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WO2010041138A3 - Complexe entre l'insuline humaine et un polymère amphiphile et utilisation de ce complexe pour la préparation d'une formulation d'insuline humaine rapide - Google Patents

Complexe entre l'insuline humaine et un polymère amphiphile et utilisation de ce complexe pour la préparation d'une formulation d'insuline humaine rapide Download PDF

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Publication number
WO2010041138A3
WO2010041138A3 PCT/IB2009/007106 IB2009007106W WO2010041138A3 WO 2010041138 A3 WO2010041138 A3 WO 2010041138A3 IB 2009007106 W IB2009007106 W IB 2009007106W WO 2010041138 A3 WO2010041138 A3 WO 2010041138A3
Authority
WO
WIPO (PCT)
Prior art keywords
complex
human insulin
minutes
less
amphiphilic polymer
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.)
Ceased
Application number
PCT/IB2009/007106
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English (en)
Other versions
WO2010041138A2 (fr
Inventor
Olivier Soula
Rémi SOULA
Gérard Soula
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
Publication of WO2010041138A2 publication Critical patent/WO2010041138A2/fr
Publication of WO2010041138A3 publication Critical patent/WO2010041138A3/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L89/00—Compositions of proteins; Compositions of derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/716—Glucans
    • A61K31/721—Dextrans
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/56—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
    • A61K47/61—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule the organic macromolecular compound being a polysaccharide or a derivative thereof
    • 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
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08B—POLYSACCHARIDES; DERIVATIVES THEREOF
    • C08B37/00—Preparation of polysaccharides not provided for in groups C08B1/00 - C08B35/00; Derivatives thereof
    • C08B37/0006—Homoglycans, i.e. polysaccharides having a main chain consisting of one single sugar, e.g. colominic acid
    • C08B37/0009—Homoglycans, i.e. polysaccharides having a main chain consisting of one single sugar, e.g. colominic acid alpha-D-Glucans, e.g. polydextrose, alternan, glycogen; (alpha-1,4)(alpha-1,6)-D-Glucans; (alpha-1,3)(alpha-1,4)-D-Glucans, e.g. isolichenan or nigeran; (alpha-1,4)-D-Glucans; (alpha-1,3)-D-Glucans, e.g. pseudonigeran; Derivatives thereof
    • C08B37/0021—Dextran, i.e. (alpha-1,4)-D-glucan; Derivatives thereof, e.g. Sephadex, i.e. crosslinked dextran
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08K—Use of inorganic or non-macromolecular organic substances as compounding ingredients
    • C08K3/00—Use of inorganic substances as compounding ingredients
    • C08K3/18—Oxygen-containing compounds, e.g. metal carbonyls
    • C08K3/20—Oxides; Hydroxides
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08K—Use of inorganic or non-macromolecular organic substances as compounding ingredients
    • C08K3/00—Use of inorganic substances as compounding ingredients
    • C08K3/32—Phosphorus-containing compounds
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08K—Use of inorganic or non-macromolecular organic substances as compounding ingredients
    • C08K5/00—Use of organic ingredients
    • C08K5/04—Oxygen-containing compounds
    • C08K5/13—Phenols; Phenolates
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08K—Use of inorganic or non-macromolecular organic substances as compounding ingredients
    • C08K5/00—Use of organic ingredients
    • C08K5/04—Oxygen-containing compounds
    • C08K5/15—Heterocyclic compounds having oxygen in the ring
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08K—Use of inorganic or non-macromolecular organic substances as compounding ingredients
    • C08K5/00—Use of organic ingredients
    • C08K5/16—Nitrogen-containing compounds
    • C08K5/17—Amines; Quaternary ammonium compounds
    • C08K5/175—Amines; Quaternary ammonium compounds containing COOH-groups; Esters or salts thereof
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L5/00—Compositions of polysaccharides or of their derivatives not provided for in groups C08L1/00 or C08L3/00
    • C08L5/02—Dextran; Derivatives thereof

Landscapes

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

Abstract

L'invention concerne un complexe entre l'insuline humaine et un polymère amphiphile comportant des groupes fonctionnels carboxyles, ledit polymère amphiphile étant choisi parmi les polysaccharides fonctionnalisés constitués en majorité de monomères glycosidiques liés par des liaisons glycosidiques de type (1,6) fonctionnalisés par au moins un dérivé du tryptophane. Elle concerne également une composition pharmaceutique comprenant au moins un complexe selon l'invention, ladite formulation pouvant être sous forme d'une solution injectable. Elle concerne plus particulièrement l'utilisation d'un complexe selon l'invention pour la préparation d'une formulation d'insuline humaine à une concentration voisine de 600 μM (100 UI/mL) dont le délai d'action est inférieur à 30 minutes, de préférence inférieur à 20 minutes, et encore de préférence inférieur à 15 minutes et/ou dont le nadir glycémique est inférieur à 120 minutes, de préférence inférieur à 105 minutes, et encore de préférence inférieur à 90 minutes.
PCT/IB2009/007106 2008-10-10 2009-10-12 Complexe entre l'insuline humaine et un polymère amphiphile et utilisation de ce complexe pour la préparation d'une formulation d'insuline humaine rapide Ceased WO2010041138A2 (fr)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US13689408P 2008-10-10 2008-10-10
FR0856896 2008-10-10
US61/136,894 2008-10-10
FR0856896A FR2940802A1 (fr) 2008-10-10 2008-10-10 Complexe entre l'insuline humaine et un polymere amphiphile et utilisation de ce complexe pour la preparation d'une formulation d'insuline humaine rapide.
FR08/56896 2008-10-10

Publications (2)

Publication Number Publication Date
WO2010041138A2 WO2010041138A2 (fr) 2010-04-15
WO2010041138A3 true WO2010041138A3 (fr) 2010-07-29

Family

ID=40547470

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2009/007106 Ceased WO2010041138A2 (fr) 2008-10-10 2009-10-12 Complexe entre l'insuline humaine et un polymère amphiphile et utilisation de ce complexe pour la préparation d'une formulation d'insuline humaine rapide

Country Status (2)

Country Link
FR (1) FR2940802A1 (fr)
WO (1) WO2010041138A2 (fr)

Families Citing this family (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9018190B2 (en) 2009-03-27 2015-04-28 Adocia Functionalized oligosaccharides
FR2943538B1 (fr) 2009-03-27 2011-05-20 Adocia Formulation a action rapide d'insuline recombinante humaine
DK2741765T3 (en) 2011-08-10 2016-06-13 Adocia Injectable solution of at least one type of basal insulin
FR2978918B1 (fr) * 2011-08-10 2013-12-27 Adocia Solution injectable a ph7 comprenant au moins une insuline basale dont le pi est compris entre 5,8 et 8,5
EP2773675B1 (fr) * 2011-11-02 2023-03-01 Adocia Formulation à action rapide d'insuline comprenant un oligosaccharide
US20130231281A1 (en) 2011-11-02 2013-09-05 Adocia Rapid acting insulin formulation comprising an oligosaccharide
BR112014016889A8 (pt) 2012-01-09 2017-07-04 Adocia composição sob a forma de uma solução aquosa injetável, sujo ph está compreendido entre 6,0 e 8,0 e, formulação de dose unitária com ph compreendido entre 7 e 7,8
US20150314003A2 (en) 2012-08-09 2015-11-05 Adocia Injectable solution at ph 7 comprising at least one basal insulin the isoelectric point of which is between 5.8 and 8.5 and a hydrophobized anionic polymer
WO2014076423A1 (fr) 2012-11-13 2014-05-22 Adocia Formulation à action rapide d'insuline comprenant un composé anionique substitué
US9795678B2 (en) 2014-05-14 2017-10-24 Adocia Fast-acting insulin composition comprising a substituted anionic compound and a polyanionic compound
FR3020947B1 (fr) 2014-05-14 2018-08-31 Adocia Composition aqueuse comprenant au moins une proteine et un agent solubilisant, sa preparation et ses utilisations
FR3043557B1 (fr) 2015-11-16 2019-05-31 Adocia Composition a action rapide d'insuline comprenant un citrate substitue
FR3084585B1 (fr) * 2018-08-03 2020-11-06 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 compose amphiphile porteur de radicaux hydrophobes

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5554388A (en) * 1989-02-25 1996-09-10 Danbiosyst Uk Limited Systemic drug delivery compositions comprising a polycationi substance
US20040234616A1 (en) * 2003-03-04 2004-11-25 The Technology Development Company Ltd. Long acting injectable insulin composition and methods of making and using thereof
WO2007116143A1 (fr) * 2006-04-07 2007-10-18 Adocia Polysaccharides bifonctionnalises
WO2008038111A1 (fr) * 2006-09-26 2008-04-03 Adocia Dextran fonctionnalise par des amino-acides hydrophobes

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5554388A (en) * 1989-02-25 1996-09-10 Danbiosyst Uk Limited Systemic drug delivery compositions comprising a polycationi substance
US20040234616A1 (en) * 2003-03-04 2004-11-25 The Technology Development Company Ltd. Long acting injectable insulin composition and methods of making and using thereof
WO2007116143A1 (fr) * 2006-04-07 2007-10-18 Adocia Polysaccharides bifonctionnalises
WO2008038111A1 (fr) * 2006-09-26 2008-04-03 Adocia Dextran fonctionnalise par des amino-acides hydrophobes

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
BAUDYS M ET AL: "Extending insulin action in vivo by conjugation to carboxymethyl dextran", BIOCONJUGATE CHEMISTRY, ACS, WASHINGTON, DC, US, vol. 9, no. 2, 5 February 1998 (1998-02-05), pages 176 - 183, XP002363506, ISSN: 1043-1802 *

Also Published As

Publication number Publication date
WO2010041138A2 (fr) 2010-04-15
FR2940802A1 (fr) 2010-07-09

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