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1. (WO2017095848) OPTIMIZED RATIOS OF AMINO ACIDS AND SUGARS AS AMORPHOUS STABILIZING COMPOUNDS IN PHARMACEUTICAL COMPOSITIONS CONTAINING HIGH CONCENTRATIONS OF PROTEIN-BASED THERAPEUTIC AGENTS
Latest bibliographic data on file with the International Bureau

Pub. No.: WO/2017/095848 International Application No.: PCT/US2016/064080
Publication Date: 08.06.2017 International Filing Date: 30.11.2016
IPC:
A61K 47/42 (2017.01) ,A61K 39/00 (2006.01) ,A61K 39/395 (2006.01) ,A61K 47/00 (2006.01)
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
30
Macromolecular compounds
42
Proteins; Polypeptides; Degradation products thereof; Derivatives thereof
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
39
Medicinal preparations containing antigens or antibodies
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
Applicants:
MEDIMMUNE, LLC [US/US]; One Medimmune Way Gaithersburg, MD 20878, US
Inventors:
PATEL, Sajal, M.; US
PANSARE, Swapnil, K.; US
Agent:
SCOTT, Derek; US
DISE, Rebecca, S.; US
GALVEZ, J., Jason; US
CARROLL, Shannon; US
ALBAN, Patrick; US
Priority Data:
62/260,67730.11.2015US
Title (EN) OPTIMIZED RATIOS OF AMINO ACIDS AND SUGARS AS AMORPHOUS STABILIZING COMPOUNDS IN PHARMACEUTICAL COMPOSITIONS CONTAINING HIGH CONCENTRATIONS OF PROTEIN-BASED THERAPEUTIC AGENTS
(FR) RAPPORTS OPTIMISÉS D’ACIDES AMINÉS ET DE SUCRES EN TANT QUE COMPOSÉS STABILISANTS AMORPHES DANS DES COMPOSITIONS PHARMACEUTIQUES CONTENANT DES CONCENTRATIONS ÉLEVÉES D’AGENTS THÉRAPEUTIQUES À BASE DE PROTÉINE
Abstract:
(EN) The present invention relates to improved pharmaceutical compositions that contain high concentrations of one or more protein biomolecule(s). In particular, the invention relates to pharmaceutical compositions that include an optimized ratio of protein biomolecule to an amorphous stabilizing compound or compounds, especially a sugar, such as sucrose, trehalose, glucose, lactose or sorbitol, or mixtures thereof, or one or more amino acid molecules such as arginine, alanine, glycine, lysine or proline, or derivatives and salts thereof, or mixtures thereof. The inclusion of such amorphous stabilizing compound(s), at such optimized ratio, provides acceptable long-term stability of the protein biomolecule, and facilitates shorter lyophilization time, more specifically shorter drying time, even more specifically shorter primary drying time.
(FR) La présente invention concerne des compositions pharmaceutiques améliorées qui contiennent des concentrations élevées d’une ou plusieurs biomolécule(s) protéique(s). En particulier, l’invention concerne des compositions pharmaceutiques qui comprennent un rapport optimisé de biomolécule protéique à un composé ou des composés stabilisant(s) amorphe(s), en particulier un sucre, tel que le saccharose, le tréhalose, le glucose, le lactose ou le sorbitol, ou des mélanges de ceux-ci, ou une ou plusieurs molécules d’acide aminé telles que l’arginine, la l'alanine, la glycine, la lysine ou la proline, ou des dérivés et des sels de celles-ci, ou des mélanges de celles-ci. L’inclusion de tel(s) composé(s) stabilisant(s) amorphe(s), à un tel rapport optimisé, confère une stabilité à long terme acceptable de la biomolécule protéique, et permet d’obtenir un temps de lyophilisation plus court, plus spécifiquement un temps de séchage plus court, encore plus spécifiquement un temps de séchage primaire plus court.
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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, JP, KE, KG, 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 Organization (AM, AZ, BY, KG, KZ, RU, TJ, TM)
European Patent Office (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)
Also published as:
EP3383435US20190046641