Method of producing transdermal absorption sheet

• US 10,441,532 B2
• Filed: 05/22/2017
• Issued: 10/15/2019
• Est. Priority Date: 05/23/2016
• Status: Active Grant

• Current Assignee: Fujifilm Corporation (Fujifilm Holdings Corporation)
• Original Assignee: Fujifilm Corporation (Fujifilm Holdings Corporation)
• Inventors: Wakamatsu, Satoshi
• Primary Examiner(s): Bell, William P
• Assistant Examiner(s): Swanson, Andrew L
• Application Number:
  US15/600,797
• Publication Number:
  US 20170333342A1
• Time in Patent Office: 876 Days
• CPC Class Codes: A61K 47/36 Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
• CPC Class Codes: A61K 47/38 Cellulose; Derivatives thereof
• CPC Class Codes: A61K 9/0021 Intradermal administration, e.g. through microneedle arrays, needleless injectors mechanical aspects A61M
• CPC Class Codes: A61K 9/7007 Drug-containing films, membranes or sheets A61K9/0041, A61K9/0043, A61K9/006, A61K9/0063 take precedence
• CPC Class Codes: A61M 2037/0053 Methods for producing microneedles
• CPC Class Codes: A61M 37/0015 by using microneedles
• CPC Class Codes: B29C 39/24 Feeding the material into the mould
• CPC Class Codes: B29D 7/01 Films or sheets
• CPC Class Codes: B29L 2031/7544 Injection needles, syringes

Abstract

A method of producing a transdermal absorption sheet includes: filling needle-like recessed portions on a mold having the needle-like recessed portions with a polymer solution; drying the filled polymer solution to form a polymer layer; and peeling off the polymer layer, wherein, in drying the polymer solution, low rate drying conditions are set in a concentration range in which an average solid content concentration of the polymer solution is 70 wt % to 80 wt %. When a constant drying rate of water is used as an index, in the concentration range in which the average solid content concentration of the polymer solution is 70 wt % to 80 wt %, and the constant drying rate is lower than a maximum value of a constant drying rate under a drying condition where the average solid content concentration of the polymer solution is less than 70 wt % and more than 80 wt %.

Claims

1. A method of producing a transdermal absorption sheet comprising, in this order:

a polymer solution filling step of filling needle-like recessed portions on a mold having the needle-like recessed portions arranged two-dimensionally with a polymer solution;

a polymer solution drying step of drying the polymer solution filling the needle-like recessed portions to form a polymer layer; and

a peeling-off step of peeling off the polymer layer from the mold,

wherein in the polymer solution drying step, low rate drying conditions are set in a concentration range in which an average solid content concentration of the polymer solution is 70 wt % or more and 80 wt % or less in terms of weight percent, and

when a constant drying rate of water is used as an index, in the concentration range in which the average solid content concentration of the polymer solution is 70 wt % or more and 80 wt % or less in terms of weight percent, the constant drying rate is set to be lower than a maximum value of a constant drying rate under drying conditions in a concentration range in which the average solid content concentration of the polymer solution is less than 70 wt % and also set to be lower than a maximum value of a constant drying rate under drying conditions in a concentration range in which the average solid content concentration of the polymer solution is more than 80 wt % in terms of weight percent, and

wherein the constant drying rate of water under the low rate drying conditions in the concentration range in which the average solid content concentration of the polymer solution is 70 wt % or more and 80 wt % or less in terms of weight percent is 0.10 kg/(h·

m²) or less.

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

wherein in the concentration range in which the average solid content concentration of the polymer solution is 70 wt % or more and 80 wt % or less in terms of weight percent, a lid having an opening portion is placed at a position where the lid covers the polymer solution.

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

a drug solution filling step of filling the needle-like recessed portions with a drug-containing solution before the polymer solution filling step.

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

a drug solution drying step of drying the drug-containing solution after the drug solution filling step before the polymer solution filling step.

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

wherein the polymer solution contains a drug.

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

wherein the constant drying rate in at least part of the concentration range in which the average solid content concentration of the polymer solution is less than 70 wt % in terms of weight percent is set to be higher than the constant drying rate in the concentration range in which the average solid content concentration of the polymer solution is 70 wt % or more and 80 wt % or less in terms of weight percent.

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

wherein the constant drying rate in at least part of the concentration range in which the average solid content concentration of the polymer solution is more than 80 wt % in terms of weight percent is set to be higher than the constant drying rate in the concentration range in which the average solid content concentration of the polymer solution is 70 wt % or more and 80 wt % or less in terms of weight percent.

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

wherein a polymer contained in the polymer solution includes at least one of sodium chondroitin sulfate, hydroxypropyl cellulose, or dextran.

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

wherein a sheet portion average thickness after the polymer solution drying step is 50 μ

m or more and 500 μ

m or less.