Adhesive preparation containing fentanyl
View Patent ↗The present invention provides a Fentanyl-containing percutaneously absorbable adhesive preparation, which is obtained from economic starting materials, has a constitution simpler than that of conventional ones, has sufficient skin permeability, and which permits control of skin permeability by changing the mixing ratio of two kinds of polyisobutylene having different molecular weights, a tackifier and an organic liquid. Specifically, the present invention provides a percutaneously absorbable adhesive preparation comprising a support and an adhesive layer laminated on one surface thereof, wherein the adhesive layer comprises Fentanyl, two kinds of polyisobutylene having different molecular weights, a tackifier and an organic liquid compatible with the aforementioned two kinds of polyisobutylene and the aforementioned tackifier.
1. A percutaneously absorbable adhesive preparation comprising a support and an adhesive layer laminated on one surface of the support,
wherein the adhesive layer comprises (a) Fentanyl, (b) two kinds of polyisobutylene having different molecular weights, (c) a tackifier, and (d) an organic liquid compatible with the two kinds of polyisobutylene and the tackifier,
wherein the organic liquid comprises a combination of (i) a fatty acid alkyl ester comprising a higher fatty acid having 12 to 16 carbon atoms and a lower monovalent alcohol having 1 to 4 carbon atoms and (ii) a branched long-chain alcohol having 16 to 22 carbon atoms in a ratio of 1:0.2-1:5 by weight,
wherein the fatty acid alkyl ester is isopropyl myristate, and the branched long-chain alcohol is at least one selected from isostearyl alcohol and octyldodecanol,
wherein the organic liquid is present in an amount of not more than 20% of the total weight of the adhesive layer, and
wherein Fentanyl is present in an amount of 1.5-2.5% of the total weight of the adhesive layer.
2. The preparation of claim 1 , wherein the two kinds of polyisobutylene comprises a first polyisobutylene having a viscosity average molecular weight of 600000-1500000 and a second polyisobutylene having a viscosity average molecular weight of 40000-85000.
3. The preparation of claim 1 , wherein the tackifier is a polybutene having a number average molecular weight of 900-2900.
4. The preparation of claim 1 , wherein the tackifier is an alicyclic saturated hydrocarbon resin having a number average molecular weight of 500-860.
5. The preparation of claim 1 , wherein the two kinds of polyisobutylene comprise a first polyisobutylene and a second polyisobutylene having a smaller molecular weight than that of the first polyisobutylene, at a mixing ratio of the first polyisobutylene:second polyisobutylene of 1:1.2-1:2 by weight.
6. The preparation of claim 2 , wherein the two kinds of polyisobutylene comprise a first polyisobutylene and a second polyisobutylene having a smaller molecular weight than that of the first polyisobutylene, at a mixing ratio of the first polyisobutylene:second polyisobutylene of 1:1.2-1:2 by weight.
7. The preparation of claim 1 , wherein the tackifier is present in an amount of 15-30% of the total weight of the adhesive layer.
8. The preparation of claim 1 , wherein the branched long-chain alcohol is octyldodecanol.