MX2015014338A - Composicion farmaceutica que continen budesonida y formoterol. - Google Patents
Composicion farmaceutica que continen budesonida y formoterol.Info
- Publication number
- MX2015014338A MX2015014338A MX2015014338A MX2015014338A MX2015014338A MX 2015014338 A MX2015014338 A MX 2015014338A MX 2015014338 A MX2015014338 A MX 2015014338A MX 2015014338 A MX2015014338 A MX 2015014338A MX 2015014338 A MX2015014338 A MX 2015014338A
- Authority
- MX
- Mexico
- Prior art keywords
- powder
- amount
- range
- formoterol
- leucine
- Prior art date
Links
- 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 title abstract 2
- 229960004436 budesonide Drugs 0.000 title abstract 2
- BPZSYCZIITTYBL-UHFFFAOYSA-N formoterol Chemical compound C1=CC(OC)=CC=C1CC(C)NCC(O)C1=CC=C(O)C(NC=O)=C1 BPZSYCZIITTYBL-UHFFFAOYSA-N 0.000 title abstract 2
- 229960002848 formoterol Drugs 0.000 title abstract 2
- 239000008194 pharmaceutical composition Substances 0.000 title abstract 2
- 239000000843 powder Substances 0.000 abstract 12
- ROHFNLRQFUQHCH-YFKPBYRVSA-N L-leucine Chemical compound CC(C)C[C@H](N)C(O)=O ROHFNLRQFUQHCH-YFKPBYRVSA-N 0.000 abstract 3
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 abstract 3
- ROHFNLRQFUQHCH-UHFFFAOYSA-N Leucine Natural products CC(C)CC(N)C(O)=O ROHFNLRQFUQHCH-UHFFFAOYSA-N 0.000 abstract 3
- 239000008101 lactose Substances 0.000 abstract 3
- 239000000203 mixture Substances 0.000 abstract 2
- 150000003839 salts Chemical class 0.000 abstract 2
- 208000006545 Chronic Obstructive Pulmonary Disease Diseases 0.000 abstract 1
- 208000006673 asthma Diseases 0.000 abstract 1
- 239000010419 fine particle Substances 0.000 abstract 1
- 238000009472 formulation Methods 0.000 abstract 1
- 230000000414 obstructive effect Effects 0.000 abstract 1
- 230000000144 pharmacologic effect Effects 0.000 abstract 1
- 230000000241 respiratory effect Effects 0.000 abstract 1
- 208000011580 syndromic disease Diseases 0.000 abstract 1
Classifications
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- 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
- 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
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
-
- 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
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
-
- 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
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
- A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Pulmonology (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Otolaryngology (AREA)
- Pain & Pain Management (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
La presente invención se refiere a formulaciones farmacológicas en forma de polvo seco para la administración por inhalación e indicadas para el tratamiento de síndromes respiratorios obstructivos como el asma y enfermedad pulmonar obstructiva crónica (COPD); en particular, la invención se refiere a una composición farmacéutica inhalable que comprende un primer polvo de budesonida, o una de sus sales farmacéuticamente admisibles, en una cantidad mayor que 5% p/p de dicho primer polvo, leucina en una cantidad en el intervalo de 5 a 70% p/p de dicho primer polvo y lactosa en una cantidad en el intervalo de 20 a 90% p/p de dicho primer polvo; un segundo polvo que consta de formoterol o una de sus sales farmacéuticamente admisibles, en una cantidad mayor de 1% p/p de dicho segundo polvo, leucina en una cantidad en el intervalo de 5 a 70% p/p de dicho segundo polvo y lactosa en una cantidad en el intervalo de 20 a 90% p/p de dicho segundo polvo; y un tercer polvo que consta de leucina en una cantidad en el intervalo de 5 a 70% p/p de dicho tercer polvo y lactosa en una cantidad en el intervalo de 20 a 90% p/p de dicho tercer polvo; dicha composición tiene una fracción de partículas finas (FPF) superior al 60% y una fracción administrada (DF) superior al 90%.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IT000571A ITMI20130571A1 (it) | 2013-04-10 | 2013-04-10 | Composizione farmaceutica contenente budesonide e formoterolo |
| PCT/EP2014/057209 WO2014167028A1 (en) | 2013-04-10 | 2014-04-09 | A pharmaceutical composition containing budesonide and formoterol. |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| MX2015014338A true MX2015014338A (es) | 2015-12-07 |
| MX373699B MX373699B (es) | 2020-05-08 |
Family
ID=48446462
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| MX2015014338A MX373699B (es) | 2013-04-10 | 2014-04-09 | Composicion farmaceutica que contiene budesonida y formoterol. |
Country Status (15)
| Country | Link |
|---|---|
| US (1) | US10226421B2 (es) |
| EP (1) | EP2983646B1 (es) |
| JP (1) | JP6415536B2 (es) |
| CN (1) | CN105338967B (es) |
| AU (1) | AU2014253120B2 (es) |
| BR (1) | BR112015025781B1 (es) |
| CA (1) | CA2909124C (es) |
| EA (1) | EA036315B1 (es) |
| ES (1) | ES2837040T3 (es) |
| IL (1) | IL241853B (es) |
| IT (1) | ITMI20130571A1 (es) |
| MX (1) | MX373699B (es) |
| MY (1) | MY187442A (es) |
| WO (1) | WO2014167028A1 (es) |
| ZA (1) | ZA201508249B (es) |
Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ITMI20130572A1 (it) * | 2013-04-10 | 2014-10-11 | Eratech Srl | Composizione comprendente almeno due polveri secche ottenute per spray dry per aumentare la stabilita' della formulazione |
| GB201408387D0 (en) * | 2014-05-12 | 2014-06-25 | Teva Pharmaceuticals Europ B V | Treatment of respiratory disorders |
| JP6684275B2 (ja) | 2014-10-08 | 2020-04-22 | ザンボン ソシエタ ペル アチオニ | ブデソニド及びホルモテロールを含有する医薬組成物 |
| CN116136523A (zh) * | 2023-03-31 | 2023-05-19 | 苏州易合医药有限公司 | 一种布地奈德富马酸福莫特罗粉雾剂含量的分离检测方法 |
Family Cites Families (14)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1086697A2 (en) | 1991-12-18 | 2001-03-28 | AstraZeneca AB | New combination of formoterol and budesonide |
| SE9603669D0 (sv) | 1996-10-08 | 1996-10-08 | Astra Ab | New combination |
| SE9703407D0 (sv) * | 1997-09-19 | 1997-09-19 | Astra Ab | New use |
| US6565885B1 (en) | 1997-09-29 | 2003-05-20 | Inhale Therapeutic Systems, Inc. | Methods of spray drying pharmaceutical compositions |
| SE9802073D0 (sv) | 1998-06-11 | 1998-06-11 | Astra Ab | New use |
| US6004537A (en) | 1998-12-18 | 1999-12-21 | Baker Norton Pharmaceuticals, Inc. | Pharmaceutical solution aerosol formulations containing fluoroalkanes, budesonide and formoterol |
| GB9904919D0 (en) * | 1999-03-03 | 1999-04-28 | Novartis Ag | Organic compounds |
| US20010036481A1 (en) | 1999-08-25 | 2001-11-01 | Advanced Inhalation Research, Inc. | Modulation of release from dry powder formulations |
| WO2002000197A1 (en) * | 2000-06-27 | 2002-01-03 | Vectura Limited | Method of making particles for use in a pharmaceutical composition |
| AU2004231342A1 (en) * | 2003-04-14 | 2004-11-04 | Vectura Ltd | Dry power inhaler devices and dry power formulations for enhancing dosing efficiency |
| US20040204439A1 (en) * | 2003-04-14 | 2004-10-14 | Staniforth John Nicholas | Composition, device, and method for treating sexual dysfunction via inhalation |
| DE10339197A1 (de) | 2003-08-22 | 2005-03-24 | Boehringer Ingelheim Pharma Gmbh & Co. Kg | Sprühgetrocknete amorphe Pulver mit geringer Restfeuchte und guter Lagerstabilität |
| 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' |
| WO2011069197A1 (en) * | 2009-12-08 | 2011-06-16 | The University Of Sydney | Inhalable formulations |
-
2013
- 2013-04-10 IT IT000571A patent/ITMI20130571A1/it unknown
-
2014
- 2014-04-09 CN CN201480020649.8A patent/CN105338967B/zh active Active
- 2014-04-09 WO PCT/EP2014/057209 patent/WO2014167028A1/en not_active Ceased
- 2014-04-09 EP EP14720059.6A patent/EP2983646B1/en active Active
- 2014-04-09 BR BR112015025781-0A patent/BR112015025781B1/pt active IP Right Grant
- 2014-04-09 JP JP2016506966A patent/JP6415536B2/ja active Active
- 2014-04-09 CA CA2909124A patent/CA2909124C/en active Active
- 2014-04-09 MX MX2015014338A patent/MX373699B/es active IP Right Grant
- 2014-04-09 MY MYPI2015703585A patent/MY187442A/en unknown
- 2014-04-09 EA EA201591871A patent/EA036315B1/ru unknown
- 2014-04-09 AU AU2014253120A patent/AU2014253120B2/en active Active
- 2014-04-09 ES ES14720059T patent/ES2837040T3/es active Active
- 2014-04-09 US US14/783,533 patent/US10226421B2/en active Active
-
2015
- 2015-10-06 IL IL241853A patent/IL241853B/en active IP Right Grant
- 2015-11-09 ZA ZA2015/08249A patent/ZA201508249B/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| CA2909124C (en) | 2021-04-06 |
| CN105338967A (zh) | 2016-02-17 |
| CN105338967B (zh) | 2020-01-21 |
| AU2014253120B2 (en) | 2019-05-30 |
| MX373699B (es) | 2020-05-08 |
| JP6415536B2 (ja) | 2018-10-31 |
| AU2014253120A1 (en) | 2015-11-12 |
| WO2014167028A1 (en) | 2014-10-16 |
| JP2016515641A (ja) | 2016-05-30 |
| EP2983646A1 (en) | 2016-02-17 |
| BR112015025781B1 (pt) | 2022-11-29 |
| IL241853B (en) | 2021-02-28 |
| EP2983646B1 (en) | 2020-09-30 |
| EA036315B1 (ru) | 2020-10-26 |
| US20160081925A1 (en) | 2016-03-24 |
| ITMI20130571A1 (it) | 2014-10-11 |
| ES2837040T3 (es) | 2021-06-29 |
| EA201591871A1 (ru) | 2016-02-29 |
| MY187442A (en) | 2021-09-22 |
| BR112015025781A2 (pt) | 2017-07-25 |
| CA2909124A1 (en) | 2014-10-16 |
| US10226421B2 (en) | 2019-03-12 |
| ZA201508249B (en) | 2017-01-25 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FG | Grant or registration |