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Title:
LYOPHILIZED THERAPEUTIC PEPTIBODY FORMULATIONS
Document Type and Number:
Japanese Patent JP2018150380
Kind Code:
A
Abstract:
PROBLEM TO BE SOLVED: To provide lyophilized therapeutic peptibody formulations and methods for preparing lyophilized compositions comprising therapeutic peptibodies.SOLUTION: Disclosed herein is a lyophilized therapeutic peptibody composition comprising a therapeutic peptibody, a buffer, a bulking agent, a stabilizing agent and optionally a surfactant, where the buffer is comprised of a pH buffering agent in a range of about 5 mM to about 20 mM to maintain pH in a range of about 3.0 to about 8.0, the bulking agent is at a concentration of about 0% to about 4.5% w/v, the stabilizing agent is at a concentration of about 0.1% to about 20% w/v, and the surfactant is at a concentration of about 0.004% to about 0.4% w/v.SELECTED DRAWING: None

Inventors:
CALLAHAN WILLIAM J
RICHARD L REMMELE JR
RATNASWAMY GAYATHRI
RAMIL F LATYPOV
LIU DINGJIANG
Application Number:
JP2018111720A
Publication Date:
September 27, 2018
Filing Date:
June 12, 2018
Export Citation:
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Assignee:
AMGEN
International Classes:
A61K38/22; A61K9/19; A61K47/02; A61K47/04; A61K47/10; A61K47/12; A61K47/14; A61K47/18; A61K47/20; A61K47/22; A61K47/24; A61K47/26; A61K47/28; A61K47/32; A61K47/34; A61K47/36; A61K47/38; A61K47/40; A61K47/60; A61K47/65; A61K47/68; A61P7/04
Domestic Patent References:
JPH11510170A1999-09-07
JP2003533187A2003-11-11
JP2001501619A2001-02-06
JP2000510813A2000-08-22
JP6356106B22018-07-11
Other References:
LIAO XIANGMIN, PHARMACEUTICAL RESEARCH, vol. V22 N11, JPN5009005504, November 2005 (2005-11-01), pages 1978 - 1985, ISSN: 0004240529
Attorney, Agent or Firm:
Kawaguchi International Patent Office