SA518400596B1 - محلول قابل للحقن عند الرقم الهيدروجيني 7 يشتمل على أنسولين قاعدي واحد على الأقل تتراوح نقطة (pi) التعادل الكهربائي الخاصة به من 5.8 إلى 8.5، و/أو أنسولين وجبات و/أو هرمون قناة هضمية، وحمض بولي أميني - Google Patents
محلول قابل للحقن عند الرقم الهيدروجيني 7 يشتمل على أنسولين قاعدي واحد على الأقل تتراوح نقطة (pi) التعادل الكهربائي الخاصة به من 5.8 إلى 8.5، و/أو أنسولين وجبات و/أو هرمون قناة هضمية، وحمض بولي أمينيInfo
- Publication number
- SA518400596B1 SA518400596B1 SA518400596A SA518400596A SA518400596B1 SA 518400596 B1 SA518400596 B1 SA 518400596B1 SA 518400596 A SA518400596 A SA 518400596A SA 518400596 A SA518400596 A SA 518400596A SA 518400596 B1 SA518400596 B1 SA 518400596B1
- Authority
- SA
- Saudi Arabia
- Prior art keywords
- insulin
- polyamino acid
- acid bearing
- injectable solution
- gastrointestinal hormone
- Prior art date
Links
- NOESYZHRGYRDHS-UHFFFAOYSA-N insulin Chemical compound N1C(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(NC(=O)CN)C(C)CC)CSSCC(C(NC(CO)C(=O)NC(CC(C)C)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CCC(N)=O)C(=O)NC(CC(C)C)C(=O)NC(CCC(O)=O)C(=O)NC(CC(N)=O)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CSSCC(NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2C=CC(O)=CC=2)NC(=O)C(CC(C)C)NC(=O)C(C)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2NC=NC=2)NC(=O)C(CO)NC(=O)CNC2=O)C(=O)NCC(=O)NC(CCC(O)=O)C(=O)NC(CCCNC(N)=N)C(=O)NCC(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC(O)=CC=3)C(=O)NC(C(C)O)C(=O)N3C(CCC3)C(=O)NC(CCCCN)C(=O)NC(C)C(O)=O)C(=O)NC(CC(N)=O)C(O)=O)=O)NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C1CSSCC2NC(=O)C(CC(C)C)NC(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)CC=1C=CC=CC=1)C(C)C)CC1=CN=CN1 NOESYZHRGYRDHS-UHFFFAOYSA-N 0.000 title abstract 8
- 102000004877 Insulin Human genes 0.000 title abstract 4
- 108090001061 Insulin Proteins 0.000 title abstract 4
- 229940125396 insulin Drugs 0.000 title abstract 4
- 239000002253 acid Substances 0.000 title abstract 2
- 150000007942 carboxylates Chemical class 0.000 title abstract 2
- 239000003629 gastrointestinal hormone Substances 0.000 title abstract 2
- 229940102223 injectable solution Drugs 0.000 title 1
- 239000007864 aqueous solution Substances 0.000 abstract 1
- 230000002209 hydrophobic effect Effects 0.000 abstract 1
- 239000000203 mixture Substances 0.000 abstract 1
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
يتعلق الاختراع الحالي بتركيبات مستقرة فيزيائيًا physically stable على هيئة محلول مائي aqueous solution قابل للحقن injectable ، يتراوح الرقم الهيدروجيني الخاص به من 6.0 إلى 8.0، تشتمل على الأقل على: أ) أنسولين قاعدي basal insulinتتراوح نقطة التعادل الكهربائي (pI) isoelectric point الخاصة به من 5.8 إلى 8.5، و ب) أنسولين وجبات prandial insulin أو هرمون قناة هضمية gastrointestinal hormone و ج) حمض بولي أمينو مشترك co-polyamino acid يحمل شحنات كربوكسيلات carboxylate charges وجذر كاره للماء hydrophobic radical واحد على الأقل. شكل 1.
Applications Claiming Priority (2)
| 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 |
| 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 |
|---|---|
| SA518400596B1 true SA518400596B1 (ar) | 2022-03-16 |
Family
ID=57348773
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| SA518400588A SA518400588B1 (ar) | 2016-06-07 | 2018-12-04 | محلول قابل للحقن عند الرقم الهيدروجيني 7يشتمل على أنسولين قاعدي واحد على (pi)الأقل تتراوح نقطة التعادل الكهربائي الخاصة به من5.8إلى8.5وحمض بولي أميني مشترك يحمل شحنات كربوكسيلات وجذور كارهة للماء |
| SA518400596A SA518400596B1 (ar) | 2016-06-07 | 2018-12-05 | محلول قابل للحقن عند الرقم الهيدروجيني 7 يشتمل على أنسولين قاعدي واحد على الأقل تتراوح نقطة (pi) التعادل الكهربائي الخاصة به من 5.8 إلى 8.5، و/أو أنسولين وجبات و/أو هرمون قناة هضمية، وحمض بولي أميني |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| SA518400588A SA518400588B1 (ar) | 2016-06-07 | 2018-12-04 | محلول قابل للحقن عند الرقم الهيدروجيني 7يشتمل على أنسولين قاعدي واحد على (pi)الأقل تتراوح نقطة التعادل الكهربائي الخاصة به من5.8إلى8.5وحمض بولي أميني مشترك يحمل شحنات كربوكسيلات وجذور كارهة للماء |
Country Status (12)
| Country | Link |
|---|---|
| US (2) | US10383920B2 (ar) |
| EP (2) | EP3463293B1 (ar) |
| JP (1) | JP2019517555A (ar) |
| CN (2) | CN109379888B (ar) |
| BR (2) | BR112018075140A2 (ar) |
| EA (2) | EA039333B1 (ar) |
| FR (1) | FR3052072A1 (ar) |
| MX (2) | MX2018015068A (ar) |
| PH (1) | PH12018502558A1 (ar) |
| SA (2) | SA518400588B1 (ar) |
| SG (2) | SG11201810937WA (ar) |
| WO (2) | WO2017211903A1 (ar) |
Families Citing this family (16)
| 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 |
| 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 |
| CN111683674A (zh) | 2017-12-07 | 2020-09-18 | 阿道恰公司 | 包含胰淀素、胰淀素激动剂受体或胰淀素类似物和共聚氨基酸的可注射水溶液形式的组合物 |
| MX2020005913A (es) | 2017-12-07 | 2020-10-19 | Adocia | 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. |
| KR20200106891A (ko) | 2017-12-07 | 2020-09-15 | 아도시아 | pI가 5.8 내지 8.5인 적어도 1종의 기저 인슐린, 및 카복실산염 전하 및 소수성 라디칼을 보유하는 코-폴리아미노산을 포함하는 pH 7의 주사용 용액 |
| US11173109B2 (en) | 2017-12-07 | 2021-11-16 | Adocia | Compositions in the form of an injectable aqueous solution comprising amylin, an amylin receptor agonist or an amylin analog and a co-polyamino acid |
| US20190275108A1 (en) * | 2017-12-07 | 2019-09-12 | Adocia | Compositions in the form of an injectable aqueous solution comprising amylin, an amylin receptor agonist or an amylin analogue and a co-polyamino acid |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| WO2020115334A1 (fr) * | 2018-12-07 | 2020-06-11 | Adocia | Procede de preparation d'une composition stable sous forme d'une solution aqueuse injectable |
| 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)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4826818A (en) | 1983-10-26 | 1989-05-02 | Kanebo Ltd. | Proteinaceous emulsifier, process for preparing same and emulsion type cosmetic compositions containing same |
| 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 |
| EP1545460A4 (en) | 2001-12-20 | 2005-11-16 | Lilly Co Eli | INSULIN MOLECULE WITH TEMPORARY EFFECT |
| FR2840614B1 (fr) | 2002-06-07 | 2004-08-27 | Flamel Tech Sa | Polyaminoacides fonctionnalises par de l'alpha-tocopherol et leurs applications notamment therapeutiques |
| EP1620465A2 (en) | 2003-04-29 | 2006-02-01 | Eli Lilly And Company | Insulin analogs having protracted time action |
| 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 |
| AU2012293463B2 (en) * | 2011-08-10 | 2016-08-04 | Adocia | Injectable solution of at least one type of basal insulin |
| 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 |
| 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 |
| 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 |
-
2016
- 2016-06-07 FR FR1655222A patent/FR3052072A1/fr not_active Withdrawn
-
2017
- 2017-06-07 MX MX2018015068A patent/MX2018015068A/es unknown
- 2017-06-07 EP EP17727910.6A patent/EP3463293B1/fr active Active
- 2017-06-07 BR BR112018075140-5A patent/BR112018075140A2/pt not_active Application Discontinuation
- 2017-06-07 JP JP2018564355A patent/JP2019517555A/ja active Pending
- 2017-06-07 SG SG11201810937WA patent/SG11201810937WA/en unknown
- 2017-06-07 WO PCT/EP2017/063865 patent/WO2017211903A1/fr unknown
- 2017-06-07 WO PCT/EP2017/063886 patent/WO2017211916A1/fr unknown
- 2017-06-07 US US15/616,128 patent/US10383920B2/en active Active
- 2017-06-07 SG SG11201810935SA patent/SG11201810935SA/en unknown
- 2017-06-07 CN CN201780035320.2A patent/CN109379888B/zh active Active
- 2017-06-07 EA EA201892736A patent/EA039333B1/ru unknown
- 2017-06-07 BR BR112018075151-0A patent/BR112018075151A2/pt not_active Application Discontinuation
- 2017-06-07 MX MX2018015067A patent/MX2018015067A/es unknown
- 2017-06-07 US US15/616,470 patent/US10548952B2/en active Active
- 2017-06-07 EA EA201892737A patent/EA039363B1/ru unknown
- 2017-06-07 CN CN201780047889.0A patent/CN109640953B/zh active Active
- 2017-06-07 EP EP17727906.4A patent/EP3463292B1/fr active Active
-
2018
- 2018-12-04 PH PH12018502558A patent/PH12018502558A1/en unknown
- 2018-12-04 SA SA518400588A patent/SA518400588B1/ar unknown
- 2018-12-05 SA SA518400596A patent/SA518400596B1/ar unknown
Also Published As
| Publication number | Publication date |
|---|---|
| BR112018075151A2 (pt) | 2019-03-26 |
| CN109640953B (zh) | 2021-10-29 |
| CN109640953A (zh) | 2019-04-16 |
| US20170348396A1 (en) | 2017-12-07 |
| EA039333B1 (ru) | 2022-01-14 |
| SA518400588B1 (ar) | 2022-03-07 |
| US10548952B2 (en) | 2020-02-04 |
| MX2018015067A (es) | 2019-05-09 |
| CN109379888B (zh) | 2021-10-29 |
| SG11201810935SA (en) | 2019-01-30 |
| EP3463292B1 (fr) | 2020-08-05 |
| CN109379888A (zh) | 2019-02-22 |
| PH12018502558A1 (en) | 2019-10-14 |
| FR3052072A1 (fr) | 2017-12-08 |
| WO2017211903A1 (fr) | 2017-12-14 |
| EA201892737A1 (ru) | 2019-05-31 |
| EA201892736A1 (ru) | 2019-05-31 |
| EA039363B1 (ru) | 2022-01-18 |
| BR112018075140A2 (pt) | 2019-03-26 |
| US10383920B2 (en) | 2019-08-20 |
| US20170348423A1 (en) | 2017-12-07 |
| WO2017211916A1 (fr) | 2017-12-14 |
| SG11201810937WA (en) | 2019-01-30 |
| EP3463292A1 (fr) | 2019-04-10 |
| JP2019517555A (ja) | 2019-06-24 |
| MX2018015068A (es) | 2019-05-09 |
| EP3463293B1 (fr) | 2021-05-12 |
| EP3463293A1 (fr) | 2019-04-10 |
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