AR086248A1 - Formulacion en forma de suspension mejorada de un corticosteroide que puede administrarse por inhalacion - Google Patents
Formulacion en forma de suspension mejorada de un corticosteroide que puede administrarse por inhalacionInfo
- Publication number
- AR086248A1 AR086248A1 ARP120101550A ARP120101550A AR086248A1 AR 086248 A1 AR086248 A1 AR 086248A1 AR P120101550 A ARP120101550 A AR P120101550A AR P120101550 A ARP120101550 A AR P120101550A AR 086248 A1 AR086248 A1 AR 086248A1
- Authority
- AR
- Argentina
- Prior art keywords
- particles
- formulation
- administered
- corticosteroid
- formulation according
- 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
- A61K31/56—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
- A61K31/13—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
- 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
- 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
- A61K9/0078—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a nebulizer such as a jet nebulizer, ultrasonic nebulizer, e.g. in the form of aqueous drug solutions or dispersions
-
- 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
- A61K9/10—Dispersions; Emulsions
-
- 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
-
- 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
- A61P11/08—Bronchodilators
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Pulmonology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Dispersion Chemistry (AREA)
- Otolaryngology (AREA)
- Emergency Medicine (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
Abstract
Formulación en forma de suspensión acuosa que comprende partículas de drogas, particularmente de corticosteroides, que puede administrarse por nebulización y que presenta una distribución óptima del tamaño de las partículas.Reivindicación 1: Una formulación farmacéutica estéril libre de propelentes que puede administrarse por nebulización, caracterizada porque comprende partículas micronizadas de un corticosteroide cristalino suspendidas en una solución acuosa, donde i) no más de 10% de las partículas suspendidas tienen un diámetro basado en el volumen [d(v,0,1)] inferior a 0,6 mm, ii) no más de 50% de las partículas tienen un diámetro basado en el volumen [d(v,0,5)] de entre 1,5 mm y 1,9 mm; y iii) al menos 90% de las partículas [d(v,0,9)] tienen un diámetro basado en el volumen igual o inferior a 4,7 mm, y donde las partículas tienen un rango de tamaños, definido como [d(v,0,9) - d(v,0,1)] / d(v,0,5), de entre 1,2 y 2,2. Reivindicación 6: La formulación de acuerdo con la reivindicación 5, caracterizada porque el corticoide es dipropionato de beclometasona. Reivindicación 13: La formulación de acuerdo con la reivindicación 12, caracterizada porque el ingrediente activo adicional es sulfato de salbutamol. Reivindicación 14: Un recipiente caracterizado porque está lleno con una formulación de acuerdo con cualquiera de las reivindicaciones 1 a 13. Reivindicación 15: Un conjunto de elementos caracterizado porque comprende (a) una formulación de acuerdo con cualquiera de las reivindicaciones 1 a 13 en un recipiente para dosis individuales; y (b) un nebulizador.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP11164575 | 2011-05-03 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| AR086248A1 true AR086248A1 (es) | 2013-11-27 |
Family
ID=44584766
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ARP120101550A AR086248A1 (es) | 2011-05-03 | 2012-05-02 | Formulacion en forma de suspension mejorada de un corticosteroide que puede administrarse por inhalacion |
Country Status (18)
| Country | Link |
|---|---|
| EP (2) | EP2704724B1 (es) |
| CN (1) | CN103501791B (es) |
| AR (1) | AR086248A1 (es) |
| BR (1) | BR112013027391A2 (es) |
| CY (1) | CY1118315T1 (es) |
| DK (1) | DK2704724T3 (es) |
| ES (2) | ES2612257T3 (es) |
| HR (1) | HRP20161757T1 (es) |
| HU (1) | HUE030016T2 (es) |
| LT (1) | LT2704724T (es) |
| ME (1) | ME02586B (es) |
| PL (2) | PL3097915T3 (es) |
| PT (1) | PT2704724T (es) |
| RS (1) | RS55477B1 (es) |
| RU (1) | RU2611665C2 (es) |
| SI (1) | SI2704724T1 (es) |
| WO (1) | WO2012150131A1 (es) |
| ZA (1) | ZA201308158B (es) |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| RU2611665C2 (ru) | 2011-05-03 | 2017-02-28 | КЬЕЗИ ФАРМАЧЕУТИЧИ С.п.А. | Улучшенный состав суспензии кортикостероида для ингаляционного введения |
| CN107260665B (zh) * | 2016-04-08 | 2021-03-30 | 天津金耀集团有限公司 | 一种吸入用糠酸莫米松混悬液组合物 |
| CN107510687B (zh) * | 2017-08-18 | 2020-07-03 | 南京海纳医药科技股份有限公司 | 一种供雾化用含有福莫特罗和布地奈德的吸入混悬液及其制备方法 |
Family Cites Families (14)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE19653969A1 (de) * | 1996-12-20 | 1998-06-25 | Boehringer Ingelheim Kg | Neue wässrige Arzneimittelzubereitung zur Erzeugung treibgasfreier Aerosole |
| SE9704186D0 (sv) | 1997-11-14 | 1997-11-14 | Astra Ab | New composition of matter |
| IT1303692B1 (it) | 1998-11-03 | 2001-02-23 | Chiesi Farma Spa | Procedimento per la preparazione di sospensioni di particelle difarmaci da somministrare per inalazione. |
| EP1496879A4 (en) | 2002-04-05 | 2008-06-18 | Univ Utah Res Found | REGULATION OF A NEW COLON-SPECIFIC RETINOL DEHYDROGENASE BY APC AND CDX2 |
| ITMI20020808A1 (it) * | 2002-04-17 | 2003-10-17 | Chiesi Farma Spa | Procedimento per la preparazione di una sospensione sterile di particelle di beclometasone dipropionato da somministrare per inalazione |
| ITMI20022674A1 (it) | 2002-12-18 | 2004-06-19 | Chiesi Farma Spa | Procedimento per la preparazione di formulazioni sterili a base di principi attivi farmaceutici cristallini micronizzati da somministrare come sospensioni acquose per inalazione. |
| EP1454636A1 (en) | 2003-03-04 | 2004-09-08 | Dompé S.P.A. | Sterilization of glucocorticoid drug particles for pulmonary delivery |
| US7811606B2 (en) * | 2003-04-16 | 2010-10-12 | Dey, L.P. | Nasal pharmaceutical formulations and methods of using the same |
| US8912174B2 (en) * | 2003-04-16 | 2014-12-16 | Mylan Pharmaceuticals Inc. | Formulations and methods for treating rhinosinusitis |
| GB0410995D0 (en) * | 2004-05-17 | 2004-06-23 | Norton Healthcare Ltd | Heat sterilization of glucocorticosteroids |
| 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' |
| US20090252801A1 (en) | 2005-11-29 | 2009-10-08 | Farmbios S.P.A. | Process for the Preparation of Micronised Sterile Steroids |
| ES2460576T3 (es) * | 2007-12-13 | 2014-05-13 | Novartis Ag | Procedimiento para preparar una sustancia farmacológica en partículas y cristalina |
| RU2611665C2 (ru) | 2011-05-03 | 2017-02-28 | КЬЕЗИ ФАРМАЧЕУТИЧИ С.п.А. | Улучшенный состав суспензии кортикостероида для ингаляционного введения |
-
2012
- 2012-04-18 RU RU2013148786A patent/RU2611665C2/ru active
- 2012-04-18 ES ES12719304.3T patent/ES2612257T3/es active Active
- 2012-04-18 DK DK12719304.3T patent/DK2704724T3/en active
- 2012-04-18 PL PL16178624.9T patent/PL3097915T3/pl unknown
- 2012-04-18 PT PT127193043T patent/PT2704724T/pt unknown
- 2012-04-18 SI SI201230800A patent/SI2704724T1/sl unknown
- 2012-04-18 BR BR112013027391A patent/BR112013027391A2/pt not_active Application Discontinuation
- 2012-04-18 ME MEP-2016-285A patent/ME02586B/me unknown
- 2012-04-18 EP EP12719304.3A patent/EP2704724B1/en not_active Revoked
- 2012-04-18 RS RS20161116A patent/RS55477B1/sr unknown
- 2012-04-18 WO PCT/EP2012/057068 patent/WO2012150131A1/en active Application Filing
- 2012-04-18 HU HUE12719304A patent/HUE030016T2/en unknown
- 2012-04-18 LT LTEP12719304.3T patent/LT2704724T/lt unknown
- 2012-04-18 PL PL12719304T patent/PL2704724T3/pl unknown
- 2012-04-18 CN CN201280021420.7A patent/CN103501791B/zh active Active
- 2012-04-18 EP EP16178624.9A patent/EP3097915B1/en active Active
- 2012-04-18 ES ES16178624T patent/ES2974900T3/es active Active
- 2012-05-02 AR ARP120101550A patent/AR086248A1/es not_active Application Discontinuation
-
2013
- 2013-10-31 ZA ZA2013/08158A patent/ZA201308158B/en unknown
-
2016
- 2016-12-08 CY CY20161101267T patent/CY1118315T1/el unknown
- 2016-12-21 HR HRP20161757TT patent/HRP20161757T1/hr unknown
Also Published As
| Publication number | Publication date |
|---|---|
| ZA201308158B (en) | 2014-09-25 |
| ME02586B (me) | 2017-06-20 |
| PL3097915T3 (pl) | 2024-05-20 |
| PL2704724T3 (pl) | 2017-03-31 |
| BR112013027391A2 (pt) | 2017-01-17 |
| CN103501791B (zh) | 2016-05-18 |
| SI2704724T1 (sl) | 2017-01-31 |
| CY1118315T1 (el) | 2017-06-28 |
| HRP20161757T1 (hr) | 2017-02-10 |
| LT2704724T (lt) | 2017-01-10 |
| ES2612257T3 (es) | 2017-05-16 |
| RS55477B1 (sr) | 2017-04-28 |
| EP2704724A1 (en) | 2014-03-12 |
| ES2974900T3 (es) | 2024-07-02 |
| PT2704724T (pt) | 2017-02-02 |
| CN103501791A (zh) | 2014-01-08 |
| RU2013148786A (ru) | 2015-05-10 |
| EP2704724B1 (en) | 2016-10-26 |
| RU2611665C2 (ru) | 2017-02-28 |
| EP3097915A1 (en) | 2016-11-30 |
| DK2704724T3 (en) | 2017-01-09 |
| EP3097915B1 (en) | 2024-01-24 |
| WO2012150131A1 (en) | 2012-11-08 |
| HUE030016T2 (en) | 2017-04-28 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FC | Refusal |