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1. (WO2019049967) AQUEOUS PHARMACEUTICAL COMPOSITION
Latest bibliographic data on file with the International BureauSubmit observation

Pub. No.: WO/2019/049967 International Application No.: PCT/JP2018/033143
Publication Date: 14.03.2019 International Filing Date: 07.09.2018
IPC:
A61K 38/46 (2006.01) ,A61K 9/08 (2006.01) ,A61K 47/02 (2006.01) ,A61K 47/10 (2006.01) ,A61K 47/26 (2006.01) ,A61K 47/68 (2017.01) ,A61P 25/00 (2006.01) ,C07K 16/28 (2006.01) ,C07K 19/00 (2006.01) ,C12N 9/14 (2006.01) ,C12N 15/62 (2006.01)
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
38
Medicinal preparations containing peptides
16
Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
43
Enzymes; Proenzymes; Derivatives thereof
46
Hydrolases (3)
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
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
06
Organic compounds
26
Carbohydrates
[IPC code unknown for A61K 47/68]
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
P
SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
25
Drugs for disorders of the nervous system
C CHEMISTRY; METALLURGY
07
ORGANIC CHEMISTRY
K
PEPTIDES
16
Immunoglobulins, e.g. monoclonal or polyclonal antibodies
18
against material from animals or humans
28
against receptors, cell surface antigens or cell surface determinants
C CHEMISTRY; METALLURGY
07
ORGANIC CHEMISTRY
K
PEPTIDES
19
Hybrid peptides
C CHEMISTRY; METALLURGY
12
BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
N
MICRO-ORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICRO-ORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
9
Enzymes, e.g. ligases (6.); Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating, or purifying enzymes
14
Hydrolases (3.)
C CHEMISTRY; METALLURGY
12
BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
N
MICRO-ORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICRO-ORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
15
Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
09
Recombinant DNA-technology
11
DNA or RNA fragments; Modified forms thereof
62
DNA sequences coding for fusion proteins
Applicants:
JCRファーマ株式会社 JCR PHARMACEUTICALS CO., LTD. [JP/JP]; 兵庫県芦屋市春日町3番19号 3-19, Kasuga-cho, Ashiya-shi, Hyogo 6590021, JP
Inventors:
安川 秀仁 YASUKAWA, Hidehito; JP
山口 裕加 YAMAGUCHI, Yuka; JP
岡部 真二 OKABE, Shinji; JP
Agent:
山本 佳希 YAMAMOTO, Yoshiki; JP
Priority Data:
2017-17215607.09.2017JP
Title (EN) AQUEOUS PHARMACEUTICAL COMPOSITION
(FR) COMPOSITION PHARMACEUTIQUE AQUEUSE
(JA) 水性医薬組成物
Abstract:
(EN) Disclosed is an aqueous pharmaceutical composition which comprises, as an active ingredient, a fused protein of an antibody with a lysosomal enzyme and has sufficient stability to enable the distribution thereof in the market. The aqueous pharmaceutical composition involves compositions having a concentration of the fused protein of an antibody with a lysosomal enzyme of 0.5-20 mg/mL, a sodium chloride concentration of 0.3-1.2 mg/mL, a sucrose concentration of 50-100 mg/mL, a nonionic surfactant concentration of 0.15-3 mg/mL, a buffer concentration of 3-30 mM and a pH value of 5.0-7.5.
(FR) L'invention concerne une composition pharmaceutique aqueuse qui comprend, en tant que principe actif, une protéine de fusion d'un anticorps avec une enzyme lysosomale et présente une stabilité suffisante pour permettre sa distribution sur le marché. La composition pharmaceutique aqueuse comprend des compositions ayant une concentration de la protéine de fusion d'un anticorps avec une enzyme lysosomale comprise entre 0,5 et 20 mg/ml, une concentration en chlorure de sodium comprise entre 0,3 et 1,2 mg/ml, une concentration en saccharose comprise entre 50 et 100 mg/ml, une concentration en tensioactif non ionique comprise entre 0,15 à 3 mg/mm, une concentration en substance tampon comprise entre 3 et 30 mM et une valeur de pH comprise entre 5,0 et 7,5.
(JA) 抗体とリソソーム酵素との融合蛋白質を有効成分として含有してなる,市場に流通させることが可能な程度に安定な水性医薬組成物が開示されている。当該水性医薬組成物は,抗体とリソソーム酵素との融合蛋白質の濃度が0.5~20mg/mLであり,塩化ナトリウムの濃度が0.3~1.2mg/mLであり,スクロースの濃度が50~100mg/mLであり,非イオン性界面活性剤の濃度が0.15~3mg/mLであり,緩衝剤の濃度が3~30mMであって,pHが5.0~7.5であるものを含む。
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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, JO, 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: Japanese (JA)
Filing Language: Japanese (JA)