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MX2018009497A - Proceso para fabricar una bolsa de infusion estable, lista para su uso para una formulacion sensible a la oxidacion. - Google Patents

Proceso para fabricar una bolsa de infusion estable, lista para su uso para una formulacion sensible a la oxidacion.

Info

Publication number
MX2018009497A
MX2018009497A MX2018009497A MX2018009497A MX2018009497A MX 2018009497 A MX2018009497 A MX 2018009497A MX 2018009497 A MX2018009497 A MX 2018009497A MX 2018009497 A MX2018009497 A MX 2018009497A MX 2018009497 A MX2018009497 A MX 2018009497A
Authority
MX
Mexico
Prior art keywords
ready
formulation
manufacturing
product
oxidation
Prior art date
Application number
MX2018009497A
Other languages
English (en)
Inventor
Hingorani Tushar
Pejaver Satish
Chaitanya Kunadharaju Sasank
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
Publication of MX2018009497A publication Critical patent/MX2018009497A/es

Links

Classifications

    • 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
    • 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
    • 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
    • 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
    • A61K9/0012—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
    • 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
    • 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
    • A61L2103/05—
    • 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]
    • A61L2103/23—
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Pain & Pain Management (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Dermatology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Hematology (AREA)
  • Biomedical Technology (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)
  • Molecular Biology (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)

Abstract

Se proporciona un proceso para minimizar la formacion de un producto de mayor degradacion durante la esterilizacion por calor humedo de una solucion farmaceutica de un ingrediente farmaceutico activo (API) susceptible a la oxidacion, en donde el agua no se desoxigena y no se usa una cubierta de nitrogeno durante la formulacion, o la formulacion se almacena en condiciones ambientales en la bolsa de polimero y se somete a autoclave. El producto de mayor degradacion en el producto farmacologico parenteral es menor que 0.1% en peso de una cantidad etiquetada del API susceptible a la oxidacion en el producto farmacologico parenteral.
MX2018009497A 2016-02-05 2017-01-23 Proceso para fabricar una bolsa de infusion estable, lista para su uso para una formulacion sensible a la oxidacion. MX2018009497A (es)

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
MX2018009497A true MX2018009497A (es) 2019-05-06

Family

ID=57915030

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2018009497A MX2018009497A (es) 2016-02-05 2017-01-23 Proceso para fabricar una bolsa de infusion estable, lista para su uso para una formulacion sensible a la oxidacion.

Country Status (21)

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

Families Citing this family (4)

* 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
EP3691748A4 (en) * 2017-10-03 2021-07-07 Nevakar, Inc ACETAMINOPHEN-PREGABALIN COMBINATIONS AND METHODS OF TREATMENT OF 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
WO2025146648A1 (en) * 2024-01-02 2025-07-10 Endo Operations Limited Oxytocin compositions and methods

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
WO2008009756A1 (es) * 2006-07-18 2008-01-24 Genfarma Laboratorio S.L. Formulación líquida inyectable de paracetamol
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
BR112014027885B1 (pt) * 2012-05-09 2022-07-26 Icrom Spa Processo para a preparação de um pó a granel de brinzolamida 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
US20170202793A1 (en) * 2014-07-25 2017-07-20 Terumo Kabushiki Kaisha Packaged acetaminophen injection solution preparation

Also Published As

Publication number Publication date
SI3411004T1 (sl) 2021-08-31
DK3411004T3 (da) 2021-04-19
BR112018014354A2 (en) 2018-12-18
IL260320A (en) 2018-08-30
HUE053952T4 (hu) 2021-09-28
JP2019506407A (ja) 2019-03-07
US20190029979A1 (en) 2019-01-31
CN108601704A (zh) 2018-09-28
WO2017134540A1 (en) 2017-08-10
US20220023238A1 (en) 2022-01-27
KR20180100615A (ko) 2018-09-11
SG11201806091YA (en) 2018-08-30
AU2019257508B2 (en) 2020-12-24
HUE053952T2 (hu) 2021-08-30
CA3013413C (en) 2020-12-01
CY1124008T1 (el) 2022-05-27
IL260320B (en) 2021-10-31
RU2018128397A3 (es) 2020-03-05
AU2019257508A1 (en) 2019-11-21
ES2867392T3 (es) 2021-10-20
RU2018128397A (ru) 2020-03-05
EP3411004A1 (en) 2018-12-12
AU2017215419A1 (en) 2018-07-19
CA3013413A1 (en) 2017-08-10
PT3411004T (pt) 2021-05-11
PL3411004T3 (pl) 2021-10-18
EP3411004B1 (en) 2021-03-10
KR102246136B1 (ko) 2021-04-29
AU2017215419B2 (en) 2019-11-21
US20200330411A1 (en) 2020-10-22
ZA201804970B (en) 2019-05-29
RU2729528C2 (ru) 2020-08-07

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