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1. (WO2017150256) PHARMACEUTICAL PREPARATION CONTAINING CAMPTOTHECIN-BASED POLYMERIC DERIVATIVE
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Pub. No.: WO/2017/150256 International Application No.: PCT/JP2017/006192
Publication Date: 08.09.2017 International Filing Date: 20.02.2017
IPC:
A61K 31/787 (2006.01) ,A61K 31/4745 (2006.01) ,A61K 35/00 (2006.01) ,A61K 47/02 (2006.01) ,A61K 47/18 (2017.01) ,A61K 47/34 (2017.01) ,A61K 47/42 (2017.01) ,A61K 47/50 (2017.01) ,A61K 9/19 (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
74
Synthetic polymeric materials
785
Polymers containing nitrogen
787
containing heterocyclic rings having nitrogen as a ring hetero atom
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
47
Quinolines; Isoquinolines
4738
ortho- or peri-condensed with heterocyclic ring systems
4745
condensed with ring systems having nitrogen as a ring hetero atom, e.g. phenanthrolines
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
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
16
containing nitrogen
18
Amines; Quaternary ammonium 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
30
Macromolecular compounds
34
Macromolecular compounds obtained otherwise than 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
47
Medicinal preparations characterised by the non-active ingredients used, e.g. carriers, inert additives
30
Macromolecular compounds
42
Proteins; Polypeptides; Degradation products thereof; Derivatives thereof
[IPC code unknown for A61K 47/50]
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
Applicants:
日本化薬株式会社 NIPPON KAYAKU KABUSHIKI KAISHA [JP/JP]; 東京都千代田区丸の内二丁目1番1号 1-1, Marunouchi 2-chome, Chiyoda-ku, Tokyo 1000005, JP
Inventors:
青木 進 AOKI Shin; JP
藤田 眞也 FUJITA Shinya; JP
Agent:
特許業務法人川口國際特許事務所 KAWAGUTI & PARTNERS; 東京都新宿区北新宿二丁目21番1号新宿フロントタワー20階 Shinjuku Front Tower 20F, 2-21-1 Kita-Shinjuku, Shinjuku-ku, Tokyo 1690074, JP
Priority Data:
2016-03894301.03.2016JP
Title (EN) PHARMACEUTICAL PREPARATION CONTAINING CAMPTOTHECIN-BASED POLYMERIC DERIVATIVE
(FR) PRÉPARATION PHARMACEUTIQUE CONTENANT UN DÉRIVÉ POLYMÈRE À BASE DE CAMPTOTHÉCINE
(JA) カンプトテシン類高分子誘導体を含有する医薬製剤
Abstract:
(EN) The present invention addresses the problem of providing a pharmaceutical preparation, i.e., a pharmaceutical preparation composition, which contains a polymerized camptothecin derivative comprising a polymer carrier and a camptothecin derivative bonded to the polymer carrier and capable of associating in an aqueous solution to exhibit a nano-particle formation property, and which has improved pharmaceutical stability. Particularly, the present invention addresses the problem of providing a pharmaceutical preparation which has an excellent associative aggregation formation property that is an important factor and also has excellent storage stability in terms of chemical stability. A pharmaceutical preparation containing a block copolymer comprising a polyethylene glycol segment and a poly(glutamic acid) segment linked to each other, wherein the poly(glutamic acid) segment contains a glutamic acid unit having a camptothecin derivative bonded thereto; and a pharmaceutical preparation containing at least one additive selected from the group consisting of arginine, histidine and sodium chloride.
(FR) La présente invention concerne une préparation pharmaceutique, à savoir, une composition de préparation pharmaceutique, qui contient un dérivé de camptothécine polymérisé comprenant un support polymère et un dérivé de camptothécine lié au support polymère et capable de s'associer en solution aqueuse pour présenter une propriété de formation de nanoparticules, et qui présente une stabilité pharmaceutique améliorée. En particulier, la présente invention concerne une préparation pharmaceutique qui présente une excellente propriété de formation d'agrégation associative qui est un facteur important et présente également une excellente stabilité au stockage en termes de stabilité chimique. L'invention concerne une préparation pharmaceutique contenant un copolymère séquencé comprenant un segment polyéthylèneglycol et un segment acide poly(acide glutamique) liés l'un à l'autre, le segment poly(acide glutamique) contenant un motif acide glutamique ayant un dérivé de camptothécine lié à lui ; et une préparation pharmaceutique contenant au moins un additif sélectionné dans le groupe constitué par l'arginine, l'histidine et le chlorure de sodium.
(JA) 水溶液中で会合してナノ粒子形成性を有するカンプトテシン誘導体を高分子担体に結合させた高分子化カンプトテシン誘導体を含有する医薬製剤であって、製剤的に安定性が向上された医薬製剤組成物を提供することを課題とする。特に、重要因子である会合性凝集体形成性と、化学的安定性において優れた保存安定性を有する医薬製剤を提供することを課題とする。 ポリエチレングリコールセグメントとカンプトテシン誘導体が結合したグルタミン酸ユニットを含むポリグルタミン酸セグメントが連結したブロック共重合体を含有する医薬製剤、並びにアルギニン、ヒスチジン及び塩化ナトリウムからなる群から選択される1種以上の添加剤を含有する医薬製剤。
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: Japanese (JA)
Filing Language: Japanese (JA)