HRP20220692T1 - Brzodjelujući pripravci inzulina - Google Patents
Brzodjelujući pripravci inzulina Download PDFInfo
- Publication number
- HRP20220692T1 HRP20220692T1 HRP20220692TT HRP20220692T HRP20220692T1 HR P20220692 T1 HRP20220692 T1 HR P20220692T1 HR P20220692T T HRP20220692T T HR P20220692TT HR P20220692 T HRP20220692 T HR P20220692T HR P20220692 T1 HRP20220692 T1 HR P20220692T1
- Authority
- HR
- Croatia
- Prior art keywords
- pharmaceutical preparation
- concentration
- insulin
- pharmaceutical
- preparation according
- Prior art date
Links
- 239000000203 mixture Substances 0.000 title claims 2
- 229940123452 Rapid-acting insulin Drugs 0.000 title 1
- 108010026951 Short-Acting Insulin Proteins 0.000 title 1
- 239000000825 pharmaceutical preparation Substances 0.000 claims 11
- 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 claims 10
- 102000004877 Insulin Human genes 0.000 claims 5
- 108090001061 Insulin Proteins 0.000 claims 5
- 229940125396 insulin Drugs 0.000 claims 5
- KRKNYBCHXYNGOX-UHFFFAOYSA-K Citrate Chemical compound [O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O KRKNYBCHXYNGOX-UHFFFAOYSA-K 0.000 claims 3
- PEDCQBHIVMGVHV-UHFFFAOYSA-N glycerol group Chemical group OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims 3
- RLSSMJSEOOYNOY-UHFFFAOYSA-N m-cresol Chemical compound CC1=CC=CC(O)=C1 RLSSMJSEOOYNOY-UHFFFAOYSA-N 0.000 claims 3
- 229940100630 metacresol Drugs 0.000 claims 3
- 239000008194 pharmaceutical composition Substances 0.000 claims 3
- 238000002360 preparation method Methods 0.000 claims 3
- 239000003755 preservative agent Substances 0.000 claims 3
- 230000002335 preservative effect Effects 0.000 claims 3
- TWRXJAOTZQYOKJ-UHFFFAOYSA-L Magnesium chloride Chemical compound [Mg+2].[Cl-].[Cl-] TWRXJAOTZQYOKJ-UHFFFAOYSA-L 0.000 claims 2
- 239000003795 chemical substances by application Substances 0.000 claims 2
- 238000002560 therapeutic procedure Methods 0.000 claims 2
- 230000001256 tonic effect Effects 0.000 claims 2
- KCXVZYZYPLLWCC-UHFFFAOYSA-N EDTA Chemical compound OC(=O)CN(CC(O)=O)CCN(CC(O)=O)CC(O)=O KCXVZYZYPLLWCC-UHFFFAOYSA-N 0.000 claims 1
- 108010065920 Insulin Lispro Proteins 0.000 claims 1
- ISWSIDIOOBJBQZ-UHFFFAOYSA-N Phenol Chemical compound OC1=CC=CC=C1 ISWSIDIOOBJBQZ-UHFFFAOYSA-N 0.000 claims 1
- HCHKCACWOHOZIP-UHFFFAOYSA-N Zinc Chemical compound [Zn] HCHKCACWOHOZIP-UHFFFAOYSA-N 0.000 claims 1
- 229940090047 auto-injector Drugs 0.000 claims 1
- 239000008280 blood Substances 0.000 claims 1
- 210000004369 blood Anatomy 0.000 claims 1
- 206010012601 diabetes mellitus Diseases 0.000 claims 1
- WNRQPCUGRUFHED-DETKDSODSA-N humalog Chemical compound C([C@H](NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CO)NC(=O)[C@H](CS)NC(=O)[C@H]([C@@H](C)CC)NC(=O)[C@H](CO)NC(=O)[C@H]([C@@H](C)O)NC(=O)[C@H](CS)NC(=O)[C@H](CS)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](C(C)C)NC(=O)[C@@H](NC(=O)CN)[C@@H](C)CC)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CC=1C=CC(O)=CC=1)C(=O)N[C@@H](CS)C(=O)N[C@@H](CC(N)=O)C(O)=O)C1=CC=C(O)C=C1.C([C@@H](C(=O)N[C@@H](CC(C)C)C(=O)N[C@H](C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](C)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC=1C=CC(O)=CC=1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CS)C(=O)NCC(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CCCNC(N)=N)C(=O)NCC(=O)N[C@@H](CC=1C=CC=CC=1)C(=O)N[C@@H](CC=1C=CC=CC=1)C(=O)N[C@@H](CC=1C=CC(O)=CC=1)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CCCCN)C(=O)N1[C@@H](CCC1)C(=O)N[C@@H]([C@@H](C)O)C(O)=O)C(C)C)NC(=O)[C@H](CO)NC(=O)CNC(=O)[C@H](CS)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC=1NC=NC=1)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CC(N)=O)NC(=O)[C@@H](NC(=O)[C@@H](N)CC=1C=CC=CC=1)C(C)C)C1=CN=CN1 WNRQPCUGRUFHED-DETKDSODSA-N 0.000 claims 1
- 238000001802 infusion Methods 0.000 claims 1
- 229960002068 insulin lispro Drugs 0.000 claims 1
- 229910001629 magnesium chloride Inorganic materials 0.000 claims 1
- 229920001542 oligosaccharide Polymers 0.000 claims 1
- 150000002482 oligosaccharides Chemical class 0.000 claims 1
- 238000005086 pumping Methods 0.000 claims 1
- 238000007920 subcutaneous administration Methods 0.000 claims 1
- 239000011701 zinc Substances 0.000 claims 1
- 229910052725 zinc Inorganic materials 0.000 claims 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
- 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
- A61K47/02—Inorganic compounds
-
- 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
- A61K47/06—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
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- 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
- 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)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- General Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Diabetes (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Endocrinology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Zoology (AREA)
- Immunology (AREA)
- Gastroenterology & Hepatology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Emergency Medicine (AREA)
- Obesity (AREA)
- Hematology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Dermatology (AREA)
- Inorganic Chemistry (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Claims (17)
1. Farmaceutski pripravak, naznačen time što sadrži:
a. inzulin, u koncentraciji od otprilike 100 do otprilike 200 MJ/ml;
b. citrat, u koncentraciji od otprilike 15 do otprilike 35 mM;
c. cink, u koncentraciji od otprilike 0,3 do otprilike 0,8 mM; i
d. konzervans; i
gdje pripravak ne sadrži EDTA ili bilo koji oligosaharid.
2. Farmaceutski pripravak u skladu s patentnim zahtjevom 1, naznačen time što dodatno sadrži magnezijev klorid u koncentraciji do otprilike 5 mM.
3. Farmaceutski pripravak u skladu s patentnim zahtjevom 1, naznačen time što je inzulin inzulin lispro.
4. Farmaceutski pripravak u skladu s patentnim zahtjevom 1, naznačen time što je koncentracija citrata od otprilike 15 do otprilike 25 mM.
5. Farmaceutski pripravak u skladu s patentnim zahtjevom 1, naznačen time što se konzervans bira između fenola ili meta-krezola.
6. Farmaceutski pripravak u skladu s patentnim zahtjevom 5, naznačen time što konzervans je meta-krezol.
7. Farmaceutski pripravak u skladu s patentnim zahtjevom 6, naznačen time što je koncentracija meta-krezola od otprilike 2,5 do otprilike 3,8 mg/ml.
8. Farmaceutski pripravak u skladu s patentnim zahtjevom 1, naznačen time što dodatno sadrži sredstvo za toničnost.
9. Farmaceutski pripravak u skladu s patentnim zahtjevom 8, naznačen time što je sredstvo za toničnost glicerol.
10. Farmaceutski pripravak u skladu s patentnim zahtjevom 1, naznačen time što je pH pripravka od otprilike 7,0 do otprilike 7,8.
11. Farmaceutski pripravak u skladu s patentnim zahtjevom 1, naznačen time što pripravak osigurava unos inzulina u krv koji je najmanje 20% brži nego za pripravke koji sadrže isti inzulin no koji ne sadrže citrat.
12. Farmaceutski pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 11, naznačen time što je namijenjen upotrebi u terapiji.
13. Farmaceutski pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 11, naznačen time što je namijenjen upotrebi u liječenju dijabetesa.
14. Proizvodni artikl, naznačen time što sadrži bilo koji od farmaceutskih pripravaka u skladu s patentnim zahtjevima 1 do 11.
15. Proizvodni artikl u skladu s patentnim zahtjevom 14, naznačen time što je bočica za višekratnu upotrebu.
16. Proizvodni artikl u skladu s patentnim zahtjevom 14, naznačen time što je autoinjektor za višekratnu upotrebu.
17. Proizvodni artikl u skladu s patentnim zahtjevom 14, naznačen time što je crpni uređaj za terapiju kontinuiranom supkutanom infuzijom inzulina.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201462092407P | 2014-12-16 | 2014-12-16 | |
EP15817678.4A EP3233108B1 (en) | 2014-12-16 | 2015-12-09 | Rapid-acting insulin compositions |
PCT/US2015/064744 WO2016100042A1 (en) | 2014-12-16 | 2015-12-09 | Rapid-acting insulin compositions |
Publications (1)
Publication Number | Publication Date |
---|---|
HRP20220692T1 true HRP20220692T1 (hr) | 2022-07-08 |
Family
ID=55066806
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20220692TT HRP20220692T1 (hr) | 2014-12-16 | 2015-12-09 | Brzodjelujući pripravci inzulina |
Country Status (17)
Country | Link |
---|---|
US (4) | US9993555B2 (hr) |
EP (2) | EP4108253A1 (hr) |
JP (4) | JP6328855B2 (hr) |
AR (1) | AR102869A1 (hr) |
DK (1) | DK3233108T3 (hr) |
ES (1) | ES2911207T3 (hr) |
HR (1) | HRP20220692T1 (hr) |
HU (1) | HUE058764T2 (hr) |
LT (1) | LT3233108T (hr) |
MA (1) | MA41188B1 (hr) |
MD (1) | MD3233108T2 (hr) |
PL (1) | PL3233108T3 (hr) |
PT (1) | PT3233108T (hr) |
RS (1) | RS63174B1 (hr) |
SI (1) | SI3233108T1 (hr) |
TW (1) | TW201630622A (hr) |
WO (1) | WO2016100042A1 (hr) |
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CN102037008B (zh) | 2008-03-18 | 2016-08-31 | 诺沃-诺迪斯克有限公司 | 蛋白酶稳定化的、酰化胰岛素类似物 |
AU2013346624B2 (en) | 2012-11-13 | 2018-08-09 | Adocia | Quick-acting insulin formulation including a substituted anionic compound |
AR102869A1 (es) | 2014-12-16 | 2017-03-29 | Lilly Co Eli | Composiciones de insulina de rápida acción |
JO3749B1 (ar) | 2015-08-27 | 2021-01-31 | Lilly Co Eli | تركيبات إنسولين سريعة المفعول |
GB201607918D0 (en) | 2016-05-06 | 2016-06-22 | Arecor Ltd | Novel formulations |
EP3518893A1 (en) | 2016-09-29 | 2019-08-07 | Arecor Limited | Novel formulations |
HUE060149T2 (hu) | 2016-12-16 | 2023-02-28 | Novo Nordisk As | Inzulint tartalmazó gyógyászati készítmények |
US20180236080A1 (en) * | 2017-02-22 | 2018-08-23 | Adocia | Fast-acting insulin composition comprising a citric acid salt |
EP3600233A4 (en) * | 2017-03-26 | 2020-10-21 | Stafford, Vivi, Robyn | METHOD OF TREATMENT OF SKIN DISEASES OF THE EYELIDS |
ES2912162T3 (es) | 2017-06-01 | 2022-05-24 | Lilly Co Eli | Composiciones de insulina de acción rápida |
WO2019193351A1 (en) | 2018-04-04 | 2019-10-10 | Arecor Limited | Medical infusion pump system for the delivery of an insulin compound |
CA3094304A1 (en) | 2018-04-04 | 2019-10-10 | Arecor Limited | Medical infusion pump system for the delivery of an insulin compound |
CA3094237A1 (en) | 2018-04-04 | 2019-10-10 | Arecor Limited | Medical infusion pump system for the delivery of an insulin compound |
FR3083985A1 (fr) | 2018-07-23 | 2020-01-24 | Adocia | Dispositif pour injecter une solution d'insuline(s) |
WO2019243627A1 (fr) | 2018-06-23 | 2019-12-26 | Adocia | Dispositif pour injecter une solution d'insuline(s) |
AU2020235643A1 (en) * | 2019-03-14 | 2021-09-30 | Augusta University Research Institute, Inc. | Methods and compositions for supporting renal health |
US10639328B1 (en) * | 2019-03-27 | 2020-05-05 | College Of William & Mary | Compositions and methods for reducing hyperglycemia and treating diabetes |
US10799564B1 (en) | 2019-05-06 | 2020-10-13 | Baxter International Inc. | Insulin premix formulation and product, methods of preparing same, and methods of using same |
WO2021055505A2 (en) * | 2019-09-17 | 2021-03-25 | Cass Pharmaceuticals, Inc. | Subcutaneously injectable insulin and glucagon formulations and methods of administration |
US11951186B2 (en) | 2019-10-25 | 2024-04-09 | Willow Laboratories, Inc. | Indicator compounds, devices comprising indicator compounds, and methods of making and using the same |
GB202004814D0 (en) | 2020-04-01 | 2020-05-13 | Arecor Ltd | Novel formulations |
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- 2015-12-09 LT LTEPPCT/US2015/064744T patent/LT3233108T/lt unknown
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- 2015-12-09 MA MA41188A patent/MA41188B1/fr unknown
- 2015-12-09 EP EP15817678.4A patent/EP3233108B1/en active Active
- 2015-12-09 WO PCT/US2015/064744 patent/WO2016100042A1/en active Application Filing
- 2015-12-09 US US14/963,279 patent/US9993555B2/en active Active
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US20220072105A1 (en) | 2022-03-10 |
LT3233108T (lt) | 2022-05-10 |
JP2023011641A (ja) | 2023-01-24 |
JP6328855B2 (ja) | 2018-05-23 |
US20190231851A1 (en) | 2019-08-01 |
HUE058764T2 (hu) | 2022-09-28 |
JP7093669B2 (ja) | 2022-06-30 |
MA41188A (fr) | 2017-10-24 |
US11872266B2 (en) | 2024-01-16 |
DK3233108T3 (da) | 2022-04-11 |
SI3233108T1 (sl) | 2022-05-31 |
RS63174B1 (sr) | 2022-05-31 |
ES2911207T3 (es) | 2022-05-18 |
US9993555B2 (en) | 2018-06-12 |
JP2021073187A (ja) | 2021-05-13 |
TW201630622A (zh) | 2016-09-01 |
MA41188B1 (fr) | 2022-08-31 |
JP2018500314A (ja) | 2018-01-11 |
EP3233108A1 (en) | 2017-10-25 |
WO2016100042A1 (en) | 2016-06-23 |
US11123406B2 (en) | 2021-09-21 |
EP4108253A1 (en) | 2022-12-28 |
JP2018138578A (ja) | 2018-09-06 |
AR102869A1 (es) | 2017-03-29 |
US20240238382A1 (en) | 2024-07-18 |
PL3233108T3 (pl) | 2022-06-20 |
PT3233108T (pt) | 2022-05-05 |
JP7159277B2 (ja) | 2022-10-24 |
EP3233108B1 (en) | 2022-03-30 |
US20160166695A1 (en) | 2016-06-16 |
MD3233108T2 (ro) | 2022-09-30 |
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