Patent SG-11201804961U-A (SG)
Title: Formulations with reduced degradation of polysorbate
Inventor: CONNOLLY BRIAN
IPC: A61K47/26
Filed: 2016-12-28
Abstract: INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (43) International Publication Date 6 July 2017 (06.07.2017) WIPO I PCT (10) International Publication Number WO 2017/117311 Al 11111111111111011101111111111101011111011101110101111101110111011111111111110111111 (51) International Patent Classification: A61K 47/40 (2006.01) A61K 9/08 (2006.01) A61K 47/26 (2006.01) A61K 39/395 (2006.01) (21) International Application Number: PCT/US2016/069046 (22) International Filing Date: 28 December 2016 (28.12.2016) (25) Filing Language: English (26) Publication Language: English (30) Priority Data: 62/272,965 30 December 2015 (30.12.2015) US (71) Applicant all designated States except AL, AT, BA, BE, BG, CH, CN, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IN, IS, IT, LT, LU, LV, MC, MK, NL, NO, PL, PT, RS, SE, SI, SK, SM, TR): GENENTECH, INC. [US/US]; 1 DNA Way, South San Francisco, CA 94080- 4990 (US). (71) Applicant (for AL, AT, BA, BE, BG, CH, CN, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IN, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR only): F. HOFFMANN-LA ROCHE AG [CH/CH]; Grenzacherstrasse 124, 4070 Basel (CH). (72) Inventors: CONNOLLY, Brian; c/o Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080 (US). HAM- BURG, Lydia; c/o Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080 (US). HOLZ, Emily; c/o Gen- entech, Inc., 1 DNA Way, South San Francisco, CA 94080 (US). (74) Agents: BASOL, Erol, C. et al.; Morrison & Foerster LLP, 755 Page Mill Road, Palo Alto, CA 94304-1018 (US). (81) Designated States (unless otherwise indicated, for every kind of national protection available): AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, IS, JP, KE, KG, KH, KN, KP, KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (84) Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, KM, ML, MR, NE, SN, TD, TG). Published: — with international search report (Art. 21(3)) W O 20 17117 / 3 11 Al (54) Title: FORMULATIONS WITH REDUCED DEGRADATION OF POLYSORBATE (57) : The invention provides methods for making such formulations and methods of using such formulations. The inven- tion further provides methods of reducing polysorbate degradation, methods of reducing the amount of visible and sub-visible particles in an aqueous formulation, and methods of disaggregating polysorbate degradation products comprising adding a cyclodex - trin to a formula comprising polysorbate and a polypeptide. The invention also provides aqueous formulations comprising a poly- peptide, a polysorbate, and a cyclodextrin with reduced polysorbate degradation.