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1. (WO2017147783) PHARMACEUTICAL COMPOSITION AND MANUFACTURING METHOD THEREOF
Latest bibliographic data on file with the International Bureau   

Pub. No.: WO/2017/147783 International Application No.: PCT/CN2016/075172
Publication Date: 08.09.2017 International Filing Date: 01.03.2016
IPC:
A61K 38/26 (2006.01) ,A61K 47/02 (2006.01) ,A61K 47/10 (2017.01) ,A61P 3/10 (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
17
from animals; from humans
22
Hormones
26
Glucagons
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
P
SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
3
Drugs for disorders of the metabolism
08
for glucose homeostasis
10
for hyperglycaemia, e.g. antidiabetics
Applicants:
深圳翰宇药业股份有限公司 HYBIO PHARMACEUTICAL CO., LTD. [CN/CN]; 中国广东省深圳市 南山区高新技术工业园中区翰宇生物医药园办公大楼四层 4th Floor of Office Building, Hybio Medicine Park, Shenzhen Hi-Tech Industrial Park Shenzhen, Guangdong 518057, CN
Inventors:
戴荣欢 DAI, Ronghuan; CN
张雷 ZHANG, Lei; CN
覃亮政 QIN, Liangzheng; CN
陶安进 TAO, Anjin; CN
袁建成 YUAN, Jiancheng; CN
Agent:
深圳市深佳知识产权代理事务所(普通合伙) SHENPAT INTELLECTUAL PROPERTY AGENCY; 中国广东省深圳市 国贸大厦15楼西座1521室 Room 1521 West Block, Guomao Building Shenzhen, Guangdong 518014, CN
Priority Data:
Title (EN) PHARMACEUTICAL COMPOSITION AND MANUFACTURING METHOD THEREOF
(FR) COMPOSITION PHARMACEUTIQUE ET SON PROCÉDÉ DE FABRICATION
(ZH) 一种药物组合物及其制备方法
Abstract:
(EN) The present invention relates to the field of polypeptides and particularly provides a pharmaceutical composition and a manufacturing method thereof. The pharmaceutical composition comprises a liraglutide, and the manufacturing method of the pharmaceutical composition comprises: mixing, in a solvent, the liraglutide and an adjuvant, stirring the resultant mixture at 500-1100 rpm until homogeneous, and adjusting the pH to 7.5-9.5. Various manufacturing process parameters can influence the stability of liraglutide and may cause significant changes in oligomerization, single maximal impurity, and total impurity. The infrared spectrum shows an amide band I (at about 1645 nm-1), indicating the presence of an α-helix structure, with strong absorption and a basically consistent peak shape. The present invention controls, by examination of the secondary structure of a polypeptide, parameter screening of a pharmaceutical preparation process.
(FR) La présente invention concerne le domaine des polypeptides et concerne en particulier une composition pharmaceutique et son procédé de fabrication. La composition pharmaceutique comprend un liraglutide, et le procédé de fabrication de la composition pharmaceutique comprend : le mélangeage, dans un solvant, du liraglutide et d'un adjuvant, l'agitation du mélange résultant à 500-1100 rpm jusqu'à homogénéité, et l'ajustement du pH à 7,5-9,5. Divers paramètres du procédé de fabrication peuvent influer sur la stabilité du liraglutide et provoquer des modifications significatives de l'oligomérisation, de l'impureté unique maximale, et du total d'impuretés. Le spectre infrarouge montre une bande d'amide I (à environ 1645 nm-1), indiquant la présence d'une structure d'hélice α, avec une forte absorption et une forme de pic fondamentalement cohérente. La présente invention commande, par examen de la structure secondaire d'un polypeptide, le criblage des paramètres d'un procédé de préparation pharmaceutique.
(ZH) 本发明涉及多肽领域,具体地提供了一种药物组合物及其制备方法。该药物组合物包括利拉鲁肽,其制备方法为:在溶剂中,取利拉鲁肽与辅料混合,以500~1100rpm搅拌至均匀,调节pH值至7.5~9.5。工艺参数对利拉鲁肽的稳定性有影响,寡聚体、最大单个杂质、总杂质有明显的变化趋势。从红外光谱色谱图可以看出,在酰胺I带(约1645nm-1)具有强吸收,且峰形基本一致,酰胺I带可以反映α-螺旋结构的存在。本发明从多肽的二级结构考察来控制制剂制备过程中的参数筛选。
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, JP, 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: Chinese (ZH)
Filing Language: Chinese (ZH)