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    • 1. 发明申请
    • PROCESS FOR MANUFACTURING GLATIRAMER ACETATE PRODUCT
    • 制备玻璃酸乙酯产品的方法
    • US20160213734A1
    • 2016-07-28
    • US14860053
    • 2015-09-21
    • Rakefet CohenSasson HabbahMuhammad Safadi
    • Rakefet CohenSasson HabbahMuhammad Safadi
    • A61K38/02A61K9/08A61K9/00A61K47/26
    • A61K38/02A61K9/0019A61K9/08A61K38/03A61K38/16A61K47/26
    • The patent provides a process of preparing a pharmaceutical preparation of glatiramer acetate and mannitol in a suitable container comprising the steps of: (i) obtaining an aqueous pharmaceutical solution of glatiramer acetate and mannitol; (ii) filtering the aqueous pharmaceutical solution at a temperature of from above 0° C. up to 17.5° C. to produce a filtrate; and (iii) filling the suitable container with the filtrate obtained after performing step (ii), so as to thereby prepare the pharmaceutical preparation of glatiramer acetate and mannitol in the suitable container. This patent further provides an aqueous pharmaceutical solution comprising 40 mg/ml glatiramer acetate and 40 mg/ml mannitol, wherein the aqueous pharmaceutical solution a) has a viscosity in the range of 2.0-3.5 cPa; or b) has an osmolality in the range of 275-325 mosmol/Kg. This patent also provides a prefilled syringe, an automated injector and a method of treatment of a human patient.
    • 该专利提供了在合适的容器中制备乙酸格拉默和甘露糖醇的药物制剂的方法,包括以下步骤:(i)获得乙酸格拉默和甘露醇的药物水溶液; (ii)在高于0℃至17.5℃的温度下过滤药物水溶液以产生滤液; 和(iii)在进行步骤(ii)之后用所得滤液填充合适的容器,从而在合适的容器中制备乙酸格拉默和甘露糖醇的药物制剂。 该专利还提供了包含40mg / ml醋酸格拉默和40mg / ml甘露醇的药物水溶液,其中药物水溶液a)的粘度范围为2.0-3.5cPa; 或b)的重量摩尔渗透压浓度范围为275-325 mosmol / Kg。 该专利还提供预充式注射器,自动注射器和治疗人类患者的方法。
    • 7. 发明授权
    • Process for manufacturing glatiramer acetate product
    • 制造醋酸格拉醋酸酯产品的方法
    • US09155775B1
    • 2015-10-13
    • US14608126
    • 2015-01-28
    • Rakefet CohenSasson HabbahMuhammad Safadi
    • Rakefet CohenSasson HabbahMuhammad Safadi
    • A61K38/02
    • A61K38/02A61K9/0019A61K9/08A61K38/03A61K38/16A61K47/26
    • The patent provides a process of preparing a pharmaceutical preparation of glatiramer acetate and mannitol in a suitable container comprising the steps of: (i) obtaining an aqueous pharmaceutical solution of glatiramer acetate and mannitol; (ii) filtering the aqueous pharmaceutical solution at a temperature of from above 0° C. up to 17.5° C. to produce a filtrate; and (iii) filling the suitable container with the filtrate obtained after performing step (ii), so as to thereby prepare the pharmaceutical preparation of glatiramer acetate and mannitol in the suitable container. This patent further provides an aqueous pharmaceutical solution comprising 40 mg/ml glatiramer acetate and 40 mg/ml mannitol, wherein the aqueous pharmaceutical solution a) has a viscosity in the range of 2.0-3.5 cPa; or b) has an osmolality in the range of 275-325 mosmol/Kg. This patent also provides a prefilled syringe, an automated injector and a method of treatment of a human patient.
    • 该专利提供了在合适的容器中制备乙酸格拉默和甘露糖醇的药物制剂的方法,包括以下步骤:(i)获得乙酸格拉默和甘露醇的药物水溶液; (ii)在高于0℃至17.5℃的温度下过滤药物水溶液以产生滤液; 和(iii)在进行步骤(ii)之后用所得滤液填充合适的容器,从而在合适的容器中制备乙酸格拉默和甘露糖醇的药物制剂。 该专利还提供了包含40mg / ml醋酸格拉默和40mg / ml甘露醇的药物水溶液,其中药物水溶液a)的粘度范围为2.0-3.5cPa; 或b)的重量摩尔渗透压浓度范围为275-325 mosmol / Kg。 该专利还提供预充式注射器,自动注射器和治疗人类患者的方法。