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DK3411004T3 - Fremgangsmåde til fremstilling af en stabil, brugsklar infusionspose til en oxidationsfølsom formulering - Google Patents

Fremgangsmåde til fremstilling af en stabil, brugsklar infusionspose til en oxidationsfølsom formulering Download PDF

Info

Publication number
DK3411004T3
DK3411004T3 DK17702164.9T DK17702164T DK3411004T3 DK 3411004 T3 DK3411004 T3 DK 3411004T3 DK 17702164 T DK17702164 T DK 17702164T DK 3411004 T3 DK3411004 T3 DK 3411004T3
Authority
DK
Denmark
Prior art keywords
ready
oxidation
preparing
stable
infusion bag
Prior art date
Application number
DK17702164.9T
Other languages
English (en)
Inventor
Tushar Hingorani
Sasank Chaitanya Kunadharaju
Satish Pejaver
Tushar Malkan
Original Assignee
Innopharma Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Innopharma Inc filed Critical Innopharma Inc
Application granted granted Critical
Publication of DK3411004T3 publication Critical patent/DK3411004T3/da

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Classifications

    • 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
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10Bag-type containers
    • 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
    • A61J3/002Compounding apparatus specially for enteral or parenteral nutritive solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/16Amides, e.g. hydroxamic acids
    • A61K31/165Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/167Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/0005Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
    • A61L2/0011Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using physical methods
    • A61L2/0023Heat
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/02Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
    • A61L2/04Heat
    • A61L2/06Hot gas
    • A61L2/07Steam
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/04Centrally acting analgesics, e.g. opioids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/10Apparatus features
    • A61L2202/18Aseptic storing means
    • A61L2202/181Flexible packaging means, e.g. permeable membranes, paper
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/20Targets to be treated
    • A61L2202/21Pharmaceuticals, e.g. medicaments, artificial body parts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/20Targets to be treated
    • A61L2202/23Containers, e.g. vials, bottles, syringes, mail

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Pain & Pain Management (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biomedical Technology (AREA)
  • Molecular Biology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Hematology (AREA)
  • Inorganic Chemistry (AREA)
  • Nutrition Science (AREA)
  • Rheumatology (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Materials For Medical Uses (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
DK17702164.9T 2016-02-05 2017-01-23 Fremgangsmåde til fremstilling af en stabil, brugsklar infusionspose til en oxidationsfølsom formulering DK3411004T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201662291589P 2016-02-05 2016-02-05
PCT/IB2017/050341 WO2017134540A1 (en) 2016-02-05 2017-01-23 Process of manufacturing a stable, ready to use infusion bag for an oxidation sensitive formulation

Publications (1)

Publication Number Publication Date
DK3411004T3 true DK3411004T3 (da) 2021-04-19

Family

ID=57915030

Family Applications (1)

Application Number Title Priority Date Filing Date
DK17702164.9T DK3411004T3 (da) 2016-02-05 2017-01-23 Fremgangsmåde til fremstilling af en stabil, brugsklar infusionspose til en oxidationsfølsom formulering

Country Status (21)

Country Link
US (3) US20190029979A1 (da)
EP (1) EP3411004B1 (da)
JP (1) JP2019506407A (da)
KR (1) KR102246136B1 (da)
CN (1) CN108601704A (da)
AU (2) AU2017215419B2 (da)
BR (1) BR112018014354A2 (da)
CA (1) CA3013413C (da)
CY (1) CY1124008T1 (da)
DK (1) DK3411004T3 (da)
ES (1) ES2867392T3 (da)
HU (1) HUE053952T4 (da)
IL (1) IL260320B (da)
MX (1) MX2018009497A (da)
PL (1) PL3411004T3 (da)
PT (1) PT3411004T (da)
RU (1) RU2729528C2 (da)
SG (1) SG11201806091YA (da)
SI (1) SI3411004T1 (da)
WO (1) WO2017134540A1 (da)
ZA (1) ZA201804970B (da)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2017177160A1 (en) 2016-04-07 2017-10-12 Nevakar Llc Formulation for use in a method of treatment of pain
US11547686B2 (en) 2017-10-03 2023-01-10 Nevakar Injectables Inc. Acetaminophen pregabalin combinations and methods of treating pain
JP7512762B2 (ja) 2020-08-20 2024-07-09 ニプロ株式会社 スガマデクス含有の液体製剤

Family Cites Families (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5314405A (en) * 1992-04-17 1994-05-24 Science Incorporated Liquid delivery apparatus
FR2751875B1 (fr) * 1996-08-05 1998-12-24 Scr Newpharm Nouvelles formulations liquides stables a base de paracetamol et leur mode de preparation
FR2809619B1 (fr) 2000-06-06 2004-09-24 Pharmatop Nouvelles formulations aqueuses de principes actifs sensibles a l'oxydation et leur procede d'obtention
CA2628806C (en) * 2006-07-18 2012-08-21 Genfarma Laboratorio S.L. Injectable liquid paracetamol formulation
CN101522223A (zh) * 2006-07-20 2009-09-02 西科尔公司 固体无菌活性药物成分的制备方法
RU2010110393A (ru) * 2010-03-18 2011-09-27 Биотекуе Корпоратион (CN) Экологически безопасный мягкий пакет для инфузионного раствора
PT2377516E (pt) * 2010-04-14 2012-07-02 Braun Melsungen Ag Composição acetaminofeno
DE102011105840A1 (de) * 2011-04-07 2012-10-11 Klosterfrau Berlin Gmbh Sterilisation von medizinischen Instrumenten für die Injektion und/oder Instillation
WO2013168186A1 (en) * 2012-05-09 2013-11-14 Icrom Spa Production of sterile active pharmaceutical ingredients
ZA201300398B (en) * 2012-11-27 2013-09-25 Genfarma Laboratories S L Injectable liquid formulation of the combination of tramadol and paracetamol
US8835505B1 (en) * 2013-03-15 2014-09-16 Welgrace Research Group Ready-to-use co-solvents pharmaceutical composition in modified flexible plastic container
US20140303254A1 (en) 2013-04-08 2014-10-09 InnoPharma Licensing LLC Process Of Manufacturing A Stable, Ready To Use Infusion Bag For An Oxidation Sensitive Formulation
US20170202793A1 (en) * 2014-07-25 2017-07-20 Terumo Kabushiki Kaisha Packaged acetaminophen injection solution preparation

Also Published As

Publication number Publication date
KR102246136B1 (ko) 2021-04-29
EP3411004B1 (en) 2021-03-10
CA3013413A1 (en) 2017-08-10
AU2019257508A1 (en) 2019-11-21
BR112018014354A2 (pt) 2018-12-18
AU2017215419B2 (en) 2019-11-21
HUE053952T2 (hu) 2021-08-30
RU2018128397A3 (da) 2020-03-05
AU2017215419A1 (en) 2018-07-19
WO2017134540A1 (en) 2017-08-10
KR20180100615A (ko) 2018-09-11
ES2867392T3 (es) 2021-10-20
RU2729528C2 (ru) 2020-08-07
EP3411004A1 (en) 2018-12-12
AU2019257508B2 (en) 2020-12-24
US20200330411A1 (en) 2020-10-22
ZA201804970B (en) 2019-05-29
IL260320B (en) 2021-10-31
PT3411004T (pt) 2021-05-11
HUE053952T4 (hu) 2021-09-28
CA3013413C (en) 2020-12-01
MX2018009497A (es) 2019-05-06
JP2019506407A (ja) 2019-03-07
SI3411004T1 (sl) 2021-08-31
CN108601704A (zh) 2018-09-28
SG11201806091YA (en) 2018-08-30
US20190029979A1 (en) 2019-01-31
IL260320A (en) 2018-08-30
RU2018128397A (ru) 2020-03-05
PL3411004T3 (pl) 2021-10-18
US20220023238A1 (en) 2022-01-27
CY1124008T1 (el) 2022-05-27

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