Claims for Patent: 6,027,714

Summary for Patent: 6,027,714

Title:	Formulation for inhalation
Abstract:	A dry powder composition comprising budesonide and a carrier substance, both 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 (SE)
Application Number:	09/004,894
Patent Claims:	1. A dry powder pharmaceutical composition comprising budesonide and a carrier substance, wherein both the budesonide and the carrier substance consist of particles having a mass median diameter of less than 10 .mu.m, and the composition has a poured bulk density of from 0.28 to 0.38 g/ml. 2. A composition according to claim 1 wherein the bulk density is from 0.30 to 0.36 g/ml. 3. A composition according to claim 1 wherein the active substance and carrier substance are substantially uniformly distributed. 4. A composition according to claim 1 for use in the treatment of a respiratory disorder. 5. A process for preparing a composition according to claim 1 which comprises (a) micronising budesonide and the carrier substance; (b) optionally conditioning the product; and (c) spheronizing until the desired bulk density is obtained. 6. A process according to claim 5 which comprises a low energy remicronisation step after step (b). 7. A method of treating a patient suffering from a respiratory disorder which comprises administering to the patient a therapeutically effective amount of a composition according to claim 1. 8. A composition according to claim 1 wherein said carrier substance is selected from the group consisting of monosaccharides, disaccharides, polysaccharides and polyols. 9. A composition according to claim 1 wherein the carrier substance is selected from the group consisting of lactose, glucose, raffinose, melezitose, lactitol, maltitol, trehalose, sucrose, mannitol and starch. 10. A composition according to claim 9 wherein said carrier substance is lactose monohydrate. 11. A composition according to claim 1 wherein the mass median diameter of the particles of budesonide and carrier is from 1 to 7 .mu.m. 12. A process according to claim 6, wherein the mass median diameter lies in the range of from 1 to 7 .mu.m. 13. A process according to claim 6, wherein the bulk density is from 0.30 to 0.36 g/ml. 14. A process according to claim 6, wherein the budesonide and the carrier substance are substantially uniformly distributed.