US2015231334A1PendingUtilityA1

Drug mixing and delivery system and method

Assignee: WINDGAP MEDICAL INCPriority: Dec 18, 2013Filed: Dec 18, 2014Published: Aug 20, 2015
Est. expiryDec 18, 2033(~7.4 yrs left)· nominal 20-yr term from priority
A61P 3/08A61P 9/02A61P 25/06A61K 38/26A61M 5/1409A61M 5/2046A61M 5/284A61M 5/2448A61M 5/44A61M 5/3294A61K 9/0019A61K 31/4045A61K 45/06A61K 38/00A61M 2205/366A61M 2205/364A61K 31/137A61M 5/19
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Claims

Abstract

The present disclosure provides methods of preparing a medical solution. In some aspects, the medical solution can be prepared from mixing a first liquid with a second liquid or mixing a solid component with a liquid in an autoinjector. In some aspects, the heat released from the mixing can promote solubility of a dry medicament in the solution.

Claims

exact text as granted — not AI-modified
1 . A method of preparing a medical solution comprising mixing a dry medicament and a first liquid, wherein the first liquid comprises a pH optimizing agent, and the dry medicament is readily solubilized upon mixing with the first liquid. 
     
     
         2 - 11 . (canceled) 
     
     
         12 . The method of  claim 1 , wherein the dry medicament is located in a first chamber of a medical device. 
     
     
         13 . The method of  claim 12 , wherein the first liquid is located in a second chamber of the medical device. 
     
     
         14 . The method of  claim 13 , wherein the medical device is an automatic injection device, prefilled syringe, or a needle assembly. 
     
     
         15 . (canceled) 
     
     
         16 . The method of  claim 1 , wherein the dry medicament is epinephrine, glucagon, or sumatriptan. 
     
     
         17 - 19 . (canceled) 
     
     
         20 . A method for forming an epinephrine solution in an automatic injection device, prefilled syringe, or needle assembly, comprising the steps of:
 placing dry epinephrine into a chamber in the automatic injection device, prefilled syringe, or needle assembly;   placing into a separate chamber within the automatic injection device, prefilled syringe, or needle assembly, a pH optimized solution;   activating the automatic injection device, prefilled syringe, or needle assembly, and causing the dry epinephrine to be dissolved by the pH optimized solution, wherein an epinephrine solution is formed inside the automatic injection device.   
     
     
         21 . The method of  claim 20 , wherein the pH optimized solution includes an acid. 
     
     
         22 - 23 . (canceled) 
     
     
         24 . The method of  claim 20 , wherein the dry epinephrine is epinephrine freebase or an epinephrine salt. 
     
     
         25 - 26 . (canceled) 
     
     
         27 . The method of  claim 20 , wherein the final concentration of the epinephrine solution is between 0.7 and 1.3 mg/ml. 
     
     
         28 . The method of  claim 20 , wherein the final pH of the epinephrine solution is between 1-5. 
     
     
         29 . The method of  claim 20  further comprising
 placing into a third chamber within the automatic injection device, prefilled syringe, or needle assembly a pH adjusting solution. 
 
     
     
         30 . (canceled) 
     
     
         31 . The method of  claim 29 , where the pH adjusting solution is a base. 
     
     
         32 - 33 . (canceled) 
     
     
         34 . The method of  claim 24 , wherein the epinephrine salt is a maleate, malate, fumarate, tartrate, bitartrate, sulfate, hydrochloride, or borate salt of epinephrine. 
     
     
         35 - 51 . (canceled) 
     
     
         52 . A method of preparing a medical solution comprising mixing a first liquid with a second liquid to generate a mixture, wherein the mixing generates heat to promote solubility of a dry medicament in the mixture. 
     
     
         53 . (canceled) 
     
     
         54 . The method of  claim 52 , wherein the dry medicament is subsequently added to the mixture. 
     
     
         55 . The method of  claim 52 , wherein the dry medicament is added to the first liquid prior to mixing with the second liquid. 
     
     
         56 . The method of  claim 52 , wherein the dry medicament is amorphous or crystalline. 
     
     
         57 - 58 . (canceled) 
     
     
         59 . The method of  claim 52 , wherein the dry medicament comprises one or more therapeutic agents. 
     
     
         60 - 178 . (canceled) 
     
     
         179 . A method of preparing a medical solution comprising mixing a dry medicament and a first liquid, wherein the first liquid comprises an aqueous solution, and the dry medicament is a salt and readily solubilized upon mixing with the first liquid. 
     
     
         180 . A method for forming an epinephrine solution in an automatic injection device, prefilled syringe, or needle assembly, comprising the steps of:
 placing dry epinephrine salt into a chamber in the automatic injection device, prefilled syringe, or needle assembly;   placing into a separate chamber within the automatic injection device, prefilled syringe, or needle assembly, a liquid;   activating the automatic injection device, prefilled syringe, or needle assembly, and causing the dry epinephrine to be dissolved by the liquid.

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