US2005255051A1PendingUtilityA1

Formulation for inhalation

58
Assignee: QUADRANT DRUG DELIVERY LTDPriority: Jun 30, 1998Filed: Jul 22, 2005Published: Nov 17, 2005
Est. expiryJun 30, 2018(expired)· nominal 20-yr term from priority
Inventors:Stuart RobinsonSusan Stewart Smith
A61K 9/0073A61K 9/1688A61K 38/4826A61K 38/063A61K 38/28
58
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Claims

Abstract

Microparticles, obtainable by spray-drying a substantially pure solution of a therapeutic agent, consist essentially of the agent having its therapeutic activity when administered to the lung. In a preferred embodiment the agent is insulin.

Claims

exact text as granted — not AI-modified
1 . Microparticles, obtainable by spray-drying a substantially pure solution of a therapeutic agent, wherein the microparticles consist essentially only of the therapeutic agent having its therapeutic activity when administered to the lung, and further wherein the therapeutic agent is selected from the group consisting of insulin, DNase and trypsin.  
   
   
       2 . Microparticles according to  claim 1 , wherein the therapeutic agent is non-crystalline/amorphous.  
   
   
       3 . Microparticles according to  claim 1 , consisting essentially of the agent and a salt formed in dissolution of the agent.  
   
   
       4 . Microparticles according to  claim 2 , consisting essentially of the agent and a salt formed in dissolution of the agent.  
   
   
       5 . Microparticles according to  claim 3 , wherein the salt is formed from an alkali and a mineral acid.  
   
   
       6 . Microparticles according to  claim 4 , wherein the salt is formed from an alkali and a mineral acid.  
   
   
       7 . Microparticles according to  claim 5 , wherein the microparticles comprise less than 4% salt by weight of total solids.  
   
   
       8 . Microparticles according to  claim 6 , wherein the microparticles comprise less than 4% salt by weight of total solids.  
   
   
       9 . A closed container containing, at ambient humidity, microparticles according to  claim 1 .  
   
   
       10 . A closed container containing, at ambient humidity, microparticles according to  claim 2 .  
   
   
       11 . An inhaler device comprising microparticles according to  claim 1 .  
   
   
       12 . An inhaler device comprising microparticles according to  claim 2 .  
   
   
       13 . A process for the preparation of microparticles according to  claim 1 , which comprise spray-drying a substantially pure solution of the therapeutic agent.  
   
   
       14 . A process according to  claim 13 , wherein the solution contains more than 10 mg/ml of agent.  
   
   
       15 . A process according to  claim 14 , wherein the solution contains 20 to 200 mg/ml agent.  
   
   
       16 . A process according to  claim 14 , wherein the solution contains 50 to 100 mg/ml agent.  
   
   
       17 . A process according to  claim 13 , wherein the solution contains less than 4% salt.  
   
   
       18 . A process according to  claim 13 , wherein the solution is free of buffer salt.  
   
   
       19 . A process according to  claim 17 , wherein the solution is free of buffer salt.  
   
   
       20 . An inhaler device comprising microparticles according to  claim 3 .  
   
   
       21 . An inhaler device comprising microparticles according to  claim 4 .  
   
   
       22 . An inhaler device comprising microparticles according to  claim 5 .  
   
   
       23 . An inhaler device comprising microparticles according to  claim 6 .  
   
   
       24 . An inhaler device comprising microparticles according to  claim 7 .  
   
   
       25 . An inhaler device comprising microparticles according to  claim 8 .  
   
   
       26 . A closed container containing, at ambient humidity, microparticles according to  claim 3 .  
   
   
       27 . A closed container containing, at ambient humidity, microparticles according to  claim 4 .  
   
   
       28 . A closed container containing, at ambient humidity, microparticles according to  claim 5 .  
   
   
       29 . A closed container containing, at ambient humidity, microparticles according to  claim 6 .  
   
   
       30 . A closed container containing, at ambient humidity, microparticles according to  claim 7 .  
   
   
       31 . A closed container containing, at ambient humidity, microparticles according to  claim 8 .  
   
   
       32 . A process for the preparation of microparticles according to  claim 2 , which comprise spray-drying a substantially pure solution of a therapeutic agent.  
   
   
       33 . A process according to  claim 32 , wherein the solution contains more than 10 mg/ml of agent.  
   
   
       34 . A process according to  claim 33 , wherein the solution contains 20 to 200 mg/ml agent.  
   
   
       35 . A process according to  claim 33 , wherein the solution contains 50 to 100 mg/ml agent.  
   
   
       36 . A process according to  claim 33 , wherein the solution contains less than 4% salt.  
   
   
       37 . A process according to  claim 33 , wherein the solution is free of buffer salt.  
   
   
       38 . A process according to  claim 36 , wherein the solution is free of buffer salt.

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