BR112015016930A2 - formulações farmacêuticas estabilizadas de análogos de insulina e/ou derivados de insulina - Google Patents

formulações farmacêuticas estabilizadas de análogos de insulina e/ou derivados de insulina

Info

Publication number
BR112015016930A2
BR112015016930A2 BR112015016930A BR112015016930A BR112015016930A2 BR 112015016930 A2 BR112015016930 A2 BR 112015016930A2 BR 112015016930 A BR112015016930 A BR 112015016930A BR 112015016930 A BR112015016930 A BR 112015016930A BR 112015016930 A2 BR112015016930 A2 BR 112015016930A2
Authority
BR
Brazil
Prior art keywords
insulin
pharmaceutical formulations
stabilized pharmaceutical
derivatives
analogues
Prior art date
Application number
BR112015016930A
Other languages
English (en)
Other versions
BR112015016930B1 (pt
Inventor
Bidlingmaier Bernd
Berchtold Harald
Bley Oliver
Loos Petra
Kamm Walter
Original Assignee
Sanofi Sa
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 Sanofi Sa filed Critical Sanofi Sa
Priority to BR122019026852-5A priority Critical patent/BR122019026852B1/pt
Publication of BR112015016930A2 publication Critical patent/BR112015016930A2/pt
Publication of BR112015016930B1 publication Critical patent/BR112015016930B1/pt

Links

Classifications

    • 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
    • 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
    • A61K38/18—Growth factors; Growth regulators
    • A61K38/1825—Fibroblast growth factor [FGF]
    • 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
    • A61K38/26—Glucagons
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • 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
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • 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
    • A61K9/02—Suppositories; Bougies; Bases therefor; Ovules
    • 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
    • A61K9/10—Dispersions; Emulsions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/48—Drugs for disorders of the endocrine system of the pancreatic hormones
    • A61P5/50—Drugs for disorders of the endocrine system of the pancreatic hormones for increasing or potentiating the activity of insulin

Abstract

resumo patente de invenção: "formulações farmacêuticas estabilizadas de análogos de insulina e/ou derivados de insulina". a presente invenção refere-se a formulações farmacêuticas estabilizadas de análogos de insulina e/ou derivados de insulina.
BR112015016930-9A 2013-02-04 2014-02-03 Formulações farmacêuticas estabilizadas de análogos e/ou derivados de insulina, seu processo de preparação e kits e dispositivo médico que as compreendem BR112015016930B1 (pt)

Priority Applications (1)

Application Number Priority Date Filing Date Title
BR122019026852-5A BR122019026852B1 (pt) 2013-02-04 2014-02-03 Usos de formulações farmacêuticas estabilizadas de análogos e/ou derivados de insulina

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
EP13305126 2013-02-04
EP13305126.8 2013-02-04
US201361761434P 2013-02-06 2013-02-06
US61/761,434 2013-02-06
PCT/EP2014/051976 WO2014118355A1 (en) 2013-02-04 2014-02-03 Stabilized pharmaceutical formulations of insulin analogues and/or insulin derivatives

Publications (2)

Publication Number Publication Date
BR112015016930A2 true BR112015016930A2 (pt) 2017-07-11
BR112015016930B1 BR112015016930B1 (pt) 2021-10-13

Family

ID=47710070

Family Applications (2)

Application Number Title Priority Date Filing Date
BR122019026852-5A BR122019026852B1 (pt) 2013-02-04 2014-02-03 Usos de formulações farmacêuticas estabilizadas de análogos e/ou derivados de insulina
BR112015016930-9A BR112015016930B1 (pt) 2013-02-04 2014-02-03 Formulações farmacêuticas estabilizadas de análogos e/ou derivados de insulina, seu processo de preparação e kits e dispositivo médico que as compreendem

Family Applications Before (1)

Application Number Title Priority Date Filing Date
BR122019026852-5A BR122019026852B1 (pt) 2013-02-04 2014-02-03 Usos de formulações farmacêuticas estabilizadas de análogos e/ou derivados de insulina

Country Status (17)

Country Link
US (4) US9839675B2 (pt)
EP (2) EP3747426A1 (pt)
JP (2) JP6445461B2 (pt)
KR (2) KR102234908B1 (pt)
CN (2) CN104968329B (pt)
AR (1) AR095114A1 (pt)
AU (4) AU2014211324B9 (pt)
BR (2) BR122019026852B1 (pt)
CA (1) CA2896375C (pt)
MX (2) MX2015010113A (pt)
PL (1) PL2950780T3 (pt)
RU (1) RU2702345C2 (pt)
SG (1) SG11201504972RA (pt)
TW (2) TWI641381B (pt)
UY (1) UY35306A (pt)
WO (1) WO2014118355A1 (pt)
ZA (1) ZA201504582B (pt)

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PL2498802T3 (pl) 2009-11-13 2015-06-30 Sanofi Aventis Deutschland Kompozycja farmaceutyczna zawierająca agonistę GLP-1, insulinę i metioninę
EP2498801B1 (de) 2009-11-13 2018-01-24 Sanofi-Aventis Deutschland GmbH HARMAZEUTISCHE ZUSAMMENSETZUNG UMFASSEND desPro36Exendin-4(1-39)-Lys6-NH2 UND METHIONIN
EP2611458B1 (en) 2010-08-30 2016-09-21 Sanofi-Aventis Deutschland GmbH Use of ave0010 for the manufacture of a medicament for the treatment of diabetes mellitus type 2
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BR112014004726A2 (pt) 2011-08-29 2017-04-04 Sanofi Aventis Deutschland combinação farmacêutica para uso no controle glicêmico em pacientes de diabetes tipo 2
AR087744A1 (es) 2011-09-01 2014-04-16 Sanofi Aventis Deutschland Composicion farmaceutica para uso en el tratamiento de una enfermedad neurodegenerativa
TWI641381B (zh) * 2013-02-04 2018-11-21 法商賽諾菲公司 胰島素類似物及／或胰島素衍生物之穩定化醫藥調配物
US9839692B2 (en) 2014-01-09 2017-12-12 Sanofi Stabilized pharmaceutical formulations of insulin analogues and/or insulin derivatives
MX2016008978A (es) 2014-01-09 2016-10-04 Sanofi Sa Formulaciones farmaceuticas de analogos de insulina y/o derivados de insulina estabilizadas y que estan libres de glicerol.
JP6735674B2 (ja) 2014-01-09 2020-08-05 サノフイＳａｎｏｆｉ インスリンアスパルトの安定化された医薬製剤
EP3229828B1 (en) 2014-12-12 2023-04-05 Sanofi-Aventis Deutschland GmbH Insulin glargine/lixisenatide fixed ratio formulation
TWI748945B (zh) 2015-03-13 2021-12-11 德商賽諾菲阿凡提斯德意志有限公司 第２型糖尿病病患治療
TW201705975A (zh) 2015-03-18 2017-02-16 賽諾菲阿凡提斯德意志有限公司 第２型糖尿病病患之治療
US20210187078A1 (en) 2016-02-25 2021-06-24 Wockhardt Limited Pharmaceutical composition of insulin glargine and amino acids
GB201607918D0 (en) 2016-05-06 2016-06-22 Arecor Ltd Novel formulations
GB201707187D0 (en) * 2017-05-05 2017-06-21 Arecor Ltd Novel formulations
CN108114270B (zh) * 2018-02-06 2019-08-20 美药星（南京）制药有限公司 一种门冬胰岛素注射液的制备方法
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