Claims for Patent: 6,881,398

Summary for Patent: 6,881,398

Title:	Therapeutic dry powder preparation
Abstract:	A therapeutic dry powder preparation and a method of administering such a preparation are disclosed for effectively de-aggregating and dispersing into air a dose of medication powder in an administration the dose to a user. The present dry powder preparation and method do not require other sources of energy besides the power of an inhalation effort by a user to produce a very high degree of de-aggregation and efficient dispersal into air of the dry powder medication dose. Utilizing an effort of sucking air through a nozzle, the particles of the therapeutic powder dose, made available to the nozzle, are gradually de-aggregated and dispersed into a stream of air entering the nozzle. The gradual de-aggregation and dispersal is produced by an air-razor effect due to a relative motion introduced between the nozzle and the powder dose
Inventor(s):	Myrman; Mattias (Stockholm, SE), Nilsson; Per-Gunnar (Malmo, SE)
Assignee:	Microdrug AG (Hergiswil NW, CH)
Application Number:	10/134,597
Patent Claims:	1. A method of administering a medication dose of therapeutic dry powder to a user through inhalation, comprising the steps of: providing a metered dose of the therapeutic dry powder on a surface of a substrate, the metered dose being arranged on the surface so as to have an elongated shape; providing an inhaler constructed to receive the substrate, the inhaler being constructed and arranged so as to allow relative movement between a nozzle and the substrate at a predefined speed along a path that follows a length of the elongated metered dose, so that the nozzle passes by the metered dose; and having the user inhale through a mouthpiece connected to the nozzle while the nozzle moves with respect to the substrate so as to release, de-aggregate, disperse into air, and deliver the therapeutic dry powder to the airways of the user over a predefined interval; wherein the therapeutic dry powder comprises at least one finely divided, pharmacologically active substance; wherein the pharmacologically active substance as it is delivered to the user comprises at least 50% fine particle fraction, with fine particle fraction defined as a fraction of the delivered pharmacologically active substance by mass with a maximum aerodynamic particle size of 5.mu.m, where aerodynamic particle size is defined as a diameter of a spherical particle having a density of 1 g/cm.sup.3 that has the same inertial properties in air as the particle of the pharmacologically active substance. 2. The method of claim 1, wherein the pharmacologically active substance is an alpha1-proteinase inhibitor. 3. The method of claim 1, wherein the pharmacologically active substance is an interleukin 1. 4. The method of claim 1, wherein the pharmacologically active substance is a parathyroid hormone. 5. The method of claim 1, wherein the pharmacologically active substance is a genotropin. 6. The method of claim 1, wherein the pharmacologically active substance consists of colony stimulating factors. 7. The method of claim 1, wherein the pharmacologically active substance is an erythropoietin. 8. The method of claim 1, wherein the pharmacologically active substance is an interferon. 9. The method of claim 1, wherein the pharmacologically active substance is calcitonin. 10. The method of claim 1, wherein the pharmacologically active substance is factor VIII. 11. The method of claim 1, wherein the pharmacologically active substance is an alpha-1-antitrypsin. 12. The method of claim 1, wherein the pharmacologically active substance is a follicle stimulating hormone. 13. The method of claim 1, wherein the pharmacologically active substance is an LHRH agonist. 14. The method of claim 1, wherein the pharmacologically active substance is IGF-I. 15. The method of claim 1, wherein the pharmacologically active substance is insulin. 16. The method of claim 1, wherein the pharmacologically active substance is a protein. 17. The method of claim 1, wherein the pharmacologically active substance is a peptide. 18. The method of claim 1, wherein the pharmacologically active substance has an electrostatic specific charge capability of at least 0.1 .mu.C/g and a discharge rate factor of at least 0.1 s half-life period (Q.sub.50). 19. The method of claim 1, wherein the pharmacologically active substance is systemically acting. 20. The method of claim 1, wherein the pharmacologically active substance is locally acting in the lung of the user. 21. The method of claim 1, wherein the dry powder is adapted for oral administration. 22. The method of claim 1, wherein the dry powder is adapted for nasal administration. 23. The method of claim 1, wherein the user inhales so as to produce a pressure difference within the inhaler in a range of 1-8 kPa. 24. The method of claim 1, wherein the user inhales so as to produce a pressure difference within the inhaler in a range of 1-4 kPa. 25. A method of administering a medication dose of therapeutic dry powder to a user through inhalation, comprising the steps of: providing a metered dose of the therapeutic dry powder on a surface of a substrate, the metered dose being arranged on the surface so as to have an elongated shape; providing an inhaler constructed to receive the substrate, the inhaler being constructed and arranged so as to allow relative movement between a nozzle and the substrate at a predefined speed along a path that follows a length of the elongated metered dose, so that the nozzle passes by the metered dose; and having the user inhale through a mouthpiece connected to the nozzle while the nozzle moves with respect to the substrate so as to release, de-aggregate, disperse into air, and deliver the therapeutic dry powder to the airways of the user over a predefined interval; wherein the therapeutic dry powder comprises at least one finely divided, pharmacologically active substance; wherein the pharmacologically active substance has an electrostatic specific charge capability of at least 0.1 .mu.C/g and a discharge rate factor of at least 0.1 s half-life period (Q.sub.50). 26. The method of claim 25, wherein the pharmacologically active substance is an alpha1-proteinase inhibitor. 27. The method of claim 25, wherein the pharmacologically active substance is an interleukin 1. 28. The method of claim 25, wherein the pharmacologically active substance is a parathyroid hormone. 29. The method of claim 25, wherein the pharmacologically active substance is a genotropin. 30. The method of claim 25, wherein the pharmacologically active substance consists of colony stimulating factors. 31. The method of claim 25, wherein the pharmacologically active substance is an erythropoietin. 32. The method of claim 25, wherein the pharmacologically active substance is an interferon. 33. The method of claim 25, wherein the pharmacologically active substance is calcitonin. 34. The method of claim 25, wherein the pharmacologically active substance is factor VIII. 35. The method of claim 25, wherein the pharmacologically active substance is an alpha-1-antitrypsin. 36. The method of claim 25, wherein the pharmacologically active substance is a follicle stimulating hormone. 37. The method of claim 25, wherein the pharmacologically active substance is an LHRH agonist. 38. The method of claim 25, wherein the pharmacologically active substance is IGF-I. 39. The method of claim 25, wherein the pharmacologically active substance is insulin. 40. The method of claim 25, wherein the pharmacologically active substance is a protein. 41. The method of claim 25, wherein the pharmacologically active substance is a peptide. 42. The method of claim 25, wherein the pharmacologically active substance is systemically acting. 43. The method of claim 25, wherein the pharmacologically active substance is locally acting in the lung of the user. 44. The method of claim 25, wherein the dry powder is adapted for oral administration. 45. The method of claim 25, wherein the dry powder is adapted for nasal administration. 46. The method of claim 25, wherein the user inhales so as to produce a pressure difference within the inhaler in a range of 1-8 kPa. 47. The method of claim 25, wherein the user inhales so as to produce a pressure difference within the inhaler in a range of 1-4 kPa. 48. A method of administering a medication dose of therapeutic dry powder to a user through inhalation, comprising the steps of: providing a metered dose of the therapeutic dry powder on a surface of a substrate, the metered dose being arranged on the surface so as to have an elongated shape; providing a means for releasing the metered dose from the substrate by subjecting an edge of the elongated metered dose to shearing stresses and inertia of an airstream sufficient to de-aggregate, release, disperse, and entrain individual particles of the metered dose into the airstream, and moving the metered dose with respect to the airstream so that the airstream moves said edge along a length of the metered dose as the dry powder is released from the substrate; having the user inhale through a mouthpiece on the releasing means so as to inhale the de-aggregated dry powder entrained in the airstream into airways of the user; wherein the therapeutic dry powder comprises at least one finely divided, pharmacologically active substance; and wherein the user inhales so as to produce a pressure difference within the releasing means in a range of 1-8 kPa. 49. The method of claim 48, wherein the pharmacologically active substance as it is delivered to the user comprises at least 50% fine particle fraction, with fine particle fraction defined as a fraction of the delivered pharmacologically active substance by mass with a maximum aerodynamic particle size of 5 .mu.m, where aerodynamic particle size is defined as a diameter of a spherical particle having a density of 1 g/cm.sup.3 that has the same inertial properties in air as the particle of the pharmacologically active substance. 50. The method of claim 48, wherein the pharmacologically active substance has an electrostatic specific charge capability of at least 0.1 .mu.C/g and a discharge rate factor of at least 0.1 s half-life period (Q.sub.50). 51. The method of claim 48, wherein the user inhales so as to produce a pressure difference within the releasing means in a range of 1-4 kPa. 52. The method of claim 49, wherein the user inhales so as to produce a pressure difference within the releasing means in a range of 1-8 kPa. 53. The method of claim 49, wherein the user inhales so as to produce a pressure difference within the releasing means in a range of 1-4 kPa. 54. The method of claim 50, wherein the user inhales so as to produce a pressure difference within the releasing means in a range of 1-8 kPa. 55. The method of claim 50, wherein the user inhales so as to produce a pressure difference within the releasing means in a range of 1-4 kPa. 56. The method of claim 48, wherein the pharmacologically active substance is an alpha1-proteinase inhibitor. 57. The method of claim 48, wherein the pharmacologically active substance is an interleukin 1. 58. The method of claim 48, wherein the pharmacologically active substance is a parathyroid hormone. 59. The method of claim 48, wherein the pharmacologically active substance is a genotropin. 60. The method of claim 48, wherein the pharmacologically active substance consists of colony stimulating factors. 61. The method of claim 48, wherein the pharmacologically active substance is an erythropoietin. 62. The method of claim 48, wherein the pharmacologically active substance is an interferon. 63. The method of claim 48, wherein the pharmacologically active substance is calcitonin. 64. The method of claim 48, wherein the pharmacologically active substance is factor VIII. 65. The method of claim 48, wherein the pharmacologically active substance is an alpha-1-antitrypsin. 66. The method of claim 48, wherein the pharmacologically active substance is a follicle stimulating hormone. 67. The method of claim 48, wherein the pharmacologically active substance is an LHRH agonist. 68. The method of claim 48, wherein the pharmacologically active substance is IGF-I. 69. The method of claim 48, wherein the pharmacologically active substance is insulin. 70. The method of claim 48, wherein the pharmacologically active substance is a protein. 71. The method of claim 48, wherein the pharmacologically active substance is a peptide. 72. The method of claim 48, wherein the pharmacologically active substance has an electrostatic specific charge capability of at least 0.1 .mu.C/g and a discharge rate factor of at least 0.1 s half-life period (Q.sub.50). 73. The method of claim 48, wherein the pharmacologically active substance is systemically acting. 74. The method of claim 48, wherein the pharmacologically active substance is locally acting in the lung of the user. 75. The method of claim 48, wherein the dry powder is adapted for oral administration. 76. The method of claim 48, wherein the dry powder is adapted for nasal administration.

Details for Patent 6,881,398

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Pharmacia & Upjohn Company Llc	GENOTROPIN	somatropin	For Injection	020280	08/24/1995		2022-04-12
Pharmacia & Upjohn Company Llc	GENOTROPIN	somatropin	For Injection	020280	01/27/1998		2022-04-12
Pharmacia & Upjohn Company Llc	GENOTROPIN	somatropin	For Injection	020280	10/23/1996		2022-04-12
Nps Pharmaceuticals, Inc.	NATPARA	parathyroid hormone	For Injection	125511	01/23/2015		2022-04-12