RS53784B2 - Inhalacioni lek koji obuhvata amorfni tiotropijum bromid - Google Patents
Inhalacioni lek koji obuhvata amorfni tiotropijum bromidInfo
- Publication number
- RS53784B2 RS53784B2 RS20140699A RSP20140699A RS53784B2 RS 53784 B2 RS53784 B2 RS 53784B2 RS 20140699 A RS20140699 A RS 20140699A RS P20140699 A RSP20140699 A RS P20140699A RS 53784 B2 RS53784 B2 RS 53784B2
- Authority
- RS
- Serbia
- Prior art keywords
- solid
- tiotropium bromide
- drug
- inhalation
- pharmaceutically acceptable
- 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
- A61K9/14—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
- 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
- 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
-
- 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
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1682—Processes
- A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
-
- 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
-
- 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
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Life Sciences & Earth Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Pulmonology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Otolaryngology (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Nitrogen Condensed Heterocyclic Rings (AREA)
Claims (15)
1. Inhalacioni lek u obliku suvog praha koji obuhvata čvrste amorfne čestice i jedan ili više farmaceutski prihvatljivih ekscipijenata, gde čvrste amorfne čestice obuhvataju homogenu smešu tiotropijum bromida zajedno sa farmaceutski prihvatljivom ko-čvrstom materijom odabranom iz grupe koja se sastoji od dekstroze, fruktoze, glukozamina, glukoze, laktoze, manitola, maltitola, manoze, sorbitola, saharoze, trehaloze, ksilitola i njihovih kombinacija.
2. Lek prema zahtevu 1, gde ko-čvrsta materija ima rastvorljivost u vodi od najmanje 20 mg na 100 ml na 20°C.
3. Lek prema bilo kom od prethodnih zahteva, gde je veličina čvrstih amorfnih čestica 1-10 mikrona.
4. Lek prema bilo kom od prethodnih zahteva, gde je maseni odnos tiotropijum bromida prema ko -čvrstoj materiji od 1:1 do 1:1000.
5. Lek prema zahtevu 4, gde je maseni odnos tiotropijum bromida prema ko-čvrstoj materiji od 1:10 do 1:500.
6. Postupak za pripremanje inhalacionog leka u obliku suvog praha koji obuhvata čvrste amorfne čestice tiotropijum bromida, koji obuhvata liofilizaciju vodenog rastvora tiotropijum bromida, zajedno sa farmaceutski prihvatljivom ko-čvrstom materijom odabranom iz grupe koja se sastoji od dekstroze, fruktoze, glukozamina, glukoze, laktoze, manitola, maltitola, manoze, sorbitola, saharoze, trehaloze, ksilitola i njihovih kombinacija.
7. Postupak prema zahtevu 6, gde ko-čvrsta materija ima rastvorljivost u vodi od najmanje 20 mg na 100 ml na 20°C.
8. Postupak prema bilo kom od zahteva 6 do 7, koji dalje obuhvata mikronizovanje čestica.
9. Postupak prema bilo kom od zahteva 6 do 8, gde nagrađene čestice imaju veličinu od 1-10 mikrona.
10. Inhalacioni lek u obliku suvog praha koji se može dobiti postupkom prema bilo kom od zahteva 6 do 9.
11. Inhalacioni lek prema zahtevu 10, koji dalje obuhvata jedan ili više farmaceutski prihvatljivih ekscipijenata.
12. Inhalacioni lek prema zahtevu 11, gde jedan ili više farmaceutski prihvatljivih ekscipijenata uključuje inertni nosač.
13. Inhalacioni lek prema zahtevu 12, gde je inertni nosač odabran između laktoze, glukoze, natrijum skrob glikolata ili njihovih mešavina.
14. Kapsula koja se sastoji od inhalacionog leka prema bilo kom od zahteva 11 do 13.
15. Inhalator u obliku suvog praha koji obuhvata noseću konstrukciju, komoru za doziranje, usnik i lek prema bilo kom od zahteva 11 do 13 ili kapsulu prema zahtevu 14.
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US95882307P | 2007-07-09 | 2007-07-09 | |
| GBGB0716026.0A GB0716026D0 (en) | 2007-08-16 | 2007-08-16 | An inhalable medicament |
| PCT/GB2008/002294 WO2009007687A2 (en) | 2007-07-09 | 2008-07-03 | An inhalable medicament |
| EP08775842.1A EP2175838B2 (en) | 2007-07-09 | 2008-07-03 | An inhalable medicament containinig amorphous tiotropium bromide |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| RS53784B1 RS53784B1 (sr) | 2015-06-30 |
| RS53784B2 true RS53784B2 (sr) | 2018-07-31 |
Family
ID=38566522
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RS20140699A RS53784B2 (sr) | 2007-07-09 | 2008-07-03 | Inhalacioni lek koji obuhvata amorfni tiotropijum bromid |
Country Status (20)
| Country | Link |
|---|---|
| US (3) | US8759369B2 (sr) |
| EP (1) | EP2175838B2 (sr) |
| JP (1) | JP5552049B2 (sr) |
| KR (1) | KR101542632B1 (sr) |
| CN (1) | CN101754749B (sr) |
| BR (1) | BRPI0813564A2 (sr) |
| CA (1) | CA2692606C (sr) |
| CY (1) | CY1115937T1 (sr) |
| DK (1) | DK2175838T4 (sr) |
| EA (2) | EA030829B1 (sr) |
| ES (1) | ES2526647T5 (sr) |
| GB (1) | GB0716026D0 (sr) |
| HR (1) | HRP20141175T4 (sr) |
| IL (2) | IL203180A (sr) |
| MX (1) | MX2010000315A (sr) |
| PL (1) | PL2175838T5 (sr) |
| PT (1) | PT2175838E (sr) |
| RS (1) | RS53784B2 (sr) |
| SI (1) | SI2175838T2 (sr) |
| WO (1) | WO2009007687A2 (sr) |
Families Citing this family (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1697035B1 (en) * | 2003-12-22 | 2017-11-15 | Warren H. Finlay | Powder formation by atmospheric spray-freeze drying |
| EP1925295A1 (de) * | 2006-11-22 | 2008-05-28 | Boehringer Ingelheim Pharma GmbH & Co. KG | Stabile Pulverformulierung enthaltend ein Anticholinergikum |
| EP2534957B1 (en) | 2007-12-14 | 2015-05-27 | AeroDesigns, Inc | Delivering aerosolizable products |
| GB0801876D0 (en) * | 2008-02-01 | 2008-03-12 | Vectura Group Plc | Suspension formulations |
| EP2172190A1 (en) * | 2008-10-02 | 2010-04-07 | Laboratorios Liconsa, S.A. | Inhalable particles comprising tiotropium |
| US8834931B2 (en) | 2009-12-25 | 2014-09-16 | Mahmut Bilgic | Dry powder formulation containing tiotropium for inhalation |
| GB201200525D0 (en) | 2011-12-19 | 2012-02-29 | Teva Branded Pharmaceutical Prod R & D Inc | An inhalable medicament |
| EP2705838A1 (en) * | 2012-09-06 | 2014-03-12 | Xspray Microparticles Ab | Tiotropium preparations |
| CN103110584A (zh) * | 2013-01-29 | 2013-05-22 | 青岛大学 | 一种噻托溴铵粉雾剂及其制备方法 |
| AU2014248455B2 (en) | 2013-04-01 | 2018-12-06 | Pulmatrix Operating Company, Inc. | Tiotropium dry powders |
| EP2913332A1 (en) * | 2014-02-27 | 2015-09-02 | Euticals S.P.A. | Crystalline form of tiotropium bromide with lactose |
| GB201409603D0 (en) * | 2014-05-30 | 2014-07-16 | Teva Pharmaceuticals Europ B V | An inhalable medicament |
| US10034866B2 (en) | 2014-06-19 | 2018-07-31 | Teva Branded Pharmaceutical Products R&D, Inc. | Inhalable medicament comprising tiotropium |
| KR101728116B1 (ko) * | 2015-11-03 | 2017-04-18 | 한미약품 주식회사 | 티오트로피움 또는 이의 약학적으로 허용가능한 염을 함유하는 흡입용 건조분말 조성물 |
| US20240058538A1 (en) * | 2022-08-16 | 2024-02-22 | Kaleo, Inc. | Devices and methods for delivering reconstituted medicaments |
Family Cites Families (34)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB8828477D0 (en) | 1988-12-06 | 1989-01-05 | Riker Laboratories Inc | Medical aerosol formulations |
| US5610163A (en) | 1989-09-16 | 1997-03-11 | Boehringer Ingelheim Gmbh | Esters of thienyl carboxylic acids and amino alcohols and their quaternization products |
| DE3931041C2 (de) | 1989-09-16 | 2000-04-06 | Boehringer Ingelheim Kg | Ester von Thienylcarbonsäuren mit Aminoalkoholen, ihre Quaternierungsprodukte, Verfahren zu ihrer Herstellung und diese enthaltende Arzneimittel |
| GB9027234D0 (en) * | 1990-12-15 | 1991-02-06 | Harris Pharma Ltd | An inhalation device |
| IL104068A (en) | 1991-12-12 | 1998-10-30 | Glaxo Group Ltd | Surfactant-free pharmaceutical aerosol formulation comprising 1,1,1,2-tetrafluoroethane or 1,1,1,2,3,3,3-heptafluoro-n- propane as propellant |
| NZ246046A (en) | 1991-12-12 | 1995-12-21 | Glaxo Group Ltd | Aerosol comprising a particulate medicament in a fluorocarbon or chlorofluorohydrocarbon and a polar cosolvent |
| US6309671B1 (en) * | 1995-04-14 | 2001-10-30 | Inhale Therapeutic Systems | Stable glassy state powder formulations |
| US6258341B1 (en) * | 1995-04-14 | 2001-07-10 | Inhale Therapeutic Systems, Inc. | Stable glassy state powder formulations |
| GB9616237D0 (en) | 1996-08-01 | 1996-09-11 | Norton Healthcare Ltd | Aerosol formulations |
| PL200941B1 (pl) * | 1998-11-13 | 2009-02-27 | Jagotec Ag | Suchy proszkowy preparat inhalacyjny |
| JP4691298B2 (ja) | 1999-10-12 | 2011-06-01 | 科研製薬株式会社 | 粉末吸入用製剤及びその製造方法 |
| TR200402367T4 (tr) * | 2000-10-12 | 2004-12-21 | Boehringer Ingelheim Pharma Gmbh& Co.Kg | Yeni tiotropyum içeren inhalasyon tozları |
| US6908928B2 (en) | 2000-10-12 | 2005-06-21 | Bi Pharma Kg. | Crystalline tiotropium bromide monohydrate, processes for the preparation thereof, and pharmaceutical compositions |
| WO2002030928A1 (de) | 2000-10-12 | 2002-04-18 | Boehringer Ingelheim Pharma Gmbh & Co. Kg | Kristallines monohydrat, verfahren zu dessen herstellung und dessen verwendung zur herstellung eines arzneimittels |
| DE10126924A1 (de) | 2001-06-01 | 2002-12-05 | Boehringer Ingelheim Pharma | Inhalationskapseln |
| US20030070679A1 (en) * | 2001-06-01 | 2003-04-17 | Boehringer Ingelheim Pharma Kg | Capsules containing inhalable tiotropium |
| ME00412B (me) | 2001-06-22 | 2011-10-10 | Boehringer Ingelheim Pharma | Kristalni antiholinergik , postupak za njegovo pripremanje i njegova primjena u proizvodnji lijeka |
| US6608055B2 (en) | 2001-06-22 | 2003-08-19 | Boehringer Ingelheim Pharma Kg | Crystalline anticholinergic, processes for preparing it and its use for preparing a pharmaceutical composition |
| US7309707B2 (en) | 2002-03-20 | 2007-12-18 | Boehringer Ingelheim Pharma Gmbh & Co. Kg | Crystalline micronisate, process for the manufacture thereof and use thereof for the preparation of a medicament |
| DE10212264A1 (de) | 2002-03-20 | 2003-10-02 | Boehringer Ingelheim Pharma | Kristallines Mikronisat, Verfahren zu dessen Herstellung und dessen Verwendung zur Herstellung eines Arzneimittels |
| GB0219511D0 (en) | 2002-08-21 | 2002-10-02 | Norton Healthcare Ltd | Method of preparing dry powder inhalation compositions |
| DE10339197A1 (de) * | 2003-08-22 | 2005-03-24 | Boehringer Ingelheim Pharma Gmbh & Co. Kg | Sprühgetrocknete amorphe Pulver mit geringer Restfeuchte und guter Lagerstabilität |
| CA2576410A1 (en) * | 2003-09-18 | 2006-03-31 | Norton Healthcare Ltd. | Particles |
| US7968717B2 (en) | 2003-11-03 | 2011-06-28 | Boehringer Ingelhein International Gmbh | Crystalline anhydrate with anticholinergic efficacy |
| ME00349B (me) | 2003-11-03 | 2011-05-10 | Boehringer Ingelheim Int | Novi kristalni anhidrat sa antiholinergij skim dejstvom |
| SE0303570L (sv) | 2003-12-03 | 2005-06-04 | Microdrug Ag | Fukt-känslig medicinsk produkt |
| CN1270709C (zh) * | 2004-01-19 | 2006-08-23 | 复旦大学 | 一种噻托溴铵吸入粉雾剂及其制备方法 |
| EP1737499A4 (en) * | 2004-03-09 | 2009-07-22 | Arriva Pharmaceuticals Inc | TREATMENT OF CHRONIC OBSTRUCTIVE LUNG DISEASE BY INHALATION OF LOW DOSES OF A PROTEASE HEMMER |
| CN1593414A (zh) * | 2004-07-02 | 2005-03-16 | 上海华拓医药科技发展有限公司 | 一种噻托溴铵胶囊型吸入粉雾剂及其制备方法 |
| WO2006117299A2 (en) | 2005-05-02 | 2006-11-09 | Boehringer Ingelheim International Gmbh | Novel crystalline forms of tiotropium bromide |
| JP2008540367A (ja) | 2005-05-02 | 2008-11-20 | ベーリンガー インゲルハイム インターナショナル ゲゼルシャフト ミット ベシュレンクテル ハフツング | 新規結晶性臭化チオトロピウム |
| NZ564697A (en) | 2005-06-15 | 2010-04-30 | Boehringer Ingelheim Int | Process for preparing tiotropium salts, tiotropium salts as such and pharmaceutical compositions thereof |
| US8163913B2 (en) | 2005-12-19 | 2012-04-24 | Sicor Inc. | Forms of tiotropium bromide and processes for preparation thereof |
| EP1923393A1 (en) | 2006-11-17 | 2008-05-21 | Boehringer Ingelheim Pharma GmbH & Co. KG | Crystalline form of tiotropium bromide and urea |
-
2007
- 2007-08-16 GB GBGB0716026.0A patent/GB0716026D0/en not_active Ceased
-
2008
- 2008-07-03 EA EA201500111A patent/EA030829B1/ru not_active IP Right Cessation
- 2008-07-03 DK DK08775842.1T patent/DK2175838T4/en active
- 2008-07-03 KR KR1020107002911A patent/KR101542632B1/ko active Active
- 2008-07-03 RS RS20140699A patent/RS53784B2/sr unknown
- 2008-07-03 BR BRPI0813564-9A patent/BRPI0813564A2/pt not_active Application Discontinuation
- 2008-07-03 SI SI200831348T patent/SI2175838T2/sl unknown
- 2008-07-03 US US12/668,546 patent/US8759369B2/en active Active
- 2008-07-03 JP JP2010515588A patent/JP5552049B2/ja active Active
- 2008-07-03 PL PL08775842T patent/PL2175838T5/pl unknown
- 2008-07-03 CN CN200880023636.0A patent/CN101754749B/zh active Active
- 2008-07-03 EA EA201070115A patent/EA020968B1/ru not_active IP Right Cessation
- 2008-07-03 HR HRP20141175TT patent/HRP20141175T4/hr unknown
- 2008-07-03 MX MX2010000315A patent/MX2010000315A/es active IP Right Grant
- 2008-07-03 EP EP08775842.1A patent/EP2175838B2/en active Active
- 2008-07-03 PT PT87758421T patent/PT2175838E/pt unknown
- 2008-07-03 WO PCT/GB2008/002294 patent/WO2009007687A2/en not_active Ceased
- 2008-07-03 ES ES08775842.1T patent/ES2526647T5/es active Active
- 2008-07-03 CA CA2692606A patent/CA2692606C/en active Active
-
2010
- 2010-01-06 IL IL203180A patent/IL203180A/en active IP Right Grant
-
2014
- 2014-01-09 US US14/151,172 patent/US20140127304A1/en not_active Abandoned
- 2014-12-12 CY CY20141101038T patent/CY1115937T1/el unknown
- 2014-12-18 IL IL236360A patent/IL236360A0/en active IP Right Grant
-
2015
- 2015-02-12 US US14/620,929 patent/US20150150808A1/en not_active Abandoned
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