Method of enhancing needleless transdermal powered drug delivery

• US 20070196490A1
• Filed: 07/18/2006
• Published: 08/23/2007
• Est. Priority Date: 01/22/1999
• Status: Abandoned Application

• Current Assignee: Powderject Research Limited (Pfizer Inc.)
• Original Assignee: Powderject Research Limited (Pfizer Inc.)
• Inventors: Kwon, Sung-Yun, Burkoth, Terry
• Application Number:
  US11/488,192
• Publication Number:
  US 20070196490A1
• Time in Patent Office: Days
• US Class Current: 424/477
• CPC Class Codes: A61K 38/28 Insulins
• CPC Class Codes: A61K 9/0021 Intradermal administration, e.g. through microneedle arrays, needleless injectors mechanical aspects A61M

Abstract

A method is provided for enhancing the transdermal or intradermal delivery of a therapeutic agent using a needleless syringe drug delivery system. In one embodiment, the method entails first administering to a predetermined area of skin or mucosa particles comprising the therapeutic agent, a placebo and/or a permeation enhancing agent. A transdermal delivery device or occlusive dressing is then topically positioned over the area of skin or mucosa. In another embodiment, the method entails administering a formulation of particles wherein the formulation includes particles that contain a therapeutic agent and placebo particles.

Claims

1-40. -40. (canceled)

41. A method for administering a therapeutic agent to a predetermined area of skin or mucosa of a vertebrate subject, said method comprising:

(a) accelerating particles into, across or both into and across the area of skin or mucosa, wherein the particles are accelerated toward the skin or mucosa using a needleless syringe device; and

(b) topically positioning a first occlusive dressing over the area of skin or mucosa, wherein the particles comprise the therapeutic agent.

42. The method of claim 41, wherein the particles comprise a placebo.

43. The method of claim 41, wherein step (b) comprises topically positioning the first occlusive dressing over the area of skin or mucosa.

44. The method of claim 41, wherein the particles comprise an antigen.

45. The method of claim 41, wherein the particles comprise an adjuvant.

46. The method of claim 44, wherein the method further comprises a pretreatment step to administer an adjuvant to the area of skin or mucosa before step (a).

47. The method of claim 46, wherein the pretreatment step comprises topically positioning a second occlusive dressing containing an adjuvant over the area of skin or mucosa.

48. The method of claim 44, wherein step (b) comprises topically positioning the first occlusive dressing over the area of skin or mucosa, and further wherein the first occlusive dressing contains an adjuvant.

49. The method of claim 41, wherein the particles comprise a permeation enhancing agent.

50. The method of claim 41, wherein the particles are accelerated toward the skin or mucosal tissue at a velocity of about 200 to 3,000 m/sec.

51. The method of claim 41, wherein the particles have a diameter predominantly in the range of about 0.1 to 250 μ

m.

52. The method of claim 41, wherein the particles comprise a biologically active protein, a peptide, an oligosaccharide, a polysaccharide or a vaccine composition.

53. The method of claim 41, wherein step (a) provides for rapid delivery onset from the first transdermal delivery device.

54. The method of claim 43, wherein the particles and the first occlusive dressing comprise the same therapeutic agent.

55. The method of claim 42, wherein the placebo comprises particles selected from the group consisting of a metal particle and a metal particle coated with a permeation enhancing agent.

56. The method of claim 55, wherein the particles comprise a permeation enhancing agent.

57. The method of claim 41, further comprising before step (a), topically positioning over the area of skin or mucosa a second occlusive dressing.

58. The method of claim 57, wherein the second occlusive dressing contains a permeation enhancing agent.