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1. 发明授权

US06864301B2 Preparation and use of photopolymerized microparticles 失效
公开(公告)号：US06864301B2
公开(公告)日：2005-03-08
申请号：US10161544
申请日：2002-06-03
申请人： Theodore Randolph , Kristi Anseth , Jennifer L. Owens , Corinne Lengsfeld
发明人： Theodore Randolph , Kristi Anseth , Jennifer L. Owens , Corinne Lengsfeld
IPC分类号： A61K9/16 , C08F2/06 , C08F2/18 , C08F2/46 , C08J3/28 , C08J9/00 , C08K5/00
CPC分类号： A61K9/1635 , A61K9/1694 , C08F2/06 , C08F2/18 , C08F2/46 , Y10T428/2982 , Y10T428/2984 , Y10T428/2985 , Y10T428/2989
摘要： Methods of forming crosslinked polymer particles in situ from polymer precursors such as monomers or oligomers, comprising exposing a composition comprising at least one polymer precursor, a solvent or solvent mixture, and an antisolvent or antisolvent mixture to photoradiation under conditions whereby particles are formed are provided. The polymer precursor may be photosensitive, or a separate polymerization initiator may be used. In a preferred embodiment, the polymer precursor is insoluble in the antisolvent or antisolvent mixture and the solvent or solvent mixture is soluble in the antisolvent or antisolvent mixture at the concentrations used. Crosslinked polymer particles and crosslinked polymer particles comprising a polymer and a bioactive material are also provided. The polymer may be erodable, and the polymer particles formed may be used in a variety of applications, including controlled release of bioactive materials such as drugs. Polymer particles formed using the methods of the invention have low residual solvent levels and high additive encapsulation efficiencies. The processes of the invention allow control of particle size and morphology, use low operating temperatures and are useful for efficient bulk production.

2. 发明授权

US06403672B1 Preparation and use of photopolymerized microparticles 失效
标题翻译：光聚合微粒的制备和应用
公开(公告)号：US06403672B1
公开(公告)日：2002-06-11
申请号：US09451481
申请日：1999-11-30
申请人： Theodore Randolph , Kristi Anseth , Jennifer L. Owens , Corinne Lengsfeld
发明人： Theodore Randolph , Kristi Anseth , Jennifer L. Owens , Corinne Lengsfeld
IPC分类号： C08F246
CPC分类号： A61K9/1694 , A61K9/1635 , C08F2/06 , C08F2/18 , C08F2/46
摘要： Methods of forming polymer particles in situ from polymer precursors such as monomers or oligomers, comprising exposing a composition comprising at least one polymer precursor, a solvent or solvent mixture, and an antisolvent or antisolvent mixture to photoradiation under conditions whereby particles are formed are provided. The polymer precursor may be photosensitive, or a separate polymerization initiator may be used. In a preferred embodiment, the polymer precursor is insoluble in the antisolvent or antisolvent mixture and the solvent or solvent mixture is soluble in the antisolvent or antisolvent mixture at the concentrations used. Polymer particles comprising a polymer and a bioactive material are also provided. The polymer may be erodable, and the polymer particles formed may be used in a variety of applications, including controlled release of bioactive materials such as drugs. Polymer particles formed using the methods of the invention have low residual solvent levels and high additive encapsulation efficiencies. The processes of the invention allow control of particle size and morphology, use low operating temperatures and are useful for efficient bulk production.
摘要翻译：提供从聚合物前体例如单体或低聚物原位形成聚合物颗粒的方法，其包括将包含至少一种聚合物前体，溶剂或溶剂混合物的组合物以及抗溶剂或抗溶剂混合物暴露于形成颗粒的条件下进行光引发。聚合物前体可以是光敏的，或者可以使用单独的聚合引发剂。在优选的实施方案中，聚合物前体不溶于抗溶剂或抗溶剂混合物，溶剂或溶剂混合物可以以所使用的浓度溶于抗溶剂或抗溶剂混合物。还提供了包含聚合物和生物活性材料的聚合物颗粒。聚合物可能是可侵蚀的，并且形成的聚合物颗粒可以用于各种应用中，包括诸如药物的生物活性材料的控制释放。使用本发明方法形成的聚合物颗粒具有低的残留溶剂水平和高的添加剂包封效率。本发明的方法允许控制颗粒尺寸和形态，使用低的操作温度，并且可用于高效批量生产。

3. 发明申请

US20050192371A1 Preparation and use of photopolymerized microparticles 审中-公开
标题翻译：光聚合微粒的制备和应用
公开(公告)号：US20050192371A1
公开(公告)日：2005-09-01
申请号：US11070506
申请日：2005-03-02
申请人： Theodore Randolph , Kristi Anseth , Jennifer Owens , Corinne Lengsfeld
发明人： Theodore Randolph , Kristi Anseth , Jennifer Owens , Corinne Lengsfeld
IPC分类号： A61K9/16 , C08F2/06 , C08F2/18 , C08F2/46 , C08K3/00
CPC分类号： A61K9/1635 , A61K9/1694 , C08F2/06 , C08F2/18 , C08F2/46 , Y10T428/2982 , Y10T428/2984 , Y10T428/2985 , Y10T428/2989
摘要： Methods of forming crosslinked polymer particles in situ from polymer precursors such as monomers or oligomers, comprising exposing a composition comprising at least one polymer precursor, a solvent or solvent mixture, and an antisolvent or antisolvent mixture to photoradiation under conditions whereby particles are formed are provided. The polymer precursor may be photosensitive, or a separate polymerization initiator may be used. In a preferred embodiment, the polymer precursor is insoluble in the antisolvent or antisolvent mixture and the solvent or solvent mixture is soluble in the antisolvent or antisolvent mixture at the concentrations used. Crosslinked polymer particles and crosslinked polymer particles comprising a polymer and a bioactive material are also provided. The polymer may be erodable, and the polymer particles formed may be used in a variety of applications, including controlled release of bioactive materials such as drugs. Polymer particles formed using the methods of the invention have low residual solvent levels and high additive encapsulation efficiencies. The processes of the invention allow control of particle size and morphology, use low operating temperatures and are useful for efficient bulk production.
摘要翻译：提供从聚合物前体如单体或低聚物原位形成交联聚合物颗粒的方法，包括将包含至少一种聚合物前体，溶剂或溶剂混合物的组合物以及抗溶剂或抗溶剂混合物暴露于形成颗粒的条件下进行光引发。聚合物前体可以是光敏的，或者可以使用单独的聚合引发剂。在优选的实施方案中，聚合物前体不溶于抗溶剂或抗溶剂混合物，溶剂或溶剂混合物可以以所使用的浓度溶于抗溶剂或抗溶剂混合物。还提供了交联聚合物颗粒和包含聚合物和生物活性材料的交联聚合物颗粒。聚合物可能是可侵蚀的，并且形成的聚合物颗粒可以用于各种应用中，包括诸如药物的生物活性材料的控制释放。使用本发明方法形成的聚合物颗粒具有低的残留溶剂水平和高的添加剂包封效率。本发明的方法允许控制颗粒尺寸和形态，使用低的操作温度，并且可用于高效批量生产。

4. 发明申请

US20050051917A1 Devices and methods for the production of particles 失效
标题翻译：用于生产颗粒的装置和方法
公开(公告)号：US20050051917A1
公开(公告)日：2005-03-10
申请号：US10483194
申请日：2002-07-10
申请人： Willy Grothe , Daniel Jarmer , Corinne Lengsfeld , Theodore Randolph
发明人： Willy Grothe , Daniel Jarmer , Corinne Lengsfeld , Theodore Randolph
IPC分类号： B01D11/04 , B01F5/00 , B01J2/04 , B29B9/00
CPC分类号： B01J2/04 , B01D11/0403 , B01D11/0407 , B01D11/0473 , B01F5/0057 , B01F2003/0064
摘要： The present invention provides methods and devices for producing particles with an average diameter less than about 15 μm using the precipitation with compressed fluid-antisolvent (PCA) process and the carbon-dioxide assisted nebulization with a bubble dryer (CAN-BD) process. In the methods and nozzles of the invention, at least one jet of supercritical or near-supercritical fluid and at least one jet of solution interact to mix the supercritical or near-supercritical fluid and the solution within a chamber. The solution contains at least one solvent and at least one solute. At least one of the jets is a swirling jet. To form particles, the solvent and supercritical or near-supercritical fluid are then injected into a PCA or a CAN-BD process chamber. The degree of mixing depends in part on the power input into the mixing chamber. Power inputs of about 6.5×109 W/m3 enhance the degree of mixing and allow production of nanoscale particles with the PCA process. The nanoscale particles have a size distribution so that polydispersity is less than about 1.75.
摘要翻译：本发明提供了使用压缩流体 - 反溶剂（PCA）沉淀法和用气泡干燥器（CAN-BD）方法进行二氧化碳辅助雾化来生产平均直径小于约15μm的颗粒的方法和装置。在本发明的方法和喷嘴中，至少一个超临界或近超临界流体射流和至少一个溶液射流相互作用以将超临界或近超临界流体和溶液在腔室内混合。该溶液含有至少一种溶剂和至少一种溶质。至少有一架喷气式飞机是旋流式飞机。为了形成颗粒，然后将溶剂和超临界或近临界流体注入PCA或CAN-BD处理室中。混合程度部分取决于输入混合室的功率。大约6.5×10 9 W / m 3的功率输入提高了混合的程度，并允许用PCA工艺生产纳米级颗粒。纳米级颗粒具有尺寸分布，使得多分散性小于约1.75。

5. 发明授权

US07332111B2 Devices and methods for the production of particles 失效
标题翻译：用于生产颗粒的装置和方法
公开(公告)号：US07332111B2
公开(公告)日：2008-02-19
申请号：US10483194
申请日：2002-07-10
申请人： Willy Grothe , Daniel Jarmer , Corinne Lengsfeld , Theodore Randolph
发明人： Willy Grothe , Daniel Jarmer , Corinne Lengsfeld , Theodore Randolph
IPC分类号： B29B9/00
CPC分类号： B01J2/04 , B01D11/0403 , B01D11/0407 , B01D11/0473 , B01F5/0057 , B01F2003/0064
摘要： The present invention provides methods and devices for producing particles with an average diameter less than about 15 μm using the precipitation with compressed fluid-antisolvent (PCA) process and the carbon-dioxide assisted nebulization with a bubble dryer (CAN-BD) process. In the methods and nozzles of the invention, at least one jet of supercritical or near-supercritical fluid and at least one jet of solution interact to mix the supercritical or near-supercritical fluid and the solution within a chamber. The solution contains at least one solvent and at least one solute. At least one of the jets is a swirling jet. To form particles, the solvent and supercritical or near-supercritical fluid are then injected into a PCA or a CAN-BD process chamber. The degree of mixing depends in part on the power input into the mixing chamber. Power inputs of about 6.5×109 W/m3 enhance the degree of mixing and allow production of nanoscale particles with the PCA process. The nanoscale particles have a size distribution so that polydispersity is less than about 1.75.
摘要翻译：本发明提供了使用压缩流体 - 反溶剂（PCA）沉淀法和用气泡干燥器（CAN-BD）方法进行二氧化碳辅助雾化来生产平均直径小于约15μm的颗粒的方法和装置。在本发明的方法和喷嘴中，至少一个超临界或近超临界流体射流和至少一个溶液射流相互作用以将超临界或近超临界流体和溶液在腔室内混合。该溶液含有至少一种溶剂和至少一种溶质。至少有一架喷气式飞机是旋流式飞机。为了形成颗粒，然后将溶剂和超临界或近临界流体注入PCA或CAN-BD处理室中。混合程度部分取决于输入混合室的功率。大约6.5×10 9 W / m 3的功率输入提高了混合的程度并允许用PCA工艺生产纳米尺寸的颗粒。纳米级颗粒具有尺寸分布，使得多分散性小于约1.75。

6. 发明申请

US20060078573A1 Methods of modifying crystal habit 审中-公开
标题翻译：改变水晶习惯的方法
公开(公告)号：US20060078573A1
公开(公告)日：2006-04-13
申请号：US11152041
申请日：2005-06-13
申请人： Theodore Randolph , Corinne Lengsfeld , Daniel Jarmer
发明人： Theodore Randolph , Corinne Lengsfeld , Daniel Jarmer
IPC分类号： A61K9/00
CPC分类号： A61K9/146
摘要： The invention provides methods of modifying the crystal habit of a compound without altering the crystal structure of the compound through a controlled precipitation technique in the presence of a crystal growth inhibitor as well as the crystallized compounds formed by these methods. Using these methods, the crystal habit of the compound may be modified from acicular to bipyramidal. The modification in crystal habit is attributable to a preferential adsorption mechanism of the crystal growth inhibitor to a fast growing crystal face of the compound. Powder flow properties of the crystallized product are significantly enhanced with the habit modification. This selective crystal habit modification using a crystal growth inhibitor provides a strategy to circumvent the manufacturing difficulties associated with acicular crystal habits, and may increase the manufacturing capability of supercritical fluid based crystallization and precipitation technologies.
摘要翻译：本发明提供了在晶体生长抑制剂存在下通过受控沉淀技术改变化合物的晶体结构而不改变化合物的晶体结构的方法以及通过这些方法形成的结晶化合物。使用这些方法，可以将化合物的晶体习性从针状体改为双锥体状。晶体习性的改变归功于晶体生长抑制剂对化合物快速生长晶面的优先吸附机理。随着习惯的改变，结晶产物的粉末流动性显着增强。使用晶体生长抑制剂的这种选择性晶体习性修饰提供了避免与针状晶体习惯相关的制造困难的策略，并且可以增加超临界流体的结晶和沉淀技术的制造能力。

7. 发明申请

US20110106044A1 METHODS FOR EVALUATING THE AGGREGATION OF A PROTEIN IN A SUSPENSION INCLUDING ORGANOPOLYSILOXANE AND MEDICAL ARTICLES COATED WITH ORGANOPOLYSILOXANE CONTAINING A PROTEIN SOLUTION 有权
标题翻译：评估含有蛋白质组合的蛋白质的方法，包括包含有机蛋白质组合的蛋白质和包含蛋白质溶液的含有代谢物的医药品
公开(公告)号：US20110106044A1
公开(公告)日：2011-05-05
申请号：US12739009
申请日：2008-10-22
申请人： Joseph T. Trotter , Jean-Bernard Hamel , John Frank Carpenter , Theodore Randolph , John Paul Gabrielson
发明人： Joseph T. Trotter , Jean-Bernard Hamel , John Frank Carpenter , Theodore Randolph , John Paul Gabrielson
IPC分类号： A61J1/05 , G01N21/76
CPC分类号： A61K47/34 , A61K47/26 , G01N33/582 , G01N33/6803
摘要： This invention relates to methods for evaluating or inhibiting the aggregation of a protein in an aqueous suspension including organopolysiloxane and medical articles coated with organopolysiloxane containing a protein solution including sugar and a non-ionic surfactant.
摘要翻译：本发明涉及用于评估或抑制包含有机聚硅氧烷的水性悬浮液中的蛋白质聚集的方法，以及包含含有糖和非离子表面活性剂的蛋白质溶液的有机聚硅氧烷的医用制品。

8. 发明申请

US20100129379A1 STABILIZED ANTIBODY FORMULATIONS AND USES THEREOF 审中-公开
标题翻译：稳定的抗体制剂及其用途
公开(公告)号：US20100129379A1
公开(公告)日：2010-05-27
申请号：US12442655
申请日：2007-09-25
申请人： John Carpenter , Hasige Sathish , Theodore Randolph , Branden Salinas , Christian Allan , Steven Bishop
发明人： John Carpenter , Hasige Sathish , Theodore Randolph , Branden Salinas , Christian Allan , Steven Bishop
IPC分类号： A61K39/395 , A61P35/00 , A61P37/02
CPC分类号： C07K16/244 , A61K9/0019 , A61K39/39591 , A61K2039/505 , C07K16/00 , C07K2317/56 , C07K2317/565
摘要： The present invention provides methods of optimizing certain stable liquid formulations of antibodies that immunospecifically bind to antigens of interest. Such formulations are suitable for parenteral administration to a subject, and exhibit increased stability, low to undetectable levels of aggregation, low to undetectable levels of antibody fragmentation/degradation, and very little to no loss of the biological activities of the antibodies, even during long periods of storage. The methods of the invention provide formulations that offer multiple advantages over formulations produced by non-optimized methods, including less stringent or more readily available transportation and storage conditions, less frequent dosing, and/or smaller dosage amounts in the therapeutic, prophylactic and diagnostic uses of such formulations. The invention further provides methods of identifying antibodies exhibiting certain phase behaviors such that the antibodies can be formulated by the methods of the invention. Also provided are prophylactic, therapeutic, and diagnostic uses of such antibody formulations.
摘要翻译：本发明提供了优化与感兴趣的抗原免疫特异性结合的抗体的某些稳定液体制剂的方法。这样的制剂适合于对受试者的肠胃外给药，并且表现出增加的稳定性，低至不可检测的聚集水平，低至不可检测的抗体断裂/降解水平，以及甚至在长时间内抗体的生物活性很少甚至没有损失储存期本发明的方法提供了与通过非优化方法制备的制剂相比具有多种优点的配方，包括在治疗，预防和诊断用途中包括较不严格或更易于获得的运输和储存条件，较不频繁的给药和/或较小的剂量的这种制剂。本发明还提供了鉴定表现出某些相行为的抗体的方法，使得可以通过本发明的方法配制抗体。还提供了这种抗体制剂的预防，治疗和诊断用途。

9. 发明申请

US20060188970A1 High pressure refolding of protein aggregates and inclusion bodies 有权
公开(公告)号：US20060188970A1
公开(公告)日：2006-08-24
申请号：US11341013
申请日：2006-01-27
申请人： Theodore Randolph , John Carpenter , Richard St. John
发明人： Theodore Randolph , John Carpenter , Richard St. John
IPC分类号： C12N9/00
CPC分类号： C07K14/61 , C07K1/1133 , C07K1/1136 , C12N9/2462
摘要： The present disclosure provides an effective method for the refolding of denatured proteins in solution so that properly folded, biologically active protein in solution is recovered in high yield. The refolding takes place at pressures between about 0.25 kbar to about 3.5 kbar, advantageously at about 1.5 kbar to about 3 kbar. Typically a chaotropic agent is present at a concentration which is not effective for denaturing protein at atmospheric pressure, and optionally, oxidation-reduction reagents can be incorporated in the refolding solution so that native intramolecular disulfide bonds can be formed where that is desired. The method is applicable to substantially all proteins, especially after solubilization and/or denaturation of insoluble protein aggregates, inclusion bodies, or abnormal oligomeric (soluble) aggregates.

10. 发明申请

US20060079450A1 Hydroxyethyl starch-containing polypeptide compositions 有权
公开(公告)号：US20060079450A1
公开(公告)日：2006-04-13
申请号：US11236213
申请日：2005-09-27
申请人： Nicholas Warne , Rebecca Koval , John Carpenter , Theodore Randolph , Suchart Chongpraset
发明人： Nicholas Warne , Rebecca Koval , John Carpenter , Theodore Randolph , Suchart Chongpraset
IPC分类号： A61K38/16 , A61K31/7012 , A61K31/718
CPC分类号： A61K9/0019 , A61K9/19 , A61K31/7012 , A61K31/717 , A61K38/2073 , A61K47/26 , A61K47/36 , A61K2300/00
摘要： The invention provides compositions containing hydroxyethyl starch and polypeptides, including therapeutic polypeptides such as interleukin-11, that provide for enhanced stability of the polypeptide following storage at room temperature or elevated temperatures.

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