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Claims for Patent: 6,645,466

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Claims for Patent: 6,645,466

Title: Dry powder for inhalation
Abstract:The aim of the invention is to improve the moisture resistance of dry powder formulations for inhalation which contain a pharmaceutically ineffective carrier of not-inhalable particle size and a finely divided pharmaceutically active compound of inhalable particle size and to also improve the storage stability of said formulations. To this end, magnesium stearate is used in said formulations. One of the features of the inventive dry powder is that a high fine particle dosage or fine particle fraction can be maintained also under relatively extreme temperature and humidity conditions.
Inventor(s): Keller; Manfred (Bad Krozingen, DE), Muller-Walz; Rudi (Schopfheim, DE)
Assignee: Jago Research AG (Muttenz, CH)
Application Number:09/831,011
Patent Claims: 1. A dry powder formulation for inhalation in the form of an ordered mixture, comprising a) a pharmaceutically inactive carrier having particles of noninhalable particle size, b) a finely divided pharmaceutically active compound having particles of inhalable particle size, said pharmaceutically active compound being selected from the group consisting of formioterol, ipratropium, tiotropium and pharmaceutically acceptable salts thereof, and c) magnesium stearate adhering to said particles of said pharmaceutically inactive carrier, the magnesium stearate being in an amount of 0.1 to 2% by weight, based on the total weight of the formulation, said amount being sufficient to provide the formulation with an improved resistance to moisture.

2. The formulation of claim 1, wherein the magnesium stearate is present in an amount of 0.25 to 1% by weight, based on the total weight of the formulation.

3. The formulation of claim 1, wherein the magnesium stearate is present in an amount of 0.4 to 0.8% by weight, based on the total weight of the formulation.

4. The formulation of claim 1, wherein the carrier is selected from the group consisting of monosaccharides, disaccharides, sugar alcohols, polylactic acid and cyclodextrin.

5. The formulation of claim 1, wherein the carrier is selected from the group consisting of glucose, lactose monohydrate and trehalose.

6. The formulation of claim 1, further comprising particles of micronized lactose monohydrate wherein at least 50% of the particles thereof have a maximum particle size of 10 .mu.m.

7. The formulation of claim 1 wherein the pharmaceutically acceptable salt is a member selected from the group consisting of formoterol fumarate, formoterol tartrate, ipratropium bromide and tiotropium bromide.

8. The formulation of claim 7, wherein the magnesium stearate is present in an amount of 0.25 to 1% by weight, based on the total weight of the formulation.

9. The formulation of claim 7, wherein the magnesium stearate is present in an amount of 0.4 to 0.8% by weight, based on the total weight of the formulation.

10. The formulation of claim 7, wherein the carrier is selected from the group consisting of monosaccharides, disaccharides, sugar alcohols, polylactic acid and cyclodextrin.

11. The formulation of claim 7, wherein the carrier is selected from the group consisting of glucose, lactose monohydrate and trehalose.

12. The formulation of claim 7, wherein the pharmaceutically active compound is formoterol fumarate, the carrier is lactose monohydrate, and the magnesium stearate is present in an amount of 0.4 to 0.8% by weight, based on the total weight of the formulation.

13. The formulation of claim 7, further comprising particles of micronized lactose monohydrate wherein at least 50% of the particles thereof have a maximum particle size of 10 .mu.m.

14. The formulation of claim 7, wherein the pharmaceutically active compound is present in an amount of 0.1 to 5% by weight, based on the total weight of the formulation.

15. The formulation of claim 14 wherein the pharmaceutically active compound is formoterol fumarate, the carrier is lactose monohydrate, and the magnesium stearate is present in an amount of 0.4 to 0.8% by weight, based on the total weight of the formulation.
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