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1. (WO2017193048) FULVESTRANT FORMULATIONS AND METHODS OF THEIR USE
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Pub. No.: WO/2017/193048 International Application No.: PCT/US2017/031376
Publication Date: 09.11.2017 International Filing Date: 05.05.2017
IPC:
A61K 9/00 (2006.01) ,A61K 9/10 (2006.01) ,A61K 47/10 (2017.01) ,A61K 47/32 (2006.01) ,A61K 31/565 (2006.01) ,A61P 35/00 (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
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
10
Dispersions; Emulsions
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
08
containing oxygen
10
Alcohols; Phenols; Salts thereof
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
32
Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31
Medicinal preparations containing organic active ingredients
56
Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
565
not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
P
SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
35
Antineoplastic agents
Applicants:
EAGLE PHARMACEUTICALS, INC. [US/US]; 50 Tice Boulevard Suite 315 Woodcliff Lake, New Jersey 07677, US
Inventors:
CHEN, Feng-Jing; US
KRILL, Steven L.; US
SHMEIS, Rama Abu; US
Agent:
VALLA, Maurice S.; US
LODISE, Stephanie, A.; US
SMITH, Hans, P.; US
Priority Data:
62/332,84206.05.2016US
62/420,55510.11.2016US
Title (EN) FULVESTRANT FORMULATIONS AND METHODS OF THEIR USE
(FR) FORMULATIONS DE FULVESTRANT ET MÉTHODES D'UTILISATION DE CELLES-CI
Abstract:
(EN) The disclosure is directed to fulvestrant formulations including suspensions of fulvestrant particles suitable for injection. The formulations can comprise fulvestrant particles having an LD Dv(10) less than about 3 microns, for example, between about 1 micron to about 3 microns, an LD Dv(50) less than about 35 microns, for example, between about 2 microns and about 35 microns, and an LD Dv(90) less than about 120 microns, for example, between about 4 microns and about 120 microns. The formulations can comprise fulvestrant particles having a CE Dv(90) less than about 200 microns, for example, between about 10 microns and about 200 microns, a CE Dv(50) less than about 60 microns, for example, between about 5 microns and about 60 microns, and a CE Dv(10) less than about 25 microns, for example, between about 1 micron and about 25 microns.
(FR) L'invention concerne des formulations de fulvestrant comprenant des suspensions de particules de fulvestrant appropriées pour une injection. Les formulations peuvent comprendre des particules de fulvestrant ayant un LD Dv(10) inférieur à environ 3 microns, par exemple, entre environ 1 micron et environ 3 microns, un LD Dv(50) inférieur à environ 35 microns, par exemple, entre environ 2 microns et environ 35 microns, et un LD Dv(90) inférieur à environ 120 microns, par exemple, entre environ 4 microns et environ 120 microns. Les formulations peuvent comprendre des particules de fulvestrant ayant un CE Dv(90) inférieur à environ 200 microns, par exemple, entre environ 10 microns et environ 200 microns, un CE Dv(50) inférieur à environ 60 microns, par exemple, entre environ 5 microns et environ 60 microns, et un CE Dv(10) inférieur à environ 25 microns, par exemple, entre environ 1 micron et environ 25 microns.
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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, 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)