CY1124008T1 - Μεθοδος παραγωγης σταθερου, ετοιμου για χρηση σακου εγχυσης για ευαισθητο στην οξειδωση σκευασμα - Google Patents

Μεθοδος παραγωγης σταθερου, ετοιμου για χρηση σακου εγχυσης για ευαισθητο στην οξειδωση σκευασμα

Info

Publication number
CY1124008T1
CY1124008T1 CY20211100304T CY211100304T CY1124008T1 CY 1124008 T1 CY1124008 T1 CY 1124008T1 CY 20211100304 T CY20211100304 T CY 20211100304T CY 211100304 T CY211100304 T CY 211100304T CY 1124008 T1 CY1124008 T1 CY 1124008T1
Authority
CY
Cyprus
Prior art keywords
ready
oxidation
stable
formulation
producing
Prior art date
Application number
CY20211100304T
Other languages
English (en)
Inventor
Tushar HINGORANI
Sasank Chaitanya Kunadharaju
Tushar Malkan
Satish Pejaver
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.
Publication of CY1124008T1 publication Critical patent/CY1124008T1/el

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/16—Amides, e.g. hydroxamic acids
    • A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/167—Amides, 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS 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
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/0005—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
    • A61L2/0011—Methods 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
    • A61L2/0023—Heat
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS 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
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/002—Compounding apparatus specially for enteral or parenteral nutritive solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS 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
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
    • A61L2/04—Heat
    • A61L2/06—Hot gas
    • A61L2/07—Steam
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/04—Centrally acting analgesics, e.g. opioids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS 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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10—Bag-type containers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS 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
    • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/10—Apparatus features
    • A61L2202/18—Aseptic storing means
    • A61L2202/181—Flexible packaging means, e.g. permeable membranes, paper
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS 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
    • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/20—Targets to be treated
    • A61L2202/21—Pharmaceuticals, e.g. medicaments, artificial body parts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS 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
    • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/20—Targets to be treated
    • A61L2202/23—Containers, e.g. vials, bottles, syringes, mail

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (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)
  • Dermatology (AREA)
  • Molecular Biology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Hematology (AREA)
  • Inorganic Chemistry (AREA)
  • Nutrition Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Rheumatology (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)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Materials For Medical Uses (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

Παρέχεται μέθοδος για ελαχιστοποίηση σχηματισμού υψηλότερου προϊόντος αποικοδόμησης κατά τη διάρκεια αποστείρωσης με υγρή θερμότητα διαλύματος φαρμάκου, επιδεκτικού σε οξείδωση δραστικού φαρμακευτικού συστατικού (API), όπου το ύδωρ δεν είναι αποξυγονωμένο και δεν χρησιμοποιείται στρώμα αζώτου κατά τη διάρκεια μορφοποίησης ή το σκεύασμα αποθηκεύεται σε συνθήκες περιβάλλοντος στον σάκο πολυμερούς και υποβάλλεται σε αυτόκλειστο. Το έντονης αποικοδόμησης προϊόν στο προϊόν παρεντερικού φαρμάκου είναι λιγότερο από 0,1% κατά βάρος επισημασμένης ποσότητας του επιδεκτικού σε οξείδωση API στο προϊόν παρεντερικού φαρμάκου.
CY20211100304T 2016-02-05 2021-04-08 Μεθοδος παραγωγης σταθερου, ετοιμου για χρηση σακου εγχυσης για ευαισθητο στην οξειδωση σκευασμα CY1124008T1 (el)

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
CY1124008T1 true CY1124008T1 (el) 2022-05-27

Family

ID=57915030

Family Applications (1)

Application Number Title Priority Date Filing Date
CY20211100304T CY1124008T1 (el) 2016-02-05 2021-04-08 Μεθοδος παραγωγης σταθερου, ετοιμου για χρηση σακου εγχυσης για ευαισθητο στην οξειδωση σκευασμα

Country Status (21)

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

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10052296B2 (en) 2016-04-07 2018-08-21 Nevakar Inc. Formulations for treating pain
US11547686B2 (en) 2017-10-03 2023-01-10 Nevakar Injectables Inc. Acetaminophen pregabalin combinations and methods of treating pain

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
ES2389760T3 (es) * 2010-04-14 2012-10-31 B. Braun Melsungen Ag Composición de acetaminofeno
DE202011102490U1 (de) 2011-04-07 2012-06-28 Klosterfrau Berlin Gmbh Sterilisation von medizinischen Instrumenten für die Injektion und/oder Instillation
ES2624250T3 (es) * 2012-05-09 2017-07-13 Icrom Spa Producción de brinzolamida farmacéutica estéril
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
EP3171868B1 (en) * 2014-07-25 2020-09-30 Terumo Kabushiki Kaisha Packaged acetaminophen injection solution preparation

Also Published As

Publication number Publication date
US20190029979A1 (en) 2019-01-31
CA3013413C (en) 2020-12-01
US20220023238A1 (en) 2022-01-27
AU2019257508B2 (en) 2020-12-24
PL3411004T3 (pl) 2021-10-18
EP3411004B1 (en) 2021-03-10
RU2018128397A (ru) 2020-03-05
AU2017215419B2 (en) 2019-11-21
JP2019506407A (ja) 2019-03-07
CA3013413A1 (en) 2017-08-10
WO2017134540A1 (en) 2017-08-10
EP3411004A1 (en) 2018-12-12
MX2018009497A (es) 2019-05-06
HUE053952T4 (hu) 2021-09-28
SI3411004T1 (sl) 2021-08-31
IL260320B (en) 2021-10-31
ES2867392T3 (es) 2021-10-20
CN108601704A (zh) 2018-09-28
KR20180100615A (ko) 2018-09-11
AU2017215419A1 (en) 2018-07-19
RU2729528C2 (ru) 2020-08-07
RU2018128397A3 (el) 2020-03-05
IL260320A (en) 2018-08-30
AU2019257508A1 (en) 2019-11-21
US20200330411A1 (en) 2020-10-22
ZA201804970B (en) 2019-05-29
KR102246136B1 (ko) 2021-04-29
HUE053952T2 (hu) 2021-08-30
BR112018014354A2 (pt) 2018-12-18
PT3411004T (pt) 2021-05-11
DK3411004T3 (da) 2021-04-19
SG11201806091YA (en) 2018-08-30

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