CY1122146T1 - Μια υγρη μορφοποιηση μακρας διαρκειας δρασης και ινσουλινοτροπο πεπτιδιο - Google Patents

Μια υγρη μορφοποιηση μακρας διαρκειας δρασης και ινσουλινοτροπο πεπτιδιο

Info

Publication number
CY1122146T1
CY1122146T1 CY20191100898T CY191100898T CY1122146T1 CY 1122146 T1 CY1122146 T1 CY 1122146T1 CY 20191100898 T CY20191100898 T CY 20191100898T CY 191100898 T CY191100898 T CY 191100898T CY 1122146 T1 CY1122146 T1 CY 1122146T1
Authority
CY
Cyprus
Prior art keywords
liquid formulation
insulin
peptide
long
moduling
Prior art date
Application number
CY20191100898T
Other languages
English (en)
Inventor
Hyung Kyu Lim
Hyun Uk Kim
Mi Kyoung Lee
Sung Min Bae
Se Chang Kwon
Jong-Soo Lee
Original Assignee
Hanmi Pharm. Co., Ltd.
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=49997583&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CY1122146(T1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Hanmi Pharm. Co., Ltd. filed Critical Hanmi Pharm. Co., Ltd.
Publication of CY1122146T1 publication Critical patent/CY1122146T1/el

Links

Classifications

    • 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
    • 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
    • A61K47/68—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 antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6801—Drug-antibody or immunoglobulin conjugates defined by the pharmacologically or therapeutically active agent
    • A61K47/6803—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates
    • A61K47/6811—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being a protein or peptide, e.g. transferrin or bleomycin
    • 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
    • A61K38/26—Glucagons
    • 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
    • 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
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • 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
    • A61K47/68—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 antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • 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

Abstract

Η παρούσα εφεύρεση σχετίζεται με μια υγρή μορφοποίηση ενός συνδυασμού ινσουλίνης και ινσουλινοτρόπου πεπτιδίου μακράς διάρκειας δράσης, που περιλαμβάνει ινσουλίνη η οποία είναι ένα ενεργό από άποψη φυσιολογίας πεπτίδιο, ινσουλινοτρόπο πεπτίδιο, και σταθεροποιητή χωρίς αλβουμίνη, όπου ο σταθεροποιητής περιλαμβάνει ένα ρυθμιστικό διάλυμα, μια αλκοόλη σακχάρου, μια μη ιοντική επιφανειοδραστική ουσία, και έναν ισοτονικό παράγοντα· και με μια μέθοδο για την παρασκευή της υγρής μορφοποίησης. Η υγρή μορφοποίηση της παρούσας εφεύρεσης δεν περιέχει μια αλβουμίνη ορού ανθρώπου και δυνητικά τοξικούς παράγοντες για το σώμα, και έτσι έχει εξαιρετική σταθερότητα αποθήκευσης για το σύζευγμα ινσουλίνης και το ινσουλινοτρόπο πεπτιδικό σύζευγμα σε υψηλή συγκέντρωση, χωρίς κάποιον κίνδυνο μόλυνσης από ιό.
CY20191100898T 2012-07-25 2019-08-22 Μια υγρη μορφοποιηση μακρας διαρκειας δρασης και ινσουλινοτροπο πεπτιδιο CY1122146T1 (el)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR20120081478 2012-07-25
PCT/KR2013/006676 WO2014017849A1 (en) 2012-07-25 2013-07-25 A liquid formulation of long-acting insulin and insulinotropic peptide

Publications (1)

Publication Number Publication Date
CY1122146T1 true CY1122146T1 (el) 2021-01-27

Family

ID=49997583

Family Applications (1)

Application Number Title Priority Date Filing Date
CY20191100898T CY1122146T1 (el) 2012-07-25 2019-08-22 Μια υγρη μορφοποιηση μακρας διαρκειας δρασης και ινσουλινοτροπο πεπτιδιο

Country Status (20)

Country Link
US (1) US9833516B2 (el)
EP (1) EP2877201B1 (el)
JP (2) JP6403670B2 (el)
KR (1) KR102088863B1 (el)
CN (2) CN104519904A (el)
AR (1) AR092862A1 (el)
AU (1) AU2013293720B2 (el)
BR (1) BR112015001593B1 (el)
CA (1) CA2880037C (el)
CY (1) CY1122146T1 (el)
DK (1) DK2877201T3 (el)
ES (1) ES2743918T3 (el)
HK (1) HK1204291A1 (el)
HU (1) HUE045837T2 (el)
MX (1) MX358647B (el)
PL (1) PL2877201T3 (el)
PT (1) PT2877201T (el)
RU (1) RU2643766C2 (el)
TW (1) TWI630214B (el)
WO (1) WO2014017849A1 (el)

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TW201410704A (zh) 2014-03-16
EP2877201A4 (en) 2016-03-30
US9833516B2 (en) 2017-12-05
CN110269930A (zh) 2019-09-24
RU2015104489A (ru) 2016-09-20
EP2877201A1 (en) 2015-06-03
MX358647B (es) 2018-08-29
AU2013293720A1 (en) 2015-02-12
BR112015001593B1 (pt) 2023-12-26
MX2015001217A (es) 2015-09-07
CA2880037A1 (en) 2014-01-30
WO2014017849A1 (en) 2014-01-30
HK1204291A1 (en) 2015-11-13
US20150190528A1 (en) 2015-07-09
JP6686070B2 (ja) 2020-04-22
CA2880037C (en) 2021-08-17
CN104519904A (zh) 2015-04-15
TWI630214B (zh) 2018-07-21
KR102088863B1 (ko) 2020-03-13
ES2743918T3 (es) 2020-02-21
RU2643766C2 (ru) 2018-02-05
JP2015524429A (ja) 2015-08-24
AR092862A1 (es) 2015-05-06
AU2013293720B2 (en) 2018-05-10
JP2018138615A (ja) 2018-09-06
KR20140015208A (ko) 2014-02-06
HUE045837T2 (hu) 2020-01-28
EP2877201B1 (en) 2019-06-05
BR112015001593A2 (pt) 2019-07-30
JP6403670B2 (ja) 2018-10-10
PT2877201T (pt) 2019-09-10
PL2877201T3 (pl) 2019-12-31
DK2877201T3 (da) 2019-09-16

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