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1. (WO2018041246) PHARMACEUTICAL COMPOSITION COMPRISING NEPTINIB OR SALT THEREOF AND METHOD FOR CONTROLLING IMPURITY THEREOF
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Pub. No.: WO/2018/041246 International Application No.: PCT/CN2017/100189
Publication Date: 08.03.2018 International Filing Date: 01.09.2017
Chapter 2 Demand Filed: 29.06.2018
IPC:
A61K 31/517 (2006.01) ,A61K 9/00 (2006.01) ,A61K 47/26 (2006.01) ,A61K 47/36 (2006.01) ,A61K 47/38 (2006.01) ,A61K 47/14 (2006.01) ,A61K 47/12 (2006.01) ,A61P 35/00 (2006.01)
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
495
having six-membered rings with two nitrogen atoms as the only ring hetero atoms, e.g. piperazine
505
Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
517
ortho- or peri-condensed with carbocyclic ring systems, e.g. quinazoline, perimidine
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
47
Medicinal preparations characterised by the non-active ingredients used, e.g. carriers, inert additives
06
Organic compounds
26
Carbohydrates
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
36
Polysaccharides; Derivatives 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
36
Polysaccharides; Derivatives thereof
38
Cellulose; Derivatives 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
06
Organic compounds
08
containing oxygen
14
Esters of carboxylic acids
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
12
Carboxylic acids; Salts or anhydrides thereof
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
P
SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
35
Antineoplastic agents
Applicants: SHENZHEN NEPTUNUS PHARMACEUTICAL RESEARCH INSTITUTE CO., LTD.[CN/CN]; No. 26 High Tech North No. 2 Road, Nanshan District Shenzhen, Guangdong 518057, CN
Inventors: YANG, Jingan; CN
WANG, Zhiguo; CN
CUI, Jing; CN
LIU, Xiaorou; CN
Agent: LECOME INTELLECTUAL PROPERTY AGENT LTD.; Fl.16, Tower B, INDO Mansion, No. 48-Jia Zhichun Road, Haidian District Beijing 100098, CN
Priority Data:
201610801047.705.09.2016CN
Title (EN) PHARMACEUTICAL COMPOSITION COMPRISING NEPTINIB OR SALT THEREOF AND METHOD FOR CONTROLLING IMPURITY THEREOF
(FR) COMPOSITION PHARMACEUTIQUE COMPRENANT DU NEPTINIB OU UN SEL CORRESPONDANT ET PROCÉDÉ DE LUTTE CONTRE LES IMPURETÉS CORRESPONDANTES
(ZH) 一种含萘普替尼或其盐的药物组合物及其杂质控制方法
Abstract:
(EN) Provided is a pharmaceutical composition comprising neptinib. The composition comprises neptinib or a pharmaceutically acceptable salt thereof, and an excipient at a low risk of compatibleness. Furthermore, the pharmaceutical composition of the present invention may also comprise a pharmaceutically acceptable organic acid or inorganic acid as a stabilizer. The content of impurity A maintains a non-significant increase in the long-term and accelerated stability investigation for the pharmaceutical composition.
(FR) L'invention concerne une composition pharmaceutique comprenant du neptinib. La composition comprend du néptinib ou un sel pharmaceutiquement acceptable correspondant et un excipient à un faible risque de compatibilité. En outre, la composition pharmaceutique de la présente invention peut également comprendre un acide organique ou un acide inorganique pharmaceutiquement acceptable en tant que stabilisant. La teneur en impureté A subvient à une augmentation non significative dans l'étude de stabilité à long terme et accélérée de la composition pharmaceutique.
(ZH) 本发明提供了一种含萘普替尼的药物组合物,所述组合物含有萘普替尼或其药学上可接受的盐,以及低配伍性风险的赋形剂。进一步地,本发明的所述药物组合物还可含有作为稳定剂的药学上可接受的有机酸或无机酸,所述药物组合物在长期及加速稳定性考察中杂质A的含量保持不明显增长。
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: Chinese (ZH)
Filing Language: Chinese (ZH)