Method of producing transdermal absorption sheet

• US 10,639,822 B2
• Filed: 07/07/2017
• Issued: 05/05/2020
• Est. Priority Date: 07/27/2016
• Status: Active Grant

• Current Assignee: Fujifilm Corporation (Fujifilm Holdings Corporation)
• Original Assignee: Fujifilm Corporation (Fujifilm Holdings Corporation)
• Inventors: Okano, Keio, Katagiri, Yoshinobu
• Primary Examiner(s): Del Sole, Joseph S
• Assistant Examiner(s): Moreno Hernandez, Jerzi H
• Application Number:
  US15/643,484
• Publication Number:
  US 20180029258A1
• Time in Patent Office: 1,033 Days
• CPC Class Codes: A61K 38/385 Serum albumin
• CPC Class Codes: A61K 9/0021 Intradermal administration, e.g. through microneedle arrays, needleless injectors mechanical aspects A61M
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• 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: B29C 31/041 using filling or dispensing heads placed in closed moulds or in contact with mould walls B29C45/27 takes precedence
• CPC Class Codes: B29C 31/044 with moving heads for distributing liquid or viscous material into the moulds
• CPC Class Codes: B29C 39/026 characterised by the shape of the surface
• CPC Class Codes: B29C 39/24 Feeding the material into the mould

Abstract

A method of producing a transdermal absorption sheet including: preparing a mold having needle-like recessed portions including tapered inlet portions; preparing a liquid feeder including an opening portion and a lip land portion; filling the needle-like recessed portions with a solution by feeding the solution to the mold and moving the liquid feeder in a traveling direction while bringing an upstream end of the lip land portion on an upstream side of the liquid feeder in the traveling direction into contact with the mold; and forming needle portions and a sheet portion using a polymer solution. In the filling of the solution, when the upstream end of the lip land portion on the upstream side aligns with an upstream side inlet surface of one of the needle-like recessed portions, the shortest distance from a downstream side inlet surface of the needle-like recessed portion to a surface of the lip land portion on the upstream side is 220 μm or less.

Claims

1. A method of producing a transdermal absorption sheet comprising:

preparing a mold having needle-like recessed portions and at least one flat portion located on its upper surface, each of the needle-like recessed portions includes a tapered inlet portion, the at least one flat portion is adjacent to one of the needle-like recessed portions, wherein the at least one flat portion and the tapered inlet portion of the one of the needle-like recessed portions form an angle of 120°

or more and 160°

or less;

preparing a liquid feeding apparatus including a slit-shaped opening portion formed at a nozzle tip end portion and a lip land portion;

a filling step of filling the needle-like recessed portions with a solution by feeding the solution to the mold from the liquid feeding apparatus and moving the liquid feeding apparatus in a travelling direction, wherein the opening portion of the liquid feeding apparatus divides the lip land portion into two sides, a side at a downstream side with respect to the traveling direction is set as a primary side, and another side at an upstream side with respect to the traveling direction is set as a secondary side, wherein the liquid feeding apparatus is moved such that at least an upstream end of the lip land portion on the secondary side is in contact with the mold; and

a sheet portion forming step of forming needle portions and a sheet portion using a polymer solution,

wherein in the filling step, when the upstream end of the lip land portion on the secondary side aligns with a side of the tapered inlet portion of the needle-like recessed portion on the secondary side, the shortest distance between a side of the tapered inlet portion of the needle-like recessed portion on the primary side and a surface of the lip land portion of the liquid feeding apparatus on the secondary side nearest to the side of the tapered inlet portion of the needle-like recessed portion on the primary side is 220 μ

m or less,

wherein the lip land portion of the liquid feeding apparatus on the primary side is not in contact with the mold,

wherein the shortest distance between the lip land portion of the liquid feeding apparatus on the primary side and the upper surface of the mold is 500 μ

m or less and 100 μ

m or more.

2. The method of producing a transdermal absorption sheet according to claim 1,

wherein the lip land portion of the liquid feeding apparatus on the secondary side is parallel with a straight line connecting the side of the tapered inlet portion of the needle-like recessed portion on the primary side and the side of the tapered inlet portion of the needle-like recessed portion on secondary side.

3. The method of producing a transdermal absorption sheet according to claim 1,

wherein the lip land portion of the liquid feeding apparatus on the secondary side is inclined to a straight line connecting the side of the tapered inlet portion of the needle-like recessed portion on the primary side and the side of the tapered inlet portion of the needle-like recessed portion on secondary side.

4. The method of producing a transdermal absorption sheet according to claim 3,

wherein an angle is formed between the lip land portion of the liquid feeding apparatus on the secondary side and the straight line connecting the side of the tapered inlet portion of the needle-like recessed portion on the primary side and the side of the tapered inlet portion of the needle-like recessed portion on the secondary side.

5. The method of producing a transdermal absorption sheet according to claim 2,

wherein a length extending along the traveling direction of the lip land portion of the liquid feeding apparatus on the secondary side that is in contact with the mold is 5,000 μ

m or less.

6. The method of producing a transdermal absorption sheet according to claim 2,

wherein a length extending along the traveling direction of the lip land portion of the liquid feeding apparatus on the secondary side that is in contact with the mold is equal to or shorter than the longest length of an opening portion of the needle-like recessed portion.

7. The method of producing a transdermal absorption sheet according to claim 1,

wherein a surface of the lip land portion of the liquid feeding apparatus on the primary side is formed of a material which is more hydrophobic than the surface of the mold.

8. The method of producing a transdermal absorption sheet according to claim 1,

wherein the surface of the lip land portion of the liquid feeding apparatus on the secondary side is formed of a material which is more hydrophilic than a surface of lip land portion of the liquid feeding apparatus on the primary side.

9. The method of producing a transdermal absorption sheet according to claim 1,

wherein the lip land portion of the liquid feeding apparatus on the primary side has a notch portion which widens the opening portion of the liquid feeding apparatus on the primary side.

10. The method of producing a transdermal absorption sheet according to claim 1,

wherein the at least one flat portion is provided between adjacent two of the needle-like recessed portions of the mold, and a length of the at least one flat portion is 0.1 mm or more.