# US 5,350,581 A · Method for manufacturing transdermal devices

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- Number: US 5,350,581 A
- Document ID: US5350581A
- Status: Granted
- Kind: A
- Application number: 07/450,409
- Filed: 1989-12-14
- Granted: 1994-09-27
- Earliest claimed: 1989-12-14
- Assignees: Pharmetrix Corporation
- Inventors: Frank Kochinke
- Web page: https://patentgrep.com/patent/US5350581A

## CPC

- A61K 9/703: {characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches}
- A61K 9/7084: {Transdermal patches having a drug layer or reservoir, and one or more separate drug-free skin-adhesive layers, e.g. between drug reservoir and skin, or surrounding the drug reservoir; Liquid-filled reservoir patches}
- A61K 9/7092: {Transdermal patches having multiple drug layers or reservoirs, e.g. for obtaining a specific release pattern, or for combining different drugs}
- A61F 2013/0296: {for making transdermal patches (chemical processes excluded)}
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)

## Abstract

A method for fabrication of multilayer transdermal drug release devices that divides the assembly of the various drug delivery components of the device into their unit operations; treats the prefabricated units as modules that are later combined to obtain the finished transdermal drug delivery device. A variety of different configurations are available depending upon the drug or drugs to be administered.

## Claims

### Claim 1

A method for the fabrication of transdermal delivery devices comprising:
a) joining by an adhesive means, the surface most distal to the protective backing of an incipient device to,
b) the surface most distal from the release layer of a complement device, where said complement device is comprised of at least one layer in addition to a release liner and
c) recovering said transdermal device.

### Claim 2 (depends on 1)

A method according to claim 1 where said incipient device is comprised of:
a) an protective backing layer,
b) a zone of drug containment,
c) a zone of transport enhancement,
d) a zone of transport control, and
said complement device is comprised of:
e) an adhesive layer,
f) a support layer,
g) a second adhesive layer,
h) a removable release liner, and
i) recovering said device.

### Claim 3 (depends on 1)

A method according to claim 1 where said incipient device is comprised of:
a) an protective backing layer,
b) a zone of drug containment,
c) a zone of transport control, and
said complement device is comprised of:
d) an adhesive layer,
e) a support layer,
f) a second adhesive,
g) a zone of transport enhancement,
h) a removable release liner, and
i) recovering said device.

### Claim 4 (depends on 1)

A method according to claim 1 where said incipient device is comprised of:
a) an protective backing layer,
b) a zone of drug containment,
c) a zone of transport enhancement, and
said complement device is comprised of:
d) an adhesive layer,
e) a support layer,
f) a second adhesive layer,
g) a zone of transport control,
h) a removable release liner, and
i) recovering said device.

### Claim 5 (depends on 1)

A method according to claim 1 where said incipient device is comprised of:
a) an protective backing layer,
b) a zone of drug containment, and said complement device is comprised of:
c) an adhesive layer,
d) a support layer,
e) a zone of transport enhancement,
f) a zone of transport control,
g) a second adhesive layer, and
h) a removable release liner,
i) recovering said device.

### Claim 6 (depends on 1)

A method according to claim 1 where said incipient device is comprised of:
a) an protective backing layer,
b) a zone of drug containment,
c) a zone of transport control, and
said complement device is comprised of:
d) an adhesive layer,
e) a support layer,
f) a second adhesive layer,
g) a removable release liner, and
h) recovering said device.

### Claim 7 (depends on 1)

A method according to claim 1 where said incipient device is comprised of:
a) an protective backing layer,
b) a zone of drug containment, and said complement device is comprised of:
c) an adhesive layer,
d) a zone of transport control,
e) a support layer,
f) a second adhesive layer,
g) a removable release liner, and
h) recovering said device.

### Claim 8 (depends on 1)

A method according to claim 1 where said incipient device is comprised of:
a) an protective backing layer,
b) a zone of drug containment.
c) a zone of transport enhancement, and
said complement device is comprised of:
d) an adhesive layer,
e) a support layer,
f) a second adhesive layer,
g) a removable release liner, and
h) recovering said device.

### Claim 9 (depends on 1)

A method according to claim 1 where said incipient device is comprised of:
a) an protective backing layer,
b) a zone of drug containment, and
said complement device is comprised of:
c) an adhesive layer,
d) a zone of transport enhancement,
e) a support layer,
f) a second adhesive layer,
g) a removable release liner, and
h) recovering said device.

### Claim 10 (depends on 1)

A method according to claim 1 where said incipient device is comprised of:
a) an protective backing layer
b) a zone of drug containment, and
said complement device is comprised of:
c) an adhesive layer,
d) a support layer,
e) a second adhesive layer,
f) a removable release liner, and
g) recovering said device.

### Claim 11 (depends on 1)

A method according to claim 1 where said incipient device is comprised of:
a) an protective backing layer,
b) a zone of transport enhancement,
c) a zone of transport control, and
said complement device is comprised of:
d) an adhesive layer,
e) a support layer,
f) a zone of drug containment,
g) a second adhesive layer,
h) a removable release liner, and
i) recovering said device.

### Claim 12 (depends on 1)

A method according to claim 1 where said incipient device is comprised of:
a) an protective backing layer,
b) a zone of transport enhancement, and
said complement device is comprised of:
c) an adhesive layer,
d) a support layer,
e) a zone of transport control,
f) a zone of drug containment,
g) a second adhesive layer,
h) a removable release liner, and
i) recovering said device.

### Claim 13 (depends on 1)

A method according to claim 1 where said incipient device is comprised of:
a) an protective backing layer,
b) a zone of transport enhancement, and
said complement device is comprised of:
c) an adhesive layer,
d) a support layer,
e) a zone of drug containment,
f) a second adhesive layer,
g) a removable release liner, and
h) recovering said device.

### Claim 14 (depends on 1)

A method according to claim 1 where said incipient device is comprised of:
a) an protective backing layer,
b) a zone of transport control, and
said complement device is comprised of:
c) an adhesive layer,
d) a support layer,
e) a zone of transport enhancement, and
f) a zone of drug containment,
g) a second adhesive layer,
h) a removable release liner, and
i) recovering said device.

### Claim 15 (depends on 1)

A method according to claim 1 where said incipient device is comprised of:
a) an protective backing layer,
b) a zone of transport control, and
said complement device is comprised of:
c) an adhesive layer,
d) a support layer,
e) a zone of drug containment,
f) a second adhesive layer,
g) a removable release liner, and
h) recovering said device.

### Claim 16 (depends on 1)

A method according to claim 1 where said incipient device is comprised of:
a) an protective backing layer,
b) a zone of drug containment,
c) a zone of transport enhancement,
d) a zone of transport control,
e) an adhesive layer, and
said complement device is comprised of:
f) a support layer,
g) a second adhesive layer,
h) a removable release liner, and
i) recovering said device.

### Claim 17 (depends on 1)

A method according to claim 1 where said incipient device is comprised of:
a) an protective backing layer,
b) a zone of drug containment,
c) a zone of transport control,
d) an adhesive layer, and
said complement device is comprised of:
e) a support layer,
f) a second adhesive,
g) a zone of transport enhancement,
h) a removable release liner, and
i) recovering said device.

### Claim 18 (depends on 1)

A method according to claim 1 where said incipient device is comprised of:
a) an protective backing layer,
b) a zone of drug containment,
c) a zone of transport enhancement,
d) an adhesive layer, and
said complement device is comprised of:
e) a support layer,
f) a second adhesive layer,
g) a zone of transport control,
h) a removable release liner, and
i) recovering said device.

### Claim 19 (depends on 1)

A method according to claim 1 where said incipient device is comprised of:
a) an protective backing layer,
b) a zone of drug containment,
c) an adhesive layer, and
said complement device is comprised of:
d) a support layer,
e) a zone of transport enhancement,
f) a zone of transport control,
g) a second adhesive layer, and
h) a removable release liner,
i) recovering said device.

### Claim 20 (depends on 1)

A method according to claim 1 where said incipient device is comprised of:
a) an protective backing layer,
b) a zone of drug containment,
c) a zone of transport control,
d) an adhesive layer, and
said complement device is comprised of:
e) a support layer,
f) a second adhesive layer,
g) a removable release liner, and
h) recovering said device.

### Claim 21 (depends on 1)

A method according to claim 1 where said incipient device is comprised of:
a) an protective backing layer,
b) a zone of drug containment,
c) an adhesive layer, and
said complement device is comprised of:
d) a zone of transport control,
e) a support layer,
f) a second adhesive layer,
g) a removable release liner, and
h) recovering said device.

### Claim 22 (depends on 1)

A method according to claim 1 where said incipient device is comprised of:
a) an protective backing layer,
b) a zone of drug containment,
c) a zone of transport enhancement,
d) an adhesive layer, and
said complement device is comprised of:
e) a support layer,
f) a second adhesive layer,
g) a removable release liner, and
h) recovering said device.

### Claim 23 (depends on 1)

A method according to claim 1 where said incipient device is comprised of:
a) an protective backing layer,
b) a zone of drug containment,
c) an adhesive layer, and
said complement device is comprised of:
d) a zone of transport enhancement,
e) a support layer,
f) a second adhesive layer,
g) a removable release liner, and
h) recovering said device.

### Claim 24 (depends on 1)

A method according to claim 1 where said incipient device is comprised of:
a) an protective backing layer
b) a zone of drug containment,
c) an adhesive layer, and
said complement device is comprised of:
d) a support layer,
e) a second adhesive layer,
f) a removable release liner, and
g) recovering said device.

### Claim 25 (depends on 1)

A method according to claim 1 where said incipient device is comprised of:
a) an protective backing layer,
b) a zone of transport enhancement,
c) a zone of transport control,
d) an adhesive layer, and
said complement device is comprised of:
e) a support layer,
f) a zone of drug containment,
g) a second adhesive layer,
h) a removable release liner, and
i) recovering said device.

### Claim 26 (depends on 1)

A method according to claim 1 where said incipient device is comprised of:
a) an protective backing layer,
b) a zone of transport enhancement,
c) an adhesive layer, and
said complement device is comprised of:
d) a support layer,
e) a zone of transport control,
f) a zone of drug containment,
g) a second adhesive layer,
h) a removable release liner, and
i) recovering said device.

### Claim 27 (depends on 1)

A method according to claim 1 where said incipient device is comprised of:
a) an protective backing layer,
b) a zone of transport enhancement,
c) an adhesive layer, and
said complement device is comprised of:
d) a support layer,
e) a zone of drug containment,
f) a second adhesive layer,
g) a removable release liner, and
h) recovering said device.

### Claim 28 (depends on 1)

A method according to claim 1 where said incipient device is comprised of:
a) an protective backing layer,
b) a zone of transport control,
c) an adhesive layer, and
said complement device is comprised of:
d) a support layer,
e) a zone of transport enhancement, and
f) a zone of drug containment,
g) a second adhesive layer,
h) a removable release liner, and
i) recovering said device.

### Claim 29 (depends on 1)

A method according to claim 1 where said incipient device is comprised of:
a) an protective backing layer,
b) a zone of transport control,
c) an adhesive layer, and
said complement device is comprised of:
d) a support layer,
e) a zone of drug containment,
f) a second adhesive layer,
g) a removable release liner, and
h) recovering said device.

### Claim 30 (depends on 1)

A method according to claim 1 where said drug is nicotine.