Delamination resistant pharmaceutical glass containers containing active pharmaceutical ingredients
申请人:Corning Incorporated
公开号:EP2805930A1
公开(公告)日:2014-11-26
The present invention is based, at least in part, on the identification of a pharmaceutical container formed, at least in part, of a glass composition which exhibits a reduced propensity to delaminate, i.e., a reduced propensity to shed glass particulates. As a result, the presently claimed containers are particularly suited for storage of pharmaceutical compositions and, specifically, a pharmaceutical solution comprising a pharmaceutically active ingredient, for example, LYXUMIA (lixisenatide), LEMTRADA (alemtuzumab), REGN727/SAR236553 (alirocumab), SAR2405550/BSI-201 (iniparib), OTAMIXABAN (otamixaban), SARILUMAB (sarilumab), LANTUS and LYXUMIA (insulin glargine and lixisenatide) or VISAMERIN/MULSEVO (semuloparin sodium).
本发明至少部分是基于对至少部分由玻璃组合物形成的药用容器的鉴定,这种玻璃组合物显示出较低的分层倾向,即较低的玻璃微粒脱落倾向。因此,本发明的容器特别适用于储存药物组合物,特别是包含药物活性成分的药液,例如 LYXUMIA(利西那肽)、LEMTRADA(阿来珠单抗)、REGN727/SAR236553(阿利珠单抗)、SAR2405550/BSI-201(依尼帕利布)、OTAMIXABAN(奥他米沙班)、SARILUMAB(沙利单抗)、LANTUS 和 LYXUMIA(格列酮胰岛素和利塞那肽)或 VISAMERIN/MULSEVO(semuloparin sodium)。