Medicated device for warts, corns, calluses and nails

Details Medicated device for warts, corns, calluses and nails Medicated device for warts, corns, calluses and nails

1999-10-13

2001-10-16

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...

C424S061000, C424S400000, C424S449000, C424S486000

Reexamination Certificate

active

06303140

ABSTRACT:

BACKGROUND
Self-adhesive topical products based on salicylic acid containing plasters as the active ingredient are used widely in a number of corn removers, callus remover and wart remover medicated patches sold over-the-counter (OTC). Many of these products are commonly based on natural rubber. However, many individuals are allergic to natural rubbers and government regulatory agencies have responded by mandating that medical devices containing natural rubber must bear label warnings of possible allergic sensitization after mid-1998. Another problem with presently available com/callus/wart remover plasters is that they are subject to a phenomena known as “cold flow” in which during storage the plaster or polymeric component tends to ooze out or extrude beyond the edge of the medicated disk. Further, a number of presently available plasters may not have adequate tack properties for adhering to the site of application on the skin. Thus, it would be desirable to provide a salicylic acid containing plaster for treating and/or removing warts, corns and calluses that overcomes the above problems.
SUMMARY OF THE INVENTION
The present invention has the advantage of providing a corn/callus/wart remover medicated plaster, which utilizes polymeric materials other than natural rubber, which might cause undesirable allergic reactions in some individuals.
Another advantage of the present invention is that it provides a medicated plaster disk which significantly reduces “creep” or “cold flow” from the disk upon standing, storage or use. Such creep or cold flow can cause the plaster component of the disk to migrate out from under the plaster substance and slide or smear onto both target non-target areas, such as the packaging, socks, foot or skin surface, hosiery, shoes and the like.
Another advantage of the present invention is that it provides a medicated plaster, which has sufficient or improved tack or adhesive properties for adhering securely to the site of application on the skin surface.
Another advantage of the present invention is that it provides a medicated plaster, which is efficacious and can release the active ingredient into the skin at a sufficient rate and/or quantity to treat or remove warts, corns and calluses.
Another advantage of the present invention is that it provides a medicated plaster, which has adequate shelf-life stability with respect to the content of the active ingredient at the expiry date assigned to the product.
Another advantage of the present invention is that it provided for a medicated product whose plaster component has improved and more uniform product consistency compared to previous devices.
Another advantage of the present invention is that it provides a medicated device, which is simpler to manufacture, compared to devices, which utilize natural rubbers.
DETAILED DESCRIPTION OF THE INVENTION
The present invention is directed to medicated plaster preparations comprising salicylic acid or a pharmaceutically acceptable salt or ester thereof. The present invention includes medicated plaster preparations comprising a synthetic rubber; a reinforcing agent based on silica or random styrene-butadiene, copolymer; a tackifier; salicylic acid or a pharmaceutically acceptable salt or ester thereof, and optionally other ingredients.
The term “medicated plaster” refers to a combination of salicylic acid or a salt, ester or mixture intimately dispersed in a plaster preparation.
The term “plaster” refers to any non-liquid vehicle, which can be applied to the skin or nail and which can hold the salicylic acid against the skin or nail surface. Suitable plaster vehicles include, but are not limited to, plasters or preformed films based upon rubbers, acrylics, polyvinylalkylethers, gels or impregnated microporous membranes. Alternatively, the plaster could be combined with or formed into shape of an artificial or fake nail to improve cosmetic appearance.
Preferably, the plaster preparation is self-adhesive, i.e. self-adhering to the nail or skin, although any suitable means such as a bandage could be used to hold the plaster against the nail or skin surface.
The term “rubber” or “synthetic rubber” refers to any of a number of synthetic (i.e. man-made) high molecular weight homopolymers (e.g., weight average nuclear weight of 50,000 Daltons or higher) and/or random synthetic copolymers having unique properties of deformation (elongation or yield under stress). Thus, the present invention does not include the class of rubbers known as “natural rubbers” whose properties from batch to batch may be highly variable and whose use may give rise to allergic reactions in certain individuals. Preferably the synthetic rubber has a low glass transition temperature such as from −10° C. to about −100° C. Representative synthetic rubbers can include nitrile butadiene rubbers (NBR), polyisoprene rubbers, polybutadiene rubbers (PBD), and styrene-butadiene rubbers (SBR). Preferably the synthetic rubber is cis-1,4polyisoprene, commercially available, for example, as Natsyn 2200 or Natsyn 2205, available from the Goodyear Tire and Rubber Company, Akron, Ohio. The amount of synthetic rubber in the plaster formulation can range from about 15 to about 50% by weight of the plaster formulation, more preferably from about 20 to about 40% by weight, most preferably from about 25 to about 35% by weight.
The plaster preparations can be reinforced with a suitable reinforcing agent such as silica-based compositions such as silica, zirconium silicate or silica aerogels. Preferably the reinforcing agent is a silica-based composition, including any of the following silicas: silazane treated silica, precipitated silica, fumed silica, mined silica or mixtures of any of the above, as well as various reinforcing silica fillers taught in U.S. Pat. No. 3,635,743. More preferably, the reinforcing filler is a precipitated amorphous silica (silicon dioxide), such as that found in the Hi Sil 2000 Series, available from PPG Industries, Chemical Division, Pittsburgh, Pa. The surface area of the silica-based reinforcing agent can range from about 80 to about 400 square meters/gram (m
2
/g), preferably from about 200 to about 400 m
2
/g. Where the reinforcing agent is silica-based, the amount of reinforcing agent in the plaster preparation can range from about 2 to about 20% by weight of the plaster preparation, more preferably from about 5 to about 15% by weight, most preferably from about 6 to about 12% by weight. Alternatively, the reinforcing agent can be a styrene-butadiene rubber or copolymer (SBR), preferably a random styrene-butadiene rubber such as Plioflex 1028 M85-017 and Plioflex 1027 available from the Goodyear Tire and Rubber Company. Where the reinforcing agent is a styrene-butadiene rubber, the amounts of the reinforcing agent can range from about 5 to about 40% by weight of plaster preparation, preferably from about 10 to about 30% by weight of the plaster preparation, more preferably from about 12 to about 20% by weight.
A tackifier is a substance, which enhances the tack or adhesive properties of the plaster preparation. Suitable tackifiers include rosin acid derivatives such as Pentalyn H from the Hercules Corporation, terpene based derivatives and synthetic C-5 tackifiers based on synthetic derivatives of petroleum stream fractions such as Escorez 2520 and Escorez 1310 from the Exxon Corporation or synthetic polyterpene resins such as Wingtack 10 from the Goodyear Tire and Rubber Company. The amount of tackifier in the plaster preparation can range from about 2 to about 20% by weight of the plaster preparation, preferably from about 5 to about 15%, more preferably from about 6 to about 12% by weight.
Salicylic acid, salts or esters thereof can be employed as the active ingredient in the plaster preparation. Suitable salts include the sodium, potassium, calcium, lithium or magnesium salts thereof. Suitable esters include the C-1 to C-4 esters thereof, such as methyl salicylate. Other esters include salsalate (salicylsalicylic acid), the salicylate ester of salicylic acid. Most prefe

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