Patent SG-11201806091Y-A (SG)
Title: Process of manufacturing a stable, ready to use infusion bag for an oxidation sensitive formulation
Inventor: HINGORANI TUSHAR
IPC: A61L2/07
Filed: 2017-01-23
Abstract: INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property -, Organization 111111110111101110101011111010111110111011111111110011101101111101111011111 International Bureau 0.. .... .. (10) International Publication Number (43) International Publication Date ..... .....!;,' WO 2017/134540 Al 10 August 2017(10.08.2017) WIPO I PCT (51) International Patent Classification: BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, A61J 1/10 (2006.01) A61L 2/07 (2006.01) DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, A61K 9/08 (2006.01) A61K 31/167 (2006.01) 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, (21) International Application Number: MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, PCT/IB2017/050341 NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, (22) International Filing Date: RU, RW, SA, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, 23 January 2017 (23.01.2017) TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (25) Filing Language: English (84) Designated States (unless otherwise indicated, for every (26) Publication Language: English kind of regional protection available): ARIPO (BW, GH, (30) Priority Data: GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, 62/291,589 5 February 2016 (05.02.2016) US TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, (71) Applicant: INNOPHARMA, INC. [US/US]; 235 East DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, 42nd Street, New York, New York 10017 (US). LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, S (72) Inventors: HINGORANI, Tushar; 84 Royal Drive, M, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, Apartment No. 321, Piscataway, New Jersey 08854 (US). GW, KM, ML, MR, NE, SN, TD, TG). KUNADHARAJU, Sasank Chaitanya; 32 Stony Road, Declarations under Rule 4.17: Edison, New Jersey 08817 (US). MALKAN, Tushar; 28 — as to the identity of the inventor (Rule 4.170) — Jeremy Drive, Dayton, New Jersey 08810 (US). PE- JAVER, Satish; 563 Glen Ridge Drive South, Bridgewa- — as to applicant's entitlement to apply for and be granted a ter, New Jersey 08807 (US). patent (Rule 4.17(ii)) — as to the applicant's entitlement to claim the priority of the = (74) Agent: WALDRON, Roy F.; Pfizer Inc., 235 East 42nd earlier application (Rule 4.17(iii)) Street, MS 235/9/S20, New York, New York 10017 (US). = (81) Designated States (unless otherwise indicated, for every Published: = kind of national protection available): AE, AG, AL, AM, — with international search report (Art. 21(3)) = AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, = = = = = = = = = 1-1 © 7r 11 in ii- en 1-1 (54) Title: PROCESS OF MANUFACTURING A STABLE, READY TO USE INFUSION BAG FOR AN OXIDATION SENSIT- IVE FORMULATION 1-1 C (57) : A process for minimizing formation of a highest degradation product during moist heat sterilization of a drug solu - ei tion of an oxidation susceptible active pharmaceutical ingredient (API) is provided, wherein the water is not deoxygenated and a ni - O trogen blanket is not used during formulation, or the formulation is stored in ambient conditions in the polymer bag and autoclaved. ,1 . The highest degradation product in the parenteral drug product is less than 0.1% by weight of a labeled amount of the oxidation sus - ceptible API in the parenteral drug product.