STARTING MATERIAL FOR BULK DRUG OR ADDITIVES FOR DRUG, AND BULK DRUG OR DRUG USING SAME

Title:

STARTING MATERIAL FOR BULK DRUG OR ADDITIVES FOR DRUG, AND BULK DRUG OR DRUG USING SAME

Document Type and Number:

WIPO Patent Application WO/2019/131515

Kind Code:

A1

Abstract:

Provided are a starting material for a bulk drug and an additive for a drug, said starting material and additive achieving high formulation stability and excellent temporal stability of drug efficacy after being used for modifying a bulk drug, a polypeptide, a physiologically active protein, an enzyme, etc. The present invention pertains to a starting material for a bulk drug or an additive for a drug, said starting material or additive comprising a polyether composition (A) represented by general formula (1), wherein: composition (A) shows a single peak molecular weight distribution; the ratio (Mw/Mn) of the weight-average molecular weight (Mw) of composition (A) to the number-average molecular weight (Mn) thereof is 1.20 or less; and composition (A) contains 90 wt% or more, relative to the weight of composition (A), of a compound wherein m in general formula (1) is 1. In general formula (1): OR1, R2O, R3O and R4O independently represent an oxyalkylene group having 2-8 carbon atoms, provided that multiple OR1's, R2O's, R3O's and R4O's, if present, may be either the same or different and bonded together in either random or block manner; a, b, c and d independently represent an integer of 50-1200; X1 to X4 independently represent a hydrogen atom, a substituent represented by general formula (2) or a substituent represented by general formula (3); and m is an integer of 1-10.

Inventors:

MOTOFUJI SHIHEI (JP)
NAKAI KENICHIRO (JP)
MICHIGAMI KYOSUKE (JP)
MATSUMOTO ITSUKA (JP)

Application Number:

PCT/JP2018/047261

Publication Date:

July 04, 2019

Filing Date:

December 21, 2018

Export Citation:

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Assignee:

SANYO CHEMICAL IND LTD (JP)

International Classes:

A61K47/10; A61K47/34; C08G65/28; C08G65/332; C08G65/333

Domestic Patent References:

WO2011063156A2

2011-05-26

Foreign References:

JPH02149335A	1990-06-07
JP2014208794A	2014-11-06
JPH10139878A	1998-05-26

Other References:

SONG, XIAOWAN ET AL.: "Preparation of pH-sensitive amphiphilic block star polymers, their self-assembling characteristics and release behavior on encapsulated molecules", POLYMER BULLETIN, vol. 74, no. 1, January 2017 (2017-01-01), pages 183 - 194, XP036126087, doi:10.1007/s00289-016-1707-2
S. MORI: "Size Exclusion Chromatography", KYORITSU, 10 December 1991 (1991-12-10), pages 1 - 25, XP055857024