DK2773331T3 - Formuleringer til behandling af diabetes - Google Patents
Formuleringer til behandling af diabetes Download PDFInfo
- Publication number
- DK2773331T3 DK2773331T3 DK12798470.6T DK12798470T DK2773331T3 DK 2773331 T3 DK2773331 T3 DK 2773331T3 DK 12798470 T DK12798470 T DK 12798470T DK 2773331 T3 DK2773331 T3 DK 2773331T3
- Authority
- DK
- Denmark
- Prior art keywords
- insulin
- formulation
- acid
- buffer
- aprotic polar
- Prior art date
Links
Classifications
-
- 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
- A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
-
- 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
-
- 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
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Diabetes (AREA)
- Endocrinology (AREA)
- Zoology (AREA)
- Gastroenterology & Hepatology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Immunology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Dermatology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Obesity (AREA)
- Emergency Medicine (AREA)
- Hematology (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
Claims (35)
1. Formulering til parenteral indgivelse omfattende: (a) insulin, som omfatter et pH-lager (EN: "pH memory") mellem 1 til 4 eller mellem 6 til 8, og som tidligere er blevet tørret fra en ikke-volatil puffer; og (b) et aprot polært solvent, hvor insulinet er solubiliseret i det aprote polære solvent, hvor størstedelen af det solubil i -serede insulin omfatter stabile monomere eller dimere former af insulin eller blandinger deraf, og hvor vandindholdet af formuleringen er lig med eller mindre end 15% w/v.
2. Formulering ifølge krav 1, hvor pH-lageret af insulinet er mellem 1 til 4 eller mellem 1 til 3, eller cirka 2, eller hvor pH-lageret af insulinet er mellem 6 til 8 eller cirka 7.
3. Formulering ifølge et hvilket som helst af kravene 1-2, hvor det aprote polære solvent er dimethylsulfoxid (DMSO), n-methylpyrrolidon (NMP), ethylacetat, dimethylfor-mamid (DMF), dimethylacetamid (DMA) eller propylencarbonat eller blandinger deraf, især dimethylsulfoxid (DMSO).
4. Formulering ifølge et hvilket som helst af kravene 1-3, hvor formuleringen omfatter 3 mg/ml til 50 mg/ml, 3 mg/ml til 10 mg/ml eller 10 mg/ml til 50 mg/ml af insulin.
5. Formulering ifølge et hvilket som helst af kravene 1-4, hvor størstedelen af det solubiliserede insulin er i monomer eller dimer form.
6. Formulering ifølge et hvilket som helst af kravene 1-5 yderligere omfattende en ingrediens, som er i stand til at mindske aggregering af monomere eller dimere former af insulin.
7. Formulering ifølge krav 6, hvor ingrediensen, som er i stand til at mindske aggregering af monomere eller dimere former af insulin, er urea, guanidiniumchlorid, en aminosyre, en sukker, en polyol, en polymer, en syre eller en surfaktant eller blandinger deraf.
8. Formulering ifølge krav 7, hvor syren er eddikesyre, ascorbinsyre, citronsyre, glutaminsyre, asparaginsyre, ravsyre, fumarsyre, maleinsyre eller adipinsyre eller blandinger deraf.
9. Formulering ifølge et hvilket som helst af kravene 1-7 yderligere omfattende et cosolvent, især vand.
10. Formulering ifølge et hvilket som helst af kravene 1-9, hvor formuleringen ikke omfatter zink, eller hvor zink tilstede i formuleringen er bundet til et chelaterende middel.
11. Formulering ifølge krav 10, hvor den ikke-volatile puffer er en glycinpuffer, en citratpuffer eller en phosphatpuffer eller blandinger deraf.
12. Formulering ifølge krav 11, hvor pufferen omfatter et chelaterende middel, især ethylendiamintetraeddikesyre (EDTA), ethylenglycoltetraeddikesyre (EGTA), vinsyre, glycerin eller citronsyre.
13. Formulering ifølge et hvilket som helst af kravene 1-12 yderligere omfattende en ingrediens, som er i stand til at sænke frysepunktet af det aprote polære solvent til cirka 0°C, især vand, en sukker, en sukkeralkohol eller blandinger deraf.
14. Formulering ifølge et hvilket som helst af kravene 1-13, hvor insulinet er ikke-modificeret humant insulin.
15. Formulering ifølge et hvilket som helst af kravene 1-14, yderligere omfattende en amylinanalog, som er solubiliseret i formuleringen, især pramlintid.
16. Formulering ifølge krav 15, hvor pramlintidet har et pH-lager af cirka 2, eller hvor pramlintidet har et pH-lager af cirka 2, og insulinet har et pH-lager af cirka 2.
17. Formulering ifølge krav 16, hvor pramlintidet tidligere er blevet tørret i en ikke-volatil puffer, hvilken puffer har et pH af cirka 2.
18. Formulering ifølge et hvilket som helst af kravene 15-17, hvor vandindholdet af formuleringen er mellem 5 til 15% w/v, 7 til 12% w/v eller 8 til 10% w/v eller cirka 9% w/v.
19. Formulering ifølge et hvilket som helst af kravene 1-18, hvor formuleringen er i flydende form, især en opløsning.
20. Formulering ifølge et hvilket som helst af kravene 1-19, hvor mindst 90% af insulinet i formuleringen forbliver kemisk og fysisk stabilt, når formuleringen opbevares ved stuetemperatur i én måned.
21. Formulering ifølge et hvilket som helst af kravene 1-20, hvor formuleringen er omfattet i en beholder, især en sprøjte, en pen-injektionsindretning, en autoinjektorindret-ning, en pumpe eller en perfusionspose.
22. Formulering ifølge et hvilket som helst af kravene 1-21, hvor det aprote polære solvent er den kontinuerlige fase af formuleringen.
23. Formulering ifølge et hvilket som helst af kravene 1-22, hvor formuleringen omfatter mindst 75, 80, 85, 90 eller 95% w/v af det aprote polære solvent.
24. Formulering ifølge et hvilket som helst af kravene 1-23, hvor det solubiliserede insulin er metastabilt.
25. Formulering ifølge et hvilket som helst af kravene 1-24 til anvendelse i en fremgangsmåde til at mindske blodglucoseniveau omfattende indgivelse til en patient med behov derfor af formuleringen i en mængde, der er virkningsfuld til at mindske blodgluco-seniveauet i patienten.
26. Formulering ifølge krav 25, hvor blodglucoseniveauet i patienten mindskes inden for 30 minutter, 60 minutter eller 90 minutter efter indgivelse.
27. Formulering ifølge et hvilket som helst af kravene 25-26, hvor det tidlige Vi Tmax-blodinsulinniveau i patienten forekomner inden for 30 til 60 minutter efter indgivelse.
28. Formulering ifølge et hvilket som helst af kravene 25-27, hvor patienten er blevet diagnosticeret med Type-I- eller Type-II-diabetes.
29. Formulering ifølge et hvilket som helst af kravene 25-28, hvor formuleringen indgives inden for 10 minutter, 5 minutter eller 1 minut før indtagelse af mad af patienten eller inden for 1 minut, 5 minutter eller 10 minutter efter indtagelse af mad af patienten.
30. Fremgangsmåde til fremstilling af formuleringen ifølge et hvilket som helst af kravene 1-24 omfattende: (a) tørring af en blanding omfattende insulin og en ikke-volatil puffer for at tilvejebringe tørret insulin, hvor det tørrede insulin har et pH-lager mellem 1 til 4 eller 6 til 8; og (b) rekonstituering af det tørrede insulin i et aprot polært solvent, hvor insulinet solubiliseres i det aprote polære solvent, hvor det solubiliserede insulin omfatter stabile monomere eller dimere former af insulin eller blandinger deraf, og hvor vandindholdet af formuleringen er lig med eller mindre end 15% w/v.
31. Fremgangsmåde ifølge krav 30, hvor formuleringen omfatter 3 mg/ml til 50 mg/ml, 3 mg/ml til 10 mg/ml eller 10 mg/ml til 50 mg/ml af insulin eller 50 mg/ml til 100 mg/ml af insulin.
32. Fremgangsmåde ifølge et hvilket som helst af kravene 30-31 yderligere omfattende: (c) tørring af en blanding omfattende en amylinanalog og den samme ikke-volatile puffer i trin (a) eller en anden ikke-volatil puffer for at tilvejebringe en tørret amylinanalog; og (b) rekonstituering af den tørrede amylinanalog i det aprote polære solvent sammen med det tørrede insulin, hvor den tørrede amylinanalog solubiliseres i det aprote polære solvent.
33. Fremgangsmåde ifølge krav 32, hvor amylinanalogen er pramlintid, og hvor pramlintidet har et pH-lager af cirka 2, eller hvor pramlintidet har et pH-lager af cirka 2, og insulinet har et pH-lager af cirka 2.
34. Fremgangsmåde ifølge et hvilket som helst af kravene 32-33, hvor den ikke-volatile puffer har et pH område af cirka 2.
35. Fremgangsmåde ifølge et hvilket som helst af kravene 32-34, yderligere omfattende tilsætning af vand mellem 5 til 15% w/v af formuleringen som et cosolvent.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201161553388P | 2011-10-31 | 2011-10-31 | |
| US201261609123P | 2012-03-09 | 2012-03-09 | |
| PCT/US2012/062816 WO2013067022A1 (en) | 2011-10-31 | 2012-10-31 | Formulations for the treatment of diabetes |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK2773331T3 true DK2773331T3 (da) | 2016-03-14 |
Family
ID=47324375
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK12798470.6T DK2773331T3 (da) | 2011-10-31 | 2012-10-31 | Formuleringer til behandling af diabetes |
Country Status (16)
| Country | Link |
|---|---|
| US (1) | US9138479B2 (da) |
| EP (1) | EP2773331B1 (da) |
| JP (1) | JP6117811B2 (da) |
| KR (1) | KR102007057B1 (da) |
| CN (1) | CN103930096B (da) |
| AU (1) | AU2012332556B2 (da) |
| BR (1) | BR112014010275A2 (da) |
| CA (1) | CA2853942C (da) |
| DK (1) | DK2773331T3 (da) |
| EA (1) | EA027744B1 (da) |
| ES (1) | ES2574761T3 (da) |
| MX (1) | MX349383B (da) |
| PL (1) | PL2773331T3 (da) |
| SG (1) | SG11201401921YA (da) |
| WO (1) | WO2013067022A1 (da) |
| ZA (1) | ZA201403795B (da) |
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| CN106573106B (zh) | 2014-08-06 | 2021-06-22 | Xeris药物公司 | 用于皮内和/或皮下注射糊剂的注射器、试剂盒和方法 |
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| US9649364B2 (en) | 2015-09-25 | 2017-05-16 | Xeris Pharmaceuticals, Inc. | Methods for producing stable therapeutic formulations in aprotic polar solvents |
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| US11590205B2 (en) | 2015-09-25 | 2023-02-28 | Xeris Pharmaceuticals, Inc. | Methods for producing stable therapeutic glucagon formulations in aprotic polar solvents |
| EP3518892B1 (en) * | 2016-09-29 | 2023-06-21 | Arecor Limited | Pharmaceutical formulation comprising an insulin compound |
| MA46568A (fr) * | 2016-10-24 | 2019-08-28 | Novo Nordisk As | Dosage biologique de formulations d'insuline |
| CN106310232A (zh) * | 2016-10-25 | 2017-01-11 | 南京师范大学 | 一种稳定的胰岛素解聚体超分子复合物及其制备方法 |
| CN110366424B (zh) | 2016-12-27 | 2024-05-24 | 阿道恰公司 | 包含胰淀素、胰淀素受体激动剂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 |
| EP4290320A3 (en) | 2017-05-05 | 2024-02-21 | Ypsomed AG | Closed loop control of physiological glucose |
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| AU2018308692A1 (en) * | 2017-07-27 | 2020-03-05 | Adocia | Compositions in the form of an injectable aqueous solution comprising at least human insulin A21G and a prandial action glucagon suppressor |
| FR3082426A1 (fr) | 2018-06-14 | 2019-12-20 | Adocia | Compositions sous forme d'une solution aqueuse injectable comprenant au moins de l'insuline humaine a21g et un suppresseur de glucagon a action prandiale |
| CA3084699A1 (en) | 2017-12-07 | 2019-06-13 | Adocia | Compositions in the form of an injectable aqueous solution comprising amylin, an amylin agonist receptor or an amylin analog 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 |
| WO2019110788A1 (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 |
| FR3083085B1 (fr) | 2018-06-29 | 2020-10-02 | 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 |
| 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 |
| CN111565710A (zh) | 2017-12-07 | 2020-08-21 | 阿道恰公司 | 包含胰淀素、胰淀素受体激动剂或胰淀素类似物以及共聚氨基酸的呈可注射水溶液形式的组合物 |
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-
2012
- 2012-10-31 EA EA201490913A patent/EA027744B1/ru not_active IP Right Cessation
- 2012-10-31 DK DK12798470.6T patent/DK2773331T3/da active
- 2012-10-31 EP EP12798470.6A patent/EP2773331B1/en active Active
- 2012-10-31 JP JP2014539160A patent/JP6117811B2/ja active Active
- 2012-10-31 SG SG11201401921YA patent/SG11201401921YA/en unknown
- 2012-10-31 CN CN201280053399.9A patent/CN103930096B/zh active Active
- 2012-10-31 PL PL12798470T patent/PL2773331T3/pl unknown
- 2012-10-31 AU AU2012332556A patent/AU2012332556B2/en active Active
- 2012-10-31 BR BR112014010275A patent/BR112014010275A2/pt not_active IP Right Cessation
- 2012-10-31 US US14/354,848 patent/US9138479B2/en active Active
- 2012-10-31 KR KR1020147014882A patent/KR102007057B1/ko active IP Right Grant
- 2012-10-31 CA CA2853942A patent/CA2853942C/en active Active
- 2012-10-31 MX MX2014005311A patent/MX349383B/es active IP Right Grant
- 2012-10-31 WO PCT/US2012/062816 patent/WO2013067022A1/en active Application Filing
- 2012-10-31 ES ES12798470.6T patent/ES2574761T3/es active Active
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Also Published As
| Publication number | Publication date |
|---|---|
| KR20140107228A (ko) | 2014-09-04 |
| ES2574761T3 (es) | 2016-06-21 |
| SG11201401921YA (en) | 2014-05-29 |
| US20140349926A1 (en) | 2014-11-27 |
| MX2014005311A (es) | 2014-10-06 |
| WO2013067022A1 (en) | 2013-05-10 |
| ZA201403795B (en) | 2016-01-27 |
| PL2773331T3 (pl) | 2016-08-31 |
| US9138479B2 (en) | 2015-09-22 |
| JP6117811B2 (ja) | 2017-04-19 |
| JP2014532667A (ja) | 2014-12-08 |
| CN103930096A (zh) | 2014-07-16 |
| EA201490913A1 (ru) | 2014-09-30 |
| CA2853942A1 (en) | 2013-05-10 |
| CA2853942C (en) | 2020-08-25 |
| AU2012332556A1 (en) | 2014-06-19 |
| KR102007057B1 (ko) | 2019-08-02 |
| MX349383B (es) | 2017-07-26 |
| EP2773331B1 (en) | 2016-02-10 |
| BR112014010275A2 (pt) | 2017-04-18 |
| EP2773331A1 (en) | 2014-09-10 |
| EA027744B1 (ru) | 2017-08-31 |
| AU2012332556B2 (en) | 2016-05-26 |
| CN103930096B (zh) | 2017-05-31 |
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