BR112018075140A2 - composição na forma de uma solução aquosa injetável, e, formulação de dose única a um ph de 7 a 7,8 - Google Patents

composição na forma de uma solução aquosa injetável, e, formulação de dose única a um ph de 7 a 7,8

Info

Publication number
BR112018075140A2
BR112018075140A2 BR112018075140-5A BR112018075140A BR112018075140A2 BR 112018075140 A2 BR112018075140 A2 BR 112018075140A2 BR 112018075140 A BR112018075140 A BR 112018075140A BR 112018075140 A2 BR112018075140 A2 BR 112018075140A2
Authority
BR
Brazil
Prior art keywords
composition
aqueous solution
single dose
injectable aqueous
dose formulation
Prior art date
Application number
BR112018075140-5A
Other languages
English (en)
Inventor
Alexandre Geissler
Ségolène LAAGE
Richard Charvet
Olivier Soula
Original Assignee
Adocia
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 filed Critical Adocia
Publication of BR112018075140A2 publication Critical patent/BR112018075140A2/pt

Links

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
    • 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
    • A61K47/50—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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

resumo "composição na forma de uma solução aquosa injetável, e, formulação de dose única a um ph de 7 a 7,8"
BR112018075140-5A 2016-06-07 2017-06-07 composição na forma de uma solução aquosa injetável, e, formulação de dose única a um ph de 7 a 7,8 BR112018075140A2 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
FR1655222A FR3052072A1 (fr) 2016-06-07 2016-06-07 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
FR1655222 2016-06-07
PCT/EP2017/063886 WO2017211916A1 (fr) 2016-06-07 2017-06-07 Solution injectable a ph 7 comprenant au moins une insuline basale dont le pi est compris entre 5,8 et 8,5, une insuline prandiale et/ou une hormone gastrointestinale, et un co-polyaminoacide porteur de charges carboxylates et de radicaux hydrophobes

Publications (1)

Publication Number Publication Date
BR112018075140A2 true BR112018075140A2 (pt) 2019-03-26

Family

ID=57348773

Family Applications (2)

Application Number Title Priority Date Filing Date
BR112018075140-5A BR112018075140A2 (pt) 2016-06-07 2017-06-07 composição na forma de uma solução aquosa injetável, e, formulação de dose única a um ph de 7 a 7,8
BR112018075151-0A BR112018075151A2 (pt) 2016-06-07 2017-06-07 composição na forma de uma solução aquosa injetável, cujo ph é de 6,0 a 8,0

Family Applications After (1)

Application Number Title Priority Date Filing Date
BR112018075151-0A BR112018075151A2 (pt) 2016-06-07 2017-06-07 composição na forma de uma solução aquosa injetável, cujo ph é de 6,0 a 8,0

Country Status (12)

Country Link
US (2) US10383920B2 (pt)
EP (2) EP3463293B1 (pt)
JP (1) JP2019517555A (pt)
CN (2) CN109379888B (pt)
BR (2) BR112018075140A2 (pt)
EA (2) EA039363B1 (pt)
FR (1) FR3052072A1 (pt)
MX (2) MX2018015068A (pt)
PH (1) PH12018502558A1 (pt)
SA (2) SA518400588B1 (pt)
SG (2) SG11201810935SA (pt)
WO (2) WO2017211916A1 (pt)

Families Citing this family (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR3070264A1 (fr) * 2017-08-24 2019-03-01 Adocia Solution injectable a ph 7 comprenant au moins une insuline basale dont le pi est compris de 5,8 a 8,5 et un co-polyaminoacide porteur de charges carboxylates et de radicaux hydrophobes
FR3083089A1 (fr) * 2018-06-29 2020-01-03 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 co-polyaminoacide porteur de charges carboxylates et de radicaux hydrophobes
FR3083086A1 (fr) * 2018-06-29 2020-01-03 Adocia Compositions sous forme d'une solution aqueuse injectable comprenant de l'amyline, un agoniste au recepteur de l'amyline ou un analogue d'amyline et un co-polyaminoacide
JP2021505607A (ja) 2017-12-07 2021-02-18 アドシア 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
WO2019110797A1 (fr) * 2017-12-07 2019-06-13 Adocia Compositions sous forme d'une solution aqueuse injectable comprenant de l'amyline, un agoniste au recepteur de l'amyline ou un analogue d'amyline et un co-polyaminoacide
JP2021505616A (ja) 2017-12-07 2021-02-18 アドシア アミリン、アミリンアゴニスト受容体またはアミリン類似体およびコポリアミノ酸を含む注射水溶液の形態の組成物
CN111836616B (zh) 2017-12-07 2024-01-16 阿道恰公司 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 7为7的可注射溶液
WO2019110773A1 (fr) 2017-12-07 2019-06-13 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 co-polyaminoacide porteur de charges carboxylates et de radicaux hydrophobes
WO2019115411A1 (fr) * 2017-12-07 2019-06-20 Adocia Compositions sous forme d'une solution aqueuse injectable comprenant de l'amyline, un agoniste au recepteur de l'amyline ou un analogue d'amyline et un co-polyaminoacide
FR3067247A1 (fr) * 2018-06-07 2018-12-14 Adocia Compositions sous forme d'une solution aqueuse injectable comprenant du glucagon humain et un co-polyaminoacide
WO2019243628A1 (fr) * 2018-06-22 2019-12-26 Adocia Composition injectable a ph 7 comprenant un co-polyaminoacide porteur de charges carboxylates et de radicaux hydrophobes et au moins une insuline basale presentant au moins un effet prandial et un effet basal
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
FR3084586B1 (fr) * 2018-08-03 2020-11-06 Adocia Compositions sous forme d'une solution aqueuse injectable comprenant de l'amyline, un agoniste au recepteur de l'amyline ou un analogue d'amyline et un compose amphiphile porteur de radicaux hydrophobes
WO2020115334A1 (fr) * 2018-12-07 2020-06-11 Adocia Procede de preparation d'une composition stable sous forme d'une solution aqueuse injectable
US20200179489A1 (en) * 2018-12-07 2020-06-11 Adocia Injectable solution at ph 7 comprising at least one basal insulin which pi is from 5.8 to 8.5 and a co-polyamino-acid bearing carboxylate charges and hydrophobic radicals and a limited amount of m-cresol
WO2020245470A1 (fr) 2019-06-07 2020-12-10 Adocia Solution injectable a ph 7 comprenant au moins une insuline basale dont le pi est compris entre 5,8 et 8,5, du liraglutide et un co-polyaminoacide porteur de charges carboxylates et de radicaux hydrophobes

Family Cites Families (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3482551D1 (de) 1983-10-26 1990-07-26 Kanebo Ltd Proteinhaltiges emulgiermittel, dessen herstellung und dieses enthaltende emulgierte kosmetische zusammensetzung.
DE3837825A1 (de) 1988-11-08 1990-05-10 Hoechst Ag Neue insulinderivate, ihre verwendung und eine sie enthaltende pharmazeutische zubereitung
FR2801226B1 (fr) 1999-11-23 2002-01-25 Flamel Tech Sa Suspension colloidale de particules submicroniques de vectorisation de principes actifs et son mode de preparation
CZ2004710A3 (cs) 2001-12-20 2005-02-16 Eli Lilly And Company Inzulínová sloučenina s protrahovaným účinkem
FR2840614B1 (fr) 2002-06-07 2004-08-27 Flamel Tech Sa Polyaminoacides fonctionnalises par de l'alpha-tocopherol et leurs applications notamment therapeutiques
BRPI0409600A (pt) 2003-04-29 2006-04-18 Lilly Co Eli análogo de insulina, composição, método de tratamento de hiperglicemia, e, análogo de pró-insulina
FR2862535B1 (fr) * 2003-11-21 2007-11-23 Flamel Tech Sa Formulations pharmaceutiques pour la liberation prolongee d'interleukines et leurs applications therapeutiques
FR2915683B1 (fr) * 2007-05-03 2009-08-07 Flamel Technologies Sa Formulations pharmaceutiques auto-precipitantes pour la liberation modifiee de principe actif
CA2843586A1 (fr) * 2011-08-10 2013-02-14 Adocia Solution injectable d'au moins une insuline basale
FR2985429B1 (fr) 2012-01-09 2016-07-29 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 obtenu par un procede de polymerisation controle
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
FR3001896B1 (fr) 2013-02-12 2015-07-03 Adocia Solution injectable a ph 7 comprenant au moins une insuline basale dont le point isolectrique est compris entre 5,8 et 8,5 et un polymere anionique hydrophobise
FR3001895B1 (fr) 2013-02-12 2015-07-03 Adocia Solution injectable a ph7 comprenant au moins une insuline basale dont le point isoelectrique est compris en 5,8 et 8,5 et un compose anionique porteur de charges carboxylates et de radicaux hydrophobes

Also Published As

Publication number Publication date
JP2019517555A (ja) 2019-06-24
US10383920B2 (en) 2019-08-20
US20170348423A1 (en) 2017-12-07
US20170348396A1 (en) 2017-12-07
EP3463292B1 (fr) 2020-08-05
SG11201810937WA (en) 2019-01-30
MX2018015068A (es) 2019-05-09
SA518400596B1 (ar) 2022-03-16
CN109640953A (zh) 2019-04-16
EP3463293A1 (fr) 2019-04-10
BR112018075151A2 (pt) 2019-03-26
PH12018502558A1 (en) 2019-10-14
CN109379888B (zh) 2021-10-29
FR3052072A1 (fr) 2017-12-08
EA201892736A1 (ru) 2019-05-31
CN109640953B (zh) 2021-10-29
EA201892737A1 (ru) 2019-05-31
SG11201810935SA (en) 2019-01-30
MX2018015067A (es) 2019-05-09
SA518400588B1 (ar) 2022-03-07
WO2017211903A1 (fr) 2017-12-14
US10548952B2 (en) 2020-02-04
EP3463292A1 (fr) 2019-04-10
EP3463293B1 (fr) 2021-05-12
WO2017211916A1 (fr) 2017-12-14
EA039333B1 (ru) 2022-01-14
EA039363B1 (ru) 2022-01-18
CN109379888A (zh) 2019-02-22

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Legal Events

Date Code Title Description
B11A Dismissal acc. art.33 of ipl - examination not requested within 36 months of filing
B11Y Definitive dismissal - extension of time limit for request of examination expired [chapter 11.1.1 patent gazette]
B350 Update of information on the portal [chapter 15.35 patent gazette]