US2013115283A1PendingUtilityA1

Solid naproxen concentrates and related dosage forms

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Assignee: PHARMACEUTICS INTERNATIONAL INCPriority: Aug 25, 2009Filed: Dec 26, 2012Published: May 9, 2013
Est. expiryAug 25, 2029(~3.1 yrs left)· nominal 20-yr term from priority
Inventors:Emadeldin M. HassanSridhar Gumudavelli
A61P 29/00A61K 9/1688A61K 9/4833A61K 9/1617A61K 9/4866A61K 31/192
44
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Claims

Abstract

The invention provides a composition consisting essentially of a solid naproxen concentrate, wherein the solid naproxen concentrate comprises (a) a solid naproxen free acid and (b) a solid naproxen alkali salt, and wherein at least 90% of the weight of the solid naproxen concentrate is naproxen free acid and naproxen alkali salt, as well methods of producing such a solid naproxen concentrate.

Claims

exact text as granted — not AI-modified
1 . A pharmaceutical composition consisting essentially of a solid naproxen concentrate, wherein the solid naproxen concentrate comprises (a) a solid naproxen free acid and (b) a solid naproxen alkali salt, and wherein at least 90% of the weight of the solid naproxen concentrate is naproxen free acid and naproxen alkali salt. 
     
     
         2 . The composition of  claim 1 , wherein at least 92% of the weight of the solid naproxen concentrate is naproxen free acid and naproxen alkali salt. 
     
     
         3 . The composition of  claim 1 , wherein at least 95% of the weight of the solid naproxen concentrate is naproxen free acid and naproxen alkali salt. 
     
     
         4 . The composition of  claim 1 , wherein at least 97% of the weight of the solid naproxen concentrate is naproxen free acid and naproxen alkali salt. 
     
     
         5 . The composition of  claim 1 , wherein the composition is a hard shell capsule, soft gelatin capsule, liquid suspension, liquid solution, or tablet. 
     
     
         6 . The composition of  claim 5 , wherein the composition is a tablet. 
     
     
         7 . The composition of  claim 6 , equivalent to about 200 to about 1000 mg naproxen per tablet. 
     
     
         8 . The composition of  claim 1 , wherein the solid naproxen alkali salt is selected from the group consisting of naproxen sodium salt, naproxen potassium salt, naproxen ammonium salt, and mixtures thereof. 
     
     
         9 . The composition of  claim 1 , wherein the solid naproxen concentrate does not comprise one or more binders. 
     
     
         10 . A pharmaceutical formulation comprising
 (a) a solid naproxen concentrate, wherein the solid naproxen concentrate comprises a solid naproxen free acid and a solid naproxen alkali salt, and wherein at least 90% of the weight of the solid naproxen concentrate is naproxen free acid and naproxen alkali salt; and   (b) a pharmaceutically acceptable carrier.   
     
     
         11 . The composition of  claim 10 , wherein at least 92% of the weight of the solid naproxen concentrate is naproxen free acid and naproxen alkali salt. 
     
     
         12 . The composition of  claim 10 , wherein at least 95% of the weight of the solid naproxen concentrate is naproxen free acid and naproxen alkali salt. 
     
     
         13 . The composition of  claim 10 , wherein at least 97% of the weight of the solid naproxen concentrate is naproxen free acid and naproxen alkali salt. 
     
     
         14 . The composition of  claim 10 , wherein the composition is a hard shell capsule, soft gelatin capsule, liquid suspension, liquid solution, or tablet. 
     
     
         15 . The composition of  claim 14 , wherein the composition is a tablet. 
     
     
         16 . The composition of  claim 15 , equivalent to about 200 to about 1000 mg naproxen per tablet. 
     
     
         17 . The composition of  claim 10 , wherein the solid naproxen alkali salt is selected from the group consisting of naproxen sodium salt, naproxen potassium salt, naproxen ammonium salt, and mixtures thereof. 
     
     
         18 . The composition of  claim 10 , wherein the solid naproxen concentrate does not comprise one or more binders. 
     
     
         19 . A method of manufacturing a solid naproxen concentrate, wherein at least 90% of the weight of the naproxen concentrate is naproxen free acid and naproxen alkali salt, comprising:
 (a) mixing a naproxen alkali salt with at least one acidic substance to form a composition; and   (b) optionally drying the composition to produce a solid naproxen concentrate.   
     
     
         20 . The method of  claim 19 , wherein the at least one acidic substance is in the form of an aqueous or hydro-alcoholic solution. 
     
     
         21 . The method of  claim 20 , further comprising sieving the composition prior to drying. 
     
     
         22 . The method of  claim 21 , further comprising adding water or a water-miscible solvent to the composition. 
     
     
         23 . The method of  claim 19 , wherein the acidic substance is selected from the group consisting of organic acids with 2-18 carbon atoms, hydroxyl-acids, inorganic acids, amino acids, and mixtures thereof. 
     
     
         24 . The method of  claim 19 , wherein the acidic substance is selected from the group consisting of lactic acid, gluconic acid, citric acid, tartaric acid, hydrochloric acid, phosphoric acid, nitric acid, sulfuric acid, maleic acid, monosodium citrate, disodium citrate, potassium citrate, monosodium tartrate, disodium tartrate, potassium tartrate, aspartic acid, carboxy-methylcellulose, acrylic polymers, methacrylic polymers, and mixtures thereof. 
     
     
         25 . The method of  claim 21 , further comprising filling the solid naproxen concentrate in hard shell capsules. 
     
     
         26 . A solid naproxen concentrate obtained by the method of  claim 19 . 
     
     
         27 . A method of preparing a soft gelatin capsule formulation comprising:
 (a) providing a solid naproxen concentrate comprising a solid naproxen free acid and a solid naproxen alkali salt, wherein at least 90% of the weight of the solid naproxen concentrate is naproxen free acid and naproxen alkali salt;   (b) dissolving the solid naproxen concentrate in a soft gelatin capsule vehicle to form a soft gelatin fill; and   (c) encapsulating the soft gelatin fill in a soft gelatin capsule;   thereby preparing a soft gelatin capsule formulation.   
     
     
         28 . The method of  claim 27 , wherein the soft gelatin capsule vehicle is polyethylene glycol. 
     
     
         29 . A composition consisting essentially of a solid naproxen concentrate, wherein the solid naproxen concentrate comprises (a) a solid naproxen free acid and (b) a solid naproxen alkali salt, and wherein at least 90% of the weight of the solid naproxen concentrate is naproxen free acid and naproxen alkali salt, wherein the naproxen free acid is produced from a solid naproxen alkali salt using at least one acidic substance. 
     
     
         30 . The composition of  claim 29 , wherein at least 95% of the weight of the solid naproxen concentrate is naproxen free acid and naproxen alkali salt. 
     
     
         31 . The composition of  claim 29  wherein the composition is a hard shell capsule, soft gelatin capsule, liquid suspension, liquid solution, or tablet.

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