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ME03810B - Tekuće formulacije levotiroksina - Google Patents

Tekuće formulacije levotiroksina

Info

Publication number
ME03810B
ME03810B MEP-2020-145A MEP2020145A ME03810B ME 03810 B ME03810 B ME 03810B ME P2020145 A MEP2020145 A ME P2020145A ME 03810 B ME03810 B ME 03810B
Authority
ME
Montenegro
Prior art keywords
vol
glycerol
solution
edta
pharmaceutical
Prior art date
Application number
MEP-2020-145A
Other languages
German (de)
English (en)
French (fr)
Inventor
Nilesh Parikh
William Hite
Original Assignee
Tap Pharmaceuticals Ag
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
Application filed by Tap Pharmaceuticals Ag filed Critical Tap Pharmaceuticals Ag
Publication of ME03810B publication Critical patent/ME03810B/me

Links

Classifications

    • 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
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/195Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • A61K31/198Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
    • 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
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0087Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Cosmetics (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pyridine Compounds (AREA)

Claims (15)

1. Farmaceutska otopina, naznačena time što sadrži: - od 0,00 1% tež./vol. do 0,0 1% tež./vol. levotiroksina; - najmanje 70% tež./tež. gliceroia; - manje od 30% tež./tež. vode; i - od 0,01% tež./tež. do 1.5% tež./tež. etilendiamintetraoctene kiseiine (EDTA), igdje je otopina stabilna za skladištenje.
2. Farmaceutska otopina u skladu s patentnim zahtjevom 1, naznačena time što je levotiroksin levotiroksin-natrij.
3. Farmaceutska otopina u skiadu s patentnim zahtjevom 2, naznačena time što je EDTA dinatrij-EDTA.
4. Farmaceutska otopina u skladu s patentnim zahtjevom 3, naznačena time što otopina sadrži od 0,05% tež./tež. do 1,0% tež./tež. EDTA.
5. Farmaceutska otopina u skiadu s patentnim zahtjevom 4, naznačena time što otopina sadrži najmanje 80% tež./tež. giicerola, po mogucnosti najmanje 85% tež./tež. giicerola.
6. Farmaceutska otopina u skiadu s patentnim zahtjevom 5, naznačena time što otopina sadrži najmanje 90% tež./tež. gliceroia, po mogucnosti najmanje 95% tež./tež. glicerola.
7. Farmaceutska otopina u skiadu s patentnim zahtjevom 1, naznačena time što je farmaceutska otopina koja sadrži: - 0,002% tež./vol., 0,004% tež./vol., 0,006% tež./vol., 0,008% tež./vol., ili 0,01% tež./vol. levotiroksina; - najmanje 80% tež./tež. glicerola; - manje od 20% tež./tež. vode; i - od 0,05% tež./tež. do 1,0% tež./tež. EDTA, igdje je otopina stabiina za skiadistenje.
8. Farmaceutska otopina u skiadu s patentnim zahtjevom 7, naznačena time što je levotiroksin levotiroksin-natrij.
9. Fannaceutska otopina u skladu s patentnim zahtjevom 8, naznačena time što je EDTA dinatrij-EDTA.
10.Fannaceutska otopina u skladu s patentnim zahtjevom 9, naznačena time što otopina sadrži najmanje 85% tež./tež. glicerola, po mogućnosti najmanje 90% tež./tež. glicerola.
11. Farmaceutska otopina u skladu s patentnim zahtjevom l 0, naznačena time što otopina sadrži najmanje 95% tež./tež. glicerola.
12. Farmaceutska otopina u skladu s patentnim zahtjevom l , naznačena time što je farmaceutska otopina koja sadrži: - 0,002% tež./vol. ili 0,004% tež./vol. levotiroksina; - najmanje 80% tež./tež. glicerola; - manje od 20% tež./tež. vode; i - 0,08% tež./tež. EDTA, igdje je otopina stabilna za skladistenje.
13.Fannaceutska otopina u skladu s patentnim zahtjevom 12, naznačena time što otopina sadrži od 85% tež./tež. do 99% tež./tež. glicerola.
14.Farmaceutska otopina u skladu s patentnim zahtjevom 13, naznačena time što otopina sadrži od 90%tež./tež. do 99% tež./tež. glicerola.
15. Farmaceutska otopina u skladu s patentnim zahtjevom l, naznačena time što je farmaceutska otopina koja sadrži: - 0,002% tež./vol., 0,004%ttež./vol., ili 0,006% tež./vol. levotiroksina; - 95% tež./vol. glicerola; - 5% tež./vol. vode; i - 0,08% tež./tež. EDTA, igdje je otopina stabilna za skladistenje.
MEP-2020-145A 2015-02-27 2016-02-23 Tekuće formulacije levotiroksina ME03810B (me)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US14/634,452 US9345772B1 (en) 2015-02-27 2015-02-27 Liquid levothyroxine formulations
EP16756169.5A EP3261676B1 (en) 2015-02-27 2016-02-23 Liquid levothyroxine formulations
PCT/US2016/019093 WO2016137969A2 (en) 2015-02-27 2016-02-23 Liquid levothyroxine formulations

Publications (1)

Publication Number Publication Date
ME03810B true ME03810B (me) 2021-04-20

Family

ID=55969545

Family Applications (1)

Application Number Title Priority Date Filing Date
MEP-2020-145A ME03810B (me) 2015-02-27 2016-02-23 Tekuće formulacije levotiroksina

Country Status (8)

Country Link
US (1) US9345772B1 (me)
EP (1) EP3261676B1 (me)
ES (1) ES2814129T3 (me)
HR (1) HRP20201354T1 (me)
HU (1) HUE050783T2 (me)
ME (1) ME03810B (me)
SI (1) SI3261676T1 (me)
WO (1) WO2016137969A2 (me)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE112016005058T5 (de) * 2015-11-04 2018-07-19 Leiutis Pharmaceuticals Pvt Ltd Neue Levothyroxin-Formulierungen zur oralen Anwendung
NL2017110B1 (en) 2016-07-05 2018-01-12 Emp Levo Gmbh Methods for the preparation of a levothyroxine solution
WO2018069805A2 (en) 2016-10-10 2018-04-19 Ftf Pharma Private Limited Method for preparation of liquid oral composition of l-thyroxin
EP3311844A1 (en) * 2016-10-18 2018-04-25 Altergon S.A. High-stability packaged solutions of t4 thyroid hormone
US9782376B1 (en) 2016-12-01 2017-10-10 Fresenius Kabi Usa Llc Levothyroxine liquid formulations
WO2019023791A1 (en) * 2017-07-31 2019-02-07 Apollo Pharmaceuticals Inc. LEVOTHYROXIN FORMULATIONS
IT201900003013A1 (it) * 2019-03-01 2020-09-01 Altergon Sa Regime di somministrazione di composizioni di ormone tiroideo T4 con elevato assorbimento orale
US11241382B2 (en) * 2019-03-01 2022-02-08 Altergon Sa Administration regimen of compositions of T4 thyroid hormone with high oral absorption
GR1009815B (el) * 2019-07-25 2020-09-15 Ιουλια Κλεωνος Τσετη Μη αλκοολουχο ελευθερο απο συντηρητικα και καταλληλο για απο του στοματος χορηγηση πολυδοσικο διαλυμα λεβοθυροξινης για την αντιμετωπιση του υποθυρεοειδισμου
GR1010807B (el) 2023-09-15 2024-10-24 Ιουλια Κλεωνος Τσετη Σφραγισμενος μονοδοσικος περιεκτης υδατικου διαλυματος λεβοθυροξινης καταλληλος για απο του στοματος χορηγηση

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB9401891D0 (en) 1994-02-01 1994-03-30 Boots Co Plc Therapeutic agents
US5951989A (en) * 1997-04-07 1999-09-14 Heymann; Warren R. Method for the treatment of dry skin
ITMI20011401A1 (it) 2001-07-02 2003-01-02 Altergon Sa Formulazioni farmaceutiche per ormoni tiroidei
ES2559818T5 (es) * 2011-03-10 2024-06-27 Helm Swiss Gmbh Procedimiento de preparación de una solución de levotiroxina

Also Published As

Publication number Publication date
US9345772B1 (en) 2016-05-24
HRP20201354T1 (hr) 2020-11-27
HUE050783T2 (hu) 2021-01-28
EP3261676A4 (en) 2018-10-17
EP3261676B1 (en) 2020-06-17
SI3261676T1 (sl) 2020-10-30
WO2016137969A2 (en) 2016-09-01
ES2814129T3 (es) 2021-03-26
EP3261676A2 (en) 2018-01-03
WO2016137969A3 (en) 2016-11-03

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