RU2017108432A - Жидкая ингаляционная композиция, содержащая rpl 554 - Google Patents
Жидкая ингаляционная композиция, содержащая rpl 554 Download PDFInfo
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- RU2017108432A RU2017108432A RU2017108432A RU2017108432A RU2017108432A RU 2017108432 A RU2017108432 A RU 2017108432A RU 2017108432 A RU2017108432 A RU 2017108432A RU 2017108432 A RU2017108432 A RU 2017108432A RU 2017108432 A RU2017108432 A RU 2017108432A
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- pharmaceutical composition
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- 239000007788 liquid Substances 0.000 title claims 22
- 239000000203 mixture Substances 0.000 title claims 7
- CSOBIBXVIYAXFM-UHFFFAOYSA-N rpl-554 Chemical compound C1=2C=C(OC)C(OC)=CC=2CCN(C(N2CCNC(N)=O)=O)C1=CC2=NC1=C(C)C=C(C)C=C1C CSOBIBXVIYAXFM-UHFFFAOYSA-N 0.000 title claims 2
- 239000008194 pharmaceutical composition Substances 0.000 claims 21
- 239000002245 particle Substances 0.000 claims 10
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 claims 4
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 4
- 208000006673 asthma Diseases 0.000 claims 4
- 201000010099 disease Diseases 0.000 claims 4
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 4
- CSOBIBXVIYAXFM-BYNJWEBRSA-N ensifentrine Chemical compound c-12cc(OC)c(OC)cc2CCn(c(n2CCNC(N)=O)=O)c-1c\c2=N/c1c(C)cc(C)cc1C CSOBIBXVIYAXFM-BYNJWEBRSA-N 0.000 claims 4
- 239000004094 surface-active agent Substances 0.000 claims 4
- 229920001213 Polysorbate 20 Polymers 0.000 claims 3
- 239000000872 buffer Substances 0.000 claims 3
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 claims 3
- 206010001052 Acute respiratory distress syndrome Diseases 0.000 claims 2
- 208000006545 Chronic Obstructive Pulmonary Disease Diseases 0.000 claims 2
- 229920003171 Poly (ethylene oxide) Polymers 0.000 claims 2
- 208000013616 Respiratory Distress Syndrome Diseases 0.000 claims 2
- 208000011341 adult acute respiratory distress syndrome Diseases 0.000 claims 2
- 201000000028 adult respiratory distress syndrome Diseases 0.000 claims 2
- 239000003085 diluting agent Substances 0.000 claims 2
- WGCNASOHLSPBMP-UHFFFAOYSA-N hydroxyacetaldehyde Natural products OCC=O WGCNASOHLSPBMP-UHFFFAOYSA-N 0.000 claims 2
- 238000000034 method Methods 0.000 claims 2
- 239000008363 phosphate buffer Substances 0.000 claims 2
- -1 polyoxyethylene Polymers 0.000 claims 2
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 claims 2
- 208000005069 pulmonary fibrosis Diseases 0.000 claims 2
- 239000011780 sodium chloride Substances 0.000 claims 2
- 239000007921 spray Substances 0.000 claims 2
- XZIIFPSPUDAGJM-UHFFFAOYSA-N 6-chloro-2-n,2-n-diethylpyrimidine-2,4-diamine Chemical compound CCN(CC)C1=NC(N)=CC(Cl)=N1 XZIIFPSPUDAGJM-UHFFFAOYSA-N 0.000 claims 1
- 208000035285 Allergic Seasonal Rhinitis Diseases 0.000 claims 1
- 208000023275 Autoimmune disease Diseases 0.000 claims 1
- 201000006474 Brain Ischemia Diseases 0.000 claims 1
- 206010008120 Cerebral ischaemia Diseases 0.000 claims 1
- KRKNYBCHXYNGOX-UHFFFAOYSA-K Citrate Chemical compound [O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O KRKNYBCHXYNGOX-UHFFFAOYSA-K 0.000 claims 1
- 201000003883 Cystic fibrosis Diseases 0.000 claims 1
- 206010012438 Dermatitis atopic Diseases 0.000 claims 1
- 206010014561 Emphysema Diseases 0.000 claims 1
- 206010015943 Eye inflammation Diseases 0.000 claims 1
- 208000019693 Lung disease Diseases 0.000 claims 1
- 229910019142 PO4 Inorganic materials 0.000 claims 1
- 201000004681 Psoriasis Diseases 0.000 claims 1
- 206010039085 Rhinitis allergic Diseases 0.000 claims 1
- LWZFANDGMFTDAV-BURFUSLBSA-N [(2r)-2-[(2r,3r,4s)-3,4-dihydroxyoxolan-2-yl]-2-hydroxyethyl] dodecanoate Chemical compound CCCCCCCCCCCC(=O)OC[C@@H](O)[C@H]1OC[C@H](O)[C@H]1O LWZFANDGMFTDAV-BURFUSLBSA-N 0.000 claims 1
- 201000009961 allergic asthma Diseases 0.000 claims 1
- 201000010105 allergic rhinitis Diseases 0.000 claims 1
- 201000008937 atopic dermatitis Diseases 0.000 claims 1
- 201000009267 bronchiectasis Diseases 0.000 claims 1
- 206010006451 bronchitis Diseases 0.000 claims 1
- 230000003139 buffering effect Effects 0.000 claims 1
- 206010008118 cerebral infarction Diseases 0.000 claims 1
- 208000029771 childhood onset asthma Diseases 0.000 claims 1
- 239000007979 citrate buffer Substances 0.000 claims 1
- 230000002757 inflammatory effect Effects 0.000 claims 1
- 239000002736 nonionic surfactant Substances 0.000 claims 1
- 230000002085 persistent effect Effects 0.000 claims 1
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 claims 1
- 239000010452 phosphate Substances 0.000 claims 1
- 229940068977 polysorbate 20 Drugs 0.000 claims 1
- 230000002265 prevention Effects 0.000 claims 1
- 150000003839 salts Chemical class 0.000 claims 1
- 208000017520 skin disease Diseases 0.000 claims 1
- BBMHARZCALWXSL-UHFFFAOYSA-M sodium dihydrogenphosphate monohydrate Chemical compound O.[Na+].OP(O)([O-])=O BBMHARZCALWXSL-UHFFFAOYSA-M 0.000 claims 1
- 239000001488 sodium phosphate Substances 0.000 claims 1
- 229910000162 sodium phosphate Inorganic materials 0.000 claims 1
- 235000011008 sodium phosphates Nutrition 0.000 claims 1
- 229940035044 sorbitan monolaurate Drugs 0.000 claims 1
- 235000011067 sorbitan monolaureate Nutrition 0.000 claims 1
- 150000003431 steroids Chemical class 0.000 claims 1
- 239000000725 suspension Substances 0.000 claims 1
- RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical compound [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O RYFMWSXOAZQYPI-UHFFFAOYSA-K 0.000 claims 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 1
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- 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
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- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
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- 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
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
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- 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
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- A61K9/08—Solutions
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- A61K9/12—Aerosols; Foams
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Claims (36)
1. Жидкая фармацевтическая композиция, подходящая для введения посредством ингаляции, содержащая разбавитель и суспензию частиц 9,10-диметокси-2-(2,4,6-триметилфенилимино)-3-(N-карбамоил-2-аминоэтил)-3,4,6,7-тетрагидро-2Н-пиримидо[6,1-а]изохинолин-4-она (RPL554) или его фармацевтически приемлемой соли.
2. Жидкая фармацевтическая композиция по п. 1, в которой частицы RPL554 имеют распределение частиц по размеру со значением Dv50 (средний размер частиц по объему) от около 0.2 до около 5 мкм.
3. Жидкая фармацевтическая композиция по п. 2, в которой частицы RPL554 имеют распределение частиц по размеру со значением Dv50 от около 0.7 до около 2.5 мкм.
4. Жидкая фармацевтическая композиция по п. 1, причем концентрация частиц RPL554 в жидкой фармацевтической композиции составляет от около 0.01 до около 40 мг/мл.
5. Жидкая фармацевтическая композиция по п. 1, причем композиция имеет значение рН от около 6 до около 8.
6. Жидкая фармацевтическая композиция по п. 1, которая дополнительно содержит одно или более поверхностно-активных веществ.
7. Жидкая фармацевтическая композиция по п. 6, в которой одно или более поверхностно-активных веществ выбираются из одного или более неионных поверхностно-активных веществ.
8. Жидкая фармацевтическая композиция по п. 7, в которой одно или более поверхностно-активных веществ выбираются из сложных алкиловых эфиров полиоксиэтиленгликоля и сорбитана и сложных алкиловых эфиров сорбитана.
9. Жидкая фармацевтическая композиция по п. 1, которая дополнительно содержит один или более буферов.
10. Жидкая фармацевтическая композиция по п. 9, в которой один или более буферов выбираются из цитратного или фосфатного буферов.
11. Жидкая фармацевтическая композиция по п. 1, причем композиция содержит:
(a) частицы RLP554 при концентрации от около 0.01 до около 40 мг/мл;
(b) одно или более поверхностно-активных веществ при концентрации от около 0.01 до около 5 мг/мл; и
(c) буфер при концентрации от около 5 до около 20 мг/мл.
12. Жидкая фармацевтическая композиция по п. 1, причем композиция дополнительно содержит регулятор тоничности, где регулятором тоничности необязательно является хлорид натрия.
13. Жидкая фармацевтическая композиция по п. 1, в которой разбавителем является вода.
14. Жидкая фармацевтическая композиция по п. 1, причем композиция содержит:
(а) частицы RLP554 при концентрации от 0.01 до 30 мг/мл;
(b) сложный алкиловый эфир полиоксиэтиленгликоля и сорбитана при концентрации от 0.1 до 2 мг/мл;
(c) сложный алкиловый эфир сорбитана при концентрации от 0.01 до 0.1 мг/мл;
(d) первый фосфатный буферный компонент при концентрации от 5 до 10 мг/мл;
(e) второй фосфатный буферный компонент при концентрации от 5 до 10 мг/мл; и
(f) регулятор тоничности при концентрации от 2 до 8 мг/мл.
15. Жидкая фармацевтическая композиция по п. 1, причем композиция содержит:
(a) частицы RLP554 при концентрации от 0.05 до 25 мг/мл;
(b) полиоксиэтилен (20) сорбитан монолаурат (Полисорбат 20, Tween 20) при концентрации от 0.1 до 2 мг/мл;
(c) сорбитан монолаурат (Span 20) при концентрации от 0.01 до 0.1 мг/мл;
(d) моногидрат мононатрия фосфата при концентрации от 5 до 10 мг/мл;
(e) двухосновный безводный фосфат натрия при концентрации от 5 до 10 мг/мл; и
(f) хлорид натрия при концентрации от 2 до 8 мг/мл.
16. Жидкая фармацевтическая композиция по п. 1, которая подходит для введения с помощью распылителя.
17. Распылитель, содержащий композицию по любому из пп. 1-16.
18. Жидкая фармацевтическая композиция по любому из п.п. 1-16 для применения для лечения человека или животного.
19. Жидкая фармацевтическая композиция по любому из пп. 1-16 для применения для лечения или профилактики заболевания или состояния, выбранного из астмы, аллергической астмы, сенной лихорадки, аллергического ринита, бронхита, эмфиземы, бронхоэктаза, хронического обструктивного заболевания легких (COPD), синдрома расстройства дыхания у взрослых (ARDS), стероид-устойчивой астмы, тяжелой астмы, детской астмы, кистозного фиброза, фиброза легких, легочного фиброза, интерстициальной легочной болезни, кожных заболеваний, атопического дерматита, псориаза, воспаления глаз, церебральной ишемии, воспалительных заболеваний и аутоиммунных заболеваний.
20. Жидкая фармацевтическая композиция для применения по п. 19, где заболеванием или состоянием является хроническое обструктивное заболевание легких (COPD).
21. Способ лечения или профилактики заболевания или состояния, как определено в п. 19 или 20, у субъекта, причем способ включает введение указанному субъекту эффективного количества жидкой фармацевтической композиции по любому из пп. 1-16.
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GBGB1416274.7A GB201416274D0 (en) | 2014-09-15 | 2014-09-15 | Formulation |
| GB1416274.7 | 2014-09-15 | ||
| GB1504662.6 | 2015-03-19 | ||
| GBGB1504662.6A GB201504662D0 (en) | 2015-03-19 | 2015-03-19 | Formulation |
| PCT/GB2015/052668 WO2016042313A1 (en) | 2014-09-15 | 2015-09-15 | Liquid inhalation formulation comprising rpl554 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| RU2017108432A true RU2017108432A (ru) | 2018-10-17 |
| RU2017108432A3 RU2017108432A3 (ru) | 2019-04-01 |
| RU2699995C2 RU2699995C2 (ru) | 2019-09-12 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2017108432A RU2699995C2 (ru) | 2014-09-15 | 2015-09-15 | Жидкая ингаляционная композиция, содержащая rpl 554 |
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| EP (3) | EP3494962B1 (ru) |
| JP (2) | JP6860477B2 (ru) |
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| CN (3) | CN106794157B (ru) |
| AU (3) | AU2015316592B2 (ru) |
| CA (1) | CA2959943C (ru) |
| CY (3) | CY1120264T1 (ru) |
| DK (3) | DK3494962T3 (ru) |
| ES (3) | ES2875584T3 (ru) |
| HK (1) | HK1249415B (ru) |
| HR (3) | HRP20180833T1 (ru) |
| HU (3) | HUE055527T2 (ru) |
| IL (1) | IL250895B (ru) |
| LT (3) | LT3193835T (ru) |
| MX (1) | MX2017003102A (ru) |
| MY (1) | MY196072A (ru) |
| NO (1) | NO3193835T3 (ru) |
| PH (1) | PH12017500479B1 (ru) |
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| RU (1) | RU2699995C2 (ru) |
| SG (1) | SG11201701854WA (ru) |
| SI (3) | SI3193835T1 (ru) |
| SM (3) | SMT202100479T1 (ru) |
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Families Citing this family (21)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| PL3231444T3 (pl) | 2014-05-12 | 2020-05-18 | Verona Pharma Plc | Nowe leczenie |
| HUE055527T2 (hu) * | 2014-09-15 | 2021-12-28 | Verona Pharma Plc | RPL554-t tartalmazó folyékony inhalációs készítmény |
| GB201502260D0 (en) | 2015-02-11 | 2015-04-01 | Verona Pharma Plc | Salt of Pyrimido[6,1-A]Isoquinolin-4-one compound |
| JP6814754B2 (ja) | 2015-07-24 | 2021-01-20 | エフ．ホフマン−ラ ロシュ アーゲーＦ． Ｈｏｆｆｍａｎｎ−Ｌａ Ｒｏｃｈｅ Ａｋｔｉｅｎｇｅｓｅｌｌｓｃｈａｆｔ | Ｂａｃｅ１阻害剤ペプチド |
| GB201613054D0 (en) | 2016-07-28 | 2016-09-14 | Verona Pharma Plc | New compound and process |
| GB2578093B (en) | 2018-10-09 | 2020-11-18 | Verona Pharma Plc | Liquid pharmaceutical composition comprising RPL554 and HFA-134A |
| JP6994061B2 (ja) * | 2019-02-15 | 2022-01-14 | ノバルティス アーゲー | ４－（７－ヒドロキシ－２－イソプロピル－４－オキソ－４ｈ－キナゾリン－３－イル）－ベンゾニトリルの製剤 |
| GB201911517D0 (en) | 2019-08-12 | 2019-09-25 | Verona Pharma Plc | Pharmaceutical composition |
| EP4092025B9 (en) * | 2020-01-15 | 2024-11-06 | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Pharmaceutical composition of tricyclic pde3/pde4 dual inhibitor compound |
| GB202002786D0 (en) * | 2020-02-27 | 2020-04-15 | Verona Pharma Plc | Liquid pharmaceutical composition |
| GB202202297D0 (en) * | 2022-02-21 | 2022-04-06 | Verona Pharma Plc | Formulation production process |
| AU2023324461A1 (en) * | 2022-08-08 | 2025-02-06 | Verona Pharma Plc | Ensifentrine (rpl-554) for decreasing the frequency and/or severity of copd exacerbations |
| CA3263545A1 (en) * | 2022-08-08 | 2024-02-15 | Verona Pharma Plc | LIQUID PHARMACEUTICAL COMPOSITION |
| JP2025534762A (ja) * | 2022-10-28 | 2025-10-17 | 江蘇恒瑞医薬股▲ふん▼有限公司 | イソキノリノン系化合物を含む医薬組成物及びその調製方法 |
| EP4378942A1 (en) | 2022-12-02 | 2024-06-05 | Sandoz AG | Crystal form of a pde3/4 inhibitor |
| US12194045B1 (en) | 2023-06-26 | 2025-01-14 | Verona Pharma Plc | Particulate composition |
| WO2025003643A1 (en) * | 2023-06-26 | 2025-01-02 | Verona Pharma Plc | Particulate composition comprising ensifetrine |
| US20250073240A1 (en) * | 2023-09-06 | 2025-03-06 | Verona Pharma Plc | New treatment |
| US20250249006A1 (en) * | 2024-02-05 | 2025-08-07 | Verona Pharma Plc | Treatment |
| US20250249008A1 (en) * | 2024-02-07 | 2025-08-07 | Verona Pharma Plc | Pharmaceutical compositions of ensifentrine for chronic obstructive pulmonary disease |
| US20250249007A1 (en) * | 2024-02-07 | 2025-08-07 | Verona Pharma Plc | Pharmaceutical compositions of ensifentrine for chronic obstructive pulmonary disease |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| GB9410222D0 (en) * | 1994-05-21 | 1994-07-06 | Glaxo Wellcome Australia Ltd | Medicaments |
| CA2305256C (en) | 1997-10-09 | 2005-05-17 | Schering Corporation | Mometasone furoate suspensions for nebulization |
| SE9704186D0 (sv) | 1997-11-14 | 1997-11-14 | Astra Ab | New composition of matter |
| US6630169B1 (en) * | 1999-03-31 | 2003-10-07 | Nektar Therapeutics | Particulate delivery systems and methods of use |
| WO2000058308A1 (en) | 1999-03-31 | 2000-10-05 | Vernalis Limited | DERIVATIVES OF PYRIMIDO[6,1-a]ISOQUINOLIN-4-ONE |
| GB0008660D0 (en) * | 2000-04-07 | 2000-05-31 | Arakis Ltd | The treatment of respiratory diseases |
| GB0122031D0 (en) * | 2001-09-12 | 2001-10-31 | Pfizer Ltd | Use of pde4 inhibitors in a dry powder inhaler |
| US7579505B2 (en) | 2004-12-17 | 2009-08-25 | Cipla Limited | Crystalline levosalbutamol sulphate and polymorphic forms thereof |
| ITMI20051999A1 (it) | 2005-10-21 | 2007-04-22 | Eratech S R L | Formulazioni inalatorie di farmaci in fora di polvere secca per somministrazione come tale o con nebulizzatore e dotate di elevata erogabilita' respirabilita' e stabilita' |
| BR112012032332A2 (pt) | 2010-06-22 | 2016-11-08 | Chiesi Farma Spa | composto, uso de um composto, composição farmacêutica, combinação de um composto e dispositivo |
| DK2603509T3 (da) | 2010-08-09 | 2014-09-08 | Verona Pharma Plc | KRYSTALLINSK FORM AF PYRIMIDIO [6,1- a] ISOQUINOLIN-4-ON-FORBINDELSE |
| CN103732213A (zh) * | 2011-06-07 | 2014-04-16 | 帕里昂科学公司 | 治疗方法 |
| US8945605B2 (en) | 2011-06-07 | 2015-02-03 | Parion Sciences, Inc. | Aerosol delivery systems, compositions and methods |
| EP2647627A1 (en) * | 2012-04-02 | 2013-10-09 | Almirall, S.A. | Salts of 5-[(1r)-2-({2-[4-(2,2-difluoro-2-phenylethoxy)phenyl] ethyl}amino)-1-hydroxyethyl]-8-hydroxyquinolin-2(1h)-one. |
| WO2014037727A1 (en) | 2012-09-06 | 2014-03-13 | Verona Pharma Plc | Carcainium salts |
| PT2968312T (pt) | 2013-03-15 | 2018-04-19 | Verona Pharma Plc | Combinação de fármacos |
| JP6702634B2 (ja) * | 2014-03-11 | 2020-06-03 | エルジー エレクトロニクス インコーポレイティド | 無線通信システムにおいて装置対装置端末のディスカバリ信号伝送方法及び装置 |
| PL3231444T3 (pl) | 2014-05-12 | 2020-05-18 | Verona Pharma Plc | Nowe leczenie |
| HUE055527T2 (hu) * | 2014-09-15 | 2021-12-28 | Verona Pharma Plc | RPL554-t tartalmazó folyékony inhalációs készítmény |
| GB201502260D0 (en) * | 2015-02-11 | 2015-04-01 | Verona Pharma Plc | Salt of Pyrimido[6,1-A]Isoquinolin-4-one compound |
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