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United States Patent (10) Patent No.: US 9,554,989 B2 Kaplan Et Al

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United States Patent (10) Patent No.: US 9,554,989 B2 Kaplan Et Al USO09554989B2 (12) United States Patent (10) Patent No.: US 9,554,989 B2 Kaplan et al. (45) Date of Patent: *Jan. 31, 2017 (54) SILK RESERVOIRS FOR DRUG DELIVERY 3,773.919 A 11/1973 Boswell 4,806,355 A 2f1989 Goosen et al. (71) Applicant: RSTEES OF TUF is COLLEGE, 5,093,4895,015,476 A 3/19925/1991 CochrumDiamantoglou et al. edIOrd, (US) 5,263,992 A 11/1993 Guire 5,270,419 A 12, 1993 Domb (72) Inventors: David L. Kaplan, Concord, MA (US); 5,538,735 A 7, 1996 Ahn Tuna Yucel, Medford, MA (US); 5,576,881 A 11/1996 Doerr et al. Michael L. Lovett, Peabody, MA (US); 386 A 58. l al Xiaoqin Wang, Winchester, MA (US) 6,127,143- W4- A 10/2000 Gunasekarana 6,245,537 B1 6/2001 Williams et al. (73) Assignee: Trustees of Tufts College, Medford, 6,267,776 B1 7/2001 O'Connell MA (US) 6,302,848 B1 10/2001 Larson et al. 6,310,188 B1 10/2001 Mukherjee (*)c Notice:- r Subject to any site the still 6,337,1986,325,810 B1 12/20011/2002 LeveneHamilton et etal. al. patent 1s extended or adjusted under 6,372,244 B1 4/2002 Antanavich et al. U.S.C. 154(b) by 0 days. 6,379,690 B2 4/2002 Blanchard et al. 6,395,734 B1 5, 2002 Tang et al. This patent is Subject to a terminal dis- 7,842,780 B2 11/2010 Rii. et al. claimer. 8, 178,656 B2 5/2012 Kaplan et al. 8, 187.616 B2 5/2012 Wang et al. (21) Appl. No.: 14/386,545 2002/0028243 A1 3/2002 Masters 2003/OOOT991 A1 1/2003 Masters 1-1. 2007/0212730 A1 9/2007 Vepari et al. (22) PCT Filed: Mar. 11, 2013 2008/0085272 A1 4/2008 Kaplan et al. 2009, 0232963 A1 9/2009 Kaplan et al. (86). PCT No.: PCT/US2O13/O3O2O6 2009,0263430 A1 10, 2009 Scheibel et al. S 371 (c)(1), 2009,0263460 A1 10, 2009 McDonald (2) Date: Sep. 19, 2014 (Continued) (87) PCT Pub. No.: WO2013/142119 FOREIGN PATENT DOCUMENTS PCT Pub. Date: Sep. 26, 2013 WO WO-93.11161 A1 6, 1993 WO WO-2005/O12606 A2 2, 2005 (65) Prior Publication Data (Continued) US 2015/OO45764 A1 Feb. 12, 2015 OTHER PUBLICATIONS Related U.S. Application Data Acharya, C. et al., Performance evaluation of a silk protein-based (60) Provisional application No. 61/613,185, filed on Mar. matrix for the enzymatic conversion of tyrosine to -DOPA. 20, 2012. Biotechnol. J., 3:226-233 (2008). Bayraktar, O. et al., Silk fibroin as a novel coating material for (51) Int. Cl. controlled release of theophylline, European Journal of A6 IK 9/00 (2006.01) Pharmaceutics and Biopharmaceutics, 60:373-381 (2005). A 6LX 9/50 (2006.01) Beaucage, S. L. and Iyer, R. P. The Functionalization of Oligo A6 IK3I/00 (2006.01) nucleotides Via Phosphoramidite Derivatives, Tetrahedron Report No. 329, 49(10): 1925-1963 (1993). 3. t3. 3. Chothia, C. and Lesk, A. M., Canonical Structures for the ( .01) Hypervariable Regions of Immunoglobulins, J. Mol. Biol. 196:901 A6 IK3I/545 (2006.01) 917 (1987). (52) U.S. Cl. Demura, M and Asakura, T., Immobilization of Glucose Oxidase CPC ........... A61K 9/0024 (2013.01); A61K 9/0019 with Bombyx mori Silk Fibroin by Only Stretching Treatment and (2013.01); A61K 9/0092 (2013.01); A61 K Its Application to Glucose Sensor, 33 Biotech Bioengin., 33:598 9/4825 (2013.01); A61K 9/5052 (2013.01); (1989). A6 IK3I/00 (2013.01); A61K 31/13 (2013.01); (Continued) A61K 3.1/5415 (2013.01) (58) Field of Classification Search Primary Examiner — Robert A Wax CPC ... A61 K9/0024; A61K 9/0092: A61K 31/00; Assistant Examiner — Olga V Tcherkasskaya A61K 31/13; A61K 31/4196; A61 K (74) Attorney, Agent, or Firm — Brenda Herschbach 31/4402: A61K 3.1/5415: A61 K Jarrell; Brian E. Reese; Choate, Hall & Stewart LLP 47/42: A61 K9/0019; A61 K 9/70 See application file for complete search history. (57) ABSTRACT The present invention is directed to silk-based drug delivery (56) References Cited compositions for controlled, Sustained delivery of therapeu U.S. PATENT DOCUMENTS tic agent(s) as well as methods of making and using the SaC. 387,413 A 8, 1888 Griffin et al. 3,270,960 A 9/1966 Phillips 13 Claims, 7 Drawing Sheets US 9,554,989 B2 Page 2 (56) References Cited Jin, H. et al., Water-Stable Silk Films with Reduced B-Sheet Content, Adv, Funct. Mater. 15:1241-1247 (2005). U.S. PATENT DOCUMENTS Li, M. et al., Study on Porous Silk Fibroin Materials. II. Preparation and Characteristics of Spongy Porous Silk Fibroin Materials, J. 2010, 0028451 A1 2/2010 Kaplan et al. Applied Polymer Science, 79:2192-2199 (2001). 2010/0178304 A1 7/2010 Wang et al. Lovett, M. et al., Gel spinning of silk tubes for tissue engineering, 2010/027.9112 A1 11/2010 Kaplan et al. Biomaterials, 29(35):4650-4657 (2008). 2011 0171239 A1 7/2011 Kaplan et al. Lu, S. et al., Stabilization of Enzymes in Silk Films, 2012/0052124 A1 3/2012 Kaplan et al. 2012,0070427 A1 3/2012 Kaplan et al. Biomacromolecules 10:1032-1042 (2009). 2012/OO76771 A1* 3/2012 Vepari ................... A61L 31,005 Lucas, F. et al., The Silk Fibroins, Adv. Protein Chem., 13:107-242 424,130.1 (1958). 2012/O187591 A1 7/2012 Wang et al. Meier, C. and Engels, J. W., Peptide Nucleic Acids (PNAS)— 2013,0210726 A1 8, 2013 Franklin Unusual Properties of Nonionic Oligonucleotide Analogues, 2014/0378661 A1* 12/2014 LO ............................. DO1F1F10 Angew. Chem. Int. Ed. Engl. 31(8): 1008-1010 (1992). 530.353 Min, S. et al., Preparation and Characterization of Crosslinked 2015/0202351 A1* 7/2015 Kaplan ................ A61B 5,0478 Porous Silk Fibroin Gel, Transaction, 54(2):85-92 (1998). 607,116 Miyairi, S. and Sugiura, M., Properties of B-Glucosidase Immobi lized in Sericin Membrane, J. Germent. Technol. 56(4):303-308 FOREIGN PATENT DOCUMENTS (1978). Nazarov, R. et al., Porous 3-D Scaffolds from Regenerated Silk WO WO-2006/076711 A2 T 2006 Fibroin, Biomacromolecules 5:718-726 (2004). WO WO-2008, 150861 A1 12/2008 Pritchard, E. M. et al., Silk Fibroin Encapsulated Powder Reservoirs WO WO-2009/023615 A1 2, 2009 for Sustained Release of Adenosine, J. Control Release, 144(2): 159 WO WO-2009.126689 A2 10, 2009 167 (2010). WO WO-2010/057142 A2 5, 2010 Pritchard, E.M. and Kaplan, D.L., Silk fibroin biomaterials for WO WO-2011/005381 A2 1, 2011 controlled release drug delivery, Expert Opinion on Drug Delivery, WO WO-2011/006133 A2 1, 2011 WO WO-2011/011347 A2 1, 2011 8(6):797-811 (2011). WO WO-2011 (109691 A2 9, 2011 Rosenberg, M. et al., Eds. The Pharmacology of Monoclonal WO WO-2012/145739 A1 10, 2012 Antibodies, Springer-Verlag Berlin Heidelberg, Chapter 11 (1994). Schaffner, P. and Dard, M. M., Structure and function of RGD peptides involved in bone biology, Cell. Mol. Life Sci., 60:119-132 OTHER PUBLICATIONS (2003). Eckstein, Fritz, Oligonucleotides and Analogues: A Practical Steller, K. E. and Letsinger, R. L., Effects of Distant Substituents on Approach, Oxford University Press, 26 pages (1991). Photoinduced Aromatic Substitution Reactions, The Journal of Egholm, M. et al., Peptide Nucleic Acids (PNA). Oligonucleotide Organic Chemistry, 35(2):308-313 (1970). Analogues with an Achiral Peptide Backbone, J. Am. Chem. Soc. Takahashi, K. et al., Induction of Pluripotent StemCells form Adult 114: 1895-1897 (1992). Human Fibroblasts by Defined Factors, Cell 131:861-872 (2007). Egholm, M. et al., PNA hybridizes to complementary oligonucle Urquhart, J. et al., Rate-Controlled Delivery Systems in Drug and otides obeying the Watson-Crick hydrogen-bonding rules, Nature, Hormone Research, Ann. Re. Pharmacol. Toxicol. 24: 199-236 365:566-568 (1993). (1984). Elgin, Y. M. et al., Controlled Release of Endothelial Cell Growth Yu, J. et al., Induced Pluripotent Stem Cell Lines Derived from Factor form Chitosan-Albumin Microspheres for Localized Human Somatic Cells, Science 3 18:1917-1920 (2007). Angiogenesis: In Vitro and InVivo Studies, Art. Cells, Blood Subs. Zapata, G. et al., Engineering linear F(ab')2 fragments for efficient and Immob. Biotech., 24(3):257-271 (1996). production in Escherichia coli and enhanced antiproliferative activ Heath, Carole A. Cells for tissue engineering, TIBTECH 18:17-19 ity, Protein Engineering, 8(10): 1057-1062 (1995). (2000). Zarkoob, S., Structure and Morphology of Regenerated Silk Nano Hersel, U. et al., RGD modified polymers: biomaterials for stimu Fibers Produced by Electrospinning, Dissertation, UMI Microform lated cell adhesion and beyond, Biomaterials 24:4385-4415 (2003). 9842114, 121 pages (1998). Hoffman, S. et al., Silk fibroin as an organic polymer of controlled Extended European Search Report for EP 13764579.2, 6 pages drug delivery, Journal of Controlled Release, 111:219-227 (2006). (Aug. 18, 2015). Hollinger, P. et al., Diabodies: Small bivalent and bispecific anti International Search Report for PCT/US2013/030206, 4 pages (Jun. body fragments, Proc. Natl. Acad. Sci., 90:6444-6448 (1993). 21, 2013). Hu, X. et al., Regulation of Silk Material Structure by Temperature International Search Report for PCT/US2013/033171, 4 pages Controlled Water Vapor Annealing, Biomacromolecules 12:1686 (Nov. 27, 2013). 1696 (2011). Wang, X. et al., Silk microspheres for encapsulation and controlled International Preliminary Report on Patentability with Opinion, release, Journal of Controlled Release, 117(3):360-370 (2007). International Application No. PCT/US2013/030206, 9 pages (Oct. Written Opinion for PCT/US2013/030206, 7 pages (Jun.
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