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Claims for Patent: 4,842,864

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Claims for Patent: 4,842,864

Title: Self-adhesive device for the percutaneous administration of an active ingredient
Abstract:The present invention relates to a novel self-adhesive matrix for the percutaneous administration of an active ingredient. This matrix comprises a combination of the following: (a) 40 to 60 parts by weight of an ethylene/vinyl acetate copolymer material, (b) 40 to 60 parts by weight of a higher aliphatic monoalcohol compound, (c) 1 to 20 parts by weight of a cellulose derivative material, (d) 0.1 to 8 parts by weight of a polyhydric alcohol compound, and (e) 0.01 to 10 parts by weight of an active ingredient which can be administered percutaneously, the weight ratio a+c/b+d being between 0.7 and 1.3.
Inventor(s): Guillemet; Alain (Dijon, FR), Teillaud; Eric (Talant, FR), Reginault; Philippe (Fontaine les Dijon, FR)
Assignee: Laboratories D'Hygiene et de Dietetique (Paris, FR)
Application Number:07/174,414
Patent Claims: 1. A self-adhesive matrix for the percutaneous administration of an active ingredient, which comprises:

(a) 40 to 60 parts by weight of an ethylene/vinyl acetate copolymer material,

(b) 40 to 60 parts by weight of a higher aliphatic monoalcohol compound,

(c) 1 to 20 parts by weight of a cellulose derivative material,

(d) 0.1 to 8 parts by weight of a polyhydric alcohol compound, and

(e) 0.01 to 10 parts by weight of an active ingredient which can be administered percutaneously,

the weight ratio a+c/b+d being between 0.7 and 1.3.

2. A self-adhesive matrix for the percutaneous administration of an active ingredient, which comprises:

(a) 40 to 60 parts by weight of an ethylene/vinyl acetate copolymer material,

(b) 40 to 60 parts by weight of a higher aliphatic monoalcohol compound,

(c) 1 to 20 parts by weight of a cellulose derivative material,

(d) 0.1 to 8 parts by weight of a polyhydric alcohol compound, and

(e) 0.01 to 10 parts by weight of a steroid selected from the group consisting of estradiol, progesterone, testosterone and derivative materials thereof, and corticosteroids,

the weight ratio a+c/b+d being between 0.7 and 1.3.

3. The matrix as claimed in claim 1, wherein the ethylene/vinyl acetate copolymer material has a content of vinyl acetate units of between 35 and 55% by weight, relative to the weight of the said copolymer material.

4. The matrix as claimed in claim 3, wherein the ethylene/vinyl acetate copolymer material has a content of vinyl acetate units of the order of 45% by weight, relative to the weight of the said copolymer material.

5. The matrix as claimed in claim 1, wherein the higher aliphatic monoalcohol compound is selected from the group consisting of saturated or unsaturated monoalcohol compounds having from 12 to 20 carbon atoms.

6. The matrix as claimed in claim 1, wherein the cellulose derivative material is selected from the group consisting of alkyl celluloses and hydroxyalkyl celluloses.

7. The matrix as claimed in claim 1, wherein the cellulose derivative material is selected from the group consisting of methyl cellulose, ethyl cellulose, propyl cellulose, methylpropyl cellulose, hydroxymethyl cellulose, hydroxyethyl cellulose and hydroxypropyl cellulose.

8. The matrix as claimed in claim 1, wherein the polyhydric alcohol compound is a glycol compound selected from the group consisting of alkylene glycols.

9. The matrix as claimed in claim 8, wherein the glycol compound is selected from the group consisting of ethylene glycol, propylene glycol, butylene glycol, triethylene glycol, diethylene glycol, polyethylene glycol and polypropylene glycol.

10. The matrix as claimed in claim 1, which comprises:

(a) 40 to 60 parts by weight of an ethylene/vinyl acetate copolymer material,

(b) 40 to 60 parts by weight of 2-octyldodecan-1-o1,

(c) 1 to 20 parts by weight of ethyl cellulose,

(d) 0.1 to 8 parts by weight of dipropylene glycol, and

(e) 0.01 to 10 parts by weight of estradiol,

the weight ratio a+c/b+d being between 0.7 and 1.3.

11. The matrix as claimed in claim 1 which comprises:

(a) about 45 parts by weight of an ethylene/vinyl acetate copolymer containing about 45% by weight of vinyl acetate units, relative to the weight of the said copolymer material,

(b) 40 to 45 parts by weight of 2-octyldodecan-1-o1,

(c) 5 to 10 parts by weight of ethyl cellulose with a viscosity of between 2.times.10.sup.-2 and 2.times.10.sup.-1 Pa.s,

(d) 1 to 5 parts by weight of dipropylene glycol, and

(e) 3 to 5 parts by weight of .beta.-estradiol.

12. A method for the preparatoin of a matrix as claimed in claim 1, wherein:

(1) the means (a) and part of the means (b) are mixed, with stirring, at a temperature greater than or equal to 110.degree. C.

(2) the means (c) is incorporated into the mixture resulting from stage 1, with stirring, at a temperature greater than or equal to 110.degree. C. , and then homogenized.

(3) the remainder of the means (b) is incorporated into the mixture resulting from stage 2, with stirring, at a temperature greater than or equal to 110.degree. C.,

(4) the resulting mixture obtained in this way is homogenized at a temperature greater than or equal to 110.degree. C. and then left to stand for at least 8 hours,

(5) the resulting mixture obtained in this way is heated at a temperature of 50.degree.-70.degree. C., preferably 60.degree. C. , for at least 0.25 h, after which the means (d) and the active ingredient in a solvent for the said active ingredient are then incorporated at this temperature.

(6) the resulting mixture is homogenized for at least 0.5 h without heating,

(7) the resulting mixture homogenized in this way is deposited on a temporary support, especially silicone-treated paper, at a temperature of the order of 50.degree.-70.degree. C., at a rate of 100 to 300 g/m.sup.2,

(8)the whole comprising the said temporary support and the matrix is heated at a temperature of the order of 70.degree.-90.degree. C. in order to evaporate the solvent for the active ingredient until the residual proportion is less than 5% by weight, and

(9) the resulting dry matrix is transferred onto an appropriate support.
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