Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Implant or insert
Reexamination Certificate
1999-06-28
2004-04-27
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Implant or insert
C424S424000, C424S401000, C424S049000
Reexamination Certificate
active
06726922
ABSTRACT:
FIELD OF THE INVENTION
The present invention is directed to a process and composition for treating the surface of the skin or other tissue. More particularly, the invention is directed to a process and composition for suppressing pain topically on the eye, skin or mucosa tissue.
BACKGROUND OF THE INVENTION
Many substances are commonly applied to the skin, mucosa tissue and to other tissue of humans and animals to treat the surface of the skin or tissue. Typical examples of compositions that are applied to the skin include cosmetics, sunscreens and the like. Other compositions often include a pharmaceutical agent such as an antibiotic or bactericide for treating the surface of the tissue.
Topically applied compositions are generally in the form of liquids, creams, lotions and gels. In many instances, the compositions that are applied topically contain various components, which inherently cause irritation and inflammation when applied to the skin or the mucosa. The occurrence and frequency of the irritation can vary depending on the person, the specific components in the composition and the various components present.
Common symptoms of irritation from topically applied compositions include itching, stinging, burning, tingling, tightness, redness and swelling. The irritation can be due to the direct effect on the skin or the mucosa of the active ingredient or the carrier or in response to the immune system directly toward the chemicals alone or in combination with the skin components.
Many ingredients used in topically applied products are known irritants or are potentially irritating, especially for certain people with some allergies or sensitivities. Ingredients which can act as irritants include solvents, fragrances, preservatives, propellants, and pharmaceutical agents. Examples of common topical compositions, which can cause irritation, include exfolients and skin renewal agents, antiperspirants, antihistamines, anti-inflammatory agents, skin protective agents, insect repellants and sunscreens. Where more than one irritant compound is present, the effects can be additive. In addition, various components can interact with each other to cause irritation which might not occur when used alone.
Various efforts have been proposed to attempt to find methods and compositions for reducing or eliminating irritation caused by the topical application of various compositions. For example, one such method attempts to reduce the irritation caused by hydroxy acids and keto-acids in topically applied products by adding a strong alkali base metal such as sodium or potassium hydroxide. The effect of the hydroxide is to raise the pH and to reduce the acidity of the composition. However, this approach has the disadvantage of reducing the effectiveness of the hydroxy acid to penetrate the skin and to reduce the effectiveness of the acid. Other hydroxides and organic amines have also been proposed to adjust the pH of the composition. However, raising the pH using these bases also reduces the effectiveness of the composition.
A further example of methods reducing irritation caused by topically applied compositions is disclosed ion U.S. Pat. No. 5,716,625 to Hahn. This patent discloses the use of a strontium metal cation to reduce irritation. It is proposed that the cation interacts with the epidermis nerve cells to prevent or counteract the sensation of irritation by interfering with the irritation inducing components of the skin cells. The strontium cation is proposed to alter the ability of the epidermal cells to depolarize by blocking or interfering with ion channel or pump operation or by altering the transmembranal action potential. It has also been proposed that the strontium cation acts to inhibit or modify the action of skin cell protease or other irritation inducing components.
The human skin and mucosa tissue presents a complicated structural and sensory environment. The skin contains nerves and highly specific sensory cells that are specialized. These cells are developed to differentiate the stimuli leading to specific sensation such as pain. In addition, nerves in the skin are responsive to native or foreign chemicals such as proteases, prostaglandins, complement system molecules, allergens and the like. Agents that are effective in combating one stimulus are often ineffective against another stimulus.
Many pharmaceutical agents when applied topically produce a burning sensation, especially when applied to a cut or sensitive tissue. For example, various eye drops containing a pharmaceutical agent when applied to the eye result in a painful burning of the eye.
Accordingly, there is a continuing need in the industry for a method of reducing or eliminating the pain associated with the topical application of various components.
SUMMARY OF THE INVENTION
The present invention is directed to a process and composition for inhibiting pain and irritation caused by topically applied compositions. More particularly, the invention is directed to a process for treating tissue with a composition and temporarily suppressing pain of the tissue being treated.
Accordingly, a primary object of the invention is to provide a process for treating skin with a composition where the composition contains an effective amount of an anti-irritant.
Another object of the invention is to provide a process for treating cuts in the skin with a composition containing an effective amount of an anti-irritant to temporarily suppress pain and irritation of the cut.
A further object of the invention is to provide a process for introducing a solution onto the surface of the eye substantially without pain or irritation.
A still further object of the invention is to provide a process for treating mucosa with a composition containing a pharmaceutical agent and an effective amount of an anti-irritant.
Another object of the invention is to provide a process for temporarily suppressing pain and irritation by topically applying a composition containing an effective amount of an anti-irritant.
A further object of the invention is to provide a method and composition for removing calculus from tooth surfaces substantially without irritation to the gums and the tooth using an acidic solution and an effective amount of an anti-irritant.
Another object of the invention is to provide a solution containing an active component for applying topically to the skin or mucosa, where the solution contains a pain suppressing amount of saccharine.
Another object of the invention is to provide an ophthalmological solution containing a pain suppressing amount of a natural or synthetic non-nutritive sweetener.
A further object of the invention is to provide a process for topically treating skin or mucosa with a solution having a pH of about 4.0 or less and a pain and irritation suppressing amount of a synthetic sweetener.
The objects and advantages of the invention are basically attained by providing a process for treating tissue of an animal with at least one bioactive compound by providing an aqueous medium of at least one bioactive compound and at least one sweetener. The sweetener is included in an effective amount to block pain receptors temporarily in animal tissue. The aqueous medium is applied to the tissue of the animal in an effective amount to treat the tissue with the bioactive compound and to suppress pain and irritation of the tissue.
The objects of the invention are further attained by providing a process for removing calculus and other deposits from the surface of the teeth of an animal comprising the steps of: providing an aqueous medium containing an edible acid in an amount to form a solution having a pH of about 6.0 or less and at least one sweetener in an amount to suppress irritation of gum tissue. The aqueous medium is applied to the surfaces of the teeth for an effective amount of time to substantially remove calculus and deposits from the teeth.
The objects and advantages of the invention are also attained by providing a process for temporarily suppressing pain receptors and reducing irritation of the tissue of an animal compri
Minu, L.L.C.
Page Thurman K.
Pulliam Amy E
Roylance Abrams Berdo & Goodman L.L.P.
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