Preparation for body surface application and preparation for body surface application-holding sheet
It is an objective to provide a microneedle and a microneedle array formed from a self-dissolving base which can realize higher absorption efficiency and a higher pharmacological availability. A preparation 1 for body surface application has two sections divided in the insertion direction, namely, an acral portion 5 and a rear end portion 6 . The acral portion 5 is a section including a body surface insertion end 2 , and holds a target substance soluble in base. The rear end portion 6 is a section including a pressing end 3 , and is formed mainly only from the base. The rear end portion 6 does not hold the target substance. When the preparation 1 for body surface application is inserted into a body surface such as the skin, since the target substance is contained in the acral portion 5 , even if part of the rear end side thereof is subsequently not fully inserted into the body surface, high absorption efficiency and high pharmacological effect can be realized where the actual dose of the target substance is not below the desired amount of the drug.
1. A needle-shaped preparation for body surface application, comprising:
a base formed from a biosoluble substance and containing a target substance, the preparation being configured to be inserted into a body surface, and the target substance being capable of being absorbed into the body by dissolution of the base,
wherein the preparation comprises at least a first section and a second section divided by an interface in an insertion direction;
the second section is the rearmost end section of the preparation in the insertion direction;
the first section contains the target substance evenly distributed therein;
the first section is a solidified first liquid base in which the target substance is dissolved;
the second section is a solidified second liquid base not containing the target substance; and
the solidified first liquid base and the solidified second liquid base have different compositions which were prepared separately.
2. A needle-shaped preparation for body surface application, comprising:
a base formed from a biosoluble substance and containing a target substance, the preparation being configured to be inserted into a body surface, and the target substance being capable of being absorbed into the body by dissolution of the base,
wherein the preparation comprises at least a first section and a second section divided by an interface in an insertion direction;
the second section is the rearmost end section of the preparation in the insertion direction;
the first section contains the target substance evenly distributed therein;
the first section is:
(a) a solidified first liquid base in which cells are dispersed,
(b) a solidified first liquid base in which the target substance is dispersed as a lipid dispersion, or
(c) a solidified first liquid base in which the target substance formed from fine particles having an average particle size of 10 micrometers or less is dispersed therein;
the second section is a solidified second liquid base not containing the target substance; and
the solidified first liquid base and the solidified second liquid base have different compositions which were prepared separately.
3. The preparation for body surface application according to claim 1 or 2 , wherein the first section is the frontmost end section.
4. The preparation for body surface application according to claim 1 or 2 , wherein the total length in the insertion direction is in a range of 200 to 600 micrometers.
5. The preparation for body surface application according to claim 4 , wherein the total length in the insertion direction is in a range of 400 to 600 micrometers.
6. The preparation for body surface application according to claim 5 , wherein a sum of the lengths in the insertion direction of the sections excluding the rearmost end section is 350 micrometers or less.
7. A needle-shaped preparation for body surface application, comprising:
a base formed from a biosoluble substance and containing a target substance, the preparation being configured to be inserted into a body surface, and the target substance being capable of being absorbed into the body by dissolution of the base,
wherein the preparation comprises at least a first section, a second section and a third section divided by interfaces in an insertion direction;
the first section contains the target substance and is not either the frontmost end section or the rearmost end section of the preparation in the insertion direction; and
the first section is a solidified first liquid base in which the target substance is dissolved or evenly dispersed therein;
the second section is a solidified second liquid base not containing the target substance; and
the solidified first liquid base and the solidified second liquid base have different compositions which were prepared separately.
8. The preparation for body surface application according to claim 7 , wherein the first section is adjacent to the frontmost end section.
9. The preparation for body surface application according to claim 7 or 8 , wherein the total length in the insertion direction is in a range of 200 to 600 micrometers.
10. The preparation for body surface application according to claim 9 , wherein the total length in the insertion direction is in a range of 400 to 600 micrometers.
11. The preparation for body surface application according to claim 10 , wherein a sum of the lengths in the insertion direction of the sections excluding the rearmost end section is 350 micrometers or less.
12. The preparation for body surface application according to claim 7 or 8 , wherein the target substance is
encapsulated in a microcapsule or comprises
fine particles having an average particle size of 10 micrometers or less.
13. The preparation for body surface application according to any one of claim 1 , 2 , or 7 , wherein the body surface comprises skin, cornea, oral soft tissue, gum, or nasal cavity mucous membrane.
14. The preparation for body surface application according to any one of claim 1 , 2 , or 7 , wherein the base is a high molecular weight substance.
15. The preparation for body surface application according to claim 14 , wherein the high molecular weight substance is at least one selected from the group consisting of polysaccharide, protein, polyvinyl alcohol, carboxy vinyl polymer, a copolymer thereof, and a salt thereof.
16. The preparation for body surface application according to any one of claim 1 , 2 , or 7 , wherein the target substance comprises a peptide, a protein, a nucleic acida, or a polvsaccharide.
17. The preparation for body surface application according to any one of claim 1 , 2 , or 7 , wherein the target substance comprises a drug, a vaccine, a nutrient, or a cosmetic component.
18. The preparation for body surface application according to any one of claim 1 , 2 , or 7 , wherein the base includes a porous substance, and the target substance is held in the porous substance, so that the target substance can be sustained-released.
19. A preparation for body surface application-holding sheet, in which one or two or more of the preparation for body surface application according to any one of claim 1 , 2 , or 7 are held on at least one surface of a sheet-like support, wherein the preparation for body surface application is configured to be inserted into a body surface by pressing against the body surface.
20. The preparation for body surface application-holding sheet according to claim 19 , wherein the preparation for body surface application includes an adhesive substance in the rearmost end section.