US 2006O194759A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2006/0194759 A1 Eidelson (43) Pub. Date: Aug. 31, 2006

(54) TOPICAL COMPOSITIONS AND METHODS Publication Classification FOR TREATING PAN AND NFLAMMATION (51) Int. Cl. A 6LX 3L/737 (2006.01) (76) Inventor: Stewart G. Eidelson, Boca Raton, FL A6II 3L/728 (2006.01) (US) A 6LX 3/573 (2006.01) A6II 3L/045 (2006.01) A61K 3 1/7008 (2006.01) Correspondence Address: (52) U.S. Cl...... 514/54: 514/171; 514/729; Raymond P. Niro 514/62 Niro, Scavone, Haller & Niro Suite 4600 (57) ABSTRACT 181 W. Madison A topical composition and method for treating pain and Chicago, IL 60602 (US) inflammation by administering an effective amount of a topical composition comprising an anti-inflammatory Ste roid such as hydrocortisone, a topical anesthetic Such as (21) Appl. No.: 11/066,863 lidocaine, menthol, and a medically acceptable carrier into which the forgoing are incorporated. A chondroprotective (22) Filed: Feb. 25, 2005 agent can also be added. US 2006/0194759 A1 Aug. 31, 2006

TOPCAL COMPOSITIONS AND METHODS FOR as lidocaine, and the steroidal anti-inflammatory drug Such TREATING PAN AND INFLAMMATION as hydrocortisone are each preferably in amounts from about 1% to about 4% of the composition by weight. The active BACKGROUND OF THE INVENTION ingredients of the invention at Such concentration ranges will relieve pain and inflammation in an enhanced and 0001) 1. Field of the Invention synergistic manner. Such benefits may diminish if the con 0002 This invention relates to the relief of pain and centrations of the individual ingredients are significantly inflammation, in particular to the control of pain and inflam below or significantly above the preferred ranges. For mation by the application of a topical composition contain instance, active ingredient concentrations significantly ing active ingredients in a suitable carrier for their transport above the preferred ranges may produce unwanted side through a patient's skin. effects Such as the thinning of the epidermis, skin rashes, Suppression of the adrenal glands, or excessive desensitiza 0003 2. Description of the Related Art tion of the skin. On the other hand, active ingredient 0004. Managing pain and inflammation remains a chal concentrations significantly below the preferred ranges may lenge today in medicine. Current treatment options include not be in sufficient amounts to produce the desired effects of the oral administration of opioid analgesics such as mor the present invention. phine, codeine and hydrocodone. The oral administration of DETAILED DESCRIPTION OF THE non-steroidal anti-inflammatory drugs (NSAID) such as INVENTION aspirin and ketoprofen provides another option in managing 0007. The present invention relates to topical composi pain and inflammation. Despite their effectiveness, the oral tions that can contain a combination of an anti-inflammatory use of the above classes of drugs is associated with various steroid Such as hydrocortisone, a topical anesthetic Such as adverse events. For instance, opioid analgesics dispose a lidocaine, menthol, and a medically acceptable carrier at patient to iatrogenic addiction, where the patient develops a appropriate concentrations to relieve pain and inflammation. dependency on the potent drug and consequently abuses it. In another embodiment, the above compositions may con The use of opioid analgesics is also associated with undes tain one or more chondroprotective agents such as chon ired symptoms Such as sedation and constipation. Likewise, droitin Sulfate and/or glucosamine at therapeutically effec pain management by the oral administration of non-steroidal anti-inflammatory drugs is associated with irritation to the tive concentrations. gastrointestinal tract, gastric bleeding, and ulcer. Other more 1. Anti-Inflammatory Steroid serious adverse events associated with the oral administra 0008 Many steroids have potent anti-inflammatory prop tion of NSAID’s include increased risks in heart attacks and erties and are used to treat a variety of conditions such as related cardiovascular diseases, as identified in AleveR) and arthritis, colitis, asthma, bronchitis, certain skin rashes, and Vioxx(R). Thus, many topical compositions containing allergic or inflammatory conditions of the nose and eyes. NSAIDs and opioid analgesics, either alone or in combi Unlike NSAID's that reduce inflammation by inhibiting the nation with other active ingredients, have been developed to biosynthesis of prostaglandins, steroidal anti-inflammatory by-pass the gastrointestinal tract and therefore mitigate the agents reduce inflammation by inducing protein synthesis adverse events associated with oral administration. Such via gene expression. A desirable anti-inflammatory steroid topical compositions also have the additional advantage of for the present invention is hydrocortisone. Hydrocortisone acting much faster in relieving pain and inflammation. is a natural corticosteroid produced by the adrenal glands. However, a challenge remains in optimizing and enhancing Other steroids suitable for the present invention include the therapeutic effects of these topical compositions. alcometasone, clocortolone, dexamethasone, hydrocortisone 21-acetate, prednisone, hydrocortisone 17-Valerate, hydro SUMMARY OF THE INVENTION cortisone 17-butyrate, betamethasone Valerate, triamcino lone acetonide, flucinonide, desonide, flucinolone acetonide, 0005 The present invention relates to the relief of pain dexamethasone 21-phosphate, prednisolone, prednisolone and inflammation by the topical application of a composition 21-phosphate, haloprednone, cortisone acetate, hydrocorti comprising a combination of remedies in a carrier compo Sone cyclopentylpropionate, cortodoxone, flucetonide, sition to enhance their transport through a patient’s skin. In fludrocortisone acetate, flurandrenolone acetonide, particular, the present invention achieves new and unex medrysone, amcinafal, amcinafide, betamethasone, pected Synergistic effects in treating pain and inflammation betamethasone benzoate, chloroprednisone acetate, clocor from the combination of an anti-inflammatory steroid Such tolone acetate, descinolone acetonide, desoximetaSone, as hydrocortisone, a topical anesthetic Such as lidocaine, and dichlorisone acetate, difluprednate, flucloronide, flumetha menthol at appropriate concentrations in a medically Sone, flumethasone pivalate, flunisolide acetate, flucor accepted carrier composition. Chondroprotective agents tolone, fluorometholone, fluperolone acetate, flupredniso Such as chondroitin Sulfate and/or glucosamine can also be lone, fluprednisolone Valerate, meprednisone, methyl added to further enhance the pain-relieving and anti-inflam prednisolone, paramethasone acetate, prednisolamate, pred matory properties of the present invention. nival, triamcinolone, triamcinolone hexacetonide, cortiva 0006. In the present invention, the appropriate concen Zol, formocortal. nivaZol or methylprednisone, beclometha tration of the medically accepted carrier may be the amount sone 17,21-dipropionate, betamethasone 17-valerate, effective to facilitate the transmission of the topical compo betamethasone 17,21-dipropionate, clobetasol 17-propi sitions of the present invention through the skin. The appro onate, clobetasone 17-butyrate, mixtures thereof, and priate concentration of menthol is preferably in an amount equivalents thereof. from about 1% to about 10% of the composition by weight. 0009. In the present invention, the steroidal anti-inflam The appropriate concentrations of the topical anesthetic Such matory compound Such as hydrocortisone is preferably US 2006/0194759 A1 Aug. 31, 2006 present in an amount from about 1% to about 4%, preferably agents have anti-inflammatory and pain relieving properties from about 1% to about 2%, and more preferably approxi in patients Suffering from osteoarthritis and other inflamma mately 1% of the composition by weight. The steroidal tory conditions. It is hypothesized that chondroprotective anti-inflammatory compound at the above concentration agents have such effects by interfering with the inflamma ranges, in combination with the other active ingredients of tory cascade, inhibiting cartilage-degrading enzymes, stimu the present invention at appropriate concentrations, lating the production of new matrix and structural proteins, enhances and synergizes the relief of pain and inflammation. improving the quality of synovial fluid to enhance cartilage Steroidal anti-inflammatory drug concentrations signifi nutrition and lubrication, stimulating the production of free cantly below 1% may be too low to produce such effects. radical Scavenging enzymes, and improving blood flow to The therapeutic effects of the present invention may also be joint tissues. Examples of chondroprotective agents Suitable affected at Steroidal concentrations significantly above 4%. for the present invention include but are not limited to Continued and prolonged usage at Such concentrations may chondroitin Sulfate, glucosamine, N-acetyl glucosamine, enhance a patient's disposition to various skin conditions polysulfated glycosaminoglycan, hyaluronic acid, pentosan Such as drying, cracking, irritation, Suppression of the adre polysulfate, and derivatives thereof. Chondroitin sulfate and nal glands, Cushing's syndrome, excessive fluid retention, glucosamine are the best studied and therefore the preferred dermatitis, allergic reactions, thinning of the skin, and chondroprotective agents for use in the present invention. It susceptibility to infections. is also desirable that glucosamine and chondroitin Sulfate be 2. Topical Anesthetic used together in the same composition due to enhanced and 0010 Topical anesthetics operate by desensitizing and synergistic effects. In the present invention, chondroprotec blocking pain pathways at the skin level. The preferred tive agents will be present in therapeutically effect amounts. topical anesthetic for the present invention is lidocaine. Such concentration ranges may span from about 0.5% to Other topical anesthetics suitable for the present invention about 95%, preferably from about 5% to about 40%, and include but are not limited to benzocaine, butamben, more preferably about 30% by weight of the composition. dibucaine, propoxycaine, procaine, mepivacaine, bupiv 5. Medically Acceptable Carriers and Additives acaine, pramoxine, tetracaine, mixtures thereof and equiva lents thereof. The topical anesthetic such as lidocaine in the 0013 The active components of the topical compositions present invention is preferably in an amount from about 1% of the present invention can be suspended in a Suitable to about 4%, preferably from about 2% to about 4%, and carrier that promotes their rapid transport through a patients more preferably approximately 2% of the composition by skin. Medically acceptable carriers of the present invention weight. Such concentration ranges will ensure that appro are chosen so that they are generally compatible with the priate amounts of the topical anesthetic penetrates the epi individual components of the present invention and do not dermis and produces the enhanced and synergistic effects of interfere significantly with their transport through a patients the present invention in relieving pain and inflammation. skin. The carrier composition may be an individual com Topical anesthetic concentrations significantly below 1% pound or a plurality of compounds. Examples of carrier may be insufficient for producing such effects. On the other compounds that may be used in the compositions of the hand, the prolonged usage of topical anesthetics on the skin present invention include but are not limited to water at concentrations significantly above 4% may lead to exces (preferably deionized), mineral oil, Salicylic acid, methyl sive dermal desensitization, the Swelling and itching of the sulfonylmethane (MSM), jojoba oil, alcohol (e.g., ethanol, skin, the development of skin rashes, or burning sensations isopropanol), a mono- or polyglycol (e.g., ethylene glycol, on the skin. propylene glycol, polyethylene glycol, polyethylene gly col-8 Stearate, polyoxyalkylene derivatives, propylene gly 3. Menthol col), fatty acid esters (e.g., alkyl Stearates, oleates, linoleates, 0011 Menthol is a compound obtained from peppermint isopropyl palmitate) or other organic compounds or poly oil with local anesthetic and counterirritant qualities. Men merS Such as polyacrylamides, dimethylsulfoxide, dimeth thol is readily absorbed by the skin, providing a temporary ylformamide, dimethylacetamide, 1.2.6-hexanetriol, butane cooling effect to limit Swelling, decrease pain, and relax diol, and equivalents thereof. muscles. In addition, menthol enhances the transport of chemicals through the skin by enhancing skin penetration 0014. In addition to the carrier composition and active and absorption. In the present invention, menthol will pref ingredients, the topical compositions of the present inven erably be present in an amount from about 1% to about 10%, tion may include additives such as anti-oxidants (e.g. buty preferably from about 2% to about 5%, and more preferably lated hydroxytoluene, butylated hydroxyanisole, propyl gal approximately 3% of the composition by weight. Menthol late), perfumes (e.g. rosemary oil), colorants, moisturizers concentrations significantly below 1% may not be sufficient and emollients (e.g. Sunflower oil, jojoba oil, isopropyl to produce the desired synergistic and enhanced effects of palmitate). Agents such as peppermint oil may also be added the present invention in relieving pain and inflammation. to the compositions of the present invention to enhance their Menthol concentrations significantly above 10% may miti cooling effects. Other suitable additives include preserva gate such effects by producing excessive and undesired tives for maintaining the chemical structure and Stability of cooling sensations on the skin after prolonged usage. Thus, the active ingredients in the compositions of the present it is desirable for the compositions of the present invention invention. Preservatives may include anti-microbial agents to use menthol in the preferred concentration ranges. and anti-fungal agents such as propylene glycol, methyl paraben, propyl paraben, and diaZodinyl urea. An example 4. Chondroprotective Agents of a commercially available product that contains a blend of 0012 Chondroprotective agents are integral components Such agents and is Suitable for the present invention is of connective tissues such as the articular cartilage. These Germaben(R) II by Nature Bath (North Ridgeville, Ohio). US 2006/0194759 A1 Aug. 31, 2006

00.15 Emulsifying agents can also be added to the topical limited to osteoarthritis, rheumatoid arthritis, psoriatic compositions of the present invention. Examples of emul arthritis, acute gouty arthritis, ankylosing spondylitis, juve Sifying agents suitable for the present invention include but nile arthritis, arthritis associated with an infection, hemato are not limited to C13-C14 isoparaffin, laureth-7, polyacry mas, sarcomas, osteosarcomas, metastic cancer, breast can lamides, and polyglycols. cer, and prostrate cancer. The compositions of the present 0016. Like the carrier composition, the additional com invention may also be used to alleviate pain and inflamma ponents of the present invention are chosen so that they are tion associated with the joints, head, neck, face, shoulder, generally compatible with the active ingredients in the and back. Specific examples include myofascial pain and compositions of the present invention and do not signifi migraine headaches. Other non-limiting examples of condi cantly hinder their absorption through a patient’s skin. tions associated with pain and inflammation that may be treated with the compositions of the present invention 6. Various Forms of the Topical Composition of the Present include muscle tension, pinched nerves, strains, sprains, Invention spasms, whiplashes, systemic lupus, psoriasis, Crohn's dis 0017. The topical compositions of the present invention ease, dermatitis herpeptiformis, temporal mandibular joint may be in the form of a liquid, lotion, ointment, cream, syndrome, carpal tunnel syndrome, and fibromyalgia. salve, spray, gel, or other equivalent forms. Such forms of the topical composition are achieved by using conventional 0023. It is desirable that the topical compositions of the methods used in the art. present invention be used to treat pain and inflammation in 0018. The degree of viscosity of topical compositions in human patients. However, the topical compositions of the the present invention may be controlled by the use of present invention may also be used to treat pain and inflam Suitable gelling and/or thickening agents that include but are mation in animals. not limited to oils, alcohols, fatty acids, various polymers, and mixtures thereof. Specific examples of thickening and/ 8. Methods of Using the Disclosed Compositions or gelling agents suitable for the present invention include 0024. The topical compositions of the present invention but are not limited to peanut oil, castor oil, peppermint oil, may be used to treat pain and inflammation by various rosemary oil, jojoba oil, Sunflower oil, aluminum Stearate, methods. In one embodiment, the composition is poured on cetostearyl alcohol, propylene glycol, polyethylene glycols, to the area on the skin affected with pain and inflammation. polyacrylamides, hydroxypropyl cellulose, hydroxypropyl The area is then massaged or rubbed until the composition methyl cellulose, hydroxyethyl cellulose, carboxyl vinyl is distributed evenly or disappears. The process can be polymers, C13-C14 isoparaffin, liquid paraffin, Soft paraffin, repeated several times, preferably 5-6 times and more pref laureth-7, woolfat, hydrogenated lanolin, beeswax, and erably 1-2 times in a day. In another method, the topical combinations thereof. These agents are added to the com composition is applied to a dermal patch, which is then ponents of the present invention in any order and agitated in mounted onto the affected area of the skin for 30 minutes to a container to homogeneity. several hours. In another embodiment, the topical compo 0019. Like the additives and carrier compositions, the sition of the present invention is delivered to the affected agents used to achieve the various forms of the present area using iontophoresis. In this method, the topical com invention are chosen so that they are generally compatible position is placed in a container or a patch that is connected with the active components in the topical compositions of to an electrode. The container is then placed on the affected the present invention and do not significantly hinder their area, and the electrode is activated. This leads to the gen absorption through a patient’s skin. eration of a current that delivers the topical composition through the skin by electrical repulsion. 0020. It is also to be understood that many of the ingre dients suitable for the present invention can serve more than 0025. Other suitable methods for delivering the topical one function. For instance, polyacrylamides and polyglycols compositions of the present invention through the skin can serve both as carriers and emulsifying agents in a include phonophoresis and cellophane wrapping. In phono composition. Polyglycols can also serve as preservatives. phoresis, the topical composition is first applied to the Likewise, isopropyl palmitate and jojoba oil in a composi affected area on the skin. An ultrasound apparatus is then tion can serve as emollients, moisturizers and carriers. placed on the affected area. Once activated, the apparatus Similarly, laureth-7 and C13-C14 isoparaffin can serve as delivers the composition through the skin by ultrasonic emulsifiers, gelling agents, and thickening agents. energy. In cellophane wrapping, the composition is applied 7. Applications of the Disclosed Compositions to the affected area and wrapped with a cellophane film anywhere from several minutes to several hours. 0021. The topical compositions of the present invention may be used to alleviate pain and inflammation, including 0026. It is to be understood that there are many other but not limited to pain and inflammation associated with the ways of using the compositions of the present invention. The muscular system, the skeletal system, the nervous system, above examples simply illustrate various embodiments and and the epidermis. The compositions herein may also be do not limit the scope of the present invention. used to alleviate pain and inflammation associated with connective tissues. DESCRIPTION OF THE PREFERRED EMBODIMENTS 0022. Examples of conditions that can be treated with the compositions of the present invention include but are not 0027. The following antidotal examples illustrate the limited to pain and inflammation associated with arthritis invention. The scope of the present invention is not limited and cancer. More specific examples include but are not these or any other examples. US 2006/0194759 A1 Aug. 31, 2006

Example 1 TABLE 1-continued Preparation of a Topical Composition TABLE 1.

0028 Sunflower oil, jojoba oil, isopropyl palmitate and Pain level Pain level polyethylene glycol-8 Stearate are mixed in an appropriate Case Before topical 2 hours after stainless Steel tank, blended at high speed and heated. A History Condition application topical application separate mixture of deionized water, methylsulfonylmethane (MSM), lidocaine and hydrocortisone are also prepared in a 3 Myofascial pain 5 2 similar fashion. The two compositions are then combined, 4 Neck pain 6 2 agitated and further heated. Next, menthol, rosemary oil and peppermint oil are added to the composition and agitated to 0034. It is to be understood that the individual compo homogeneity. The anti-microbial preservative blend, nents of the present invention, either alone or in association Germaben R. II, which contains propylene glycol, diazolidi with other ingredients, may not act as effectively as when in nyl urea, methylparaben and propylparaben is then added. the compositions of the present invention at the appropriate This is followed by the addition of an emulsifier blend concentrations. It will be evident that there are numerous containing polyacrylamide, C 13-14 isoparaffin and laureth embodiments of the present invention which, while not 7. After blending the mixture to homogeneity, the compo expressly described above, are clearly within the scope and sition is assayed for menthol, lidocaine and hydrocortisone. spirit of the invention. The above description is therefore The final concentrations of menthol, lidocaine, and hydro intended to be exemplary only and the scope of the invention cortisone in the composition will be 3%, 2%, and 1% by weight, respectively. is to be determined solely by the appended claims. What is claimed: Example 2 1- A topical composition for treating pain and inflamma tion comprising: Treating Pain in Human Patients with the Topical (a) about 1% to about 4% by weight of an anti-inflam Composition of Example 1 matory steroid; 0029 Case history 1. The composition of Example 1 was b) about 1% to about 4% byy weight of a topicalp anes applied to the area of the skin associated with back pain on thetic; a patient. On a 0-10 scale, where 10 is the worst pain possible and 0 is no pain, the patient's pain level decreased (c) about 1% to about 10% by weight of menthol; and from 6 before treatment to 3 two hours after treatment. (d) a medically acceptable carrier at a concentration effective to transport said composition through skin. 0030 Case history 2. The composition of Example 1 was 2- The topical composition of claim 1 further comprising applied to the area of the skin associated with wrist pain on a chondroprotective agent. a patient. The patient’s pain level decreased from level 5 3- The topical composition of claim 2 wherein the chon before topical application to level 3 two hours after treat droprotective agent is selected from the group consisting of ment. chondroitin Sulfate, glucosamine, polysulfated glycosami noglycan, hyaluronic acid, pentosan polysulfate, and mix 0031 Case History 3. The composition of Example 1 was tures thereof. applied to the area of the skin associated with myofascial 4- The topical composition of claim 2 wherein the con pain on a patient. The pain level decreased from level 5 centration range of the chondroprotective agent is from before topical application to level 2 two hours after treat about 0.5% to about 95% by weight of the composition. ment. 5- The topical composition of claim 1 wherein the anti 0032 Case History 4. The composition of Example 1 was inflammatory Steroid is selected from the group consisting of applied to the area of the skin associated with neck pain on alcometasone, clocortolone, dexamethasone, hydrocorti a patient. The pain level decreased from level 6 before Sone, hydrocortisone 21-acetate, prednisone, hydrocortisone topical application to level 2 two hours after treatment. 17-valerate, hydrocortisone 17-butyrate, betamethasone val erate, triamcinolone acetonide, flucinonide, desonide, fluci 0033. The above tests and results are antidotal reports nolone acetonide, dexamethasone 21-phosphate, predniso only. They are not intended to be exhaustive or complete. lone, prednisolone 21-phosphate, haloprednone, cortisone Nevertheless, the studies demonstrate the effectiveness of acetate, hydrocortisone cyclopentylpropionate, cortodox the compositions of the present invention in relieving pain. one, flucetonide, fludrocortisone acetate, flurandrenolone The above studies are summarized in acetonide, medrysone, amcinafal, amcinafide, betametha Sone, betamethasone benzoate, chloroprednisone acetate, TABLE 1. clocortolone acetate, descinolone acetonide, desoximeta Sone, dichlorisone acetate, difluprednate, flucloronide, flu TABLE 1. methasone, flumethasone pivalate, flunisolide acetate, flu Pain level Pain level cortolone, fluorometholone, fluperolone acetate, Case Before topical 2 hours after fluprednisolone, fluprednisolone Valerate, meprednisone, History Condition application topical application methyl prednisolone, paramethasone acetate, prednisola 1 Back pain 6 3 mate, prednival, triamcinolone, triamcinolone hexacetonide, 2 Wrist pain 5 3 cortivaZol, formocortal. nivazol or methylprednisone, beclomethasone 17,21-dipropionate, betamethasone 17-val US 2006/0194759 A1 Aug. 31, 2006

erate, betamethasone 17,21-dipropionate, clobetasol 17-pro hexacetonide, cortivaZol, formocortal. nivaZol or methyl pionate, clobetasone 17-butyrate, and mixtures thereof. prednisone, beclomethasone 17,21-dipropionate, 6- The topical composition of claim 1 wherein the topical betamethasone 17-valerate, betamethasone 17,21-dipropi anesthetic is selected from the group consisting of ben onate, clobetasol 17-propionate, clobetasone 17-butyrate, Zocaine, butamben, dibucaine, lidocaine, propoxycaine, and mixtures thereof. procaine, mepivacaine, bupivacaine, pramoxine or tetra 14- The topical composition of claim 10 wherein the caine, and mixtures thereof. topical anesthetic is selected from the group consisting of 7- The topical composition of claim 1 wherein the medi benzocaine, butamben, dibucaine, lidocaine, propoxycaine, cally acceptable carrier is selected from the group consisting procaine, mepivacaine, bupivacaine, pramoxine or tetra of water, mineral oil, salicylic acid, methylsulfonylmethane, caine, and mixtures thereof. jojoba oil, alcohol, ethylene glycol, propylene glycol, poly 15- The topical composition of claim 10 wherein the ethylene glycol, polyethylene glycol-8 stearate, alkyl Stear medically acceptable carrier is selected from the group ates, oleates, linoleates, isopropyl palmitate, polyacryla consisting of water, mineral oil, Salicylic acid, methylsulfo mides, dimethylsulfoxide, dimethylformamide, nylmethane, jojoba oil, alcohol, ethylene glycol, propylene dimethylacetamide, 1.2.6-hexanetriol, butanediol, and mix glycol, polyethylene glycol, polyethylene glycol-8 stearate, tures thereof. alkyl Stearates, oleates, linoleates, isopropyl palmitate, poly 8- The topical composition of claim 1 further comprising acrylamides, dimethylsulfoxide, dimethylformamide, dim anti-oxidants, perfumes, colorants, moisturizers, emollients, ethylacetamide, 1.2.6-hexanetriol, butanediol, and mixtures anti-fungal agents, anti-microbial agents, preservatives, thereof. emulsifying agents, thickening agents, gelling agents, and 16- The topical composition of claim 10 further compris other conventional additives known to be effective and ing anti-oxidants, perfumes, colorants, moisturizers, emol Suitable for topical applications. lients, anti-fungal agents, anti-microbial agents, preserva 9- The topical composition of claim 1, wherein the tives, emulsifying agents, thickening agents, gelling agents, composition is in the form of a liquid, lotion, ointment, and other conventional additives known to be effective and cream, gel, Salve, spray, aerosol, or equivalents thereof. Suitable for topical applications. 10- A topical composition for treating pain and inflam 17- The topical composition of claim 10, wherein the mation comprising: composition is in the form of a liquid, lotion, ointment, (a) about 1% to about 4% by weight of an anti-inflam cream, gel, Salve, spray, aerosol, or equivalents thereof. matory steroid: 18- A method for treating pain and inflammation by administering an effective amount of a composition com b) about 1% to about 4% byy weight of a topicalp anes prising: thetic; (a) about 1% to about 4% by weight of an anti-inflam (c) about 1% to about 10% by weight of menthol: matory steroid; (d) at least one chondroprotective agent; and b) about 1% to about 4% byy weight of a topicalp anes (e) a medically acceptable carrier at a concentration thetic; effective to transport said composition through skin. 11- The topical composition of claim 10 wherein the (c) about 1% to about 10% by weight of menthol; and chondroprotective agent is selected from the group consist ing of chondroitin Sulfate, glucosamine, polysulfated gly (d) a medically acceptable carrier at a concentration cosaminoglycan, hyaluronic acid, pentosan polysulfate, and effective to transport said composition through skin. 19- The method of claim 18 wherein the composition mixtures thereof. further comprises a chondroprotective agent. 12- The topical composition of claim 10 wherein the concentration range of the chondroprotective agent is from 20- The method of claim 18 wherein the chondroprotec about 0.5% to about 95% by weight of the composition. tive agent is selected from the group consisting of chon 13- The topical composition of claim 10 wherein the droitin Sulfate, glucosamine, polysulfated glycosaminogly anti-inflammatory steroid is selected from the group con can, hyaluronic acid, pentosan polysulfate, and mixtures sisting of alcometasone, clocortolone, dexamethasone, thereof. hydrocortisone, hydrocortisone 21-acetate, prednisone, 21- The method of claim 18 wherein the concentration hydrocortisone 17-valerate, hydrocortisone 17-butyrate, range of the chondroprotective agent is from about 0.5% to betamethasone Valerate, triamcinolone acetonide, flucinon about 95% by weight of the composition. ide, desonide, flucinolone acetonide, dexamethasone 22- The method of claim of claim 18 wherein the topical 21-phosphate, prednisolone, prednisolone 21-phosphate, composition is applied by direct application, dermal patches, haloprednone, cortisone acetate, hydrocortisone cyclopen cellophane wrapping, iontophoresis, phonophoresis, or tylpropionate, cortodoxone, flucetonide, fludrocortisone equivalent methods thereof. acetate, flurandrenolone acetonide, medrysone, amcinafal, 23- The method of claim 18 wherein the composition is amcinafide, betamethasone, betamethasone benzoate, chlo used to treat pain and inflammation associated with the roprednisone acetate, clocortolone acetate, descinolone muscular system, the skeletal system, the nervous system, acetonide, desoximetasone, dichlorisone acetate, diflupred the epidermis, and connective tissues. nate, flucloronide, flumethasone, flumethasone pivalate, 24- The method of claim 18 wherein the composition is flunisolide acetate, flucortolone, fluorometholone, fluper used to treat pain and inflammation associated with muscles, olone acetate, fluprednisolone, fluprednisolone Valerate, joints, nerves, the neck, the shoulders, the back, preoperative meprednisone, methyl prednisolone, paramethasone acetate, and postoperative treatments, bone injuries, arthritis, and prednisolamate, prednival, triamcinolone, triamcinolone CaCC. US 2006/0194759 A1 Aug. 31, 2006

25- A method for treating pain and inflammation by 26- The method of claim 25 wherein the topical compo administering an effective amount of a composition com sition is applied by direct application, dermal patches, prising: cellophane wrapping, iontophoresis, phonophoresis, or equivalent methods thereof. (a) about 1% to about 4% by weight of an anti-inflam 27- The method of claim 25 wherein the composition is matory steroid; used to treat pain and inflammation associated with the b) about 1% to about 4% byy weight of a topicalp anes muscular system, the skeletal system, the nervous system, thetic; the epidermis, and connective tissues. 28- The method of claim 25 wherein the composition is (c) about 1% to about 10% by weight of menthol: used to treat pain and inflammation associated with muscles, (d) at least one chondroprotective agent; and joints, nerves, the neck, the shoulders, the back, preoperative (e) a medically acceptable carrier at a concentration and postoperative treatments, bone injuries, and arthritis. effective to transport said composition through skin. k k k k k