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(12) United States Patent (10) Patent No.: US 6,994,863 B2 Eini Et Al

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(12) United States Patent (10) Patent No.: US 6,994,863 B2 Eini Et Al USOO6994.863B2 (12) United States Patent (10) Patent No.: US 6,994,863 B2 Eini et al. (45) Date of Patent: Feb. 7, 2006 (54) PHARMACEUTICAL AND COSMETIC (56) References Cited CARRIER AND COMPOSITION FOR TOPCAL APPLICATION U.S. PATENT DOCUMENTS (75) Inventors: Meir Eini, Ness Ziona (IL); Dov 4,151.272 A 4/1979 Geary et al. .................. 424/68 Tamarkin, Maccabim (IL) 4,229,432 A 10/1980 Geria 4,661,524 A * 4/1987 Thomson et al. ........... 514/682 4,992.478 A 2/1991 Geria (73) Assignee: Foamix Ltd., Ness Ziona (IL) 5,719,197 A 2/1998 Kanios et al. 5,817,322 A 10/1998 Xu ............................. 424/401 (*) Notice: Subject to any disclaimer, the term of this 5,837.270 A 11/1998 Burgess patent is extended or adjusted under 35 5,925,669 A 7/1999 Katz et al. U.S.C. 154(b) by 0 days. 5,952,392 A * 9/1999 Katz et al. .................. 514/724 6.224.888 B1 5/2001 Vatter et al. (21) Appl. No.: 10/392,071 6,348.229 B1 2/2002 Eini et al. ................... 426/611 (22) Filed: Mar 19, 2003 FOREIGN PATENT DOCUMENTS WO 98/18472 5/1998 (65) Prior Publication Data US 2003/O157138 A1 Aug. 21, 2003 * cited by examiner Primary Examiner-Gary Kunz Related U.S. Application Data Assistant Examiner-Mina Haghighatian (62) Division of application No. 09/653,267, filed on Aug. (74) Attorney, Agent, or Firm-Wilmer Cutler Pickering 31, 2000. Hale and Dorr LLP (60) Provisional application No. 60/216,162, filed on Jul. (57) ABSTRACT 3, 2000. (51) Int. Cl. A pharmaceutical or cosmetic carrier or composition for A6 IK 7700 (2006.01) topical application characterized by rheological properties A6 IK 7/48 (2006.01) which render the carrier or composition Semi-Solid at rest A6 IK3I/74 (2006.01) and a liquid upon application of shear forces thereto. The (52) U.S. Cl. ................ 424/401; 424/78.03; 424/78.07; composition or carrier are prepared by mixing 1-25 percent 424/78.05; 424/78.06; 424/434; 514/682; of a solidifying agent and 75-99 percent of a hydrophobic 514/724 Solvent, by weight, wherein at least one of them has thera (58) Field of Classification Search ................ 424/401, peutic or cosmetic benefits, in the presence or absence of a 424/78.03, 434, 78.07, 78.05, 78.06; 514/682, biologically active Substance. 514/724 See application file for complete Search history. 29 Claims, 1 Drawing Sheet U.S. Patent Feb. 7, 2006 US 6,994,863 B2 US 6,994,863 B2 1 2 PHARMACEUTICAL AND COSMETIC plaques on, for example, the knees, elbows, buttocks, and CARRIER AND COMPOSITION FOR which are esthetically unpleasant and cause discomfort to TOPCAL APPLICATION the affected subject. Skin diseases or disorders are usually treated by creams, CROSS REFERENCE TO RELATED gels or ointments containing antifungal agents, Steroidal APPLICATIONS agents and/or antibacterial agents. In many instances Such creams, gels and ointments are difficult to Spread, result in This application is a divisional of U.S. patent application a greasy and Sticky appearance and are usually not appealing Ser. No. 09/653,267, filed on Aug. 31, 2000, which is a for use. utility application claiming priority under 35 U.S.C. S 119(e) Genital infections are caused by fungal, Viral and micro to U.S. Provisional Patent Application No. 60/216,162, filed bial agents. Genitals infections are treated either Systemati on Jul. 3, 2000, all of which applications are hereby incor cally, or by the use of creams, ointments or pessaries, which porated by reference. usually leak or otherwise fail to spread well and lead to ineffective therapeutic concentration of the therapeutically FIELD AND BACKGROUND OF THE 15 active agent(s) therein. INVENTION Genital herpes infections are widespread from the 70's and apart from the discomfort they inflict, genital herpes The present invention relates to a pharmaceutical or infections may, in Some cases, develop into Severe disease. cosmetic carrier or composition for topical application onto Presently, there is no effective medication for genital herpes. skin and/or mucosal membranes (e.g., the mucosa of the Trichomoniasis is an infection of the urogenital tract nose, mouth, eye, ear, vagina or rectum). More particularly, caused due to infection by the protozoan Trichomonas the present invention relates to (i) a cosmetic or pharma vaginalis. Trichomoniasis is associated with uncomfort itch ceutical carrier or composition characterized by rheological ing and vaginal excretion in Women. properties which render the carrier or composition Semi Candidiasis is caused by Candida albicans and results in Solid at rest and liquid upon application of Shear forces (e.g., 25 itching in the genital area and white discharge therefrom. spread forces) thereto; (ii) methods of preparing same; and Mucosal membrane inflammations can affect other organs (iii) methods of utilizing same for treating a variety of skin Such as for example, the eye. Conjuctivitis, caused by or mucosal membrane diseases or disorders. different types of bacteria, Such as, but not limited to, Most of the skin or mucosal membrane diseases or StaphylococcuS aureus, StreptococcuS pneumoniae or Hae disorders are the result of inflammation caused by inflam mophilus influenzae, is generally treated with antibiotic matory agents, Such as, but not limited to, bacterial, fungal, ointments, e.g., bacitracin 500 U/g or gentamicin 0.3 percent Viral, parasitic, autoimmune, allergic, hormonal and/or ophthalmic ointment instilled into the affected eye. The malignant inflammatory agents. The most common skin compliance to these ointments is usually poor due to the diseases or disorders include eczema, psoriasis and derma 35 Sticky feeling they exert. titis, including contact dermatitis, atopic dermatitis and AS is evident from the above descriptions, one of the Seborrheic dermatitis. important routes of administration of a drug for treating a Eczema and dermatitis result from inflammatory pro skin or mucosal membrane is by topical application of a drug ceSSes that involve the upper dermis and epidermis of the onto the skin or mucosal membrane. This method is useful skin. When eczema develops, the keratinocytes in the epi 40 for local treatment but it is also possible to apply pessaries dermis distend from one another and fluid is accumulated via the rectum as an efficient delivery method of Systemic there amongst in a process known as Spongiosis. agents that are not degraded in the intestine. In chronic forms of eczema or dermatitis the main change Many pharmaceutical carriers are presently known, most include thickening of the epidermis, which leads to itching, of them have disadvantages when topically applied onto the roughening and Scaling of the skin Surface. The loss of water 45 skin or mucosal membranes. For example, when ointments from the Skin leads to inflammation of the horny layer, containing petroleum as a carrier are applied onto a skin which later result in cracked and Sore skin. wound, metabolic products and excreta from the wound Dermatitis is further classified into contact dermatitis cannot be easily removed therefrom because of the difficulty (allergic or non allergic), atopic dermatitis and Seborrheic of passing through the hydrophobic petroleum barrier. In dermatitis. 50 addition, the active drug ingredient, which is dissolved or Non allergic contact dermatitis occurs in response to skin dispersed in the petroleum carrier, is not efficiently absorbed irritants, Such as acids, alkalis, oils, detergents and Solvents. into the wound tissue, thus, the efficacy of the drug is Allergic contact dermatitis occurs as a result of Sensiti affected. Another example is ophthalmologic ointments, Zation to repeated exposure to an antigen. Allergic contact which are applied into the eye, and make the eye area Sticky 55 and uncomfortable. Moreover, in physiological aspect, dermatitis appears in Skin areas that were in direct contact petroleum restricts respiration of a wound tissue and is with the antigen. disturbing to the normal respiration of the skin. Atopic dermatitis, which affects mainly infants, is char Many groups of drugs including, for example, antibiotic, acterized by Sensitization of the skin to a wide range of antifungal, antiinflammatory, anesthetic, analgesic, antialler common antigens. 60 gic, corticosteroid, retinoid and antiproliferative medica Seborrheic dermatitis affects the scalp and other hairy tions are preferably administered typically using a hydro areas, the face, and flexural areas and results from yeast or phobic carrier Such as petroleum. However, due to the bacteria induced inflammation. Most people suffer from undesirable consistency of petroleum and Similar hydropho dandruff which is a mild form of Seborrheic dermatitis. bic carriers, their topical use is limited. An additional Psoriasis is a dominant autosomal inherited inflammatory 65 disadvantage of petroleum-carrier including products relates disease characterized by enhanced proliferation of kerati to the greasy feeling following their topical application to nocytes which proliferation leads to formation of Scaly the skin or mucosal membranes. US 6,994,863 B2 3 4 Besides petroleum, other hydrophobic pharmaceutical and further mixing into the mixture a therapeutically or carriers are known, including liquid paraffin, lanolin, bees cosmetically effective amount of a biologically active Sub wax, vegetable oil, glycerin monoStearate, higher alcohols, Stance. polyethylene glycol and Some emulsifying agents. All of According to yet an additional aspect of the present these agents either Suffer the limitations described herein invention there is provided a method of treating a disease or above with respect to petroleum or have undesirable (fast) disorder of a skin or a mucosal membrane, the method flow properties. comprising the Step of topically administrating to the skin or Several hydrophobic liquids, e.g., mono- and poly-unsat the mucosal membrane a pharmaceutical or cosmetic com urated oils from Vegetable and marine Sources, Silicone oils, position containing, by weight, 1-25 percent of a Solidifying mineral oils, and liquid hydrophobic plant-derived oils are agent and 75-99 percent of a hydrophobic solvent, wherein known for their therapeutic effects when applied topically.
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