RU2010141333A - Новая доза и препаративная форма - Google Patents
Новая доза и препаративная форма Download PDFInfo
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- RU2010141333A RU2010141333A RU2010141333/15A RU2010141333A RU2010141333A RU 2010141333 A RU2010141333 A RU 2010141333A RU 2010141333/15 A RU2010141333/15 A RU 2010141333/15A RU 2010141333 A RU2010141333 A RU 2010141333A RU 2010141333 A RU2010141333 A RU 2010141333A
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- pharmaceutical composition
- aclidinium
- composition according
- aklidinium
- pharmaceutically acceptable
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- 239000008194 pharmaceutical composition Substances 0.000 claims abstract 24
- ASMXXROZKSBQIH-VITNCHFBSA-N aclidinium Chemical compound C([C@@H](C(CC1)CC2)OC(=O)C(O)(C=3SC=CC=3)C=3SC=CC=3)[N+]21CCCOC1=CC=CC=C1 ASMXXROZKSBQIH-VITNCHFBSA-N 0.000 claims abstract 19
- 229940019903 aclidinium Drugs 0.000 claims abstract 13
- 239000000843 powder Substances 0.000 claims abstract 11
- 150000003839 salts Chemical class 0.000 claims abstract 9
- 229960005012 aclidinium bromide Drugs 0.000 claims abstract 6
- 239000002245 particle Substances 0.000 claims abstract 6
- CPELXLSAUQHCOX-UHFFFAOYSA-M Bromide Chemical compound [Br-] CPELXLSAUQHCOX-UHFFFAOYSA-M 0.000 claims abstract 5
- 238000009472 formulation Methods 0.000 claims abstract 5
- 239000000203 mixture Substances 0.000 claims abstract 5
- 239000003937 drug carrier Substances 0.000 claims abstract 4
- GUBGYTABKSRVRQ-QKKXKWKRSA-N lactose group Chemical group OC1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@H](O)[C@@H](O)[C@@H](O)[C@H](O2)CO)[C@H](O1)CO GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims abstract 4
- 239000008101 lactose Substances 0.000 claims abstract 2
- 238000000034 method Methods 0.000 claims 10
- 239000013543 active substance Substances 0.000 claims 8
- 208000006545 Chronic Obstructive Pulmonary Disease Diseases 0.000 claims 3
- 208000006673 asthma Diseases 0.000 claims 3
- 230000000241 respiratory effect Effects 0.000 claims 3
- OBRNDARFFFHCGE-PERKLWIXSA-N (S,S)-formoterol fumarate Chemical group OC(=O)\C=C\C(O)=O.C1=CC(OC)=CC=C1C[C@H](C)NC[C@@H](O)C1=CC=C(O)C(NC=O)=C1.C1=CC(OC)=CC=C1C[C@H](C)NC[C@@H](O)C1=CC=C(O)C(NC=O)=C1 OBRNDARFFFHCGE-PERKLWIXSA-N 0.000 claims 2
- VOVIALXJUBGFJZ-KWVAZRHASA-N Budesonide Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@@H]2[C@@H]1[C@@H]1C[C@H]3OC(CCC)O[C@@]3(C(=O)CO)[C@@]1(C)C[C@@H]2O VOVIALXJUBGFJZ-KWVAZRHASA-N 0.000 claims 2
- GIIZNNXWQWCKIB-UHFFFAOYSA-N Serevent Chemical compound C1=C(O)C(CO)=CC(C(O)CNCCCCCCOCCCCC=2C=CC=CC=2)=C1 GIIZNNXWQWCKIB-UHFFFAOYSA-N 0.000 claims 2
- 229940124748 beta 2 agonist Drugs 0.000 claims 2
- 229960004436 budesonide Drugs 0.000 claims 2
- 239000003246 corticosteroid Substances 0.000 claims 2
- 229960001334 corticosteroids Drugs 0.000 claims 2
- BPZSYCZIITTYBL-UHFFFAOYSA-N formoterol Chemical group C1=CC(OC)=CC=C1CC(C)NCC(O)C1=CC=C(O)C(NC=O)=C1 BPZSYCZIITTYBL-UHFFFAOYSA-N 0.000 claims 2
- 229960002848 formoterol Drugs 0.000 claims 2
- 229960000193 formoterol fumarate Drugs 0.000 claims 2
- 229960001664 mometasone Drugs 0.000 claims 2
- QLIIKPVHVRXHRI-CXSFZGCWSA-N mometasone Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@]2(Cl)[C@@H]1[C@@H]1C[C@@H](C)[C@@](C(=O)CCl)(O)[C@@]1(C)C[C@@H]2O QLIIKPVHVRXHRI-CXSFZGCWSA-N 0.000 claims 2
- 229960002744 mometasone furoate Drugs 0.000 claims 2
- WOFMFGQZHJDGCX-ZULDAHANSA-N mometasone furoate Chemical group O([C@]1([C@@]2(C)C[C@H](O)[C@]3(Cl)[C@@]4(C)C=CC(=O)C=C4CC[C@H]3[C@@H]2C[C@H]1C)C(=O)CCl)C(=O)C1=CC=CO1 WOFMFGQZHJDGCX-ZULDAHANSA-N 0.000 claims 2
- 239000002587 phosphodiesterase IV inhibitor Substances 0.000 claims 2
- 229960004017 salmeterol Drugs 0.000 claims 2
- 239000002552 dosage form Substances 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
Classifications
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- 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
- A61K31/439—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 the ring forming part of a bridged ring system, e.g. quinuclidine
-
- 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
- A61K31/16—Amides, e.g. hydroxamic acids
- A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
- A61K31/167—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
-
- 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
- A61K31/46—8-Azabicyclo [3.2.1] octane; Derivatives thereof, e.g. atropine, cocaine
-
- 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
- A61K9/007—Pulmonary tract; Aromatherapy
- A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
- A61K9/0075—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
-
- 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
-
- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/06—Antiasthmatics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/08—Bronchodilators
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2121/00—Preparations for use in therapy
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
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- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Pulmonology (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Otolaryngology (AREA)
- Emergency Medicine (AREA)
- Pain & Pain Management (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Nitrogen Condensed Heterocyclic Rings (AREA)
Abstract
1. Фармацевтическая композиция для ингаляции, содержащая аклидиний в форме сухого порошка фармацевтически приемлемой соли в смеси с фармацевтически приемлемым носителем в форме сухого порошка, которая содержит отмеренную номинальную дозу аклидиния, эквивалентную примерно 400 мкг аклидиния бромида. ! 2. Фармацевтическая композиция по п.1 в виде однодозовой препаративной формы в виде сухого порошка, содержащей одну отмеренную номинальную дозу аклидиния, эквивалентную примерно 400 мкг аклидиния бромида. ! 3. Фармацевтическая композиция по п.1 в виде мультидозовой препаративной формы в виде сухого порошка, предназначенная для введения с помощью мультидозового ингаляторного устройства для сухого порошка, которое откалибровано для обеспечения введения отмеренной номинальной дозы аклидиния, эквивалентной примерно 400 мкг аклидиния бромида. ! 4. Фармацевтическая композиция по одному из предыдущих пунктов, в которой фармацевтически приемлемая соль аклидиния представляет собой аклидиния бромид. ! 5. Фармацевтическая композиция по п.1, в которой фармацевтически приемлемый носитель представляет собой частицы лактозы. ! 6. Фармацевтическая композиция по п.1, в которой массовое соотношение аклидиния и носителя составляет от 1:25 до 1:75. ! 7. Фармацевтическая композиция по п.6, в которой массовое соотношение аклидиния и носителя составляет от 1:50 до 1:75. ! 8. Фармацевтическая композиция по п.1, в которой средний диаметр частиц аклидиния составляет 2-5 мкм. ! 9. Фармацевтическая композиция по п.1, в которой частицы носителя характеризуются величиной dl0, составляющей 90-160 мкм, величиной d50, составляющей 170-270 мкм, и величиной d90, составляю�
Claims (26)
1. Фармацевтическая композиция для ингаляции, содержащая аклидиний в форме сухого порошка фармацевтически приемлемой соли в смеси с фармацевтически приемлемым носителем в форме сухого порошка, которая содержит отмеренную номинальную дозу аклидиния, эквивалентную примерно 400 мкг аклидиния бромида.
2. Фармацевтическая композиция по п.1 в виде однодозовой препаративной формы в виде сухого порошка, содержащей одну отмеренную номинальную дозу аклидиния, эквивалентную примерно 400 мкг аклидиния бромида.
3. Фармацевтическая композиция по п.1 в виде мультидозовой препаративной формы в виде сухого порошка, предназначенная для введения с помощью мультидозового ингаляторного устройства для сухого порошка, которое откалибровано для обеспечения введения отмеренной номинальной дозы аклидиния, эквивалентной примерно 400 мкг аклидиния бромида.
4. Фармацевтическая композиция по одному из предыдущих пунктов, в которой фармацевтически приемлемая соль аклидиния представляет собой аклидиния бромид.
5. Фармацевтическая композиция по п.1, в которой фармацевтически приемлемый носитель представляет собой частицы лактозы.
6. Фармацевтическая композиция по п.1, в которой массовое соотношение аклидиния и носителя составляет от 1:25 до 1:75.
7. Фармацевтическая композиция по п.6, в которой массовое соотношение аклидиния и носителя составляет от 1:50 до 1:75.
8. Фармацевтическая композиция по п.1, в которой средний диаметр частиц аклидиния составляет 2-5 мкм.
9. Фармацевтическая композиция по п.1, в которой частицы носителя характеризуются величиной dl0, составляющей 90-160 мкм, величиной d50, составляющей 170-270 мкм, и величиной d90, составляющей 290-400 мкм.
10. Фармацевтическая композиция по п.1, которая содержит также в эффективном количестве одно или несколько дополнительных действующих веществ, выбранных из β2-агонистов, ингибиторов PDE IV и кортикостероидов.
11. Фармацевтическая композиция по п.10, в которой дополнительное действующее вещество выбрано из формотерола, салметерола, будесонида и мометазона в свободной форме или в форме фармацевтически приемлемой соли.
12. Фармацевтическая композиция по п.11, в которой дополнительное действующее вещество представляет собой формотерола фумарат в количестве, составляющем примерно 5-25 мкг на дозу.
13. Фармацевтическая композиция по п.11, в которой дополнительное действующее вещество представляет собой мометазона фуроат в количестве, составляющем примерно 100-900 мкг на отмеренную номинальную дозу.
14. Способ лечения респираторного состояния, выбранного из астмы и хронического обструктивного заболевания легких, у пациента, который нуждается в таком лечении, заключающийся в том, что вводят ежедневно аклидиний в количестве, составляющем одну отмеренную номинальную дозу, которая эквивалентна примерно 400 мкг аклидиния бромида.
15. Способ лечения респираторного состояния, выбранного из астмы и хронического обструктивного заболевания легких, у пациента, нуждающегося в таком лечении, который заключается в том, что вводят дважды в день аклидиний в количестве, составляющем отмеренную номинальную дозу, которая эквивалентна примерно 400 мкг аклидиния бромида.
16. Способ по п.14 или 15, заключающийся в том, что вводят фармацевтическую композицию по одному из пп.1-13.
17. Способ по п.14, в котором дополнительно вводят в эффективном количестве одно или несколько дополнительных действующих веществ, выбранных из β2-агонистов, ингибиторов PDE IV и кортикостероидов.
18. Способ по п.17, в котором дополнительное действующее вещество выбирают из формотерола, салметерола, будесонида и мометазона в свободной форме или в форме фармацевтически приемлемой соли.
19. Способ по п.18, в котором дополнительное действующее вещество представляет собой формотерола фумарат в количестве, составляющем примерно 5-25 мкг на отмеренную номинальную дозу.
20. Способ по п.18, в котором дополнительное действующее вещество представляет собой мометазона фуроат в количестве, составляющем примерно 100-900 мкг на отмеренную номинальную дозу.
21. Применение аклидиния в свободной форме или в форме фармацевтически приемлемой соли для приготовления лекарственного средства, предназначенного для введения согласно способу по одному из пп.14-20.
22. Применение аклидиния в свободной форме или в форме фармацевтически приемлемой соли для приготовления фармацевтической композиции по одному из пп.1-13.
23. Аклидиний в свободной форме или в форме фармацевтически приемлемой соли, предназначенный для применения согласно одному из способов по пп.14-20.
24. Препаративная форма по п.1, предназначенная для применения согласно одному из способов по пп.14-20.
25. Препаративная форма по п.1, предназначенная для лечения респираторного состояния, выбранного из астмы и хронического обструктивного заболевания легких.
26. Мультидозовое ингаляторное устройство для сухого порошка, откалиброванное для обеспечения введения после его задействования отмеренной номинальной дозы аклидиния, эквивалентной примерно 400 мкг аклидиния бромида.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP08382010.0 | 2008-03-13 | ||
| EP08382010A EP2100599A1 (en) | 2008-03-13 | 2008-03-13 | Inhalation composition containing aclidinium for treatment of asthma and chronic obstructive pulmonary disease |
| PCT/EP2009/001832 WO2009112274A2 (en) | 2008-03-13 | 2009-03-13 | Novel dosage and formulation |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2014140674A Division RU2014140674A (ru) | 2008-03-13 | 2014-10-08 | Новая дозировка и препаративная форма |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| RU2010141333A true RU2010141333A (ru) | 2012-04-20 |
| RU2608713C2 RU2608713C2 (ru) | 2017-01-23 |
| RU2608713C3 RU2608713C3 (ru) | 2018-09-10 |
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Family Applications (3)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2010141333A RU2608713C3 (ru) | 2008-03-13 | 2009-03-13 | Новая доза и препаративная форма |
| RU2014140674A RU2014140674A (ru) | 2008-03-13 | 2014-10-08 | Новая дозировка и препаративная форма |
| RU2019100425A RU2019100425A (ru) | 2008-03-13 | 2019-01-11 | Новая доза и препаративная форма |
Family Applications After (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2014140674A RU2014140674A (ru) | 2008-03-13 | 2014-10-08 | Новая дозировка и препаративная форма |
| RU2019100425A RU2019100425A (ru) | 2008-03-13 | 2019-01-11 | Новая доза и препаративная форма |
Country Status (36)
| Country | Link |
|---|---|
| US (4) | US20110020412A1 (ru) |
| EP (5) | EP2100599A1 (ru) |
| JP (3) | JP2011513451A (ru) |
| KR (3) | KR20200054329A (ru) |
| CN (2) | CN102083416A (ru) |
| AR (1) | AR070835A1 (ru) |
| AU (1) | AU2009224895B9 (ru) |
| BR (1) | BRPI0905775B1 (ru) |
| CA (1) | CA2716724C (ru) |
| CL (1) | CL2009000602A1 (ru) |
| CO (1) | CO6290636A2 (ru) |
| CY (3) | CY1116926T1 (ru) |
| DK (3) | DK2954889T3 (ru) |
| EC (1) | ECSP10010300A (ru) |
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| EA201590030A1 (ru) * | 2012-07-05 | 2015-09-30 | Арвен Айлак Санайи Ве Тиджарет А.С. | Ингаляторы сухого порошка, содержащие носитель, отличный от лактозы, и третий компонент |
| US10111957B2 (en) | 2012-07-05 | 2018-10-30 | Arven Ilac Snayi ve Ticaret A.S. | Inhalation compositions comprising glucose anhydrous |
| LT2931275T (lt) * | 2012-12-17 | 2022-06-27 | Almirall S.A. | Aklidiniumas, skirtas naudoti fizinio aktyvumo kasdieniniame gyvenime padidinimui pacientui, sergančiam lėtine obstrukcine plaučių liga |
| EP2991626A1 (en) * | 2013-04-29 | 2016-03-09 | Sanofi SA | Inhalable pharmaceutical compositions and the inhaler devices containing them |
| EP2923702A1 (en) * | 2014-03-28 | 2015-09-30 | Universite De Liege | Composition of cyclodextrin with budesonide derivatives for treatment and prevention of pulmonary inflammatory disease |
| ES2773142T3 (es) | 2014-05-12 | 2020-07-09 | Verona Pharma Plc | Nuevo tratamiento |
| CZ2015257A3 (cs) * | 2015-04-16 | 2016-10-26 | Zentiva, K.S. | Způsob pro zmenšování velikosti částic bromidu [(3R)-1-(3-fenoxypropyl)chinuklidin-1-ium-3-yl] 2-hydroxy-2,2-bis(2-thienyl)acetátu |
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