MX2019012931A - Proceso para preparar una formulacion de polvo seco que comprende un anticolinergico, un corticosteroide y un beta-adrenergico. - Google Patents
Proceso para preparar una formulacion de polvo seco que comprende un anticolinergico, un corticosteroide y un beta-adrenergico.Info
- Publication number
- MX2019012931A MX2019012931A MX2019012931A MX2019012931A MX2019012931A MX 2019012931 A MX2019012931 A MX 2019012931A MX 2019012931 A MX2019012931 A MX 2019012931A MX 2019012931 A MX2019012931 A MX 2019012931A MX 2019012931 A MX2019012931 A MX 2019012931A
- Authority
- MX
- Mexico
- Prior art keywords
- physiologically acceptable
- acceptable excipient
- weight
- carrier
- mixture
- Prior art date
Links
- 239000000203 mixture Substances 0.000 title abstract 7
- 238000009472 formulation Methods 0.000 title abstract 3
- 239000000843 powder Substances 0.000 title abstract 3
- 239000003246 corticosteroid Substances 0.000 title abstract 2
- 238000004519 manufacturing process Methods 0.000 title abstract 2
- 230000001078 anti-cholinergic effect Effects 0.000 title 1
- 239000002245 particle Substances 0.000 abstract 6
- 239000000546 pharmaceutical excipient Substances 0.000 abstract 5
- 239000011859 microparticle Substances 0.000 abstract 3
- PZSMUPGANZGPBF-UHFFFAOYSA-N 4-[5-(dithiolan-3-yl)pentanoylamino]butanoic acid Chemical compound OC(=O)CCCNC(=O)CCCCC1CCSS1 PZSMUPGANZGPBF-UHFFFAOYSA-N 0.000 abstract 2
- VPNYRYCIDCJBOM-UHFFFAOYSA-M Glycopyrronium bromide Chemical compound [Br-].C1[N+](C)(C)CCC1OC(=O)C(O)(C=1C=CC=CC=1)C1CCCC1 VPNYRYCIDCJBOM-UHFFFAOYSA-M 0.000 abstract 2
- 239000011362 coarse particle Substances 0.000 abstract 2
- 235000014113 dietary fatty acids Nutrition 0.000 abstract 2
- 229930195729 fatty acid Natural products 0.000 abstract 2
- 239000000194 fatty acid Substances 0.000 abstract 2
- 150000004665 fatty acids Chemical class 0.000 abstract 2
- 229960002462 glycopyrronium bromide Drugs 0.000 abstract 2
- 229940125389 long-acting beta agonist Drugs 0.000 abstract 2
- 150000003839 salts Chemical class 0.000 abstract 2
- 239000004480 active ingredient Substances 0.000 abstract 1
- 239000000556 agonist Substances 0.000 abstract 1
- 229940112141 dry powder inhaler Drugs 0.000 abstract 1
- 238000000034 method Methods 0.000 abstract 1
- 238000003801 milling Methods 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
- A61K9/14—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
-
- 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
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
-
- 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
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/138—Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine
-
- 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
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
-
- 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
- A61K31/47—Quinolines; Isoquinolines
- A61K31/4704—2-Quinolinones, e.g. carbostyril
-
- 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
-
- 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
- A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
- A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
-
- 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
- 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
- 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
- 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
- A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
-
- 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
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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
-
- 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
- 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)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Pulmonology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Otolaryngology (AREA)
- Pain & Pain Management (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Emergency Medicine (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
La presente invención se relaciona con un proceso para preparar una formulación en polvo para inhalación para el uso en un inhalador de polvo seco, en donde el polvo comprende: (A) un vehículo que comprende: (a) 80 a 95 por ciento en peso, basado en el peso total del vehículo, de partículas gruesas de un excipiente fisiológicamente aceptable que tiene un tamaño medio de partículas de por lo menos 175 micrómetros; y (b) 19.6 a 4.9 por ciento en peso, basado en el peso total del vehículo, de partículas micronizadas de un excipiente fisiológicamente aceptable, y (c) 0.1 a 0.4 por ciento en peso, basado en el peso total del vehículo, de una sal de un ácido graso; y (B) partículas micronizadas de bromuro de glicopirronio, un agonista ß2 de acción prolongada (LABA) y un corticosteroide inhalado (ICS), como ingredientes activos, tal proceso comprende: (i) preparar co-molienda micropartículas que consisten de bromuro de glicopirronio y una primera parte de un ICS en una relación que varía de 80:20 a 70:30 en peso, en donde el diámetro de volumen de las micropartículas no es más de 15 micrómetros; (ii) mezclar las partículas gruesas de un excipiente fisiológicamente aceptable, la sal de un ácido graso, una primera parte de tales partículas micronizadas de un excipiente fisiológicamente aceptable, las partículas micronizadas de tal LABA, las micropartículas co-molidas obtenidas en la etapa (i), y la parte restante del ICS en un recipiente de un agitador mezclador a una velocidad de rotación no menor de 16 rpm por un tiempo no menor de 60 minutos, para obtener un primera mezcla; y (iii) adicionar la parte restante de las partículas micronizadas de un excipiente fisiológicamente aceptable a la primera mezcla, para obtener una segunda mezcla, y mezclar la segunda mezcla a una velocidad de rotación no menor de 16 rpm durante un tiempo de por lo menos 120 minutos para obtener una formulación.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP17170657 | 2017-05-11 | ||
| PCT/EP2018/061953 WO2018206618A1 (en) | 2017-05-11 | 2018-05-09 | A process for preparing a dry powder formulation comprising an anticholinergic, a corticosteroid and a beta-adrenergic |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| MX2019012931A true MX2019012931A (es) | 2020-01-20 |
Family
ID=58707349
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| MX2019012931A MX2019012931A (es) | 2017-05-11 | 2018-05-09 | Proceso para preparar una formulacion de polvo seco que comprende un anticolinergico, un corticosteroide y un beta-adrenergico. |
Country Status (12)
| Country | Link |
|---|---|
| US (1) | US10786450B2 (es) |
| EP (1) | EP3621590B1 (es) |
| KR (3) | KR102637303B1 (es) |
| CN (1) | CN110582269B (es) |
| BR (1) | BR112019023378A2 (es) |
| CA (1) | CA3060020A1 (es) |
| ES (1) | ES2891346T3 (es) |
| MA (1) | MA48621A (es) |
| MX (1) | MX2019012931A (es) |
| PL (1) | PL3621590T3 (es) |
| RU (1) | RU2742376C1 (es) |
| WO (1) | WO2018206618A1 (es) |
Family Cites Families (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| PE20011227A1 (es) * | 2000-04-17 | 2002-01-07 | Chiesi Farma Spa | Formulaciones farmaceuticas para inhaladores de polvo seco en la forma de aglomerados duros |
| GB0015043D0 (en) | 2000-06-21 | 2000-08-09 | Glaxo Group Ltd | Medicament dispenser |
| PT1658872E (pt) | 2002-07-31 | 2011-05-12 | Chiesi Farma Spa | Inalador de p? |
| GB0525254D0 (en) * | 2005-12-12 | 2006-01-18 | Jagotec Ag | Powder compositions for inhalation |
| GB0613161D0 (en) * | 2006-06-30 | 2006-08-09 | Novartis Ag | Organic Compounds |
| CN102665679B (zh) | 2009-12-23 | 2014-11-26 | 奇斯药制品公司 | 用于copd的联合治疗 |
| MY165888A (en) * | 2012-01-25 | 2018-05-18 | Chiesi Farm Spa | Dry powder formulation comprising a corticosteroid and a beta-adrenergic for administration by inhalation |
| WO2015004243A1 (en) * | 2013-07-11 | 2015-01-15 | Chiesi Farmaceutici S.P.A. | Dry powder formulation comprising an anticholinergic, a corticosteroid and a beta-adrenergic for administration by inhalation |
| KR102437658B1 (ko) | 2014-06-30 | 2022-08-29 | 치에시 파마슈티시 에스.피.아. | 건조 분말 흡입기와 흡입 작동 메커니즘 |
| PT3377109T (pt) | 2015-11-16 | 2020-05-13 | Chiesi Farm Spa | Processo para preparar uma formulação de pó seco que compreende um anticolinérgico, um corticoide e um betaadrenérgico |
| PT3620176T (pt) * | 2015-11-16 | 2021-09-28 | Chiesi Farm Spa | Processo para preparar uma formulação de pó seco que compreende um anticolinérgico, um corticosteroide e um beta-adrenérgico |
| EP3621589B1 (en) * | 2017-05-11 | 2021-07-07 | Chiesi Farmaceutici S.p.A. | A process for preparing a dry powder formulation comprising an anticholinergic, a corticosteroid and a beta-adrenergic |
-
2018
- 2018-05-09 BR BR112019023378-4A patent/BR112019023378A2/pt unknown
- 2018-05-09 KR KR1020197033082A patent/KR102637303B1/ko active IP Right Grant
- 2018-05-09 MA MA048621A patent/MA48621A/fr unknown
- 2018-05-09 WO PCT/EP2018/061953 patent/WO2018206618A1/en unknown
- 2018-05-09 US US15/975,146 patent/US10786450B2/en active Active
- 2018-05-09 CA CA3060020A patent/CA3060020A1/en active Pending
- 2018-05-09 MX MX2019012931A patent/MX2019012931A/es unknown
- 2018-05-09 ES ES18725443T patent/ES2891346T3/es active Active
- 2018-05-09 RU RU2019139869A patent/RU2742376C1/ru active
- 2018-05-09 PL PL18725443T patent/PL3621590T3/pl unknown
- 2018-05-09 EP EP18725443.8A patent/EP3621590B1/en active Active
- 2018-05-09 CN CN201880029982.3A patent/CN110582269B/zh active Active
- 2018-05-09 KR KR1020247021477A patent/KR20240104225A/ko active Search and Examination
- 2018-05-09 KR KR1020227038724A patent/KR20220155395A/ko not_active IP Right Cessation
Also Published As
| Publication number | Publication date |
|---|---|
| EP3621590A1 (en) | 2020-03-18 |
| ES2891346T3 (es) | 2022-01-27 |
| US20180325816A1 (en) | 2018-11-15 |
| KR102637303B1 (ko) | 2024-02-20 |
| CN110582269B (zh) | 2023-02-28 |
| CA3060020A1 (en) | 2018-11-15 |
| KR20190142770A (ko) | 2019-12-27 |
| EP3621590B1 (en) | 2021-09-01 |
| PL3621590T3 (pl) | 2022-01-17 |
| US10786450B2 (en) | 2020-09-29 |
| KR20220155395A (ko) | 2022-11-22 |
| MA48621A (fr) | 2021-04-28 |
| KR20240104225A (ko) | 2024-07-04 |
| BR112019023378A2 (pt) | 2020-06-16 |
| RU2742376C1 (ru) | 2021-02-05 |
| WO2018206618A1 (en) | 2018-11-15 |
| CN110582269A (zh) | 2019-12-17 |
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