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(12) Patent Application Publication (10) Pub. No.: US 2008/0299220 A1 Tamarkin Et Al

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(12) Patent Application Publication (10) Pub. No.: US 2008/0299220 A1 Tamarkin Et Al US 20080299220A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2008/0299220 A1 Tamarkin et al. (43) Pub. Date: Dec. 4, 2008 (54) HYDROPHILIC, NON-AQUEOUS filed on Nov. 29, 2006, provisional application No. PHARMACEUTICAL CARRIERS AND 60/530,015, filed on Dec. 16, 2003, provisional appli COMPOSITIONS AND USES cation No. 60/492.385, filed on Aug. 4, 2003, provi sional application No. 60/784.793, filed on Mar. 21, (76) Inventors: Dov Tamarkin, Maccabim (IL); 2006, provisional application No. 60/530,015, filed on Meir Eini, Ness Ziona (IL); Doron Dec. 16, 2003, provisional application No. 60/492, Friedman, Karmei Yosef (IL); Alex 385, filed on Aug. 4, 2003, provisional application No. Besonov, Rehovot (IL); David 60/492.385, filed on Aug. 4, 2003, provisional appli Schuz. Moshav Gimzu (IL); Tal cation No. 60/679,020, filed on May 9, 2005. Berman, Rishon LeZiyyon (IL); Jorge Danziger, Rishom Lezion Publication Classification (IL); Rita Keynan, Rehovot (IL); (51) Int. Cl. Ella Zlatkis, Rehovot (IL) A633/00 (2006.01) Correspondence Address: A6II 47/34 (2006.01) WILMERHALEABOSTON A 6LX 3L/375 (2006.01) 6O STATE STREET A 6LX 3L/355 (2006.01) BOSTON, MA 02109 (US) A63L/35 (2006.01) A6II 3/442 (2006.01) (21) Appl. No.: 12/014,088 A63L/047 (2006.01) (22) Filed: Jan. 14, 2008 A 6LX 3/57 (2006.01) Related U.S. Application Data A6IR 9/12 (2006.01) (63) Continuation-in-part of application No. 1 1/430,599, A6II 3/522 (2006.01) filed on May 9, 2006, which is a continuation-in-part A63L/35 (2006.01) of application No. 10/835,505, filed on Apr. 28, 2004, (52) U.S. Cl. ...................... 424/600: 514/772.7: 514/474; Continuation-in-part of application No. 1 1/947,751, 514/458: 514/460, 514/345; 514/729; 514/178; filed on Nov. 29, 2007, which is a continuation-in-part 424/45; 514/263.38: 514/649 of application No. 1 1/430,599, filed on May 9, 2006, which is a continuation-in-part of application No. (57) ABSTRACT 10/835,505, filed on Apr. 28, 2004, Continuation-in A waterless composition suitable for delivery of an active part of application No. 1 1/653,205, filed on Jan. 12, agent to a body Surface or cavity includes a vehicle having 2007, which is a continuation-in-part of application about 70% to about 99% by weight of a hydrophilic polar No. 10/835,505, filed on Apr. 28, 2004, said applica Solvent, said hydrophilic solvent selected from the group tion No. 1 1/653,205 is a continuation-in-part of appli consisting of (i) a mixture of two or more different polyeth cation No. 10/911.367, filed on Aug. 4, 2004, said ylene glycols (PEGs), wherein at least one PEG is a high application No. 1 1/653.205 is a continuation-in-part of molecular weight PEG having a melting point greater than application No. 1 1/430,599, filed on May 9, 2006. 25° C.; and (ii) propylene glycol (PG); about 0% to about 10% of at least one surface active agent; about 0% to about (60) Provisional application No. 607880,434, filed on Jan. 5% of a polymeric agent; about 0% to about 30% of a sec 12, 2007, provisional application No. 60/919,303, ondary hydrophilic solvent; and about 0% to about 5% of a filed on Mar. 21, 2007, provisional application No. silicone oil; and about 3% to about 25% hydrophobic propel 60/679,020, filed on May 9, 2005, provisional appli lant. The composition is otherwise substantially free of a cation No. 60/.530,015, filed on Dec. 16, 2003, provi hydrophobic solvent and includes at least one of a surface sional application No. 60/492.385, filed on Aug. 4. active agent and a polymeric agent. The vehicle and the pro 2003, provisional application No. 60/679,020, filed on pellant are sufficiently miscible that the components may be May 9, 2005, provisional application No. 60/861,620, homogeneously distributed with mild shaking. Candida albicans Composition A effective Compositions B and Cineffective €inpositions Š ress S. Š Š & Congositing Patent Application Publication Dec. 4, 2008 Sheet 1 of 4 US 2008/0299220 A1 Candida albicans Trichophyton rubrum Composition A effective Compositions A, B and C effective FIGURE 1A FIGURE 1 B Patent Application Publication Dec. 4, 2008 Sheet 2 of 4 US 2008/0299220 A1 Trichophyton mentagrophytes Microsporum canis Compositions A and B effective Composition A and B effective Composition Cineffective Composition Cineffective s m sno, : FIGURE 1C FIGURE 1D Patent Application Publication Dec. 4, 2008 Sheet 3 of 4 US 2008/0299220 A1 5.8 i. s 3. Adhesive force -8 SiR is Figure 2 Patent Application Publication Dec. 4, 2008 Sheet 4 of 4 US 2008/0299220 A1 35.88 S. E.8s S. St 5.88 S. Adhesive force - Et3a is Figure 3 US 2008/0299220 A1 Dec. 4, 2008 HYDROPHILIC, NON-AQUEOUS 0007 External topical administration is an important PHARMACEUTICAL CARRIERS AND route for the administration of drugs in disease treatment. COMPOSITIONS AND USES Many groups of drugs, including, for example, antibiotic, anti-fungal, anti-inflammatory, anesthetic, analgesic, anti-al CROSS REFERENCE TO RELATED lergic, corticosteroid, retinoid and anti-proliferative medica APPLICATIONS tions are preferably administered in hydrophobic media, namely ointment. However, ointments often form an imper 0001. This application claims the benefit of priority under meable barrier, so that metabolic products and excreta from 35 U.S.C. S 199(e) to co-pending U.S. Provisional Applica the wounds to which they are applied are not easily removed tion No. 60/880,434 filed Jan. 12, 2007, and entitled “Hydro or drained away. Furthermore, it is difficult for the active drug philic or Waterless Vehicle and Foamable Pharmaceutical dissolved in the carrier to pass through the white petrolatum Compositions.” which is incorporated in its entirety by refer barrier layer into the wound tissue, so the efficacy of the drug CCC. is reduced. In addition, ointments and creams often do not 0002 This application claims the benefit of priority under create an environment for promoting respiration of the wound 35 U.S.C. S 199(e) to co-pending U.S. Provisional Applica tissue and it is not favorable to the normal respiration of the tion No. 60/919,303 filed Mar. 21, 2008, and entitled “Hydro skin. An additional disadvantage of petroleum jelly-based philic and Non-Aqueous Pharmaceutical Carriers and Com products relates to the greasy feeling left following their positions and Uses,” which is incorporated in its entirety by topical application onto the skin, mucosal membranes and reference. wounds. 0003. This application is a continuation-in-part applica 0008 Foams and, in particular, foams that are substan tion of co-pending U.S. patent application Ser. No. 1 1/430, tially based on non-aqueous solvents are complicated sys 599, filed on May 9, 2006, entitled “Foamable Vehicle and tems which do not form under all circumstances. Pharmaceutical Compositions Thereof which is a continu 0009. There remains an unmet need for improved, easy to ation-in-part application of co-pending U.S. patent applica use, stable and non-irritating foam formulations, intended for tion Ser. No. 10/835,505, filed on Apr. 28, 2004, entitled treatment of dermal and mucosal tissues. Particularly, there “Oleaginous Pharmaceutical and Cosmetic Foam, which remains an unmet need for improved, easy to use, stable and claims the benefit of priority under 35 U.S.C. S 119(e) to U.S. non-irritating foam formulations, with unique therapeutic Patent Application Ser. No. 60/530,015, filed on Dec. 16, properties. There is more particularly a need to develop 2003, entitled “Oleaginous Pharmaceutical Foam”, and U.S. hygroscopic carriers and compositions, foamable carriers and Patent Application Ser. No. 60/492.385, filed on Aug. 4, 2003, foamable compositions and foams with active agents, which entitled “Cosmetic and Pharmaceutical Foam;’ and which are stable, are non irritating, that facilitate penetration at a claims the benefit under 35 U.S.C. S 119(e) of U.S. Provi target, that are presentable in an easily applicable stable form, sional Patent Application No. 60/679,020, filed on May 9, that can be handled with ease thereby facilitating compliance 2005, entitled “Hygroscopic Anti-Infective Compositions: and that are adaptable where there is a need to minimize the and of U.S. Provisional Patent Application No. 60/784,793, amount of free water and in consequence, the potential break filed on Mar. 21, 2006, entitled “Polyol Foamable Vehicle and down of ingredients/agents by oxidation/hydrolysis. Pharmaceutical Compositions Thereof, which are herein 0010 Some active agents are known to be generally incorporated by reference in their entirety. unstable or susceptible to isomerization or to breakdown, 0004. This application is a continuation-in-part applica resulting in loss of activity and the use of Stabilizers, anti tion of co-pending application U.S. patent application Ser. oxidants antimicrobials and buffers and the like in aqueous No. 1 1/653,205, filed on Jan. 12, 2007, which is a continua compositions to protect active or cosmetic agents is known. tion-in-part application of co-pending U.S. patent application The problems of protecting active pharmaceutical and cos Ser. No. 10/835,505, filed on Apr. 28, 2004, both entitled metic agents in waterless environments, such as polar com “Oleaginous Pharmaceutical And Cosmetic Foam, which positions are multifold and can vary according to the type of claims the benefit of priority under 35 U.S.C.
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