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(12) United States Patent (10) Patent No.: US 7,955,618 B2 Metselaar Et Al

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(12) United States Patent (10) Patent No.: US 7,955,618 B2 Metselaar Et Al US007955618B2 (12) United States Patent (10) Patent No.: US 7,955,618 B2 Metselaar et al. (45) Date of Patent: Jun. 7, 2011 (54) COMPOSITION FORTREATMENT OF FOREIGN PATENT DOCUMENTS NFLAMMLATORY DSORDERS EP O 622 O72 A2 3, 1994 EP O 622 O72 B1 11, 1994 EP 1 O72 617 A1 7, 1999 (75) Inventors: Josbert Maarten Metselaar, Utrecht EP 1044 679 A1 * 10/2000 (NL); Marca Henriette M. Wauben, EP 1 190 706 * 3f2OO2 Utrecht (NL); Gerrit Storm, Utrecht EP 1 190 706 A1 3, 2002 (NL) JP 62-42733 2, 1987 WO WO94,07466 * 4f1994 WO WO94,07466 4f1994 (73) Assignee: Enceladus Pharmaceuticals B.V., WO WO94,07468 4f1994 Amsterdam (NL) WO WO9842.283 10, 1998 WO WO98 50040 11, 1998 WO WO98 50041 11, 1998 (*) Notice: Subject to any disclaimer, the term of this WO WOOO,25748 A1 5, 2000 patent is extended or adjusted under 35 WO WOOO.38653 T 2000 U.S.C. 154(b) by 182 days. WO WOO2,45688 A2 12/2001 WO WOO2,45688 A2 6, 2002 WO WOO3,105805 A1 12/2003 (21) Appl. No.: 10/455.257 WO WO 2004 O19916 A1 3, 2004 OTHER PUBLICATIONS (22) Filed: Jun. 5, 2003 PCT International Search Report, PCT/EPO 1/14633, dated May 8, 2002, 2 pages. (65) Prior Publication Data PCT International Preliminary Examination Report, PCT/EP01/ US 2004/OO37875A1 Feb. 26, 2004 14633, dated Apr. 2, 2003, 2 pages. Al-Muhammad et al., Studies on the formulation and in vitro release of ophthalmic liposomes containing dexamethasone sodium phos Related U.S. Application Data phate, J. Microencapsulation, 1996, pp. 123-130, vol. 13, No. 2. Farshi et al., In-vivo studies in the treatment of oral ulcers with (63) Continuation of application No. PCT/EP01/14633, liposomal dexamethasone sodium phosphate, J. Microencapsulation, filed on Dec. 7, 2001. 1996, pp. 537-544, vol. 13. No. 5. Vion-Dury et al., Specific in Vitro Labeling of Cells with a Fluorine 19 Probe Ensapsulated in Antibody-Targeted Liposomes: A F-19 (51) Int. Cl. NMR Spectroscopy Study, Magnetic Resonance in Medicine, 1993, A 6LX 9/27 (2006.01) pp. 252-255, vol. 29, No. 2. Matselaar et al., Liposomes for Intravenous Drug Targeting: Design (52) U.S. Cl. ......................... 424/450; 977/801;977/907 and Applications, Mini Reviews in Medicinal Chemistry, 2002, pp. (58) Field of Classification Search ................... 424/450 319-329, vol. 2. See application file for complete search history. Shibata et al., Preparation and Characterization of Liposomes Incor porating Hydrophobic Poly(Amino Acid)s with Different Secondary Structure, Chemical & Pharmaceutical Bulletin, May 1994, pp. (56) References Cited 1151-1153, vol. 42, No. 5. Gonzalez-Rothi et al., Pulmonary Target ing of Liposomal Triamcinolone Acetonida Phosphate, Pharmaceu U.S. PATENT DOCUMENTS tical Research, 1996, pp. 1699-1703, vol. 13, No. 11. 4,370,349 A 1/1983 Evans et al. PCT International Preliminary Examination Report, PCT/NL03/ 4,522,803 A 6, 1985 Lenk et al. 00596, dated Dec. 4, 2003. 4,818,537 A 4, 1989 Guo PCT International Search Report, PCT/NL03/00596, dated Dec. 7, 4.954,345 A 9, 1990 Muller 2004. 4,994,443 A 2f1991 Folkman et al. PCT International Preliminary Examination Report, PCT/NL03/ 5,139,803 A 8/1992 Haynes et al. 00419, Dated Apr. 14, 2004. 5, 190,936 A 3/1993 Laugier PCT International Search Report, PCT/NL03/00419, dated Sep. 8, 5, 192,528 A * 3/1993 Radhakrishnan et al. ...... 424/45 2003. 5,316,771 A 5, 1994 Barenholz et al. U.S. Appl. No. 12/387,598, filed May 5, 2009, Metselaar, Composi 5,356,633 A * 10/1994 Woodle et al. ................ 424/450 tion for Treatment of Inflammatory Disorders. 5,569,464 A 10, 1996 Endo et al. 5,762.918 A 6/1998 Thorpe (Continued) 5,786,344 A 7, 1998 Ratain et al. 5,853,752 A 12/1998 Unger et al. Primary Examiner — Carlos A Azpuru 6,028,066 A 2/2000 Unger (74) Attorney, Agent, or Firm — TraskBritt, P.C. 6,090,800 A 7/2000 Unger et al. 6,120,751 A 9/2000 Unger (57) ABSTRACT 6,126,966 A 10, 2000 Abra et al. A pharmaceutical composition for parenteral administration, 6,316,260 B1 1 1/2001 Freisleben et al. comprising liposomes composed of non-charged vesicle 6,403,056 B1 6/2002 Unger forming lipids, including up to 20 mole percent of an amphi 6,423,735 B1 7/2002 Camden et al. pathic vesicle-forming lipid derivatized with polyethyleneg 6,444,660 Bl 9/2002 Unger et al. 6,511,676 B1 1/2003 Boulikas lycol, and optionally including not more than 10 mole percent 6,562,371 B1 5/2003 Kawahara et al. of negatively charged vesicle-forming lipids, the liposomes 2002fOO58060 A1 5, 2002 Kan et al. having a selected mean particle diameter in the size range 2002fO159951 A1 10/2002 Unger et al. between about 40-200 nm and containing a water soluble 2003/005O236 A1 3/2003 Dawson et al. corticosteroid for the site-specific treatment of inflammatory 2003/0054O27 A1 3/2003 Unger 2005/O152962 A1 7/2005 Metselaar disorders, is provided. 2009/0226509 A1 9, 2009 Metselaar 17 Claims, No Drawings US 7,955,618 B2 Page 2 OTHER PUBLICATIONS Banciu et al., Liposomal glucocorticoids as tumor-targeted anti angiogenic nanomedicine in B16 melanoma-bearing mice. Journal of Trosko et al. in Mutation Research, 480-481, pp. 219–229, 2001. Gonzalez-Rothi et al., Pharmaceutical Research, vol. 13. No. 11 Steroid Biochemistry and Molecular Biology, 2008, pp. 101-110, 1996, pp. 1699-1703. vol. 111. Office Action for U.S. Appl. No. 10/455.257, dated Aug. 9. 2004. Herr et al., Glucocorticoid use in prostate cancer and other Solid Office Action for U.S. Appl. No. 10/455.257, dated Mar. 3, 2005. tumours: implications for effectiveness of cytotoxic treatment and Office Action for U.S. Appl. No. 10/455.257, dated Oct. 3, 2005. metastases. Lancet Oncol., 2006, pp. 425-430, vol. 7. Office Action for U.S. Appl. No. 10/455.257, dated May 4, 2006. Rutz et al., Effects of corticosteroid use on treatment of solid Office Action for U.S. Appl. No. 10/455.257, dated Jul. 13, 2007. tumours, The Lancet, Dec. 14, 2002, pp. 1969-1970, vol. 360. Office Action for U.S. Appl. No. 10/455.257, dated Dec. 3, 2007. U.S. Appl. No. 1 1/065,692, filed Feb. 24, 2005, Schiffelers et al., Office Action for U.S. Appl. No. 10/455.257, dated Oct. 8, 2008. Vesicle-Encapsulated Corticosteroids for the Treatment of Cancer. Office Action for U.S. Appl. No. 10/455.257, dated Jun. 5, 2009. Office Action for U.S. Appl. No. 10/455.257, dated Jan. 5, 2010. * cited by examiner US 7,955,618 B2 1. 2 COMPOSITION FORTREATMENT OF 11-fludrocortisol, triamcinolone, betamethasone and dexam NFLAMMLATORY DISORDERS ethasone. The steroids listed belong to the group of steroids which are systemically administered. Example No. 12 is the CROSS-REFERENCE TO RELATED only example of a glucocorticoid-containing PEG-liposome APPLICATION in this patent and relates to the preparation of beclomethasone dipropionate-containing PEG-liposomes. However, no in This application is a continuation of PCT International Vivo data were provided. On preparing dexamethasone-con Patent Application No. PCT/EP01/14633 filed on Dec. 7, taining PEG-liposomes according to the disclosure in 2001, designating the United States of America, and pub EP-0662820 and on intravenous administration of the same in lished, in English, as PCT International Publication No. WO 10 an in vivo experimental arthritis model, the present inventors 02/45688A2 on Jun. 13, 2002, the contents of the entirety of noted that the beneficial effects, as taught in EP-0662820, which is incorporated by this reference. could not be observed at all. There was no difference in pharmacokinetic profile between a suspension containing the TECHNICAL FIELD glucocorticoid and the PEG-liposomes in which the same 15 glucocorticoid had been encapsulated. The invention relates generally to pharmaceutical compo Since glucocorticoids often are the most effective drugs in sitions, and more particularly to a pharmaceutical composi the treatment of inflammatory disorders, there is a need to tion for parenteral and intravenous administration, compris provide liposomal compositions which after parenteral ing liposomes composed of non-charged vesicle-forming administration can more efficiently deliver effective amounts lipids, including up to about 20 mole percent of an amphip of glucocorticoid at the inflamed region or tissue for enhanced athic vesicle-forming lipid derivatized with polyethylenegly and prolonged local activity. col (PEG) and optionally including not more than 10 mole percent of negatively charged vesicle-forming lipids, the lipo BRIEF SUMMARY OF THE INVENTION Somes having a selected mean particle diameter in the size range between about 40-200 nm and containing a corticos 25 The invention provides a pharmaceutical composition for teroid for the site-specific treatment of inflammatory disor parenteral administration, comprising liposomes composed ders. of non-charged vesicle-forming lipids, including up to 20 mole percent of an amphipathic vesicle-forming lipid deriva BACKGROUND OF THE INVENTION tized with polyethyleneglycol and optionally including not 30 more than 10 mole percent of negatively charged vesicle Intravenous administration of compositions based on forming lipids, the liposomes having a selected mean particle PEG-containing liposomes for the site-specific treatment of diameter in the size range between about 40-200 nm and inflamed tissues and regions is already disclosed in containing a water Soluble corticosteroid for the site-specific EP-0662820. It is well known that long-circulating small treatment of inflammatory disorders.
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