Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Cosmetic – antiperspirant – dentifrice
Reexamination Certificate
1998-01-29
2001-02-06
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Cosmetic, antiperspirant, dentifrice
C514S844000, C514S944000
Reexamination Certificate
active
06183758
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to the phytochemical, nutrient & medication for improved structure, function &/or treatment of specific conditions in humans and animals through the process of skin penetration, and more particularly it relates to a skin ointment with improved skin penetration properties.
BACKGROUND OF THE INVENTION
Phytochemicals, nutrients & medications intended for transmission via the blood stream are typically entered into a person's blood stream through oral ingestion or syringe injection. An alternative form of treatment is the application of the phytochemicals, nutrients or medications to the skin with the medication being absorbed through the skin into the blood vessels underlying the epidermis part of the skin.
There are advantages of the skin application technique, i.e. the compounds can be applied to the place of the needed improvement of the structure, function or ailment and absorption into the blood vessels surrounding this condition provides a more direct and often a more effective treatment/repair of the structure, function or ailment. The problem with the technique is achieving penetration of the skin and specifically the stratum corneum area of the skin.
The compounds themselves are often not skin absorbable (evidence shows the only possible exceptions to this are sodium ions and water) and must be dissolved into a carrier or transport solution. There are solutions that can be made to be somewhat skin absorbent, especially when they are applied and then covered with a barrier such as plastic (example is Dow's Saran wrap) and this causes water to travel in and out of this upper layer of skin. This system is limited to “patches” already prepared, is expensive and limits the amount of ingredient that can be applied and the physical area that the plastic patch can be applied. Solvents are known that will achieve this in the presence of a “patch” but they must be at a precise ratio of ingredient to the solvent (near saturation point). Known solutions that are acceptable for topical application and used without a “patch” are either not sufficiently absorbable into the skin or not sufficiently solvent, e.g., if the ingredient is one having large molecules, the solution does not readily dissolve the medication.
SUMMARY OF THE INVENTION
The present invention involves the combination of two separate and seemingly unrelated solutions. The first solution has a makeup of water, methyl sulfonyl methane (MSM—the oxide form of DMSO) and urea. MSM & urea in combination produce some but no significant penetration of the skin and they do not dissolve the large molecules often found in phytochemicals (active plant compounds), organic nutrients or prescribed medications. The combination of MSM and urea, used topically, is itself patented (U.S. Pat. No. 4,477,469) and has a number of benefits. One not so well known or appreciated is its ability not only to “soften” the skin but actually open the “horny layer” (stratum corneum, stratum lucidum & stratum granulosum) to allow penetration of water and organic solvents such as propylene glycol.
The second solution includes as one of the ingredients propylene glycol. Propylene glycol is recognized as being beneficial for skin penetration and it dissolves large molecules, e.g., at temperatures of between about 25° and 150° C. However, in the past to get the large organic molecules to pass the horny layer and be released one had to use a minimum amount of propylene glycol to solublize the compound and cover the area with the before mentioned “patch”. In this current invention it has been found that the before mentioned limits do not apply. Therefore with this second solution the desired ingredient (phytochemical, nutrient or medication) is dissolved in the propylene glycol completely and without being at the saturation point.
Upon mixing the two solutions, the mixture surprisingly produces rapid penetration of the ingredient through the skin tissue (epidermis) and into the blood vessels underlying the skin tissue (the dermis & subcutaneous tissues). It is theorized that the MSM & urea, although only a mediocre skin penetration, expands the platelets of the skin particularly in the horny layer of the skin. The expansion of the platelets opens the interstices and enables the rapid penetration of the propylene glycol solution, i.e., containing the active compound (phytochemical, nutrient or medication).
The invention will be more fully appreciated upon reference to the following detailed description of a preferred embodiment of the invention having reference to the accompanying drawings.
REFERENCES:
patent: 4477469 (1984-10-01), Herschler
patent: 5874074 (1999-02-01), Smith
Article entitled “Skin Penetration Enhancers Cited in the Technical Literature” from Pharmaceutical Technology, Nov., 1997.
Article entitled “Advances in Drug Delivery” from Pharmaceutical Technology, Jan., 1998.
“Percutaneous Absorption” from 14th Ed. Remington's Pharmaceutical Science.
Harrington Robert L.
Highland Laboratories, Inc.
Howard S.
Page Thurman K.
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