US4867982A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Transdermal drug delivery device
Assignee: Alza Corp
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Filing: 1988-01-26
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Granted: 1989-09-19
•
Expires: 2008-01-26
Abstract
Abstract A medical device for the transdermal delivery of an active agent through sensitive intact skin is provided. The device comprises a matrix containing the drug having reinforcing means, preferably in the form of a fabric, embedded in the upper surface of the matrix. The matrix is formed of an agent permeable material which is tacky but does not adhesively bond to the skin. The device is sufficiently flexible and deformable that the combination of tackiness, flexibility, and deformation permits the device to be maintained in agent transmitting relationship upon skin at such sensitive areas as the scrotum, labia, breast, or penis, for example. In certain embodiments, the skin distal surface is provided with a layer of an agent impermeable material to reduce transfer of the agent from the patient to others.
Inventors
- 👤 Patricia S. Campbell
- 👤 James B. Eckenhoff
- 👤 Virgil A. Place
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-30 05:24
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/70; A61K9/7023; A61K9/703; A61K9/7038; A61K9/7046; A61K9/7053; A61K9/0012; A61K9/0034; A61K9/0041; A61K9/7069; Y; Y10; Y10S; Y10S424/00; Y10S424/14
Claims Analysis
Total Claims: 44
Claim 1
Independent Claim
243 words
A flexible and compliant medical device for the transdermal administration of testosterone through intact skin at sensitive body locations, said device being from 2-10 mils thick and having an extension modulus at 15% elongation in at least one direction in the range of 1000 to 15,000 gm/cm 2 , a stress decay from 15% elongation at 5 minutes in the range of 25-45%, a 2 cm wide strip of said device requiring an elongation force of from 30-300 gm to produce said 15% elongation, said device comprising, in combination; (a) a testosterone reservoir comprisign testosterone dissolved in ethylene/vinyl acetate copolymer having a vinyl acetate content in the range of 40-60%, said reservoir having a body contacting surface through which agent is released to the skin and a body distal surface opposite said body contacting surface, the body contacting surface of said reservoir having a tack in the range of about 100-300 g/cm 2 at 35° C.; (b) fibrous reinforcing means imbedded in said reservoir to a depth that does not penetrate through said body contacting surface and does not submerge said reinforcing means in said reservoir, said imbedded fibrous reinforcing means forming the body distal surface of said device; said fibrous reinforcing means being non-elastically deformable in at least one direction; whereby the body distal surface of said device retains a fibrous texture and said device is capable of non-adhesively clinging to the skin at sensitive body locations in testosterone transmitting relationship thereto.
Claim 2
Dependent Claim
243 words
A flexible and compliant medical device for the transdermal administration of testosterone through intact skin at sensitive body locations, said device being from 2-10 mils thick and having an extension modulus at 15% elongation in at least one direction in the range of 1000 to 15,000 gm/cm 2 , a stress decay from 15% elongation at 5 minutes in the range of 25-45%, a 2 cm wide strip of said device requiring an elongation force of from 30-300 gm to produce said 15% elongation, said device comprising, in combination; (a) a testosterone reservoir comprisign testosterone dissolved in ethylene/vinyl acetate copolymer having a vinyl acetate content in the range of 40-60%, said reservoir having a body contacting surface through which agent is released to the skin and a body distal surface opposite said body contacting surface, the body contacting surface of said reservoir having a tack in the range of about 100-300 g/cm 2 at 35° C.; (b) fibrous reinforcing means imbedded in said reservoir to a depth that does not penetrate through said body contacting surface and does not submerge said reinforcing means in said reservoir, said imbedded fibrous reinforcing means forming the body distal surface of said device; said fibrous reinforcing means being non-elastically deformable in at least one direction; whereby the body distal surface of said device retains a fibrous texture and said device is capable of non-adhesively clinging to the skin at sensitive body locations in testosterone transmitting relationship thereto.
Claim 3
Dependent Claim
21 words
The device of claim 1 wherein said reservoir comprises an ethylene/vinyl acetate copolymer having a vinyl acetate content of about 51%.
Claim 4
Dependent Claim
24 words
The device of claim 2 wherein said reinforcing means comprises a spun bonded fabric having a weight of up to about 0.3 oz./sq. yd.
Claim 5
Dependent Claim
14 words
The device of claim 1 wherein said reservoir contains up to about 2.5% testosterone.
Claim 6
Dependent Claim
14 words
The device of claim 2 wherein said reservoir contains up to about 2.5% testosterone.
Claim 7
Dependent Claim
24 words
The device of claim 1 wherein said device is free of undissolved testosterone and contains testosterone at a loading of from about 5-15 mg.
Claim 8
Dependent Claim
24 words
The device of claim 3 wherein said device is free of undissolved testosterone and contains testosterone at a loading of from about 5-15 mg.
Claim 9
Dependent Claim
21 words
The device of claim 1 wherein said reservoir comprises an ethylene/vinyl acetate copolymer having a vinyl acetate content of about 40%.
Claim 10
Dependent Claim
24 words
The device of claim 8 wherein said reinforcing means comprises a spun bonded fabric having a weight of up to about 0.3 oz./sq. yd.
Claim 11
Dependent Claim
14 words
The device of claim 8 wherein said reservoir contains up to about 2.5% testosterone.
Claim 12
Dependent Claim
14 words
The device of claim 9 wherein said reservoir contains up to about 2.5% testosterone.
Claim 13
Dependent Claim
24 words
The device of claim 9 wherein said device is free of undissolved testosterone and contains testosterone at a loading of from about 5-15 mg.
Claim 14
Dependent Claim
39 words
A method for testosterone replacement in hypogonadal males which comprises applying a device according to claim 1 to the genitalia of a hypogonadal male and maintaining said device in testosterone transmitting relationship thereto for at least about 8 hours.
Claim 15
Dependent Claim
26 words
The method of claim 13 wherein said device is replaced with a fresh device on a daily basis for so long as testosterone replacement is desired.
Claim 16
Dependent Claim
40 words
A method for testosterone replacement in hypogonadic males which comprises applying the device of claim 1 to the scrotum of a hypogonadic male and maintaining said system in testosterone transferring relationship to said scrotum for a least about 8 hours.
Claim 17
Dependent Claim
37 words
The method of claim 15 wherein said system is maintained in place for up to about 24 hours and is replaced with a fresh device on a daily basis for so long as testosterone replacement is desired.
Claim 18
Dependent Claim
39 words
A method for testosterone replacement in hypogonadal males which comprises applying a device according to claim 1 to the genitalia of a hypogonadal male and maintaining said device in testosterone transmitting relationship thereto for a least about 8 hours.
Claim 19
Dependent Claim
26 words
The method of claim 17 wherein said device is replaced with a fresh device on a daily basis for so long as testosterone replacement is desired.
Claim 20
Dependent Claim
40 words
A method for testosterone replacement in hypogonadic males which comprises applying the device of claim 7 to the scrotum of a hypogonadic male and maintaining said system in testosterone transferring relationship to said scrotum for at least about 8 hours.
Claim 21
Dependent Claim
37 words
The method of claim 19 wherein said system is maintained in place for up to about 24 hours and is replaced with a fresh device on a daily basis for so long as testosterone replacement is desired.
Claim 22
Dependent Claim
39 words
A method for testosterone replacement in hypogonadal males which comprises applying a device according to claim 12 to the genitalia of a hypogonadal male and maintaining said device in testosterone transmitting relationship thereto for at least about 8 hours.
Claim 23
Dependent Claim
26 words
The method of claim 21 wherein said device is replaced with a fresh device on a daily basis for so long as testosterone replacement is desired.
Claim 24
Dependent Claim
40 words
A method for testosterone replacement in hypogonadic males which comprises applying the device of claim 12 to the scrotum of a hypogonadic male and maintaining said system in testosterone transferring relationship to said scrotum for at least about 8 hours.
Claim 25
Dependent Claim
37 words
The method of claim 23 wherein said system is maintained in place for up to about 24 hours and is replaced with a fresh device on a daily basis for so long as testosterone replacement is desired.
Claim 26
Independent Claim
41 words
A method for testosterone replacement in human males which comprises applying a testosterone releasing delivery device comprising a testosterone containing polymeric matrix to the male genitalia and maintaining said device in testosterone transmitting relationship thereto for a least about 8 hours.
Claim 27
Independent Claim
41 words
A method for testosterone replacement in human males which comprises applying a testosterone releasing delivery device comprising a testosterone containing polymeric matrix to the male genitalia and maintaining said device in testosterone transmitting relationship thereto for a least about 8 hours.
Claim 28
Dependent Claim
33 words
The method of claim 25 further comprising the steps of removing the used device and replacing it with a fresh device on a daily basis for so long as testosterone replacement is desired.
Claim 29
Independent Claim
40 words
A method for testosterone replacement in human males which comprises applying a testosterone releasing delivery device comprising a testosterone containing polymeric matrix to the scrotum and maintaining said device in testosterone transmitting relationship thereto for a least about 8 hours.
Claim 30
Independent Claim
40 words
A method for testosterone replacement in human males which comprises applying a testosterone releasing delivery device comprising a testosterone containing polymeric matrix to the scrotum and maintaining said device in testosterone transmitting relationship thereto for a least about 8 hours.
Claim 31
Independent Claim
58 words
A method for testosterone replacement in the human male which comprises applying a stretchable testosterone releasing delivery device to the male genitalia by non-elastically stretching the delivery device about the genitalia whereby the device conforms to and clings to the skin of the genitalia and maintaining said device in testosterone transmitting relationship thereto for a least 8 hours.
Claim 32
Independent Claim
58 words
A method for testosterone replacement in the human male which comprises applying a stretchable testosterone releasing delivery device to the male genitalia by non-elastically stretching the delivery device about the genitalia whereby the device conforms to and clings to the skin of the genitalia and maintaining said device in testosterone transmitting relationship thereto for a least 8 hours.
Claim 33
Dependent Claim
13 words
The method of claim 28 wherein the site of administration is the scrotum.
Claim 34
Dependent Claim
27 words
The method of claim 28 wherein the body contacting surface of said delivery device has a tack in the range of 100-300 g/cm 2 at 35° C.
Claim 35
Dependent Claim
27 words
The method of claim 29 wherein the body contacting surface of said delivery device has a tack in the range of 100-300 g/cm 2 at 35° C.
Claim 36
Independent Claim
95 words
The method for testosterone replacement in human males whose testosterone blood levels are below those of normal males which comprises applying a testosterone releasing delivery device to the genitalia of a human male, maintaining said device in testosterone transmitting relationship to the genitalia during an administration period of at least about 8 hours, and delivering testosterone to the male from said delivery device at a varying rate over said administration period, said varying rate being selected to produce testosterone blood levels which approximate the circadian pattern of testosterone blood levels exhibited by a normal male.
Claim 37
Independent Claim
95 words
The method for testosterone replacement in human males whose testosterone blood levels are below those of normal males which comprises applying a testosterone releasing delivery device to the genitalia of a human male, maintaining said device in testosterone transmitting relationship to the genitalia during an administration period of at least about 8 hours, and delivering testosterone to the male from said delivery device at a varying rate over said administration period, said varying rate being selected to produce testosterone blood levels which approximate the circadian pattern of testosterone blood levels exhibited by a normal male.
Claim 38
Dependent Claim
14 words
The method of claim 32 wherein said site for the administration is the scrotum.
Claim 39
Dependent Claim
33 words
The method of claim 27 further comprising the steps of removing the used device and replacing it with a fresh device on a daily basis for so long as testosterone replacement is desired.
Claim 40
Dependent Claim
33 words
The method of claim 28 further comprising the steps of removing the used device and replacing it with a fresh device on a daily basis for so long as testosterone replacement is desired.
Claim 41
Dependent Claim
33 words
The method of claim 29 further comprising the steps of removing the used device and replacing it with a fresh device on a daily basis for so long as testosterone replacement is desired.
Claim 42
Dependent Claim
33 words
The method of claim 30 further comprising the steps of removing the used device and replacing it with a fresh device on a daily basis for so long as testosterone replacement is desired.
Claim 43
Dependent Claim
33 words
The method of claim 32 further comprising the steps of removing the used device and replacing it with a fresh device on a daily basis for so long as testosterone replacement is desired.
Claim 44
Dependent Claim
33 words
The method of claim 33 further comprising the steps of removing the used device and replacing it with a fresh device on a daily basis for so long as testosterone replacement is desired.
References Cited (Backward Citations)
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1992-09-18 | 1993-03-20 | 1993-09-19 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1996-09-18 | 1997-03-20 | 1997-09-19 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2000-09-18 | 2001-03-20 | 2001-09-19 | $7700.00 | Window Closed / Lapsed |