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1. (WO2017018433) PHARMACEUTICAL COMPOSITION INCLUDING RAPAMYCIN OR DERIVATIVE THEREOF, AND PRODUCTION METHOD THEREFOR
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Pub. No.: WO/2017/018433 International Application No.: PCT/JP2016/071957
Publication Date: 02.02.2017 International Filing Date: 27.07.2016
IPC:
A61K 31/436 (2006.01) ,A61K 9/14 (2006.01) ,A61K 47/26 (2006.01) ,A61P 35/00 (2006.01) ,A61P 37/06 (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
435
having six-membered rings with one nitrogen as the only ring hetero atom
4353
ortho- or peri-condensed with heterocyclic ring systems
436
the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin
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
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
P
SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
35
Antineoplastic agents
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
P
SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
37
Drugs for immunological or allergic disorders
02
Immunomodulators
06
Immunosuppressants, e.g. drugs for graft rejection
Applicants: NIPPON KAYAKU KABUSHIKI KAISHA[JP/JP]; 1-1, Marunouchi 2-chome, Chiyoda-ku, Tokyo 1000005, JP
Inventors: KAWAMURA Dai; JP
Agent: SIKS & CO.; 8th Floor, Kyobashi-Nisshoku Bldg., 8-7, Kyobashi 1-chome, Chuo-ku, Tokyo 1040031, JP
Priority Data:
2015-14897828.07.2015JP
2016-00076606.01.2016JP
Title (EN) PHARMACEUTICAL COMPOSITION INCLUDING RAPAMYCIN OR DERIVATIVE THEREOF, AND PRODUCTION METHOD THEREFOR
(FR) COMPOSITION PHARMACEUTIQUE COMPRENANT DE LA RAPAMYCINE OU UN DÉRIVÉ DE CELLE-CI, ET SON PROCÉDÉ DE PRODUCTION
(JA) ラパマイシン又はその誘導体を含有する医薬組成物及びその製造方法
Abstract:
(EN) The present invention addresses the problem of providing a pharmaceutical composition which inhibits reduction in active ingredient content accompanying oxidation and decomposition of rapamycin or a derivative thereof, is capable of ensuring long-term stability, and exhibits high safety. According to the present invention, provided are: a pharmaceutical composition which includes (A) rapamycin or a derivative thereof, and (B) trehalose; and a production method for the pharmaceutical composition including rapamycin or a derivative thereof, said production method including a step in which a solution including rapamycin or a derivative thereof is added to a sugar having a critical relative humidity at 25˚C of at least 95%.
(FR) La présente invention aborde le problème de la fourniture d'une composition pharmaceutique qui inhibe la réduction de la teneur en principe actif accompagnant l'oxydation et la décomposition de la rapamycine ou d'un dérivé de celle-ci, est capable d'assurer une stabilité à long terme, et présente une sécurité élevée. La présente invention fournit : une composition pharmaceutique qui comprend (A) de la rapamycine ou un dérivé de celle-ci, et (B) du tréhalose; et un procédé de production de la composition pharmaceutique comprenant de la rapamycine ou un dérivé de celle-ci, ce procédé de production comprenant une étape dans laquelle une solution comprenant de la rapamycine ou un dérivé de celle-ci est ajoutée à un sucre possédant une humidité relative critique à 25 °C d'au moins 95 %.
(JA) 本発明の課題は、ラパマイシン又はその誘導体の酸化や分解に伴う有効成分含量の低減を抑制し、長期安定性が確保でき、且つ安全性が高い医薬組成物を提供することである。本発明によれば、(A)ラパマイシン又はその誘導体、並びに(B)トレハロースを含有する医薬組成物、並びにラパマイシン又はその誘導体を含有する溶液を、25℃における臨界相対湿度が95%以上の糖類に添加する工程を含む、ラパマイシン又はその誘導体を含有する医薬組成物の製造方法が提供される。
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, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, IS, KE, KG, KN, KP, KR, 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)