Photostable sunscreen compositions and methods of stabilizing

Drug – bio-affecting and body treating compositions – Topical sun or radiation screening – or tanning preparations

Reexamination Certificate

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C424S060000, C424S400000, C424S401000, C424S725000, C424S773000, C424S774000, C424S775000, C424S778000, C424S779000

Reexamination Certificate

active

06440402

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to the use of Kaempferia Galanga extract to photostabilize a topical sunscreen composition and synergistically enhance the UV absorbency of a sunscreen composition. More particularly, the present invention relates to a sunscreen composition having a sunscreen active, particularly dibenzoylmethane and/or its derivatives, and an extract of Kaempferia Galanga, particularly from the root thereof. The present invention also relates to a method of photostabilizing a sunscreen active in the topical sunscreen composition. The present invention further relates to a method of synergistically enhancing the UV absorbance of a sunscreen active in the topical sunscreen composition.
2. Description of the Prior Art
Commercial sunscreen compositions commonly employ a sunscreen active, such as a dibenzoylmethane derivative, e.g. butylmethoxydibenzoylmethane (avobenzone).
A common problem associated with some sunscreen compositions is a tendency of sunscreen actives, including dibenzoylmethane and/or derivatives thereof, to photodegrade over time from exposure to UV (ultraviolet) light. This results in an alteration of the UV absorbance of the composition and, thus, a diminution in sunscreen protection for the user during extended exposure to sunlight.
U.S. Pat. No. 5,952,391 relates to sunscreen compositions having dibenzoylmethane sunscreen actives. The compositions have flavone or flavanone derivatives to stabilize the dibenzoylmethane actives.
An extract of Kaempferia Galanga is disclosed in Naturally Occurring Isoamyl p-Methoxycinnamate, Cosmetics and Toiletries magazine, vol. 112, pp. 74-77, Jan. 1997, which is incorporated herein by reference thereto. Topical compositions having the extract are disclosed in Japanese Application Nos. 8157346A2, 61291515A2, S61-291515 and 9030948A2. The extract has been disclosed as useful as a sunscreen, anti-inflammatory agent, skin lightening agent and food ingredient.
It would be desirable to have a sunscreen composition that is photostable and affords the claimed sunscreen protection for an extended period of time. It would be further desirable to have a photostable sunscreen composition that has a dibenzoylmethane and/or derivative thereof (hereafter collectively “dibenzoylmethane”). It would be still further desirable to have a photostable sunscreen composition that affords an enhanced degree of sunscreen protection.
SUMMARY OF THE INVENTION
It is an object of the present invention to provide a topical sunscreen composition having a photostable sunscreen active.
It is another object of the present invention to provide a topical sunscreen composition affording enhanced photostability for a dibenzoylmethane sunscreen active.
It is still another object of the present invention to provide a topical sunscreen composition that exhibits synergistic UV absorbance benefits upon prolonged exposure to sunlight.
These and other objects and advantages of the present invention are achieved by a topical sunscreen composition having a sunscreen active, a photostabilizing and/or UV absorbance enhancing amount of an extract of Kaempferia Galanga, and a cosmetically acceptable vehicle.
There is also provided a method of enhancing the photostability of a sunscreen active in a topical sunscreen composition. An extract of Kaempferia Galanga is introduced into the composition in an amount sufficient to enhance the photostability of the sunscreen active.
There is also provided a method of synergistically enhancing the UV absorbance of a topical sunscreen composition having a sunscreen active. An extract of Kaempferia Galanga is introduced into the composition in an amount sufficient to synergistically enhance UV absorption.
DETAILED DESCRIPTION OF THE INVENTION
It was found surprising and unexpected that the photostability of a topical sunscreen composition having a sunscreen active, particularly dibenzoylmethane and/or derivatives thereof, could be enhanced by the introduction of an extract of Kaempferia Galanga, particularly from the root thereof. It was also found surprising and unexpected that UV absorption capability of such a composition was synergistically enhanced by the introduction into the composition of the extract of Kaempferia Galanga.
The present composition has one or more active sunscreens. Such sunscreen actives may be organic or inorganic and water-soluble or oil-soluble. Such actives include those for UVA and UVB protection (290 to 400 nanometer solar radiation). Such sunscreen actives include, but are not limited to, one or more of the following: dibenzoylmethane, oxybenzone, sulisobenzone, dioxybenzone, menthyl anthranilate, para aminobenzoic acid (PABA), octyl methoxycinnamate, DEA methoxycinnamate, octocrylene, drometrizole trisiloxane, octyl salicylate, homomenthyl salicylate, octyl dimethyl PABA, TEA salicylate, 4-methyl benzilidene camphor, octyl triazone, terephthalydiene dicamphor sulfonic acid, phenyl benzimidazole sulfonic acid, ethyl PABA, hydroxy methylphenyl benzotriazole, methylene bis-benzotriazoyltetramethylbutylphenol, bis-ethylhexyloxyphenol methoxyphenol triazine, titanium dioxide, zinc oxide, or any derivatives or any combinations thereof. Other useful sunscreen actives include those disclosed in U.S. Pat. No. 5,000,937, which is incorporated herein by reference.
Sunscreen actives of the present invention may be present at up to about 70 percentage by weight (wt %), of the total weight of the composition. Preferably, sunscreen actives are present from about 0.05 wt % to about 50 wt %, more preferably about 0.1 wt % to about 30 wt %, and most preferably about 0.5 wt % to about 20 wt %, based on the total weight of the composition. For example, octyl methoxycinnamate is present in an amount about 2 wt % to about 10 wt %, octyl salicylate in an amount about 3 wt % to about 5 wt %, and oxybenzone in an amount about 2 wt % to about 6 wt %.
The preferred sunscreen active is dibenzoylmethane and derivatives thereof. The dibenzoylmethane sunscreen active preferably conforms to the structure:
wherein R
1
and R
2
are alkyl groups having 1-36 carbons. The dibenzoylmethane sunscreen active includes, but is not limited to, butylmethoxydibenzoylmethane (avobenzone) and 4-isopropyldibenzoylmethane. The most preferred active is butylmethoxydibenzoylmethane.
The dibenzoylmethane sunscreen active is present at up to about 20 wt %, of the total weight of the composition. Preferably, the dibenzoylmethane sunscreen active is present from about 0.05 wt % to about 10 wt %, and most preferably about 0.5 wt % to about 3 wt %, based on the total weight of the composition.
The amount of sunscreen active employed will depend on the level of protection desired. Although not to be construed as limiting, compositions will typically range in level of sunscreen protection factor (SPF) from about 2 up to about 100, preferably about 2 to about 70, more preferably about 4 to about 30, and most preferably about 15 to about 30.
The present composition has an extract of Kaempferia Galanga. The extract is a crystalline solid obtained from the Kaempferia Galanga plant, also referred to as the Spice Lilly. The extract may be obtained from any part of the plant, such as the leaves, flowers, stem, bark and, most preferably, the root. The essential oil can include among its components the following: p-methoxycinnamic acid ethyl ester, p-methoxycinnamic acid methyl ester, cinnamic acid ethyl ester, n-pentadecane, 3-Carene borneol and 1,8-cineole.
The weight ratio of the extract of Kaempferia Galanga to the sunscreen active is 0.01:3 to 3:0.01. This ratio is preferably 0.01 to 0.5:1, more preferably 0.05:3, even more preferably 0.02 to 0.2:1, and most preferably 1.5:1.
Although an extract of Kaempferia Galanga is known to be useful as a sunscreen active, the effects observed in the present invention upon combination with other sunscreen actives, particularly dibenzoylmethane and/or derivatives thereof, is surprising and unexpected. First, the extract enhances or improves the photostability of

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