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1. (WO2019048527) FORMULATIONS OF COPANLISIB
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Pub. No.: WO/2019/048527 International Application No.: PCT/EP2018/073965
Publication Date: 14.03.2019 International Filing Date: 06.09.2018
IPC:
A61K 9/19 (2006.01) ,A61K 9/08 (2006.01) ,A61K 47/02 (2006.01) ,A61K 47/26 (2006.01)
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
14
Particulate form, e.g. powders
19
lyophilised
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
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
02
Inorganic 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
Applicants:
BAYER PHARMA AKTIENGESELLSCHAFT [DE/DE]; Müllerstr. 178 13353 Berlin, DE
BAYER CONSUMER CARE AG [CH/CH]; Peter-Merian-Str. 84 4002 Basel, CH
Inventors:
FREUNDLIEB, Julia; DE
JACOBS, Tia; DE
Agent:
BIP PATENTS; Alfred-Nobel-Str. 10 40789 Monheim am Rhein NRW, DE
Priority Data:
17190117.608.09.2017EP
17207771.115.12.2017EP
Title (EN) FORMULATIONS OF COPANLISIB
(FR) FORMULATIONS DE COPANLISIB
Abstract:
(EN) The present invention relates to : a method of preparing a stable, copanlisib-containing aqueous bulk solution suitable for lyophilisation and for therapeutic applications; a stable, copanlisib-containing bulk solution, of increased solubility which is directly suitable for lyophilisation; a method of lyophilizing such a copanlisib-containing aqueous bulk solution; a stable, lyophilized, copanlisib-containing solid, in particular powder or cake, particularly containing a therapeutic dose of copanlisib in one or two containers, particularly one sealed container; a method of reconstituting such lyophilisates; and a stable, reconstituted, copanlisib-containing solution of increased solubility, suitable for further dilution and for therapeutic applications.
(FR) La présente invention concerne : un procédé de préparation d'une solution mère aqueuse stable contenant du copanlisib, appropriée pour la lyophilisation et pour des applications thérapeutiques ; une solution mère stable contenant du copanlisib, dotée d'une solubilité accrue et directement appropriée pour la lyophilisation ; un procédé de lyophilisation d'une telle solution mère aqueuse contenant du copanlisib ; un solide stable et lyophilisé contenant du copanlisib, en particulier une poudre ou un gâteau, contenant en particulier une dose thérapeutique de copanlisib dans un ou deux contenants, en particulier un contenant scellé ; un procédé de reconstitution de tels lyophilisats ; et une solution reconstituée stable contenant du copanlisib, dotée d'une solubilité accrue, appropriée pour une dilution supplémentaire et pour des applications thérapeutiques.
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)