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(12) United States Patent (10) Patent No.: US 9.226,996 B2 Moro Et Al

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(12) United States Patent (10) Patent No.: US 9.226,996 B2 Moro Et Al USOO922.6996B2 (12) United States Patent (10) Patent No.: US 9.226,996 B2 Moro et al. (45) Date of Patent: Jan. 5, 2016 (54) EMULSIONS OR MICROEMULSIONS FOR FOREIGN PATENT DOCUMENTS USE IN ENDOSCOPCMUCOSAL f EP 2494.957 A1 9, 2012 WO OO,78301 A1 12/2000 WO 2009,070793 A1 6, 2009 (71) Applicant: COSMO TECHNOLOGIES LTD., WO 2011, 103245 A1 8, 2011 Dublin (IE) OTHER PUBLICATIONS (72) Inventors: ongo,s Moro, Lainate Lainate (IT); Enrico(IT): Luigi Frimonti, Maria Polymeros, D. et al., “Comparative Performance of Novel Solutions Lainate (IT); Alessandro Repici, Turin for Submucosal Injection in Porcine Stomachs: An Ex Vivo Study.” (IT) s s Digestive and Liver Disease, 2010, vol. 42, pp. 226-229. Jeppsson, R. et al., “The Influence of Emulsifying Agents and of (73) Assignee: COSMO TECHNOLOGIES LTD., Lipid Soluable Drugs on the Fractional Removal Rate of Lipid Emul Dublin (IE) sions from the Blood Stream of the Rabbit.” Acta Pharmacol. et Toxicol., 1975, vol. 37, 134-144. (*) Notice: Subject to any disclaimer, the term of this Fernandez-Esparrach, G. et al., Efficacy of a Reverse-Phase Poly atent is extended or adjusted under 35 mer as a Submucosal Injection Solution for EMR: A Comparative p Study (with video).” Gastrointestinal Endoscopy, 2009, vol. 69, No. U.S.C. 154(b) by 0 days. 6, pp. 1135-1139 Uraoka, T. et al., “Submucosal Injection Solution for Gastrointestinal (21) Appl. No.: 14/546,925 Tract Endoscopic Mucosal Resection and Endoscopic Submucosal (22) Filed: Nov. 18, 2014 Dissection.” Drug Design, Development and Therapy, 2008, vol. 2, e - V.9 pp. 131-138. O O Eun, S.H. et al., “Effectiveness of Sodium Alginate as a Submucosal (65) Prior Publication Data Injection Material for Endoscopic Mucosal Resection in Animal.” US 2015/O141526A1 May 21, 2015 Gut and Liver, vol. 1, No. 1, 2007, pp. 27-32. Escobar-Chavez, J.J. et al., “Applications of Thermo-Reversible (30) Foreign Application Priority Data Pluronic F-127 Gels in Pharmaceutical Formulations.' J. Pharm Pharmaceutic Sci (www.cspsCanada.org), 2006, vol. 9, No. 3, pp. Nov. 20, 2013 (IT) .............................. MI2O13A1924 339-358. Yapar, E.A. et al., “Poly(ethylene oxide)-Poly(propylene oxide)- (51) Int. Cl. Based Copolymers for Transdermal Drug Delivery: An Overview.” A6 IK 47/00 (2006.01) Tropical Journal of Pharmaceutical Research, 2012, vol. 11, No. 5, A6IL3/14 (2006.01) pp. 855-866. A6 IK 49/00 (2006.01) Eccleston, G.M., "Emulsions and Microemulsions.” Encyclopedia of A6IL 24/00 (2006.01) Pharmaceutical Technology, pp. 1548-1565, copyright 2007 by A6IL 24/04 2006.O1 Informa Healthcare USA, Inc. A6 IK9/00 30 6 8: Italian Search Report and Written Opinion, Applicant: Cosmo Tech A 6LX 9/07 (2006.015 nologies Limited, Application No. ITMI20131924, dated Jul. 24. 2014, 11 pages. A6 IK 47/10 (2006.01) Mayo Clinic, Clinical Update, Current Trends in the Practice of 3C7 3:08: Medicine, 2011, vol. 27. No. 6, 2 pages. (52) U.S. Cl. * cited by examiner CPC ............... A61L 31/14 (2013.01); A61 K9/0019 (2013.01); A61 K9/107 (2013.01); A61 K Primary Examiner — Rei-Tsang Shiao 9/1075 (2013.01); A61K 47/10 (2013.01); (74) Attorney, Agent, or Firm — Rothwell, Figg, Ernst & A61K 47/22 (2013.01); A61K 49/006 Manbeck PC (2013.01); A61L 24/001 (2013.01); A61L - Y - 24/046 (2013.01); A61L 31/06 (2013.01); A61 L (57) ABSTRACT 2300/442 (2013.01); A61L 2400/06 (2013.01) (58) Field of Classification Search The present invention relates tO a pharmaceutical compos1 USPC .......................................................... 514f784 tion inform of emulsion or microemulsion and the use thereof See application file for complete search history. as aid during endoscopic procedures in which it is injected in a target tissue in order to form a cushion. More in details, the (56) References Cited invention relates to a method for performing an endoscopic procedure, which comprises injecting said pharmaceutical U.S. PATENT DOCUMENTS composition inform of emulsion or microemulsion in a target tissue of a patient, in order to form a cushion, which cushion 3,740,421 A * 6/1973 Schmolka ....................... 424,65 7,909,809 B2 3/2011 Scopton et al. is then optionally subjected to an endoscopic Surgical proce 8,282,621 B2 10/2012 Scopton et al. dure, such as a resection. 8,864,738 B2 10/2014 Scopton et al. 2011/0052490 A1* 3/2011 Vogel ........................... 424,165 14 Claims, 16 Drawing Sheets U.S. Patent Jan. 5, 2016 Sheet 1 of 16 US 9.226,996 B2 U.S. Patent Jan. 5, 2016 Sheet 2 of 16 US 9.226,996 B2 FIGURE 2 U.S. Patent Jan. 5, 2016 Sheet 3 of 16 US 9.226,996 B2 GUR E. U.S. Patent Jan. 5, 2016 Sheet 4 of 16 US 9.226,996 B2 FIGURE 4 U.S. Patent Jan. 5, 2016 Sheet 5 of 16 US 9.226,996 B2 FIGURE 5 U.S. Patent Jan. 5, 2016 Sheet 6 of 16 US 9.226,996 B2 FIGURE 6 U.S. Patent Jan. 5, 2016 Sheet 7 of 16 US 9.226,996 B2 FIGURE 7 U.S. Patent Jan. 5, 2016 Sheet 8 of 16 US 9.226,996 B2 FIGURE 8 Size Distribution by intensity Size (d.nm) U.S. Patent Jan. 5, 2016 Sheet 9 of 16 US 9.226,996 B2 FIGURE 9 Size Distribution by intensity Size (d.nm) U.S. Patent Jan. 5, 2016 Sheet 10 of 16 US 9.226,996 B2 FT GUR F. 1 O Size Distribution by intensity 2OsO 5 O. O OO OOO OOOO Size (d.nm) U.S. Patent Jan. 5, 2016 Sheet 11 of 16 US 9.226,996 B2 FIGURE 11 Size Distribution by intensity O. O OO OOO OOOO Size (d.nm) U.S. Patent Jan. 5, 2016 Sheet 12 of 16 US 9.226,996 B2 FIGUR E 12 U.S. Patent Jan. 5, 2016 Sheet 13 of 16 US 9.226,996 B2 GUR Hi 13 U.S. Patent Jan. 5, 2016 Sheet 14 of 16 US 9.226,996 B2 GUR 14 U.S. Patent Jan. 5, 2016 Sheet 15 of 16 US 9.226,996 B2 GUR Hi 15 U.S. Patent Jan. 5, 2016 Sheet 16 of 16 US 9.226,996 B2 IGURE 16 Viscosity vs Temperature 0.0070 0.0065 0.0060 i 0.0055 0.0050 0.0045 0.0040 T (c) US 9,226,996 B2 1. 2 EMULSIONS OR MICROEMULSIONS FOR logic lesions (polyps, adenomas, dysplasias, Barrett's dyspla USE IN ENDOSCOPCMUCOSAL sia, pre-neoplastic and neoplastic formations, tumors). Sur RESECTIONING AND/ORENDOSCOPIC gical interventions include two endoscopic resection SUBMUCOSAL DISSECTION procedures commonly used in gastrointestinal endoscopy to remove pathological lesions: endoscopic mucosal resection FIELD OF THE INVENTION (EMR) and endoscopic submucosal dissection (ESD). These two techniques have provided new alternatives for minimally The present invention relates to a pharmaceutical compo invasive treatment of gastrointestinal polyps, adenomas, dys sition in form of emulsion or microemulsion and the use plasias, Barrett's dysplasia and early-stage cancers that thereof as aid during endoscopic procedures in which it is 10 involve a minimum risk of lymph-node metastasis. EMR is an injected in a target tissue in order to form a cushion. More in endoscopic technique developed for removal of sessile or flat details, the invention relates to a method for performing an neoplasms confined to the Superficial layers (mucosa and endoscopic procedure, which comprises injecting said phar submucosa) of the GI tract. EMR is typically used for removal maceutical composition in form of emulsion or microemul of lesions Smaller than 2 cm or piecemeal removal of larger sion in a target tissue of a patient, in order to form a cushion, 15 lesions. EMR also plays an important role in the assessment which cushion is then optionally subjected to an endoscopic of resected specimens for accurate pathological staging. In Surgical procedure. Such as a resection. contrast to polypectomy, EMR involves the lifting up of a lesion from the muscular layer by injecting a fluid agent, BACKGROUND OF THE INVENTION commonly normal saline (NS) solution, into the Submucosal layer. EMR is also useful for obtaining specimens for accu Endoscopy is a diagnostic and medical procedure which rate histopathological staging to determine the risk of lymph allows to examine the interior of a hollow organ or cavity of node metastasis. EMR facilitates the complete removal of the the body by means of an instrument called endoscope, with affected mucosa by excising through the middle or deeper out employing invasive Surgery. Endoscopy is commonly portion of the gut wall submucosa. Various EMR techniques used for diagnostic purposes, even though minor, non-inva 25 have been described and four methods involving snare resec sive Surgical and non-Surgical interventions can be performed tion are commonly used: (1) the inject and cut method; (2) the during an endoscopic procedure. Typically, said minor inter inject, lift, and cut method; (3) cap-assisted EMR (EMRC); ventions comprise cauterization of a bleeding vessel, widen and (4) EMR with ligation (EMRL). The inject and cut tech ing a narrow esophagus, removing polyps, adenomas and nique, also known as Submucosal injection polypectomy, has Small tumors, performing biopsies or removing a foreign 30 become widely used in recent years because of its simplicity. object. Endoscopy is used by specialists to examine, for The diseased mucosa is lifted up from the muscular layer by example, the gastrointestinal tract, the respiratory tract, the creating a submucosal fluid cushion, captured, strangulated ear, the urinary tract, the female reproductive system and, using an electroSurgical Snare, and then resected.
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