Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Web – sheet or filament bases; compositions of bandages; or...
Reexamination Certificate
2001-08-08
2004-05-04
Page, Thurman K. (Department: 1616)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Web, sheet or filament bases; compositions of bandages; or...
C424S449000, C424S486000, C424S487000
Reexamination Certificate
active
06730318
ABSTRACT:
This invention is directed to a method and composition for the alteration of the adhesiveness of pressure-sensitive adhesives used in transdermal delivery devices. Patch-type devices are well known for the transdermal administration of pharmaceutical agents as well as cosmetics, emollients and other skin treating agents. These patch-type devices are used for the administration of numerous classes of drugs or skin treating products. This invention is directed to a composition and method whereby the adhesiveness of the associated pressure sensitive adhesive of a transdermal delivery device is altered, rendering the device inherently less damaging to the skin of the patient than prior art patches.
Matrix-type transdermal delivery devices are designed to adhere to the skin for a period of time sufficient to allow administration of an active permeant or skin treating agent. Unfortunately, the adhesives in common use in transdermal devices often adhere too strongly to the area of application resulting in skin irritation or peeling of the skin layer when the patch is removed. The strength with which the device adheres to the skin is determined, to some extent, by the chemicals used and the molecular weight properties of the pressure sensitive adhesive.
The strength with which the device adheres to the skin is often touted as a beneficial attribute. This perspective is especially true where the device displays an ability to adhere strongly to the skin for extended periods of time. However, this adhesion tenacity is counter-productive if the removal of the device causes damage to the tissue to which it had been adhered. This is especially true where the device is a transdermal device which is adhered to sensitive tissue. This sensitive tissue may be, for example, an infected area in need of treatment, a preferred skin site for the administration of a type of drug to be transdermally delivered or a skin area which is inherently sensitive.
An infected skin site could be treated by a transdermal delivery system to administer an useful pharmaceutical agent directly to the infected tissue. Such treatment may be to compromised tissue to which an adhesive device will be bound and removal of the transdermal device could cause additional damage.
A preferred site of application is largely determined by the pharmaceutical agent, cosmetic, emollient, etc., that is administered. For example, a drug designed to alleviate an erectile dysfunction condition might need to be applied to the penis or nearby tissue. The application of an adhesive device to such sensitive tissue creates the ability of the adhesive to be removed easily and painlessly.
Moreover, transdermal treatment with emollients, cosmetics or bioactive agents has been found to be useful for the treatment of wrinkles. The treatment of wrinkles involves the adhesion of a transdermal device to a site, such as around the eye, for a short duration, such as overnight. Removal of adhesive patches from facial tissues and particularly around the eye is painful and can be emotionally traumatic. Following such treatment it would be useful for the device to be removed without causing additional dermal trauma or visible irritation.
Regardless of the application site, it would be desirous to have an adhesive combination which adheres effectively, but less strongly, than adhesives now known. It would be further desirous to have an adhesive for use in transdermal administration devices which facilitated both the transdermal delivery of the pharmaceutical or other bioactive agent and the facile removal of the device from the application site without the associated irritation, pain and trauma often caused by removal of pressure-sensitive adhesives.
One shortcoming of patch-type devices, particularly matrix devices in which the active agent is intimately dissolved or dispersed in the adhesive, involves the irritation caused to the skin secondary to removal of the adhesive device. The damage caused by strong adherence to the skin often involves substantial desquamation and ulceration upon removal of the device. Additionally, such devices cause substantial irritation of the adhered tissue during administration of the drug or other agent.
It would therefore be desirable to provide a transdermal device where the adhesive composition did not cause these undesirable irritations, desquamation and ulcerations.
OBJECTS OF THE INVENTION
It is therefore an object of the invention to provide a pressure-sensitive adhesive transdermal delivery device which upon removal following use, does not result in irritation, desquamation or ulceration of the treatment site.
It is another object of the invention to provide a pressure-sensitive adhesive transdermal delivery device which minimizes the damage caused to tissue secondary to the removal of the adhesive device.
It is still a further object of the invention to regulate the adhesive strength of a pressure sensitive adhesive patch.
SUMMARY OF THE INVENTION
These and other objects of the invention are accomplished through the incorporation of an adhesion-adjusting member, such as a polydiorganosiloxane polymer, intimately admixed with the pressure-sensitive adhesive portion of a matrix-type transdermal delivery device system. It has been discovered that the inclusion of a polydiorganosiloxane polymer into the adhesive portion of a pressure-sensitive adhesive device decreases the strength with which the adhesive adheres to the skin. Furthermore the intimate admixture of a suitable amount of a polydiorganosiloxane polymer member with the adhesive of a matrix-type pressure-sensitive adhesive device provides a device which is designed for short duration applications, such as overnight. In practice, the use of a polydiorganosiloxane polymer member as part of a pressure-sensitive adhesive formulation minimizes the damage caused by the adhesive secondary to the removal of the previously adhered device.
Polydiorganosiloxanes as a class may be utilized as more fully described below. Of that class the polydimethylsiloxanes are particularly preferred and are specifically exemplified. Polydimethylsiloxane polymers and copolymers are also known by the generic name dimethicone. These terms will be used interchangeably throughout this description.
One preferred embodiment is directed to the inclusion of a polydiorganosiloxane polymer into an adhesive formulation which is part of a pressure-sensitive matrix-type device for the treatment of wrinkles. In this matrix patch device the objective is to adhere the device to the skin area to be treated for an effective yet limited time. For example, this area might typically be the skin area around the eye where wrinkles traditionally develop incident to the aging process. After a desired period of time the transdermal device is removed by peeling the adhesive from the skin.
Also, as a result of transdermal administration, the treated skin is sensitive and more prone to irritation or damage. The removal of a patch, where the adhesive portion has been advantageously formulated using the siloxane polymer to adhere less strongly than pressure sensitive adhesives alone, is facile and painless. Where the pressure sensitive adhesives conventionally used in the art would damage and irritate the skin upon their removal, the modulated adhesive composition of this invention is easily removed without discomfort or damage to the underlying skin.
The following definitions will be useful in describing the invention and will eliminate the need for repetitive explanations.
By “transdermal” is meant transdermal or percutaneous administration of an active permeant for delivery through the skin for translocation or systemic delivery. Also, this term includes the application of a skin-treating composition directly to the skin area to be treated. To the extent that the invention can be utilized in the treatment of mucosal tissues they are also included in the term “transdermal.” Hence the terms “skin,” “derma,” “epidermis,” “mucosa,” and the like shall also be used interchangeably unless specifically stated otherwise.
B
Ebert Charles D.
Quan Danyi
Venkateshwaran Srinivasan
Choi Frank
Page Thurman K.
Thorpe North & Western LLP
Watson Pharmaceuticals, Inc.
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