申请人:Shirley A. Bret
公开号:US20050266046A1
公开(公告)日:2005-12-01
A highly concentrated, low salt-containing, biologically active syrup form of IGF-I or variant thereof and methods for its preparation are provided. This novel syrup form of IGF-I has an IGF-I concentration of at least about 250 mg/ml, a density of about 1.0 g/ml to about 1.2 g/ml, and a viscosity of about 13,000 centipoise (cps) to about 19,000 cps, as measured at ambient temperature (23° C.). The IGF-I syrup is prepared by precipitating or partitioning IGF-I from solution, preferably by adjusting the solution pH or by use of a solubility enhancer to concentrate IGF-I in solution followed by removal of the solubility enhancer. The precipitated syrup is useful as a means of storing IGF-I in a stable form and as a means of preparing compositions comprising biologically active IGF-I. Pharmaceutical compositions and kits comprising this concentrated IGF-I syrup are provided. The precipitated IGF-I syrup, IGF-I reconstituted from the IGF-I syrup, pharmaceutical compositions, and kits are useful in IGF-I therapy directed to IGF-I-responsive conditions.
本研究提供了一种高浓度、低含盐、生物活性糖浆形式的 IGF-I 或其变体及其制备方法。这种新型 IGF-I 糖浆的 IGF-I 浓度至少约为 250 毫克/毫升,密度约为 1.0 克/毫升至约 1.2 克/毫升,粘度约为 13,000 厘泊(cps)至约 19,000 厘泊(在环境温度(23° C)下测量)。制备 IGF-I 糖浆的方法是从溶液中沉淀或分离 IGF-I,最好是调节溶液的 pH 值,或使用溶解度增强剂浓缩溶液中的 IGF-I,然后去除溶解度增强剂。沉淀糖浆可用于以稳定的形式储存 IGF-I,也可用于制备含有生物活性 IGF-I 的组合物。我们提供了包含这种浓缩 IGF-I 糖浆的药物组合物和试剂盒。沉淀的 IGF-I 糖浆、由 IGF-I 糖浆重组的 IGF-I、药物组合物和试剂盒可用于针对 IGF-I 反应性疾病的 IGF-I 治疗。