DK2377557T3 - Sammensætninger, der omfatter azelastin, og metoder til brug deraf - Google Patents
Sammensætninger, der omfatter azelastin, og metoder til brug deraf Download PDFInfo
- Publication number
- DK2377557T3 DK2377557T3 DK11173623.7T DK11173623T DK2377557T3 DK 2377557 T3 DK2377557 T3 DK 2377557T3 DK 11173623 T DK11173623 T DK 11173623T DK 2377557 T3 DK2377557 T3 DK 2377557T3
- Authority
- DK
- Denmark
- Prior art keywords
- azelastine
- sucralose
- budesonide
- loteprednol
- fluticasone
- Prior art date
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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
- A61K9/0043—Nose
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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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
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- 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
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- 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
- 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
- A61K9/0048—Eye, e.g. artificial tears
-
- 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
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
-
- 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
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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
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7007—Drug-containing films, membranes or sheets
-
- 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
- A61P27/00—Drugs for disorders of the senses
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
- A61P27/02—Ophthalmic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
- A61P27/02—Ophthalmic agents
- A61P27/14—Decongestants or antiallergics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
- A61P27/16—Otologicals
-
- 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]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/08—Antiallergic agents
-
- 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
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- 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
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A90/00—Technologies having an indirect contribution to adaptation to climate change
- Y02A90/10—Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Otolaryngology (AREA)
- Pulmonology (AREA)
- Ophthalmology & Optometry (AREA)
- Biochemistry (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Molecular Biology (AREA)
- Zoology (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Immunology (AREA)
- Pain & Pain Management (AREA)
- Rheumatology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Claims (20)
1. Farmaceutisk sammensætning, der omfatter en terapeutisk effektiv dosis af azelastin, eller et farmaceutisk acceptabelt salt eller ester deraf, ved en koncentration på mellem 0,005 % og 5 % efter vægt, og et eller flere farmaceutisk acceptable bærestoffer eller hjælpestoffer, hvor mindst et af de farmaceutisk acceptable bærestoffer eller hjælpestoffer er sucralose, og et eller flere steroider, hvor sammensætningen er formuleret til intranasal indgift.
2. Farmaceutisk sammensætning ifølge krav 1, hvor det ene eller de flere steroider er udvalgt fra den grupper, der omfatter flourmethalon, fluticason, mometa-son, triamcinolon, betamethason, flunisolid, budesonid, beclomethason, budeso-nid, rimexolon, loteprednol, dexamethason-beloxil, prednison, loteprednol og dexamethason.
3. Farmaceutisk sammensætning ifølge krav 1, hvor azelastinen er til stede i sammensætningen ved en koncentration på mellem 0,125 % og 0,15 % efter vægt.
4. Farmaceutisk sammensætning ifølge krav 1, hvor sucralosen er til stede i sammensætningen ved en koncentration på mellem 0,05 % og 0,15 % efter vægt.
5. Farmaceutisk sammensætning ifølge krav 1, hvor sammensætningen endvidere omfatter et eller flere midler mod kongestion.
6. Farmaceutisk sammensætning ifølge krav 1, hvor sammensætningen omfatter azelastin, eller et farmaceutisk acceptabelt salt eller ester deraf, ved en koncentration på mellem 0,05 % og 0,15 % efter vægt, sucralose ved en koncentration på mellem 0,05 % og 0,15 % efter vægt, og et eller flere steroider ved en koncentration på mellem 0,01 % og 0,1 % efter vægt.
7. Farmaceutisk sammensætning ifølge krav 5, hvor sammensætningen omfatter azelastin, eller et farmaceutisk acceptabelt salt eller ester deraf, ved en koncentration på mellem 0,05 % og 0,15 % efter vægt, sucralose ved en koncentration på mellem 0,05 % og 0,15 % efter vægt og et eller flere midler mod kon-gestion ved en koncentration på mellem 0,1 % og 1,0 %.
8. Farmaceutisk sammensætning ifølge krav 1, hvor sammensætningen omfatter azelastin, eller et farmaceutisk acceptabelt salt eller ester deraf, ved en koncentration på mellem 0,05 % og 0,15 % efter vægt, sucralose ved en koncentration på mellem 0,05 % og 0,15 % efter vægt, et eller flere steroider ved en koncentration på mellem 0,01 % og 0,1 % efter vægt og et eller flere midler mod kongestion ved en koncentration på mellem 0,1 % og 1,0 %.
9. Farmaceutisk sammensætning ifølge krav 1, der omfatter: 0,1 % (w/v) azelastinhydrochlorid; 0,01 % til 0,1 % (w/v) steroid udvalgt fra gruppen, der omfatter fluticason, mometason, dexamethason-beloxil, loteprednol, budesonid og triamcinolon; og 0,1 % (w/v) sucralose.
10. Farmaceutisk sammensætning ifølge krav 1, der omfatter: 0,1 % (w/v) azelastinhydrochlorid; 0,01 % til 0,1 % (w/v) steroid udvalgt fra gruppen, der omfatter fluticason, mometason, dexamethason-beloxil, loteprednol, budesonid og triamcinolon; og 0,15 % (w/v) sucralose.
11. Farmaceutisk sammensætning ifølge krav 1, der omfatter: 0,15 % (w/v) azelastinhydrochlorid; 0,01 % til 0,1 % (w/v) steroid udvalgt fra gruppen, der omfatter fluticason, mometason, dexamethason-beloxil, loteprednol, budesonid og triamcinolon; og 0,15 % (w/v) sucralose.
12. Farmaceutisk sammensætning ifølge krav 5, der omfatter: 0,05 % til 0,15 % (w/v) azelastinhydrochlorid; 0,01 % til 0,1 % (w/v) steroid udvalgt fra gruppen, der omfatter fluticason, mometason, dexamethason-beloxil, loteprednol, budesonid og triamcinolon; 0,1 % til 1,0 % (w/v) middel mod kongestion udvalgt fra gruppen, der omfatter pseudoephedrin og phenylephrin; og 0,1 % til 0,15 % (w/v) sucralose.
13. Farmaceutisk sammensætning ifølge krav 5, der omfatter: 0,1 % (w/v) azelastinhydrochlorid; 0,01 % til 0,1 % (w/v) steroid udvalgt fra gruppen, der omfatter fluticason, mometason, dexamethason-beloxil, loteprednol, budesonid og triamcinolon; 0,1 % til 1,0 % (w/v) middel mod kongestion udvalgt fra gruppen, der omfatter pseudoephedrin og phenylephrin; og 0,1 % (w/v) sucralose.
14. Farmaceutisk sammensætning ifølge krav 5, der omfatter: 0,1 % (w/v) eller 0,15 % (w/v) azelastinhydrochlorid; 0,01 % til 0,1 % (w/v) steroid udvalgt fra gruppen, der omfatter fluticason, mometason, dexamethason-beloxil, loteprednol, budesonid og triamcinolon; 0,1 % til 1,0 % (w/v) middel mod kongestion udvalgt fra gruppen, der omfatter pseudoephedrin og phenylephrin; og 0,15 % (w/v) sucralose.
15. Farmaceutisk sammensætning ifølge krav 1, der omfatter: 0,05 % til 0,15 % (w/v) azelastinhydrochlorid; 0,01 % til 0,1 % (w/v) steroid udvalgt fra gruppen, der omfatter fluticason, mometason, dexamethason-beloxil, loteprednol, budesonid og triamcinolon; 0,001 % til 5,00 % (w/v) af en vandopløselig polymer; 0,01 % til 0,1 % (w/v) dinatriumedetat; 0,001 % til 0,5 % (w/v) benzalkoniumchlorid; 0,1 % til 0,15 % sucralose; en tilstrækkelig mængde af en farmaceutisk acceptabel buffer til at opretholde sammensætningens pH-værdi inden for et område mellem 4,5 og 7,4; en tilstrækkelig mængde af et isotonicitetsmiddel til at give en osmolalitet på 220 mosmol/kg til 350 mosmol/kg; og QS-vand.
16. Farmaceutisk sammensætning ifølge krav 5, der omfatter: 0,05 % til 0,15 % (w/v) azelastinhydrochlorid; 0,01 % til 0,1 % (w/v) steroid udvalgt fra gruppen, der omfatter fluticason, mometason, dexamethason-beloxil, loteprednol, budesonid og triamcinolon; 0,1 % til 1 % (w/v) middel mod kongestion udvalgt fra gruppen, der omfatter pseudoephedrin og phenylephrin; 0,001 % til 5,00 % (w/v) af en vandopløselig polymer; 0,01 % til 0,1 % (w/v) dinatriumedetat; 0,001 % til 0,5 % (w/v) benzalkoniumchlorid; 0,1 % til 0,15 % sucralose; en tilstrækkelig mængde af en farmaceutisk acceptabel buffer til at opretholde sammensætningens pH-værdi inden for et område mellem 4,5 og 7,4; en tilstrækkelig mængde af et isotonicitetsmiddel til at give en osmolalitet på 220 mosmol/kg til 350 mosmol/kg; og QS-vand.
17. Farmaceutisk sammensætning ifølge ethvert af kravene 1-16 til brug i en metode til behandling eller forebyggelse af allergisk rhinitis, ikke-allergisk vasomotor-rhinitis eller allergisk conjunctivitis hos et pattedyr, som lider deraf eller er disponeret derfor, hvor metoden omfatter indgift af en effektiv mængde af sammensætningen.
18. Farmaceutisk sammensætning ifølge krav 17, hvor pattedyret er et menneske.
19. Farmaceutisk sammensætning ifølge krav 5, hvor det ene eller de flere midler mod kongestion er udvalgt fra gruppen, der omfatter pseudoephedrin, pheny- lephedrin, phenylephrin, phenylpropanolamin, oxymetazolin, propylhexedrin, xy-lometazolin, epinephrin, ephedrin, desoxyephedrin, naphazolin og tetrahy-drozolin.
20. Farmaceutisk sammensætning ifølge ethvert af de foregående krav, hvor den intranasale formulering er i form af næsespray eller -dråber.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US63027404P | 2004-11-24 | 2004-11-24 | |
EP05824835A EP1827499A4 (en) | 2004-11-24 | 2005-11-22 | COMPOSITIONS COMPRISING AZELASTIN AND METHODS OF USE |
Publications (1)
Publication Number | Publication Date |
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DK2377557T3 true DK2377557T3 (da) | 2017-02-06 |
Family
ID=36498307
Family Applications (3)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DK12167578.9T DK2486942T3 (da) | 2004-11-24 | 2005-11-22 | Sammensætninger, der omfatter azelastin og fremgangsmåder til anvendelse deraf |
DK11173623.7T DK2377557T3 (da) | 2004-11-24 | 2005-11-22 | Sammensætninger, der omfatter azelastin, og metoder til brug deraf |
DK12167579.7T DK2522365T3 (da) | 2004-11-24 | 2005-11-22 | Sammensætninger, der omfatter azelastin, og metoder til brug deraf |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DK12167578.9T DK2486942T3 (da) | 2004-11-24 | 2005-11-22 | Sammensætninger, der omfatter azelastin og fremgangsmåder til anvendelse deraf |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DK12167579.7T DK2522365T3 (da) | 2004-11-24 | 2005-11-22 | Sammensætninger, der omfatter azelastin, og metoder til brug deraf |
Country Status (25)
Country | Link |
---|---|
US (3) | US8071073B2 (da) |
EP (4) | EP2522365B1 (da) |
JP (2) | JP5607291B2 (da) |
KR (3) | KR20070104884A (da) |
CN (1) | CN101098714B (da) |
AU (2) | AU2005309657B2 (da) |
BR (1) | BRPI0517891A (da) |
CA (1) | CA2588338C (da) |
CY (1) | CY1121330T1 (da) |
DK (3) | DK2486942T3 (da) |
ES (3) | ES2617253T3 (da) |
HK (1) | HK1113310A1 (da) |
HR (1) | HRP20182133T1 (da) |
HU (2) | HUE030388T2 (da) |
IL (2) | IL183372A (da) |
LT (3) | LT2486942T (da) |
MX (2) | MX344036B (da) |
NZ (1) | NZ555501A (da) |
PL (3) | PL2486942T3 (da) |
PT (3) | PT2486942T (da) |
RS (1) | RS58377B1 (da) |
SI (3) | SI2522365T1 (da) |
TR (1) | TR201820559T4 (da) |
WO (1) | WO2006058022A1 (da) |
ZA (1) | ZA200704902B (da) |
Families Citing this family (95)
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ES2493641T3 (es) * | 2007-06-28 | 2014-09-12 | Cydex Pharmaceuticals, Inc. | Administración nasal de soluciones acuosas de corticosteroides |
KR100910848B1 (ko) | 2007-09-13 | 2009-08-06 | 재단법인서울대학교산학협력재단 | 알러지성 비염 치료약물을 유효성분으로 함유하는 비강분무용 마이크로스피어 및 이의 제조방법 |
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