FR3074681B1 - Solution injectable a ph 7 comprenant au moins une insuline basale dont le pi est compris entre 5,8 et 8,5 et un co-polyaminoacide porteur de charges carboxylates et de radicaux hydrophobes - Google Patents

Solution injectable a ph 7 comprenant au moins une insuline basale dont le pi est compris entre 5,8 et 8,5 et un co-polyaminoacide porteur de charges carboxylates et de radicaux hydrophobes Download PDF

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Publication number
FR3074681B1
FR3074681B1 FR1761807A FR1761807A FR3074681B1 FR 3074681 B1 FR3074681 B1 FR 3074681B1 FR 1761807 A FR1761807 A FR 1761807A FR 1761807 A FR1761807 A FR 1761807A FR 3074681 B1 FR3074681 B1 FR 3074681B1
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France
Prior art keywords
basal insulin
polyaminoacid
carboxylates
carrying
injection solution
Prior art date
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Application number
FR1761807A
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English (en)
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FR3074681A1 (fr
Inventor
You-Ping Chan
Alexandre GEISSLER
Romain Noel
Richard Charvet
Nicolas LAURENT
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Adocia SAS
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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.)
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Publication date
Application filed by Adocia SAS filed Critical Adocia SAS
Priority to FR1761807A priority Critical patent/FR3074681B1/fr
Priority to CN201880088662.5A priority patent/CN111698999A/zh
Priority to PCT/EP2018/083558 priority patent/WO2019110625A1/fr
Priority to EP18812169.3A priority patent/EP3720472A1/fr
Priority to US16/770,787 priority patent/US20220040099A1/en
Priority to MA051597A priority patent/MA51597A/fr
Priority to SG11202005322RA priority patent/SG11202005322RA/en
Priority to CN201880088456.4A priority patent/CN111727049A/zh
Priority to KR1020207019244A priority patent/KR20200106891A/ko
Priority to BR112020011570-3A priority patent/BR112020011570A2/pt
Priority to PCT/EP2018/083896 priority patent/WO2019110773A1/fr
Priority to TW107144180A priority patent/TWI813604B/zh
Priority to CA3084688A priority patent/CA3084688A1/fr
Priority to US16/213,809 priority patent/US20190216931A1/en
Priority to EP18814899.3A priority patent/EP3740229A1/fr
Priority to JP2020531052A priority patent/JP2021505607A/ja
Priority to MX2020005913A priority patent/MX2020005913A/es
Publication of FR3074681A1 publication Critical patent/FR3074681A1/fr
Priority to US16/563,027 priority patent/US20190388515A1/en
Application granted granted Critical
Publication of FR3074681B1 publication Critical patent/FR3074681B1/fr
Priority to PH12020550827A priority patent/PH12020550827A1/en
Priority to IL275192A priority patent/IL275192A/en
Priority to US16/902,176 priority patent/US11883496B2/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22Hormones
    • A61K38/28Insulins
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions

Abstract

L'invention concerne des compositions stables physiquement sous forme d'une solution aqueuse injectable, dont le pH est compris entre 6,0 et 8,0, comprenant au moins : a) une insuline basale dont le point isoélectrique (pI) est compris entre 5,8 et 8,5 et b) un co-polyaminoacide porteur de charges carboxylates et d'au moins un radical hydrophobe.
FR1761807A 2017-12-06 2017-12-07 Solution injectable a ph 7 comprenant au moins une insuline basale dont le pi est compris entre 5,8 et 8,5 et un co-polyaminoacide porteur de charges carboxylates et de radicaux hydrophobes Active FR3074681B1 (fr)

Priority Applications (21)

Application Number Priority Date Filing Date Title
FR1761807A FR3074681B1 (fr) 2017-12-07 2017-12-07 Solution injectable a ph 7 comprenant au moins une insuline basale dont le pi est compris entre 5,8 et 8,5 et un co-polyaminoacide porteur de charges carboxylates et de radicaux hydrophobes
PCT/EP2018/083558 WO2019110625A1 (fr) 2017-12-06 2018-12-04 Solution injectable a ph 7 comprenant au moins une insuline basale dont le pi est compris entre 5,8 et 8,5 et un co-polyaminoacide porteur de charges carboxylates et de radicaux hydrophobes
EP18812169.3A EP3720472A1 (fr) 2017-12-06 2018-12-04 Solution injectable a ph 7 comprenant au moins une insuline basale dont le pi est compris entre 5,8 et 8,5 et un co-polyaminoacide porteur de charges carboxylates et de radicaux hydrophobes
US16/770,787 US20220040099A1 (en) 2017-12-06 2018-12-04 Injectable solution at ph 7 comprising at least a basal insulin which pi is comprised between 5.8 and 8.5 and a copolyamino acid bearing carboxylate charges and hydrophobic radicals
CN201880088662.5A CN111698999A (zh) 2017-12-06 2018-12-04 包含至少一种pi在5.8与8.5之间的基础胰岛素和带有羧酸根电荷及疏水基的共聚氨基酸的ph为7的可注射溶液
TW107144180A TWI813604B (zh) 2017-12-07 2018-12-07 包含至少一具有pi從5.8至8.5之基礎胰島素以及一帶有羧酸鹽電荷及疏水基之共聚胺基酸的可注射ph7溶液
CN201880088456.4A CN111727049A (zh) 2017-12-07 2018-12-07 Ph 7的包含至少一种pi在5.8与8.5之间的基础胰岛素和带有羧酸根电荷及疏水基的共聚氨基酸的可注射溶液
KR1020207019244A KR20200106891A (ko) 2017-12-07 2018-12-07 pI가 5.8 내지 8.5인 적어도 1종의 기저 인슐린, 및 카복실산염 전하 및 소수성 라디칼을 보유하는 코-폴리아미노산을 포함하는 pH 7의 주사용 용액
BR112020011570-3A BR112020011570A2 (pt) 2017-12-07 2018-12-07 Solução injetável a um ph 7 compreendendo pelo menos uma insulina basal apresentando um pi entre 5,8 e 8,5 e um co-poliaminoácido contendo cargas de carboxilato e radicais hidrofóbicos
PCT/EP2018/083896 WO2019110773A1 (fr) 2017-12-07 2018-12-07 Solution injectable a ph 7 comprenant au moins une insuline basale dont le pi est compris entre 5,8 et 8,5 et un co-polyaminoacide porteur de charges carboxylates et de radicaux hydrophobes
MA051597A MA51597A (fr) 2017-12-07 2018-12-07 Solution injectable a ph 7 comprenant au moins une insuline basale dont le pi est compris entre 5,8 et 8,5 et un co-polyaminoacide porteur de charges carboxylates et de radicaux hydrophobes
SG11202005322RA SG11202005322RA (en) 2017-12-07 2018-12-07 Injectable solution at ph 7 comprising at least one basal insulin having a pi of between 5.8 and 8.5 and a copolyamino acid carrying carboxylate charges and hydrophobic radicals
US16/213,809 US20190216931A1 (en) 2017-12-07 2018-12-07 Injectable ph 7 solution comprising at least one basal insulin having a pi from 5.8 to 8.5 and a co-polyamino acid bearing carboxylate charges and hydrophobic radicals
EP18814899.3A EP3740229A1 (fr) 2017-12-07 2018-12-07 Solution injectable a ph 7 comprenant au moins une insuline basale dont le pi est compris entre 5,8 et 8,5 et un co-polyaminoacide porteur de charges carboxylates et de radicaux hydrophobes
JP2020531052A JP2021505607A (ja) 2017-12-07 2018-12-07 5.8〜8.5のpIを有する少なくとも1つの基礎インスリンならびにカルボキシレート電荷および疎水性ラジカルを有するコポリアミノ酸を含むpH7の注射溶液
MX2020005913A MX2020005913A (es) 2017-12-07 2018-12-07 Solución inyectable a ph 7 que comprende al menos una insulina basal que tiene un pi de entre 5.8 y 8.5 y un copoliaminoácido con cargas de carboxilato y radicales hidrofóbicos.
CA3084688A CA3084688A1 (fr) 2017-12-07 2018-12-07 Solution injectable a ph 7 comprenant au moins une insuline basale dont le pi est compris entre 5,8 et 8,5 et un co-polyaminoacide porteur de charges carboxylates et de radicaux hydrophobes
US16/563,027 US20190388515A1 (en) 2017-12-07 2019-09-06 Injectable solution at ph 7 comprising at least one basal insulin the pi of which is from 5.8 to 8.5 and a co-polyamino acid bearing carboxylate charges and hydrophobic radicals
PH12020550827A PH12020550827A1 (en) 2017-12-07 2020-06-04 Injectable solution at ph 7 comprising at least one basal insulin having a pi of between 5.8 and 8.5 and a copolyamino acid carrying carboxylate charges and hydrophobic radicals
IL275192A IL275192A (en) 2017-12-07 2020-06-07 Solution for injection at pH 7 containing at least one basic insulin with a PI of between 5.8 and 8.5 and a copolyamino acid bearing carboxylate charges and hydrophobic radicals
US16/902,176 US11883496B2 (en) 2017-12-07 2020-06-15 Injectable pH 7 solution comprising at least one basal insulin having a pI from 5.8 to 8.5 and a co-polyamino acid bearing carboxylate charges and hydrophobic radicals

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR1761807 2017-12-07
FR1761807A FR3074681B1 (fr) 2017-12-07 2017-12-07 Solution injectable a ph 7 comprenant au moins une insuline basale dont le pi est compris entre 5,8 et 8,5 et un co-polyaminoacide porteur de charges carboxylates et de radicaux hydrophobes

Publications (2)

Publication Number Publication Date
FR3074681A1 FR3074681A1 (fr) 2019-06-14
FR3074681B1 true FR3074681B1 (fr) 2020-01-03

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FR1761807A Active FR3074681B1 (fr) 2017-12-06 2017-12-07 Solution injectable a ph 7 comprenant au moins une insuline basale dont le pi est compris entre 5,8 et 8,5 et un co-polyaminoacide porteur de charges carboxylates et de radicaux hydrophobes

Country Status (1)

Country Link
FR (1) FR3074681B1 (fr)

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2840614B1 (fr) * 2002-06-07 2004-08-27 Flamel Tech Sa Polyaminoacides fonctionnalises par de l'alpha-tocopherol et leurs applications notamment therapeutiques
FR2985428B1 (fr) * 2012-01-09 2016-05-27 Adocia Solution injectable a ph 7 comprenant au moins une insuline basale dont le pi est compris entre 5,8 et 8,5 et un polyaminoacide substitue
CN104114155B (zh) * 2012-01-09 2019-02-15 阿道恰公司 Ph为7并且至少包含pi为5.8至8.5之基础胰岛素和经取代共聚(氨基酸)的可注射溶液

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FR3074681A1 (fr) 2019-06-14

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