US20070185082A1 - Treating rhinitis by topically administering an epinastine solution to the nasal mucous membrane - Google Patents
Treating rhinitis by topically administering an epinastine solution to the nasal mucous membrane Download PDFInfo
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- US20070185082A1 US20070185082A1 US11/734,512 US73451207A US2007185082A1 US 20070185082 A1 US20070185082 A1 US 20070185082A1 US 73451207 A US73451207 A US 73451207A US 2007185082 A1 US2007185082 A1 US 2007185082A1
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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
- 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
- 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
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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
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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
- A61P11/02—Nasal agents, e.g. decongestants
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- 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
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- 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
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- 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
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- 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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- 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
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- 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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- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F01—MACHINES OR ENGINES IN GENERAL; ENGINE PLANTS IN GENERAL; STEAM ENGINES
- F01L—CYCLICALLY OPERATING VALVES FOR MACHINES OR ENGINES
- F01L9/00—Valve-gear or valve arrangements actuated non-mechanically
- F01L9/20—Valve-gear or valve arrangements actuated non-mechanically by electric means
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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
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T137/00—Fluid handling
- Y10T137/0318—Processes
Definitions
- the invention relates to topically administered aqueous solutions containing epinastine, optionally in the form of its racemates, its enantiomers, and optionally in the form of the pharmacologically acceptable acid addition salts thereof.
- Allergic reactions of the eye signifies a series of differently defined syndromes.
- Examples of allergic reactions of the nose include seasonal allergic rhinitis and perennial allergic rhinitis, for example.
- the immunological mechanism on which ocular and nasal allergic reactions are based comprises, inter alia, inflammatory processes caused by histamine.
- the allergic reactions produced by the release of histamine occur at an early stage of the ocular and nasal allergic reactions mentioned above.
- ocular and nasal allergic reactions may be due to the release of other mast cell mediators as well as toxic eosinophilic granule proteins and enzymes.
- the influx of neutrophils and eosinophils into the tissue of the ocular conjunctiva and the nasal mucous membrane leads to a late phase reaction, hereinafter referred to as LPR.
- LPR normally occurs within a period of 3-6 hours after the initial histamine-mediated allergic reaction.
- LPR is also characterized by the occurrence of vasodilation and chemosis and by the swelling of the conjunctiva and the nasal mucous membrane.
- histamine-produced allergic reactions can be counteracted by administering antihistamines
- the influx of neutrophils and eosinophils into the tissue of the ocular conjunctiva and the nasal mucous membrane remains unaffected by administering pure antihistamines.
- the problem of the present invention is therefore to provide topically administrable solutions which inhibit the influx of neutrophils and eosinophils into the tissue of the ocular conjunctiva and the nasal mucous membrane, thereby reducing or preventing the occurrence of LPR and are therefore characterized by a longer lasting duration of activity.
- topically administrable aqueous solutions containing epinastine may be used to solve the problem on which the invention is based, since they inhibit the influx of neutrophils and eosinophils into the tissue of the ocular conjunctiva and nasal mucous membrane, thereby reducing or preventing the occurrence of LPR and are accordingly characterized by a longer lasting duration of activity.
- the animals pretreated with epinastine solution according to the invention (0.05-0.5%) had a significantly lower content of eosinophils in their conjunctiva.
- the animals pretreated with epinastine solution according to the invention had a significantly lower content of lymphocytes in their conjunctiva (p ⁇ 0.01).
- a roughly 35% inhibition of mast cell degranulation was determined (p ⁇ 0.01).
- the invention relates to topically administered aqueous solutions containing epinastine, optionally in the form of its racemate, its enantiomers and optionally in the form of the pharmacologically acceptable addition salts thereof, in a concentration of 0.005 to 0.5, preferably 0.02 to 0.1, most preferably 0.03 to 0.07 mg/ml of solution.
- topically administered aqueous solutions containing epinastine hydrochloride are preferred according to the invention.
- Suitable aqueous solvents are physiologically acceptable aqueous solvents, physiologically acceptable saline solutions being particularly preferred.
- topically administered solutions are preferably prepared which typically contain 0.005 to 0.5, preferably 0.02 to 0.1, most preferably 0.03 to 0.07 mg/ml of epinastine, optionally in the form of its racemate, its enantiomers and optionally in the form of the pharmacologically acceptable acid addition salts thereof, as well as physiological saline solutions as the main carriers.
- the pH of the solutions according to the invention should preferably be maintained within the range from 6.5 to 7.2 by means of a suitable buffer system.
- the preparations may also contain conventional, pharmaceutically acceptable excipients, preservatives, stabilizers, and/or penetration promoters.
- the preferred carrier which may be used in the solutions according to the invention is purified water and preferably a physiological saline solution.
- the excipients which may be used according to the invention include viscosity agents such as polyvinyl alcohol, povidone, hydroxypropylmethylcellulose, poloxamers, carboxymethylcellulose, carbomers, and hydroxyethylcellulose.
- the preferred preservatives which may be used in the solutions according to the invention include benzalkonium chloride, chlorobutanol, thimerosal, phenyl mercury acetate, and phenyl mercury nitrate.
- the penetration promoters may be, for example, surfactants, specific organic solvents such as dimethylsulfoxide and other sulfoxides, dimethylacetamide and pyrrolidone, specific amides of heterocyclic amines, glycols such as propylene glycol, propylene carbonate, oleic acid, alkylamines and derivatives thereof, various cationic, anionic, non-ionogenic, and amphoteric surfactants and the like.
- specific organic solvents such as dimethylsulfoxide and other sulfoxides, dimethylacetamide and pyrrolidone
- specific amides of heterocyclic amines such as propylene glycol, propylene carbonate, oleic acid, alkylamines and derivatives thereof
- various cationic, anionic, non-ionogenic, and amphoteric surfactants and the like may be, for example, surfactants, specific organic solvents such as dimethylsulfoxide and other sulfoxides, dimethyl
- Substances may be added as necessary or as desired in order to adjust the tonicity of the solution.
- Such substances include salts and especially sodium chloride, potassium chloride, mannitol, and glycerol or other suitable physiologically acceptable agents for adjusting tonicity, without restricting the invention to the above.
- buffers and substances may be used to adjust the pH, provided that the preparation obtained is physiologically acceptable.
- These buffers might include acetate buffer, citrate buffer, phosphate buffer and borate buffer.
- physiologically acceptable antioxidants which may be used according to the invention include sodium metabisulphite, sodium thiosulphate, acetylcysteine, butylated hydroxyanisole, and butylated hydroxytoluene, without restricting the invention to this list.
- carrier components which may be incorporated in the solutions according to the invention are chelating agents.
- the preferred chelating agent is disodium edetate (Na-EDTA), although other chelating agents may also be used instead of or in conjunction with disodium edetate.
- topically administered aqueous solutions according to the invention may be applied either to the conjunctiva or to the nasal mucous membrane. Solutions for ophthalmic use are of equal importance to solutions for nasal application for the purposes of the present invention.
- the invention relates not only to the solutions according to the invention mentioned hereinbefore but also to the use of the abovementioned topically administered aqueous solutions for inhibiting the influx of neutrophils and eosinophils into the tissue of the ocular conjunctiva or the tissue of the nasal mucous membrane.
- the present invention also relates to the use of epinastine, optionally in the form of its racemate, its enantiomers and optionally in the form of the pharmacologically acceptable acid addition salts thereof, for producing the topically administered aqueous solutions according to the invention for treating disorders of the ocular conjunctiva or the nasal mucous membranes in which there is therapeutic value in inhibiting the influx of neutrophils and eosinophils into the tissue of the ocular conjunctiva or the nasal mucous membrane in allergic reactions.
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Abstract
A method for treating allergic rhinitis, comprising topically administering to the nasal mucus membrane of a host in need of such treatment a solution comprising: epinastine, optionally in the form of its racemate, its enantiomers, or its pharmacologically acceptable acid addition salts, in a pharmacologically acceptable carrier.
Description
- This application is a continuation of U.S. Ser. No. 10/271,180, filed Oct. 15, 2002, which is a continuation of U.S. Ser. No. 09/706,650, filed Nov. 6, 2000, now abandoned, which claims priority to German Application No. 199 54 516.2, filed Nov. 12, 1999, and claims benefit of U.S. Provisional Application Ser. No. 60/167,771, filed on Nov. 29, 1999, each of which is hereby incorporated by reference.
- The invention relates to topically administered aqueous solutions containing epinastine, optionally in the form of its racemates, its enantiomers, and optionally in the form of the pharmacologically acceptable acid addition salts thereof.
- Allergic reactions of the eye (hereinafter referred to as ocular allergic reactions) signifies a series of differently defined syndromes. The following are examples of ocular allergic reactions, e.g., seasonal allergic conjunctivitis, perennial allergic conjunctivitis, giant cell conjunctivitis, vernal keratoconjunctivitis, or atopic keratoconjunctivitis. Examples of allergic reactions of the nose (hereinafter referred to as nasal allergic reactions) include seasonal allergic rhinitis and perennial allergic rhinitis, for example.
- The immunological mechanism on which ocular and nasal allergic reactions are based comprises, inter alia, inflammatory processes caused by histamine. The allergic reactions produced by the release of histamine occur at an early stage of the ocular and nasal allergic reactions mentioned above. Moreover, ocular and nasal allergic reactions may be due to the release of other mast cell mediators as well as toxic eosinophilic granule proteins and enzymes. The influx of neutrophils and eosinophils into the tissue of the ocular conjunctiva and the nasal mucous membrane leads to a late phase reaction, hereinafter referred to as LPR. LPR normally occurs within a period of 3-6 hours after the initial histamine-mediated allergic reaction. LPR is also characterized by the occurrence of vasodilation and chemosis and by the swelling of the conjunctiva and the nasal mucous membrane.
- Whereas histamine-produced allergic reactions can be counteracted by administering antihistamines, the influx of neutrophils and eosinophils into the tissue of the ocular conjunctiva and the nasal mucous membrane remains unaffected by administering pure antihistamines.
- The problem of the present invention is therefore to provide topically administrable solutions which inhibit the influx of neutrophils and eosinophils into the tissue of the ocular conjunctiva and the nasal mucous membrane, thereby reducing or preventing the occurrence of LPR and are therefore characterized by a longer lasting duration of activity.
- It has been found, surprisingly, that topically administrable aqueous solutions containing epinastine, optionally in the form of its racemate, its enantiomers and possibly in the form of the pharmacologically acceptable acid addition salts thereof, may be used to solve the problem on which the invention is based, since they inhibit the influx of neutrophils and eosinophils into the tissue of the ocular conjunctiva and nasal mucous membrane, thereby reducing or preventing the occurrence of LPR and are accordingly characterized by a longer lasting duration of activity.
- The compound epinastine (3-amino-9,13b-dihydro-1H-dibenz-[c,f]imidazol[1,5-a]azepine) and the acid addition salts thereof were described for the first time in German Patent Application P 30 08 944.2.
- The effect of the topically administered solutions containing epinastine as inhibitors of the influx of eosinophils and neutrophils was demonstrated using the so-called passive ocular anaphylaxis model in rats.
- 72 hours after the rats have been sensitized by injecting antiserum into the eyelids of the test animals, a fresh provocation was induced in them by intravenous administration of ovalbumin. Some of the experimental animals were pretreated by the administration of solution containing epinastine according to the invention into the conjunctival sac 15 minutes before the ovalbumin is administered. Two hours after the administration of ovalbumin the experimental animals were killed and the conjunctiva was investigated for its content of eosinophils and neutrophils and the mast cell granulation was determined.
- Results
- The animals pretreated with epinastine solution according to the invention (0.05-0.5%) had a significantly lower content of eosinophils in their conjunctiva. The animals pretreated with epinastine solution according to the invention had a significantly lower content of lymphocytes in their conjunctiva (p<0.01). In the animals pretreated with epinastine solution according to the invention, a roughly 35% inhibition of mast cell degranulation was determined (p<0.01).
- Consequently, the invention relates to topically administered aqueous solutions containing epinastine, optionally in the form of its racemate, its enantiomers and optionally in the form of the pharmacologically acceptable addition salts thereof, in a concentration of 0.005 to 0.5, preferably 0.02 to 0.1, most preferably 0.03 to 0.07 mg/ml of solution.
- The abovementioned topically administered aqueous solutions containing epinastine hydrochloride are preferred according to the invention.
- Suitable aqueous solvents are physiologically acceptable aqueous solvents, physiologically acceptable saline solutions being particularly preferred.
- According to the invention, topically administered solutions are preferably prepared which typically contain 0.005 to 0.5, preferably 0.02 to 0.1, most preferably 0.03 to 0.07 mg/ml of epinastine, optionally in the form of its racemate, its enantiomers and optionally in the form of the pharmacologically acceptable acid addition salts thereof, as well as physiological saline solutions as the main carriers. The pH of the solutions according to the invention should preferably be maintained within the range from 6.5 to 7.2 by means of a suitable buffer system. The preparations may also contain conventional, pharmaceutically acceptable excipients, preservatives, stabilizers, and/or penetration promoters.
- The preferred carrier which may be used in the solutions according to the invention is purified water and preferably a physiological saline solution.
- Without restricting the subject matter of the invention to the following, the excipients which may be used according to the invention include viscosity agents such as polyvinyl alcohol, povidone, hydroxypropylmethylcellulose, poloxamers, carboxymethylcellulose, carbomers, and hydroxyethylcellulose.
- Without restricting the subject matter of the invention to the following, the preferred preservatives which may be used in the solutions according to the invention include benzalkonium chloride, chlorobutanol, thimerosal, phenyl mercury acetate, and phenyl mercury nitrate.
- The penetration promoters may be, for example, surfactants, specific organic solvents such as dimethylsulfoxide and other sulfoxides, dimethylacetamide and pyrrolidone, specific amides of heterocyclic amines, glycols such as propylene glycol, propylene carbonate, oleic acid, alkylamines and derivatives thereof, various cationic, anionic, non-ionogenic, and amphoteric surfactants and the like.
- Substances may be added as necessary or as desired in order to adjust the tonicity of the solution. Such substances include salts and especially sodium chloride, potassium chloride, mannitol, and glycerol or other suitable physiologically acceptable agents for adjusting tonicity, without restricting the invention to the above.
- Various buffers and substances may be used to adjust the pH, provided that the preparation obtained is physiologically acceptable. These buffers might include acetate buffer, citrate buffer, phosphate buffer and borate buffer.
- Similarly, physiologically acceptable antioxidants which may be used according to the invention include sodium metabisulphite, sodium thiosulphate, acetylcysteine, butylated hydroxyanisole, and butylated hydroxytoluene, without restricting the invention to this list.
- Other carrier components which may be incorporated in the solutions according to the invention are chelating agents. The preferred chelating agent is disodium edetate (Na-EDTA), although other chelating agents may also be used instead of or in conjunction with disodium edetate.
- The abovementioned topically administered aqueous solutions according to the invention may be applied either to the conjunctiva or to the nasal mucous membrane. Solutions for ophthalmic use are of equal importance to solutions for nasal application for the purposes of the present invention.
- The invention relates not only to the solutions according to the invention mentioned hereinbefore but also to the use of the abovementioned topically administered aqueous solutions for inhibiting the influx of neutrophils and eosinophils into the tissue of the ocular conjunctiva or the tissue of the nasal mucous membrane.
- The present invention also relates to the use of epinastine, optionally in the form of its racemate, its enantiomers and optionally in the form of the pharmacologically acceptable acid addition salts thereof, for producing the topically administered aqueous solutions according to the invention for treating disorders of the ocular conjunctiva or the nasal mucous membranes in which there is therapeutic value in inhibiting the influx of neutrophils and eosinophils into the tissue of the ocular conjunctiva or the nasal mucous membrane in allergic reactions.
- The abovementioned use for inhibiting LPR is preferred, whilst it is particularly preferable to use the preparation to treat the diseases listed at the beginning.
- The Examples shown in Table 1 illustrate the invention without restricting it.
TABLE 1 Solution 1 Solution 2 Solution 3 Solution 4 Solution 5 Solution 6 Solution 7 0.05% 0.01% 0.05% 0.10% 0.01% 0.05% 0.10% [g/100 ml] [g/100 ml] [g/100 ml] [g/100 ml] [g/100 ml] [g/100 ml] [g/100 ml] Epinastine hydrochloride 0.0500 0.0100 0.0500 0.1000 0.0100 0.0500 0.1000 Na-EDTA 0.0500 0.0500 0.0500 0.0500 — — — Sodium chloride 0.5000 0.5000 0.5000 0.5000 0.5000 0.5000 0.5000 Sodium dihydrogen phosphate 0.7800 0.7800 0.7800 0.7800 0.4100 0.4100 0.4100 dihydrate Benzalkonium chloride 0.0101 0.0101 0.0101 0.0101 0.0101 0.0101 0.0101 Sodium hydroxide 0.0001 0.0001 0.0001 0.0001 — — — Sodium dihydrogen phosphate — — — — 0.6500 0.6500 0.6500 dihydrate Hydroxyethylcellulose — — — — 0.1000 0.1000 0.1000 Water 99.4198 99.4598 99.4198 99.3698 99.0749 99.0349 99.9849 100.8100 100.8100 100.8100 100.8100 100.7550 100.7550 100.7550
Claims (28)
1-55. (canceled)
56. A method for treating allergic rhinitis comprising:
topically administering to the nasal mucous membrane of a host in need thereof, a solution comprising epinastine, optionally in the form of its racemate, an enantiomer thereof, or a pharmacologically acceptable acid addition salt thereof, in a pharmacologically acceptable carrier.
57. The method according to claim 56 , wherein the concentration of epinastine, optionally in the form of its racemate, an enantiomer thereof, or a pharmacologically acceptable acid addition salt thereof, in the solution is 0.005 to 0.5 mg/ml.
58. The method according to claim 56 , wherein the concentration of epinastine, optionally in the form of its racemate, an enantiomer thereof, or a pharmacologically acceptable acid addition salt thereof, in the solution is 0.02 to 0.1 mg/ml.
59. The method according to claim 56 , wherein the concentration of epinastine, optionally in the form of its racemate, an enantiomer thereof, or a pharmacologically acceptable acid addition salt thereof, in the solution is 0.03 to 0.07 mg/ml.
60. The method according to claim 56 , wherein the epinastine is epinastine hydrochloride.
61. The method according to claim 56 , wherein the solution further comprises a viscosity agent.
62. The method according to claim 56 , wherein the solution further comprises a penetration promoter.
63. The method according to claim 56 , wherein the solution further comprises a substance to adjust the tonicity of the solution selected from: sodium chloride, potassium chloride, mannitol, and glycerol.
64. The method according to claim 56 , wherein the solution further comprises a buffer selected from: acetate buffer, citrate buffer, phosphate buffer, and borate buffer.
65. The method according to claim 56 , wherein the solution further comprises an antioxidant selected from: sodium metabisulphite, sodium thiosulphate, acetylcysteine, butylated hydroxyanisole, and butylated hydroxytoluene.
66. The method according to claim 56 , wherein the solution further comprises the chelating agent disodium edetate.
67. The method according to claim 56 , wherein the solution comprises epinastine hydrochloride, water, sodium chloride, sodium hydrogen phosphate dihydrate, benzalkonium chloride, hydroxyethylcellulose, and optionally sodium EDTA and sodium hydroxide.
68. The method according to claim 56 , wherein the method is for treating late phase reactions of allergic rhinitis.
69. A method for treating allergic rhinitis by topically administering to the nasal mucous membrane of a host in need of such treatment a solution comprising:
(a) epinastine, optionally in the form of its racemate, an enantiomer thereof, or a pharmacologically acceptable acid addition salt thereof, in a concentration of 0.005 to 0.5 mg/ml of solution;
(b) water or physiologically acceptable saline; and
(c) a preservative,
wherein the pH is adjusted to between 6.5 and 7.2 by means of a physiologically acceptable buffer, and
optionally also including one or more chelating agents, viscosity agents, penetration promoters, antioxidants, or substances to adjust the tonicity of the solution.
70. The method according to claim 69 , wherein the concentration of epinastine, optionally in the form of its racemate, an enantiomer thereof, or a pharmacologically acceptable acid addition salt thereof, in the solution is 0.02 to 0.1 mg/ml.
71. The method according to claim 69 , wherein the concentration of epinastine, optionally in the form of its racemate, an enantiomer thereof, or a pharmacologically acceptable acid addition salt thereof, in the solution is 0.03 to 0.07 mg/ml.
72. The method according to claim 69 , wherein the solution comprises epinastine hydrochloride.
73. The method according to claim 69 , wherein the preservative is selected from: benzalkonium chloride, chlorobutanol, thimerosal, phenyl mercury acetate, and phenyl mercury nitrate.
74. The method according to claim 69 , wherein the solution comprises a viscosity agent selected from: polyvinyl alcohol, povidone, hydroxypropylmethylcellulose, poloxamers, carboxymethylcellulose, carbomers, and hydroxyethylcellulose.
75. The method according to claim 69 , wherein the solution comprises a penetration promoter selected from: cationic, anionic, non-ionogenic, and amphoteric surfactants; dimethylsulfoxide and other sulfoxides; dimethylacetamide and pyrrolidone; amides of heterocyclic amines; glycols; propylene carbonate; oleic acid; and alkylamines and derivatives thereof.
76. The method according to claim 69 , wherein the solution further comprises a substance to adjust the tonicity of the solution selected from: sodium chloride, potassium chloride, mannitol, and glycerol.
77. The method according to claim 69 , wherein the solution comprises a buffer selected from: acetate buffer, citrate buffer, phosphate buffer, and borate buffer.
78. The method according to claim 69 , wherein the solution comprises an antioxidant selected from: sodium metabisulphite, sodium thiosulphate, acetylcysteine, butylated hydroxyanisole, and butylated hydroxytoluene.
79. The method according to claim 69 , wherein the solution further comprises the chelating agent disodium edetate.
80. The method according to claim 69 , wherein the method is for treating late phase reactions of allergic rhinitis.
81. The method of claim 56 , further comprising identifying a host suffering from or at risk for allergic rhinitis and topically administering the solution to the nasal mucous membrane of such host.
82. The method of claim 69 , further comprising identifying a host suffering from or at risk for allergic rhinitis and topically administering the solution to the nasal mucous membrane of such host.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US11/734,512 US20070185082A1 (en) | 1999-11-12 | 2007-04-12 | Treating rhinitis by topically administering an epinastine solution to the nasal mucous membrane |
Applications Claiming Priority (6)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE19954516A DE19954516A1 (en) | 1999-11-12 | 1999-11-12 | Solutions containing epinastine |
DE19954516.2 | 1999-11-12 | ||
US16777199P | 1999-11-29 | 1999-11-29 | |
US70665000A | 2000-11-06 | 2000-11-06 | |
US10/271,180 US20030050303A1 (en) | 1999-11-12 | 2002-10-15 | Solutions containing epinastin |
US11/734,512 US20070185082A1 (en) | 1999-11-12 | 2007-04-12 | Treating rhinitis by topically administering an epinastine solution to the nasal mucous membrane |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US10/271,180 Continuation US20030050303A1 (en) | 1999-11-12 | 2002-10-15 | Solutions containing epinastin |
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US20070185082A1 true US20070185082A1 (en) | 2007-08-09 |
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Family Applications (6)
Application Number | Title | Priority Date | Filing Date |
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US10/271,180 Abandoned US20030050303A1 (en) | 1999-11-12 | 2002-10-15 | Solutions containing epinastin |
US11/215,165 Abandoned US20050288274A1 (en) | 1999-11-12 | 2005-08-30 | Treating rhinitis by topically administering an epinastine solution to the nasal mucous membrane |
US11/734,512 Abandoned US20070185082A1 (en) | 1999-11-12 | 2007-04-12 | Treating rhinitis by topically administering an epinastine solution to the nasal mucous membrane |
US11/734,507 Abandoned US20070197503A1 (en) | 1999-11-12 | 2007-04-12 | Solutions containing epinastin |
US11/863,008 Expired - Lifetime US7429602B2 (en) | 1999-11-12 | 2007-09-27 | Treating conjunctivitis by topically administering an epinastine solution to the conjunctiva |
US12/394,684 Abandoned US20090239842A1 (en) | 1999-11-12 | 2009-02-27 | Solutions containing epinastin |
Family Applications Before (2)
Application Number | Title | Priority Date | Filing Date |
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US10/271,180 Abandoned US20030050303A1 (en) | 1999-11-12 | 2002-10-15 | Solutions containing epinastin |
US11/215,165 Abandoned US20050288274A1 (en) | 1999-11-12 | 2005-08-30 | Treating rhinitis by topically administering an epinastine solution to the nasal mucous membrane |
Family Applications After (3)
Application Number | Title | Priority Date | Filing Date |
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US11/734,507 Abandoned US20070197503A1 (en) | 1999-11-12 | 2007-04-12 | Solutions containing epinastin |
US11/863,008 Expired - Lifetime US7429602B2 (en) | 1999-11-12 | 2007-09-27 | Treating conjunctivitis by topically administering an epinastine solution to the conjunctiva |
US12/394,684 Abandoned US20090239842A1 (en) | 1999-11-12 | 2009-02-27 | Solutions containing epinastin |
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EP (1) | EP1231920B1 (en) |
JP (1) | JP2003514021A (en) |
KR (1) | KR100758842B1 (en) |
CN (1) | CN1292752C (en) |
AR (1) | AR026424A1 (en) |
AT (1) | ATE353218T1 (en) |
AU (2) | AU784017B2 (en) |
BG (1) | BG65775B1 (en) |
BR (1) | BR0015477A (en) |
CA (1) | CA2391076C (en) |
CO (1) | CO5251448A1 (en) |
CY (1) | CY1106375T1 (en) |
CZ (1) | CZ302483B6 (en) |
DE (2) | DE19954516A1 (en) |
DK (1) | DK1231920T3 (en) |
EA (1) | EA006937B1 (en) |
EE (1) | EE05395B1 (en) |
ES (1) | ES2281359T3 (en) |
HK (1) | HK1052303B (en) |
HR (1) | HRP20020404B1 (en) |
HU (1) | HU229502B1 (en) |
IL (2) | IL149501A0 (en) |
ME (1) | MEP36708A (en) |
MX (1) | MXPA02004556A (en) |
MY (1) | MY130441A (en) |
NO (1) | NO329417B1 (en) |
NZ (1) | NZ519425A (en) |
PE (1) | PE20010826A1 (en) |
PL (1) | PL198879B1 (en) |
PT (1) | PT1231920E (en) |
RS (1) | RS50173B (en) |
SA (1) | SA01210658B1 (en) |
SI (1) | SI1231920T1 (en) |
SK (1) | SK287343B6 (en) |
TR (1) | TR200201270T2 (en) |
TW (1) | TWI225401B (en) |
UA (1) | UA74563C2 (en) |
WO (1) | WO2001035962A1 (en) |
ZA (1) | ZA200203683B (en) |
Cited By (1)
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US20070197503A1 (en) * | 1999-11-12 | 2007-08-23 | Volker Trach | Solutions containing epinastin |
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US20040247686A1 (en) * | 2003-04-04 | 2004-12-09 | Boehringer Ingelheim International Gmbh | Pharmaceutical compositions comprising epinastine for the treatment of skin diseases |
EP1468696A1 (en) * | 2003-04-17 | 2004-10-20 | Boehringer Ingelheim International GmbH | Combinations of epinastine and antiphlogisitcs as new pharmaceutical compositions for the treatment of skin diseases |
US20060073172A1 (en) * | 2004-10-01 | 2006-04-06 | Schneider L W | Stabilized ophthalmic solution for the treatment of glaucoma and lowering intraocular pressure |
CN101217948A (en) * | 2005-07-08 | 2008-07-09 | 千寿制药株式会社 | Percutaneously absorptive ophthalmic preparation comprising epinastine |
WO2008098122A2 (en) * | 2007-02-08 | 2008-08-14 | Inspire Pharmaceuticals, Inc. | Method for treating allergic rhinitis without adverse effects |
US20080194544A1 (en) * | 2007-02-08 | 2008-08-14 | Ramesh Krishnamoorthy | Aqueous formulations of epinastine for treating allergic rhinitis |
US7378082B1 (en) | 2007-11-05 | 2008-05-27 | Inspire Pharmaceuticals, Inc. | Method for treating allergic rhinitis without adverse effects |
EP2464387A4 (en) * | 2009-08-12 | 2013-05-15 | Seros Medical Llc | Deuterated water and riboflavin solution for extending singlet oxygen lifetimes in treatment of ocular tissue and method for use |
TWI544922B (en) | 2011-05-19 | 2016-08-11 | 愛爾康研究有限公司 | High concentration olopatadine ophthalmic composition |
EP2630952A1 (en) * | 2012-02-23 | 2013-08-28 | Novagali Pharma S.A. | Self-preserved oil dispersions comprising boric acid |
BR112015014367B1 (en) * | 2012-12-19 | 2022-11-22 | Novartis Ag | LFA-1-INHIBITOR COMPOSITION, METHOD FOR STABILIZING SAID COMPOSITION, AND USE THEREOF TO TREAT AN EYE DISEASE |
CN104491876A (en) * | 2014-12-23 | 2015-04-08 | 中国药科大学 | Sodium hyaluronate-containing epinastine eye drops and preparation method thereof |
ITUB20153950A1 (en) * | 2015-09-28 | 2017-03-28 | Tred Srl | NASAL DEVICE ABLE TO ACTIVATE THE RINO-PALATHIC REFLEX FOR RINOFARINGEA HYGIENISATION |
JP6134853B1 (en) * | 2016-10-28 | 2017-05-24 | 参天製薬株式会社 | Epinastine-containing ophthalmic solution |
JP6635974B2 (en) * | 2017-04-24 | 2020-01-29 | 参天製薬株式会社 | Epinastine-containing ophthalmic solution |
KR102582048B1 (en) * | 2017-05-01 | 2023-09-21 | 산텐 세이야꾸 가부시키가이샤 | eye drops |
JP2019108320A (en) * | 2018-10-31 | 2019-07-04 | 参天製薬株式会社 | Ophthalmologic composition which suppresses deterioration of soft contact lens |
JP6736752B2 (en) * | 2019-12-17 | 2020-08-05 | 参天製薬株式会社 | Eye drops containing epinastine |
JP7118579B1 (en) | 2020-04-16 | 2022-08-16 | 参天製薬株式会社 | Aqueous composition containing epinastine or its salt |
JP6963651B2 (en) * | 2020-04-16 | 2021-11-10 | 参天製薬株式会社 | Aqueous composition containing epinastine or a salt thereof |
JP2020169213A (en) * | 2020-07-15 | 2020-10-15 | 参天製薬株式会社 | Epinastine-containing eye drops |
CN115448927A (en) * | 2022-10-20 | 2022-12-09 | 重庆瑞泊莱医药科技有限公司 | Epinastine hydrobromide crystal form II and preparation method thereof |
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Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20070197503A1 (en) * | 1999-11-12 | 2007-08-23 | Volker Trach | Solutions containing epinastin |
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US20090239842A1 (en) * | 1999-11-12 | 2009-09-24 | Volker Trach | Solutions containing epinastin |
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