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Claims for Patent: 5,478,578

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Claims for Patent: 5,478,578

Title: Powders for inhalation
Abstract:In order to control and optimize the amount of inhalable active substance released when drugs are administered as inhalation powders, the invention calls for the use of auxiliaries consisting of mixtures of coarser particles (average particle size>20 .mu.m) and finer particles (average particle size<10 .mu.m).
Inventor(s): Arnold; Klaus (Ingelheim am Rhein, DE), Grass; Peter (Ingelheim am Rhein, DE), Knecht; Adolf (Freiburg, DE), Roos; Robert (Ingelheim am Rhein, DE), Sluke; Gerhard (Ingelheim am Rhein, DE), Thieme; Herbet (Ingelheim am Rhein, DE), Wenzel; Joachim (Ingelheim am Rhein, DE)
Assignee: Boehringer Ingelheim KG (Ingelheim am Rhein, DE)
Application Number:08/244,737
Patent Claims: 1. Powder for inhalation comprising a micronized active substance and a physiologically acceptable excipient comprising a mixture containing a fine fraction having an average particle size in the range of less than 10 .mu.m and a coarse fraction having an average particle size in the range of from about 20 .mu.m to about 150 .mu.m, wherein the weight ratio of micronized active substance to the physiologically acceptable excipient mixture is from about 0.01:5 to 0.1:5.

2. Powder for inhalation according to claim 1 characterized in that the weight ratio of the fine fraction to the coarse fraction in the physiologically acceptable excipient mixture is between 1:99 and 95:5.

3. Powder for inhalation according to claim 1 or 2 characterized in that the fine fraction and the coarse fraction in the physiologically acceptable excipient mixture are each individually selected from the group consisting of monosaccharides, disaccharide's, polysaccharides, polyalcohols and inorganic salts.

4. Powder for inhalation according to claim 3 characterized in that the fine fraction and the coarse fraction in the physiologically acceptable excipient mixture consists of the same chemical substance.

5. Powder for inhalation according to claim 3 characterized in that the fine fraction and the coarse fraction in the physiologically acceptable excipient mixture consists of a different chemical substance.

6. Powder for inhalation according to claims 1 or 2 characterized in that the weight ratio of the fine fraction to the coarse fraction in the physiologically acceptable excipient mixture is between 5:95 and 70:30.

7. Powder for inhalation according to claim 6 characterized in that the weight ratio of the fine fraction to the coarse fraction in the physiologically acceptable excipient mixture is between 10:90 and 50:50.

8. Powder for inhalation according to claim 7 characterized in that the coarse fraction has an average particle size in the range of from about 20 .mu.m to about 8 .mu.m.
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