiyiiké szedrét eljárás, ahol az: itstegtált: készülék tartalmaz ke; vagy több elemet, amely ki van választva a kél: vagy több réteg rágasztásü, lïepsgtése, volkamzálasa v agy sz.imereiése közül, hogy lehetővé tegye ezer· rétegek közötti integrációt. % A 8. igénypont szerinti: eljárás,; stately tartalmazza mtográsíős szer alkalmazását a két vagy több rétégé ágy hogy iaegköiMiyiíse a rétegek: közötti iístegrseiót,
  5. 10. Az 1)8;. igénypontok feársnelylke szermíi eljárás, ahol az összeállítás tartalmazza a következők legalább egyikét: * a szer vagy széf kibocsátó lormüláeié beágyazásit egy vagy Äh rétegbe;: - a szer bezárását iegíslább két réteg, közé:; - a. sæsr vapr szer kibocsátó: foratdiácieS kakától legalább egy pofeséf rnstiibrárt szegmensen belül; - g szer vagy szer kibocsátó íoranílácié kapcsolását a készülék egy vagy több rétegének s készülék, mm- vagy mikrorészecskék, por, folyadék vagy kotnpresszált szilárd anyagok vagy mátrix íélepinek legalább egyikéhez. Λ A 10. Igényport; szerinti eljárás, amely tartalmasad látitihálí készülék összeállítását;, steely iatiitimáz két külső jelegek mnely első míyaghől áll M egy vagy; több réteg kapSKiíiázásái, amely tartalmaz egy vagy több szalag®, amely egy második anyagból áll és íártaimazza a szert vágy szer kibocsátó íhmtuláe-d?.
  6. 12. A ií. igénypont szerinti eljárás, ahol a külső rétegek legalább egyike jjertmál? vagy perforációkat irattat nedvesítéskor. 13. A?; 1-12. igénypontok bármelyike szériát! eljárás, ahol a hajtogatás tartalmazza az integrált készülék manipulációját kompaktéit integrált készülékbe, amely legalább ötször kisebb méretű, teint az mtegrált készülék hajtogatása előtt.
  7. 14. Az 1-13. Igénypontok bármelyike szerinti eljárás gasztroretenciós orális átlagoló készülék előállítására.
  8. 15. Szer adagoló készülék {492} orális: bevételre, sorely tartáhnaz; Összehajtott: egy- vagy többrétegű integrált készüléket {452}, amely tartalmaz szer? vagy szer kibocsátó forttmláeióí, az Összehajtott integrált készülék legalább részben kapszulázva van egy kapszulán belül vagy az által, azzal jellemezve, bogy a szer asksgolo készülék m l - í:4, igényptmrák. bármelyike szerisíi eljárásstt! van elóálldva.
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