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Claims for Patent: 6,287,540

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Claims for Patent: 6,287,540

Title: Formulation for inhalation
Abstract:A dry powder composition comprising one more potent pharmaceutically active substances and a carrier substance, all of which are in finely divided form, wherein the formulation has a poured bulk density of from 0.28 to 0.38 g/ml is useful in the treatment of respiratory disorders.
Inventor(s): Trofast; Jan (Lund, SE)
Assignee: Astra Aktiebolag (Sodertalje, SE)
Application Number:09/431,916
Patent Claims: 1. A dry powder composition comprising one potent therapeutically active substance and a carrier substance, both of which are in finely divided form, wherein the composition has a poured bulk density of from 0.28 to 0.38 g/ml and said finely divided therapeutically active substance and said finely divided carrier substance are substantially uniformly distributed throughout the composition.

2. The composition according to claim 1, wherein the poured bulk density of the composition is from 0.30 to 0.36 g/ml.

3. The composition according to claim 1, for use in the treatment of a respiratory disorder.

4. The composition according to claim 1, wherein the potent therapeutically active substance is selected from the group consisting of glucocorticosteroids, .beta.2-agonists and prophylactic agents.

5. The composition according to claim 4, wherein the glucocorticosteroid is selected from the group consisting of beclomethasone dipropionate (BDP), beclomethasone monopropionate (BMP), flunisolide, triamcinolone acetonide, fluticasone propionate, ciclesonide, momethasone, tipredane, RPR 106541, rofleponide and derivatives thereof.

6. The composition according to claim 4, wherein the .beta.2-agonist is selected from the group consisting of salbutamol, salmeterol, TA 2005, pircumarol and pharmaceutically acceptable salts thereof.

7. The composition according to claim 4, wherein the prophylactic agent is selected from the group consisting of sodium chromoglycate and nedocromil sodium.

8. The composition according to claim 1, wherein the carrier substance is selected from the group consisting of monosaccharides, disaccharides, polysaccharides and polyols.

9. The composition according to claim 8, wherein the disaccharide is lactose.

10. The composition according to claim 9, wherein the disaccharide is lactose monohydrate.

11. The composition according to claim 1, wherein the therapeutically active substance and carrier substance have a mass median diameter of less than 10 .mu.m.

12. The composition according to claim 11, wherein said mass median diameter is from 1 to 7 .mu.m.

13. A process for preparing a composition according to claim 10, comprising

(a) micronizing, either separately or together, the potent therapeutically active substance and the carrier substance;

(b) either before, during, or after step (a), mixing the potent therapeutically active substance and the carrier substance, both of which are in finely divided form, until a substantially uniform mixture is obtained; and

(c) spheronizing said substantially uniform mixture until a poured bulk density of from 0.28 to 0.38 g/ml is obtained.

14. A process according to claim 13, further comprising conditioning the micronized substances.

15. A process according to claim 14, wherein the conditioning step is performed before the spheronization step.

16. A process according to claim 14, further comprising a low energy remicronization step after the conditioning step.
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