IP Library Granted Patent US 9,492,401
Granted Patent B2
US 9,492,401 · App. 12/979,120 · Granted Nov 15, 2016

Transdermal systems containing multilayer adhesive matrices to modify drug delivery

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Quick Facts
Patent No.
US 9,492,401
App. No.
12/979,120
Granted
Nov 15, 2016
Kind
B2
Abstract

A transdermal drug-containing dosage unit comprises: a backing layer substantially impervious to the drug to be delivered transdermally; a first polymeric adhesive matrix, in contact with the backing layer, having dispersed therein the drug and having a first delivery profile of the drug; a second polymeric adhesive matrix, in contact with said first polymeric adhesive matrix, having dispersed therein the drug and having a second delivery profile of the drug, wherein said second delivery profile is different from said first delivery profile; and a release liner in contact with the second polymeric adhesive matrix. The first polymeric adhesive matrix can release the drug more quickly or more slowly than the second polymeric adhesive matrix. Through the selection of the two matrices, the delivery profile of the drug through the skin can be selectively modified and controlled.

Claims (18)

1. A transdermal drug-containing dosage unit which comprises a laminate comprising:

a) a backing layer substantially impervious to the drug to be delivered transdermally;

b) a first polymeric adhesive matrix, in contact with the backing layer, having dispersed therein a therapeutically effective amount of the drug and having a first initial rate of delivery of the drug;

c) a second polymeric adhesive matrix, having dispersed therein a therapeutically effective amount of the drug and having a second initial rate of delivery of the drug, said second polymeric matrix in contact with a release liner; and

d) at least one additional adhesive matrix, laminated in between said first and second polymeric adhesive matrices, having dispersed therein a therapeutically effective amount of the drug; each said additional adhesive matrix having an initial rate of delivery of the drug;

wherein said initial rates of delivery of at least two of said matrices are different from one another;

wherein on matrix comprises an acrylic adhesive, one matrix comprises a polvisobutylene adhesive and one matrix comprises a silicon adhesive; and

wherein said drug comprises an estrogen or a combination of an estrogen and a progestin.

2. The transdermal drug-containing dosage unit of claim 1 , wherein said estrogen comprises estradiol or mono- or di-esters thereof which are transdermally absorbable.

3. The transdermal drug-containing dosage unit of claim 1 , wherein said progestin comprises norethindrone acetate or levonorgestrel.

4. The transdermal drug-containing dosage unit of claim 1 which comprises from about 0.05% to about 40% w/w of drug.

5. The transdermal drug-containing dosage unit of claim 1 , which comprises from about 0.1% to about 4.0% w/w of drug.

6. The transdermal drug-containing dosage unit of claim 1 , which comprises from about 0.1% to about 4.0% of said estrogen.

7. The transdermal drug-containing dosage unit of claim 1 , which comprises from about 0.1% to about 4.0% of said estrogen.

8. A method for administering a drug transdermally to an individual in need of such administration, comprising applying to skin of the individual a transdermal dosage unit according to claim 1 .

9. The transdermal drug-containing dosage unit of claim 1 , wherein each of said initial rates of delivery is different from said other initial rates of delivery.

10. The transdermal drug-containing dosage unit of claim 1 , which comprises one additional adhesive matrix in between said first and second polymeric adhesive matrices, such that said additional adhesive matrix is in contact with said first adhesive matrix and with said second adhesive matrix.

11. The transdermal drug-containing dosage unit of claim 1 , which comprises more than one additional adhesive matrix in between said first and second polymeric adhesive matrices.

Assignments (3)
PATENT RELEASE Recorded Dec 10, 2012
From: BANK OF AMERICA, N.A., AS ADMINISTRATIVE AGENT
To: DEY PHARMA L.P. (F/K/A DEY, L.P.); MYLAN PHARMACEUTICALS, INC.; MYLAN BERTEK PHARMACEUTICALS INC.; MYLAN TECHNOLOGIES, INC.; SOMERSET PHARMACEUTICALS, INC.; MYLAN INSTITUTIONAL INC. (F/K/A UDL LABORATORIES, INC.); MYLAN INC.
Reel/Frame 029440/0967 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 10, 2011
From: JACKSON, KRISTIN; MILLER, KENNETH JAMES, II
To: MYLAN TECHNOLOGIES, INC.
Reel/Frame 027370/0035 →
SECURITY AGREEMENT Recorded Nov 21, 2011
From: MYLAN PHARMACEUTICALS, INC.; MYLAN BERTEK PHARMACEUTICALS INC.; MYLAN TECHNOLOGIES, INC.; MYLAN INSTITUTIONAL INC. (F/K/A UDL LABORATORIES, INC.); SOMERSET PHARMACEUTICALS, INC.; DEY PHARMA, L.P. (F/K/A DEY L.P.)
To: BANK OF AMERICA, N.A., AS COLLATERAL AGENT
Reel/Frame 027270/0799 →