HRP20231621T1 - Formulacije ciklosporina za upotrebu u prevenciji ili liječenju plućnog kroničnog odbacivanja transplantanta - Google Patents
Formulacije ciklosporina za upotrebu u prevenciji ili liječenju plućnog kroničnog odbacivanja transplantanta Download PDFInfo
- Publication number
- HRP20231621T1 HRP20231621T1 HRP20231621TT HRP20231621T HRP20231621T1 HR P20231621 T1 HRP20231621 T1 HR P20231621T1 HR P20231621T T HRP20231621T T HR P20231621TT HR P20231621 T HRP20231621 T HR P20231621T HR P20231621 T1 HRP20231621 T1 HR P20231621T1
- Authority
- HR
- Croatia
- Prior art keywords
- formulation
- use according
- inhalation
- pulmonary
- transplant
- Prior art date
Links
- 238000009472 formulation Methods 0.000 title claims 29
- 239000000203 mixture Substances 0.000 title claims 29
- PMATZTZNYRCHOR-CGLBZJNRSA-N Cyclosporin A Chemical compound CC[C@@H]1NC(=O)[C@H]([C@H](O)[C@H](C)C\C=C\C)N(C)C(=O)[C@H](C(C)C)N(C)C(=O)[C@H](CC(C)C)N(C)C(=O)[C@H](CC(C)C)N(C)C(=O)[C@@H](C)NC(=O)[C@H](C)NC(=O)[C@H](CC(C)C)N(C)C(=O)[C@H](C(C)C)NC(=O)[C@H](CC(C)C)N(C)C(=O)CN(C)C1=O PMATZTZNYRCHOR-CGLBZJNRSA-N 0.000 title claims 4
- 230000001684 chronic effect Effects 0.000 title claims 4
- 230000002685 pulmonary effect Effects 0.000 title claims 4
- 108010036949 Cyclosporine Proteins 0.000 title claims 3
- 206010052779 Transplant rejections Diseases 0.000 title claims 3
- 229960001265 ciclosporin Drugs 0.000 title claims 3
- 229930182912 cyclosporin Natural products 0.000 title claims 3
- 230000002265 prevention Effects 0.000 title claims 2
- 210000004072 lung Anatomy 0.000 claims 4
- 239000004480 active ingredient Substances 0.000 claims 3
- 238000002650 immunosuppressive therapy Methods 0.000 claims 2
- 238000012544 monitoring process Methods 0.000 claims 2
- 238000002054 transplantation Methods 0.000 claims 2
- 208000006545 Chronic Obstructive Pulmonary Disease Diseases 0.000 claims 1
- 206010014561 Emphysema Diseases 0.000 claims 1
- 206010016654 Fibrosis Diseases 0.000 claims 1
- 201000009794 Idiopathic Pulmonary Fibrosis Diseases 0.000 claims 1
- 206010029888 Obliterative bronchiolitis Diseases 0.000 claims 1
- QJJXYPPXXYFBGM-LFZNUXCKSA-N Tacrolimus Chemical compound C1C[C@@H](O)[C@H](OC)C[C@@H]1\C=C(/C)[C@@H]1[C@H](C)[C@@H](O)CC(=O)[C@H](CC=C)/C=C(C)/C[C@H](C)C[C@H](OC)[C@H]([C@H](C[C@H]2C)OC)O[C@@]2(O)C(=O)C(=O)N2CCCC[C@H]2C(=O)O1 QJJXYPPXXYFBGM-LFZNUXCKSA-N 0.000 claims 1
- 239000000443 aerosol Substances 0.000 claims 1
- LMEKQMALGUDUQG-UHFFFAOYSA-N azathioprine Chemical compound CN1C=NC([N+]([O-])=O)=C1SC1=NC=NC2=C1NC=N2 LMEKQMALGUDUQG-UHFFFAOYSA-N 0.000 claims 1
- 229960002170 azathioprine Drugs 0.000 claims 1
- 201000003848 bronchiolitis obliterans Diseases 0.000 claims 1
- 208000023367 bronchiolitis obliterans with obstructive pulmonary disease Diseases 0.000 claims 1
- 239000003246 corticosteroid Substances 0.000 claims 1
- 229960001334 corticosteroids Drugs 0.000 claims 1
- 230000004761 fibrosis Effects 0.000 claims 1
- 208000036971 interstitial lung disease 2 Diseases 0.000 claims 1
- 239000012669 liquid formulation Substances 0.000 claims 1
- 239000012528 membrane Substances 0.000 claims 1
- RTGDFNSFWBGLEC-SYZQJQIISA-N mycophenolate mofetil Chemical compound COC1=C(C)C=2COC(=O)C=2C(O)=C1C\C=C(/C)CCC(=O)OCCN1CCOCC1 RTGDFNSFWBGLEC-SYZQJQIISA-N 0.000 claims 1
- 229960004866 mycophenolate mofetil Drugs 0.000 claims 1
- 239000006199 nebulizer Substances 0.000 claims 1
- 208000011580 syndromic disease Diseases 0.000 claims 1
- 229960001967 tacrolimus Drugs 0.000 claims 1
- QJJXYPPXXYFBGM-SHYZHZOCSA-N tacrolimus Natural products CO[C@H]1C[C@H](CC[C@@H]1O)C=C(C)[C@H]2OC(=O)[C@H]3CCCCN3C(=O)C(=O)[C@@]4(O)O[C@@H]([C@H](C[C@H]4C)OC)[C@@H](C[C@H](C)CC(=C[C@@H](CC=C)C(=O)C[C@H](O)[C@H]2C)C)OC QJJXYPPXXYFBGM-SHYZHZOCSA-N 0.000 claims 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
- A61K38/12—Cyclic peptides, e.g. bacitracins; Polymyxins; Gramicidins S, C; Tyrocidins A, B or C
- A61K38/13—Cyclosporins
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/007—Pulmonary tract; Aromatherapy
- A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
- A61K9/0078—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a nebulizer such as a jet nebulizer, ultrasonic nebulizer, e.g. in the form of aqueous drug solutions or dispersions
-
- 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
- A61K9/10—Dispersions; Emulsions
- A61K9/127—Liposomes
-
- 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
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
-
- 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
-
- 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
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Immunology (AREA)
- Dispersion Chemistry (AREA)
- Otolaryngology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Pulmonology (AREA)
- Gastroenterology & Hepatology (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Transplantation (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Claims (15)
1. Tekuća formulacija ciklosporina za upotrebu kao aerosola za inhalaciju u postupku prevencije ili liječenja kroničnog plućnog odbacivanja transplantanta kod pacijenata s jednim presađenim plućnim krilom, naznačena time što je formulacija liposomska formulacija.
2. Formulacija za upotrebu prema patentnom zahtjevu 1, naznačena time što se formulacija primjenjuje jednom ili dva puta dnevno.
3. Formulacija za upotrebu prema patentnim zahtjevima 1 ili 2, naznačena time što formulacija sadrži ciklosporin u koncentraciji od 1 do 5 mg/ml.
4. Formulacija za upotrebu prema bilo kojem od patentnih zahtjeva 1 do 3, naznačena time što je volumen jedinične doze formulacije 1 do 3 ml.
5. Formulacija za upotrebu prema bilo kojem od patentnih zahtjeva 1 do 4, naznačena time što je formulacija raspršena pomoću elektroničkog vibrirajućeg membranskog raspršivača.
6. Formulacija za upotrebu prema bilo kojem od patentnih zahtjeva 1 do 5, naznačena time što je formulacija raspršena raspršivačem koji sadrži značajke za praćenje vremena, datuma i trajanja inhalacije od strane pacijenta.
7. Formulacija za upotrebu prema bilo kojem od patentnih zahtjeva 1 do 6, naznačena time što se formulacija inhalira kako je predviđeno u najmanje 65% predviđenih ciklusa inhalacije.
8. Formulacija za upotrebu prema bilo kojem od patentnih zahtjeva 1 do 6, naznačena time što se formulacija inhalira kako je predviđeno u najmanje 75% predviđenih ciklusa inhalacije.
9. Formulacija za upotrebu prema patentnim zahtjevima 7 ili 8, naznačena time što se vrijeme, datum i trajanje inhalacije od strane pacijenta nadziru i ako se inhalacija formulacije ne izvrši ili nije završena kako je određeno u patentnim zahtjevima 7 ili 8, sustav za praćenje proizvodi signal koji ukazuje na nedovoljno pridržavanje pacijenta.
10. Formulacija za upotrebu prema bilo kojem od patentnih zahtjeva 1 do 9, naznačena time što se formulacija koristi u kombinaciji s jednim ili više aktivnih sastojaka koji se koriste u standardnoj imunosupresivnoj terapiji nakon presađivanja pluća.
11. Formulacija za upotrebu prema patentnom zahtjevu 10, naznačena time što je doza jednog ili više aktivnih sastojaka koja se koristi u kombinaciji s formulacijom niža od doze korištene u standardnoj imunosupresivnoj terapiji nakon presađivanja pluća.
12. Formulacija za upotrebu prema patentnim zahtjevima 10 ili 11, naznačena time što se formulacija koristi u kombinaciji s jednim ili više aktivnih sastojaka odabranih iz skupine koju čine takrolimus ili ciklosporin; mikofenolat mofetil ili azatioprin; i kortikosteroidi, osobito u oralnoj primjeni.
13. Formulacija za upotrebu prema bilo kojem od patentnih zahtjeva 1 do 12, naznačena time što je plućno kronično odbacivanje transplantanta karakterizirano sindromom obliterirajućeg bronhiolitisa.
14. Formulacija za upotrebu prema bilo kojem od patentnih zahtjeva 1 do 13, naznačena time što je plućno kronično odbacivanje transplantanta karakterizirano smanjenjem forsiranog ekspiratornog volumena u jednoj sekundi (FEV1) od najmanje 20% od maksimalnih vrijednosti pacijenta.
15. Formulacija za upotrebu prema bilo kojem od patentnih zahtjeva 1 do 14, naznačena time što se formulacija koristi kod pacijenata s jednim presađenim plućnim krilom koji su prije presađivanja pluća patili od emfizema, fibroze, kao što je idiopatska plućna fibroza, i/ili kronične opstruktivne plućne bolesti.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP15020035.0A EP3069711A1 (en) | 2015-03-16 | 2015-03-16 | Cyclosporine formulations for use in the prevention or treatment of pulmonary chronic graft rejection |
| PCT/EP2016/055609 WO2016146645A1 (en) | 2015-03-16 | 2016-03-15 | Cyclosporine formulations for use in the prevention or treatment of pulmonary chronic graft rejection |
| EP16711565.8A EP3270890B1 (en) | 2015-03-16 | 2016-03-15 | Cyclosporine formulations for use in the prevention or treatment of pulmonary chronic graft rejection |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20231621T1 true HRP20231621T1 (hr) | 2024-03-15 |
Family
ID=52686066
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20231621TT HRP20231621T1 (hr) | 2015-03-16 | 2016-03-15 | Formulacije ciklosporina za upotrebu u prevenciji ili liječenju plućnog kroničnog odbacivanja transplantanta |
Country Status (15)
| Country | Link |
|---|---|
| US (3) | US10857198B2 (hr) |
| EP (2) | EP3069711A1 (hr) |
| AU (1) | AU2016232307B2 (hr) |
| CA (1) | CA2979498C (hr) |
| DK (1) | DK3270890T3 (hr) |
| ES (1) | ES2964789T3 (hr) |
| FI (1) | FI3270890T3 (hr) |
| HR (1) | HRP20231621T1 (hr) |
| HU (1) | HUE064422T2 (hr) |
| LT (1) | LT3270890T (hr) |
| PL (1) | PL3270890T3 (hr) |
| PT (1) | PT3270890T (hr) |
| RS (1) | RS64884B1 (hr) |
| SI (1) | SI3270890T1 (hr) |
| WO (1) | WO2016146645A1 (hr) |
Families Citing this family (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP3069711A1 (en) * | 2015-03-16 | 2016-09-21 | PARI Pharma GmbH | Cyclosporine formulations for use in the prevention or treatment of pulmonary chronic graft rejection |
| CN112105374A (zh) | 2018-04-11 | 2020-12-18 | 呼吸治疗公司 | 用于治疗闭塞性细支气管炎综合征（bos）的环孢素制剂 |
| BR112020026635A2 (pt) * | 2018-06-27 | 2021-04-20 | Breath Therapeutics Gmbh | composições inaláveis compreendendo imunosupressores macrocíclicos |
| BR112020026629A2 (pt) * | 2018-06-27 | 2021-03-23 | Breath Therapeutics Gmbh | Composições farmacêuticas na forma liofilizada |
| EA202092892A1 (ru) * | 2018-12-04 | 2021-05-27 | Брес Терапьютикс Гмбх | Ингаляционные композиции, содержащие макроциклические иммуносупрессанты |
| AU2020415302A1 (en) * | 2019-12-23 | 2022-06-16 | Zambon S.P.A. | Process for the preparation of dispersions comprising inhalable immunosuppressive active ingredients |
Family Cites Families (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20020006901A1 (en) * | 1999-02-05 | 2002-01-17 | Aldo T. Iacono | Use of aerosolized cyclosporine for prevention and treatment of pulmonary disease |
| US20040247628A1 (en) | 2001-10-24 | 2004-12-09 | Frank-Christophe Lintz | Kit for the preparation of a pharmaceutical composition |
| DE102006051512A1 (de) * | 2005-12-06 | 2007-06-14 | Pari GmbH Spezialisten für effektive Inhalation | Pharmazeutische Medikamentenzusammensetzungen mit Cyclosporin |
| US20120285236A1 (en) * | 2010-01-20 | 2012-11-15 | Koninklijke Philips Electronics, N.V. | Method of using a temperature-based aerosol detector |
| EP3069711A1 (en) * | 2015-03-16 | 2016-09-21 | PARI Pharma GmbH | Cyclosporine formulations for use in the prevention or treatment of pulmonary chronic graft rejection |
| CN112105374A (zh) * | 2018-04-11 | 2020-12-18 | 呼吸治疗公司 | 用于治疗闭塞性细支气管炎综合征（bos）的环孢素制剂 |
| EA202092892A1 (ru) * | 2018-12-04 | 2021-05-27 | Брес Терапьютикс Гмбх | Ингаляционные композиции, содержащие макроциклические иммуносупрессанты |
-
2015
- 2015-03-16 EP EP15020035.0A patent/EP3069711A1/en not_active Ceased
-
2016
- 2016-03-15 PL PL16711565.8T patent/PL3270890T3/pl unknown
- 2016-03-15 WO PCT/EP2016/055609 patent/WO2016146645A1/en active Application Filing
- 2016-03-15 LT LTEPPCT/EP2016/055609T patent/LT3270890T/lt unknown
- 2016-03-15 FI FIEP16711565.8T patent/FI3270890T3/fi active
- 2016-03-15 DK DK16711565.8T patent/DK3270890T3/da active
- 2016-03-15 SI SI201631769T patent/SI3270890T1/sl unknown
- 2016-03-15 PT PT167115658T patent/PT3270890T/pt unknown
- 2016-03-15 CA CA2979498A patent/CA2979498C/en active Active
- 2016-03-15 HU HUE16711565A patent/HUE064422T2/hu unknown
- 2016-03-15 RS RS20231137A patent/RS64884B1/sr unknown
- 2016-03-15 ES ES16711565T patent/ES2964789T3/es active Active
- 2016-03-15 AU AU2016232307A patent/AU2016232307B2/en active Active
- 2016-03-15 EP EP16711565.8A patent/EP3270890B1/en active Active
- 2016-03-15 US US15/558,102 patent/US10857198B2/en active Active
- 2016-03-15 HR HRP20231621TT patent/HRP20231621T1/hr unknown
-
2020
- 2020-10-30 US US17/086,254 patent/US11744872B2/en active Active
-
2023
- 2023-07-17 US US18/353,524 patent/US20240016885A1/en active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| EP3270890A1 (en) | 2018-01-24 |
| DK3270890T3 (da) | 2023-12-11 |
| CA2979498C (en) | 2021-09-07 |
| HUE064422T2 (hu) | 2024-03-28 |
| BR112017018339A2 (pt) | 2018-04-17 |
| US20210046150A1 (en) | 2021-02-18 |
| US20240016885A1 (en) | 2024-01-18 |
| CA2979498A1 (en) | 2016-09-22 |
| US10857198B2 (en) | 2020-12-08 |
| FI3270890T3 (fi) | 2023-12-05 |
| US20180042988A1 (en) | 2018-02-15 |
| WO2016146645A1 (en) | 2016-09-22 |
| PT3270890T (pt) | 2023-11-27 |
| AU2016232307B2 (en) | 2019-04-18 |
| EP3069711A1 (en) | 2016-09-21 |
| AU2016232307A1 (en) | 2017-08-17 |
| LT3270890T (lt) | 2023-12-11 |
| US11744872B2 (en) | 2023-09-05 |
| RS64884B1 (sr) | 2023-12-29 |
| ES2964789T3 (es) | 2024-04-09 |
| PL3270890T3 (pl) | 2024-03-04 |
| SI3270890T1 (sl) | 2024-02-29 |
| EP3270890B1 (en) | 2023-09-13 |
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