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1. (WO2017134597) GALENIC FORMULATIONS OF ORGANIC COMPOUNDS
Latest bibliographic data on file with the International Bureau

Pub. No.: WO/2017/134597 International Application No.: PCT/IB2017/050569
Publication Date: 10.08.2017 International Filing Date: 02.02.2017
IPC:
A61K 9/20 (2006.01) ,A61K 9/28 (2006.01) ,A61K 9/48 (2006.01) ,A61K 31/216 (2006.01) ,A61K 31/41 (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
20
Pills, lozenges or tablets
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
20
Pills, lozenges or tablets
28
Dragees; Coated pills or tablets
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
48
Preparations in capsules, e.g. of gelatin, of chocolate
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31
Medicinal preparations containing organic active ingredients
21
Esters, e.g. nitroglycerine, selenocyanates
215
of carboxylic acids
216
of acids having aromatic rings, e.g. benactizyne, clofibrate
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
41
having five-membered rings with two or more ring hetero atoms, at least one of which is nitrogen, e.g. tetrazole
Applicants:
NOVARTIS AG [CH/CH]; Lichtstrasse 35 4056 Basel, CH
Inventors:
WINZENBURG, Gesine; CH
TRUEBY, Bernd; CH
CHEN, Fabian; US
AYALASOMAYAJULA, Surya Prakash; US
BUSH, Christopher; US
BERKHIN, Masha; US
Agent:
LARBIG, Karen; CH
Priority Data:
16154153.703.02.2016EP
62/293,00509.02.2016US
Title (EN) GALENIC FORMULATIONS OF ORGANIC COMPOUNDS
(FR) FORMES PHARMACEUTIQUES À BASE DE COMPOSÉS ORGANIQUES
Abstract:
(EN) The present invention relates to a solid unit oral dosage form comprising sacubitril and valsartan in a 1:1 molar ratio, preferably in the form of the so-called angiotensin receptor neprilysin inhibitor (ARNI) LCZ696, which is a complex salt hydrate of sacubitril, valsartan, and sodium ions, appropriate for use in pediatrics or other patients where low and individual dosing is required or who encounter problems with swallowing e.g. as a result of a disease or because of age, to the manufacture of said solid dosage form and to invention embodiments relating to therapy using said dosage form.
(FR) La présente invention concerne une forme posologique unitaire solide pour voie orale contenant du sacubitril et du valsartan selon un rapport molaire de 1 : 1, de préférence sous la forme de ce que l'on appelle l'inhibiteur du récepteur de l'angiotensine et de la néprilysine LCZ696, qui est un sel hydraté complexe de sacubitril, de valsartan et d'ions sodium, forme posologique appropriée à une utilisation chez des patients pédiatriques ou autres chaque fois que des doses individuelles faibles sont nécessaires ou lorsque le patient a des difficultés à avaler, par exemple à la suite d'une maladie ou en raison de son âge. L'invention concerne également la fabrication de ladite forme posologique solide et des modes de réalisation de l'invention se rapportant à un traitement à l'aide de ladite forme posologique.
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 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:
AU2017215530CA3010778KR1020180103940CN108601741EP3411018IL260955
US20190083406