METHODS FOR MANUFACTURING MICROPROJECTION ARRAYS

• US 20110006458A1
• Filed: 04/23/2010
• Published: 01/13/2011
• Est. Priority Date: 04/24/2009
• Status: Abandoned Application

• Current Assignee: Corium International, Inc.
• Original Assignee: Corium International, Inc.
• Inventors: Singh, Parminder, Trautman, Joseph C., Sagi, Appala, Worsham, Robert Wade, Chen, Guohua
• Application Number:
  US12/766,783
• Publication Number:
  US 20110006458A1
• Time in Patent Office: Days
• US Class Current: 264/319
• CPC Class Codes: A61M 2037/0053 Methods for producing microneedles
• CPC Class Codes: A61M 37/0015 by using microneedles

Abstract

Methods for the manufacture of a microprojection array are provided. In the methods, a formulation is introduced into cavities of a microprojection array mold by means that achieve a uniform amount of formulation retained in each cavity.

Claims

1-17. -17. (canceled)

20-28. -28. (canceled)

29. A method of forming a microprojection array, comprising:

dispensing a quantity of a formulation on a substrate,

contacting a mold having a plurality of cavities for individual microprojections in the array with the formulation dispensed on the substrate, wherein the mold and the formulation are contacted such that the plurality of cavities are in fluid communication with the formulation,

transferring formulation into the plurality of cavities; and

disengaging the mold from the formulation and the substrate in a manner that retains formulation in each of the plurality of cavities.

30. The method of claim 29, wherein transferring comprises transferring formulation into the plurality of cavities by applying pressure to the mold when in contact with the formulation dispensed on the substrate.

31. The method of claim 30, wherein applying comprises applying a pressure in the range of 0.1-1 atmosphere (10.1-101 kPa).

32. The method of claim 29, wherein dispensing comprises dispensing formulation into a cavity of the substrate.

33. The method of claim 29, wherein dispensing comprises dispensing formulation on a substrate that comprises channels for venting a gas.

34. The method of claim 29, wherein disengaging the mold from the formulation and the substrate achieves a uniform retention of formulation in each of the plurality of cavities, as evidenced by a standard deviation in amount of formulation retained in each cavity less than or equal to about 10% of the average amount of formulation retained in the cavities.

35. The method of claim 29, wherein disengaging the mold from the formulation and the substrate is achieved by lifting an edge of the mold and gradually peeling the mold from the formulation and substrate at a controlled rate.

36. The method of claim 35, wherein the controlled rate of disengaging is carried out by a rotatable member attachable to the mold.

37. The method of claim 29, further comprising recovering formulation that is not retained in the plurality of cavities.

38. The method of claim 37, wherein at least about 90% of the formulation not retained in the plurality of the cavities is recovered.

39. The method of claim 29, wherein the steps of dispensing, contacting, transferring and disengaging are conducted at a temperature of between about 23-25°

C.

40. The method of claim 29, wherein disengaging comprises disengaging at a rate of less than or equal to 5 mm/min.

41. The method of claim 29, further comprising after disengaging, drying the formulation retained in the plurality of cavities.

42. The method of claim 29 further comprising after said drying, applying a second formulation onto the mold.

43. The method of claim 29, wherein the plurality of cavities project into the mold from an approximately planar mold surface.

44. The method of claim 43, wherein for at least one cavity in the plurality of cavities, the diameter of the at least one cavity'"'"'s intersection with a plane parallel to the planar mold surface decreases monotonically as a function of the plane'"'"'s distance from the mold surface.

45. The method of claim 44, wherein the diameter of the intersection of the at least one cavity with a plane parallel to the planar mold surface decreases more rapidly as when the plane is close to the mold surface than when the plane is further from the mold surface.

46. The method of claim 45, wherein the diameter of the intersection of the at least one cavity with a plane parallel to the planar mold surface decreases linearly as a function of distance to the mold surface for a range of distances close to the mold surface and then decreases linearly but more slowly for a second range of distances further away from the mold surface.

47. A method of fabricating a microprojection array, comprising:

positioning a mold comprising a plurality of cavities for forming microprojections in an array of microprojections in a fixture, the fixture comprised of a first member and a second member and at least one port, the mold positioned between the first and second members;

introducing a formulation into the fixture through the at least one port such that the formulation contacts openings to the plurality of cavities in the mold;

transferring the formulation introduced into the fixture into the plurality of cavities; and

withdrawing formulation from the fixture at a rate whereby formulation transferred into the plurality of cavities is retained in each cavity in the plurality.

48. The method of claim 47, wherein transferring comprises pressurizing the formulation within the fixture.

49. The method of claim 47, wherein positioning comprises positioning more than one mold in the fixture.

50. The method of claim 47, wherein the steps of transferring and withdrawing achieve a uniform retention of formulation in each of the plurality of cavities, as evidenced by a standard deviation in amount of formulation retained in each cavity less than or equal to about 10% of the average amount of formulation retained in the cavities.

51. The method of claim 47, wherein the introducing and withdrawing formulation are conducted under the control of a microprocessor.

52. The method of claim 47, wherein positioning includes positioning a mold wherein the plurality of cavities are elongated cavities with a longer dimension and a shorter dimension, and the mold is held in the fixture in a way that the longer dimension of each cavity in the plurality of cavities is approximately horizontal.

53. The method of claim 47, further comprising removing the mold with retained formulation from the fixture.

54. The method of claim 47, further comprising removing solvent from the retained formulation in each of the plurality of cavities.