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1. (WO2018162475) STABLE FORMULATIONS FOR IMMUNE-MODULATORY MACROLIDES
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Pub. No.: WO/2018/162475 International Application No.: PCT/EP2018/055465
Publication Date: 13.09.2018 International Filing Date: 06.03.2018
IPC:
A61K 35/16 (2015.01) ,A61K 31/436 (2006.01)
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
35
Medicinal preparations containing material or reaction products thereof with undetermined constitution
12
Materials from mammals or birds
14
Blood
16
Plasma; Serum
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31
Medicinal preparations containing organic active ingredients
33
Heterocyclic compounds
395
having nitrogen as a ring hetero atom, e.g. guanethidine, rifamycins
435
having six-membered rings with one nitrogen as the only ring hetero atom
4353
ortho- or peri-condensed with heterocyclic ring systems
436
the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin
Applicants:
ROCHE DIAGNOSTICS GMBH [DE/DE]; Sandhofer Straße 116 68305 Mannheim, DE (DE)
F. HOFFMANN-LA ROCHE AG [CH/CH]; Grenzacherstrasse 124 4070 Basel, CH (AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BE, BF, BG, BH, BJ, BN, BR, BW, BY, BZ, CA, CF, CG, CH, CI, CL, CM, CN, CO, CR, CU, CY, CZ, DJ, DK, DM, DO, DZ, EC, EE, EG, ES, FI, FR, GA, GB, GD, GE, GH, GM, GN, GQ, GR, GT, GW, HN, HR, HU, ID, IE, IL, IN, IR, IS, IT, JO, JP, KE, KG, KH, KM, KN, KP, KR, KW, KZ, LA, LC, LK, LR, LS, LT, LU, LV, LY, MA, MC, MD, ME, MG, MK, ML, MN, MR, MT, MW, MX, MY, MZ, NA, NE, NG, NI, NL, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, SD, SE, SG, SI, SK, SL, SM, SN, ST, SV, SY, SZ, TD, TG, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, UZ, VC, VN, ZA, ZM, ZW)
ROCHE DIAGNOSTICS OPERATIONS, INC. [US/US]; Business Area Roche Applied Science 9115 Hague Road Indianapolis, 46250, US (US)
Inventors:
HEGEL, Ewelina; DE
JOSEL, Hans-Peter; DE
LOPEZ-CALLE, Eloisa; DE
ROEDL, Josef; DE
WEISS, Noah; US
TIEMANN, Benjamin; DE
Agent:
HERZOG FIESSER & PARTNER PATENTANWÄLTE PARTG MBB; Dudenstraße 46 68167 Mannheim, DE
Priority Data:
17159619.007.03.2017EP
Title (EN) STABLE FORMULATIONS FOR IMMUNE-MODULATORY MACROLIDES
(FR) FORMULATIONS STABLES POUR MACROLIDES IMMUNOMODULATEURS
Abstract:
(EN) The present invention relates to a liquid composition comprising at least one immune- modulatory macrolide compound and an essentially cell-free blood hemolysate. The present invention further relates to a method for manufacturing a stabilized immune-modulatory macrolide calibration solution, comprising a) preparing a solution comprising an essentially cell-free blood hemolysate, b) admixing a predetermined amount of at least one immune- modulatory macrolide into said solution comprising an essentially cell-free blood hemolysate, and, thereby c) manufacturing a stabilized immune-modulatory macrolide calibration solution. Furthermore, the present invention relates to kits, uses, devices, methods and to an immune-modulatory macrolide compound calibration solution related thereto.
(FR) La présente invention concerne une composition liquide comprenant au moins un composé macrolide immunomodulateur et un hémolysat de sang sensiblement exempt de cellules. La présente invention concerne en outre un procédé de fabrication d'une solution d'étalonnage de macrolide immunomodulateur stabilisé, consistant a) à préparer une solution comprenant un hémolysat de sang sensiblement exempt de cellules, b) à mélanger une quantité prédéterminée d'au moins un macrolide immunomodulateur dans ladite solution comprenant un hémolysat de sang sensiblement exempt de cellules, et, de ce fait, c) à fabriquer une solution d'étalonnage de macrolide immunomodulateur stabilisé. En outre, la présente invention concerne des kits, des utilisations, des dispositifs, des procédés et une solution d'étalonnage de composé macrolide immunomodulateur associé à celui-ci.
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)