BR112021020997A2 - Formulação e produto de pré-mistura de insulina, métodos de preparação dos mesmos, e métodos de uso dos mesmos - Google Patents

Formulação e produto de pré-mistura de insulina, métodos de preparação dos mesmos, e métodos de uso dos mesmos

Info

Publication number
BR112021020997A2
BR112021020997A2 BR112021020997A BR112021020997A BR112021020997A2 BR 112021020997 A2 BR112021020997 A2 BR 112021020997A2 BR 112021020997 A BR112021020997 A BR 112021020997A BR 112021020997 A BR112021020997 A BR 112021020997A BR 112021020997 A2 BR112021020997 A2 BR 112021020997A2
Authority
BR
Brazil
Prior art keywords
insulin
methods
product
formulation
premix
Prior art date
Application number
BR112021020997A
Other languages
English (en)
Inventor
Chung Tak Wong Joseph
Elizabeth Lee Sarah
Original Assignee
Baxter Healthcare Sa
Baxter Int
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 Baxter Healthcare Sa, Baxter Int filed Critical Baxter Healthcare Sa
Publication of BR112021020997A2 publication Critical patent/BR112021020997A2/pt

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/28—Insulins
    • 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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1468—Containers characterised by specific material properties
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • 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
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/04—Macromolecular materials
    • A61L31/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • 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
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials

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)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Engineering & Computer Science (AREA)
  • Vascular Medicine (AREA)
  • Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Zoology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Inorganic Chemistry (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Diabetes (AREA)
  • Endocrinology (AREA)
  • Hematology (AREA)
  • Dermatology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • General Chemical & Material Sciences (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Peptides Or Proteins (AREA)

Abstract

formulação e produto de prémistura de insulina, métodos de preparação dos mesmos, e métodos de uso dos mesmos. a presente invenção refere-se a uma formulação de pré-mistura de insulina farmaceuticamente aceitável contém cerca de 0,1-10,0 unidade/ml de insulina para administração intravenosa e de preferência contém ainda um agente para ajuste da tonicidade. os métodos para fazer e usar tal formulação também estão apresentados. a formulação de pré-mistura de insulina farmaceuticamente aceitável deve ser introduzida de forma asséptica em um conjunto de recipiente flexível para formar um produto farmacêutico de pré-mistura de insulina. o produto de pré-mistura de insulina pode ser uma solução aquosa estéril e pronta para uso para o controle glicêmico em um indivíduo com distúrbios metabólicos através de infusão intravenosa. o produto de pré-mistura de insulina é inesperadamente estável quando recém-preparado e também durante sua vida de prateleira de armazenamento a temperaturas de refrigeração de 2°c a 5°c por 24 meses seguidos de mais 30 dias à temperatura ambiente de 23°c a 27°c, mesmo sem qualquer conservante adicionado, qualquer zinco adicionado, qualquer tensoativo adicionado ou qualquer outro excipiente estabilizante adicionado.
BR112021020997A 2019-05-06 2020-05-04 Formulação e produto de pré-mistura de insulina, métodos de preparação dos mesmos, e métodos de uso dos mesmos BR112021020997A2 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201962843881P 2019-05-06 2019-05-06
US201962862573P 2019-06-17 2019-06-17
PCT/US2020/031322 WO2020227214A1 (en) 2019-05-06 2020-05-04 Insulin premix formulation and product, methods of preparing same, and methods of using same

Publications (1)

Publication Number Publication Date
BR112021020997A2 true BR112021020997A2 (pt) 2021-12-14

Family

ID=70919005

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112021020997A BR112021020997A2 (pt) 2019-05-06 2020-05-04 Formulação e produto de pré-mistura de insulina, métodos de preparação dos mesmos, e métodos de uso dos mesmos

Country Status (8)

Country Link
US (3) US10799564B1 (pt)
EP (1) EP3965802A1 (pt)
JP (1) JP7565299B2 (pt)
CN (1) CN113825525A (pt)
AU (2) AU2020267734B2 (pt)
BR (1) BR112021020997A2 (pt)
CA (1) CA3139001A1 (pt)
WO (1) WO2020227214A1 (pt)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10799564B1 (en) 2019-05-06 2020-10-13 Baxter International Inc. Insulin premix formulation and product, methods of preparing same, and methods of using same

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US2143591A (en) 1936-09-26 1939-01-10 Univ Alberta Therapeutic preparation and process of making and using it
US2143590A (en) 1936-09-26 1939-01-10 Univ Alberta Insulin preparation and process of producing crystals of insulin
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JPS5058213A (pt) * 1973-09-26 1975-05-21
JPS56147751A (en) * 1980-02-29 1981-11-16 Hospital For Sick Children Polypeptide disaggregation solution
US5747445A (en) * 1993-06-24 1998-05-05 Astra Aktiebolag Therapeutic preparation for inhalation
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US10799564B1 (en) * 2019-05-06 2020-10-13 Baxter International Inc. Insulin premix formulation and product, methods of preparing same, and methods of using same

Also Published As

Publication number Publication date
US20210052704A1 (en) 2021-02-25
US20210315976A1 (en) 2021-10-14
US11033608B2 (en) 2021-06-15
AU2022204014B2 (en) 2022-11-17
AU2020267734A1 (en) 2021-11-04
WO2020227214A1 (en) 2020-11-12
AU2020267734B2 (en) 2022-07-07
US11707509B2 (en) 2023-07-25
CN113825525A (zh) 2021-12-21
JP2022531670A (ja) 2022-07-08
AU2022204014A1 (en) 2022-06-30
JP7565299B2 (ja) 2024-10-10
CA3139001A1 (en) 2020-11-12
EP3965802A1 (en) 2022-03-16
US10799564B1 (en) 2020-10-13

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Legal Events

Date Code Title Description
B154 Notification of filing of divisional application [chapter 15.50 patent gazette]

Free format text: O PEDIDO FOI DIVIDIDO NO BR122023009076-4 PROTOCOLO 870230039502 EM 11/05/2023 15:29.

B07A Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]
B06A Patent application procedure suspended [chapter 6.1 patent gazette]