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41. 发明授权

US07833549B2 Dry powder formulations of antihistamine for nasal administration 有权
标题翻译：用于鼻内给药的抗组胺药的干粉制剂
公开(公告)号：US07833549B2
公开(公告)日：2010-11-16
申请号：US09766362
申请日：2001-01-19
申请人： Solomon S. Steiner , Bryan R. Wilson
发明人： Solomon S. Steiner , Bryan R. Wilson
IPC分类号： A61K9/14 , A61K9/16
CPC分类号： A61K31/4402 , A61K9/0043 , A61K9/145 , A61K9/146 , A61K9/1617 , A61K9/1629 , A61K9/19 , A61K31/55
摘要： Dry powder formulations of drugs such as antihistamine for nasal administration are provided where the drug is retained in the nasal cavity, and systemic side effects minimized or eliminated, through the selection of a narrow particle size range, between approximately 10 and 20 microns in diameter. In a preferred embodiment wherein the drug is an antihistamine, retention of the antihistamine at the nasal mucosa is improved and the bitter aftertaste associated with liquid antihistamine formulations significantly reduced. By making a dry powder formulation of an antihistamine (e.g., azelastine) having an average particle size of between 10 and 20 microns, the antihistamine is restricted primarily to the desired target organ, the nasal mucosa. Because the active ingredient stays in the nasal region, a lower dose can be used to achieve the same desired effect. As demonstrated by the examples, this lower dose reduces the incidence of somnolence, and because the active ingredient remains at the target organ and does not accumulate in the back of the throat and mouth, this formulation does not impart a bitter taste.
摘要翻译：提供药物的干粉制剂，例如用于鼻内给药的抗组胺药物，其中药物保留在鼻腔中，通过选择直径约10至20微米之间的窄粒度范围，将全身副作用最小化或消除。在其中药物是抗组胺剂的优选实施方案中，抗组胺剂在鼻粘膜处的保留性得到改善，并且与液体抗组胺药配方相关的苦味回味显着降低。通过制备平均粒度为10至20微米的抗组胺药（例如氮卓斯汀）的干粉制剂，抗组织胺主要限于所需的靶器官鼻粘膜。因为活性成分停留在鼻区域，所以可以使用较低的剂量来达到相同的期望效果。如实施例所示，该较低剂量降低嗜睡的发生率，并且由于活性成分保留在目标器官处并且不积聚在喉部和口腔的后部，所以该制剂不赋予苦味。

42. 发明授权

US07794754B2 Methods for fine powder formation 有权
标题翻译：精细粉末形成方法
公开(公告)号：US07794754B2
公开(公告)日：2010-09-14
申请号：US11385513
申请日：2006-03-21
申请人： Robert Feldstein , Solomon S. Steiner
发明人： Robert Feldstein , Solomon S. Steiner
IPC分类号： A61K38/00 , C07K14/00
CPC分类号： A61K9/0073 , A61K9/1652 , A61K9/1658 , A61K9/1688 , A61K9/1694 , F26B5/065
摘要： Improved methods for forming fine particles of a material have been developed, wherein the method steps include dissolving the material in a solvent to form a dilute solution, immobilizing the dilution solution, and then removing the solvent to yield particles of the material. Methods of immobilizing the dilute solution include freezing, gelation, and chelation. In a preferred embodiment, the immobilized solvent is removed by lyophilization, i.e. reducing the ambient pressure while avoiding application of sufficient heat to power a phase transition. Essentially any material and solvent for the material can be used in the methods described herein. Proteins and peptides in an aqueous solvent are the preferred systems.
摘要翻译：已经开发了用于形成材料细颗粒的改进方法，其中所述方法步骤包括将所述材料溶解在溶剂中以形成稀溶液，固定所述稀释溶液，然后除去所述溶剂以产生所述材料的颗粒。固定稀释溶液的方法包括冷冻，凝胶化和螯合。在一个优选的实施方案中，通过冻干除去固定的溶剂，即降低环境压力，同时避免施加足够的热量以对相变作用。基本上可以在本文所述的方法中使用材料的任何材料和溶剂。水性溶剂中的蛋白质和肽是优选的体系。

43. 发明申请

US20100227795A1 INSULIN FORMULATIONS FOR RAPID UPTAKE 有权
标题翻译：胰岛素制剂用于快速摄取
公开(公告)号：US20100227795A1
公开(公告)日：2010-09-09
申请号：US12397219
申请日：2009-03-03
申请人： Solomon S. Steiner , Roderike Pohl , Ming Li , Robert Hauser
发明人： Solomon S. Steiner , Roderike Pohl , Ming Li , Robert Hauser
IPC分类号： A61K38/28 , A61P3/10
CPC分类号： A61K9/0019 , A61K38/00 , A61K38/28 , A61K47/12 , A61K47/183 , C07K14/62
摘要： Injectable insulin formulations with improved stability and rapid onset of action are described herein. The formulations may be for subcutaneous, intradermal or intramuscular administration. In the preferred embodiment, the formulations are administered via subcutaneous injection. The formulations contain insulin in combination with a chelator and dissolution agent, and optionally additional excipients. In the preferred embodiment, the formulation contains human insulin, a zinc chelator such as EDTA and a dissolution agent such as citric acid or sodium citrate. These formulations are rapidly absorbed into the blood stream when administered by subcutaneous injection. In the preferred embodiment, the insulin is provided as a clear liquid, neutral pH, in a multi-use sterile vial. In an alternative embodiment, the insulin is provided as a powder in a sterile vial. This is mixed with a diluent containing a pharmaceutically acceptable carrier, such as water, a zinc chelator such as EDTA and a dissolution agent such as citric acid shortly before or at the time of administration. In another embodiment, the insulin is stored as a frozen mixture, ready for use upon thawing.
摘要翻译：本文描述了具有改善的稳定性和快速起效的可注射的胰岛素制剂。制剂可用于皮下，皮内或肌内给药。在优选的实施方案中，通过皮下注射施用制剂。制剂含有与螯合剂和溶解剂以及任选的其它赋形剂组合的胰岛素。在优选的实施方案中，制剂含有人胰岛素，锌螯合剂如EDTA和溶解剂如柠檬酸或柠檬酸钠。当通过皮下注射给药时，这些制剂被快速地吸收到血流中。在优选的实施方案中，胰岛素以多用途无菌小瓶中的透明液体中性pH提供。在替代实施方案中，胰岛素以无菌小瓶中的粉末形式提供。将其与包含药学上可接受的载体如水，锌螯合剂如EDTA的稀释剂和不久之前或给药时的溶解剂如柠檬酸混合。在另一个实施方案中，将胰岛素作为冷冻混合物储存，准备在解冻时使用。

44. 发明授权

US07648960B2 Method for delivery of monomeric or dimeric insulin complexed to diketopiperazine microparticles 有权
标题翻译：用于递送与二酮哌嗪微粒络合的单体或二聚体胰岛素的方法
公开(公告)号：US07648960B2
公开(公告)日：2010-01-19
申请号：US10719734
申请日：2003-11-21
申请人： Solomon S. Steiner , Rodney J. Woods , Joseph W. Sulner
发明人： Solomon S. Steiner , Rodney J. Woods , Joseph W. Sulner
IPC分类号： A61K38/28 , A61K38/00 , A61K9/00 , A61K9/14
CPC分类号： A61K47/22 , A61K9/0019 , A61K9/0073 , A61K9/0075 , A61K9/14 , A61K9/145 , A61K9/1617 , A61K9/1676 , A61K38/28 , A61K47/6949 , B82Y5/00 , C07D241/08 , C07K1/30 , C07K1/32 , C07K14/605 , C07K14/62 , Y10S514/866
摘要： Methods are provided for purifying peptides and proteins by incorporating the peptide or protein into a diketopiperazine or competitive complexing agent to facilitate removal of one or more impurities from the peptide or protein. Formulations and methods also are provided for the improved transport of active agents across biological membranes, resulting for example in a rapid increase in blood agent concentration. The formulations include microparticles formed of (i) the active agent, which may be charged or neutral, and (ii) a transport enhancer that masks the charge of the agent and/or that forms hydrogen bonds with the target biological membrane in order to facilitate transport. In one embodiment insulin is administered via the pulmonary delivery of microparticles comprising fumaryl diketopiperazine and insulin in its biologically active form. This method of delivering insulin results in a rapid increase in blood insulin concentration that is comparable to the increase resulting from intravenous delivery.
摘要翻译：提供了通过将肽或蛋白质掺入二酮哌嗪或竞争性络合剂来促进从肽或蛋白质中去除一种或多种杂质来纯化肽和蛋白质的方法。提供制剂和方法用于改善活性剂在生物膜上的转运，导致例如血药剂浓度的快速增加。制剂包括由（i）可以带电或中性的活性剂形成的微粒，和（ii）掩蔽试剂的电荷和/或与靶生物膜形成氢键的运输增强剂，以便于运输。在一个实施方案中，胰岛素经由包含富马酰二酮基哌嗪和胰岛素的微生物的肺部递送以其生物活性形式施用。这种递送胰岛素的方法导致血浆胰岛素浓度的快速增加，其与由静脉内递送产生的增加相当。

45. 发明申请

US20090137455A1 RAPID ACTING AND LONG ACTING INSULIN COMBINATION FORMULATIONS 有权
标题翻译：快速行动和长期行动胰岛素组合制剂
公开(公告)号：US20090137455A1
公开(公告)日：2009-05-28
申请号：US12324717
申请日：2008-11-26
申请人： Solomon S. Steiner , Roderike Pohl
发明人： Solomon S. Steiner , Roderike Pohl
IPC分类号： A61K38/28 , A61P3/00
CPC分类号： A61K31/185 , A61K9/0014 , A61K31/19 , A61K31/385 , A61K38/28 , A61K47/02 , A61K47/10 , A61K47/12 , A61K47/18 , A61K47/183 , A61K47/26 , A61K2300/00
摘要： An injectable formulation containing a combination of a rapid acting insulin and a long acting insulin has been developed wherein the pH of the rapid acting insulin is adjusted so that the long acting insulin, e.g. insulin glargine, remains soluble when they are mixed together. In the preferred embodiment, this injectable basal bolus insulin is administered before breakfast, provides adequate bolus insulin levels to cover the meal, does not produce hypoglycemia after the meal and provides adequate basal insulin for up to 24 hours. Lunch and dinner can be covered by two bolus injections of a fast acting, or a rapid acting or a very rapid acting insulin. Alternatively, through adjustment of the ratio of rapid acting insulin to long acting insulin, the long acting insulin may be shortened to a 12 hour formulation. This rapid and long acting blend is re-administered to the patient at dinner time, providing a safe and effective basal insulin level until morning. As a result, a patient using intensive insulin therapy should only inject three, rather than four, times a day.
摘要翻译：已经开发了含有快速作用的胰岛素和长效胰岛素的组合的可注射制剂，其中调节快速作用的胰岛素的pH，使得长效胰岛素例如。甘精胰岛素，当它们混合在一起时，保持可溶。在优选的实施方案中，该可注射的基础推注胰岛素在早餐之前施用，提供足够的推注胰岛素水平以覆盖膳食，在餐后不产生低血糖并提供足够的基础胰岛素达24小时。午餐和晚餐可以通过快速作用或快速作用或非常快速作用的胰岛素的两次快速注射来覆盖。或者，通过调整速效胰岛素与长效胰岛素的比例，长效胰岛素可缩短至12小时制剂。这种快速和长效的混合物在晚餐时间重新施用于患者，提供安全有效的基础胰岛素水平直到早晨。因此，使用强化胰岛素治疗的患者每天只能注射三次，而不是四次。

46. 发明授权

US07278843B2 Methods for fine powder formation 失效
标题翻译：精细粉末形成方法
公开(公告)号：US07278843B2
公开(公告)日：2007-10-09
申请号：US10224676
申请日：2002-08-20
申请人： Robert Feldstein , Solomon S. Steiner
发明人： Robert Feldstein , Solomon S. Steiner
IPC分类号： B29B9/00
CPC分类号： A61K9/0073 , A61K9/1652 , A61K9/1658 , A61K9/1688 , A61K9/1694 , F26B5/065
摘要： Improved methods for forming fine particles of a material have been developed, wherein the method steps include dissolving the material in a solvent to form a dilute solution, immobilizing the dilution solution, and then removing the solvent to yield particles of the material. Methods of immobilizing the dilute solution include freezing, gelation, and chelation. In a preferred embodiment, the immobilized solvent is removed by lyophilization, i.e. reducing the ambient pressure while avoiding application of sufficient heat to power a phase transition. Essentially any material and solvent for the material can be used in the methods described herein. Proteins and peptides in an aqueous solvent are the preferred systems.
摘要翻译：已经开发了用于形成材料细颗粒的改进方法，其中所述方法步骤包括将所述材料溶解在溶剂中以形成稀溶液，固定所述稀释溶液，然后除去所述溶剂以产生所述材料的颗粒。固定稀释溶液的方法包括冷冻，凝胶化和螯合。在一个优选的实施方案中，通过冻干除去固定的溶剂，即降低环境压力，同时避免施加足够的热量以对相变作用。基本上可以在本文所述的方法中使用材料的任何材料和溶剂。水性溶剂中的蛋白质和肽是优选的体系。

47. 发明授权

US06991779B2 Compositions for treatment or prevention of bioterrorism 有权
标题翻译：用于治疗或预防生物恐怖主义的组成部分
公开(公告)号：US06991779B2
公开(公告)日：2006-01-31
申请号：US10347932
申请日：2003-01-17
申请人： Solomon S. Steiner , Cohava Gelber , Robert S. Feldstein , Roderike Pohl
发明人： Solomon S. Steiner , Cohava Gelber , Robert S. Feldstein , Roderike Pohl
IPC分类号： A61K9/12 , A61K9/72
CPC分类号： A61K9/0075 , A61K9/1617 , A61K9/1641 , A61K31/46 , A61K31/495 , A61K39/00 , A61K39/07 , A61K2039/505 , A61K2039/55555 , C07K16/12
摘要： Compositions containing biologically active molecules encapsulated in self-assembling, diketopiperazine microspheres (TECHNOSPHEREs™) and methods for making and administering such compositions are described herein. The compositions can be used to immunize individuals against agents of biological warfare. The biologically active molecules include atropine, antibodies, antigens, and antibiotics. The compositions can be placed in an inhalation device for self-administration. Pulmonary delivery of TECHNOSPHERE™ encapsulated atropine, antibodies, vaccines, and antibiotics provides an accelerated onset of immunity to the targeted disease. Furthermore, the TECHNOSPHERE™ encapsulated atropine, antibodies, vaccines, and antibiotics are stable formulations, suitable for stockpiling, rapid dissemination and mass treatment.
摘要翻译：包含自组装，二酮哌嗪微球体（TECHNOSPHERE TM）中的生物活性分子的组合物以及制备和施用此类组合物的方法在本文中描述。组合物可用于免疫个体对生物战的药剂。生物活性分子包括阿托品，抗体，抗原和抗生素。组合物可以放置在用于自我给药的吸入装置中。包含阿托品，抗体，疫苗和抗生素的TECHNOSPHERE TM的肺转运提供了对目标疾病免疫的加速发作。此外，TECHNOSPHERE（TM）包裹阿托品，抗体，疫苗和抗生素是稳定的配方，适合储存，快速传播和大量治疗。

48. 发明授权

US06440463B1 Methods for fine powder formation 有权
标题翻译：精细粉末形成方法
公开(公告)号：US06440463B1
公开(公告)日：2002-08-27
申请号：US09543309
申请日：2000-04-05
申请人： Robert Feldstein , Solomon S. Steiner
发明人： Robert Feldstein , Solomon S. Steiner
IPC分类号： A61K914
CPC分类号： A61K9/0073 , A61K9/1652 , A61K9/1658 , A61K9/1688 , A61K9/1694 , F26B5/065
摘要： Improved methods for forming fine particles of a material have been developed, wherein the method steps include dissolving the material in a solvent to form a dilute solution, immobilizing the dilution solution, and then removing the solvent to yield particles of the material. Methods of immobilizing the dilute solution include freezing, gelation, and chelation. In a preferred embodiment, the immobilized solvent is removed by lyophilization, i.e. reducing the ambient pressure while avoiding application of sufficient heat to power a phase transition. Essentially any material and solvent for the material can be used in the methods described herein. Proteins and peptides in an aqueous solvent are the preferred systems.
摘要翻译：已经开发了用于形成材料细颗粒的改进方法，其中所述方法步骤包括将所述材料溶解在溶剂中以形成稀溶液，固定所述稀释溶液，然后除去所述溶剂以产生所述材料的颗粒。固定稀释溶液的方法包括冷冻，凝胶化和螯合。在一个优选的实施方案中，通过冻干除去固定的溶剂，即降低环境压力，同时避免施加足够的热量以对相变作用。基本上可以在本文所述的方法中使用材料的任何材料和溶剂。水性溶剂中的蛋白质和肽是优选的体系。

49. 发明授权

US4976968A Anhydrous delivery systems for pharmacological agents 失效
标题翻译：无机物药剂递送系统
公开(公告)号：US4976968A
公开(公告)日：1990-12-11
申请号：US315440
申请日：1989-02-24
申请人： Solomon S. Steiner
发明人： Solomon S. Steiner
IPC分类号： A61K9/16
CPC分类号： A61K9/1641
摘要： Substantially anhydrous pharmacological agents microencapsulated within protective hollow proteinoid microspheres are produced by contacting an aqueous mixture of such agent with an insoluble proteinoid and lyophilizing the resulting microspheres. Such encapsulation and dehydration results in a free flowing powder that has a long shelf life under naturally occurring temperature conditions and that quickly reabsorbs water without damage to the capsular wall. Gastrointestinally labile or poorly absorbed agents, such as insulin, heparin or dopamine redox carrier system, which are so microencapsulated in protective microspheres are rapidly rehydrated by body fluids in the gastrointestinal tract. Those microspheres having a diameter of about 10 microns or less penetrate the gastrointestinal mucosa and release the agent into the bloodstream in physiologically active form.
摘要翻译：通过将这种试剂的水性混合物与不溶性蛋白激素接触并将所得微球冻干，制备微胶囊化在保护性中空蛋白质微球内的基本无水的药理学试剂。这种包封和脱水产生自然流动的粉末，其在天然存在的温度条件下具有长的保质期，并且快速地重新吸收水而不损坏荚膜壁。在保护性微球中如此微囊化的胃肠不适或吸收不良的药物，例如胰岛素，肝素或多巴胺氧化还原载体系统，通过胃肠道中的体液迅速再水化。具有约10微米或更小直径的那些微球穿透胃肠粘膜，并以生理活性形式将药剂释放到血流中。

50. 发明申请

US20140207105A1 Methods for Effectively and Rapidly Desensitizing Allergic Patients 审中-公开
标题翻译：有效和快速脱敏过敏患者的方法
公开(公告)号：US20140207105A1
公开(公告)日：2014-07-24
申请号：US14240706
申请日：2012-08-30
申请人： Bryan E. Laulicht , Sasha H. Bakhru , Solomon S. Steiner , Edith Mathiowitz
发明人： Bryan E. Laulicht , Sasha H. Bakhru , Solomon S. Steiner , Edith Mathiowitz
IPC分类号： A61K39/35 , A61M37/00
CPC分类号： A61K39/35 , A61K31/43 , A61K31/60 , A61K39/36 , A61K2039/54 , A61K2039/55511 , A61K2039/55555 , A61K2039/55583 , A61K2039/577 , A61M37/0015 , A61M2037/0023 , A61M2037/003 , A61M2037/0061
摘要： Methods and compositions for delivering antigens to the lymphatic system in doses that desensitize patients to future exposure to antigens have been developed. Rapid desensitization is achieved by introducing small quantities of antigen into the lymphatic system. In preferred embodiments, the compositions are administered to yield therapeutically effective levels of antigen within the lymph, where macrophages reside in the greatest concentration, by intradermal administration, using for example, microneedles or microparticles, oral administration, using for example, enteric coated capsules or tablets, or autologous transfusion. In some embodiments, the methods and compositions for delivering antigens orally achieve uptake by the Peyer's patches of the small intestines.
摘要翻译：已经开发了用于将患者未来接触抗原脱敏的剂量将抗原递送至淋巴系统的方法和组合物。通过将少量抗原引入淋巴系统来实现快速脱敏。在优选的实施方案中，施用组合物以通过皮内给药，使用例如微针或微粒，口服给药，使用例如肠溶衣胶囊或淋巴细胞，以产生治疗有效水平的淋巴内的抗原，其中巨噬细胞以最大浓度存在片剂或自体输血。在一些实施方案中，用于递送抗原的方法和组合物通过小肠的派尔氏贴片摄取。

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