Method and apparatus for coating skin piercing microprojections

• US 6,855,372 B2
• Filed: 03/15/2002
• Issued: 02/15/2005
• Est. Priority Date: 03/16/2001
• Status: Expired due to Term

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Trautman, Joseph C., Cormier, Michel J. N., Wright, Cedric T.
• Primary Examiner(s): Lamb, Brenda A.
• Application Number:
  US10/099,604
• Publication Number:
  US 20020132054A1
• Time in Patent Office: 1,068 Days
• Field of Search: 427/2.1, 427/2.14, 427/2.31, 427/287, 427/256, 427/428, 427/429, 427/430.1, 427/434.3, 101/490
• US Class Current: 427/287
• CPC Class Codes: A61B 17/205 Vaccinating by means of needles or other puncturing devices
• CPC Class Codes: A61K 9/0021 Intradermal administration, e.g. through microneedle arrays, needleless injectors mechanical aspects A61M
• CPC Class Codes: A61M 2037/0046 Solid microneedles
• CPC Class Codes: A61M 2037/0053 Methods for producing microneedles
• CPC Class Codes: A61M 37/0015 by using microneedles
• CPC Class Codes: B05D 1/18 performed by dipping
• CPC Class Codes: B05D 1/28 performed by transfer from the surfaces of elements carrying the liquid or other fluent material, e.g. brushes, pads, rollers

Abstract

An apparatus and method are provided for selectively applying an agent-containing liquid coating to extremely tiny skin piercing microprojections (10). The coating solution is applied to the skin piercing microprojections (10) using a coating technique which selectively coats only the skin piercing microprojections (10) and not the substrate (12) from which the microprojections (10) extend, and then dried. The coating method includes providing an agent-containing coating liquid and conveying the liquid to a liquid holding surface having a coating transfer region. The depth of the coating liquid at the coating transfer region is precisely controlled. The microprojections are then immersed to a predetermined level in the coating liquid. The liquid that coats the microprojections (10) is then dried to form a solid agent-containing coating on the microprojections (10).

Claims

1. A method of coating a liquid onto a plurality of microprojections extending from a surface or edge of a substrate substantially without coating the liquid onto the substrate, comprising the steps of:

providing an agent-containing coating liquid;

providing a cylindrically shaped roller having a liquid-holding surface, the liquid holding surface having a coating transfer region;

conveying said coating liquid onto said liquid-holding surface;

controlling the depth of said coating liquid at said coating transfer region to a predetermined depth; and

immersing the microprojections to a predetermined level in said coating liquid disposed at said coating transfer region, wherein the microprojections have a length, as measured from a surface or edge of the substrate, which is greater than said predetermined depth of said coating liquid at said coating transfer region.

2. A method of coating a liquid onto a plurality of microprojections extending from a surface or edge of a substrate substantially without coating the liquid onto the substrate, comprising the steps of:

providing an agent-containing coating liquid;

providing a cylindrically shaped roller having a liquid-holding surface, the liquid holding surface having a coating transfer region;

conveying said coating liquid onto said liquid-holding surface;

controlling the depth of said coating liquid at said coating transfer region to a predetermined depth; and

immersing the microprojections to a predetermined level in said coating liquid disposed at said coating transfer region, wherein the microprojections have a length, as measured from a surface or edge of the substrate, which is greater than said predetermined depth, and wherein the depth of said coating liquid at said coating transfer region is greater than said microprojection immersion level.

3. A method of coating a liquid onto a plurality of microprojections extending from a surface or edge of a substrate substantially without coating the liquid onto the substrate, comprising the steps of:

providing an agent-containing coating liquid;

providing a cylindrically shaped roller having a liquid holding surface, said liquid-holding surface having a coating transfer region;

conveying said coating liquid onto said liquid-holding surface;

controlling the depth of said coating liquid at said coating transfer region to a predetermined depth; and

immersing the microprojections to a predetermined level in said coating liquid disposed at said coating transfer region.

4. A method of coating a liquid onto a plurality of microprojections extending from a surface or edge of a substrate substantially without coating the liquid onto the substrate, comprising the steps of:

providing an agent-containing coating liquid;

providing a cylindrically shaped roller having a liquid holding surface, said liquid-holding surface having a coating transfer region;

conveying said coating liquid onto said liquid-holding surface by rotating a portion of said roller through a bath of said coating liquid;

controlling the depth of the coating liquid at the coating transfer region to a predetermined depth; and

immersing the microprojections to a predetermined level in said coating liquid disposed at said coating transfer region.

5. A method of coating a liquid onto a plurality of microprojections extending from a surface or edge of a substrate substantially without coating the liquid onto the substrate, comprising the steps of:

providing an agent-containing coating liquid;

providing a cylindrically shaped roller having a liquid holding surface, said liquid-holding surface having a coating transfer region;

conveying said coating liquid onto said liquid-holding surface by rotating a portion of said roller through a bath of said coating liquid;

controlling the depth of said coating liquid at said coating transfer region to a predetermined depth by controlling the rotational speed of said roller; and

immersing the microprojections to a predetermined level in said coating liquid disposed at said coating transfer region.

6. A method of coating a liquid onto a plurality of microprojections extending from a surface or edge of a substrate substantially without coating the liquid onto the substrate, comprising the steps of:

providing an agent-containing coating liquid;

providing a cylindrically shaped roller having a liquid-holding surface, the liquid holding surface having a coating transfer region;

conveying said coating liquid onto said liquid-holding surface;

controlling the depth of said coating liquid at said coating transfer region to a predetermined depth; and

immersing the microprojections to a predetermined level in said coating liquid disposed at said coating transfer region, wherein said step of immersing of the microprojections is accomplished by conveying the substrate along a predetermined pathway adjacent said coating transfer region.

7. A method of coating a liquid onto a plurality or microprojections extending from a surface or edge of a substrate substantially without coating the liquid onto the substrate, comprising the steps of:

providing an agent-containing coating liquid;

providing a cylindrically shaped roller having a liquid-holding surface, the liquid holding surface having a coating transfer region;

conveying said coating liquid onto said liquid-holding surface;

controlling the depth of said coating liquid at said coating transfer region to a predetermined depth; and

immersing the microprojections to a predetermined level in said coating liquid disposed at said coating transfer region, wherein said step of immersing of the microprojections is accomplished by continuously conveying a web comprised of a plurality of the substrates along a predetermined pathway adjacent said coating transfer region.

8. A method of forming a solid coating on a plurality of microprojections extending from a surface or edge of a substrate without forming a coating on the substrate, comprising the steps of:

providing an agent-containing coating liquid;

providing a cylindrically shaped roller having a liquid-holding surface, the liquid holding surface having a coating transfer region;

conveying said coating liquid onto said liquid-holding surface;

controlling the depth of said coating liquid at said coating transfer region to a predetermined depth;

immersing the microprojections to a predetermined level in said coating liquid disposed at said coating transfer region;

removing the microprojcctions from said coating liquid; and

drying the coating liquid coated on the microprojections thereby forming a solid agent-containing coating on the microprojections.

9. A method of forming a solid coating on a plurality of microprojections extending from a surface or edge of a substrate without forming a coating on the substrate, comprising the steps of:

providing an agent-containing coating liquid;

providing a cylindrically shaped roller having a liquid-holding surface, the liquid holding surface having a coating transfer region;

conveying said coating liquid onto said liquid-holding surface;

controlling the depth of said coating liquid at said coating transfer region to a predetermined depth;

immersing the microprojections to a predetermined level in said coating liquid disposed at said coating transfer region;

removing the microprojections from said coating liquid; and

drying the coating liquid coated on the microprojections thereby forming a solid agent-containing coating on the microprojections; and

repeating said immersing, removing and drying steps to provide multiple layers of said solid agent-containing coating.

10. A method of forming a solid coating on a plurality of microprojections extending from a surface or edge of a substrate without forming a coating on the substrate, comprising the steps of:

providing an agent-containing coating liquid;

providing a cylindrically shaped roller having a liquid-holding surface, the liquid holding surface having a coating transfer region;

conveying said coating liquid onto said liquid-holding surface;

controlling the depth of said coating liquid at said coating transfer region to a predetermined depth;

immersing the microprojections to a predetermined level in said coating liquid disposed at said coating transfer region;

removing the microprojections from said coating liquid; and

drying the coating liquid coated on the microprojections thereby forming solid agent-containing coating on the microprojections, wherein said agent comprises a drug or a vaccine and the liquid comprises water.

11. A method of forming a solid coating on a plurality of microprojections extending from a surface or edge of a substrate without forming a coating on the substrate, comprising the steps of:

providing an agent-containing coating liquid;

providing a cylindrically shaped roller having a liquid-holding surface, the liquid holding surface having a coating transfer region;

conveying said coating liquid onto said liquid-holding surface;

controlling the depth of said coating liquid at said coating transfer region to a predetermined depth;

immersing the microprojections to a predetermined level in said coating liquid disposed at said coating transfer region;

removing the microprojections from said coating liquid; and

drying the coating liquid coated on the microprojections thereby forming solid agent-containing coating on the microprojections, wherein said coating liquid comprise a liquid solvent and said agent, wherein said coating liquid has an agent concentration, and wherein said agent concentration is controlled by a method selected from the group consisting of conducting said coating at a temperature which reduces evaporative loss of said liquid solvent, conducting said coating in an atmosphere containing sufficiently high amounts of gascous solvent to reduce evaporative loss of said liquid solvent, infusing liquid solvent into said coating liquid at a rate which compensates for evaporative loss of said liquid solvent, and combinations thereof.

12. A method of forming a solid coating on a plurality of microprojections extending from a surface or edge of a substrate without forming a coating on the substrate, comprising the steps of:

providing an agent-containing coating liquid;

providing a cylindrically shaped roller having a liquid-holding surface, the liquid holding surface having a coating transfer region;

conveying said coating liquid onto said liquid-holding surface;

controlling the depth of said coating liquid at said coating transfer region to a predetermined depth;

immersing the microprojections to a predetermined level in said coating liquid disposed at said coating transfer region;

removing the microprojections from said coating liquid; and

drying the coating liquid coated on the microprojections thereby forming solid agent-containing coating on the microprojections, wherein said coating liquid comprises a liquid solvent and said agent, wherein said coating liquid has an agent concentration, and wherein said agent concentration is controlled by a method selected from the group consisting of conducting said coating at a temperature which reduces evaporative loss of said liquid solvent, conducting said coating in an atmosphere containing sufficiently high amounts of gaseous solvent to reduce evaporative loss of said liquid solvent, infusing liquid solvent into said coating liquid at a rate which compensates for evaporative loss of said liquid solvent, and combinations thereof, and

wherein said liquid solvent comprises water, wherein said temperature is less than about 10°

C., and wherein said atmosphere has a relative humidity greater than about 60%.