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1. (WO2018158716) NOVEL PROTEIN DRUG CONJUGATE FORMULATION
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Pub. No.: WO/2018/158716 International Application No.: PCT/IB2018/051302
Publication Date: 07.09.2018 International Filing Date: 01.03.2018
Chapter 2 Demand Filed: 30.07.2018
IPC:
A61K 39/395 (2006.01) ,A61K 47/68 (2017.01)
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
39
Medicinal preparations containing antigens or antibodies
395
Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
[IPC code unknown for A61K 47/68]
Applicants:
CADILA HEALTHCARE LIMITED [IN/IN]; Zydus Tower, Satellite Cross Roads Ahmedabad, Gujarat 380015, IN
Inventors:
MENDIRATTA, Sanjeev Kumar; IN
BANDYOPADHYAY, Sanjay; IN
SINGH, Avanish Kumar; IN
PATEL, Chintan; IN
Agent:
KULSHRESHTHA, Garima; IN
GANDHI, Ritu; IN
BHASIN, Gayatri; IN
KAPOOR, Divya; IN
MAHLA, Aaysu; IN
VENKITACHALAM, Manoj; IN
Priority Data:
20172100736802.03.2017IN
Title (EN) NOVEL PROTEIN DRUG CONJUGATE FORMULATION
(FR) NOUVELLE FORMULATION DE CONJUGUÉ PROTÉINE-MÉDICAMENT
Abstract:
(EN) Novel protein drug conjugate formulation The invention provides stable pharmaceutical formulation comprising a protein drug conjugate along with one or more suitable excipient(s) such that the formulation is devoid of any buffer components and methods of making the same. The protein drug conjugate according to the present invention is antibody drug conjugate, preferably trastuzumab maytansinoid conjugate. Suitable excipient(s) according to the present invention is selected from suitable bulking agents, suitable tonicity modifiers, suitable stabilizers and the like.
(FR) L'invention concerne une nouvelle formulation de conjugué protéine-médicament qui produit une formulation pharmaceutique stable comprenant un conjugué protéine-médicament conjointement avec un ou plusieurs excipients appropriés, de telle sorte que la formulation est exempte de composants tampons quelconques, ainsi que des procédés de fabrication de celle-ci. Le conjugué protéine-médicament selon la présente invention est un conjugué anticorps-médicament, de préférence un conjugué de trastuzumab-maytansinoïdes. Un ou plusieurs excipients appropriés selon la présente invention sont choisis parmi des diluants appropriés, des modificateurs de tonicité appropriés, des stabilisants appropriés et analogues.
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Designated States: 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, JO, 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
African Regional Intellectual Property Organization (ARIPO) (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ, UG, ZM, ZW)
Eurasian Patent Office (AM, AZ, BY, KG, KZ, RU, TJ, TM)
European Patent Office (EPO) (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)
African Intellectual Property Organization (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, KM, ML, MR, NE, SN, TD, TG)
Publication Language: English (EN)
Filing Language: English (EN)