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1. 发明授权

US07169359B2 Bioequivalence test for iron-containing formulations 有权
标题翻译：含铁配方的生物等效性试验
公开(公告)号：US07169359B2
公开(公告)日：2007-01-30
申请号：US10979796
申请日：2004-11-02
申请人： Mary Jane Helenek , Ralf A. Lange , Richard P. Lawrence
发明人： Mary Jane Helenek , Ralf A. Lange , Richard P. Lawrence
IPC分类号： G01N33/20
CPC分类号： G01N33/84 , A61K31/295 , Y10T436/142222 , Y10T436/143333
摘要： A rapid method for assessing the bioequivalence of iron in iron-supplement formulations, particularly iron-sucrose formulations is described, which is based upon the kinetics of reduction of iron (III) to iron (II) in a sample of the formulation. Quality control methods and associated kits also are described.
摘要翻译：描述了一种用于评估铁补充制剂，特别是铁 - 蔗糖制剂中铁的生物等效性的快速方法，其基于在制剂样品中还原铁（III）至铁（II）的动力学。还描述了质量控制方法和相关工具包。

2. 发明授权

US06911342B2 Bioequivalence test for iron-containing formulations 有权
标题翻译：含铁配方的生物等效性试验
公开(公告)号：US06911342B2
公开(公告)日：2005-06-28
申请号：US10227445
申请日：2002-08-26
申请人： Mary Jane Helenek , Ralf A. Lange , Richard P. Lawrence
发明人： Mary Jane Helenek , Ralf A. Lange , Richard P. Lawrence
IPC分类号： G01N31/00 , A61K31/295 , G01N31/22 , G01N33/20 , G01N33/84
CPC分类号： A61K31/295 , G01N31/22 , G01N33/84 , Y10T436/142222 , Y10T436/143333
摘要： A rapid method for assessing the bioequivalence of iron in iron-supplement formulations, particularly iron-sucrose formulations is described, which is based upon the kinetics of reduction of iron (III) to iron (II) in a sample of the formulation. Quality control methods and associated kits also are described.
摘要翻译：描述了一种用于评估铁补充制剂，特别是铁 - 蔗糖制剂中铁的生物等效性的快速方法，其基于在制剂样品中还原铁（III）至铁（II）的动力学。还描述了质量控制方法和相关工具包。

3. 发明申请

US20100266644A1 METHODS AND COMPOSITIONS FOR ADMINISTRATION OF IRON 有权
标题翻译：铁管理的方法和组成
公开(公告)号：US20100266644A1
公开(公告)日：2010-10-21
申请号：US12787283
申请日：2010-05-25
申请人： Mary Jane Helenek , Marc L. Tokars , Richard P. Lawrence
发明人： Mary Jane Helenek , Marc L. Tokars , Richard P. Lawrence
IPC分类号： A61K33/26 , A61K9/00 , A61P3/00 , A61P19/02 , A61P35/02 , A61P35/00 , A61P1/00 , A61P9/04 , A61P13/12
CPC分类号： A61K31/7135 , A61K31/715 , A61K31/721 , C07H23/00
摘要： The present invention generally relates to treatment of iron-related conditions with iron carbohydrate complexes. One aspect of the invention is a method of treatment of iron-related conditions with a single unit dosage of at least about 0.6 grams of elemental iron via an iron carbohydrate complex. The method generally employs iron carbohydrate complexes with nearly neutral pH, physiological osmolarity, and stable and non-immunogenic carbohydrate components so as to rapidly administer high single unit doses of iron intravenously to patients in need thereof.
摘要翻译：本发明一般涉及用铁碳水化合物络合物处理铁相关条件。本发明的一个方面是通过铁碳水化合物复合物以单一单位剂量至少约0.6克元素铁处理铁相关条件的方法。该方法通常使用具有接近中性pH，生理渗透压和稳定和非免疫原性碳水化合物组分的铁碳水化合物复合物，以便将需要的患者静脉内快速施用高单一单位剂量的铁。

4. 发明授权

US07754702B2 Methods and compositions for administration of iron 有权
标题翻译：铁的给药方法和组合物
公开(公告)号：US07754702B2
公开(公告)日：2010-07-13
申请号：US11620986
申请日：2007-01-08
申请人： Mary Jane Helenek , Marc L. Tokars , Richard P. Lawrence
发明人： Mary Jane Helenek , Marc L. Tokars , Richard P. Lawrence
IPC分类号： A61K31/715 , A61K31/716
CPC分类号： A61K31/7135 , A61K31/715 , A61K31/721 , C07H23/00
摘要： The present invention generally relates to treatment of iron-related conditions with iron carbohydrate complexes. One aspect of the invention is a method of treatment of iron-related conditions with a single unit dosage of at least about 0.6 grams of elemental iron via an iron carbohydrate complex. The method generally employs iron carbohydrate complexes with nearly neutral pH, physiological osmolarity, and stable and non-immunogenic carbohydrate components so as to rapidly administer high single unit doses of iron intravenously to patients in need thereof.
摘要翻译：本发明一般涉及用铁碳水化合物络合物处理铁相关条件。本发明的一个方面是通过铁碳水化合物复合物以单一单位剂量至少约0.6克元素铁处理铁相关条件的方法。该方法通常使用具有接近中性pH，生理渗透压和稳定和非免疫原性碳水化合物组分的铁碳水化合物复合物，以便将需要的患者静脉内快速施用高单一单位剂量的铁。

5. 发明授权

US08431549B2 Methods and compositions for administration of iron 有权
标题翻译：铁的给药方法和组合物
公开(公告)号：US08431549B2
公开(公告)日：2013-04-30
申请号：US12787283
申请日：2010-05-25
申请人： Mary Jane Helenek , Marc L. Tokars , Richard P. Lawrence
发明人： Mary Jane Helenek , Marc L. Tokars , Richard P. Lawrence
IPC分类号： A61K31/721 , A61K31/718 , A61K31/295
CPC分类号： A61K31/7135 , A61K31/715 , A61K31/721 , C07H23/00
摘要： The present invention generally relates to treatment of iron-related conditions with iron carbohydrate complexes. One aspect of the invention is a method of treatment of iron-related conditions with a single unit dosage of at least about 0.6 grams of elemental iron via an iron carbohydrate complex. The method generally employs iron carbohydrate complexes with nearly neutral pH, physiological osmolarity, and stable and non-immunogenic carbohydrate components so as to rapidly administer high single unit doses of iron intravenously to patients in need thereof.
摘要翻译：本发明一般涉及用铁碳水化合物络合物处理铁相关条件。本发明的一个方面是通过铁碳水化合物复合物以单一单位剂量至少约0.6克元素铁处理铁相关条件的方法。该方法通常使用具有接近中性pH，生理渗透压和稳定和非免疫原性碳水化合物组分的铁碳水化合物复合物，以便将需要的患者静脉内快速施用高单一单位剂量的铁。

6. 发明授权

US5624668A Iron dextran formulations 失效
标题翻译：铁葡聚糖配方
公开(公告)号：US5624668A
公开(公告)日：1997-04-29
申请号：US536984
申请日：1995-09-29
申请人： Richard P. Lawrence , Ralf A. Lange , Chin Wu , Mary J. Helenek
发明人： Richard P. Lawrence , Ralf A. Lange , Chin Wu , Mary J. Helenek
IPC分类号： A61K9/08 , A61K31/00 , A61K33/26 , A61K47/36 , A61K47/48 , A61P7/00 , A61P7/06 , A01N59/16
CPC分类号： A61K33/26 , A61K47/4823 , A61K47/48853
摘要： Ferric oxyhydroxide-dextran compositions for treating iron deficiency having ellipsoidal particles with a preferred molecular weight range of about 250,000 to 300,000 daltons.
摘要翻译：用于治疗具有优选分子量范围为约250,000至300,000道尔顿的椭圆形颗粒的缺铁的羟基氢氧化铁 - 葡聚糖组合物。

7. 发明授权

US4931441A Stabilized aqueous leucovorin calcium compositions 失效
标题翻译：稳定的含水甲酰四氢叶酸钙组合物
公开(公告)号：US4931441A
公开(公告)日：1990-06-05
申请号：US269130
申请日：1988-11-09
申请人： Richard P. Lawrence
发明人： Richard P. Lawrence
IPC分类号： A61K9/00 , A61K31/505 , A61K47/12
CPC分类号： A61K31/505 , A61K47/12 , A61K9/0019
摘要： A leucovorin composition having improved properties is provided by an aqueous, isotonic, sterile leucovorin calcium solution having a pH in the range 6.5-8.5 and containing as a buffer therein sodium citrate dihydrate in the amount in the range 1 mg-32 mg/mL, the leucovorin composition containing leucovorin calcium pentahydrate in the amount 6.35 mg/mL, equivalent to 5 mg/mL leucovorin content. A preferred sterile, aqueous leucovorin solution in accordance with this invention contains 6.35 mg/mL leucovorin calcium pentahydrate, 22 mg/mL sodium citrate dihydrate, the remainder being sterile water. The pH of this solution is adjusted to 8.1.+-.0.1 with 1N NaOH solution and/or 1N citric acid solution.
摘要翻译：具有改善性质的亚甲素组合物由pH为6.5-8.5的水性等渗无菌亚叶酸钙溶液提供，并含有1mg-32mg / mL范围内的柠檬酸钠二水合物作为缓冲液，含有甲酰四氢钙五水合物的亚叶酸钙组合物含量为6.35mg / mL，相当于5mg / mL亚叶酸钙含量。根据本发明的优选的无菌，含水甲酰四氢叶酸溶液含有6.35mg / mL亚叶酸钙五水合物，22mg / mL柠檬酸钠二水合物，其余为无菌水。用1N NaOH溶液和/或1N柠檬酸溶液将该溶液的pH调节至8.1 +/- 0.1。

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