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HRP20220692T1 - Brzodjelujući pripravci inzulina - Google Patents

Brzodjelujući pripravci inzulina Download PDF

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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
Application number
HRP20220692TT
Other languages
English (en)
Inventor
Michael Patrick AKERS
Ranajoy Majumdar
Chi A. Nguyen
Chad D. Paavola
Virender Kumar Sarin
Nanette Elizabeth Schulte
Original Assignee
Eli Lilly And Company
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=55066806&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=HRP20220692(T1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Eli Lilly And Company filed Critical Eli Lilly And Company
Publication of HRP20220692T1 publication Critical patent/HRP20220692T1/hr

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22Hormones
    • A61K38/28Insulins
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs 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.
HRP20220692TT 2014-12-16 2015-12-09 Brzodjelujući pripravci inzulina HRP20220692T1 (hr)

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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Also Published As

Publication number Publication date
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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