DK2575769T3 - Stabiliseret tacrolismussammensætning - Google Patents
Stabiliseret tacrolismussammensætning Download PDFInfo
- Publication number
- DK2575769T3 DK2575769T3 DK11704177.2T DK11704177T DK2575769T3 DK 2575769 T3 DK2575769 T3 DK 2575769T3 DK 11704177 T DK11704177 T DK 11704177T DK 2575769 T3 DK2575769 T3 DK 2575769T3
- Authority
- DK
- Denmark
- Prior art keywords
- composition
- tacrolimus
- acid
- tartaric acid
- peg
- Prior art date
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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/143—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with inorganic compounds
-
- 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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/4353—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems
- A61K31/436—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
- A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Epidemiology (AREA)
- Immunology (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Dermatology (AREA)
- Inorganic Chemistry (AREA)
- Transplantation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Claims (15)
1. Farmaceutisk sammensætning indeholdende en fast dispersion af tacrolimus i en blanding af en vehikel, der omfatter en blanding af polyethylenglycol og en poloxamer og et stabiliseringsmiddel, der er i stand til at forbedre en pH-værdi i sammensætningen i området af 3,0-3,6, hvor stabiliseringsmidlet er vinsyre.
2. Sammensætning ifølge krav 1, der omfatter fra 0,5 til 5 vægt-% tacrolimus baseret på sammensætningens totalvægt.
3. Sammensætning ifølge krav 1 eller 2, hvor sammensætningen omfatter mindre end 0,5 vægt-% 8-epitacrolimus efter 12 ugers lagring ved 25°C og 60% relativ fugtighed.
4. Sammensætning ifølge krav 1 eller 2, hvor sammensætningen omfatter mindre en 0,5 vægt-% af 8-epitacrolimus efter 10 måneders lagring ved 25°C og 60% relativ fugtighed.
5. Sammensætning ifølge krav 1 eller 2, hvor sammensætningen omfatter mindre end 0,5 vægt-% af 8-epitacrolimus efter 3 ugers lagring ved 40°C og 75% relativ fugtighed.
6. Sammensætning ifølge krav 1 eller 2, hvor sammensætningen omfatter mindre end 0,5 vægt-% 8-epitacrolimus efter 19 ugers lagring ved 40°C og 75% relativ fugtighed.
7. Sammensætning ifølge krav 1 eller 2, der omfatter vinsyre i en koncentration på mindre end 5 w/w, eller mindre end 3 w/w, eller mindre end 2 w/w, eller mindre end 1 w/w, eller mindre end 0,8 w/w.
8. Sammensætning ifølge krav 1 eller 2, der omfatter fra 0,05 til 0,6 vægt-% vinsyre.
9. Sammensætning ifølge krav 1 eller 2, der omfatter fra 0,1 til 0,3 vægt-% eller fra 0,1 til 0,2 vægt-% vinsyre.
10. Sammensætning ifølge krav 1 eller 2, der omfatter 0,15 vægt-% vinsyre.
11. Sammensætning ifølge krav 1 eller 2, der omfatter tacrolimus og vinsyre i et vægtforhold fra 19:0,5 til 20:6.
12. Sammensætning ifølge krav 1 eller 2, hvor blandingen af en polyethylengly-col og en polyxamer foreligger i et forhold, på en vægt/vægt-basis, på mellem 2:1 og 3:1.
13. Sammensætning ifølge et hvilket som helst af de foregående krav, hvor sammensætningen er i det væsentlige fri for organisk opløsningsmiddel.
14. Oral doseringsform, der omfatter den farmaceutiske sammensætning ifølge et hvilket som helst af kravene 1-13.
15. Oral doseringsform ifølge krav 14, der er en tablet eller en kapsel.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DKPA201000137 | 2010-02-17 | ||
US30594110P | 2010-02-18 | 2010-02-18 | |
PCT/DK2011/050046 WO2011100975A2 (en) | 2010-02-17 | 2011-02-17 | Stabilized tacrolimus composition |
Publications (1)
Publication Number | Publication Date |
---|---|
DK2575769T3 true DK2575769T3 (da) | 2016-09-26 |
Family
ID=44370081
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DK11704177.2T DK2575769T3 (da) | 2010-02-17 | 2011-02-17 | Stabiliseret tacrolismussammensætning |
Country Status (14)
Country | Link |
---|---|
US (3) | US9549918B2 (da) |
EP (1) | EP2575769B1 (da) |
AR (1) | AR081520A1 (da) |
DK (1) | DK2575769T3 (da) |
EA (1) | EA027869B1 (da) |
ES (1) | ES2591352T3 (da) |
HU (1) | HUE028847T2 (da) |
LT (1) | LT2575769T (da) |
PL (1) | PL2575769T3 (da) |
PT (1) | PT2575769T (da) |
RS (1) | RS55118B1 (da) |
SI (1) | SI2575769T1 (da) |
TW (1) | TWI510238B (da) |
WO (1) | WO2011100975A2 (da) |
Families Citing this family (11)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US10265265B2 (en) | 2007-03-15 | 2019-04-23 | Drug Delivery Solutions Limited | Topical composition |
US9775802B2 (en) | 2009-03-24 | 2017-10-03 | Bausch & Lomb Incorporated | Method for preparing suspensions of low-solubility materials |
US9168246B2 (en) | 2013-06-27 | 2015-10-27 | Veloxis Pharmaceutical A/S | Regimen for suppressing organ rejection |
GB201600376D0 (en) | 2016-01-08 | 2016-02-24 | Chronos Therapeutics Ltd | Novel therapeutic agents |
US11458125B2 (en) | 2016-04-04 | 2022-10-04 | MC2 Therapeutics Limited | Topical composition comprising tacrolimus |
CN107722038A (zh) * | 2017-10-31 | 2018-02-23 | 无锡福祈制药有限公司 | 一种他克莫司8‑差向异构体的提纯方法 |
EP3542788A1 (en) | 2018-03-19 | 2019-09-25 | MC2 Therapeutics Limited | Topical composition comprising calcipotriol and betamethasone dipropionate |
CN108904459B (zh) * | 2018-09-11 | 2021-03-05 | 南京瑞捷医药科技有限公司 | 一种他克莫司固体分散体片剂的制备方法 |
WO2020117134A1 (en) | 2018-12-04 | 2020-06-11 | İlko İlaç Sanayi̇ Ve Ti̇caret A.Ş. | Stable tacrolimus ointment formulation for topical treatment of skin conditions |
AU2022230995A1 (en) | 2021-03-03 | 2023-09-14 | Sana Biotechnology, Inc. | Immunosuppressive therapies for use with cardiomyocyte cell therapies, and associated methods and compositions |
CN114533852A (zh) * | 2022-02-25 | 2022-05-27 | 四川恒通动保生物科技有限公司 | 一种复方阿莫西林硫酸黏菌素混悬注射液及其制备方法 |
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WO2006136175A2 (en) * | 2005-06-22 | 2006-12-28 | Lifecycle Pharma A/S | Pharmaceutical compositions comprising tacrolimus and a cyp3a4 inhibitor |
KR100693461B1 (ko) * | 2005-07-29 | 2007-03-12 | 동국제약 주식회사 | 마크로라이드계 항생물질을 유효성분으로 함유하는약제학적 조성물 및 이의 제조방법과, 상기 약제학적조성물을 함유하는 서방성 제제 |
US20090011013A1 (en) * | 2005-10-07 | 2009-01-08 | Lifecycle Pharma A/S | Tacrolimus Combination Products |
JP2008037808A (ja) | 2006-08-07 | 2008-02-21 | Astellas Pharma Inc | タクロリムスカプセル剤 |
CA2664641A1 (en) * | 2006-09-26 | 2008-04-10 | Astellas Pharma, Inc. | Controlled release dosage form of tacrolimus |
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EP2167033B1 (en) | 2007-05-30 | 2017-04-19 | Veloxis Pharmaceuticals A/S | Once daily oral dosage form comprising tacrolimus |
RU2574006C2 (ru) | 2008-07-08 | 2016-01-27 | Лайфсайкл Фарма А/С | Такролимус для улучшенного лечения пациентов с трансплантатами |
-
2011
- 2011-02-17 LT LTEP11704177.2T patent/LT2575769T/lt unknown
- 2011-02-17 HU HUE11704177A patent/HUE028847T2/en unknown
- 2011-02-17 PL PL11704177.2T patent/PL2575769T3/pl unknown
- 2011-02-17 US US13/029,304 patent/US9549918B2/en active Active
- 2011-02-17 EA EA201390412A patent/EA027869B1/ru not_active IP Right Cessation
- 2011-02-17 SI SI201130948A patent/SI2575769T1/sl unknown
- 2011-02-17 ES ES11704177.2T patent/ES2591352T3/es active Active
- 2011-02-17 WO PCT/DK2011/050046 patent/WO2011100975A2/en active Application Filing
- 2011-02-17 PT PT117041772T patent/PT2575769T/pt unknown
- 2011-02-17 DK DK11704177.2T patent/DK2575769T3/da active
- 2011-02-17 EP EP11704177.2A patent/EP2575769B1/en active Active
- 2011-02-17 AR ARP110100483A patent/AR081520A1/es not_active Application Discontinuation
- 2011-02-17 RS RS20160748A patent/RS55118B1/sr unknown
- 2011-02-17 TW TW100105285A patent/TWI510238B/zh active
-
2017
- 2017-01-13 US US15/405,879 patent/US10166190B2/en active Active
-
2018
- 2018-11-13 US US16/188,805 patent/US11419823B2/en active Active
Also Published As
Publication number | Publication date |
---|---|
EP2575769A2 (en) | 2013-04-10 |
US10166190B2 (en) | 2019-01-01 |
ES2591352T3 (es) | 2016-11-28 |
HUE028847T2 (en) | 2017-01-30 |
US20110201639A1 (en) | 2011-08-18 |
TWI510238B (zh) | 2015-12-01 |
LT2575769T (lt) | 2016-10-10 |
US9549918B2 (en) | 2017-01-24 |
AR081520A1 (es) | 2012-10-03 |
US20190282504A1 (en) | 2019-09-19 |
US20140038998A9 (en) | 2014-02-06 |
RS55118B1 (sr) | 2016-12-30 |
WO2011100975A2 (en) | 2011-08-25 |
PT2575769T (pt) | 2016-09-22 |
EA201390412A1 (ru) | 2013-07-30 |
EP2575769B1 (en) | 2016-06-15 |
PL2575769T3 (pl) | 2016-12-30 |
SI2575769T1 (sl) | 2016-11-30 |
WO2011100975A3 (en) | 2012-05-10 |
TW201143770A (en) | 2011-12-16 |
EA027869B1 (ru) | 2017-09-29 |
US20170119675A1 (en) | 2017-05-04 |
US11419823B2 (en) | 2022-08-23 |
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