HRP20201354T1 - Tekuće formulacije levotiroksina - Google Patents
Tekuće formulacije levotiroksina Download PDFInfo
- Publication number
- HRP20201354T1 HRP20201354T1 HRP20201354TT HRP20201354T HRP20201354T1 HR P20201354 T1 HRP20201354 T1 HR P20201354T1 HR P20201354T T HRP20201354T T HR P20201354TT HR P20201354 T HRP20201354 T HR P20201354T HR P20201354 T1 HRP20201354 T1 HR P20201354T1
- Authority
- HR
- Croatia
- Prior art keywords
- glycerol
- levothyroxine
- pharmaceutical solution
- edta
- solution according
- Prior art date
Links
- XUIIKFGFIJCVMT-LBPRGKRZSA-N L-thyroxine Chemical compound IC1=CC(C[C@H]([NH3+])C([O-])=O)=CC(I)=C1OC1=CC(I)=C(O)C(I)=C1 XUIIKFGFIJCVMT-LBPRGKRZSA-N 0.000 title claims 9
- 229950008325 levothyroxine Drugs 0.000 title claims 7
- XUIIKFGFIJCVMT-UHFFFAOYSA-N thyroxine-binding globulin Natural products IC1=CC(CC([NH3+])C([O-])=O)=CC(I)=C1OC1=CC(I)=C(O)C(I)=C1 XUIIKFGFIJCVMT-UHFFFAOYSA-N 0.000 title claims 7
- 238000009472 formulation Methods 0.000 title 1
- 239000007788 liquid Substances 0.000 title 1
- 239000000203 mixture Substances 0.000 title 1
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims 39
- 239000003186 pharmaceutical solution Substances 0.000 claims 18
- 239000000243 solution Substances 0.000 claims 11
- 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 10
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 4
- 239000003109 Disodium ethylene diamine tetraacetate Substances 0.000 claims 2
- 235000019301 disodium ethylene diamine tetraacetate Nutrition 0.000 claims 2
- 229960003918 levothyroxine sodium Drugs 0.000 claims 2
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
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/197—Carboxylic 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
- A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
-
- 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
- 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
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; 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)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Cosmetics (AREA)
- Pyridine Compounds (AREA)
Claims (15)
1. Farmaceutska otopina, naznačena time što sadrži:
– od 0,001% tež./vol. do 0,01% tež./vol. levotiroksina;
– najmanje 70% tež./tež. glicerola;
– manje od 30% tež./tež. vode; i
– od 0,01% tež./tež. do 1.5% tež./tež. etilendiamintetraoctene kiseline (EDTA), i
gdje 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 skladu 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 skladu s patentnim zahtjevom 4, naznačena time što otopina sadrži najmanje 80% tež./tež. glicerola, po mogućnosti najmanje 85% tež./tež. glicerola.
6. Farmaceutska otopina u skladu s patentnim zahtjevom 5, naznačena time što otopina sadrži najmanje 90% tež./tež. glicerola, po mogućnosti najmanje 95% tež./tež. glicerola.
7. Farmaceutska otopina u skladu 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, i
gdje je otopina stabilna za skladištenje.
8. Farmaceutska otopina u skladu s patentnim zahtjevom 7, naznačena time što je levotiroksin levotiroksin-natrij.
9. Farmaceutska otopina u skladu s patentnim zahtjevom 8, naznačena time što je EDTA dinatrij-EDTA.
10. Farmaceutska 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 10, naznačena time što otopina sadrži najmanje 95% tež./tež. glicerola.
12. Farmaceutska otopina u skladu s patentnim zahtjevom 1, 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, i
gdje je otopina stabilna za skladištenje.
13. Farmaceutska 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 1, naznačena time što je farmaceutska otopina koja sadrži:
– 0,002% tež./vol., 0,004%tež./vol., ili 0,006% tež./vol. levotiroksina;
– 95% tež./tež. glicerola;
– 5% tež./tež. vode; i
– 0,08% tež./tež. EDTA, i
gdje je otopina stabilna za skladištenje.
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 |
|---|---|
| HRP20201354T1 true HRP20201354T1 (hr) | 2020-11-27 |
Family
ID=55969545
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20201354TT HRP20201354T1 (hr) | 2015-02-27 | 2020-08-27 | Tekuće formulacije levotiroksina |
Country Status (8)
| Country | Link |
|---|---|
| US (1) | US9345772B1 (hr) |
| EP (1) | EP3261676B1 (hr) |
| ES (1) | ES2814129T3 (hr) |
| HR (1) | HRP20201354T1 (hr) |
| HU (1) | HUE050783T2 (hr) |
| ME (1) | ME03810B (hr) |
| SI (1) | SI3261676T1 (hr) |
| WO (1) | WO2016137969A2 (hr) |
Families Citing this family (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US11364196B2 (en) * | 2015-11-04 | 2022-06-21 | Leiutis Pharmaceuticals Pvt. Ltd. | Levothyroxine formulations for oral use |
| 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 |
| 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 |
Family Cites Families (4)
| 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 |
| EP2683361B2 (en) * | 2011-03-10 | 2023-11-29 | HELM SWISS GmbH | Method for the preparaton of a levothyroxine solution |
-
2015
- 2015-02-27 US US14/634,452 patent/US9345772B1/en active Active
-
2016
- 2016-02-23 SI SI201630876T patent/SI3261676T1/sl unknown
- 2016-02-23 ME MEP-2020-145A patent/ME03810B/me unknown
- 2016-02-23 WO PCT/US2016/019093 patent/WO2016137969A2/en active Application Filing
- 2016-02-23 EP EP16756169.5A patent/EP3261676B1/en active Active
- 2016-02-23 ES ES16756169T patent/ES2814129T3/es active Active
- 2016-02-23 HU HUE16756169A patent/HUE050783T2/hu unknown
-
2020
- 2020-08-27 HR HRP20201354TT patent/HRP20201354T1/hr unknown
Also Published As
| Publication number | Publication date |
|---|---|
| WO2016137969A2 (en) | 2016-09-01 |
| ME03810B (me) | 2021-04-20 |
| SI3261676T1 (sl) | 2020-10-30 |
| HUE050783T2 (hu) | 2021-01-28 |
| EP3261676B1 (en) | 2020-06-17 |
| EP3261676A2 (en) | 2018-01-03 |
| EP3261676A4 (en) | 2018-10-17 |
| ES2814129T3 (es) | 2021-03-26 |
| WO2016137969A3 (en) | 2016-11-03 |
| US9345772B1 (en) | 2016-05-24 |
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