US2016120811A1PendingUtilityA1

Methods of administering antihistamines

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Assignee: APTAPHARMA INCPriority: Aug 25, 2011Filed: Jan 13, 2016Published: May 5, 2016
Est. expiryAug 25, 2031(~5.1 yrs left)· nominal 20-yr term from priority
A61K 9/485A61K 9/2027A61K 9/0095A61K 9/0056A61K 31/4545A61K 31/138A61K 9/2086A61K 31/4439A61K 31/495A61K 9/2054A61K 47/10A61K 31/513A61K 9/2031A61K 31/445A61P 37/08A61K 9/4858A61K 9/4866A61K 31/435A61K 2300/00A61K 9/2018A61K 31/496A61K 9/2059A61K 9/209A61K 9/2009A61K 9/0053A61K 31/4402A61K 9/08A61K 31/135A61K 9/2013
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Claims

Abstract

Methods of using combinations of antihistamines by administering an attenuated dosage amount of a first generation antihistamine for a quick onset concomitantly with a maintenance dosage amount of a second or third generation antihistamine are disclosed.

Claims

exact text as granted — not AI-modified
1 . An oral antihistamine dosage formulation, comprising
 a first generation antihistamine in an attenuated dosage amount to provide a quick onset of action wherein a patient receiving the formulation experiences substantially no sedative effect,   wherein the first generation antihistamine is
 diphenhydramine HCl in an attenuated dosage amount of 2.5 mg to 10 mg, or 
 doxylamine succinate in an attenuated dosage amount of 0.625 mg to 4.1 mg; 
   a second or third generation antihistamine in a maintenance dosage amount to provide continued antihistaminic effect; and   a pharmaceutically acceptable excipient,   wherein the first generation antihistamine and the second or third generation antihistamine are formulated together into a single oral dosage form to be administered to an adult human patient regardless of the time of day.   
     
     
         2 . The formulation of  claim 1 ,
 wherein the first generation antihistamine is   diphenhydramine HCl in an attenuated dosage amount of 5.0 mg to 6.25 mg, or   doxylamine succinate in an attenuated dosage amount of 2.0 mg to 4.1 mg.   
     
     
         3 . The formulation of  claim 1 , wherein the second or third generation antihistamine is acrivastine, astemizole, cetirizine, desloratadine, fexofenadine, levocetirizine, loratadine, mizolastine, terfenadine, a pharmaceutically acceptable salt thereof, or a combination thereof. 
     
     
         4 . The formulation of  claim 1 , wherein the second or third generation antihistamine is cetirizine hydrochloride, fexofenadine hydrochloride, loratadine, or a combination thereof. 
     
     
         5 . The formulation of  claim 1 , wherein the formulation is a tablet, a capsule, a pellet, a film, a solution, a suspension, an emulsion, a powder, or a granule. 
     
     
         6 . The formulation of  claim 1 , to be administered once a day. 
     
     
         7 . The formulation of  claim 1 , to be administered twice a day. 
     
     
         8 . The formulation of  claim 1 , wherein the first generation antihistamine when administered to a patient provides therapeutic prophylactic and symptomatic treatment of seasonal or perennial allergic rhinitis, vasomotor rhinitis, or other respiratory allergies for the first 1 hour after administration. 
     
     
         9 . The formulation of  claim 1 , wherein the first generation antihistamine when administered to a patient provides therapeutic prophylactic and symptomatic treatment of seasonal or perennial allergic rhinitis, vasomotor rhinitis, or other respiratory allergies for the first 2 hours after administration. 
     
     
         10 . An oral antihistamine dosage formulation, comprising
 a first generation antihistamine in an attenuated dosage amount to provide a quick onset of action wherein a patient receiving the formulation experiences substantially no sedative effect,   wherein the first generation antihistamine is
 diphenhydramine HCl in an attenuated dosage amount of 2.5 mg to 5 mg, or 
 doxylamine succinate in an attenuated dosage amount of 0.625 mg to 4.1 mg; 
   a second or third generation antihistamine in a maintenance dosage amount to provide continued antihistaminic effect; and   a pharmaceutically acceptable excipient,   wherein the first generation antihistamine and the second or third generation antihistamine are formulated together into a single oral dosage form to be administered to a human patient regardless of the time of day   
     
     
         11 . The formulation of  claim 10 , wherein the first generation antihistamine is doxylamine succinate in an attenuated dosage amount of 1.3 mg to 3.4 mg. 
     
     
         12 . The formulation of  claim 10 , wherein the first generation antihistamine is doxylamine succinate in an attenuated dosage amount of 1.6 mg to 2.5 mg. 
     
     
         13 . The formulation of  claim 10 , wherein the second or third generation antihistamine is acrivastine, astemizole, cetirizine, desloratadine, fexofenadine, levocetirizine, loratadine, mizolastine, terfenadine, a pharmaceutically acceptable salt thereof, or a combination thereof. 
     
     
         14 . The formulation of  claim 10 , wherein the second or third generation antihistamine is cetirizine hydrochloride, fexofenadine hydrochloride, loratadine, or a combination thereof. 
     
     
         15 . The formulation of  claim 10 , wherein the formulation is a tablet, a capsule, a pellet, a film, a solution, a suspension, an emulsion, a powder, or a granule. 
     
     
         16 . The formulation of  claim 10 , to be administered once a day. 
     
     
         17 . The formulation of  claim 10 , to be administered twice a day. 
     
     
         18 . The formulation of  claim 10 , wherein the first generation antihistamine when administered to a patient provides therapeutic prophylactic and symptomatic treatment of seasonal or perennial allergic rhinitis, vasomotor rhinitis, or other respiratory allergies for the first 1 hour after administration. 
     
     
         19 . The formulation of  claim 10 , wherein the first generation antihistamine when administered to a patient provides therapeutic prophylactic and symptomatic treatment of seasonal or perennial allergic rhinitis, vasomotor rhinitis, or other respiratory allergies for the first 2 hours after administration. 
     
     
         20 . The formulation of  claim 10 , wherein the formulation is a pediatric formulation. 
     
     
         21 . An oral antihistamine dosage formulation, comprising
 a first generation antihistamine in an attenuated dosage amount to provide a quick onset of action wherein a patient receiving the formulation experiences substantially no sedative effect;   a second or third generation antihistamine in a maintenance dosage amount to provide continued antihistaminic effect; and   a pharmaceutically acceptable excipient,   wherein the first generation antihistamine and the second or third generation antihistamine are formulated in a single oral dosage form to be administered to a human patient regardless of the time of day.

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