DK2793886T3 - Inhalerbart medikament omfattende tiotropium - Google Patents
Inhalerbart medikament omfattende tiotropium Download PDFInfo
- Publication number
- DK2793886T3 DK2793886T3 DK12806382.3T DK12806382T DK2793886T3 DK 2793886 T3 DK2793886 T3 DK 2793886T3 DK 12806382 T DK12806382 T DK 12806382T DK 2793886 T3 DK2793886 T3 DK 2793886T3
- Authority
- DK
- Denmark
- Prior art keywords
- formulation
- tiotropium
- ethanol
- water
- hfa
- Prior art date
Links
Classifications
-
- 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
- A61K31/33—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
- 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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- 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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- 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
- A61K9/008—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy comprising drug dissolved or suspended in liquid propellant for inhalation via a pressurized metered dose inhaler [MDI]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M15/00—Inhalators
- A61M15/009—Inhalators using medicine packages with incorporated spraying means, e.g. aerosol cans
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Public Health (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Pulmonology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Otolaryngology (AREA)
- Emergency Medicine (AREA)
- Hematology (AREA)
- Heart & Thoracic Surgery (AREA)
- Biomedical Technology (AREA)
- Anesthesiology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Nitrogen Condensed Heterocyclic Rings (AREA)
Claims (15)
1. Opløsningsformulering omfattende et tiotropiumsalt, 12-20% ethanol, 0,1-1,5% vand, 0,05-0,10% citronsyre og et HFA-drivmiddel, hvor procenterne er vægtprocenter af formuleringens samlede vægt.
2. Formulering ifølge krav 1, hvor tiotropiumsaltet er tiotropiumbromid.
3. Formulering ifølge kravene 1 eller 2, hvor tiotropiumsaltet er til stede i en mængde for at tilvejebringe 1-10 mikrogram, fortrinsvis 2-6 mikrogram, tiotropiumbase, uden ventil, pr. aktivering.
4. Formulering ifølge et hvilket som helst af de foregående krav, hvor HFA-drivmidlet er HFA 134a og/eller HFA 227.
5. Formulering ifølge et hvilket som helst af de foregående krav, hvor formuleringen endvidere omfatter glycerol.
6. Formulering ifølge et hvilket som helst af de foregående krav, hvor mængden af ethanol er 12-15%.
7. Formulering ifølge et hvilket som helst af de foregående krav, hvor mængden af vand er 0,30-0,60%.
8. Formulering ifølge et hvilket som helst af de foregående krav omfattende ca. 15% ethanol, ca. 0,5% vand og ca. 0,06% citronsyre og et HFA-drivmiddel.
9. Formulering ifølge et hvilket som helst af de foregående krav bestående af et tiotropiumsalt, 12-20% ethanol, 0,1-1,5% vand, 0,05-0,10% citronsyre, et HFA-drivmiddel og eventuelt 0,5-5% glycerol.
10. Tryksat afmålt dosisinhalator omfattende en beholder, hvor beholderen indeholder opløsningsformuleringen ifølge et hvilket som helst af de foregående krav, eller et hvilket som helst af kravene 11 til 13.
11. Opløsningsformulering omfattende et tiotropiumsalt, 12-20% ethanol, 0,1 -1,5% vand, 0,05-0,10% ascorbinsyre, og et HFA-drivmiddel, hvor procenterne er vægtprocenter baseret på formuleringens samlede vægt.
12. Formulering ifølge krav 11 omfattende ca. 15% ethanol, ca. 0,5% vand og ca. 0,06% ascorbinsyre og et HFA-drivmiddel.
13. Formulering ifølge et hvilket som helst af kravene 11 eller 12 bestående af et tiotropiumsalt, 12-20% ethanol, 0,1-1,5% vand, 0,05-0,10% ascorbinsyre, et HFA-drivmiddel og eventuelt 0,5-5% glycerol.
14. Formulering ifølge et hvilket som helst af kravene 1-9 eller 11 til 13 til anvendelse til behandling af kronisk obstruktiv lungesygdom.
15. Anvendelse afen opløsningsformulering omfattende 12-20% ethanol, 0,1-1,5% vand, 0,05-0,10% citronsyre og et HFA-drivmiddel til at stabilisere et tiotropiumsalt, hvor procenterne er vægtprocenter baseret på formuleringens samlede vægt.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201161577315P | 2011-12-19 | 2011-12-19 | |
| GBGB1200525.2A GB201200525D0 (en) | 2011-12-19 | 2012-01-13 | An inhalable medicament |
| PCT/EP2012/074690 WO2013092237A1 (en) | 2011-12-19 | 2012-12-06 | An inhalable medicament comprising tiotropium |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK2793886T3 true DK2793886T3 (da) | 2016-12-05 |
Family
ID=45813952
Family Applications (3)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK16185402.1T DK3143998T3 (da) | 2011-12-19 | 2012-12-06 | Inhalerbart lægemiddel omfattende tiotropium |
| DK12806382.3T DK2793886T3 (da) | 2011-12-19 | 2012-12-06 | Inhalerbart medikament omfattende tiotropium |
| DK12196725.1T DK2606891T3 (da) | 2011-12-19 | 2012-12-12 | Inhalerbart lægemiddel omfattende tiotropium |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK16185402.1T DK3143998T3 (da) | 2011-12-19 | 2012-12-06 | Inhalerbart lægemiddel omfattende tiotropium |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK12196725.1T DK2606891T3 (da) | 2011-12-19 | 2012-12-12 | Inhalerbart lægemiddel omfattende tiotropium |
Country Status (29)
| Country | Link |
|---|---|
| US (1) | US9655969B2 (da) |
| EP (3) | EP3143998B1 (da) |
| JP (1) | JP5791166B2 (da) |
| KR (2) | KR20160111539A (da) |
| CN (1) | CN103998039A (da) |
| AR (1) | AR089302A1 (da) |
| AU (1) | AU2012358475B2 (da) |
| BR (1) | BR112014014535A2 (da) |
| CA (1) | CA2856047C (da) |
| CY (1) | CY1116142T1 (da) |
| DK (3) | DK3143998T3 (da) |
| EA (1) | EA028461B1 (da) |
| ES (3) | ES2728940T3 (da) |
| GB (1) | GB201200525D0 (da) |
| HK (2) | HK1200343A1 (da) |
| HR (1) | HRP20141176T1 (da) |
| HU (2) | HUE044647T2 (da) |
| IL (1) | IL232946A0 (da) |
| MX (1) | MX361925B (da) |
| PL (3) | PL2793886T3 (da) |
| PT (1) | PT2606891E (da) |
| RS (1) | RS53783B1 (da) |
| SI (1) | SI2606891T1 (da) |
| SM (1) | SMT201400192B (da) |
| TR (1) | TR201908429T4 (da) |
| TW (1) | TWI468187B (da) |
| UY (1) | UY34525A (da) |
| WO (1) | WO2013092237A1 (da) |
| ZA (2) | ZA201403041B (da) |
Families Citing this family (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| SG181870A1 (en) | 2009-12-23 | 2012-07-30 | Chiesi Farma Spa | Aerosol formulation for copd |
| GB201200525D0 (en) | 2011-12-19 | 2012-02-29 | Teva Branded Pharmaceutical Prod R & D Inc | An inhalable medicament |
| EP2819669B1 (de) | 2012-02-28 | 2021-04-21 | Boehringer Ingelheim International GmbH | Neue treibgashaltige tiotropium-formulierung |
| TR201911194T4 (tr) | 2013-11-22 | 2019-08-21 | Teva Branded Pharmaceutical Products R&D Inc | Solunabilir bir ilaç. |
| HK1212903A1 (zh) * | 2013-11-22 | 2016-06-24 | Teva Branded Pharmaceutical Products R & D, Inc. | 可吸入藥物 |
| US10034866B2 (en) | 2014-06-19 | 2018-07-31 | Teva Branded Pharmaceutical Products R&D, Inc. | Inhalable medicament comprising tiotropium |
| WO2017075018A1 (en) * | 2015-10-29 | 2017-05-04 | 3M Innovative Properties Company | Formulation and aerosol canisters, inhalers, and the like containing the formulation |
| CN114712337A (zh) * | 2016-09-19 | 2022-07-08 | 墨西哥氟石股份公司 | 药物组合物 |
| WO2020006017A1 (en) * | 2018-06-27 | 2020-01-02 | 3M Innovative Properties Company | Tiotropium formulation and inhaler |
| EP4731184A1 (en) | 2024-08-26 | 2026-04-29 | Glenmark Pharmaceuticals Limited | A pressurized inhalation composition of tiotropium |
| WO2026047392A1 (en) | 2024-08-26 | 2026-03-05 | Glenmark Specialty S.A. | A pressurized inhalation composition of tiotropium |
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| GB8828477D0 (en) | 1988-12-06 | 1989-01-05 | Riker Laboratories Inc | Medical aerosol formulations |
| 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 |
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| 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 |
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| ES2185606T3 (es) * | 2001-03-21 | 2003-05-01 | Sanol Arznei Schwarz Gmbh | Nuevo uso de una clase de compuestos peptidicos para tratamiento de la alodinia u otros tipos diferentes de dolor cronico o fantasma. |
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| DE10214263A1 (de) | 2002-03-28 | 2003-10-16 | Boehringer Ingelheim Pharma | HFA-Suspensionsformulierungen enthaltend ein Anticholinergikum |
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| DE10339197A1 (de) | 2003-08-22 | 2005-03-24 | Boehringer Ingelheim Pharma Gmbh & Co. Kg | Sprühgetrocknete amorphe Pulver mit geringer Restfeuchte und guter Lagerstabilität |
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| 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 |
| 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 |
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| EP1850831B1 (en) * | 2005-02-25 | 2015-12-02 | CHIESI FARMACEUTICI S.p.A. | Pharmaceutical aerosol formulations for pressurized metered dose inhalers comprising a sequestering agent |
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| EP2819669B1 (de) | 2012-02-28 | 2021-04-21 | Boehringer Ingelheim International GmbH | Neue treibgashaltige tiotropium-formulierung |
-
2012
- 2012-01-13 GB GBGB1200525.2A patent/GB201200525D0/en not_active Ceased
- 2012-12-06 KR KR1020167025194A patent/KR20160111539A/ko not_active Withdrawn
- 2012-12-06 MX MX2014007357A patent/MX361925B/es active IP Right Grant
- 2012-12-06 PL PL12806382T patent/PL2793886T3/pl unknown
- 2012-12-06 HU HUE16185402 patent/HUE044647T2/hu unknown
- 2012-12-06 CN CN201280060763.4A patent/CN103998039A/zh active Pending
- 2012-12-06 US US14/367,031 patent/US9655969B2/en active Active
- 2012-12-06 AU AU2012358475A patent/AU2012358475B2/en not_active Ceased
- 2012-12-06 PL PL16185402T patent/PL3143998T3/pl unknown
- 2012-12-06 TR TR2019/08429T patent/TR201908429T4/tr unknown
- 2012-12-06 HK HK15100893.1A patent/HK1200343A1/xx unknown
- 2012-12-06 CA CA2856047A patent/CA2856047C/en not_active Expired - Fee Related
- 2012-12-06 EA EA201491206A patent/EA028461B1/ru not_active IP Right Cessation
- 2012-12-06 BR BR112014014535A patent/BR112014014535A2/pt not_active Application Discontinuation
- 2012-12-06 DK DK16185402.1T patent/DK3143998T3/da active
- 2012-12-06 HK HK14111996.5A patent/HK1198512A1/xx unknown
- 2012-12-06 WO PCT/EP2012/074690 patent/WO2013092237A1/en not_active Ceased
- 2012-12-06 EP EP16185402.1A patent/EP3143998B1/en not_active Revoked
- 2012-12-06 EP EP12806382.3A patent/EP2793886B1/en not_active Revoked
- 2012-12-06 KR KR1020147017716A patent/KR101670564B1/ko not_active Expired - Fee Related
- 2012-12-06 ES ES16185402T patent/ES2728940T3/es active Active
- 2012-12-06 ES ES12806382.3T patent/ES2602314T3/es active Active
- 2012-12-06 HU HUE12806382A patent/HUE030983T2/en unknown
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- 2012-12-06 DK DK12806382.3T patent/DK2793886T3/da active
- 2012-12-12 PL PL12196725T patent/PL2606891T3/pl unknown
- 2012-12-12 SI SI201230113T patent/SI2606891T1/sl unknown
- 2012-12-12 EP EP12196725.1A patent/EP2606891B1/en not_active Revoked
- 2012-12-12 DK DK12196725.1T patent/DK2606891T3/da active
- 2012-12-12 RS RS20140691A patent/RS53783B1/sr unknown
- 2012-12-12 ES ES12196725.1T patent/ES2526685T3/es active Active
- 2012-12-12 PT PT121967251T patent/PT2606891E/pt unknown
- 2012-12-18 AR ARP120104795A patent/AR089302A1/es not_active Application Discontinuation
- 2012-12-18 UY UY0001034525A patent/UY34525A/es not_active Application Discontinuation
- 2012-12-19 TW TW101148516A patent/TWI468187B/zh not_active IP Right Cessation
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2014
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- 2014-06-02 IL IL232946A patent/IL232946A0/en active IP Right Grant
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- 2014-12-19 CY CY20141101072T patent/CY1116142T1/el unknown
- 2014-12-22 SM SM201400192T patent/SMT201400192B/xx unknown
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2015
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