Claims for Patent: 8,632,802

Summary for Patent: 8,632,802

Title:	Device for transdermal administration of drugs including acrylic polymers
Abstract:	A transdermal delivery system is provided where the drug delivery rates, onset and profiles of at least one active agent are controlled by selectively manipulating the monomeric make up of an acrylic-based polymer in the transdermal drug delivery system. The drug carrier composition may be comprised of (a) one or more acrylic-based polymers having one or more different monomers selected from the group consisting of hard and soft monomers; (b) one or more silicone-based polymers; and (c) one or more active agents where the device provides a desired solubility for the active agent and controls drug delivery rates, onset and profiles of at least one active agent.
Inventor(s):	Kanios; David (Miami, FL)
Assignee:	Noven Pharmaceuticals, Inc. (Miami, FL)
Application Number:	13/229,007
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,632,802
Patent Claims:	1. A transdermal drug delivery system comprising a blend of: (a) a polymer composition comprising at least one acrylic-based polymer polymerized with monomers that include: (i) a soft acrylic monomer having a glass transition temperature (T.sub.g) from about -70.degree. C. to about -10.degree. C. in an amount of from 50% to 70% by weight of the acrylic-based polymer; and (ii) a hard acrylic monomer having a glass transition temperature (T.sub.g) from about -5.degree. C. to about 120.degree. C. in an amount of from 30% to 50% by weight of the acrylic-based polymer; and (b) 0.1% to about 50% by weight of the transdermal drug delivery system of one or more drugs incorporated into the polymer composition, wherein all acrylic-based polymers present in said polymer composition of the transdermal drug delivery system are acrylic-based polymers polymerized with monomers that include: (i) a soft acrylic monomer having a glass transition temperature (T.sub.g) from about -70.degree. C. to about -10.degree. C. in an amount of from 50% to 70% by weight of the acrylic-based polymer; and (ii) a hard acrylic monomer having a glass transition temperature (T.sub.g) from about -5.degree. C. to about 120.degree. C. in an amount of from 30% to 50% by weight of the acrylic-based polymer, and wherein said acrylic-based polymers are not polymerized with methacrylic acid monomers. 2. The transdermal drug delivery system according to claim 1, wherein the drug is a crystalline drug. 3. The transdermal drug delivery system according to claim 2, wherein the crystalline drug is selected from the group consisting of estradiol, norethindrone acetate, testosterone and scopolamine. 4. The transdermal drug delivery system according to claim 1, wherein the drug is present in said transdermal drug delivery system from about 0.3% to 30% by weight. 5. The transdermal drug delivery system according to claim 1, wherein the drug is present in said transdermal drug delivery system from about 0.5% to about 15% by weight. 6. The transdermal drug delivery system according to claim 1, wherein the drug is present in said transdermal drug delivery system from about 1% to about 10% by weight. 7. The transdermal drug delivery system according to claim 1, wherein the soft acrylic monomer has a glass transition temperature (T.sub.g) from about -60.degree. C. to about -20.degree. C. 8. The transdermal drug delivery system according to claim 1, wherein the soft acrylic monomer has a glass transition temperature (Tg) from about, -60.degree. C. to about -24.degree. C. 9. The transdermal drug delivery system according to claim 1, wherein the soft acrylic monomer is selected from the group consisting of 2-ethyl hexyl acrylate, isobutyl acrylate, ethyl acrylate, butyl acrylate, dodecyl methacrylate, 2-ethylhexyl methacrylate, 2-ethoxyethyl acrylate, isopropyl acrylate, and 2-methoxyethyl acrylate. 10. The transdermal drug delivery system according to claim 1, wherein the hard acrylic monomer has a glass transition temperature (T.sub.g) from about 10.degree. C. to about 120.degree. C. 11. The transdermal drug delivery system according to claim 1, wherein the hard acrylic monomer has a glass transition temperature (T.sub.g) from about, 10.degree. C. to about 105.degree. C. 12. The transdermal drug delivery system according to claim 1, wherein the hard acrylic monomer is selected from the group consisting of methacrylate, N-butyl acrylate, acrylic acid, butyl methacrylate, ethyl methacrylate, methyl methacrylate, hexyl methacrylate, and methyl acrylate. 13. The transdermal drug delivery system according to claim 1, wherein said polymer composition further includes a rubber-based polymer or silicon-based polymer. 14. The transdermal drug delivery system according to claim 13, wherein said acrylic-based polymer comprises from 2 to about 95% by weight of the transdermal drug delivery system and said rubber-based polymer or silicon-based polymer comprises from 4 to about 97% by weight of the transdermal drug delivery system. 15. The transdermal drug delivery system according to claim 13, wherein said rubber-based polymer or silicon-based polymer is a rubber adhesive selected from the group consisting of natural and synthetic polyisoprene, polybutylene, polyisobutylene, styrene based polymers, styrene block copolymers, butadiene based polymers, styrene/butadiene polymers, styrene-isoprene-styrene block copolymers, hydrocarbon polymers, halogen-containing polymers and polysiloxanes. 16. The transdermal drug delivery system according to claim 15, wherein said rubber adhesive includes polyisobutylene. 17. The transdermal drug delivery system according to claim 13, wherein said rubber-based polymer or silicon-based polymer includes a polysiloxane polymer. 18. The transdermal drug delivery system according to claim 1, further comprising a backing layer formed on a first surface of said polymer composition. 19. A method for transdermally delivering a drug to a user in need thereof comprising administering the transdermal drug delivery device according to claim 1 to said user. 20. A transdermal drug delivery system comprising a blend of: (a) a polymer composition comprising at least one acrylic-based polymer polymerized with monomers that include: (i) a soft acrylic monomer selected from the group consisting of 2-ethyl hexyl acrylate, isobutyl acrylate, dodecyl methacrylate, 2-ethoxyethyl acrylate, isopropyl acrylate, and 2-methoxyethyl acrylate in an amount of from about 20 to about 70% by weight of the acrylic-based polymer; and (ii) a hard acrylic monomer selected from the group consisting of N-butyl acrylate, acrylic acid, ethyl methacrylate, hexyl methacrylate, and methyl acrylate in an amount of from about 30 to about 80% by weight of the acrylic-based polymer; and (b) 0.1% to about 50% by weight of the transdermal drug delivery system of one or more drugs incorporated into the polymer composition, wherein all acrylic-based polymers present in said polymer composition of the transdermal drug delivery system are acrylic-based polymers polymerized with monomers that include: (i) a soft acrylic monomer having a glass transition temperature (T.sub.g) from about -70.degree. C. to about -10.degree. C. in an amount of from 620% to 70% by weight of the acrylic-based polymer; and (ii) a hard acrylic monomer having a glass transition temperature (T.sub.g) from about -5.degree. C. to about 120.degree. C. in an amount of from 30% to 680% by weight of the acrylic-based polymer, and wherein said acrylic-based polymers are not polymerized with methacrylic acid monomers.