FR3074422B1 - SOLUTION FOR INJECTION AT PH 7 COMPRISING AT LEAST ONE BASAL INSULIN WHOSE PI IS BETWEEN 5.8 AND 8.5 AND A CO-POLYAMINOACID CARBOXYLATE CHARGES AND HYDROPHOBIC RADICALS - Google Patents

SOLUTION FOR INJECTION AT PH 7 COMPRISING AT LEAST ONE BASAL INSULIN WHOSE PI IS BETWEEN 5.8 AND 8.5 AND A CO-POLYAMINOACID CARBOXYLATE CHARGES AND HYDROPHOBIC RADICALS Download PDF

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Publication number
FR3074422B1
FR3074422B1 FR1761736A FR1761736A FR3074422B1 FR 3074422 B1 FR3074422 B1 FR 3074422B1 FR 1761736 A FR1761736 A FR 1761736A FR 1761736 A FR1761736 A FR 1761736A FR 3074422 B1 FR3074422 B1 FR 3074422B1
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France
Prior art keywords
polyaminoacid
injection
basal insulin
solution
insulin whose
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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
FR1761736A
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French (fr)
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FR3074422A1 (en
Inventor
David Duracher
Alexandre Geissler
Richard Charvet
Guilhem Mora
Romain Noel
You-Ping Chan
Nicolas Laurent
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
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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 FR1761736A priority Critical patent/FR3074422B1/en
Priority to PCT/EP2018/083558 priority patent/WO2019110625A1/en
Priority to CN201880088662.5A priority patent/CN111698999A/en
Priority to US16/770,787 priority patent/US20220040099A1/en
Priority to EP18812169.3A priority patent/EP3720472A1/en
Publication of FR3074422A1 publication Critical patent/FR3074422A1/en
Application granted granted Critical
Publication of FR3074422B1 publication Critical patent/FR3074422B1/en
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    • 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
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular 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
    • 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
    • A61K9/08—Solutions
    • 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

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Diabetes (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Engineering & Computer Science (AREA)
  • Endocrinology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Inorganic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Hematology (AREA)
  • Emergency Medicine (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Obesity (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Dermatology (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)

Abstract

[0001] L'invention concerne une composition 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 de formule I Q[Hy]j[PLG]k Formule I Dans laquelle : j ≥ 1 ; k≥ 2The 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) a basal insulin whose isoelectric point (pi) is between 5.8 and 8.5 and b) a co-polyamino acid of formula IQ [Hy] j [PLG] k Formula I Wherein: j ≥ 1; k ≥ 2

FR1761736A 2017-12-06 2017-12-06 SOLUTION FOR INJECTION AT PH 7 COMPRISING AT LEAST ONE BASAL INSULIN WHOSE PI IS BETWEEN 5.8 AND 8.5 AND A CO-POLYAMINOACID CARBOXYLATE CHARGES AND HYDROPHOBIC RADICALS Active FR3074422B1 (en)

Priority Applications (5)

Application Number Priority Date Filing Date Title
FR1761736A FR3074422B1 (en) 2017-12-06 2017-12-06 SOLUTION FOR INJECTION AT PH 7 COMPRISING AT LEAST ONE BASAL INSULIN WHOSE PI IS BETWEEN 5.8 AND 8.5 AND A CO-POLYAMINOACID CARBOXYLATE CHARGES AND HYDROPHOBIC RADICALS
PCT/EP2018/083558 WO2019110625A1 (en) 2017-12-06 2018-12-04 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
CN201880088662.5A CN111698999A (en) 2017-12-06 2018-12-04 Injectable solution with pH7 comprising at least one basal insulin with PI between 5.8 and 8.5 and a polyamino acid with carboxylate charge and hydrophobic group
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
EP18812169.3A EP3720472A1 (en) 2017-12-06 2018-12-04 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

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR1761736 2017-12-06
FR1761736A FR3074422B1 (en) 2017-12-06 2017-12-06 SOLUTION FOR INJECTION AT PH 7 COMPRISING AT LEAST ONE BASAL INSULIN WHOSE PI IS BETWEEN 5.8 AND 8.5 AND A CO-POLYAMINOACID CARBOXYLATE CHARGES AND HYDROPHOBIC RADICALS

Publications (2)

Publication Number Publication Date
FR3074422A1 FR3074422A1 (en) 2019-06-07
FR3074422B1 true FR3074422B1 (en) 2021-11-19

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
FR1761736A Active FR3074422B1 (en) 2017-12-06 2017-12-06 SOLUTION FOR INJECTION AT PH 7 COMPRISING AT LEAST ONE BASAL INSULIN WHOSE PI IS BETWEEN 5.8 AND 8.5 AND A CO-POLYAMINOACID CARBOXYLATE CHARGES AND HYDROPHOBIC RADICALS

Country Status (1)

Country Link
FR (1) FR3074422B1 (en)

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2985428B1 (en) * 2012-01-09 2016-05-27 Adocia PH 7 INJECTABLE SOLUTION COMPRISING AT LEAST ONE BASIC INSULIN WITH A PI BETWEEN 5.8 AND 8.5 AND A SUBSTITUTED POLYAMINOACIDE
CN107583039A (en) * 2012-01-09 2018-01-16 阿道恰公司 PH is 7 and the Injectable solution at least containing the PI basal insulins for being 5.8 to 8.5 and substitution copolymerization (amino acid)
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

Also Published As

Publication number Publication date
FR3074422A1 (en) 2019-06-07

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