FR3084585B1 - SOLUTION FOR INJECTION AT PH 7 INCLUDING AT LEAST ONE BASAL INSULIN WHOSE PI IS BETWEEN 5.8 AND 8.5 AND AN AMPHIPHILIC COMPOUND CARRIER OF HYDROPHOBIC RADICALS - Google Patents

SOLUTION FOR INJECTION AT PH 7 INCLUDING AT LEAST ONE BASAL INSULIN WHOSE PI IS BETWEEN 5.8 AND 8.5 AND AN AMPHIPHILIC COMPOUND CARRIER OF HYDROPHOBIC RADICALS Download PDF

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Publication number
FR3084585B1
FR3084585B1 FR1857268A FR1857268A FR3084585B1 FR 3084585 B1 FR3084585 B1 FR 3084585B1 FR 1857268 A FR1857268 A FR 1857268A FR 1857268 A FR1857268 A FR 1857268A FR 3084585 B1 FR3084585 B1 FR 3084585B1
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FR
France
Prior art keywords
basal insulin
amphiphilic compound
injection
solution
insulin whose
Prior art date
Legal status (The legal status 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 status listed.)
Active
Application number
FR1857268A
Other languages
French (fr)
Other versions
FR3084585A1 (en
Inventor
Emmanuel Dauty
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Adocia SAS
Original Assignee
Adocia SAS
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 Adocia SAS filed Critical Adocia SAS
Priority to FR1857268A priority Critical patent/FR3084585B1/en
Priority to PCT/EP2019/070952 priority patent/WO2020025824A1/en
Publication of FR3084585A1 publication Critical patent/FR3084585A1/en
Application granted granted Critical
Publication of FR3084585B1 publication Critical patent/FR3084585B1/en
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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
    • 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
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • 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
    • 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

[0001] L'invention concerne une composition stable physiquement sous forme d'une solution aqueuse injectable, dont le pH est compris entre 6,0 et 8,0, comprenant au moins: - une insuline basale dont le point isoélectrique (pI) est compris entre 5,8 et 8,5, et - un composé amphiphile comprenant un squelette hydrophile HB, substitué par au moins un radical hydrophobe -Hy de formule I, - et un sel de cation au moins divalent.The invention relates to a physically stable composition in the form of an injectable aqueous solution, the pH of which is between 6.0 and 8.0, comprising at least: - a basal insulin whose isoelectric point (pI) is between 5.8 and 8.5, and - an amphiphilic compound comprising a hydrophilic backbone HB, substituted by at least one hydrophobic radical —Hy of formula I, - and an at least divalent cation salt.

FR1857268A 2018-08-03 2018-08-03 SOLUTION FOR INJECTION AT PH 7 INCLUDING AT LEAST ONE BASAL INSULIN WHOSE PI IS BETWEEN 5.8 AND 8.5 AND AN AMPHIPHILIC COMPOUND CARRIER OF HYDROPHOBIC RADICALS Active FR3084585B1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
FR1857268A FR3084585B1 (en) 2018-08-03 2018-08-03 SOLUTION FOR INJECTION AT PH 7 INCLUDING AT LEAST ONE BASAL INSULIN WHOSE PI IS BETWEEN 5.8 AND 8.5 AND AN AMPHIPHILIC COMPOUND CARRIER OF HYDROPHOBIC RADICALS
PCT/EP2019/070952 WO2020025824A1 (en) 2018-08-03 2019-08-03 Injectable solution at ph 7, comprising at least one basal insulin with a pi between 5.8 and 8.5, at least one ionic species, and an amphiphilic compound bearing hydrophobic radicals

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR1857268 2018-08-03
FR1857268A FR3084585B1 (en) 2018-08-03 2018-08-03 SOLUTION FOR INJECTION AT PH 7 INCLUDING AT LEAST ONE BASAL INSULIN WHOSE PI IS BETWEEN 5.8 AND 8.5 AND AN AMPHIPHILIC COMPOUND CARRIER OF HYDROPHOBIC RADICALS

Publications (2)

Publication Number Publication Date
FR3084585A1 FR3084585A1 (en) 2020-02-07
FR3084585B1 true FR3084585B1 (en) 2020-11-06

Family

ID=65201006

Family Applications (1)

Application Number Title Priority Date Filing Date
FR1857268A Active FR3084585B1 (en) 2018-08-03 2018-08-03 SOLUTION FOR INJECTION AT PH 7 INCLUDING AT LEAST ONE BASAL INSULIN WHOSE PI IS BETWEEN 5.8 AND 8.5 AND AN AMPHIPHILIC COMPOUND CARRIER OF HYDROPHOBIC RADICALS

Country Status (2)

Country Link
FR (1) FR3084585B1 (en)
WO (1) WO2020025824A1 (en)

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3837825A1 (en) 1988-11-08 1990-05-10 Hoechst Ag NEW INSULIN DERIVATIVES, THEIR USE AND A PHARMACEUTICAL PREPARATION CONTAINING THEM
FR2801226B1 (en) 1999-11-23 2002-01-25 Flamel Tech Sa COLLOIDAL SUSPENSION OF SUBMICRONIC PARTICLES FOR VECTORIZATION OF ACTIVE INGREDIENTS AND METHOD OF PREPARATION
PL374949A1 (en) 2001-12-20 2005-11-14 Eli Lilly And Company Insulin molecule having protracted time action
FR2840614B1 (en) 2002-06-07 2004-08-27 Flamel Tech Sa POLYAMINOACIDS FUNCTIONALIZED BY ALPHA-TOCOPHEROL AND THEIR PARTICULARLY THERAPEUTIC APPLICATIONS
US20060217290A1 (en) 2003-04-29 2006-09-28 Kohn Wayne D Insulin analogs having protracted time action
TWI451876B (en) * 2008-06-13 2014-09-11 Lilly Co Eli Pegylated insulin lispro compounds
FR2940802A1 (en) * 2008-10-10 2010-07-09 Adocia COMPLEXITY BETWEEN HUMAN INSULIN AND AN AMPHIPHILIC POLYMER AND USE OF THIS COMPLEX FOR PREPARING RAPID HUMAN INSULIN FORMULATION
FR3001896B1 (en) * 2013-02-12 2015-07-03 Adocia PH 7 INJECTABLE SOLUTION COMPRISING AT LEAST ONE BASIC INSULIN WHERE THE ISO-ELECTRIC POINT IS BETWEEN 5.8 AND 8.5 AND A HYDROPHOBIC ANIONIC POLYMER
FR3052072A1 (en) * 2016-06-07 2017-12-08 Adocia PH 7 INJECTABLE SOLUTION COMPRISING AT LEAST ONE BASIC INSULIN WITH A PI BETWEEN 5.8 AND 8.5 AND A CO-POLYAMINOACIDE CARRYING CARBOXYLATE LOADS AND HYDROPHOBIC RADICALS

Also Published As

Publication number Publication date
WO2020025824A1 (en) 2020-02-06
FR3084585A1 (en) 2020-02-07

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