Claims for Patent: 9,675,700

Summary for Patent: 9,675,700

Title:	Topical tetracycline compositions
Abstract:	A topical therapeutic hydrophobic breakable composition includes a carrier comprising, (a) about 60% to about 99% by weight of at least one hydrophobic oil; (b) at least one viscosity-modifying agents selected from the group consisting of a fatty alcohol, a fatty acid and a wax; and (c) a tetracycline antibiotic, characterized in that at least part of the tetracycline antibiotic is suspended in the composition; the viscosity of the composition is at least about 30% higher than the viscosity of the carrier without the tetracycline antibiotic; and is higher than the viscosity of the hydrophobic oil and the tetracycline antibiotic without the viscosity modifying agents. The tetracycline is chemically stable in the composition for at least six months; wherein more than about 90% of the tetracycline has not broken down. The composition is packaged as a breakable foam that breaks easily upon application of shear force.
Inventor(s):	Tamarkin; Dov (Macabim, IL), Gazal; Elana (Rehovot, IL), Papiashvili; Irakliy (Ashkelon, IL), Hazot; Yohan (Rehovot, IL), Schuz; David (Gimzu, IL), Keynan; Rita (Rehovot, IL)
Assignee:	FOAMIX PHARMACEUTICALS LTD. (Rehovot, IL)
Application Number:	14/595,882
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,675,700
Patent Claims:	1. A waterless composition comprising a tetracycline antibiotic and a carrier, the carrier comprising: a) at least one hydrophobic oil; and b) an agent comprising (i) at least one fatty alcohol and at least one wax; (ii) at least one fatty acid and at least one wax; (iii) at least one fatty alcohol, at least one fatty acid, and at least one wax; (iv) a wax comprising a hydrogenated oil; or (v) a combination of two or more waxes; wherein the composition does not contain one or more minocycline incompatible substance selected from the group consisting of dimethyl sulfoxide (DMSO), dimethylformamide (DMF), acetonitrile, acetone, methyl ethyl ketone, 1,4-dioxane, tetrahydrofuran (THF), N-methylpyrrolidone, pyridine, piperidine, N-methyl-2-pyrrolidone and 1-methyl-2-pyrrolidinone), azone (1-dodecylazacycloheptan-2-one), dimethyl isosorbide, glycerin, ethanol, propylene glycol, butylene glycol, PEG 200, hexylene glycol, PEG 400, diethylene glycol monoethyl ether, pomegranate seed oil, isostearic acid, and ethocel; and wherein the composition does not contain a polyol and/or polyethylene glycol. 2. The composition of claim 1, wherein after storage at 25.degree. C. for at least six months the composition retains at least 90% of the tetracycline initially present in the composition. 3. The composition of claim 1, wherein the composition is in the form of a gel that liquefies and spreads upon application of shear force. 4. The composition of claim 1, wherein the at least one hydrophobic oil is selected from the group consisting of a mineral oil, a hydrocarbon oil, an ester oil, an ester of a dicarboxylic acid, a triglyceride oil, an oil of plant origin, an oil from animal origin, an unsaturated or polyunsaturated oil, a diglyceride, a PPG alkyl ether, an essential oil, a silicone oil, liquid paraffin, an isoparaffin, a polyalphaolefin, a polyolefin, polyisobutylene, a synthetic isoalkane, isohexadecane, isododecane, alkyl benzoate, alkyl octanoate, C12-C15 alkyl benzoate, C12-C15 alkyl octanoate, arachidyl behenate, arachidyl propionate, benzyl laurate, benzyl myristate, benzyl palm itate, bis (octyldodecyl stearoyl) dimer dilinoleate, butyl myristate, butyl stearate, cetearyl ethylhexanoate, cetearyl isononanoate, cetyl acetate, cetyl ethylhexanoate, cetyl lactate, cetyl myristate, cetyl octanoate, cetyl palm itate, cetyl ricinoleate, decyl oleate, diethyleneglycol diethylhexanoate, diethyleneglycol dioctanoate, diethyleneglycol diisononanoate, diethyleneglycol diisononanoate, diethylhexanoate, diethylhexyl adipate, diethylhexyl malate, diethylhexyl succinate, diisopropyl adipate, diisopropyl dimerate, diisopropyl sebacate, diisosteary dimer dilinoleate, diisostearyl fumerate, dioctyl malate, dioctyl sebacate, dodecyl oleate, ethylhexyl palm itate, ester derivatives of lanolic acid, ethylhexyl cocoate, ethylhexyl ethylhexanoate, ethylhexyl hydroxystarate, ethylhexyl isononanoate, ethylhexyl palmytate, ethylhexyl pelargonate, ethylhexyl stearate, hexadecyl stearate, hexyl laurate, isoamyl laurate, isocetyl isocetyl behenate, isocetyl lanolate, isocetyl palm itate, isocetyl stearate, isocetyl salicylate, isocetyl stearate, isocetyl stearoyl stearate, isocetearyl octanoate, isodecyl ethylhexanoate, isodecyl isononanoate, isodecyl oleate, isononyl isononanoate, isodecyl oleate, isohexyl decanoate, isononyl octanoate, isopropyl isostearate, isopropyl lanolate, isopropyl laurate, isopropyl myristate, isopropyl palm itate, isopropyl stearate, isostearyl behenate, isosteary citrate, isostearyl erucate, isostearyl glycolate, isostearyl isononanoate, isostearyl isostearate, isostearyl lactate, isostearyl linoleate, isostearyl linolenate, isostearyl malate, isostearyl neopentanoate, isostearyl palm itate, isosteary salicylate, isosteary tartarate, isotridecyl isononanoate, isotridecyl isononanoate, lauryl lactate, myristyl lactate, myristyl myristate, myristyl neopentanoate, myristyl propionate, octyldodecyl myristate, neopentylglycol dicaprate, octyl dodecanol, octyl stearate, octyl palmitate, octyldodecyl behenate, octyldodecyl hydroxystearate, octyldodecyl myristate, octyldodecyl stearoyl stearate, oleyl erucate, oleyl lactate, oleyl oleate, propyl myristate, propylene glycol myristyl ether acetate, propylene glycol dicaprate, propylene glycol dicaprylate, maleated soybean oil, stearyl caprate, stearyl heptanoate, stearyl propionate, tocopheryl acetate, tocopheryl linoleate, glyceryl oleate, tridecyl ethylhexanoate, tridecyl isononanoate, triisocetyl citrate, an alexandria laurel tree oil, an avocado oil, an apricot stone oil, a barley oil, a borage seed oil, a calendula oil, a canelle nut tree oil, a canola oil, caprylic/capric triglycerides, a castor oil, a coconut oil, a corn oil, a cotton oil, a cottonseed oil, an evening primrose oil, a flaxseed oil, a groundnut oil, a hazelnut oil, glycereth triacetate, glycerol triheptanoate, glyceryl trioctanoate, glyceryl triundecanoate, a hempseed oil, a jojoba oil, a lucerne oil, a maize germ oil, a marrow oil, a millet oil, a neopentylglycol dicaprylate/dicaprate, an olive oil, a palm oil, a passionflower oil, pentaerythrityl tetrastearate, a poppy oil, propylene glycol ricinoleate, a rapeseed oil, a rye oil, a safflower oil, a sesame oil, a shea butter, a soya oil, a soybean oil, a sweet almond oil, a sunflower oil, a sysymbrium oil, a syzigium aromaticum oil, a tea tree oil, a walnut oil, wheat germ glycerides, a wheat germ oil, a PPG-2 butyl ether, a PPG-4 butyl ether, a PPG-5 butyl ether, a PPG-9 butyl ether, a PPG-12 butyl ether, a PPG-14 butyl ether, a PPG-15 butyl ether, a PPG-15 stearyl ether, a PPG-16 butyl ether, a PPG-17 butyl ether, a PPG-18 butyl ether, a PPG-20 butyl ether, a PPG-22 butyl ether, a PPG-24 butyl ether, a PPG-26 butyl ether, a PPG-30 butyl ether, a PPG-33 butyl ether, a PPG-40 butyl ether, a PPG-52 butyl ether, a PPG-53 butyl ether, a PPG-10 cetyl ether, a PPG-28 cetyl ether, a PPG-30 cetyl ether, a PPG-50 cetyl ether, a PPG-30 isocetyl ether, a PPG-4 lauryl ether, a PPG-7 lauryl ether, a PPG-2 methyl ether, a PPG-3 methyl ether, a PPG-3 myristyl ether, a PPG-4 myristyl ether, a PPG-10 oleyl ether, a PPG-20 oleyl ether, a PPG-23 oleyl ether, a PPG-30 oleyl ether, a PPG-37 oleyl ether, a PPG-40 butyl ether, a PPG-50 oleyl ether, a PPG-11 stearyl ether, a herring oil, a cod-liver oil, a salmon oil, a cyclomethicone, a dimethyl polysiloxane, a dimethicone, an epoxy-modified silicone oil, a fatty acid-modified silicone oil, a fluoro group-modified silicone oil, a methylphenylpolysiloxane, phenyl trimethicone, a polyether group-modified silicone oil, and mixtures of any two or more thereof. 5. The composition of claim 1, wherein at least one or both of the fatty alcohol or the fatty acid has at least 12 carbon atoms in its carbon backbone. 6. The composition of claim 5, wherein the carbon chain of at least one or both of the fatty alcohol or the fatty acid is substituted with a hydroxyl group. 7. The composition of claim 5, wherein the fatty acid is 12-hydroxy stearic acid. 8. The composition of claim 1, wherein at least one or both of the fatty alcohol or the fatty acid have a melting point of more than 40.degree. C. 9. The composition of claim 8, wherein the fatty alcohol is selected from the group consisting of lauryl alcohol, myristyl alcohol, cetyl alcohol, stearyl alcohol, arachidyl alcohol, behenyl alcohol, tetracosanol, hexacosanol, octacosanol, triacontanol, tetratriacontanol; and wherein the fatty acid is selected from the group consisting of dodecanoic acid, tetradecanoic acid, hexadecanoic acid, heptadecanoic acid, octadecanoic acid, eicosanoic acid, docosanoic acid, tetracosanoic acid, hexacosanoic acid, heptacosanoic acid, octacosanoic acid, triacontanoic acid, dotriacontanoic acid, tritriacontanoic acid, tetratriacontanoic acid, and pentatriacontanoic acid. 10. The composition of claim 1, wherein the wax is selected from the group consisting of a plant wax, an animal wax, a petroleum derived wax, and a vegetable wax; or wherein the wax is selected from the group consisting of an albacer wax, an atlasene wax, a cardis wax, a ceramid, an alkyl-substituted aromatic compound, a naphthene-substituted aromatic compound, a beeswax, a carnauba wax, a chinese wax, a cotton wax, a bayberry wax, a carnauba wax, a castor wax, a cuban palm wax, a duroxon wax, an esparto wax, a fat wax, a flax wax, a fischer-tropsch wax, a fir wax, a flexo wax a flower wax, glyco waxes, a japan wax, a jojoba oil, a lanolin wax, a palm wax, a rice bran wax, a rice-oil wax, a shellac wax, a soy wax, an ucuhuba wax, a hydrogenated oil, a hydrogenated castor oil, a hydrogenated cottonseed oil, a hydrogenated jojoba oil, a mink wax, a mixture of saturated n- and isoalkanes, a montan wax, a naphthene, an ouricury wax, an oxazoline wax, an ozokerite, a paraffin wax, a paraffin 58-62.degree. C. wax, paraffin 51-53.degree. C. wax, paraffin 42-44.degree. C. wax, a polyethylene wax, a PEG-6 beeswax, a polymekon wax, a retamo wax, a rezo wax, a sandy wax, a spent grain wax, a stearyl dimethicone, a sugarcane wax, a synthetic mineral wax, and mixtures of any two or more thereof. 11. The composition of claim 1, wherein the wax is selected from the group consisting of a carnauba wax, an ouricury wax, a sugarcane wax, a retamo wax, a jojoba oil, a beeswax, a petroleum derived wax, a paraffin wax, a polyethylene wax, a hydrogenated castor oil, and mixtures of any two or more thereof. 12. The composition of claim 1, wherein the agent comprises at least one fatty alcohol, at least one fatty acid, and least one wax, wherein the at least one wax comprises a beeswax, a hydrogenated oil, or both. 13. The composition of claim 1, wherein the composition contains less than 0.4% by weight of a protic solvent, a polar aprotic solvent, and a silicone thickening agent. 14. The composition of claim 13, wherein the composition contains less than 0.2% by weight of a protic solvent, a polar aprotic solvent, and a silicone thickening agent. 15. The composition of claim 14, wherein the composition contains less than 0.1% by weight of a protic solvent, a polar aprotic solvent, and a silicone thickening agent. 16. The composition of claim 1, wherein the composition contains less than 0.4% by weight of a polymeric gelling agent, a polyol, a short chain alcohol, and a silicone thickening agent. 17. The composition of claim 1, wherein the tetracycline antibiotic is selected from the group consisting of a tetracycline, an oxytetracycline, a demeclocycline, a doxycycline, a lymecycline, a meclocycline, a methacycline, a minocycline, a rolitetracycline, a chlorotetracycline, and a tigecycline. 18. The composition of claim 1, wherein the tetracycline antibiotic is hydrophobic. 19. The composition of claim 1, wherein the tetracycline antibiotic is present in a free base form, a hydrate form, a salt form, or a complex form. 20. The composition of claim 19, wherein the Log of the distribution constant of the tetracycline antibiotic at pH 7.0 (buffer/chloroform) is equal to or less than 0.2. 21. The composition of claim 19, wherein the tetracycline antibiotic does not comprise a hydroxy group at carbons 5, 6, and 7. 22. The composition of claim 19, wherein the tetracycline antibiotic is selected from the group consisting of a minocycline, a doxycycline, and mixtures thereof. 23. The composition of claim 22, wherein the tetracycline antibiotic is a minocycline. 24. The composition of claim 22, wherein when packaged in an aerosol container and pressurized with a propellant, the composition affords upon release from the container a foam that breaks upon application of shear force. 25. The composition of claim 22, wherein the carrier comprises: a) 35% to 65% by weight of a soybean oil; b) 16.5% to 30.7% by weight of a coconut oil; c) 3.5% to 6.5% by weight of a cyclomethicone; d) 0.67% to 5.7% by weight of a light mineral oil; e) 2.45% to 4.5% by weight of cetostearyl alcohol; f) 2% to 4% by weight of stearic acid; g) 1.7% to 3.2% by weight of myristyl alcohol; h) 1.4% to 2.6% by weight of hydrogenated castor oil; i) 1.4% to 2.6% by weight of beeswax; j) 1% to 1.9% by weight of stearyl alcohol; and k) 0.8% to 1.4% by weight of behenyl alcohol. 26. The composition of claim 22, wherein the carrier comprises: a) 45% to 55% by weight of a soybean oil; b) 21.2% to 26% by weight of a coconut oil; c) 4.5% to 5.5% by weight of a cyclomethicone; d) 0.85% to 4.8% by weight of a light mineral oil; e) 3.2% to 3.9% by weight of cetostearyl alcohol; f) 2.7% to 3.3% by weight of stearic acid; g) 2.3% to 2.8% by weight of myristyl alcohol; h) 1.8% to 2.2% by weight of hydrogenated castor oil; i) 1.8% to 2.2% by weight of beeswax; j) 1.4% to 1.7% by weight of stearyl alcohol; and k) 1% to 1.2% by weight of behenyl alcohol. 27. The composition of claim 1, further comprising an additional active agent. 28. The composition of claim 27, wherein the additional active agent is selected form the group consisting of an active herbal extract, an acaricide, an age spot and keratose removing agent, an allergen, an alpha hydroxyl acid, an analgesic agent, an androgen, an antiacne agent, an antiallergic agent, an antiaging agent, an antibacterial agent, an antibiotic, an antiburn agent, an anticancer agent, an antidandruff agent, an antidepressant, an antidermatitis agent, an antiedemic agent, an antifungal agent, an antihistamine, an antihelminth agent, an anti-hyperkeratosis agent, an anti-infective agent, an antiinflammatory agent, an antiirritant, an antilipemic agent, an antimicrobial agent, an antimycotic agent, an antioxidant, an antiparasitic agent, an antiproliferative agent, an antipruritic agent, an antipsoriatic agent, an antirosacea agent, an antiseborrheic agent, an antiseptic agent, an antiswelling agent, an antiviral agent, an anti-wart agent, an anti-wrinkle agent, an antiyeast agent, an astringent, a beta-hydroxy acid, benzoyl peroxide, a topical cardiovascular agent, a chemotherapeutic agent, a corticosteroid, an immunogenic substance, a dicarboxylic acid, a disinfectant, an estrogen, a fungicide, a hair growth regulator, a haptene, a hormone, a hydroxy acid, an immunosuppressant, an immunoregulating agent, an immunomodulator, an immunostimulant, an insecticide, an insect repellent, a keratolytic agent, a lactam, a local anesthetic agent, a lubricating agent, a masking agent, a metal, a metal oxide, a mitocide, a neuropeptide, a non-steroidal anti-inflammatory agent, an oxidizing agent, a pediculicide, a peptide, a pesticide, a protein, a photodynamic therapy agent, a progesterone, a radical scavenger, a refatting agent, a retinoid, a sanative, a scabicide, a sedative, a self tanning agent, a skin protective agent, a skin whitening agent, a steroid, a steroid hormone, a vasoactive agent, a vasoconstrictor, a vasodilator, a vitamin, a vitamin A, a vitamin A derivative, a vitamin B, a vitamin B derivative, a vitamin C, a vitamin C derivative, a vitamin D, a vitamin D derivative, a vitamin D analog, a vitamin F, a vitamin F derivative, a vitamin K, a vitamin K derivative, a wound healing agent, and a wart remover. 29. The composition of claim 1, wherein the composition is free of one or more of a protic solvent, a polar aprotic solvent, a polymeric gelling agent, a polyol, a short chain alcohol, and a silicone thickening agent. 30. The composition of claim 1, wherein the viscosity of the composition is at least 100% higher than the viscosity of the composition without the tetracycline antibiotic. 31. The composition of claim 1, wherein the agent is about 0.1% to about 40% by weight of the composition. 32. The composition of claim 31, wherein the agent is about 0.4% to about 18% by weight of the composition. 33. The composition of claim 32, wherein the agent is about 1% to about 12% by weight of the composition. 34. The composition of claim 1, wherein the tetracycline antibiotic is about 0.001% to about 10% by weight of the composition. 35. The composition of claim 34, wherein the tetracycline antibiotic is about 0.025% to about 6% by weight of the composition. 36. The composition of claim 1, wherein the carrier is free of or contains less than 0.1% by weight of a surfactant. 37. The composition of claim 1, wherein the composition is free of or comprises less than 10% petrolatum by weight of the composition. 38. The composition of claim 1, wherein the agent is between about 0.1% to about 20% by weight of the composition. 39. The composition of claim 1, wherein the agent is between about 10% and about 20% by weight. 40. The composition of claim 1, wherein the hydrophobic oil is an emollient or the composition further comprises an emollient. 41. The composition of claim 1, wherein the ratio of fatty alcohol to wax or fatty acid to wax or fatty alcohol and fatty acid to wax is between about 1:10 to about 10:1. 42. The composition of claim 1, wherein minimal to no skin pigmentation change is observed following application of the composition onto skin. 43. The composition of claim 1, wherein the composition is a non-irritant composition. 44. The composition of claim 1, wherein the composition is capable of inhibiting the growth of one or more of streptococcus pyogenes, pseudomonas aeruginosa, staphylococcus aureus, methicillin-resistant strain of staphylococcus aureus (MRSA), and propionbacterium acnes. 45. The composition of claim 1, wherein the composition has an Aw value selected from the ranges of (1) about 0.8 and about 0.9; (2) about 0.7 and about 0.8; and (3) less than about 0.7. 46. The composition of claim 1, wherein the at least one hydrophobic oil is about 60% to 99% by weight of the composition. 47. The composition of claim 1, wherein the wax is a solid at room temperature. 48. The composition of claim 1, wherein the carrier is free of one or more surfactants selected from the group consisting of a non-ionic surfactant, an anionic surfactant, a cationic surfactant, a zwitterionic surfactant, an amphoteric surfactant, and an amphiphilic surfactant. 49. The composition of claim 1, wherein the carrier is free of one or more polymers selected from the group consisting of xanthan gum, a poloxamer, a carbomer, methocel, and sodium CMC. 50. The composition of claim 1, wherein the amount of the tetracycline antibiotic is selected from the group consisting of about 0.1% by weight of the composition, about 0.5% by weight of the composition, about 1% by weight of the composition, about 1.5% by weight of the composition, about 2% by weight of the composition, about 2.5% by weight of the composition, about 3% by weight of the composition, about 3.5 by weight of the composition, about 4% by weight of the composition, about 4.5% by weight of the composition, about 5% by weight of the composition, about 5.5% by weight of the composition, about 6% by weight of the composition, about 6.5% by weight of the composition, about 7% by weight of the composition, about 7.5% by weight of the composition, about 8% by weight of the composition, about 8.5% by weight of the composition, about 9% by weight of the composition, about 9.5% by weight of the composition, and about 10% by weight of the composition. 51. The composition of claim 1, wherein the composition comprises less than 0.4% by weight of a polymeric gelling agent. 52. The composition of claim 1, wherein the composition is free of a polymeric gelling agent. 53. The composition of claim 1, wherein the carrier is free of one or more surfactants selected from the group consisting of polyoxyethylene sorbitan esters (polysorbates), polysorbate 20, polysorbate 40, polysorbate 60 and polysorbate 80, sorbitan esters, Sorbitan monolaurate, sorbitan monooleate, polyoxyethylene fatty acid esters, PEG-8 Stearate, PEG-20 Stearate, PEG-40 Stearate, PEG-100 Stearate, PEG-150 Distearate, PEG-8 laurate, PEG-10 laurate, PEG-12 laurate, PEG-20 laurate, PEG-8 oleate, PEG-9 oleate, PEG-10 oleate, PEG-12 oleate, PEG-15 oleate, PEG-20 oleate, PEG-fatty acid diesters, polyethylene glycol (PEG) ethers of fatty alcohols, glycerol esters, glyceryl monostearate, glyceryl monolaurate, glyceryl monopalmitate, glyceryl monooleate, PEG-fatty acid mono- and di-ester mixtures, polyethylene glycol glycerol fatty acid esters, propylene glycol fatty acid esters, mono- and diglycerides, sugar esters (mono-, di- and tri-esters of sucrose with fatty acids), and polyethylene glycol alkyl phenols. 54. The composition of claim 1, wherein the composition does not contain either a polyol or polyethylene glycol. 55. The composition of claim 1, wherein the composition does not contain a polar solvent. 56. The composition of claim 1, wherein the carrier has a neutral pH. 57. A waterless composition comprising a tetracycline antibiotic and a carrier, the carrier comprising: a) at least one hydrophobic oil; and b) an agent comprising (i) at least one fatty alcohol and at least one wax; (ii) at least one fatty acid and at least one wax; (iii) at least one fatty alcohol, at least one fatty acid, and at least one wax; (iv) a gelled mineral oil; (v) a wax comprising a hydrogenated oil; or (vi) a combination of two or more waxes; wherein the composition does not contain a polyol and/or polyethylene glycol. 58. The waterless composition of claim 57, wherein the agent comprises a gelled mineral oil. 59. A method of treating or alleviating the symptoms of a dermatological, an ophthalmological, a gynecological, or a mucosal disorder, comprising: applying to a target area the composition of claim 1, wherein the disorder includes at least one etiological factor selected from the group consisting of an infection, an inflammation, oxidative stress, neurodegeneration, and apoptosis. 60. The method of claim 59, wherein the dermatological disorder is selected from the group consisting of an abscess, acne, acne conglobata, acne fulminans, acne vulgaris, acne scars, acute febrile neutrophilic dermatosis, acute lymphangitis, allergic contact dermatitis, alopecia, athlete's foot, atopic dermatitis, bacterial skin infections, bullous pemphigoid, burn, calluses candidiasis, carbuncles, cellulitis, chemical burns, chicken pox, cholinergic urticaria, chronic effects of sunlight, comedones, corns, creeping eruption, cutaneous abscess, cutaneous myiasis, delusional parasitosis, dermatitis, dermatitis herpetiform is, dermatological inflammation, dermatophytoses, drug eruptions and reactions, dyshidrotic eczema, eczema, epidermoid cyst, epidermal necrolysis, exfoliative dermatitis, erythema multiforme, folliculitis, fungal nail infections, fungal skin infections, furuncles, gangrene, genital herpes, head lice, impetigo, inflammatory acne, ingrown nails, intertrigo, irritant contact dermatitis, ischemic necrosis, itching, jock itch, Kaposi's sarcoma, molluscum contagiosum, MRSA, necrotizing subcutaneous infection, necrotizing fasciitis, necrotizing myositis, nodular papulopustular acne, non-inflammatory acne, nummular dermatitis, parapsoriasis paronychia, parasitic skin infections, pemphigus, photo-allergy, photo-damage, photo-irritation, photosensitivity, papules, pediculosis, perioral dermatitis, pimples, pityriasis rosea, pityriasis rosea, pityriasis rubra pilaris, poison ivy, post-operative or post-surgical skin conditions, pressure ulcers, pressure urticaria, pruritis, pseudofolliculitis barbae, psoriasis, pustules, rosacea, scabies, scarring, scleroderma, sebaceous cyst, seborrheic dermatitis, seborrheic keratosis, shingles, skin aging, skin rash, skin ulcers, staphylococcal scalded skin syndrome, sunburn, thermal burns, tinea corporis, tinea cruris, tinea pedis, tinea versicolor, toxic epidermal necrolysis, trauma or injury to the skin, varicella zoster virus, viral skin infections, wrinkles, and yeast skin infections. 61. The method of claim 59, wherein the gynecological or mucosal disorder is selected from the group consisting of a disorder of a body cavity or mucosal surface, a disorder of the nose, mouth, eye, ear, respiratory system, vagina, urethra, or rectum, chlamydia infection, gonorrhea infection, herpes, human papillomavirus (HPV), genital warts, bacterial vaginosis, candidiasis, molluscum contagiosum, nongonococcal urethritis (NGU), trichomoniasis, vulvodynia, yeast infection, pelvic inflammation, anal abscess/fistula, anal fissure, and hemorrhoids. 62. The method of claim 59, wherein the ophthalmological disorder is selected from the group consisting of an eye infection, an eye redness, eyelid problems, ophtahlmic allergy, blepharitis, corneal abrasion, corneal edema, corneal ulcer, conjunctivitis, contact lens complications, dry eye, eyelid cellulitis, glaucoma, macular degeneration, macular edema, ocular cicatricial pemphigoid, obstructed tear duct, ocular rosacea, optic neuritis, orbital cellulitis, recurrent corneal erosion, trachoma, and uveitis.