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1. (WO2018162503) LIQUID PHARMACEUTICAL COMPOSITION
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Pub. No.: WO/2018/162503 International Application No.: PCT/EP2018/055509
Publication Date: 13.09.2018 International Filing Date: 06.03.2018
IPC:
A61K 39/395 (2006.01) ,A61K 47/18 (2017.01) ,A61K 47/26 (2006.01) ,A61K 9/08 (2006.01)
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
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47
Medicinal preparations characterised by the non-active ingredients used, e.g. carriers, inert additives
06
Organic compounds
16
containing nitrogen
18
Amines; Quaternary ammonium compounds
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47
Medicinal preparations characterised by the non-active ingredients used, e.g. carriers, inert additives
06
Organic compounds
26
Carbohydrates
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9
Medicinal preparations characterised by special physical form
08
Solutions
Applicants:
ARES TRADING S.A. [CH/CH]; Zone Industrielle de L'Ouriettaz 1170 Aubonne, CH
Inventors:
BADIALI, Luca; GB
GERRING, David; GB
JEZEK, Jan; GB
Agent:
NACHSHEN, Neil; GB
Priority Data:
17159458.306.03.2017EP
Title (EN) LIQUID PHARMACEUTICAL COMPOSITION
(FR) COMPOSITION PHARMACEUTIQUE LIQUIDE
Abstract:
(EN) The present invention relates to novel liquid pharmaceutical compositions of adalimumab, which include adalimumab or a biosimilar thereof, arginine and/or methionine, and a small polyol stabiliser such as glycerol. Such a combination of components furnishes formulations having a stability (e.g. on storage and when exposed to stress) which is comparable to or an improvement upon those known in the art, and with fewer ingredients. Such advances will help adalimumab treatments to become more widely available at lower cost, and prolong the viability of pre-loaded delivery devices (e.g. pre-filled syringes) to reduce unnecessary waste of the drug.
(FR) La présente invention concerne de nouvelles compositions pharmaceutiques liquides d'adalimumab, qui comprennent de l'adalimumab ou un biosimilaire de celui-ci, de l'arginine et/ou de la méthionine, et un petit stabilisateur de polyol tel que le glycérol. Une telle combinaison de constituants permet d'obtenir des formulations ayant une stabilité (par exemple, lorsque cette formulation est stockée et exposée à une contrainte) qui est comparable ou supérieure à la stabilité de formulations connues de l'état de la technique, et ce, avec moins d'ingrédients. De tels avancées vont aider les traitements d'adalimumab à devenir plus largement disponibles à moindre coût, et à prolonger la viabilité de dispositifs d'administration pré-chargés (par exemple, des seringues pré-remplies) pour réduire les déchets de médicament inutiles.
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)