Turmeric as an anti-irritant in compositions containing...

Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Ester doai

Reexamination Certificate

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C514S558000, C514S560000, C514S578000, C514S675000

Reexamination Certificate

active

06277881

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates to the use of turmeric in a composition and a method for reducing or eliminating skin irritation or sting induced by hydroxy acids or retinoids.
BACKGROUND OF THE INVENTION
Hydroxy acids (HAs) and retinoids have been proven to deliver cosmetic benefits, such as improvement in the appearance of photodamaged or naturally aged skin, skin lightening, treatment of age spots, etc. Unfortunately, their use at high concentrations may occasionally be associated with skin irritation, e.g., skin redness and stinging sensation upon application. The irritation can be ameliorated by lowering the amount of an active ingredient in the composition or by reducing the active's penetration through the skin. A serious drawback of both approaches is that the efficacy is impaired. The HA related irritation can be reduced by raising the composition's pH but this method yields reduced efficacy due to a decreased HA penetration through the skin. It is desirable to reduce or eliminate the irritation potential of HAs and/or retinoids while maintaining their efficacy.
Turmeric is a powdered rhizome of the plant
Curcuma longa
Linn. The biological activities of turmeric have generally been attributed to curcumin, a component of turmeric extract. Curcumin has been reported to have anti-inflammatory and anti-oxidant activity. See Huang et al., “Inhibitory Effects of Curcumin on Tumorigenesis in Mice”, Journal of Cellular Biochemistry Supplement 27:26-34 (1997), Mukundan et al., “Effect of turmeric and curcumin on BP-DNA adducts”, Carciogenesis, Vol. 14, No. 3, pp. 493-496 (1993) and Huang et al., “Inhibitory Effects of Curcumin on in Vitro Lipoxygenase and Cyclooxygenase Activities in Mouse Epidermis”, Cancer Research 51, 813-819 (1991).
U.S. Pat. No. 5,053,222 (Takasu et al.) discloses a hair cosmetic composition for dandruff treatment which may contain a variety of optional ingredients, including certain alpha-hydroxy acids, vitamin A, and turmeric. U.S. Pat. No. 5,152,983 (Nambudiry et al.) discloses sunscreen compositions comprising a 1,3-diketone, which may be curcumin. The 1,3-diketone is present in the Nambudiry composition at 0.01 to 15%. By contrast, the curcumin content in the compositions of the present invention, even if up to 20% of turmeric extract is used, is at most 0.0002%, i.e., orders of magnitude below the minimum amount in the Nambudiry patent. If turmeric extract were used at levels sufficient to provide curcumin amount of Nambudiry patent, unacceptable yellow color would result.
The art discussed above does not teach any compositions containing turmeric extract at a level presently claimed in combination with HAs and/or retinoids. The art does not appear to teach the use of turmeric extract or curcumin to reduce irritation or sting associated with the use of HAs and/or retinoids. Even more importantly, the art does not disclose the criticality of employing turmeric extract rather than curcumin, to reduce skin irritation. On the contrary, the literature appears to equate the activities of turmeric extract and curcumin.
SUMMARY OF THE INVENTION
The present invention includes, in part, a composition containing a cosmetic benefit ingredient selected from the group consisting of hydroxy acids (“HAs”) and certain retinoids and further containing turmeric extract.
The invention also includes a method for reducing irritation or sting induced by the topical application of a composition containing HAs or retinoids, the method comprising topically applying turmeric extract. According to the inventive method, turmeric extract may be co-present with HAs and/or retinoids in the same composition, or turmeric extract may be applied from a separate composition.
According to the present invention, by virtue of topical application of turmeric extract, the irritation or sting induced by the topical application of HAs and/or retinoids is reduced or eliminated. It has been found as part of the present invention that not all known anti-irritants, ameliorate HA/retinoid induced irritation.
DETAILED DESCRIPTION OF THE INVENTION
Except in the operating and comparative examples, or where otherwise explicitly indicated, all numbers in this description indicating amounts of material or conditions of reaction, physical properties of materials and/or use are to be understood as modified by the word “about.” All amounts are by weight of the composition unless otherwise specified.
Turmeric extract is an essential ingredient of the inventive compositions and is employed according to the present invention to reduce or eliminate the skin irritation induced by hydroxy acids and/or retinoids.
The amount of turmeric extract in the inventive compositions ranges generally from 0.01 to 20% by weight of the composition, preferably from 0.1% to 10%, most preferably from 1% to 5%.
Hydroxyacids enhance proliferation and increase ceramide biosynthesis in keratinocytes, increase epidermal thickness, and increase desquamation of normal skin resulting in smoother, younger looking skin.
The hydroxy acid can be chosen from alpha-hydroxy acids, beta-hydroxyacids (e.g., salicylic acid), other hydroxycarboxylic acids (e.g., dihydroxycarboxylic acid, hydroxy-dicarboxylic, hydroxytricarboxylic) and mixtures thereof or combination of their stereoisomers (DL, D or L).
Preferably the hydroxy acid is chosen from alpha-hydroxy acids having the general structure (1):
where M is hydrogen or a saturated or an unsaturated, straight or branched hydrocarbon chain containing from 1 to 27 carbon atoms.
Even more preferably the hydroxy acid is chosen from lactic acid, 2-hydroxyoctanoic acid, hydroxylauric acid, glycolic acid, and mixtures thereof. When stereo isomers exist, L-isomer is most preferred.
It is to be understood that depending on the pH of the composition, the hydroxy acid may be present as a salt, e.g., ammonium or potassium or sodium salt.
Although the inventive compositions may have any pH in the general range of 2.0 to 10, the inventive compositions are particularly useful when they are at an acidic pH (especially if they contain a hydroxy acid), most preferably at a pH of 2 to 4, because such compositions are particularly irritating.
Retinoids enhance keratinocyte proliferation in vitro, increase epidermal thickness and increase collagen synthesis by dermal fibroblasts. This results in protection from sun damage and smoothing of wrinkled skin. The term “retinoids” as used herein includes retinoic acid, retinol, retinal and C
2
-C
5
retinyl esters, because these are the most irritating. Included in the term “retinoic acid” are 13-cis retinoic acid and all-trans retinoic acid.
The term “retinol” includes the following isomers of retinol: all-trans-retinol, 13-cis-retinol, 11-cis-retinol, 9-cis-retinol, 3,4-didehydro-retinol. Preferred isomers are all-trans-retinol, 13-cis-retinol, 3,4-didehydro-retinol, 9-cis-retinol. Most preferred is all-trans-retinol, due to its wide commercial availability.
Retinyl ester is an ester of retinol. The term “retinol” has been defined above. Retinyl esters suitable for use in the present invention are C
2
-C
5
esters of retinol, preferably C
2
and C
3
esters, and most preferably C
2
ester because it is more commonly available. Retinyl esters included in the invention are also known as: retinyl acetate, retinyl propionate, retinyl butyrate, and retinyl pentanolate.
A particular advantage of the inventive compositions is that higher amounts of hydroxy acids or retinoids may be employed without causing skin irritation. Preferably the amount of the hydroxy acid component present in the composition according to the invention is from 0.01 to 20%, more preferably from 0.1 to 12% and most preferably from 4 to 12% by weight.
A retinoid may be present in the inventive compositions in an amount 33 to 330,000 IU per gram of the composition, preferably 330 to 16,500 IU, most preferably 1,650 to 6,600 IU. Again, a higher amount of a retinoid may be employed in the inventive compositions without causing skin irritation, due to the co-presence of Turmeri

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