BRPI0403316A - Formulações de solução farmacêutica em aerossol adequadas para inalação oral ou nasal contendo glucocorticóides estáveis ao armazenamento; método para formulações estabilizantes e uso de um estabilizador - Google Patents
Formulações de solução farmacêutica em aerossol adequadas para inalação oral ou nasal contendo glucocorticóides estáveis ao armazenamento; método para formulações estabilizantes e uso de um estabilizadorInfo
- Publication number
- BRPI0403316A BRPI0403316A BR0403316-7A BRPI0403316A BRPI0403316A BR PI0403316 A BRPI0403316 A BR PI0403316A BR PI0403316 A BRPI0403316 A BR PI0403316A BR PI0403316 A BRPI0403316 A BR PI0403316A
- Authority
- BR
- Brazil
- Prior art keywords
- stabilizer
- water
- formulations
- glucocorticoids
- aerosol pharmaceutical
- Prior art date
Links
- 239000000203 mixture Substances 0.000 title abstract 9
- 238000009472 formulation Methods 0.000 title abstract 5
- 239000003862 glucocorticoid Substances 0.000 title abstract 5
- 239000003381 stabilizer Substances 0.000 title abstract 5
- 239000000443 aerosol Substances 0.000 title abstract 4
- 238000000034 method Methods 0.000 title abstract 3
- 239000003186 pharmaceutical solution Substances 0.000 title abstract 3
- 229940037128 systemic glucocorticoids Drugs 0.000 title abstract 3
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 abstract 9
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 abstract 6
- FEWJPZIEWOKRBE-JCYAYHJZSA-N Dextrotartaric acid Chemical compound OC(=O)[C@H](O)[C@@H](O)C(O)=O FEWJPZIEWOKRBE-JCYAYHJZSA-N 0.000 abstract 2
- FEWJPZIEWOKRBE-UHFFFAOYSA-N Tartaric acid Natural products [H+].[H+].[O-]C(=O)C(O)C(O)C([O-])=O FEWJPZIEWOKRBE-UHFFFAOYSA-N 0.000 abstract 2
- 239000013543 active substance Substances 0.000 abstract 2
- 125000002887 hydroxy group Chemical group [H]O* 0.000 abstract 2
- 150000002576 ketones Chemical class 0.000 abstract 2
- 150000007524 organic acids Chemical class 0.000 abstract 2
- 239000008194 pharmaceutical composition Substances 0.000 abstract 2
- 230000000087 stabilizing effect Effects 0.000 abstract 2
- 239000011975 tartaric acid Substances 0.000 abstract 2
- 235000002906 tartaric acid Nutrition 0.000 abstract 2
- 208000014181 Bronchial disease Diseases 0.000 abstract 1
- 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 abstract 1
- QWOJMRHUQHTCJG-UHFFFAOYSA-N CC([CH2-])=O Chemical compound CC([CH2-])=O QWOJMRHUQHTCJG-UHFFFAOYSA-N 0.000 abstract 1
- 230000003110 anti-inflammatory effect Effects 0.000 abstract 1
- SNHRLVCMMWUAJD-SUYDQAKGSA-N betamethasone valerate Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@]2(F)[C@@H]1[C@@H]1C[C@H](C)[C@@](C(=O)CO)(OC(=O)CCCC)[C@@]1(C)C[C@@H]2O SNHRLVCMMWUAJD-SUYDQAKGSA-N 0.000 abstract 1
- 229960004436 budesonide Drugs 0.000 abstract 1
- 238000005260 corrosion Methods 0.000 abstract 1
- 230000007797 corrosion Effects 0.000 abstract 1
- 239000006184 cosolvent Substances 0.000 abstract 1
- 229960003957 dexamethasone Drugs 0.000 abstract 1
- UREBDLICKHMUKA-CXSFZGCWSA-N dexamethasone Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@]2(F)[C@@H]1[C@@H]1C[C@@H](C)[C@@](C(=O)CO)(O)[C@@]1(C)C[C@@H]2O UREBDLICKHMUKA-CXSFZGCWSA-N 0.000 abstract 1
- 201000010099 disease Diseases 0.000 abstract 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 abstract 1
- 230000004968 inflammatory condition Effects 0.000 abstract 1
- 238000010525 oxidative degradation reaction Methods 0.000 abstract 1
- 239000003380 propellant Substances 0.000 abstract 1
- 239000000243 solution Substances 0.000 abstract 1
- 150000003431 steroids Chemical class 0.000 abstract 1
- 125000001424 substituent group Chemical group 0.000 abstract 1
- 239000004094 surface-active agent Substances 0.000 abstract 1
- 230000001225 therapeutic effect Effects 0.000 abstract 1
Classifications
-
- 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
- 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
-
- 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
- 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
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0043—Nose
-
- 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
- A61P11/02—Nasal agents, e.g. decongestants
-
- 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
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth 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)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Engineering & Computer Science (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Pulmonology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Otolaryngology (AREA)
- Rheumatology (AREA)
- Pain & Pain Management (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
"FORMULAçõES DE SOLUçãO FARMACêUTICA EM AEROSSOL ADEQUADAS PARA INALAçãO ORAL OU NASAL CONTENDO GLUCOCORTICóIDES ESTáVEIS AO ARMAZENAMENTO; MéTODO PARA FORMULAçõES ESTABILIZANTES E USO DE UM ESTABILIZADOR". Formulações de solução farmacêutica em aerossol contendo glucocorticoesteróides estabilizados pela adição de água ou uma mistura de água e ácido cítrico, impedindo corrosão de elementos do container sob condições de armazenamento padrão são descritas. As formulações compreendem: - entre 0.05 e 1.0 % em peso de um glucocorticóide tendo cetona C-20 e grupo OH nos carbonos 17 e/ou 21 como substância ativa; - entre 0.10 e 3 % em peso de um estabilizador selecionado, selecionado entre água ou uma mistura de água e ácido orgânico selecionado entre ácido cítrico e ácido tartárico; - um co-solvente em quantidade suficiente para solubilizar a substância ativa; - opcionalmente um surfactante; e - propelente em quantidade suficiente para alcançar 100 % em peso de solução acabada. Glucocorticoesteróides tendo uma cetona C-20 e um grupo OH na posição C-17 e/ou 21 com substituintes variáveis, tendo muitos usos terapêuticos bem conhecidos, especialmente baseados em suas atividades antiinflamatórias. Estes tipos de esteróides, glucocorticoesteróides, e suas formulações farmacêuticas são úteis no tratamento de várias doenças incluindo doenças bronquiais e condições inflamatórias. Preferivelmente, o glucocorticóide é selecionado entre Triomcinolona Acetonide, budesonida, Dexametasona e betametasona 17-valerato. Um método para formulações de solução farmacêutica aerossol estabilizante contendo glucocorticóides suscetíveis a degradação oxidativa e uso de um estabilizador selecionado entre água e uma mistura de água e ácido orgânico selecionado entre ácido cítrico e ácido tartárico são também descritos.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| ARP030103969A AR041873A1 (es) | 2003-10-30 | 2003-10-30 | Una formulacion farmaceutica en aerosol adecuada para la inhalacion oral o nasal que contienen glucocorticoides en solucion estable al almacenamiento; un metodo para estabilzar formulaciones y uso de un agente estabilizante |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| BRPI0403316A true BRPI0403316A (pt) | 2005-06-21 |
Family
ID=34397344
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| BR0403316-7A BRPI0403316A (pt) | 2003-10-30 | 2004-08-19 | Formulações de solução farmacêutica em aerossol adequadas para inalação oral ou nasal contendo glucocorticóides estáveis ao armazenamento; método para formulações estabilizantes e uso de um estabilizador |
Country Status (4)
| Country | Link |
|---|---|
| US (1) | US20050095206A1 (pt) |
| EP (1) | EP1527772A1 (pt) |
| AR (1) | AR041873A1 (pt) |
| BR (1) | BRPI0403316A (pt) |
Families Citing this family (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| MXPA06015204A (es) * | 2004-07-02 | 2007-03-15 | Boehringer Ingelheim Int | Formulaciones en suspension de aerosol con tg 227 ea o tg 134 a como agentes propulsores. |
| US8337814B2 (en) | 2005-12-15 | 2012-12-25 | Topical Sinus Therapeutics, Inc. | Treatment of active infections, sinusitis, rhinitis, and related neurological disorders and related compositions |
| DE102006017320A1 (de) | 2006-04-11 | 2007-10-18 | Boehringer Ingelheim Pharma Gmbh & Co. Kg | Aerosolsuspensionsformulierungen mit TG 227 ea oder TG 134 a als Treibmittel |
| GB0808537D0 (en) | 2008-05-12 | 2008-06-18 | Archimedes Dev Ltd | Compositions |
| PE20121396A1 (es) | 2009-12-23 | 2012-10-24 | Chiesi Farma Spa | Composicion farmaceutica que comprende bromuro de glicopirronio y formoterol |
| WO2011135585A2 (en) * | 2010-04-28 | 2011-11-03 | Cadila Healthcare Limited | Aqueous pharmaceutical solution of ciclesonide |
| US20120204871A1 (en) * | 2011-02-10 | 2012-08-16 | Julio Cesar Vega | Stable, non-corrosive formulations for pressurized metered dose inhalers |
| CN109549935A (zh) * | 2017-09-27 | 2019-04-02 | 天津金耀集团有限公司 | 一种通过溶液方式降低糖皮质激素粒径的方法 |
| CN111939143A (zh) * | 2019-05-16 | 2020-11-17 | 鲁南制药集团股份有限公司 | 一种布地奈德溶液型气雾剂及其制备方法 |
| US11896719B2 (en) | 2022-01-24 | 2024-02-13 | Calliditas Therapeutics Ab | Pharmaceutical compositions |
| US11904046B1 (en) | 2022-11-14 | 2024-02-20 | Eton Pharmaceuticals, Inc. | Hydrocortisone oral liquid formulations |
Family Cites Families (20)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE4003272A1 (de) * | 1990-02-03 | 1991-08-08 | Boehringer Ingelheim Kg | Neue treibgasmischungen und ihre verwendung in arzneimittelzubereitungen |
| GB9202519D0 (en) * | 1992-02-06 | 1992-03-25 | Glaxo Group Ltd | Medicaments |
| SG52459A1 (en) * | 1992-12-09 | 1998-09-28 | Boehringer Ingelheim Pharma | Stabilized medicinal aerosol solution formulations |
| DE69424181T2 (de) * | 1993-12-20 | 2000-10-19 | Minnesota Mining And Mfg. Co., Saint Paul | Flunisolide aerosolformulierungen |
| DE4446891A1 (de) * | 1994-12-27 | 1996-07-04 | Falk Pharma Gmbh | Stabile wäßrige Budesonid-Lösung |
| MX9800125A (es) * | 1995-06-27 | 1998-03-31 | Boehringer Ingelheim Kg | Nuevas composiciones medicinales estables para generar aerosoles libres de gas propulsor. |
| DE69734017T2 (de) * | 1996-12-04 | 2006-06-14 | Link Products Ltd | Arzneimittelzusammensetzungen und vorrichtungen zu deren verabreichung |
| US5891420A (en) * | 1997-04-21 | 1999-04-06 | Aeropharm Technology Limited | Environmentally safe triancinolone acetonide aerosol formulations for oral inhalation |
| US6120752A (en) * | 1997-05-21 | 2000-09-19 | 3M Innovative Properties Company | Medicinal aerosol products containing formulations of ciclesonide and related steroids |
| US6423298B2 (en) * | 1998-06-18 | 2002-07-23 | Boehringer Ingelheim Pharmaceuticals, Inc. | Pharmaceutical formulations for aerosols with two or more active substances |
| AU748867B2 (en) * | 1998-07-24 | 2002-06-13 | Jagotec Ag | Medicinal aerosol formulations |
| IT1303788B1 (it) * | 1998-11-25 | 2001-02-23 | Chiesi Farma Spa | Formulazioni di aerosol medicinali. |
| US7074388B2 (en) * | 1998-12-10 | 2006-07-11 | Kos Life Science, Inc. | Water stabilized medicinal aerosol formulation |
| US6290930B1 (en) * | 1998-12-18 | 2001-09-18 | Baker Norton Pharmaceuticals, Inc. | Pharmaceutical solution aerosol formulations containing fluoroalkanes and budesonide |
| US6004537A (en) * | 1998-12-18 | 1999-12-21 | Baker Norton Pharmaceuticals, Inc. | Pharmaceutical solution aerosol formulations containing fluoroalkanes, budesonide and formoterol |
| US6315985B1 (en) | 1999-06-18 | 2001-11-13 | 3M Innovative Properties Company | C-17/21 OH 20-ketosteroid solution aerosol products with enhanced chemical stability |
| IT1313553B1 (it) * | 1999-07-23 | 2002-09-09 | Chiesi Farma Spa | Formulazioni ottimizzate costituite da soluzioni di steroidi dasomministrare per inalazione. |
| MXPA02011414A (es) * | 2000-05-22 | 2003-06-06 | Chiesi Farma Spa | Formulaciones farmaceuticas en solucion estable para inhaladores presurizados con medicion de dosis. |
| US20030113268A1 (en) | 2000-11-10 | 2003-06-19 | Mina Buenafae | Degradation-resistant glucocorticosteroid formulations |
| US20020085978A1 (en) * | 2000-11-10 | 2002-07-04 | Mina Buenafe | Degradation-resistant glucocorticosteroid formulations |
-
2003
- 2003-10-30 AR ARP030103969A patent/AR041873A1/es not_active Application Discontinuation
-
2004
- 2004-08-17 EP EP04019514A patent/EP1527772A1/en not_active Withdrawn
- 2004-08-19 BR BR0403316-7A patent/BRPI0403316A/pt active Search and Examination
- 2004-09-17 US US10/943,403 patent/US20050095206A1/en not_active Abandoned
Also Published As
| Publication number | Publication date |
|---|---|
| EP1527772A1 (en) | 2005-05-04 |
| US20050095206A1 (en) | 2005-05-05 |
| AR041873A1 (es) | 2005-06-01 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| B06F | Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette] | ||
| B07D | Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette] | ||
| B08F | Application dismissed because of non-payment of annual fees [chapter 8.6 patent gazette] |
Free format text: REFERENTE A 9A ANUIDADE. |
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| B08K | Patent lapsed as no evidence of payment of the annual fee has been furnished to inpi [chapter 8.11 patent gazette] |
Free format text: REFERENTE AO DESPACHO 8.6 PUBLICADO NA RPI 2260 DE 29/04/2014. |
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| B07F | Notification of approval that there is no relation to art. 229 of lpi (pipeline patents) [chapter 7.6 patent gazette] |
Free format text: NOTIFICACAO DE NAO ANUENCIA RELACIONADA COM O ART. 229 DA LPI |