BR112017007142A2 - composição farmacêutica contendo budesonida e formoterol - Google Patents
composição farmacêutica contendo budesonida e formoterolInfo
- Publication number
- BR112017007142A2 BR112017007142A2 BR112017007142A BR112017007142A BR112017007142A2 BR 112017007142 A2 BR112017007142 A2 BR 112017007142A2 BR 112017007142 A BR112017007142 A BR 112017007142A BR 112017007142 A BR112017007142 A BR 112017007142A BR 112017007142 A2 BR112017007142 A2 BR 112017007142A2
- Authority
- BR
- Brazil
- Prior art keywords
- powder
- weight
- amount
- lactose
- formoterol
- Prior art date
Links
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
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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
- A61K31/16—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
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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
-
- 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
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Animal Behavior & Ethology (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Pulmonology (AREA)
- Molecular Biology (AREA)
- Biophysics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (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
a presente invenção refere-se a formulações de inalação de fármacos na forma de pó seco para administração por inalação, adequadas para o tratamento de doenças obstrutivas das vias aéreas, tais como asma e doença pulmonar obstrutiva crônica (copd). em particular, a invenção refere-se a uma composição farmacêutica para inalação compreendendo um primeiro pó compreendendo budesonida ou um sal farmaceuticamente aceitável do mesmo, em uma quantidade maior que 5% em peso do dito primeiro pó, leucina em uma quantidade de 5 a 70% em peso do dito primeiro pó, lactose em uma quantidade de 20 a 90% em peso do dito primeiro pó; um segundo pó compreendendo formoterol ou um sal farmaceuticamente aceitável do mesmo, em uma quantidade maior que 1% em peso do dito segundo pó, leucina em uma quantidade de 5 a 70% em peso do dito segundo pó, lactose em uma quantidade de 20 a 90% em peso do dito segundo pó e um terceiro pó compreendendo uma mistura de uma primeira lactose que tem um x50 de 3 a 75 µm, com uma segunda lactose que tem um x50 de 1,5 a 10 µm, o teor da dita primeira e segunda lactose na dita mistura sendo respectivamente de 85% a 96% e de 4% a 15%. a dita composição tem uma fração de partícula fina (fpf) maior que 60% e uma fração distribuída (df) maior que 80%.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| ITMI2014A001762 | 2014-10-08 | ||
| ITMI20141762 | 2014-10-08 | ||
| PCT/EP2015/073190 WO2016055546A1 (en) | 2014-10-08 | 2015-10-07 | Pharmaceutical composition containing budesonide and formoterol. |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| BR112017007142A2 true BR112017007142A2 (pt) | 2017-12-19 |
| BR112017007142B1 BR112017007142B1 (pt) | 2023-07-11 |
Family
ID=
Also Published As
| Publication number | Publication date |
|---|---|
| US20170326067A1 (en) | 2017-11-16 |
| EP3203984A1 (en) | 2017-08-16 |
| EP3203984B1 (en) | 2024-01-17 |
| IL251478B (en) | 2021-06-30 |
| WO2016055546A1 (en) | 2016-04-14 |
| AU2021200396A1 (en) | 2021-03-18 |
| EA035755B1 (ru) | 2020-08-05 |
| JP6684275B2 (ja) | 2020-04-22 |
| AU2021200396B2 (en) | 2023-02-09 |
| CA2963445C (en) | 2023-07-18 |
| IL251478A0 (en) | 2017-05-29 |
| CA2963445A1 (en) | 2016-04-14 |
| AU2015330012A1 (en) | 2017-05-25 |
| EA201700183A1 (ru) | 2017-10-31 |
| CO2017004512A2 (es) | 2017-10-20 |
| MY191295A (en) | 2022-06-14 |
| US10449147B2 (en) | 2019-10-22 |
| CN115844860A (zh) | 2023-03-28 |
| KR102449403B1 (ko) | 2022-09-29 |
| MX2017004583A (es) | 2017-11-20 |
| KR20170086489A (ko) | 2017-07-26 |
| JP2017530987A (ja) | 2017-10-19 |
| CN107205958A (zh) | 2017-09-26 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| B07D | Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette] |
Free format text: DE ACORDO COM O ARTIGO 229-C DA LEI NO 10196/2001, QUE MODIFICOU A LEI NO 9279/96, A CONCESSAO DA PATENTE ESTA CONDICIONADA A ANUENCIA PREVIA DA ANVISA. CONSIDERANDO A APROVACAO DOS TERMOS DO PARECER NO 337/PGF/EA/2010, BEM COMO A PORTARIA INTERMINISTERIAL NO 1065 DE 24/05/2012, ENCAMINHA-SE O PRESENTE PEDIDO PARA AS PROVIDENCIAS CABIVEIS. |
|
| B07E | Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette] | ||
| B06U | Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette] | ||
| B09A | Decision: intention to grant [chapter 9.1 patent gazette] | ||
| B16A | Patent or certificate of addition of invention granted [chapter 16.1 patent gazette] |
Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 07/10/2015, OBSERVADAS AS CONDICOES LEGAIS |