Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Web – sheet or filament bases; compositions of bandages; or...
Reexamination Certificate
1999-04-15
2001-02-06
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Web, sheet or filament bases; compositions of bandages; or...
C424S449000, C424S447000, C424S443000
Reexamination Certificate
active
06183770
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention relates to a carrier patch for the delivery of agents to the skin, a method of producing the carrier patch and a method for the use of the carrier patch. In particular, the invention is concerned with a carrier patch having an agent to be delivered to the skin, a method of applying the agent to the patch in a manner which is minimally deleterious to the agent, and a method of delivering agents to the skin using such a carrier patch.
Delivery of agents to the skin for local skin treatment may be desirable to improve the health and appearance of the skin. Skin conditions such as dry or oily skin, blemishes, abrasions, cuts or rashes, for example, require localized skin treatment to remedy the affected area and to prevent further skin damage. If skin conditions are not treated, further skin irritation may occur resulting in infections or damage to the skin. Thus, treatment of skin conditions improves the health and appearance of the skin.
Further, the skin may provide an ideal system for the delivery of agents to be active systemically. Although the skin is thought to provide the body with a protective covering, a number of agents are absorbable through the skin, and since the skin is a highly vascularized organ, the agents also penetrate into the circulating blood supply for distribution throughout the body, ultimately reaching the targets the agent is intended to affect.
Previously described methods for using patches for the local delivery of agents to the skin or systemic delivery via the skin employ a combination of the agent to be delivered with an adhesive used both to anchor the patch to the skin and as the medium by which the agent is delivered to the skin. However, the combination of the agent with the adhesive is disadvantageous for reasons including that some agents cannot be solubilized in the adhesive, the agent and adhesive when combined can each impair the effectiveness of the other, and the agent when combined with the adhesive can be heat inactivated by the thermal, chemical or mechanical actions used to cure adhesives. Thus, the combination of agent and adhesive prior to or during adhesive preparation for many agents would require a high concentration of the agent to be used in the combination such that an effective dose would remain after adhesive treatment has been completed. For some agents this is impracticable.
It is known to form sampler devices for cosmetics, wherein the device includes one or more plys. This is disclosed in U.S. Pat. No. 5,161,688 (Muchin) which is incorporated by reference herein.
There is a need to provide a carrier patch for the delivery of agents to the skin which minimizes the disadvantages of known systems.
SUMMARY OF THE INVENTION
The invention provides a carrier patch which has advantages over known systems for delivering agents to the skin. There is also provided a method for producing the patch and a method for delivering agents to the skin utilizing the carrier patch.
According to the invention, there is provided a carrier patch for delivering agents to the skin. The carrier patch has a surface area for adhering to the skin and comprises a pad, having an upper and lower surface area, and an adhesive adhered on the lower surface area of the pad. A primary agent for delivery to the skin is applied to the patch in a manner such that the deleterious effects of the adhesive on the agent are minimized. Preferably no treatment of the adhesive is necessary after applying the agent.
In some embodiments, the agent is applied directly to discrete areas of the patch pad or adhesive.
In other embodiments, the patch includes one or more liners, secured to the pad lower surface by the adhesive. In one preferred embodiment, the adhesive is used to carry the primary agent to the skin. Further, the primary agent can be applied to the adhesive in discrete locations.
Preferably, the primary agent is applied to the adhesive through apertures which are formed in a first liner, and further the first liner is selectively removable from the adhesive after applying the agent to the adhesive. The apertures in the liner effectively form a mask through which the agent is applied to the adhesive in discrete locations where the adhesive is exposed.
In some embodiments, the primary agent is applied to the lower surface of the adhesive. In other embodiments, the agent is applied to the upper surface of the adhesive.
In alternative embodiments, apertures can be formed through any portion of or the entirety of the depth of the patch material. The apertures can contain the primary agent to be delivered to the skin. In one embodiment, where the pad contains apertures, the pad remains in place after applying the primary agent to the apertures. In another embodiment, the primary agent can be applied to a surface of the pad, without forming apertures in the pad.
In some embodiments, the primary agent is applied to the patch without the use of a first liner. In some embodiments, the patch can also include a cover, secured to the pad surface to seal the pad with the agent material adhered to the adhesive.
In yet other forms of the invention the patch can be embossed such that there are indentations for receiving the agent. The adhesive may exist at only discrete locations of the patch and may be of a nature that it is at the discrete locations that the agent is applied to the patch. In such situations the use of a liner as a mask may be optional.
The primary agent to be delivered to the skin is preferably therapeutic and may be a single agent or may consist of a combination of agents applied to the patch singly or as a mixture. The pad is a substrate which is preferably flexible.
The adhesive is any substance which holds the patch in contact with the skin. Preferably the adhesive is a polymeric adhesive composition, and more preferably a pressure sensitive adhesive. Further, the adhesive is selected to have a desired property of not interfering with the action of or the delivery of the agent to the skin and has the desired property of not requiring treatment which could be deleterious to the primary agent after the primary agent is applied. In such embodiments the adhesive is effectively cured and/or in its effective operational state or condition prior to applying the agent to the patch.
In some embodiments, the patch is further active in the removal of keratotic plugs from the pores of skin. Keratotic plugs are dead epidermal cells combined with sebaceous matter and dirt which form within skin pores, and result in conspicuously enlarged and/or darkened pores. If keratotic plugs are not periodically removed from the skin, not only do pores enlarge and darken, but further skin irritation may occur resulting in reddening blemishes or bacterial infections of the skin.
In some embodiments, the patch can contain a cosmetic composition, which may conceal the underlying skin condition.
The patch may be made in a variety of shapes. At least one of and preferably both of the pad and adhesive composition may be substantially transparent or clear, a flesh-like color or shade so as to effectively blend with the skin of wearer, or translucent. In other embodiments, the pad is effectively colored or rendered ornate or patterned on its surface.
The invention also provides a method for the use of the carrier patch to deliver agents to the skin. The method generally comprises obtaining a carrier patch, removing the liner to expose a surface of adhesive with agent to the skin, applying the patch with the adhesive and agent to the skin with the lower surface of the pad adhering to the skin through the adhesive, and subsequently removing the patch from the skin.
The invention also provides a method for producing the patch which generally comprises providing a material comprising a pad and an adhesive, the adhesive being in an effective operational state. Apertures are formed in relation to the patch thereby forming a mask effect such that discrete areas of adhesive are exposed and a primary agent is applied to the patch to adhere to the expose
Muchin Jerome D.
Muchin Michael P.
Acutek International
Ghali Isis
Oppenheimer Wolff & Donnelly LLP
Page Thurman K.
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