Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Cosmetic – antiperspirant – dentifrice
Reexamination Certificate
2001-07-31
2003-03-04
Dees, Jose′ G. (Department: 1619)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Cosmetic, antiperspirant, dentifrice
Reexamination Certificate
active
06528076
ABSTRACT:
II. FIELD OF THE INVENTION
The present invention is directed to a topical composition for treating pain in mammals. Specifically, the present invention comprises a safe and effective amount of acetone, a salicylate-based compound, an emollient and one or more compounds which can function as an analgesic and/or skin penetration enhancer, such as terpenes and essential oils.
The present invention is also directed to methods for treating pain and for topically applying an effective amount of the present composition to the area of pain.
III. BACKGROUND
An area of on-going research is the development of safer and effective methods for reducing or eliminating pain using transdermal analgesic formulations. Over time, a variety of such analgesic formulations have been developed. These include lotions and ointments containing aspirin or any of a number of non-steroidal anti-inflammatory agents. While many of the currently available analgesic formulations reduce pain to some degree, there is, nonetheless, a continued interest in identifying new formulations which provide longer lasting pain relief in a short period of time.
It is therefore an object of the present invention to provide a safe topical composition that provides effective pain relief in a sufficiently short period of time. Further objects of the present invention will be apparent from the descriptions herein.
IV. SUMMARY OF THE INVENTION
The present invention provides a composition comprising acetone, a salicylate-based compound, an emollient and one or more terpenes and essential oils. The present invention is also directed to methods for treating pain and for topically applying an effective amount of the present compositions to the area of pain.
V. DETAILED DESCRIPTION OF THE INVENTION
A. Compounds Utilized in the Present Composition
The composition of the present invention comprises acetone, a salicylate-based compound and an emollient. Preferably, the present composition comprises commercial grade acetone, substantially free of impurities, including, but not limited to, water, benzene or phenol. More preferably, the acetone is at least 95% pure and/or contains less than 1% water, less than 100 ppm phenol and less then 100 ppm benzene, and most preferably less than 50 ppm phenol and 1 ppm benzene. Ideally, the acetone is phenol and benzene free.
The salicylate-based compounds used herein include, but are not limited to, salicylic acid, or derivatives thereof, such as methyl salicylate, sodium salicylate, acetyl salicylic acid, aloxipirin, calcium carbaspirin, choline salicylate, salicoside, salicylamide, acetylsalicylic acid, salicylsufuric acid, o-hydroxybenzoic acid, methyl ester, synthetic wintergreen oil, Betula oil, and salicylic acid. Other salicylate-based compounds which may be useful in the present invention are disclosed in U.S. Pat. No. 4,275,059 to Flora, which is incorporated herein by reference. Preferably, the salicylate-based compound is commercial grade, and more preferably the compound is greater than 95% pure and more preferably greater than 99% pure. The preferred salicylate-based compound is methyl salicylate, preferably having a purity ranging between 95% and 99.9%.
The present compositions may also include terpenes and essential oils. Examples of such compounds include, but are not limited to, alpha-terpinene, gamma terpinene, linalool, camphene, limonene, menthol, sabinene, menthene, alpha-phellandrene, alpha-pinene and beta-pinene, myrcene, isopulegol, 1,8-cineole (Eucalyptol), and the like. Preferably, these compounds are commercial grade, more preferably greater than 80% pure, and most preferably between 90 and 99.9% pure. Ideally, such compounds are between 97% and 99.9% pure. Other terpenes and essential oils which may be included in the present invention include, but are not limited to, junipene, camphor, mint oils, lidocaine, peppermint oil and eucalyptus oil. Preferably, these compounds are commercial grade and more preferably greater than 80% pure.
Emollients for use in the present compositions include, but are not limited to, the following:
1. Triglyceride esters which include, but are not limited to, vegetable and animal fats and oils such as palm oil, castor oil, cocoa butter, safflower oil, cottonseed oil, corn oil, olive oil, cod liver oil, almond oil, avocado oil, palm oil, sesame oil, squalene, kikui oil and soybean oil;
2. Acetoglyceride esters, including but not limited to acetylated monoglycerides;
3. Ethoxylated glycerides such as ethoxylated glyceryl monostearate;
4. Alkyl esters of fatty acids having 10 to 20 carbon atoms which include, but are not limited to, methyl, isopropyl and butyl esters of fatty acids;
5. Alkenyl esters of fatty acids having 10 to 20 carbon atoms such as oleyl myristate, oleyl stearate, and oleyl oleate;
6. Fatty acids having 10 to 20 carbon atoms such as pelargonic, lauric, myristic, palmitic, stearic, isostearic, hydroxystearic, oleic, linoleic, ricinoleic, arachidic, behenic, and erucic acids;
7. Fatty alcohols having 10 to 20 carbon atoms such as lauryl, myristyl, cetyl, hexadecyl, stearyl, isostearyl, hydroxystearyl, oleyl, ricinoleyl, behenyl, erucyl, and 2-octyl dodecanyl alcohols;
8. Lanolin and lanolin derivatives including, but not limited to lanolin, lanolin oil, lanolin wax, lanolin alcohols, lanolin fatty acids, isopropyl lanolate, ethoxylated cholesterol and lanolin alcohols;
9. Polyhydric alcohol esters, including but not limited to, ethylene glycol mono and di-fatty acid esters, diethylene glycol mono-and di-fatty acid esters and polyethylene glycol (200-6000) mono- and di-fatty acid esters;
10. Wax esters such as beeswax, spermaceti, myristyl myristate, stearyl stearate;
11. Beeswax derivatives including but not limited to, polyoxyethylene sorbitol beeswax;
12. Vegetable waxes including, but not limited to, carnauba and candelilla waxes;
13. Phospholipids such as lecithin and derivatives;
14. Sterols including, but not limited to, cholesterol and cholesterol fatty acid esters; and
15. Amides such as fatty acid amides, ethoxylated fatty acid amides, and solid fatty acid alkanolamides.
Preferably, the emollient utilized in the present invention is commercial grade. The preferred emollient of the present invention is palm oil. Skin-conditioning compounds which may also be included in the present invention are disclosed in U.S. Pat. No. 6,174,533 to Sanogueira, Jr., which is incorporated herein by reference.
The following descriptions represent various embodiments of the present compositions. These embodiments are not intended to limit the scope of the invention. The amount of each ingredient in the composition is given in weight percent based on the total weight of the composition. Such ingredients can be synthetically prepared and/or derived from natural sources. Further, the compositions of the present invention may comprise, consist of or consist essentially of the ingredient's identified herein. Embodiments disclosed herein can be formulated by combining, adding, mixing and/or blending the herein described ingredients (e.g., in commercial grade form) using standard techniques known in the art.
The topical composition of the present invention generally comprises from about 1% to about 70% of the salicylate-based compound, about 1% to about 70% acetone and about 1% to about 30% of an emollient.
A preferred composition generally comprises from about 5% to about 60% of the salicylate-based compound, preferably from about 5% to about 30%, more preferably from about 5% to about 20%, and most preferably about 8.6%. The present compositions may also comprise from about 1% to about 7% of the salicylate-based compound, or about 10% to about 40%, or about 55% to about 70%, or about 10% to about 70%. Many patients are in the habit of taking analgesics for prolonged periods and usually in excessive doses. Thus, the preferred ranges are more appropriate to avoid analgesic overuse noted in patients.
Another preferred composition of the present invention generally comprises from about 10% to about 70% acetone, preferably from about 15% to abou
Coudert Brothers LLP
Dees Jose′ G.
George Konata M.
Magic Herb Corp.
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