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(12) United States Patent (10) Patent No.: US 9,050,293 B2 Cohen Et Al

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(12) United States Patent (10) Patent No.: US 9,050,293 B2 Cohen Et Al US009050293B2 (12) United States Patent (10) Patent No.: US 9,050,293 B2 Cohen et al. (45) Date of Patent: *Jun. 9, 2015 (54) SMALL MOLECULESOLUBLIZATION (56) References Cited SYSTEM U.S. PATENT DOCUMENTS (75) Inventors: David M. Cohen, Lauderdale By The 4,091,090 A 5/1978 Sipos Sea, FL (US); Eugene R. Cooper, 4,552,872 A 1 1/1985 Cooper et al. Berwyn, PA (US) 4,764,381 A 8, 1988 Bodor et al. 4.885,174 A 12/1989 Bodor et al. (73) Assignee: Juventio, LLC, Chatham, NJ (US) 4.954,487 A 9/1990 Cooper et al. 4,983,396 A 1/1991 Bodor et al. 5,073,372 A * 12/1991 Turner et al. .................. 424/401 (*) Notice: Subject to any disclaimer, the term of this 5,196.410 A 3, 1993 Francoeur et al. patent is extended or adjusted under 35 5,534,242 A 7/1996 Henry et al. U.S.C. 154(b) by 714 days. 5,534.246 A 7, 1996 Herb et al. 5,585,398 A 12, 1996 Ernst This patent is Subject to a terminal dis 5,853,732 A 12/1998 Munden claimer. (Continued) (21) Appl. No.: 12/503,929 FOREIGN PATENT DOCUMENTS (22) Filed: Jul. 16, 2009 CA 2446.060 A1 11 2002 EP 95813 A2 12/1983 (65) Prior Publication Data (Continued) US 2010/0016442 A1 Jan. 21, 2010 OTHER PUBLICATIONS Related U.S. Application Data United States District Court Southern District of Florida, Case No. (60) Provisional application No. 61/135,103, filed on Jul. 09-cv-60284-GRAHAM/TORRES, Complaint dated Feb. 20, 2009. 16, 2008. (Continued) (51) Int. C. Primary Examiner — Paul Zarek A6 IK3I/64 (2006.01) (74) Attorney, Agent, or Firm — Hoffmann & Baron, LLP A6 IK9/00 (2006.01) A61 K 47/10 (2006.01) (57) ABSTRACT A61 K 47/24 (2006.01) The invention provides a drug delivery system for the topical A61 K 47/38 (2006.01) administration of therapeutic agents, including therapeutic (52) U.S. C. agent in an amount between 0.001 and 20% by weight, pro CPC ............. A6 IK3I/I64 (2013.01); A61 K9/0014 pylene glycol in an amount between 2 and 6% by weight, (2013.01); A61 K47/10 (2013.01); A61 K47/24 oleyl alcohol in an amount between 2 and 6% by weight, and (2013.01); A61 K47/38 (2013.01) a volatile component in an amount between 60 and 95% by (58) Field of Classification Search weight. CPC .................................................... A61 K31 (164 See application file for complete search history. 15 Claims, 1 Drawing Sheet US 9,050,293 B2 Page 2 (56) References Cited tiffs Complaint with Affirmative Defenses and Counterclaim dated Mar. 23, 2009. U.S. PATENT DOCUMENTS International Search Report for PCT/US2009/004173 dated Jun. 26, 2008. 5,891.462 A 4/1999 Carrara et al. United States District Court Southern District of Florida, Case No 6,295,469 B1 9, 2001 Linkwitz et al. 09-cv-60284-GRAHAM/TORRES, Condensed Transcript of Confi 6,319,913 B1 1 1/2001 Mak et al. dential Deposition dated Mar. 11, 2009. 6,528,086 B2 3/2003 Zhang United States District Court Southern District of Florida, Case No. 6,579,865 B2 6, 2003 Mak et al. 09-cv-6084-GRAHAM/TORRES, Settlement Agreement and 6,635,674 B1 10/2003 Kaneko et al. Release dated Sep. 11, 2009. 6,894,078 B2 5, 2005 Castillo Galinsky et al., “Basic Pharmacokinetics and Pharmacodynamics.” 7,157,097 B2 1/2007 Mak et al. 7,273,887 B1 9/2007 Wepfer Remington: The Science and Practice of Pharmacy, (2006) p. 1171. 7,335,379 B2 2/2008 Carrara et al. Lippincott Williams & Wilkins, Baltimore. 7,504,114 B1 3/2009 Kurita et al. Rodu et al., "Clinical and chemical properties of a novel mucosal 2003/0O27833 A1 2/2003 Cleary et al. bioadhesive agent.” J Oral Pathol. (1988) 17:9-10. 2003/OO54017 A1 3/2003 Castillo Cooper, E., “Vehicle Effects on Skin Penetration.” Percutaneous 2004/O131665 A1 7/2004 Wepfer Absorption, (1985) pp. 525-529, R L. Bronaugh and H. I. 2004O162989 A1 8, 2004 Kirovski Maibach, Eds., Marcel Dekker, Inc. New York. 2004/0175416 A1 9, 2004 Taravella et al. Cooper, E. R. “Increased Skin Permeability for Lipophilic Mol 2004/0208.914 A1* 10, 2004 Richlin et al. ................ 424/448 ecules,” J. Pharm. Sci. (1984) pp. 1153-1156 73:8. 2005, OO 14823 A1 1/2005 Soderlund et al. Cooper, E. R. et al., “Effect of Fatty Acids and Alcohols on the 2005/0276842 Al 12/2005 Zhang et al. 2005/0281750 A1 12, 2005 Willcox et al. Penetration of Acyclovir Across Human Skin in Vitro. J. Pharm. 2006, O155922 A1 7/2006 Gorobets et al. Sci., (1985) pp. 688-689, 74:6. 2006/0280783 Al 12/2006 Dipietro et al. Cooper, E. R. et al., "Skin Permeability.” Methods in Skin Research, 2007, OO15590 A1 1/2007 Jackson et al. (1985) pp. 407-432, D. Skerrow and C.J. Skerrow, Eds. John Wiley 2007/O189978 A1 8/2007 Zhang et al. and Sons, Chichester. 2007/0269393 A1 1 1/2007 Wepfer Material Safety Data Sheet Cyclohexylmethanol, 99%. Fisher Sci 2008. O176948 A1 7/2008 Cohen et al. entific online). Mar. 7, 2006 retrieved on Apr. 20, 2008 Retrieved 2009 OO48347 A1 2/2009 Cohen et al. from the Internet USR:<https://fscimage.fishersci.com/msds/46753. 2010, OO16442 A1 1/2010 Cohen et al. htm>. Merritt, E. W. et al., “Diffusion Apparatus for Skin Penetration.” J. FOREIGN PATENT DOCUMENTS Controlled Release (1984) 1:161-162. Vaida, et al., “Prolongation of lidocaine spinal anesthesia with EP 129283 12, 1984 phenylephrine.” Anesthesia and Analgesia, (1986) pp. 781-785,65:7. EP 302147 A1 2, 1989 Williams, et al., “Benzyl alcohol Attenuates the Pain of Lidocaine EP 12932O3 A1 3, 2003 Injections and Prolongs anesthesia.” J. Dermatol Surg. Oncol, (1994) WO 95.29678 A1 11, 1995 20:730-733. WO 02096435 A2 12/2002 WO 2004030665 A1 4/2004 Kondo, S. at al., “Enhancement of Transdermal Delivery by Super WO 2005097196 A2 10, 2005 fluous Thermodynamic Potential. III. Percutaneous Absorption of WO 2007031753 A2 3, 2007 Nifedipien in Rats.” J. Pharmacobic-Dyn., (1987), pp. 743-794, vol. WO 2007038325 A2 4/2007 10. WO 2007070643 A2 6, 2007 International Search Report for PCT/US08/051176 dated May 20, WO 2007070679 A2 6, 2007 2008. WO 2007070694 A2 6, 2007 International Search Report for PCT/US2009/004172 dated Dec. 7, WO 2007070695 A2 6, 2007 2009. WO WO 2007070679 A2 * 6, 2007 International Preliminary Report of Patentability and Written Opin WO 2008.005240 A2 1, 2008 ion for PCT/US2008/051176 dated Jul. 21, 2009. WO 2009026178 A2 2, 2009 International Preliminary Report of Patentability for PCT/US08/ 04173 dated Jul. 27, 2009. OTHER PUBLICATIONS Cooper, E. et al., “Transport Across Epithelial Members,” J. Con trolled Release (1987) 6:23. United States District Court Southern District of Florida, Case No. 09-cv-60284-GRAHAM/TORRES, Defendant’s Answer to Plain * cited by examiner U.S. Patent Jun. 9, 2015 US 9,050,293 B2 US 9,050,293 B2 1. 2 SMALL MOLECULESOLUBLIZATION therapeutic agent, an alkane diol, a Cs-C fatty acid or cor SYSTEM responding alcohol or ester having a melting point below 40° C., and a volatile component. In certain embodiments, the RELATED APPLICATIONS therapeutic agent is present in an amount Such that upon topical application to a Surface, evaporation of the Volatile This application claims the benefit of priority to U.S. Pro component occurs such that the remaining Solution is near visional Patent Application No. 61/135,103, filed Jul. 16, saturation, at Saturation, or above Saturation with the thera 2008, which application is hereby incorporated by reference peutic agent at the temperature of the Surface. in its entirety. For example, the present invention provides a drug delivery BACKGROUND 10 system for topical administration of a therapeutic agent com prisingi) a first component which is a therapeutic agent, Such The medical community is continually engaged in efforts as any one of the therapeutic agents listed below, ii) a second to enhance the effective delivery of drugs across the skin. component selected from propylene glycol or a butane diol Many of the concerns associated with oral administration can with adjacent hydroxyl groups (e.g., butane-1,2-diol or often be avoided by topically administering an active agent to 15 butane-2,3-diol), iii) a third component selected from oleyl a subject in need thereof. For example, reliable delivery of a alcohol, oleic acid, ester derivatives of oleic acid such as the pharmaceutically active agent to organs or tissues in need methyl ester, any Co to Ca Saturated alcohol or correspond thereof via oral administration is often difficult due to vari ing acid which is a liquid at room temperature, or any C2 to able rates of absorption and metabolism associated with oral C mono- or poly-unsaturated or branched chain alcohol or delivery. In contrast, topical administration of a pharmaceu corresponding acid which is a liquid at room temperature, and tically active agent can provide high doses of the active agent iv) a fourth component which is a volatile component, such as directly to the desired area, often minimizing side effects. One Such way of delivering drugs across the skin Surface is one or more short-chain alcohols, Volatile silicones, or com by way of a non-occlusive transdermal and/or topical dosage binations thereof. form. Some non-limiting examples of non-occlusive trans In certain embodiments, the drug delivery system of the dermal and topical semi-solid dosage forms include creams, 25 present invention may further comprise a thickener, Such as ointments, gels, foams, sprays, Solutions, and lotions (i.e., any suitable thickener that is soluble in the total solvent emulsions, or Suspensions).
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