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United States Patent (10) Patent N0.: US 6,803,046 B2 Metcalfe Et Al

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United States Patent (10) Patent N0.: US 6,803,046 B2 Metcalfe Et Al US006803046B2 (12) United States Patent (10) Patent N0.: US 6,803,046 B2 Metcalfe et al. (45) Date of Patent: Oct. 12, 2004 (54) SINCALIDE FORMULATIONS OTHER PUBLICATIONS (75) Inventors: Edmund C. Metcalfe, Hillsborough, NJ SitZmann, et al., “Cholecystokinin Prevents Parenteral (US); J 0 Anna Monteferrante, Raritan Nutrition Induced Biliary Sludge in Humans,” Surgery, Township, NJ (US); Margaret Gynecology & Obstetrics, vol. 170, Jan. 1990, pp. 25—31. Newborn, Hamilton Township, NJ Teitelbaum et al., “Treatment of Parenteral Nutrition—Asso (US); Irene Ropiak, Lawrenceville, NJ ciated Cholestasis with Cholecystokinin—Octapeptide,” (US); Ernst Schramm, North Journal of Pediatric Surgery, vol. 30, No. 7, Jul. 1995, pp. Brunswick, NJ (US); Gregory W. 1082—1085. White, Monmouth Junction, NJ (US); Moss and Amii, “New Approaches to Understanding the Julius P. Zodda, Mercerville, NJ (US) Etiology and Treatment of Total Parenteral Nutrition—Asso ciated Cholestasis,” Seminars in Pediatric Surgery, vol. 8, (73) Assignee: Bracco International B.V., Amsterdam No. 3, Aug. 1999, pp. 140—147. (NL) Teitelbaum, “Parenteral Nutrition—Associated Cholestasis,” Current Opinion in Pediatrics, vol. 9, 1997, pp. 270—275. (*) Notice: Subject to any disclaimer, the term of this Teitelbaum and Tracy, “Parenteral Nutrition—Associated patent is extended or adjusted under 35 Cholestasis,” Seminars in Pediatric Surgery, vol. 10, No. 2, U.S.C. 154(b) by 0 days. May 2001, pp. 72—80. Strickley, “Parenteral Formulations of Small Molecules (21) Appl. No.: 10/222,540 Therapeutics Marketed in the United States (1999) —Part Filed: Aug. 16, 2002 1,” PDA Journal of Pharmaceutical Science & Technology, (22) vol. 53, No. 6, Nov.—Dec. 1999, pp. 324—349. (65) Prior Publication Data Strickley, “Parenteral Formulations of Small Molecules US 2004/0033243 A1 Feb. 19, 2004 Therapeutics Marketed in the United States (1999)—Part II,” PDA Journal of Pharmaceutical Science & Technology, vol. 54, No. 1, Jan.—Feb. 2000, pp. 69—96. (51) Int. Cl.7 ................................................ .. A61K 9/00 (List continued on next page.) (52) U.S. Cl. ...................... .. 424/400; 514/1.65; 514/18; 514/19; 514/951 Primary Examiner—Thurman K. Page (58) Field of Search .......................... .. 424/400; 514/18, Assistant Examiner—Konata M. George 514/19, 1.65, 951 (74) Attorney, Agent, or Firm—Kramer, Levin, Naftalis & Frankel LLP (56) References Cited (57) ABSTRACT U.S. PATENT DOCUMENTS The invention features sincalide formulations that include an 3,723,406 A 3/1973 Ondetti et al. ......... .. 260/1125 effective amount of sincalide, a bulking agent/tonicity 5,011,678 A * 4/1991 Wang et al. ..... .. 424/45 adjuster, a stabilizer, a surfactant, a chelator, and a buffer. 5,555,610 A 9/1996 Yan et a1. ......... .. 424/952 The invention also features kits and methods for preparing 5,567,414 A 10/1996 Schneider et a1. ....... .. 424/9.52 improved sincalide formulations, as well as methods for 5,833,948 A 11/1998 Tournier et al. ....... .. 424/9.321 treating, preventing, and diagnosing gall bladder-related 6,110,443 A 8/2000 Schneider et al. ....... .. 424/9.51 disorders using sincalide formulations. 6,306,905 B1 10/2001 KurZ et al. .. 514/551 6,326,406 B1 12/2001 De Tommaso . .. 514/731 6,358,528 B1 3/2002 Grimmett et a1. ......... .. 424/474 108 Claims, 12 Drawing Sheets Met 3 o o o E 0 II II : ll 5 II II H2N'—CH——C—N—CH—C| H | i, H —CH—C—}-N—CH—C—N—CH—C| :H l H | IIJHZ (3H2 : (|:H2 ; H CH2 0:0 5 CH2 I l i | : \ OH : S : i | i NH 1 CH: : US 6,803,046 B2 Page 2 OTHER PUBLICATIONS MesgarZadeh et al., “Filling, Postcholecystokinin Emptying, and Re?lling of Normal Gallbladder: Effects of TWo Dif Strickley, “Parenteral Formulations of Small Molecules ferent Doses of CCK on Re?lling: Concise Communica Therapeutics Marketed in the United States (1999)—Part tion,” Journal of Nuclear Medicine, vol. 24, No. 8, 1983, pp. III,” PDA Journal of Pharmaceutical Science & Technology, 666—671. vol. 54, No. 2, Mar.—Apr. 2000, pp. 152—169. Nema et al., “Excipients and Their Use in Injectable Prod Krishnamurthy et al., “The Gallbladder Emptying Response ucts,” PDA Journal of Pharmaceutical Science & Technol to Sequential Exogenous and Endogenous Cholecystoki ogy, vol. 51, No. 4, Jul.—Aug. 1997, pp. 166—171. nin,” Nuclear Medicine Communications, vol. 5, 1984, pp. Wang and Hanson “Parenteral Formulations of Proteins and 27—33. Peptides: Stability and Stabilizers, ” Journal of Parenteral Krishnamurthy et al., “Detection, LocaliZation, and Quan Science & Technology, vol. 42, Supplement 1988, pp. titation of Degree of Common Bile Duct Obstruction by S3—S25. Carpenter et al., “FreeZing—and Drying—Induced Perturba Scintigraphy,” Journal of Nuclear Medicine, vol. 26, No. 7, tions of Protein Structure and Mechanisms of Protein Pro Jul. 1985, pp. 726—735. tection by Stabilizing Addditives,” Drugs and the Pharma Fink—Bennett et al., “Cholecystokinin Cholescintigraphic ceutical Sciences, vol. 96, 1999, pp. 123—160. Findings in the Cystic Duct Syndrome,” Journal of Nuclear Pikal, “Mechanisms of Protein StabiliZation During FreeZ Medicine, vol. 26, No. 10, Oct. 1985, pp. 1123—1128. e—Drying and Storage: The Relative Importance of Thermo dynamic StabiliZation and Glassy State Relaxation Dynam Fink—Bennett, “The Role of Cholecystogogues in the Evalu ics,” Drugs and the Pharmaceutical Sciences, vol. 96, 1999, ation of Biliary Tract Disorders,” Nuclear Medicine Annual pp. 161—197. 1985 , Lenny Freeman and Heidi Weissman, eds., NeW York, Shah et al., “The Effects of Various Excipients on the Raven Press, 1985, pp. 107—132. Unfolding of Basic Fibroblast GroWth Factor,” PDAJournal NeWman et al., “A Simple Technique for Quantitative of Pharmaceutical Science & Technology, vol. 52, No. 5, Cholecystokinin—HIDA Scanning,” The British Journal of Sep.—Oct. 1998, pp. 209—214. Radiology, vol. 56, Jul. 1983, pp. 500—502. PoWell et al., “Compendium of Excipients for Parenteral Formulations,” PDA Journal of Pharmaceutical Science & Pickleman et al., “The Role of Sincalide Cholescintigraphy Technology, vol. 52, No. 5, Sep.—Oct. 1998, pp. 238—311. in the Evaluation of Patients With Acalculus Gallbaldder Zeissman, “Cholecystokinin Cholescintigraphy: Victim of Disease,” Archives of Surgery, vol. 120, Jun. 1985, pp. Its OWn Success?” Journal of Nuclear Medicine, vol. 40, 693—697. No. 12, Dec. 1999, pp. 2038—2042. Zeissman et al., “Calculation of a Gallbaldder Ejection Krishnamurthy and Krishnamurthy, “Gallbladder Ejection Fraction: Advantage of Continuous Sincalide Infusion Over Fraction: A Decade of Progress and Future Promise,” Jour the Three—Minute Infusion Method,” Journal of Nuclear nal of Nuclear Medicine, vol. 32, No. 4, Apr. 1992, pp. Medicine, vol. 33, No. 4, Apr. 1992, pp. 537—541. 542—544. Krishnamurthy et al., “Quantitative Biliary Dynamics: Intro Balon et al., Society of Nuclear Medicine Procedure Guide duction of a NeW Noninvasive Scintigraphic Technique,” line for Hepatobiliary Scintigraphy. Journal of Nuclear Medicine, vol. 24, No. 3, 1983, pp. 217—223. * cited by examiner U.S. Patent 0a. 12, 2004 Sheet 5 0f 12 US 6,803,046 B2 1 O 0 3%5200mmmEEoEwwmm6>< 2 4 H 0 U r S 987645 O0 2.0 2.5 3.0 3.5 4.0 4.5 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 9.0 9.5100 ___________._____________-______ pH FIG. 5 U.S. Patent 0a. 12, 2004 Sheet 6 6f 12 US 6,803,046 B2 100 ~ - 0 Hours 90-: 3%5200mmmEEoEwmmm6>< 8765 O0 _ 40 2.0 2.5 3.0 3.5 4.0 4.5 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 9.0 9.5100 pH FIG. 6 U.S. Patent 0a. 12, 2004 Sheet 7 0f 12 US 6,803,046 B2 85.5 128.9 1 0 362E;w#25$325855..\_. @ With 1mM DTPA El Without DTPA Aa_Vi2 § g 9876543210 Cr Cu Fe Pb M9 Mn Ni Zn FIG. 7 U.S. Patent 0a. 12, 2004 Sheet 8 0f 12 US 6,803,046 B2 mAu' 40< 35 30 wgxaswoée8Es:3,526+?‘If, 25 20* 15 M0385855AmHos:wgmugméi\ 10 Q _ d 52 mm Chromatogram of Kinevac Experimental Formulation (no DTPA) Spiked with 0.63 mM (:02+ FIG. 8 U.S. Patent 0a. 12, 2004 Sheet 9 0f 12 US 6,803,046 B2 DAD1 A, Sig=215,5 Ref=345.5 (0810MD11\O81OMD17 D) mAu" 4o 35 30 25* 20A QQXQESEE6as:$25.25.”? 15* K0258.33 1o 5 Chromatogram of Kinevac Experimental Formulation (1 mM DTPA) Spiked with 0.63 mM cu2+ FIG. 9 U.S. Patent 0a. 12, 2004 Sheet 10 0f 12 US 6,803,046 B2 Chromatogram of Kinevac Experimental Formulation (no DTPA) Spiked with 0.18 mM Mn2+ FIG. 10 U.S. Patent 0a. 12, 2004 Sheet 12 0f 12 US 6,803,046 B2 mAU I E "PU Y 10 7‘ 175 I ~ Sincalide (D2 = 29 min.) Sincalide (tR : 29 min‘) 15) 1: 6 m \ \ 75 . Er \ m l ‘\ Desulfated Sincalide 2' \ ‘ “R = 33 min.) ‘ H 4* 1 | 3, 2.. l 1 I 1 ‘ ‘ [ o 5 10 15 2O 25 3o 35 min Typical Full-Scale and Expanded-Scale Chromatograms of Reconstituted Kinevac FIG. 12 US 6,803,046 B2 1 2 SINCALIDE FORMULATIONS In various embodiments of the invention, the surfactant is a nonionic surfactant, preferably a polysorbate, such as polysorbate 20 or polysorbate 80; the chelator is pentetic FIELD OF THE INVENTION acid (DTPA); and the stabiliZer is an antioxidant and/or The invention relates to pharmaceutically acceptable for amino acid. In a particularly desirable embodiment of the invention, the formulation includes a plurality of stabiliZers, mulations of sincalide. preferably L-arginine monohydrochloride, L-methionine, BACKGROUND OF THE INVENTION L-lysine monohydrochloride, and sodium metabisul?te. Suitable bulking agents/tonicity adjusters include, but are KINEVAC® (Sincalide for Injection, USP) is a 10 not limited to, mannitol, lactose, sodium chloride, maltose, cholecystopancreatic-gastrointestinal hormone peptide for sucrose, PEG’s, cyclodextrins, dextran, polysucrose parenteral administration.
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