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    Stabilized protein crystals formulations containing them and methods of making them
    1.
    发明授权
    Stabilized protein crystals formulations containing them and methods of making them 有权
    含有它们的稳定化蛋白质晶体制剂及其制备方法

    公开(公告)号：US06541606B2

    公开(公告)日：2003-04-01

    申请号：US09374132

    申请日：1999-08-10

    申请人： Alexey L. Margolin ,  Nazar K. Khalaf ,  Nancy L. St. Clair ,  Scott L. Rakestraw ,  Bhami C. Shenoy

    发明人： Alexey L. Margolin ,  Nazar K. Khalaf ,  Nancy L. St. Clair ,  Scott L. Rakestraw ,  Bhami C. Shenoy

    IPC分类号： C07K1700

    CPC分类号： A61K9/50 ,  A61K9/0014 ,  A61K9/0019 ,  A61K9/1647 ,  A61K38/27 ,  A61K39/00 ,  A61K39/395 ,  A61K47/10 ,  A61K47/26 ,  A61K47/40 ,  A61K47/42 ,  C07K14/765 ,  C12N9/0004 ,  C12N9/0006 ,  C12N9/18 ,  C12N9/84 ,  C12Y101/03004 ,  C12Y301/01003 ,  C12Y305/01011 ,  Y10S530/813 ,  Y10S530/815

    摘要： This invention relates to methods for the stabilization, storage and delivery of biologically active macromolecules, such as proteins, peptides and nucleic acids. In particular, this invention relates to protein or nucleic acid crystals, formulations and compositions comprising them. Methods are provided for the crystallization of proteins and nucleic acids and for the preparation of stabilized protein or nucleic acid crystals for use in dry or slurry formulations. The present invention is further directed to encapsulating proteins, glycoproteins, enzymes, antibodies, hormones and peptide crystals or crystal formulations into compositions for biological delivery to humans and animals. According to this invention, protein crystals or crystal formulations are encapsulated within a matrix comprising a polymeric carrier to form a composition. The formulations and compositions enhance preservation of the native biologically active tertiary structure of the proteins and create a reservoir which can slowly release active protein where and when it is needed. Methods are provided preparing stabilized formulations using pharmaceutical ingredients or excipients and optionally encapsulating them in a polymeric carrier to produce compositions and using such protein crystal formulations and compositions for biomedical applications, including delivery of therapeutic proteins and vaccines. Additional uses for the protein crystal formulations and compositions of this invention involve protein delivery in human food, agricultural feeds, veterinary compositions, diagnostics, cosmetics and personal care compositions.

    摘要翻译： 本发明涉及用于稳定，储存和递送生物活性大分子如蛋白质，肽和核酸的方法。 特别地，本发明涉及包含它们的蛋白质或核酸晶体，制剂和组合物。 提供了用于蛋白质和核酸结晶的方法以及制备用于干燥或浆液制剂的稳定的蛋白质或核酸晶体。 本发明还涉及将蛋白质，糖蛋白，酶，抗体，激素和肽晶体或晶体制剂包封到用于生物递送给人和动物的组合物中。 根据本发明，将蛋白质晶体或晶体制剂包封在包含聚合物载体的基质中以形成组合物。 制剂和组合物增强蛋白质的天然生物活性三级结构的保存，并产生可以在何时何地需要缓慢释放活性蛋白质的储库。 提供了使用药物成分或赋形剂并任选将其包封在聚合物载体中以产生组合物并使用用于生物医学应用的蛋白质晶体制剂和组合物（包括递送治疗性蛋白质和疫苗）的方法。 本发明的蛋白质晶体制剂和组合物的另外用途涉及人类食物，农业饲料，兽医成分，诊断，化妆品和个人护理组合物中的蛋白质递送。

    Stabilized protein crystals, formulations comprising them and methods of making them
    2.
    发明申请
    Stabilized protein crystals, formulations comprising them and methods of making them 审中-公开
    稳定的蛋白质晶体，包含它们的制剂及其制备方法

    公开(公告)号：US20080226623A1

    公开(公告)日：2008-09-18

    申请号：US12069696

    申请日：2008-02-11

    申请人： Alexey L. Margolin ,  Nazar K. Khalaf ,  Nancy L. St. Clair ,  Scott L. Rakestraw ,  Bhami C. Shenoy

    发明人： Alexey L. Margolin ,  Nazar K. Khalaf ,  Nancy L. St. Clair ,  Scott L. Rakestraw ,  Bhami C. Shenoy

    IPC分类号： A61K39/395 ,  A61K9/48 ,  A61K38/00 ,  A61P43/00 ,  A61K38/46

    CPC分类号： A61K9/50 ,  A61K9/0014 ,  A61K9/0019 ,  A61K9/1647 ,  A61K38/27 ,  A61K39/00 ,  A61K39/395 ,  A61K47/10 ,  A61K47/26 ,  A61K47/40 ,  A61K47/42 ,  C07K14/765 ,  C12N9/0004 ,  C12N9/0006 ,  C12N9/18 ,  C12N9/84 ,  C12Y101/03004 ,  C12Y301/01003 ,  C12Y305/01011 ,  Y10S530/813 ,  Y10S530/815

    摘要： This invention relates to methods for the stabilization, storage and delivery of biologically active macromolecules, such as proteins, peptides and nucleic acids. In particular, this invention relates to protein or nucleic acid crystals, formulations and compositions comprising them. Methods are provided for the crystallization of proteins and nucleic acids and for the preparation of stabilized protein or nucleic acid crystals for use in dry or slurry formulations. The present invention is further directed to encapsulating proteins, glycoproteins, enzymes, antibodies, hormones and peptide crystals or crystal formulations into compositions for biological delivery to humans and animals. According to this invention, protein crystals or crystal formulations are encapsulated within a matrix comprising a polymeric carrier to form a composition. The formulations and compositions enhance preservation of the native biologically active tertiary structure of the proteins and create a reservoir which can slowly release active protein where and when it is needed. Methods are provided preparing stabilized formulations using pharmaceutical ingredients or excipients and optionally encapsulating them in a polymeric carrier to produce compositions and using such protein crystal formulations and compositions for biomedical applications, including delivery of therapeutic proteins and vaccines. Additional uses for the protein crystal formulations and compositions of this invention involve protein delivery in human food, agricultural feeds, veterinary compositions, diagnostics, cosmetics and personal care compositions.

    摘要翻译： 本发明涉及用于稳定，储存和递送生物活性大分子如蛋白质，肽和核酸的方法。 特别地，本发明涉及包含它们的蛋白质或核酸晶体，制剂和组合物。 提供了用于蛋白质和核酸结晶的方法以及制备用于干燥或浆液制剂的稳定的蛋白质或核酸晶体。 本发明还涉及将蛋白质，糖蛋白，酶，抗体，激素和肽晶体或晶体制剂包封到用于生物递送给人和动物的组合物中。 根据本发明，将蛋白质晶体或晶体制剂包封在包含聚合物载体的基质中以形成组合物。 制剂和组合物增强蛋白质的天然生物活性三级结构的保存，并产生可以在何时何地需要缓慢释放活性蛋白质的储库。 提供了使用药物成分或赋形剂并任选将其包封在聚合物载体中以产生组合物并使用用于生物医学应用的蛋白质晶体制剂和组合物（包括递送治疗性蛋白质和疫苗）的方法。 本发明的蛋白质晶体制剂和组合物的另外用途涉及人类食物，农业饲料，兽医成分，诊断，化妆品和个人护理组合物中的蛋白质递送。

    Stabilized protein crystals, formulations comprising them and methods of making them
    3.
    发明授权
    Stabilized protein crystals, formulations comprising them and methods of making them 有权
    稳定的蛋白质晶体，包含它们的制剂及其制备方法

    公开(公告)号：US08558048B2

    公开(公告)日：2013-10-15

    申请号：US12609650

    申请日：2009-10-30

    申请人： Alexey L. Margolin ,  Nazar K. Khalaf ,  Nancy L. St. Clair ,  Scott L. Rakestraw ,  Bhami C. Shenoy

    发明人： Alexey L. Margolin ,  Nazar K. Khalaf ,  Nancy L. St. Clair ,  Scott L. Rakestraw ,  Bhami C. Shenoy

    IPC分类号： C07C7/14 ,  C07C7/20 ,  C01C1/18

    CPC分类号： A61K9/50 ,  A61K9/0014 ,  A61K9/0019 ,  A61K9/1647 ,  A61K38/27 ,  A61K39/00 ,  A61K39/395 ,  A61K47/10 ,  A61K47/26 ,  A61K47/40 ,  A61K47/42 ,  C07K14/765 ,  C12N9/0004 ,  C12N9/0006 ,  C12N9/18 ,  C12N9/84 ,  C12Y101/03004 ,  C12Y301/01003 ,  C12Y305/01011 ,  Y10S530/813 ,  Y10S530/815

    摘要： This invention relates to methods for the stabilization, storage and delivery of biologically active macromolecules, such as proteins, peptides and nucleic acids. In particular, this invention relates to protein or nucleic acid crystals, formulations and compositions comprising them. Methods are provided for the crystallization of proteins and nucleic acids and for the preparation of stabilized protein or nucleic acid crystals for use in dry or slurry formulations. The present invention is further directed to encapsulating proteins, glycoproteins, enzymes, antibodies, hormones and peptide crystals or crystal formulations into compositions for biological delivery to humans and animals. According to this invention, protein crystals or crystal formulations are encapsulated within a matrix comprising a polymeric carrier to form a composition. The formulations and compositions enhance preservation of the native biologically active tertiary structure of the proteins and create a reservoir which can slowly release active protein where and when it is needed. Methods are provided preparing stabilized formulations using pharmaceutical ingredients or excipients and optionally encapsulating them in a polymeric carrier to produce compositions and using such protein crystal formulations and compositions for biomedical applications, including delivery of therapeutic proteins and vaccines. Additional uses for-the protein crystal formulations and compositions of this invention involve protein delivery in human food, agricultural feeds, veterinary compositions, diagnostics, cosmetics and personal care compositions.

    摘要翻译： 本发明涉及用于稳定，储存和递送生物活性大分子如蛋白质，肽和核酸的方法。 特别地，本发明涉及包含它们的蛋白质或核酸晶体，制剂和组合物。 提供了用于蛋白质和核酸结晶的方法以及制备用于干燥或浆液制剂的稳定的蛋白质或核酸晶体。 本发明还涉及将蛋白质，糖蛋白，酶，抗体，激素和肽晶体或晶体制剂包封到用于生物递送给人和动物的组合物中。 根据本发明，将蛋白质晶体或晶体制剂包封在包含聚合物载体的基质中以形成组合物。 制剂和组合物增强蛋白质的天然生物活性三级结构的保存，并产生可以在何时何地需要缓慢释放活性蛋白质的储库。 提供了使用药物成分或赋形剂并任选将其包封在聚合物载体中以产生组合物并使用用于生物医学应用的蛋白质晶体制剂和组合物（包括递送治疗性蛋白质和疫苗）的方法。 用于本发明的蛋白质晶体制剂和组合物的其它用途涉及人类食物，农业饲料，兽医成分，诊断，化妆品和个人护理组合物中的蛋白质递送。

    Controlled dissolution crosslinked protein crystals
    4.
    发明授权
    Controlled dissolution crosslinked protein crystals 失效
    受控溶解交联蛋白晶体

    公开(公告)号：US6140475A

    公开(公告)日：2000-10-31

    申请号：US834661

    申请日：1997-04-11

    申请人： Alexey L. Margolin ,  Rose A. Persichetti ,  Nancy L. St. Clair ,  Nazer K. Khalaf

    发明人： Alexey L. Margolin ,  Rose A. Persichetti ,  Nancy L. St. Clair ,  Nazer K. Khalaf

    IPC分类号： C12N9/20 ,  A23K1/16 ,  A61K8/35 ,  A61K8/36 ,  A61K8/42 ,  A61K8/46 ,  A61K8/64 ,  A61K8/66 ,  A61K8/72 ,  A61K9/22 ,  A61P31/12 ,  A61Q5/02 ,  A61Q19/00 ,  C07K1/14 ,  C07K14/765 ,  C11D3/37 ,  C11D3/386 ,  C11D17/00 ,  C12N9/56 ,  C12N11/00 ,  C12N11/04 ,  C12S99/00 ,  C07K17/00 ,  A61K38/00 ,  C12N9/96

    CPC分类号： C12N9/54 ,  A23K20/147 ,  A61K8/64 ,  A61Q19/00 ,  A61Q5/02 ,  C07K14/765 ,  C11D3/3719 ,  C11D3/38 ,  C11D3/386 ,  C12N11/00 ,  C12N9/20 ,  C12N9/92 ,  C12N9/96 ,  C12Y304/21062 ,  C12Y304/24027 ,  C12Y503/01005 ,  C30B29/58 ,  C07K2299/00 ,  Y10S530/81

    摘要： Protein crystals crosslinked with a multifunctional crosslinking agent are produced that have the ability to change from an insoluble and stable form to a soluble and active form and to release protein activity at a controlled rate when a change in environment surrounding the crystals occurs. The change in environment may be a change in temperature, pH, chemical composition or shear force acting on the crystals, or a change from a concentrate to a dilute form, or a combination of the changes. The crosslinked protein crystals have a half-life activity under storage conditions greater than at least 2 times that of the soluble protein that is crystallized to form the crystals that are crosslinked, and under conditions of use have an activity similar to the soluble protein. Crosslinking is carried out by reacting a slurry of protein crystals with a multifunctional crosslinking agent such as glutaraldehyde, glyoxal, octanedialdehyde or succinaldehyde using a concentration of crosslinking agent and time for crosslinking that provides crosslinked protein crystals having the desired ability to change due to a change in environment. An epoxide multifunctional crosslinking agent may be used in combination with glutaraldehyde for crosslinking. The crosslinked protein crystals can be used for protein delivery, and may be used in cleaning agents such as detergents, pharmaceutical compositions, vaccines, personal care compositions, veterinary compositions, foods, feeds, diagnostics and decontamination formulations. Proteins used include enzymes and therapeutic or prophylactic proteins such as hormones and antibodies.

    摘要翻译： 产生与多功能交联剂交联的蛋白质晶体，其具有从不溶性和稳定形式变为可溶性和活性形式的能力，并且当发生晶体周围环境变化时以受控的速率释放蛋白质活性。 环境变化可能是作用于晶体的温度，pH值，化学成分或剪切力的变化，或从浓缩物到稀释形式的变化，或变化的组合。 交联的蛋白质晶体在保存条件下的半衰期活性大于结晶形成交联晶体的可溶性蛋白质的至少2倍，并且在使用条件下具有类似于可溶性蛋白质的活性。 通过使用交联剂的浓度和交联时间使蛋白质晶体的浆料与多功能交联剂如戊二醛，乙二醛，辛二醛或琥珀醛反应来进行交联，从而提供具有期望由于变化而变化的能力的交联蛋白质晶体 在环境中。 环氧多官能交联剂可与戊二醛组合用于交联。 交联的蛋白质晶体可以用于蛋白质递送，并且可以用于清洁剂如洗涤剂，药物组合物，疫苗，个人护理组合物，兽医组合物，食品，饲料，诊断和去污配方中。 使用的蛋白质包括酶和治疗或预防性蛋白质，例如激素和抗体。

    Treating abdominal pain due to pancreatitis with seaprose
    6.
    发明授权
    Treating abdominal pain due to pancreatitis with seaprose 有权
    治疗由于腹水引起的胰腺炎引起的腹痛

    公开(公告)号：US07459155B2

    公开(公告)日：2008-12-02

    申请号：US10977737

    申请日：2004-10-29

    申请人： Alexey L. Margolin ,  Bhami C. Shenoy ,  Margaret McGrath

    发明人： Alexey L. Margolin ,  Bhami C. Shenoy ,  Margaret McGrath

    IPC分类号： A61K38/48

    CPC分类号： A61K38/482 ,  A61K38/1709 ,  A61K38/465 ,  A61K38/47 ,  A61K38/4826 ,  A61K2300/00

    摘要： This invention relates to methods for maintaining the basal level or reducing the level of cholecystokinin (CCK) in blood plasma of a mammal. Additionally, the invention provides methods for treating pain in a mammal and more particularly, methods for treating abdominal pain in a mammal. The methods include administering to the mammal a non-pancreatic protease or a composition comprising a non-pancreatic protease. The methods of this invention are particularly useful for treating abdominal pain in a mammal suffering from acute or chronic pancreatitis and related conditions.

    摘要翻译： 本发明涉及维持哺乳动物血浆中基底水平或降低胆囊收缩素（CCK）水平的方法。 另外，本发明提供了治疗哺乳动物疼痛的方法，更具体地，涉及治疗哺乳动物腹痛的方法。 所述方法包括向哺乳动物施用非胰蛋白酶或包含非胰蛋白酶的组合物。 本发明的方法特别可用于治疗患有急性或慢性胰腺炎和相关病症的哺乳动物的腹痛。

    Compositions and methods for treating pancreatic insufficiency
    8.
    发明授权
    Compositions and methods for treating pancreatic insufficiency 有权
    治疗胰腺功能不全的组合物和方法

    公开(公告)号：US07718169B2

    公开(公告)日：2010-05-18

    申请号：US11251278

    申请日：2005-10-14

    申请人： Alexey L. Margolin ,  Bhami C. Shenoy ,  Frederick T. Murray ,  Anthony Christopher Lee Stevens

    发明人： Alexey L. Margolin ,  Bhami C. Shenoy ,  Frederick T. Murray ,  Anthony Christopher Lee Stevens

    IPC分类号： A61K38/54

    CPC分类号： A61K38/48 ,  A61K38/465 ,  A61K38/47 ,  A61K38/54 ,  A61K2300/00

    摘要： The present invention relates to compositions for the treatment of conditions, including pancreatic insufficiency. The compositions of the present invention comprise lipase, protease and amylase in a particular ratio that provides beneficial results in patients, such as those afflicted with pancreatic insufficiency. This invention also relates to methods using such compositions for the treatment of pancreatic insufficiency. The compositions specifically comprise crosslinked Burkholderia cepacia lipase crystals, Aspergillus melleus protease crystals and amorphous Aspergillus oryzae amylase in a ratio of about 1:1:0.15 USP units.

    摘要翻译： 本发明涉及用于治疗包括胰腺功能不全的病症的组合物。 本发明的组合物以特定的比率包含脂肪酶，蛋白酶和淀粉酶，这在患者（例如患有胰腺功能不全的患者）中提供有益的结果。 本发明还涉及使用这种组合物治疗胰腺功能不全的方法。 组合物具体包括洋葱伯克霍尔德氏菌脂肪酶晶体，曲霉曲霉蛋白酶晶体和无规米曲霉淀粉酶，其比例为约1:1:0.1USU单位。

    NON-PANCREATIC PROTEASES FOR CONTROLLING PLASMA CHOLECYSTOKININ (CCK) CONCENTRATION AND FOR TREATING PAIN
    9.
    发明申请
    NON-PANCREATIC PROTEASES FOR CONTROLLING PLASMA CHOLECYSTOKININ (CCK) CONCENTRATION AND FOR TREATING PAIN 审中-公开
    用于控制等离子体CHOINEYSTOKININ（CCK）浓度和治疗疼痛的非胰蛋白酶

    公开(公告)号：US20090081184A1

    公开(公告)日：2009-03-26

    申请号：US12258122

    申请日：2008-10-24

    申请人： Alexey L. Margolin ,  Bhami C. Shenoy ,  Margaret McGrath

    发明人： Alexey L. Margolin ,  Bhami C. Shenoy ,  Margaret McGrath

    IPC分类号： A61K38/47 ,  A61K38/48 ,  A61K38/43

    CPC分类号： A61K38/482 ,  A61K38/1709 ,  A61K38/465 ,  A61K38/47 ,  A61K38/4826 ,  A61K2300/00

    摘要： This invention relates to methods for maintaining the basal level or reducing the level of cholecystokinin (CCK) in blood plasma of a mammal. Additionally, the invention provides methods for treating pain in a mammal and more particularly, methods for treating abdominal pain in a mammal. The methods include administering to the mammal a non-pancreatic protease or a composition comprising a non-pancreatic protease. The methods of this invention are particularly useful for treating abdominal pain in a mammal suffering from acute or chronic pancreatitis and related conditions.

    摘要翻译： 本发明涉及维持哺乳动物血浆中基底水平或降低胆囊收缩素（CCK）水平的方法。 另外，本发明提供了治疗哺乳动物疼痛的方法，更具体地，涉及治疗哺乳动物腹痛的方法。 所述方法包括向哺乳动物施用非胰蛋白酶或包含非胰蛋白酶的组合物。 本发明的方法特别可用于治疗患有急性或慢性胰腺炎和相关病症的哺乳动物的腹痛。