Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Web – sheet or filament bases; compositions of bandages; or...
Patent
1995-12-14
1999-07-06
Brouillette, D. Gabrielle
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Web, sheet or filament bases; compositions of bandages; or...
424448, 514946, A61F 1300
Patent
active
059194782
DESCRIPTION:
BRIEF SUMMARY
TECHNICAL FIELD
This invention relates to the transdermal delivery of drugs and other biologically active agents. More particularly, this invention relates to the transdermal delivery of drugs utilizing a novel combination of a permeation enhancer and a poly-N-vinyl amide to enhance flux, wearability, or stability of a transdermal device.
BACKGROUND ART
The transdermal route of parenteral delivery of drugs provides many advantages over other administrative routes, and transdermal systems for delivering a wide variety of drugs or other beneficial agents are described in U.S. Pat. Nos. 3,598,122; 3,598,123; 3,731,683; 3,797,494; 4,031,894; 4,201,211; 4,286,592; 4,314,557; 4,379,454; 4,435,180; 4,559,222; 4,573,995; 4,588,580; 4,645,502; 4,704,282; 4,788,062; 4,816,258; 4,849,226; 4,908,027; 4,943,435; and 5,004,610, for example. The disclosures of the above patents are incorporated herein by reference. In many instances, drugs that would appear to be ideal candidates for transdermal delivery are found to have such low permeability through intact skin that they cannot be delivered at therapeutically effective rates from reasonably sized systems.
In an effort to increase skin permeability, it has been proposed to pretreat the skin with various chemicals or to concurrently deliver the drug in the presence of a permeation enhancer. Various materials have been suggested for this purpose, as described in U.S. Pat. Nos. 3,472,931, 3,527,864, 3,896,238, 3,903,256, 3,952,099, 4,046,886, 4,130,643, 4,130,667, 4,299,826, 4,335,115, 4,343,798, 4,379,454, 4,405,616 and 4,746,515, all of which are incorporated herein by reference; British Pat. No. 1,001,949; and ldson, Percutaneous Absorption, J. Pharm. Sci., Vol. 64, No. b6, June 1975, pp 901-924 (particularly 919-921).
WO-A-9 307 870 discloses a device for the transdermal delivery administration of melatonin comprising a therapeutically effective amount of melatonin and a skin permeation-enhancing amount of a monoglyceride or mixture of monoglycerides of fatty acids with a total monoesters content of at least 51%.
WO-A-9 308 795 discloses a transdermal therapeutic system comprising a crystallization inhibitor, an active agent, and optionally penetration enhancers, in an adhesive matrix.
EP-A-0 295 411 discloses a pharmaceutical composition for percutaneous administration comprising eperisone, tolperisone, or salts thereof and a monoglyceride of an aliphatic acid having 8 to 12 carbon atoms and/or ester of lactic acid with an aliphatic alcohol having 12 to 18 carbon atoms.
EP-A-0 416 842 discloses a solid matrix system for transdermal drug delivery which may include a water-soluble polymer to improve long term wearing properties by absorbing moisture from the wearer's skin.
Many permeation enhancers interact adversely with other components of transdermal devices. One problem is that many permeation enhancers can partition into other components in the system. This can cause devices to delaminate or it can cause instability of the device, thus shortening its shelf life.
Another problem related to adhesives of transdermal systems is the problem of adhesive failure resulting in water induced fall-off of the system. Adhesive failure may be caused by accumulation of the permeation enhancer at the skin-adhesive interface. As water accumulates on the skin, particularly during exercise or bathing, the interaction between the water and the permeation enhancer causes a soapy solution to form at the interface thereby causing the transdermal system to fall off.
This invention utilizes a novel combination of permeation enhancer(s) and a poly-N-vinyl amide. The novel combination produces a significant and surprising improvement in transdermal fluxes, drug utilization, storage stability, and improved adhesion over previous transdermal devices.
SUMMARY OF THE INVENTION
The present invention comprises a device for the transdermal administration, at a therapeutically effective rate, of a drug, which device comprises a reservoir comprising a therapeutically effective amount of drug, a s
REFERENCES:
patent: 3472931 (1969-10-01), Stoughton
patent: 3527864 (1970-09-01), MacMillan et al.
patent: 3598122 (1971-08-01), Zaffaroni
patent: 3598123 (1971-08-01), Zaffaroni
patent: 3731683 (1973-05-01), Zaffaroni
patent: 3797494 (1974-03-01), Zaffaroni
patent: 3896238 (1975-07-01), Smith
patent: 3903256 (1975-09-01), MacMillan et al.
patent: 3952099 (1976-04-01), Smith
patent: 4031894 (1977-06-01), Urquhart et al.
patent: 4046886 (1977-09-01), Smith
patent: 4130643 (1978-12-01), Smith
patent: 4130667 (1978-12-01), Smith
patent: 4144317 (1979-03-01), Higuchi et al.
patent: 4201211 (1980-05-01), Chandrasekaran et al.
patent: 4286592 (1981-09-01), Chandrasekaran
patent: 4291015 (1981-09-01), Keith
patent: 4299826 (1981-11-01), Luedders
patent: 4314557 (1982-02-01), Chandrasekaran
patent: 4335115 (1982-06-01), Thompson et al.
patent: 4343798 (1982-08-01), Fawzi
patent: 4379454 (1983-04-01), Campbell et al.
patent: 4405616 (1983-09-01), Rajadhyaksha
patent: 4435180 (1984-03-01), Leeper
patent: 4438139 (1984-03-01), Keith
patent: 4466953 (1984-08-01), Keith et al.
patent: 4470962 (1984-09-01), Keith et al.
patent: 4472372 (1984-09-01), Keith et al.
patent: 4492685 (1985-01-01), Keith et al.
patent: 4559222 (1985-12-01), Enscore et al.
patent: 4573995 (1986-03-01), Cheng et al.
patent: 4579731 (1986-04-01), Fox, Jr. et al.
patent: 4588580 (1986-05-01), Gale et al.
patent: 4626539 (1986-12-01), Aungst et al.
patent: 4645502 (1987-02-01), Gale et al.
patent: 4668232 (1987-05-01), Cordes
patent: 4695465 (1987-09-01), Kigasawa
patent: 4704282 (1987-11-01), Campbell et al.
patent: 4746515 (1988-05-01), Cheng et al.
patent: 4781926 (1988-11-01), Hyon
patent: 4788062 (1988-11-01), Gale et al.
patent: 4816258 (1989-03-01), Nedberge et al.
patent: 4849226 (1989-07-01), Gale
patent: 4863970 (1989-09-01), Patel et al.
patent: 4908027 (1990-03-01), Enscore et al.
patent: 4943435 (1990-07-01), Baker et al.
patent: 4973708 (1990-11-01), Digenis et al.
patent: 4996199 (1991-02-01), Minaskanian et al.
patent: 5004610 (1991-04-01), Osborne et al.
patent: 5032402 (1991-07-01), Digenis et al.
patent: 5095054 (1992-03-01), Lay et al.
patent: 5154922 (1992-10-01), Govil et al.
patent: 5176916 (1993-01-01), Yamanaka et al.
patent: 5230898 (1993-07-01), Horstmann et al.
patent: 5232703 (1993-08-01), Blank
patent: 5252588 (1993-10-01), Azuma et al.
patent: 5411740 (1995-05-01), Lee
patent: 5413776 (1995-05-01), Suzuki et al.
patent: 5556635 (1996-09-01), Istin et al.
patent: 5676968 (1997-10-01), Lipp et al.
Idson, Bernard, Percutaneous Absorption, J. of Phar. Sci., vol. 64, No. 6, Jun. 1975 pp. 901-924.
Hearney Linda Mary
Landrau Felix A.
Nedberge Diane E.
ALZA Corporation
Brouillette D. Gabrielle
Rafa Michael J.
Stone Steve F.
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