Patent SG-11201903521X-A (SG)
Title: Pharmaceutical formulations and methods of making the same
Inventor: GOSS MONICA
IPC: A61K47/42
Filed: 2017-10-19
Abstract: INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property 1#11101111 0 11101 HOE 3E1 0 011101 1111011 Mil OFR 11110 1111 OEN Organization International Bureau (10) International Publication Number (43) International Publication Date ......0\"\" WO 2018/075818 Al 26 April 2018 (26.04.2018) WIP0 I PCT (51) International Patent A61K 9/08 (2006.01) A61K 31/70 (2006.01) A61K 47/42 (2017.01) (21) International Application (22) International Filing Date: (25) Filing Language: (26) Publication Language: (30) Priority Data: 62/411,458 (71) Applicant: AMGEN Drive, Thousand Oaks, California 91320-1799 (US). (72) Inventors: GOSS, bury Park, California _ Heatherglow Street, Classification: DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, A61P 29/00 (2006.01) HR, HU, ID, IL, IN, IR, IS, JO, JP, KE, KG, KH, KN, KP, CO7K 1/34 (2006.01) KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, C07K 14/705 (2006.01) MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, Number: OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, PCT/US2017/057472 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 19 October 2017 (19.10.2017) kind of regional protection available): ARIPO (BW, GH, English GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ, English 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, 21 October 2016 (21.10.2016) US 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, INC. [US/US]; One Amgen Center KM, ML, MR, NE, SN, TD, TG). Monica; 3050 Lodgewood Street, New- Declarations under Rule 4.17: 91320 (US). BALL, Nicole; 3260 — as to applicant's entitlement to apply for and be granted a Thousand Oaks, California 91360 patent (Rule 4.1700) Published: Karoline A.; Knobbe, Martens, 01- — with international search report (Art. 21(3)) Main Street, 14th Floor, Irvine, CA — with sequence listing part of description (Rule 5.2(a)) (unless otherwise indicated, for every available): AE, AG, AL, AM, BB, BG, BH, BN, BR, BW, BY, BZ, CR, CU, CZ, DE, DJ, DK, DM, DO, (US). = (74) Agent: DELANEY, = son & Bear, LLP, 2040 92614 (US). = (81) Designated States kind of national protection __ AO, AT, AU, AZ, BA, _ — CA, CH, CL, CN, CO, = = Figure 1: Percent HMW (peak B) as detected by SEC 25 20 15 to 41 O. 10 FORMULATIONS AND METHODS OF MAKING THE SAME Percent Peak B by SEC —i—PASST 4°C also relates to (54) Title: PHARMACEUTICAL = = = = = --M—SAST_100NaCI 4°C • 40°C —A— SAST_120NaCI 4 ° C = co • • 5 : • —41— PASST 25 ° C Z: .:A . — M — SAST_100NaCI 25°C ,, It SAST_120NaCI 25°C • ••• • PASST 40°C :.. • • g• • SAST_100NaCI 40°C • .:: • • •A• • SAST_120NaCI 40 ° C I ,.. .. 25°C d - -a-- 41 - ''' e. - r • 4 ° C • • • = _ = .... _ PSI GC 1-1 pc Ir) IN © ---.... Il © ei (57) : The invention 0 5 methods of removing buffer and of formulating pharmaceutical compositions of etanercept. 0 , 0 10 20 30 40 50 Time (weeks) relates to the formulation of pharmaceutical compositions of etanercept. The invention