Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – 9,10-seco- cyclopentanohydrophenanthrene ring system doai
Reexamination Certificate
2001-11-06
2004-06-22
Padmanabhan, Sreeni (Department: 1617)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
9,10-seco- cyclopentanohydrophenanthrene ring system doai
C514S904000, C514S905000
Reexamination Certificate
active
06753325
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a composition and method for preventing, reducing and treating radiation dermatitis.
2. Description of the Prior Art
One common effect of radiation exposure is a condition called radiation dermatitis, in which the skin in the exposed area begins to look reddened, irritated or burned. The exposed skin may also develop a moist reaction, especially where there are skin folds, and may become very sore. Patients receiving radiation therapy are especially at risk for radiation dermatitis. Radiation recall dermatitis has been identified as a particularly bad problem for patients receiving a combination of radiation therapy and chemotherapy to treat cancer.
Many attempts have been made to reduce, control or cure radiation dermatitis. U.S. Pat. No. 4,617,187 to Okuyama, et al. discloses a method for treating radiation dermatitis by topically applying ubidecarenone. However, ubidecarenone might be toxic and can cause many side effects during the treatment.
In some cases, medical care-givers use aquaphor or other products such as carasyn gel and lanolin to partially alleviate radiation dermatitis. It also has been reported that gels containing aloe vera extract can reduce or relieve radiation dermatitis. However, their effectiveness is still questionable.
Some studies have shown that epidermal permeability barrier function is impaired in patients who exhibit clinical signs of radiation dermatitis. The studies have also suggested that preservation of the epidermal permeability barrier function by topical treatment may ameliorate radiation dermatitis.
There still remains a need in the art for effective compositions and methods to prevent, reduce and treat radiation dermatitis.
Accordingly, it is an objective of certain embodiments of the present invention to provide a topical composition that, when applied to a skin area, will prevent, reduce or treat radiation dermatitis caused by exposure of that skin area to radiation.
It is another objective of certain embodiments of the present invention to provide a method to effectively prevent, reduce or treat radiation dermatitis.
It is further an objective of certain embodiments of the present invention to provide a composition for preventing, reducing or treating radiation dermatitis, which does not cause severe side effects to a patient treated with the composition.
These and other objects of the present invention will be apparent from the summary and detailed descriptions of the invention which follow.
SUMMARY OF THE INVENTION
In a first aspect, the present invention relates to a topical composition for preventing, reducing or treating radiation dermatitis. The composition includes a mixture of a compound that regulates cell differentiation and/or cell proliferation, and an antioxidant.
In a second aspect, the present invention relates to a method for the topical administration of a composition in accordance with the present invention for preventing, reducing or treating radiation dermatitis. In the method, an effective amount of the composition of the present invention is topically administered to an area of skin to prevent, reduce or treat radiation dermatitis caused by exposure of that area of skin to radiation.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
In a first aspect, the present invention relates to a topical composition for preventing, reducing or treating radiation dermatitis. The composition includes a mixture of a compound that regulates cell differentiation and/or cell proliferation, and an antioxidant.
The compound that regulates cell differentiation and/or cell proliferation may be selected from suitable compounds that have this activity. Suitable compounds that regulate cell differentiation and/or cell proliferation are those that do not induce significant, adverse side effects when topically applied to a patient in amounts that regulate cell differentiation and/or cell proliferation, and which do not react with one or more of the ingredients of the topical composition resulting in a substantial loss of activity of one or more active ingredients. Preferred compounds for regulating cell differentiation and/or cell proliferation are those that occur naturally in the human body and/or materials obtained from plants or animals which may be topically applied by humans without significant, adverse side effects in the amounts used, or derivatives thereof.
More preferably, the compounds that regulate cell differentiation and/or cell proliferation used in the present invention further inhibit or prevent cell differentiation or cell proliferation. Even more preferably, the compounds that regulate cell differentiation and/or cell proliferation used in the present invention accomplish at least one of the following: maintain the cellular homeostasis and normal cell metabolism, regulate cell differentiation, work synergistically with vitamin A to induce certain cancer cells to differentiate into normal cells, help maintain the epidermal permeability barrier, inhibit cancer cell differentiation, inhibit cancer cell proliferation.
Exemplary compounds that regulate cell differentiation and/or cell proliferation are vitamin D
3
, vitamin D
3
analogs, compounds that may be converted or metabolized into vitamin D
3
in the human body, and metabolites thereof. Exemplary compounds that may be converted or metabolized into a vitamin D
3
include common cholesterols illustrated below. The cholesterol illustrated below may be converted into Provitamin D when a hydrogen is removed from the number 7 carbon, which then forms a double bond with the number 8 carbon, in the second, or ‘B’ ring of the cholesterol molecule. The cholesterol is ‘oxidized’ (that is, an electron is removed with the hydrogen atom), so that the double bond is a consequence of 2 mutually shared electrons between carbons 7 and 8.
Provitamin D may be converted to Vitamin D
3
by the action of ultraviolet light through our skin. In this reaction, the B ring of the sterol molecule is opened.
Cholecalciferol, which is Vitamin D
3
, may be further converted into another vitamin D intermediate, 25-hydroxycholecalciferol, in the liver by mitochondrial hydroxylase, in the presence of NADPH, and molecular oxygen.
When more active vitamin D
3
is required, 25-hydroxycholecalciferol is transported to the kidney where a new hydrolase enzyme is synthesized. This enzyme introduces another hydroxyl group at position 1, and the bioactive form of Vitamin D
3
, calcitriol, is produced.
Exemplary vitamin D
3
analogs include 1(S), 3(R)-dihydroxy-20(R)-(1-ethoxy-5-ethyl-5-hydroxy-2-heptyn-1-yl)-9, 10-seco-pregna-5(Z), 7(E), 10 (19)-triene. Exemplary vitamin D
3
metabolites include vitamin D
3
1, 25-dihydroxyvitamin D
3
, which is a metabolite of vitamin D
3
. Also, pharmaceutically acceptable salts of the compounds that regulate cell differentiation and/or cell proliferation may be employed. The most preferred compound that regulates cell differentiation and/or cell proliferation is vitamin D
3
.
The compound that regulates cell differentiation and/or cell proliferation is used in an amount effective to regulate cell differentiation and/or cell proliferation when applied topically to the skin in the composition of the present invention.
In order to formulate the compound that regulates cell differentiation and/or cell proliferation in the topical composition of the present invention, it may be necessary to use a dispersant. Suitable dispersant materials are known to persons skilled in the art. A particularly suitable dispersant for the compound that regulates cell differentiation and/or cell proliferation is corn oil. Corn oil also has the advantage that it is a natural product. The amount of corn oil used is an amount sufficient to disperse the compound that regulates cell differentiation and/or cell proliferation.
Another ingredient in the composition of the present invention is the antioxidant. The antioxidant may be a single compound or a mixture of two or more compounds. Compounds which may be used
Hui San-ming
Knoble & Yoshida & Dunleavy LLC
Padmanabhan Sreeni
The Quigley Corporation
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