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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
Authority
FR
France
Prior art keywords
polyaminoacid
injection
basal insulin
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
FR1761736A
Other languages
French (fr)
Other versions
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
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 FR1761736A priority Critical patent/FR3074422B1/en
Priority to EP18812169.3A priority patent/EP3720472A1/en
Priority to PCT/EP2018/083558 priority patent/WO2019110625A1/en
Priority to US16/770,787 priority patent/US20220040099A1/en
Priority to CN201880088662.5A priority patent/CN111698999A/en
Publication of FR3074422A1 publication Critical patent/FR3074422A1/en
Application granted granted Critical
Publication of FR3074422B1 publication Critical patent/FR3074422B1/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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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
    • 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
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
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
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 (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

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

ID=64049286

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
BR112014016889A8 (en) * 2012-01-09 2017-07-04 Adocia composition in the form of an aqueous injectable solution ph is comprised between 6.0 and 8.0 and unit dose formulation with ph comprised between 7 and 7.8
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
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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