Microprojection array having a beneficial agent containing coating

• US 20020177839A1
• Filed: 04/20/2002
• Published: 11/28/2002
• Est. Priority Date: 04/20/2001
• Status: Active Grant

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Daddona, Peter E., Young, Wendy A., Johnson, Juanita A., Cormier, Michel J. N.
• Granted Patent: US 7,963,935 B2
• Time in Patent Office: Days
• US Class Current: 604/500
• CPC Class Codes: A61B 17/205 Vaccinating by means of needles or other puncturing devices
• CPC Class Codes: A61K 47/42 Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein oligopeptides having up to five amino acids A61K47/183; polyamino acids A61K47/34
• CPC Class Codes: A61K 9/0014 Skin, i.e. galenical aspects of topical compositions non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00
• CPC Class Codes: A61K 9/0021 Intradermal administration, e.g. through microneedle arrays, needleless injectors mechanical aspects A61M
• CPC Class Codes: A61M 2037/0007 having means for enhancing the permeation of substances through the epidermis, e.g. using suction or depression, electric or magnetic fields, sound waves or chemical agents
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 2037/0046 Solid microneedles
• CPC Class Codes: A61M 37/0015 by using microneedles
• CPC Class Codes: A61P 31/00 Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
• CPC Class Codes: A61P 37/06 Immunosuppressants, e.g. drugs for graft rejection
• CPC Class Codes: A61P 37/08 Antiallergic agents antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14
• CPC Class Codes: A61P 5/10 of the posterior pituitary hormones, e.g. oxytocin, ADH

Abstract

The device including a plurality of stratum corneum-piercing microprojections, and a solid coating disposed upon the microprojections, wherein the solid coating includes at least one beneficial agent and a biocompatible carrier is provided. The device is applied to the skin of a living animal (e.g., a human), causing the microprojections to pierce the stratum corneum and deliver an effective dose of the agent to the animal.

Claims

1. A device for delivering a beneficial agent through the stratum corneum, the device comprising:

a plurality of stratum corneum-piercing microprojections;

a coating disposed upon at least at portion of said microprojections, wherein the coating includes at least one beneficial agent and at least one water soluble biocompatible carrier; and

wherein said coating is placed in contact with body fluid after the microprojections have pierced the stratum corneum.

2. A device for delivering a beneficial agent through the stratum corneum, the device comprising:

a plurality of stratum corneum-piercing microprojections;

a coating disposed upon at least at portion of said microprojections, wherein the coating includes at least one beneficial agent and human albumin as a water soluble biocompatible carrier; and

wherein said coating is placed in contact with body fluid after the microprojections have pierced the stratum corneum.

3. A device for delivering a beneficial agent through the stratum corneum, the device comprising:

a plurality of stratum corneum-piercing microprojections;

a coating disposed upon at least at portion of said microprojections, wherein the coating includes at least one beneficial agent and bio-engineered human albumin as a water soluble biocompatible carrier; and

wherein said coating is placed in contact with body fluid after the microprojections have pierced the stratum corneum.

4. A device for delivering a beneficial agent through the stratum corneum, the device comprising:

a plurality of stratum corneum-piercing microprojections;

a coating disposed upon at least at portion of said microprojections, wherein the coating includes at least one beneficial agent and at least one water soluble biocompatible carrier and the coating is applied to the microprojections as an aqueous solution or suspension; and

wherein said coating is placed in contact with body fluid after the microprojections have pierced the stratum corneum.

5. A device for delivering a beneficial agent through the stratum corneum, the device comprising:

a plurality of stratum corneum-piercing microprojections;

a coating disposed upon at least at portion of said microprojections, wherein the coating includes at least one beneficial agent and at least one water soluble biocompatible carrier and the coating is in an amorphous glassy form; and

wherein said coating is placed in contact with body fluid after the microprojections have pierced the stratum corneum.

6. A device for delivering a beneficial agent through the stratum corneum, the device comprising:

a plurality of stratum corneum-piercing microprojections;

a coating disposed upon at least at portion of said microprojections, wherein the coating includes at least one beneficial agent and at least one water soluble biocompatible carrier;

said coating is placed in contact with body fluid after the microprojections have pierced the stratum corneum; and

wherein the at least one beneficial agent is suspended in the at least one biocompatible carrier.

7. A device for delivering a beneficial agent through the stratum corneum, the device comprising:

a plurality of stratum corneum-piercing microprojections;

a coating disposed upon at least at portion of said microprojections, wherein the coating includes at least one beneficial agent and at least one water soluble biocompatible carrier; and

wherein said coating is placed in contact with body fluid after the microprojections have pierced the stratum corneum.

8. A device for delivering a beneficial agent through the stratum corneum, the device comprising:

a plurality of stratum corneum-piercing microprojections;

a coating disposed upon at least at portion of said microprojections, wherein the coating includes at least one beneficial agent and at least one water soluble biocompatible carrier;

wherein said coating is placed in contact with body fluid after the microprojections have pierced the stratum corneum; and

wherein the at least one beneficial agent is selected from the group consisting of proteins, glycoproteins, peptides, polysaccharides, oligosaccharides, oligonucleotides, and DNA.

9. A device for delivering a beneficial agent through the stratum corneum, the device comprising:

a plurality of stratum corneum-piercing microprojections;

a coating disposed upon at least at portion of said microprojections, wherein the coating includes at least one beneficial agent and at least one water soluble biocompatible carrier;

wherein said coating is placed in contact with body fluid after the microprojections have pierced the stratum corneum; and

wherein the at least one beneficial agent is selected from the group consisting of vaccines and desensitizing agents.

10. A device for delivering a beneficial agent through the stratum corneum, the device comprising:

a plurality of stratum corneum-piercing microprojections;

a coating disposed upon at least at portion of said microprojections, wherein the coating includes at least one beneficial agent and at least one water soluble biocompatible carrier;

wherein said coating is placed in contact with body fluid after the microprojections have pierced the stratum corneum; and

wherein the at least one biocompatible carrier is selected from the group consisting of human albumin, dextran sulfate, pentosan polysulfate, polyglutamic acid, polyaspartic acid, polyhistidine, and non-reducing sugars.

11. A device for delivering a beneficial agent through the stratum corneum, the device comprising:

a plurality of stratum corneum-piercing microprojections;

a coating disposed upon at least at portion of said microprojections, wherein the coating includes at least one beneficial agent and at least one water soluble biocompatible carrier;

wherein said coating is placed in contact with body fluid after the microprojections have pierced the stratum corneum; and

wherein the ratio of all biocompatible carriers to all beneficial agents range from about 0.2;

1 to about 5;

1 weight/weight.

12. A device for delivering a beneficial agent through the stratum corneum, the device comprising:

a plurality of stratum corneum-piercing microprojections;

a coating disposed upon at least at portion of said microprojections, wherein the coating includes at least one beneficial agent and at least one water soluble biocompatible carrier;

wherein said coating is placed in contact with body fluid after the microprojections have pierced the stratum corneum; and

wherein the ratio of all biocompatible carriers to all beneficial agents range from about 0.5;

1 to about 2;

1 weight/weight.

13. A device for delivering a beneficial agent through the stratum corneum, the device comprising:

a plurality of stratum corneum-piercing microprojections;

a coating disposed upon at least at portion of said microprojections, wherein the coating includes at least one beneficial agent and at least one water soluble biocompatible carrier;

wherein said coating is placed in contact with body fluid after the microprojections have pierced the stratum corneum; and

wherein the at least one beneficial agent is suspended in the at least one biocompatible carrier and wherein the at least one biocompatible carrier functions as an adhesive to retain the at least one beneficial agent upon the microprojections.

14. A device for delivering a beneficial agent through the stratum corneum, the device comprising:

a plurality of stratum corneum-piercing microprojections;

a coating disposed upon at least at portion of said microprojections, wherein the coating includes at least one beneficial agent and at least one water soluble biocompatible carrier;

wherein said coating is placed in contact with body fluid after the microprojections have pierced the stratum corneum; and

wherein the at least one biocompatible carrier functions as an adhesive to retain the at least one beneficial agent upon the microprojections.

15. A device for delivering a beneficial agent through the stratum corneum, the device comprising:

a plurality of stratum corneum-piercing microprojections;

a coating disposed upon at least at portion of said microprojections, wherein the coating includes at least one beneficial agent and at least one water soluble biocompatible carrier;

wherein said coating is placed in contact with body fluid after the microprojections have pierced the stratum corneum; and

wherein at least a portion of the microprojections further includes a means adapted to retain the coating.

16. A device for delivering a beneficial agent through the stratum corneum, the device comprising:

a plurality of stratum corneum-piercing microprojections;

a coating disposed upon at least at portion of said microprojections, wherein the coating includes at least one beneficial agent and at least one water soluble biocompatible carrier;

wherein said coating is placed in contact with body fluid after the microprojections have pierced the stratum corneum; and

wherein at least a portion of the microprojections further includes an aperture formed through the microprojection as a means to retain the coating.

17. A device for delivering a beneficial agent through the stratum corneum, the device comprising:

a plurality of stratum corneum-piercing microprojections;

a coating disposed upon at least at portion of said microprojections, wherein the coating includes at least one beneficial agent and at least one water soluble biocompatible carrier;

wherein said coating is placed in contact with body fluid after the microprojections have pierced the stratum corneum; and

wherein at least a portion of the microprojections further includes at lease one groove disposed upon the microprojection as a means to retain the coating.

18. A device for delivering a beneficial agent through the stratum corneum, the device comprising:

a plurality of stratum corneum-piercing microprojections;

a coating, having a thickness of less than about 50 micrometers, disposed upon at least at portion of said microprojections, wherein the coating includes at least one beneficial agent and at least one water soluble biocompatible carrier; and

wherein said coating is placed in contact with body fluid after the microprojections have pierced the stratum corneum.

19. A device for delivering a beneficial agent through the stratum corneum, the device comprising:

a plurality of stratum corneum-piercing microprojections;

a coating, having a thickness of less than about 25 micrometers, disposed upon at least at portion of said microprojections, wherein the coating includes at least one beneficial agent and at least one water soluble biocompatible carrier; and

wherein said coating is placed in contact with body fluid after the microprojections have pierced the

20. A device for delivering a beneficial agent through the stratum corneum, the device comprising:

a plurality of stratum corneum-piercing microprojections;

a coating, having a thickness between about 1.0 micrometers and about 10 micrometers, disposed upon at least at portion of said microprojections, wherein the coating includes at least one beneficial agent and at least one water soluble biocompatible carrier; and

wherein said coating is placed in contact with body fluid after the microprojections have pierced the

21. A device for delivering a beneficial agent through the stratum corneum, the device comprising:

a plurality of stratum corneum-piercing microprojections;

a coating disposed upon at least at portion of said microprojections, wherein the coating includes at least one beneficial agent and at least one water soluble biocompatible carrier;

wherein said coating is placed in contact with body fluid after the microprojections have pierced the stratum corneum; and

wherein the at least one biocompatible carrier stabilizes the at least one beneficial agent.

22. A device for delivering a beneficial agent through the stratum corneum, the device comprising:

a plurality of stratum corneum-piercing microprojections;

a coating disposed upon at least at portion of said microprojections, wherein the coating includes at least one beneficial agent and at least one water soluble biocompatible carrier;

wherein said coating is placed in contact with body fluid after the microprojections have pierced the stratum corneum; and

wherein the at least one biocompatible carrier is a polyamino acid.

23. A device for delivering a beneficial agent through the stratum corneum, the device comprising:

a plurality of stratum corneum-piercing microprojections;

a coating disposed upon at least at portion of said microprojections, wherein the coating includes at least one beneficial agent and at least one water soluble biocompatible carrier;

wherein said coating is placed in contact with body fluid after the microprojections have pierced the stratum corneum; and

wherein the microprojections extend through the stratum corneum into the epidermis.

24. A device for delivering a beneficial agent through the stratum corneum, the device comprising:

a plurality of stratum corneum-piercing microprojections;

a coating disposed upon at least at portion of said microprojections, wherein the coating includes at least one beneficial agent and at least one water soluble biocompatible carrier;

wherein said coating is placed in contact with body fluid after the microprojections have pierced the stratum corneum; and

wherein the at least one biocompatible carrier in the coating is water soluble.

25. A device for delivering a beneficial agent through the stratum corneum, the device comprising:

a plurality of stratum corneum-piercing microprojections;

a coating disposed upon at least at portion of said microprojections, wherein the coating includes at least one beneficial agent and at least one water soluble biocompatible carrier;

wherein said coating is placed in contact with body fluid after the microprojections have pierced the stratum corneum; and

, wherein the coating is soluble in body fluid.

26. A device for delivering a beneficial agent through the stratum corneum, the device comprising:

a plurality of stratum corneum-piercing microprojections; and

a coating disposed upon at least at portion of said microprojections, wherein the coating includes a plurality of beneficial agents and at least one water soluble biocompatible carrier;

wherein said coating is placed in contact with body fluid after the microprojections have pierced the stratum corneum.

27. A device for delivering a beneficial agent through the stratum corneum, the device comprising:

a plurality of stratum corneum-piercing microprojections;

a coating disposed upon at least at portion of said microprojections, wherein the coating includes a plurality of beneficial agents and at least one water soluble biocompatible carrier;

wherein said coating is placed in contact with body fluid after the microprojections have pierced the stratum corneum; and

wherein the each of the plurality of beneficial agents are included on coatings which are on separate portions of the plurality of microprojections

28. A method for delivering a beneficial agent through the stratum corneum layer of skin, the method comprising:

providing a microprojection array having a plurality of stratum corneum-piercing microprojections, the microprojections being coated with a biocompatible coating containing at least one beneficial agent and a biocompatible carrier; and

causing the microprojections to pierce the stratum corneum layer of a predetermined skin site, whereby the beneficial agent is released into the skin tissue.

29. A method for delivering a beneficial agent through the stratum corneum layer of skin, the method comprising:

providing a microprojection array having a plurality of stratum corneum-piercing microprojections, the microprojections being coated with a biocompatible coating containing at least one beneficial agent and human albumin as a water soluble biocompatible carrier; and

causing the microprojections to pierce the stratum corneum layer of a predetermined skin site, whereby the beneficial agent is released into the skin tissue.

30. A method for delivering a beneficial agent through the stratum corneum layer of skin, the method comprising:

providing a microprojection array having a plurality of stratum corneum-piercing microprojections, the microprojections being coated with a biocompatible coating containing at least one beneficial agent and bio-engineered human albumin as a water soluble biocompatible carrier; and

causing the microprojections to pierce the stratum corneum layer of a predetermined skin site, whereby the beneficial agent is released into the skin tissue.

31. A method for delivering a beneficial agent through the stratum corneum layer of skin, the method comprising:

providing a microprojection array having a plurality of stratum corneum-piercing microprojections, the microprojections being coated with a biocompatible coating containing at least one beneficial agent and human albumin as a water soluble biocompatible carrier;

causing the microprojections to pierce the stratum corneum layer of a predetermined skin site, whereby the beneficial agent is released into the skin tissue; and

wherein the coating is applied to the microprojections as an aqueous solution or suspension.

32. A method for delivering a beneficial agent through the stratum corneum layer of skin, the method comprising:

providing a microprojection array having a plurality of stratum corneum-piercing microprojections, the microprojections being coated with a biocompatible coating containing at least one beneficial agent and human albumin as a water soluble biocompatible carrier;

wherein the coating is in an amorphous glassy form; and

causing the microprojections to pierce the stratum corneum layer of a predetermined skin site, whereby the beneficial agent is released into the skin tissue.

33. A method for delivering a beneficial agent through the stratum corneum layer of skin, the method comprising:

providing a microprojection array having a plurality of stratum corneum-piercing microprojections, the microprojections being coated with a biocompatible coating containing at least one beneficial agent and human albumin as a water soluble biocompatible carrier;

causing the microprojections to pierce the stratum corneum layer of a predetermined skin site, whereby the beneficial agent is released into the skin tissue; and

wherein the at least one beneficial agent is suspended in the at least one biocompatible carrier.

34. A method for delivering a beneficial agent through the stratum corneum layer of skin, the method comprising:

providing a microprojection array having a plurality of stratum corneum-piercing microprojections, the microprojections being coated with a biocompatible coating containing at least one beneficial agent and human albumin as a water soluble biocompatible carrier;

causing the microprojections to pierce the stratum corneum layer of a predetermined skin site, whereby the beneficial agent is released into the skin tissue; and

wherein the at least one biocompatible carrier includes at least one carrier chosen from the group consisting of polyamino acids, polysaccharides and oligosaccharides.

35. A method for delivering a beneficial agent through the stratum corneum layer of skin, the method comprising:

providing a microprojection array having a plurality of stratum corneum-piercing microprojections, the microprojections being coated with a biocompatible coating containing at least one beneficial agent and human albumin as a water soluble biocompatible carrier;

causing the microprojections to pierce the stratum corneum layer of a predetermined skin site, whereby the beneficial agent is released into the skin tissue; and

wherein the at least one beneficial agent is selected from the group consisting of proteins, glycoproteins, peptides, polysaccharides, oligosaccharides, oligonucleotides, and DNA.

36. A method for delivering a beneficial agent through the stratum corneum layer of skin, the method comprising:

providing a microprojection array having a plurality of stratum corneum-piercing microprojections, the microprojections being coated with a biocompatible coating containing at least one beneficial agent and human albumin as a water soluble biocompatible carrier;

causing the microprojections to pierce the stratum corneum layer of a predetermined skin site, whereby the beneficial agent is released into the skin tissue; and

wherein the at least one beneficial agent is selected from the group consisting of vaccines and desensitizing agents.

37. A method for delivering a beneficial agent through the stratum corneum layer of skin, the method comprising:

providing a microprojection array having a plurality of stratum corneum-piercing microprojections, the microprojections being coated with a biocompatible coating containing at least one beneficial agent and human albumin as a water soluble biocompatible carrier;

causing the microprojections to pierce the stratum corneum layer of a predetermined skin site, whereby the beneficial agent is released into the skin tissue; and

wherein the at least one biocompatible carrier is selected from the group consisting of human albumin, dextran sulfate, pentosan polysulfate, polyglutamic acid, polyaspartic acid, polyhistidine, and non-reducing sugars.

38. A method for delivering a beneficial agent through the stratum corneum layer of skin, the method comprising:

providing a microprojection array having a plurality of stratum corneum-piercing microprojections, the microprojections being coated with a biocompatible coating containing at least one beneficial agent and human albumin as a water soluble biocompatible carrier;

causing the microprojections to pierce the stratum corneum layer of a predetermined skin site, whereby the beneficial agent is released into the skin tissue; and

wherein the ratio of all biocompatible carriers to all beneficial agents range from about 0.2;

1 to about 5;

1 weight/weight.

39. A method for delivering a beneficial agent through the stratum corneum layer of skin, the method comprising:

providing a microprojection array having a plurality of stratum corneum-piercing microprojections, the microprojections being coated with a biocompatible coating containing at least one beneficial agent and human albumin as a water soluble biocompatible carrier;

causing the microprojections to pierce the stratum corneum layer of a predetermined skin site, whereby the beneficial agent is released into the skin tissue; and

wherein the ratio of all biocompatible carriers to all beneficial agents range from about 0.5;

1 to about 2;

1 weight/weight.

40. A method for delivering a beneficial agent through the stratum corneum layer of skin, the method comprising:

providing a microprojection array having a plurality of stratum corneum-piercing microprojections, the microprojections being coated with a biocompatible coating containing at least one beneficial agent and human albumin as a water soluble biocompatible carrier;

causing the microprojections to pierce the stratum corneum layer of a predetermined skin site, whereby the beneficial agent is released into the skin tissue; and

wherein the at least one beneficial agent is suspended in the at least one biocompatible carrier and wherein the at least one biocompatible carrier functions as an adhesive to retain the at least one beneficial agent upon the microprojections.

41. A method for delivering a beneficial agent through the stratum corneum layer of skin, the method comprising:

providing a microprojection array having a plurality of stratum corneum-piercing microprojections, the microprojections being coated with a biocompatible coating containing at least one beneficial agent and human albumin as a water soluble biocompatible carrier; and

causing the microprojections to pierce the stratum corneum layer of a predetermined skin site, whereby the beneficial agent is released into the skin tissue; and

wherein the at least one biocompatible carrier functions as an adhesive to retain the at least one beneficial agent upon the microprojections.

42. A method for delivering a beneficial agent through the stratum corneum layer of skin, the method comprising:

providing a microprojection array having a plurality of stratum corneum-piercing microprojections, the microprojections being coated with a biocompatible coating containing at least one beneficial agent and human albumin as a water soluble biocompatible carrier;

causing the microprojections to pierce the stratum corneum layer of a predetermined skin site, whereby the beneficial agent is released into the skin tissue; and

wherein at least a portion of the microprojections further includes a means adapted to retain the coating.

43. A method for delivering a beneficial agent through the stratum corneum layer of skin, the method comprising:

providing a microprojection array having a plurality of stratum corneum-piercing microprojections, the microprojections being coated with a biocompatible coating containing at least one beneficial agent and human albumin as a water soluble biocompatible carrier;

causing the microprojections to pierce the stratum corneum layer of a predetermined skin site, whereby the beneficial agent is released into the skin tissue; and

wherein at least a portion of the microprojections further includes an aperture formed through the microprojection as a means to retain the coating.

44. A method for delivering a beneficial agent through the stratum corneum layer of skin, the method comprising:

providing a microprojection array having a plurality of stratum corneum-piercing microprojections, the microprojections being coated with a biocompatible coating containing at least one beneficial agent and human albumin as a water soluble biocompatible carrier;

causing the microprojections to pierce the stratum corneum layer of a predetermined skin site, whereby the beneficial agent is released into the skin tissue; and

wherein at least a portion of the microprojections further includes at lease one groove disposed upon the one or more microprojections as a means to retain the coating.

45. A method for delivering a beneficial agent through the stratum corneum layer of skin, the method comprising:

providing a microprojection array having a plurality of stratum corneum-piercing microprojections, the microprojections being coated with a biocompatible coating containing at least one beneficial agent and a biocompatible carrier;

causing the microprojections to pierce the stratum corneum layer of a predetermined skin site, whereby the beneficial agent is released into the skin tissue; and

wherein the coating has a thickness less than about 50 micrometers.

46. A method for delivering a beneficial agent through the stratum corneum layer of skin, the method comprising:

providing a microprojection array having a plurality of stratum corneum-piercing microprojections, the microprojections being coated with a biocompatible coating containing at least one beneficial agent and a biocompatible carrier;

causing the microprojections to pierce the stratum corneum layer of a predetermined skin site, whereby the beneficial agent is released into the skin tissue; and

wherein the coating has a thickness less than about 25 micrometers.

47. A method for delivering a beneficial agent through the stratum corneum layer of skin, the method comprising:

providing a microprojection array having a plurality of stratum corneum-piercing microprojections, the microprojections being coated with a biocompatible coating containing at least one beneficial agent and a biocompatible carrier;

causing the microprojections to pierce the stratum corneum layer of a predetermined skin site, whereby the beneficial agent is released into the skin tissue; and

wherein the coating has a thickness between about 1.0 micrometers and about 10 micrometers.

48. A method for delivering a beneficial agent through the stratum corneum layer of skin, the method comprising:

providing a microprojection array having a plurality of stratum corneum-piercing microprojections, the microprojections being coated with a biocompatible coating containing at least one beneficial agent and a biocompatible carrier;

causing the microprojections to pierce the stratum corneum layer of a predetermined skin site, whereby the beneficial agent is released into the skin tissue; and

wherein the at least one biocompatible carrier stabilizes the at least one beneficial agent.

49. A method for delivering a beneficial agent through the stratum corneum layer of skin, the method comprising:

providing a microprojection array having a plurality of stratum corneum-piercing microprojections, the microprojections being coated with a biocompatible coating containing at least one beneficial agent and a biocompatible carrier;

causing the microprojections to pierce the stratum corneum layer of a predetermined skin site, whereby the beneficial agent is released into the skin tissue; and

wherein the at least one biocompatible carrier is a polyamino acid.

50. A method for delivering a beneficial agent through the stratum corneum layer of skin, the method comprising:

providing a microprojection array having a plurality of stratum corneum-piercing microprojections, the microprojections being coated with a biocompatible coating containing at least one beneficial agent and a biocompatible carrier;

causing the microprojections to pierce the stratum corneum layer of a predetermined skin site, whereby the beneficial agent is released into the skin tissue; and

wherein the microprojections extend through the stratum corneum into the epidermis.

51. A method for delivering a beneficial agent through the stratum corneum layer of skin, the method comprising:

providing a microprojection array having a plurality of stratum corneum-piercing microprojections, the microprojections being coated with a biocompatible water soluble coating containing at least one beneficial agent and a biocompatible carrier; and

causing the microprojections to pierce the stratum corneum layer of a predetermined skin site, whereby the beneficial agent is released into the skin tissue.

52. A method for delivering a beneficial agent through the stratum corneum layer of skin, the method comprising:

providing a microprojection array having a plurality of stratum corneum-piercing microprojections, the microprojections being coated with a biocompatible coating containing at least one beneficial agent and a biocompatible carrier;

said coating being soluble in body fluid; and

causing the microprojections to pierce the stratum corneum layer of a predetermined skin site, whereby the beneficial agent is released into the skin tissue.

53. A method for delivering a beneficial agent through the stratum corneum layer of skin, the method comprising:

providing a microprojection array having a plurality of stratum corneum-piercing microprojections, the microprojections being coated with a biocompatible coating containing a plurality of beneficial agents and a biocompatible carrier; and

causing the microprojections to pierce the stratum corneum layer of a predetermined skin site, whereby the beneficial agent is released into the skin tissue.

54. A method for delivering a beneficial agent through the stratum corneum layer of skin, the method comprising:

providing a microprojection array having a plurality of stratum corneum-piercing microprojections, the microprojections being coated with a biocompatible coating containing a plurality of beneficial agents and a biocompatible carrier;

causing the microprojections to pierce the stratum corneum layer of a predetermined skin site, whereby the beneficial agent is released into the skin tissue; and

wherein the each of the plurality of beneficial agents are included on coatings which are on separate portions of the plurality of microprojections.

55. A composition useful for forming a solid coating on microprojections in a microprojection array, said composition comprising a beneficial agent and a biocompatible carrier, wherein said composition is applied to the microprojections in a liquid form and forms a solid coating on said microprojection array, and wherein the solid coating allows release of the beneficial agent from the coating upon hydration of the coating.

56. A composition useful for forming a solid coating on microprojections in a microprojection array, said composition comprising a beneficial agent and human albumin, wherein said composition is applied to the microprojections in a liquid form and forms a solid coating on said microprojection array, and wherein the solid coating allows release of the beneficial agent from the coating upon hydration of the coating.

57. A composition useful for forming a solid coating on microprojections in a microprojection array, said composition comprising a beneficial agent and bioengineered human albumin, wherein said composition is applied to the microprojections in a liquid form and forms a solid coating on said microprojection array, and wherein the solid coating allows release of the beneficial agent from the coating upon hydration of the coating.

58. A composition useful for forming a solid coating on microprojections in a microprojection array, said composition comprising a beneficial agent and a biocompatible carrier, wherein said composition is applied to the microprojections as an aqueous solution or aqueous suspension and forms a solid coating on said microprojection array, and wherein the solid coating allows release of the beneficial agent from the coating upon hydration of the coating.

59. A composition useful for forming a solid coating on microprojections in a microprojection array, said composition comprising a beneficial agent and a biocompatible carrier, wherein said composition is applied to the microprojections in a liquid form and forms a coating on said microprojection array, said coating having an amorphous glassy form;

and wherein the solid coating allows release of the beneficial agent from the coating upon hydration of the coating.

60. A composition useful for forming a solid coating on microprojections in a microprojection array, said composition comprising a beneficial agent and a biocompatible carrier, wherein said composition is applied to the microprojections in a liquid form with the beneficial agent suspended in the liquid;

said composition forming a coating on said microprojection array, and wherein the coating allows release of the beneficial agent from the coating upon hydration of the coating.

61. A composition useful for forming a solid coating on microprojections in a microprojection array, said composition comprising a beneficial agent and a biocompatible carrier, wherein the biocompatible carrier includes at least one carrier chosen from the group consisting of polyamino acids, polysaccharides and oligosaccharides;

wherein said composition is applied to the microprojections in a liquid form and forms a solid coating on said microprojection array, and wherein the solid coating allows release of the beneficial agent from the coating upon hydration of the coating.

62. A composition useful for forming a solid coating on microprojections in a microprojection array, said composition comprising a beneficial agent and a biocompatible carrier, wherein the beneficial agent is selected from the group consisting of proteins, glycoproteins, peptides, polysaccharides, oligosaccharides, oligonucleotides, and DNA;

wherein said composition is applied to the microprojections in a liquid form and forms a coating on said microprojection array, and wherein the coating allows release of the beneficial agent from the coating upon hydration of the coating.

63. A composition useful for forming a solid coating on microprojections in a microprojection array, said composition comprising a beneficial agent and a biocompatible carrier, wherein the at least one beneficial agent is selected from the group consisting of vaccines and desensitizing agents, wherein said composition is applied to the microprojections in a liquid form and forms a solid coating on said microprojection array, and wherein the solid coating allows release of the beneficial agent from the coating upon hydration of the coating.

64. A composition useful for forming a solid coating on microprojections in a microprojection array, said composition comprising a beneficial agent and a biocompatible carrier, wherein the at least one biocompatible carrier is selected from the group consisting of human albumin, dextran sulfate, pentosan polysulfate, polyglutamic acid, polyaspartic acid, polyhistidine, and non-reducing sugars, wherein said composition is applied to the microprojections in a liquid form and forms a solid coating on said microprojection array, and wherein the solid coating allows release of the beneficial agent from the coating upon hydration of the coating.

65. A composition useful for forming a solid coating on microprojections in a microprojection array, said composition comprising a beneficial agent and a biocompatible carrier, wherein the ratio of all biocompatible carriers to all beneficial agents range from about 0.2:

1 to about 5;

1 weight/weight, wherein said composition is applied to the microprojections in a liquid form and forms a solid coating on said microprojection array, and wherein the solid coating allows release of the beneficial agent from the coating upon hydration of the coating.

66. A composition useful for forming a solid coating on microprojections in a microprojection array, said composition comprising a beneficial agent and a biocompatible carrier, wherein the ratio of all biocompatible carriers to all beneficial agents range from about 0.5:

1 to about 2;

1 weight/weight, wherein said composition is applied to the microprojections in a liquid form and forms a solid coating on said microprojection array, and wherein the solid coating allows release of the beneficial agent from the coating upon hydration of the coating.

67. A composition useful for forming a solid coating on microprojections in a microprojection array, said composition comprising a beneficial agent and a biocompatible carrier, wherein the at least one beneficial agent is suspended in the at least one biocompatible carrier and wherein the at least one biocompatible carrier functions as an adhesive to the at least one beneficial agent upon the microprojections, wherein said composition is applied to the microprojections in a liquid form and forms a solid coating on said microprojection array, and wherein the solid coating allows release of the beneficial agent from the coating upon hydration of the coating.

68. A composition useful for forming a solid coating on microprojections in a microprojection array, said composition comprising a beneficial agent and a biocompatible carrier, wherein the at least one biocompatible carrier functions as an adhesive to retain the at least one beneficial agent upon the microprojections, wherein said composition is applied to the microprojections in a liquid form and forms a solid coating on said microprojection array, and wherein the solid coating allows release of the beneficial agent from the coating upon hydration of the coating.

69. A composition useful for forming a solid coating on microprojections in a microprojection array, said composition comprising a beneficial agent and a biocompatible carrier, wherein said composition is applied to the microprojections in a liquid form and forms a solid coating on said microprojection array, wherein the composition is capable of being formed into a coating of having a thickness less than about 50 micrometers, and wherein the solid coating allows release of the beneficial agent from the coating upon hydration of the coating.

70. A composition useful for forming a solid coating on microprojections in a microprojection array, said composition comprising a beneficial agent and a biocompatible carrier, wherein said composition is applied to the microprojections in a liquid form and forms a solid coating on said microprojection array, wherein the composition is capable of being formed into a coating of having a thickness less than about 25 micrometers,

and wherein the solid coating allows release of the beneficial agent from the coating upon hydration of the coating.

71. A composition useful for forming a solid coating on microprojections in a microprojection array, said composition comprising a beneficial agent and a biocompatible carrier, wherein said composition is applied to the microprojections in a liquid form and forms a solid coating on said microprojection array, wherein the composition is capable of being formed into a coating of having a thickness between about 1.0 micrometers and about 10 micrometers, and wherein the solid coating allows release of the beneficial agent from the coating upon hydration of the coating.

72. A composition useful for forming a solid coating on microprojections in a microprojection array, said composition comprising a beneficial agent and a biocompatible carrier, wherein said composition is applied to the microprojections in a liquid form and forms a solid coating on said microprojection array, wherein the at least one biocompatible carrier stabilizes the at least one beneficial agent, and wherein the solid coating allows release of the beneficial agent from the coating upon hydration of the coating.

73. A composition useful for forming a solid coating on microprojections in a microprojection array, said composition comprising a beneficial agent and a biocompatible carrier, wherein the at least one biocompatible carrier is a polyamino acid, wherein said composition is applied to the microprojections in a liquid form and forms a solid coating on said microprojection array, and wherein the solid coating allows release of the beneficial agent from the coating upon hydration of the coating.

74. A composition useful for forming a solid coating on microprojections in a microprojection array, said composition comprising a beneficial agent and a water soluble biocompatible carrier, wherein said composition is applied to the microprojections in a liquid form and forms a solid coating on said microprojection array, and wherein the solid coating allows release of the beneficial agent from the coating upon hydration of the coating.

75. A composition useful for forming a solid coating on microprojections in a microprojection array, said composition comprising a beneficial agent and a biocompatible carrier, wherein said composition is applied to the microprojections in a liquid form and forms a solid coating on said microprojection array, said coating being soluble in body fluid, and wherein the solid coating allows release of the beneficial agent from the coating upon hydration of the coating.