首页> 外国专利> STABLE LIQUID COMPOSITION COMPRISING BOTULINUM TOXIN.

STABLE LIQUID COMPOSITION COMPRISING BOTULINUM TOXIN.

机译:包含肉毒杆菌毒素的稳定液体组合物。

摘要

The present disclosure relates to a stable liquid composition comprising a botulinum toxin as an active ingredient which is ready-to-use without the need for a reconstitution process, and particularly, to a liquid composition capable of preventing the botulinum toxin from aggregating even when the botulinum toxin is contained at a low concentration to thereby exhibit high stability, and efficiently preventing adsorption, etc., to a container, to constantly maintain an activity of the botulinum toxin for each batch or for each liquid vial. Specifically, the present disclosure relates to the liquid composition comprising (i) a botulinum toxin as an active ingredient, (ii) L-alanine or methyl cellulose, (iii) a non-ionic surfactant, and (iv) a buffer, and optionally, an isotonic agent. The liquid composition of the botulinum toxin according to the present disclosure is which is ready-to-use without performing a reconstitution process, and thus, it is possible to improve user's convenience, and reduce a deviation of botulinum toxin activity, etc., due to dilution errors in the reconstitution process, etc. Further, the liquid composition according to the present disclosure efficiently prevents the botulinum toxin from aggregating even at a low botulinum toxin concentration to thereby have extremely excellent storage stability, and efficiently prevents adsorption of the botulinum toxin to a container, thereby constantly maintaining an activity of the botulinum toxin for each batch or for each liquid vial.
机译:本公开涉及一种稳定的液体组合物,其包含肉毒杆菌毒素作为活性成分,其无需重组过程即可使用,并且特别涉及一种即使在使用时也能防止肉毒杆菌毒素聚集的液体组合物。肉毒杆菌毒素的浓度低,因此显示出高稳定性,并有效地防止了对容器的吸附等,从而对于每批或每个液体小瓶不断地保持肉毒杆菌毒素的活性。具体地,本公开涉及液体组合物,其包含(i)肉毒杆菌毒素作为活性成分,(ii)L-丙氨酸或甲基纤维素,(iii)非离子表面活性剂,和(iv)缓冲剂,和任选地,等渗剂。根据本发明的肉毒杆菌毒素的液体组合物无需进行重构即可直接使用,因此可以提高使用者的便利性,并减少肉毒杆菌毒素活性等的偏差。此外,根据本发明的液体组合物即使在低肉毒杆菌浓度下也能有效地防止肉毒杆菌毒素的聚集,从而具有极好的储存稳定性,并有效地防止肉毒杆菌毒素的吸附。到容器中,从而持续保持每批或每瓶液体肉毒杆菌毒素的活性。

著录项

  • 公开/公告号MX2019008416A

    专利类型

  • 公开/公告日2019-09-13

    原文格式PDF

  • 申请/专利权人 DAEWOONG CO. LTD.;

    申请/专利号MX20190008416

  • 发明设计人 HYEONA YIM;CHEONG-SEI KIM;

    申请日2017-10-17

  • 分类号A61K38/48;A61K9;A61K9/08;A61K47/12;A61K47/18;A61K47/26;A61K47/38;

  • 国家 MX

  • 入库时间 2022-08-21 12:01:41

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