Steroid kit and foamable composition and uses thereof

• US 20060018937A1
• Filed: 04/26/2005
• Published: 01/26/2006
• Est. Priority Date: 10/25/2002
• Status: Abandoned Application

• Current Assignee: Foamix Pharmaceuticals, Ltd. (VYNE Therapeutics, Inc.)
• Original Assignee: Foamix Ltd. (VYNE Therapeutics, Inc.)
• Inventors: Friedman, Doron, Tamarkin, Dov, Eini, Meir, Besonov, Alex
• Application Number:
  US11/114,410
• Publication Number:
  US 20060018937A1
• Time in Patent Office: Days
• US Class Current: 424/401
• CPC Class Codes: A61K 31/07 Retinol compounds, e.g. vitamin A retinoic acids A61K31/203
• CPC Class Codes: A61K 31/203 Retinoic acids ; Salts thereof
• CPC Class Codes: A61K 31/56 Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
• CPC Class Codes: A61K 31/568 substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
• CPC Class Codes: A61K 31/573 substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
• CPC Class Codes: A61K 8/046 Aerosols; Foams
• CPC Class Codes: A61K 8/671 Vitamin A; Derivatives thereof, e.g. ester of vitamin A acid, ester of retinol, retinol, retinal
• CPC Class Codes: A61K 9/0014 Skin, i.e. galenical aspects of topical compositions non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00
• CPC Class Codes: A61K 9/122 Foams; Dry foams edible foams A61K9/0056
• CPC Class Codes: A61P 11/00 Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 13/00 Drugs for disorders of the urinary system
• CPC Class Codes: A61P 15/00 Drugs for genital or sexual disorders for disorders of sex hormones A61P5/24; Contraceptives
• CPC Class Codes: A61P 15/02 for disorders of the vagina
• CPC Class Codes: A61P 17/00 Drugs for dermatological disorders
• CPC Class Codes: A61P 19/00 Drugs for skeletal disorders
• CPC Class Codes: A61P 19/02 for joint disorders, e.g. arthritis, arthrosis
• CPC Class Codes: A61P 19/08 for bone diseases, e.g. rachitism, Paget's disease
• CPC Class Codes: A61P 27/16 Otologicals
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 31/00 Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
• CPC Class Codes: A61P 33/00 : Antiparasitic agents
• CPC Class Codes: A61P 35/00 : Antineoplastic agents
• CPC Class Codes: A61P 37/00 : Drugs for immunological or allergic disorders
• CPC Class Codes: A61P 5/00 : Drugs for disorders of the endocrine system
• CPC Class Codes: A61P 5/38 : of the suprarenal hormones
• CPC Class Codes: A61Q 19/00 : Preparations for care of the skin

Abstract

A composition and therapeutic kit including an aerosol packaging assembly including a container accommodating a pressurized product and an outlet capable of releasing a foamable composition, including a steroid as a foam. The pressurized product includes a foamable composition including: a container accommodating a pressurized product; and an outlet capable of releasing the pressurized product as a foam; wherein the pressurized product comprises a foamable composition including: i. a steroid; ii. at least one organic carrier selected from the group consisting of a hydrophobic organic carrier, a polar solvent, an emollient and mixtures thereof, at a concentration of about 2% to about 50% by weight; iii. a surface-active agent; iv. about 0.01% to about 5% by weight of at least one polymeric additive selected from the group consisting of a bioadhesive agent, a gelling agent, a film forming agent and a phase change agent; v. water; and vi. liquefied or compressed gas propellant at a concentration of about 3% to about 25% by weight of the total composition. The composition further may include a therapeutically active foam adjuvant, selected from the group consisting of a fatty alcohol, a fatty acid, a hydroxyl fatty acid; and mixtures thereof.

Claims

1. A therapeutic kit to provide a safe and effective dosage of a steroid, including an aerosol packaging assembly including:

a) a container accommodating a pressurized product; and

b) an outlet capable of releasing the pressurized product as a foam;

wherein the pressurized product comprises a foamable composition including;

i. a steroid;

ii. at least one organic carrier selected from the group consisting of a hydrophobic organic carrier, an organic polar solvent, an emollient and mixtures thereof, at a concentration of about 2% to about 50% by weight;

iii. a surface-active agent;

iv. about 0.01% to about 5% by weight of at least one polymeric additive selected from the group consisting of a bioadhesive agent, a gelling agent, a film forming agent and a phase change agent;

v. water; and

vi. liquefied or compressed gas propellant at a concentration of about 3% to about 25% by weight of the total composition.

2. The kit of claim 1, wherein the foamable composition is selected from the group consisting of

i. an oil-in-water emulsion;

and

ii. a water-in-oil emulsion.

3. The kit of claim 1, wherein the outlet comprises a valve, containing a stem with 1 to 4 apertures formed in the stem.

4. The kit of claim 3, wherein each aperture formed in the stem has a diameter, selected from the group consisting of (i) about 0.2 mm to about 1 mm;

(ii) about 0.3 mm to about 0.8 mm; and

(iii) about 0.01 mm² and 1 mm².

5. The kit of claim 3, wherein the sum of areas of all apertures in the stem is between about 0.04 mm² and 0.5 mm².

6. The kit of claim 3, wherein the valve is attached to metered dose device.

7. The kit of claim 1, wherein the at least one organic carrier is present in an amount selected from the group consisting of (i) about 2% to about 5%;

(ii) about 5% to about 10%;

(iii) about 10% to about 20%; and

(iv) about 20% to about 50%.

8. The kit of claim 1, wherein the foamable composition is substantially alcohol-free.

9. The kit of claim 1, further including about 0.1% to about 5% by weight of a therapeutically active foam adjuvant is selected from the group consisting of a fatty alcohol having 15 or more carbons in their carbon chain;

a fatty acid having 16 or more carbons in their carbon chain;

fatty alcohols, derived from beeswax and including a mixture of alcohols, a majority of which has at least 20 carbon atoms in their carbon chain;

a fatty alcohol having at least one double bond;

a fatty acid having at least one double bond;

a branched fatty alcohol;

a branched fatty acid;

a fatty acid substituted with a hydroxyl group;

cetyl alcohol;

stearyl alcohol;

arachidyl alcohol;

behenyl alcohol;

1-triacontanol;

hexadecanoic acid;

stearic acid;

arachidic acid;

behenic acid;

octacosanoic acid;

12-hydroxy stearic acid and mixtures thereof.

10. The kit of claim 1, wherein the steroid is selected from the group consisting of

i a steroid compound containing a cyclopenta[a]phenanthrene skeleton;

ii a steroid compound containing a cyclopenta[a]phenanthrene skeleton carrying one or more functional groups selected from halogens, alkyl groups, aryl groups, benzyl groups, carboxy groups and alkoxy groups;

iii a steroid compound selected from the families of (a) cardanolides, (b) bufanolides, (c) spirostans, (d) furostans, (e) steroid alkaloids, (f) steroid lactones, (g) oxo-steroids, (h) steroid-alcohols and (i) steroid-amines;

iv a steroid compound, where one or more of the cyclopenta[a]phenanthrene rings is contracted by loss of an unsubstituted methylene group;

v a steroid compound, where one or more of the cyclopenta[a]phenanthrene rings is expanded by inclusion of a methylene group;

vi a steroid compound containing a cyclopenta[a]phenanthrene skeleton and a carbocyclic or heterocyclic ring component fused to it;

vii a compound, wherein two or more steroid molecules are linked together covalently;

viii a compound selected from the group consisting of 5α

-pregnane, 5^β

-pregnane, 5α

-cholane (allocholane), 5^β

-cholane, 5α

-cholestane, 5^β

-cholestane, 5α

-ergostane, 5^β

-ergostane, 5α

-campestane, 5^β

-campestane, 5α

-poriferastane, 5^β

-poriferastane, 5α

-stigmastane, 5^β

-stigmastane, 5α

-gorgostaneacrihellin, actodigin, alfacalcidol, aldosterone, androsterone, betamethasone, brassinolide, calcidiol, calciol, calcitriol, canrenone, clomegestone, cholesterol, cholic acid, corticosterone, cortisol, cortisol acetate, cortisone, cortisone acetate, cyproterone, deoxycorticosterone, dexamethasone, disogluside, ecdysone, ercalciol, ergosterol, estradiol, estriol, estrone, ethinylestradiol, fluazacort, fluocortin, fusidic acid, gestrinone, gonane, halometasone, hydrocortisone, lanosterol, lithocholic acid, mebolazine, medroxyprogesterone, meproscillarin, mespirenone, mestranol, naflocort, norenthisterone, norgesterone, norgestrel, oxandrolone, oxymetholone, pancuronium bromide, prednisolone, prednisone, progesterone, proscillardin, pseudotigogenin, roxibolone, sarsasapogenin, smilagenin, spironolactone, timobesone, testosterone, tigogenin triamcinolone, ursodeoxycholic acid;

ix an anti-inflammatory steroid;

x a steroid possessing immunomodulating and/or anti-inflammatory properties;

xi a steroid, selected from the group of low-potency anti-inflammatory steroids, medium potency anti-inflammatory steroids and high potency anti-inflammatory steroids;

xii an anti-inflammatory steroid, selected from the group consisting of hydrocortisone, hydrocortisone acetate, desonide, betamethasone valerate, clobetasone-17-butyrate, flucinonide, fluocinolone acetonide, alcometasone dipropionate, mometasone furoate, prednicarbate, triamcinolone acetonide, betamethasone-17-benzoate, methylprednisolone aceponate, betamethasone dipropionate, halcinonide, triamcinolone acetonide, halobetasol, clobetasol-17-propionate;

xiii a steroid that positively affects the McKenzie vasoconstrictor assay;

xiv a steroid hormone;

xv a steroid hormone, selected from the group consisting of an androgen, an estrogen and a progestogen;

xvi an androgen, selected from the group consisting of testosterone, testosterone cipionate, testosterone decanoate, testosterone enantate, testosterone isocaproate, testosterone phenylpropionate, testosterone propionate, testosterone undecylate, 5α

-dihydrotestosterone, dehydroepiandrosterone (also termed prasterone and DHEA), androstenedione, androstanediol, androsterone, androstenolone, prasterone enantate, prasterone sodium sulfate, ormeloxifene, mesterolone, fluoxymesterone, methyltestosterone, gestrinone, delmadinone, delmadinone acetate, chlormadinone, chlormadinone acetate, danazol and testolactone;

xvii an estrogen selected from the group consisting of estradiol, estradiol benzoate, estradiol cipionate, estradiol dipropionate, estradiol enantate, estradiol hexahydrobenzoate, estradiol phenylpropionate, estradiol valerate, polyestradiol phosphate, estriol, estriol sodium succinate, estriol succinate, polyestriol phosphate, quinestradol, ethinylestradiol, estrapronicate, mestranol, estrapronicate and equilin;

xviii a progestogen, selected from the group consisting of progesterone, norethisterone, norethisterone acetate, norethisterone enantate, medroxyprogesterone acetate, delmadinone acetate, flugestone acetate, dydrogesterone, desogestrel, norgestrel, levonorgestrel, dydrogesterone, gestodene, chlormadinone acetate, dienogest, drospirenone, lynestrenol, tybolone, cyproterone acetate, megestrol acetate, nomegestrol acetate;

xix an inhibitor of a steroid hormone;

xx an inhibitor of a steroid hormone selected from the group consisting of finasteride, dutasteride and spironolactone;

xxi a vitamin D;

xxii a steroid that exhibits qualitatively the biological activity of calciol;

xxiii a vitamin D selected from the group consisting of cholecalciferol, 25-hydroxycholecalciferol, 1α

,25-dihydroxycholecalciferol, ergocalciferol, 1α

,25-dihydroxyergocalciferol, 22,23-dihydroergocalciferol, 1,24,25-trihydroxycholecalciferol, previtamin D₃, tachysterol₃ (also termed tacalciol);

xxiv isovitamin D₃, dihydrotachysterol₃, (1S)-hydroxycalciol, (24R)-hydroxycalcidiol, 25-fluorocalciol, ercalcidiol, ertacalciol, (5E)-isocalciol, 22,23-dihydroercalciol, (24S)-methylcalciol, (5E)-(10S)-10,19-dihydroercalciol, (24S)-ethylcalciol and (22E)-(24R)-ethyl-22,23-didehydrocalciol;

xxv a phytosteroid or a phytosterol;

xxvi a steroid derived or extracted from one of the families of phytosteroids, phytosterols, phytostanols, ecdysones, withanolids, sterines, steroid saponins and soflavonoids;

xxvii a steroid selected from the group consisting of alpha-sitosterol, beta-sitosterol, stigmastanol, campesterol, alpha-sitostanol, beta-sitostanol, stigmastanol, campestanol, avenosterol, brassicasterol, desmosterol, chalinosterol, beta-ecdysone, whithaferin A, beta-sitosterine, stigmasterine, campesterine, ergosterine, diosgenin, daidzein, glycitein, genistein, muristerone, poriferasterol, clionasterol, campestanol, and cycloartenol;

xxviii a plant oil or a plant extract, which contains a steroid;

xxix a plant oil or a plant extract, selected from the group consisting of nuts seeds, sprouted seeds and grains (such as alfalfa), St. Mary'"'"'s thistle, ginkgo biloba, saw palmetto, panax, siberian ginseng, foeniculum vulgare, cimicifuga racemosa, licorice root, red clover, sage, sarsaparilla, sassafras, angelica sinensis achillea millefolium, anemone pratensis, angelica sinensis, glycyrrhiza glabra, hypericum perforatum, larrea, panax, piscidia erythrina, plantago psyllium, serenoa repens, symphytum, taraxacum officinale, trifolium pratense, turnera spp., tussilago farfara, valeriana officinalis, viburnum prunifolium, calendula officinalis;

xxx any one of the compounds exemplified in the present specification;

and salts thereof.

11. The kit of claim 1, wherein the concentration range of the steroid is selected from the group of (i) between about 0.005% and about 0.5%;

(ii) between about 0.5% and about 2%;

(iii) between about 2% and about 5%; and

(iv) between about 5% and about 12%.

12. The kit of claim 2, wherein the graded of solubility of the steroid in the aqueous phase of the emulsion is selected from the groups consisting of:

(i) “

soluble”

, “

freely soluble”

or “

very soluble”

(ii) “

very slightly soluble”

, “

slightly soluble”

or “

sparingly soluble”

(iii) insoluble i.e, “

requires 10,000 parts or more of a solvent to be solubilized”

where the descriptive grade of solubility is defined according to the the US Pharmacopoeia.

13. The kit of claim 2, wherein the grade of solubility of the steroid in the oil phase of the emulsion is selected from the groups consisting of:

(i) “

soluble”

, “

freely soluble”

or “

very soluble”

(ii) “

very slightly soluble”

, “

slightly soluble”

or “

sparingly soluble”

(iii) insoluble i.e, “

requires 10,000 parts or more of a solvent to be solubilized”

where the descriptive grade of solubility is defined according to the the US Pharmacopoeia.

14. The kit of claim 1 or 2, wherein the steroid is dissolved in at least one phase of the emulsion.

15. The kit of claim 1 or 2, wherein the steroid is suspended in the composition.

16. The kit of claim 1, wherein the foamable composition further comprises at least one additional therapeutic agent selected from the group consisting of an anti-infective, an antibiotic, an antibacterial agent, an antifungal agent, an antiviral agent, an antiparasitic agent, an immunosuppressive agent, an immunomodulator, an immunoregulating agent, a hormonal agent, vitamin A, a vitamin A derivative, vitamin B, a vitamin B derivative, vitamin C, a vitamin C derivative, vitamin D, a vitamin D derivative, vitamin E, a vitamin E derivative, vitamin F, a vitamin F derivative, vitamin K, a vitamin K derivative, a wound healing agent, a disinfectant, an anesthetic, an antiallergic agent, an alpha hydroxyl acid, lactic acid, glycolic acid, a beta-hydroxy acid, a protein, a peptide, a neuropeptide, a allergen, an immunogenic substance, a haptene, an oxidizing agent, an antioxidant, a dicarboxylic acid, azelaic acid, sebacic acid, adipic acid, fumaric acid, a retinoid, an antiproliferative agent, an anticancer agent, a photodynamic therapy agent, benzoyl chloride, calcium hypochlorite, magnesium hypochlorite, an anti-wrinkle agent, a radical scavenger, a metal, silver, a metal oxide, titanium dioxide, zinc oxide, zirconium oxide, iron oxide, silicone oxide, talc, carbon, an anti wrinkle agent, a skin whitening agent, a skin protective agent, a masking agent, an anti-wart agent, a refatting agent, a lubricating agent and mixtures thereof.

17. The kit of claim 1, wherein the concentration of the surface active agent is between about 0.1% and about 5%.

18. The kit of claim 1, wherein the surface active agent includes a mixture of at least one non-ionic surfactant and at least one ionic surfactant in a ratio in the range of about 100:

1 to 6;

1.

19. The kit of claim 1, wherein the surface active agent comprises a combination of a non-ionic surfactant and an ionic surfactant, at a ratio of between 1:

1 and 20;

1.

20. The kit of claim 2, wherein the emulsion is a water in oil emulsion and wherein the HLB of the surface active agent is between about 9 and about 14.

21. The kit of claim 2, wherein the emulsion is an oil in water emulsion and wherein the HLB of the surface active agent is between about 2 and about 9.

22. The kit of claim 1, wherein the surface active agent comprises a combination of at least one non-ionic surfactant having HLB of less than 9 and at least one non-ionic surfactant having HLB of equal or more than 9, wherein the ratio between the at least one non-ionic surfactant having HLB of less than 9 and the at least one non-ionic surfactant having HLB of equal or more than 9, is between 1:

8 and 8;

1.

23. The kit of claim 1, wherein the polymeric agent is selected from the group consisting of a water-soluble cellulose ether and naturally-occurring polymeric material.

24. The kit of claim 23, wherein the water-soluble cellulose ether is selected from the group consisting of methylcellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose (Methocel), hydroxyethyl cellulose, methylhydroxyethylcellulose, methylhydroxypropylcellulose, hydroxyethylcarboxymethylcellulose, carboxymethylcellulose, carboxymethylhydroxyethylcellulose, xanthan gum, guar gum, carrageenin gum, locust bean gum and tragacanth gum.

25. A therapeutic foamable composition including:

i. asteroid;

ii. a therapeutically active oil;

iii. a surface-active agent;

iv. about 0.01% to about 5% by weight of at least one polymeric additive selected from the group consisting of a bioadhesive agent, a gelling agent, a film forming agent and a phase change agent;

v. water; and

vi. liquefied or compressed gas propellant at a concentration of about 3% to about 25% by weight of the total composition.

Where the composition is an emulsion.

26. The composition of claim 25, further including about 0.1% to about 5% by weight of a therapeutically active foam adjuvant is selected from the group consisting of a fatty alcohol having 15 or more carbons in their carbon chain;

a fatty acid having 16 or more carbons in their carbon chain;

fatty alcohols, derived from beeswax and including a mixture of alcohols, a majority of which has at least 20 carbon atoms in their carbon chain;

a fatty alcohol having at least one double bond;

a fatty acid having at least one double bond;

a branched fatty alcohol;

a branched fatty acid;

a fatty acid substituted with a hydroxyl group;

cetyl alcohol;

stearyl alcohol;

arachidyl alcohol;

behenyl alcohol;

1-triacontanol;

hexadecanoic acid;

stearic acid;

arachidic acid;

behenic acid;

octacosanoic acid;

12-hydroxy stearic acid and mixtures thereof.

27. The composition of claim 25 or 26, wherein the graded of solubility of the steroid in the aqueous phase of the emulsion is selected from the groups consisting of:

(i) “

soluble”

, “

freely soluble”

or “

very soluble”

(ii) “

very slightly soluble”

, “

slightly soluble”

or “

sparingly soluble”

(iii) insoluble i.e, “

requires 10,000 parts or more of a solvent to be solubilizes”

where the descriptive grade of solubility is defined according to the US Pharmacopoeia.

28. The composition of claim 25 or 26, wherein the graded of solubility of the steroid in the oil phase of the emulsion is selected from the groups consisting of:

(i) “

soluble”

, “

freely soluble”

or “

very soluble”

(ii) “

very slightly soluble”

, “

slightly soluble”

or “

sparingly soluble”

(iii) insoluble i.e, “

requires 10,000 parts or more of a solvent to be solubilizes”

where the descriptive grade of solubility is defined according to the US Pharmacopoeia.

29. The composition of claim 25 or 26, wherein the steroid is dissolved in at least one phase of the emulsion.

30. The composition of claim 25 or 26, wherein the steroid is suspended in the composition.

31. The composition of claim 25 or 26, wherein the foamable composition further comprises at least one additional therapeutic agent

32. The composition of claim 25, wherein the additional therapeutic agent is selected from the group consisting of an anti-infective, an antibiotic, an antibacterial agent, an antifungal agent, an antiviral agent, an antiparasitic agent, an steroidal antiinflammatory agent, an immunosuppressive agent, an immunomodulator, an immunoregulating agent, a hormonal agent, vitamin A, a vitamin A derivative, vitamin B, a vitamin B derivative, vitamin C, a vitamin C derivative, vitamin D, a vitamin D derivative, vitamin E, a vitamin E derivative, vitamin F, a vitamin F derivative, vitamin K, a vitamin K derivative, a wound healing agent, a disinfectant, an anesthetic, an antiallergic agent, an alpha hydroxyl acid, lactic acid, glycolic acid, a beta-hydroxy acid, a protein, a peptide, a neuropeptide, a allergen, an immunogenic substance, a haptene, an oxidizing agent, an antioxidant, a dicarboxylic acid, azelaic acid, sebacic acid, adipic acid, fumaric acid, a steroid, an antiproliferative agent, an anticancer agent, a photodynamic therapy agent, benzoyl chloride, calcium hypochlorite, magnesium hypochlorite, an anti-wrinkle agent, a radical scavenger, a metal, silver, a metal oxide, titanium dioxide, zinc oxide, zirconium oxide, iron oxide, silicone oxide, talc, carbon, an anti wrinkle agent, a skin whitening agent, a skin protective agent, a masking agent, an anti-wart agent, a refatting agent, a lubricating agent and mixtures thereof.

33. The composition of claim 25, wherein the composition does not contain petrolatum.

40. The foamable composition of claim 25 wherein the foamable composition contains at least one therapeutically active oil.

41. The foamable composition of claim 25,

wherein the foamable composition contains at least one therapeutically active oil;

and

wherein the foamable composition further contains at least one therapeutically effective foam.

43. The foamable composition of claim 25 wherein the composition further contains a penetration enhancer.

34. A method of treating, alleviating or preventing a disorders of the skin, a body cavity or a mucosal surface, wherein the disorder involves inflammation as one of its etiological factors, including:

administering topically to a subject having the disorder, a foamed composition including;

a) a steroid;

b) at least one organic carrier selected from a hydrophobic organic carrier, a polar solvent, an emollient and mixtures thereof, at a concentration of about 2% to about 50% by weight;

c) about 0.1% to about 5% by weight of a surface-active agent;

d) about 0.01% to about 5% by weight of a polymeric additive selected from a bioadhesive agent, a gelling agent, a film forming agent and a phase change agent; and

e) water,

wherein the steroid is administered in a therapeutically effective amount.

35. The method of claim 34, wherein the composition further comprises about 0.1% to about 5% by weight of a therapeutically active foam adjuvant is selected from the group consisting of a fatty alcohol having 15 or more carbons in their carbon chain;

a fatty acid having 16 or more carbons in their carbon chain;

fatty alcohols, derived from beeswax and including a mixture of alcohols, a majority of which has at least 20 carbon atoms in their carbon chain;

a fatty alcohol having at least one double bond;

a fatty acid having at least one double bond;

a branched fatty alcohol;

a branched fatty acid;

a fatty acid substituted with a hydroxyl group;

cetyl alcohol;

stearyl alcohol;

arachidyl alcohol;

behenyl alcohol;

1-triacontanol;

hexadecanoic acid;

stearic acid;

arachidic acid;

behenic acid;

octacosanoic acid;

12-hydroxy stearic acid and mixtures thereof.

36. The method of claim 34, wherein the disorder is selected from the group consisting of a dermatose, a dermatitis, a vaginal disorder, a vulvar disorder, an anal disorder, a disorder of a body cavity, a disorder of the cranial cavity, the thoratic cavity, the abdominal cavity, the venteral cavity, the vagina, the rectum and penile cavities, the urinary tract, the nasal cavity, the mouth, the eye, the ear the peritoneum, the large and small bowel, the caecum, bladder, and stomach, the cavity between the uterus and the fallopian tubes, the ovaries, a disorder of the respiratory system, post-surgical adhesion, a bacterial infection, fungal infection, viral infection, dermatosis, dermatitis, parasitic infections, disorders of hair follicles and sebaceous glands, scaling papular diseases, benign tumors, malignant tumors, reactions to sunlight, bullous diseases, pigmentation disorders, disorders of cornification, pressure sores, disorders of sweating, inflammatory reactions, xerosis, ichthyosis, allergy, burn, wound, cut, chlamydia infection, gonorrhea infection, hepatitis B, herpes, HIV/AIDS, human papillomavirus (HPV), genital warts, bacterial vaginosis, candidiasis, chancroid, granuloma Inguinale, lymphogranloma venereum, mucopurulent cervicitis (MPC), molluscum contagiosum, nongonococcal urethritis (NGU), trichomoniasis, vulvar disorders, vulvodynia, vulvar pain, yeast infection, vulvar dystrophy, vulvar intraepithelial neoplasia (VIN), contact dermatitis, osteoarthritis, joint pain, hormonal disorder, pelvic inflammation, endometritis, salpingitis, oophoritis, genital cancer, cancer of the cervix, cancer of the vulva, cancer of the vagina, vaginal dryness, dyspareunia, anal and rectal disease, anal abscess/fistula, anal cancer, anal fissure, anal warts, Crohn'"'"'s disease, hemorrhoids, anal itch, pruritus ani, fecal incontinence, constipation, polyps of the colon and rectum;

37. The method of claim 34, wherein the composition is useful in the therapy of non-superficial abnormality, by providing transdermal or transmucosal delivery of a steroid that is effective against the abnormality.

38. The method of claim 37, wherein the abnormality is a disorder that responds to treatment with a steroid hormone.

39. The method of claim 34, wherein the abnormality is selected from the group consisting of a sexual dysfunction in men and women, androgen deficiency;

estrogen deficiency, growth disorders, hypogonadism, cancer, vasomotor symptoms, menopausal disorders, vulvar and vaginal atrophy, urethritis, hypoestrogenism, osteoarthritis, osteoporosis, uterine bleeding, Hirsutism, Virilization, ovarian tumors, hypothalamic pituitary unit diseases, testicular tumors, prostate cancer, hypopituitarism, Klinefelter'"'"'s syndrome, testicular feminisation, orchitectomy, vasomotor symptoms (such as “

hot flashes”

) associated with the menopause, metabolic abnormalities and mood disturbances.

and wherein the disorder is responsive to treatment with the steroid.

42. The method of claim 34, wherein the composition further comprises at least one additional therapeutic agent.

44. A pharmaceutical composition, consisting of an oilphase and an aqueous phase, containing water and a surface active agent, having an HLB value between about 9 and about 16, and a steroid, wherein the steroid is solubilized in the composition, while it is insoluble both in water and in the oil phase of the composition.

45. The pharmaceutical composition of claim 44, wherein the steroid is selected from the group of low-potency anti-inflammatory steroids, medium potency anti-inflammatory steroids and high potency anti-inflammatory steroids.

46. The pharmaceutical composition of claim 44, further containing at least one component, selected from the group consisting of

i. at least one organic carrier selected from a hydrophobic organic carrier, a polar solvent, an emollient and mixtures thereof, at a concentration of about 2% to about 50% by weight;

ii. about 0.01% to about 5% by weight of a polymeric additive selected from a bioadhesive agent, a gelling agent, a film forming agent and a phase change agent

47. The pharmaceutical composition of claim 46, further containing a propellant, wherein the composition is contained in a pressurized container.