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CN1253508A - Topical nasal anti-inflammatory composition - Google Patents

Topical nasal anti-inflammatory composition Download PDF

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Publication number
CN1253508A
CN1253508A CN98804579A CN98804579A CN1253508A CN 1253508 A CN1253508 A CN 1253508A CN 98804579 A CN98804579 A CN 98804579A CN 98804579 A CN98804579 A CN 98804579A CN 1253508 A CN1253508 A CN 1253508A
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Prior art keywords
composition
group
agent
nasal
effective amount
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Pending
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CN98804579A
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Chinese (zh)
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C·A·斯加尔
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Warner Lambert Co LLC
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Warner Lambert Co LLC
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Publication of CN1253508A publication Critical patent/CN1253508A/en
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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
    • A61K31/56—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
    • A61K31/58—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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/16—Otologicals

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

The present invention provides topically administrable nasal compositions comprising a therapeutically effective amount of an anti-inflammatory agent and a therapeutically effective amount of at least one agent selected from the group consisting of vasoconstrictors, neuraminidase inhibitors, anticholinergics, leukotriene inhibitors, antihistamines, anti-allergic agents, anesthetics, and mucolytics. The composition can be used as nasal spray and nasal drops for treating nasal and sinus conditions.

Description

Topical nasal antiinflammatory compositions
Background of invention
In the treatment field of nasal mucosa inflammation, particularly at nose and sinus part disease, alleviate as symptoms of rhinitis, the topical nasal antiinflammatory preparation is known.But, nose and sinus part disease can be to be feature with changeable symptom, need treat with the combination therapy agent.For example, allergic rhinitis can be to be feature with rhinorrhea, rhinocnesmus, sneeze, hyperemia and postnasal drip, therefore except antiinflammatory, also can need hydryllin, Decongestant, antiabnormal reaction agent and narcotic treatment.
Use multiple local nasal formulations to give multiple therapeutic agent and have distinct disadvantage.The liquid volume of nose medication is subjected to the restriction of the bioadhesive of nostril surface area and liquid effectively.In addition, need fully contacting between topical formulations and the nostril surface area, to guarantee enough therapeutic agent dosages.And spray needs the threshold surface tension to form droplet.Therefore, the release volume of each operation only limits to be retained in the nostril not by too early effusive volume.So multiple local nasal formulations administration simultaneously effectively.
Another shortcoming of multiple local nasal formulations administration is to make the patient feel inconvenience.The inconvenience in medication of multiple spray product or nasal drop can make patient's compliance have a greatly reduced quality.Patient's complaint, excessive spray flows into their throat, and can discover taste, thereby needs correctives to cover the bitterness medicine.
Therefore, exist needs to the convenient manner that is used for multiple therapeutic agent nose administration.
Summary of the invention
But the invention provides the nasal composition of local application, it comprises local anti-inflammatory agent for the treatment of effective dose and at least a medicament that is applicable to local nose administration for the treatment of effective dose, and it is selected from the group of being made up of vasoconstrictor, neuraminidase inhibitor, anticholinergic, leukotriene inhibitors, hydryllin, antiabnormal reaction agent, anesthetis and mucolytic agent.
Detailed description of the invention
But the invention provides the nasal composition of local application, it comprises local anti-inflammatory agent and at least a other therapeutic agent.Said composition can be used for treating nose and sinus part disease, for example allergic rhinitis or flu.
Local anti-inflammatory agent in the present composition is the corticosteroid of inflammation-inhibiting known in the art.A kind of preferred embodiment in, the local anti-inflammatory agent is beclomethasone dipropionate, budesonide, dexamethasone, mometasone furoate, Fluticasone Propionate or triamcinolone acetonide.Compositions contains the antiinflammatory of the selection for the treatment of effective dose.Those of ordinary skill in the art can determine to treat the amount of effective inflammation-inhibiting.Accurate amount will depend on medication and curee's age, body weight and situation.Usually, the consumption of antiinflammatory is known in the art, is effective on the therapeutics when nose administration.
The present composition further comprises at least a other therapeutic agent, thereby makes antiinflammatory and the administration expediently in single local nasal composition of at least a other therapeutic agent.Other therapeutic agent is applicable to local nose administration, is selected from the group of being made up of vasoconstrictor, neuraminidase inhibitor, leukotriene inhibitors, anticholinergic, hydryllin, antiabnormal reaction agent, local anesthetic and mucolytic agent.Other therapeutic agent provides adduction and synergism with being used in combination of antiinflammatory in the treatment of nose and sinus part disease.
The vasoconstrictor that is applicable to local nose administration in the present composition is oxymetazoline, naphazoline, xylometazoline and phenylephrine.Leukotriene inhibitors comprises Zha Fulunsite (zafirlukast), and it is the selectivity of three kinds of leukotriene Cs, D4 and E4, competitive receptor antagonist; Pu Lunsite, it is the selectivity of D4, competitive receptor antagonist; And Zileuton, it is a leukotriene inhibitors.Neuraminidase inhibitor comprises Zha Namiwa (zanamivir) (GG-167).The hydryllin that is suitable for comprises that diphenhydramine, chlorphenamine, cetirizine, terfenadine, Fei Nuofending (fenofexadine), astemizole, norastemizole, nitrogen Si fourth and A Zha are for fourth (azatidine).Antiabnormal reaction agent comprises sodium cromoglicate, Nedocromil and Levocabastine.The anticholinergic that can be used for the present composition is an atrovent.Local anesthetic comprises dyclonine, pramocaine and benzocaine.The mucolytic agent that is applicable to local nose administration is acetylcysteine, guaifenesin and carbocisteine (mucocysteine).According to the known application of these medicaments, and consideration medication and curee's age, body weight and situation, the above-mentioned medicament of treatment effective dose can be determined by those of ordinary skill.
The present composition is mixed with aqueous solution, wherein comprises antiinflammatory and at least a other therapeutic agent, further comprise pharmaceutically acceptable nose carrier.Drug combination preparation is normally known in the art, and reference standard textbook easily, " Remington pharmaceutical science " 1985 the 17th editions for example, Mack Publishing Co., Easton, Pennsylvania.
Preferred nasal formulations is nasal drop or nasal spray, contains the buffered aqueous solution of water as carrier.Compositions is preferably isoosmotic.Isotonic agent is known in the art, and for example saccharide and sodium chloride can be included in the said composition.
The present composition also can contain wetting agent, is used for increasing viscosity, moisturizes and the cilium vigor.The wetting agent that is suitable for comprises glycerol, Polyethylene Glycol, propylene glycol and composition thereof.
Additive is known in the art, comprises pharmaceutically acceptable antiseptic, stabilizing agent, correctives and pH regulator agent, also can be included in the present composition.
Another embodiment of the invention provides the compositions of preservative free, comprises antiinflammatory and at least a other therapeutic agent.Owing to reduced sensitivity, improved patient's acceptance, the compositions of preservative free is preferred.They can be made into unit dose or system, have prevented the pollution of solution in storage.
The present composition can be easily with dosage unit form to people's nose administration, to reach the therapeutical effect of required above-mentioned antiinflammatory and other therapeutic agent.Compositions can be with the dosage form administration of nasal spray or nasal drop.Nasal spray can provide in the mode of manual nose atomizing pump of squeeze bottle or metering administration, for example it is designed to discharge required dosage by spraying once or twice.Compositions also can for example be measured the pressure aerosol of administration with the mode administration of aerosol spray, wherein contains propellant, as halogenated hydrocarbon.

Claims (16)

1.可局部用药的鼻用组合物，其包含治疗有效量的局部抗炎剂和治疗有效量的至少一种适用于局部经鼻给药的药剂，它选自由血管收缩剂、神经氨酸酶抑制剂、抗胆碱能剂、白三烯抑制剂、抗组胺剂、抗变态反应剂、麻醉剂和粘液溶解剂组成的组。1. A topically administrable nasal composition comprising a therapeutically effective amount of a topical anti-inflammatory agent and a therapeutically effective amount of at least one agent suitable for topical nasal administration selected from the group consisting of vasoconstrictors, neuraminidases The group consisting of inhibitors, anticholinergics, leukotriene inhibitors, antihistamines, antiallergics, anesthetics and mucolytics. 2.权利要求1的组合物，其中所述的局部抗炎剂选自由倍氯米松二丙酸酯、布地奈德、地塞米松、糠酸莫米他松、丙酸氟地松和曲安奈德组成的组。2. The composition of claim 1, wherein said topical anti-inflammatory agent is selected from the group consisting of beclomethasone dipropionate, budesonide, dexamethasone, mometasone furoate, fludexasone propionate, and triamcinolone German group. 3.权利要求1的组合物，其中所述的血管收缩剂选自由羟甲唑啉、萘唑啉、赛洛唑啉和苯福林组成的组。3. The composition of claim 1, wherein said vasoconstrictor is selected from the group consisting of oxymetazoline, naphazoline, xylometazoline and phenylephrine. 4.权利要求1的组合物，其中所述的抗组胺剂选自由苯海拉明、氯苯那敏、特非那定、氮斯丁、去甲阿司咪唑、非诺芬丁(fexofenadine)、西替利嗪、阿司咪唑和阿扎替丁组成的组。4. The composition of claim 1, wherein said antihistamine is selected from the group consisting of diphenhydramine, chlorpheniramine, terfenadine, azepine, norastemizole, fenofentine ( fexofenadine), cetirizine, astemizole and azatidine. 5.权利要求1的组合物，其中所述的抗变态反应剂选自由色甘酸钠、左卡巴司汀和萘多罗米组成的组。5. The composition of claim 1, wherein said antiallergic agent is selected from the group consisting of cromolyn sodium, levocabastine and nedocromil. 6.权利要求1的组合物，其中所述的抗胆碱能剂为异丙阿托品。6. The composition of claim 1, wherein said anticholinergic agent is ipratropium. 7.权利要求1的组合物，其中所述的局部麻醉剂选自由达克罗宁、普莫卡因和苯佐卡因组成的组。7. The composition of claim 1, wherein said local anesthetic is selected from the group consisting of dyclonine, pramoxine, and benzocaine. 8.权利要求1的组合物，其中所述的粘液溶解剂选自由乙酰半胱氨酸、愈创甘油醚和羧甲半胱氨酸组成的组。8. The composition of claim 1, wherein said mucolytic agent is selected from the group consisting of acetylcysteine, guaifenesin, and carboxymethylcysteine. 9.权利要求1的组合物，其中所述的白三烯抑制剂选自由扎弗仑斯特、普仑斯特和弃白通组成的组。9. The composition of claim 1, wherein said leukotriene inhibitor is selected from the group consisting of zafrenast, prenmilk and zileuton. 10.权利要求1的组合物，其中所述的神经氨酸酶抑制剂为扎那米瓦。10. The composition of claim 1, wherein said neuraminidase inhibitor is zanamivar. 11.可局部用药的鼻用组合物，其包含治疗有效量的局部抗炎剂，选自由倍氯米松二丙酸酯、布地奈德、地塞米松、糠酸莫米他松、丙酸氟地松和曲安奈德组成的组，还包含治疗有效量的至少一种药剂，它选自由羟甲唑啉、苯福林、苯海拉明、氯苯那敏、特非那定、阿司咪唑、阿扎替丁、色甘酸钠、萘多罗米、溴化异丙阿托品、达克罗宁、苯佐卡因、乙酰半胱氨酸、愈创甘油醚和羧甲半胱氨酸组成的组。11. A topically administrable nasal composition comprising a therapeutically effective amount of a topical anti-inflammatory agent selected from the group consisting of beclomethasone dipropionate, budesonide, dexamethasone, mometasone furoate, fluoropropionate The group consisting of dipine and triamcinolone acetonide, further comprising a therapeutically effective amount of at least one agent selected from the group consisting of oxymetazoline, phenylephrine, diphenhydramine, chlorpheniramine, terfenadine, aspirin Composition of imidazole, azatidine, cromolyn sodium, nedocromil, ipratropium bromide, dyclonine, benzocaine, acetylcysteine, guaifenesin and carboxymethylcysteine group. 12.权利要求1或11的组合物，进一步包含至少一种湿润剂。12. The composition of claim 1 or 11, further comprising at least one humectant. 13.权利要求12的组合物，其中所述的湿润剂选自由甘油、聚乙二醇和丙二醇组成的组。13. The composition of claim 12, wherein said humectant is selected from the group consisting of glycerin, polyethylene glycol and propylene glycol. 14.权利要求1或11的组合物，包含药学上可接受的载体。14. The composition of claim 1 or 11, comprising a pharmaceutically acceptable carrier. 15.权利要求1或11的组合物，配制成鼻用喷雾剂用药。15. The composition of claim 1 or 11 formulated for administration as a nasal spray. 16.权利要求1或11的组合物，配制成滴鼻剂用药。16. The composition according to claim 1 or 11, formulated as nasal drops for administration.
CN98804579A 1997-04-30 1998-04-02 Topical nasal anti-inflammatory composition Pending CN1253508A (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US4430697P 1997-04-30 1997-04-30
US60/044,306 1997-04-30

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AU (1) AU6878098A (en)
BR (1) BR9809022A (en)
CA (1) CA2281789A1 (en)
IL (1) IL131492A0 (en)
WO (1) WO1998048839A1 (en)

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CN101128196B (en) * 2005-03-16 2013-01-02 Meda制药有限及两合公司 Combination of anticholinergics and leukotriene receptor antagonists for the treatment of respiratory diseases
CN104667256A (en) * 2015-03-18 2015-06-03 江苏威克斯医疗科技有限公司 Nasal cavity mucosa cilium nursing flushing fluid and application thereof
CN107753485A (en) * 2017-11-28 2018-03-06 赵永宏 A kind of pharmaceutical composition for having nose congestion and anesthetic effect concurrently and its application

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CN101128196B (en) * 2005-03-16 2013-01-02 Meda制药有限及两合公司 Combination of anticholinergics and leukotriene receptor antagonists for the treatment of respiratory diseases
CN104667256A (en) * 2015-03-18 2015-06-03 江苏威克斯医疗科技有限公司 Nasal cavity mucosa cilium nursing flushing fluid and application thereof
CN107753485A (en) * 2017-11-28 2018-03-06 赵永宏 A kind of pharmaceutical composition for having nose congestion and anesthetic effect concurrently and its application

Also Published As

Publication number Publication date
CA2281789A1 (en) 1998-11-05
BR9809022A (en) 2000-08-01
WO1998048839A1 (en) 1998-11-05
IL131492A0 (en) 2001-01-28
EP0979105A1 (en) 2000-02-16
AU6878098A (en) 1998-11-24
JP2001524108A (en) 2001-11-27

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