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1. 发明申请

WO2008079464A3 STABLE POWDER FORMULATIONS OF ALUM-ADSORBED VACCINES 审中-公开
标题翻译：铝吸附疫苗稳定的粉末配方
公开(公告)号：WO2008079464A3
公开(公告)日：2009-04-09
申请号：PCT/US2007078076
申请日：2007-09-10
申请人： BECTON DICKINSON CO , SULLIVAN VINCENT J , MIKSZTA JOHN A , ALARCON JASON B , FERRITER MATTHEW S , HUANG JOANNE , D SOUZA AJIT M
发明人： SULLIVAN VINCENT J , MIKSZTA JOHN A , ALARCON JASON B , FERRITER MATTHEW S , HUANG JOANNE , D SOUZA AJIT M
IPC分类号： A61K9/14 , A61K9/19 , A61K39/02 , A61K39/07 , A61K39/08 , A61K39/085 , A61K39/29 , A61K47/02 , A61P31/04 , A61P31/12
CPC分类号： A61K39/292 , A61K9/08 , A61K9/143 , A61K9/19 , A61K39/025 , A61K39/0291 , A61K39/07 , A61K39/08 , A61K39/085 , A61K39/12 , A61K2039/55505 , A61K2039/70 , C12N2730/10134
摘要： The present invention is directed to methods for preparing a stable powder formulation of an alum-adsorbed vaccine. The methods comprise atomizing a liquid formulation comprising an immunogen adsorbed onto an aluminum adjuvant to produce an atomized formulation, freezing the atomized formulation to produce frozen particles, and drying the frozen particles to produce dried powder particles. Pharmaceutical compositions comprising a stable powder formulation of an alum- adsorbed vaccine are also disclosed herein. The pharmaceutical compositions are stable at high temperatures and can be reconstituted in a pharmaceutically acceptable carrier to produce a reconstituted liquid vaccine that exhibits little or no particle agglomeration and retains immunogenicity. Methods of using the alum-adsorbed vaccine compositions for preventing and treating a disease in a subject, wherein the disease is associated with the particular immunogen, are further provided.
摘要翻译：本发明涉及制备明矾吸附疫苗的稳定粉末制剂的方法。该方法包括雾化包含吸附在铝佐剂上的免疫原的液体制剂以产生雾化制剂，冷冻雾化制剂以产生冷冻颗粒，并干燥冷冻颗粒以产生干粉末颗粒。本文还公开了包含明矾吸附疫苗的稳定粉末制剂的药物组合物。所述药物组合物在高温下稳定并且可以在药学上可接受的载体中重构以产生显示很少或没有颗粒聚集并保留免疫原性的重构液体疫苗。进一步提供了使用吸附铝的疫苗组合物预防和治疗受试者疾病的方法，其中所述疾病与特定免疫原有关。

2. 发明申请

WO2005086773A3 A METHOD FOR DELIVERING THERAPEUTIC PROTEINS TO THE INTRADERMAL COMPARTMENT 审中-公开
标题翻译：将治疗性蛋白质递送到内脏室的方法
公开(公告)号：WO2005086773A3
公开(公告)日：2007-01-25
申请号：PCT/US2005007412
申请日：2005-03-08
申请人： BECTON DICKINSON CO , MIKSZTA JOHN A , DEKKER III JOHN P
发明人： MIKSZTA JOHN A , DEKKER III JOHN P
IPC分类号： C01D15/08 , A01N63/00 , A61K38/21 , C01D7/00 , C01D17/00 , C12P33/16 , G01N33/53
CPC分类号： A61K38/212 , A61K9/0021 , A61K38/215 , A61K38/217
摘要： The present invention relates to methods and devices for intradermal delivery of substances, preferably therapeutic substances by targeting the substance to the intradermal compartment of a subject's skin. Substances delivered in accordance with the methods of the invention have an improved clinical utility and therapeutic efficacy relative to other drug delivery methods including intramuscular, and subcutaneous delivery. The present invention provides benefits and improvements over conventional drug delivery methods including but not limited to, improved pharmacokinetics and bioavailability.
摘要翻译：本发明涉及用于皮内递送物质的方法和装置，优选通过将物质靶向受试者皮肤的皮内隔室来治疗物质。根据本发明的方法递送的物质相对于包括肌内和皮下递送的其它药物递送方法具有改进的临床效用和治疗功效。本发明提供了优于常规药物递送方法的益处和改进，包括但不限于改善的药代动力学和生物利用度。

3. 发明申请

WO2004108205A1 MEDICAMENT MICRODEVICE DELIVERY SYSTEM WITH A CARTRIDGE 审中-公开
标题翻译：具有药盒的药物MICRODEVICE递送系统
公开(公告)号：WO2004108205A1
公开(公告)日：2004-12-16
申请号：PCT/US2004/017381
申请日：2004-06-01
申请人： BECTON DICKINSON AND COMPANY , SULLIVAN, Vincent, J. , PETTIS, Ronald, J. , MIKSZTA, John, A. , DEKKER, John, P., III , WOODLEY, Wendy, D. , WILLS, Anjana, Bhuta , FERRITER, Matthew, S.
发明人： SULLIVAN, Vincent, J. , PETTIS, Ronald, J. , MIKSZTA, John, A. , DEKKER, John, P., III , WOODLEY, Wendy, D. , WILLS, Anjana, Bhuta , FERRITER, Matthew, S.
IPC分类号： A61M37/00
CPC分类号： A61M37/0015 , A61K9/0021 , A61M2037/0023
摘要： A device for intradermal delivery of a reconstituted powdered medicament. The device includes a chamber (29), which is in fluid communication with a microdevice (50), e.g. microabrader or one or more microneedles. A cartridge (20) containing the powdered medicament may be located within said chamber. At least one burstable membrane (30) retains a powdered medicament within the housing.
摘要翻译：用于皮内递送重构粉末状药物的装置。该装置包括与微型装置（50）例如流体连通的腔室（29）。微型抛光机或一个或多个微针。容纳粉末状药物的药筒（20）可以位于所述腔室内。至少一个可爆破膜（30）将粉末状药物保持在壳体内。

4. 发明申请

WO2004064889A3 INTRADERMAL CELLULAR DELIVERY USING NARROW GAUGE MICRO-CANNULA 审中-公开
标题翻译：狭窄的细胞传递使用狭窄的微型插管
公开(公告)号：WO2004064889A3
公开(公告)日：2004-11-25
申请号：PCT/US2004001021
申请日：2004-01-16
申请人： BECTON DICKINSON CO , BRITTINGHAM JOHN M , MIKSZTA JOHN A , DEAN CHERYL H , WILLIAMS DOMINIQUE J
发明人： BRITTINGHAM JOHN M , MIKSZTA JOHN A , DEAN CHERYL H , WILLIAMS DOMINIQUE J
IPC分类号： A01N63/00 , A61K35/12 , A61K35/14 , A61K39/00 , A61K45/00 , A61M20060101 , A61M31/00 , A61M37/00
CPC分类号： A61K39/00 , A61K35/12 , A61K35/15 , A61K39/0005 , A61K2039/5154 , A61K2039/54 , A61M37/0015 , A61M2037/0061
摘要： A method for delivering cells into a subject by administering cells into the intradermal space of the skin of the subject by a microneedle. The cells are associated with cellular based therapeutics and vaccines and delivered by perpendicular insertion of the microneedle. The microneedle is a hollow needle having an exposed height of between about 0 and 1 mm, a total length of between about 0.3 mm to 2.5 mm, and a size of equal to or less than 30 gauge. An array of microneedles can also be used.
摘要翻译：通过微针将细胞施用到受试者皮肤的皮内空间中将细胞递送到受试者中的方法。细胞与基于细胞的治疗剂和疫苗相关联，并通过垂直插入微针递送。微针是空心针，其暴露高度在约0至1mm之间，总长度在约0.3mm至2.5mm之间，尺寸等于或小于30标准尺寸。也可以使用一系列微针。

5. 发明申请

WO2004073652A2 POWDER FORMULATIONS OF RSEB FOR IMPROVED VACCINATION 审中-公开
标题翻译：用于改善接种的RSEB粉末制剂
公开(公告)号：WO2004073652A2
公开(公告)日：2004-09-02
申请号：PCT/US2004/005135
申请日：2004-02-20
申请人： BECTON DICKINSON AND COMPANY , SULLIVAN, Vincent , MIKSZTA, John , HWANG, Robin , MAR, Kevin, D. , CAMPBELL, Robert, L.
发明人： SULLIVAN, Vincent , MIKSZTA, John , HWANG, Robin , MAR, Kevin, D. , CAMPBELL, Robert, L.
IPC分类号： A61K
CPC分类号： A61K47/36 , A61K9/0019 , A61K9/0043 , A61K9/1688 , A61K9/1694 , A61K9/19 , A61K38/28 , A61K39/085 , A61K39/12 , A61K39/145 , A61K47/26 , A61K2039/5252 , A61K2039/53 , A61K2039/543 , A61K2039/545 , A61K2039/55505 , A61K2039/55583 , C12N2760/16134
摘要： A method of preparing a pharmaceutical composition is described, comprising 1) atomizing a liquid formulation of a therapeutic agent to produce an atomized formulation; 2) freezing said atomized formulation to form solid particles; and 3) drying said solid particles to produce a powder. Compositions made by the above methods, and methods of using the compositions, are also described.
摘要翻译：描述了制备药物组合物的方法，其包括：1）雾化治疗剂的液体制剂以产生雾化制剂; 2）冷冻所述雾化制剂以形成固体颗粒; 和3）干燥所述固体颗粒以产生粉末。还描述了通过上述方法制备的组合物以及使用组合物的方法。

6. 发明申请

WO2004019777A3 SUBSTANCE DELIVERY VIA ROTATING MOCROABRADING SURFACE 审中-公开
标题翻译：物质运输通过旋转减速表面
公开(公告)号：WO2004019777A3
公开(公告)日：2004-05-21
申请号：PCT/US0326813
申请日：2003-08-27
申请人： BECTON DICKINSON CO , HAIDER M ISHAQ , LASTOVICH ALEXANDER G , ERSKINE TIMOTHY J , MIKSZTA JOHN A , MARTIN FRANK E , O'CONNOR SCOTT A , ALARCON JASON B , DEKKER JOHN P III
发明人： HAIDER M ISHAQ , LASTOVICH ALEXANDER G , ERSKINE TIMOTHY J , MIKSZTA JOHN A , MARTIN FRANK E , O'CONNOR SCOTT A , ALARCON JASON B , DEKKER JOHN P III
IPC分类号： A61B10/02 , A61B17/00 , A61B17/20 , A61B17/32 , A61F2/82 , A61M31/00 , A61M37/00
CPC分类号： A61M37/0015 , A61B17/205 , A61B2017/320004 , A61M31/002 , A61M37/00 , A61M2037/0007 , A61M2037/0023 , A61M2037/0038 , A61M2037/0046 , A61M2037/0053
摘要： A method and device for the delivery of a substance into skin via the rotational movement of a microabrader device reduces the effects of operator variability. The method includes applying a substance to an area of a patient's skin through the rotational movement of microprotrusions. The movement of the microprotrusions can be imparted by a spring device or the like present in the microabrader device or the motion of the operator through the handle of the microabrader device. The rotational motion localizes the administration of the drug or vaccine dosage in the abraded skin area. The device can include means for monitoring pressure of the device against the skin and thereby promote consistency between applications and control of penetration depth. The substance, drug or vaccine may be placed on the microprotrusions and a reconstituting liquid included in the microabrader device.
摘要翻译：用于通过微型冲击装置的旋转运动将物质输送到皮肤中的方法和装置减少了操作员变异性的影响。该方法包括通过微突然的旋转运动将物质施加到患者皮肤的区域。微冲击的运动可以通过存在于微推进器装置中的弹簧装置等或操纵者通过微型冲击装置的手柄的运动来赋予。旋转运动使得在磨损的皮肤区域中施用药物或疫苗剂量。该装置可以包括用于监测装置对皮肤的压力并由此促进应用之间的一致性和对穿透深度的控制的装置。物质，药物或疫苗可以放置在微突出物和包含在微推进器装置中的重构液体中。

7. 发明申请

WO2002083232A1 METHODS AND DEVICES FOR ADMINISTRATION OF SUBSTANCES INTO THE INTRADERMAL LAYER OF SKIN FOR SYSTEMIC ABSORPTION 审中-公开
标题翻译：用于管理物质进入皮肤内层的系统吸收的方法和装置
公开(公告)号：WO2002083232A1
公开(公告)日：2002-10-24
申请号：PCT/US2001/050440
申请日：2001-12-28
申请人： BECTON, DICKINSON AND COMPANY , PHARMACIA & UPJOHN , KAESTNER, Scott, A. , PETTIS, Ronald, J. , SUTTER, Diane, E. , MIKSZTA, John, A. , PINKERTON, Thomas, C. , STRAUSS, Paul , GARBERG, Per , WESTERBERG, Goran
发明人： KAESTNER, Scott, A. , PETTIS, Ronald, J. , SUTTER, Diane, E. , MIKSZTA, John, A. , PINKERTON, Thomas, C. , STRAUSS, Paul , GARBERG, Per , WESTERBERG, Goran
IPC分类号： A61M37/00
CPC分类号： A61K38/193 , A61K9/0019 , A61K9/0021 , A61K38/24 , A61K38/27 , A61K38/28 , A61K38/29 , A61M5/158 , A61M5/46 , A61M37/0015 , A61M2037/003 , A61M2037/0061 , A61M2202/0445
摘要： Methods and devices for administration of substances into the intradermal layer of skin for systemic absorption.
摘要翻译：用于将物质施用于皮肤内皮层的全身吸收的方法和装置。

8. 发明申请

WO2005016401A3 IMPROVED INTRA-DERMAL DELIVERY OF BIOLOGICALLY ACTIVE AGENTS 审中-公开
标题翻译：改进生物活性剂的内部递送
公开(公告)号：WO2005016401A3
公开(公告)日：2005-11-24
申请号：PCT/US2004019121
申请日：2004-06-14
申请人： BECTON DICKINSON CO , NYCZ COLLEEN , VONK GLENN , BRITTINGHAM JOHN , PETTIS RONALD J , HARVEY ALFRED , CAMPBELL ROBERT , MIKSZTA JOHN
发明人： NYCZ COLLEEN , VONK GLENN , BRITTINGHAM JOHN , PETTIS RONALD J , HARVEY ALFRED , CAMPBELL ROBERT , MIKSZTA JOHN
IPC分类号： A61K49/00 , A61M20060101
CPC分类号： A61K49/0034 , A61K9/0021 , A61K49/0043 , A61K49/0058 , A61M5/46 , A61M37/00
摘要： The present invention relates to methods and devices for delivering one or more biologically active agents, particularly a diagnostic agent to the intradermal compartment of a subject's skin. The present invention provides an improved method of delivery of biologically active agents in that it provides among other benefits, rapid uptake into the local lymphatics, improved targeting to a particular tissue, improved bioavailability, improved tissue bioavailability, improved tissue specific kinetics, improved deposition of a pre-selected volume of the agent to be administered, and rapid biological and rapid biological and pharmacodynamics and biological and pharmacokinetics. This invention provides methods for rapid transport of agents through lymphatic vasculature accessed by intradermal delivery of the agent. Methods of the invention are particularly useful for delivery of diagnostic agents.
摘要翻译：本发明涉及用于将一种或多种生物活性剂特别是诊断剂递送到受试者皮肤的真皮内隔室的方法和装置。本发明提供了递送生物活性剂的改进方法，因为它提供了其他益处，快速摄入局部淋巴管，改善对特定组织的靶向，改善的生物利用度，改善的组织生物利用度，改善的组织特异性动力学，改进的沉积预先选定体积的药剂，以及快速生物和快速的生物和药效学以及生物和药代动力学。本发明提供了通过皮内递送试剂获得的通过淋巴脉管系统快速转运药剂的方法。本发明的方法对于递送诊断剂特别有用。

9. 发明申请

WO2005074460A3 METHODS OF ENHANCING IMMUNE RESPONSE IN THE INTRADERMAL COMPARTMENT AND COMPOUNDS USEFUL IN THE METHODS 审中-公开
标题翻译：在方法中有用的增强室内容物和化合物中的免疫应答的方法
公开(公告)号：WO2005074460A3
公开(公告)日：2005-09-29
申请号：PCT/US2004041021
申请日：2004-12-06
申请人： BECTON DICKINSON CO , CAMPBELL ROBERT , DOLAN KEVIN G , ALARCON JASON , WOODLEY WENDY D , MIKSZTA JOHN
发明人： CAMPBELL ROBERT , DOLAN KEVIN G , ALARCON JASON , WOODLEY WENDY D , MIKSZTA JOHN
IPC分类号： A61K31/7048 , A61K39/00 , A61K39/39 , A61K45/00 , A61K47/00 , G01N33/53
CPC分类号： A61K39/39 , A61K31/7048 , A61K39/12 , A61K39/145 , A61K2039/55511 , A61K2039/55516 , A61K2039/55555 , A61K2039/55588 , C12N2760/16134
摘要： The present invention relates to immunogenic compositions for intradermal delivery of an antigenic or immunogenic agent in combination with one or more excipients. The immunogenic compositions of the invention comprise an antigenic or immunogenic agent and at least one excipient which acts as an adjuvant, i.e., enhances the immune response to the antigenic or immunogenic agent, once delivered to the intradermal compartment of a subject's skin. The immunogenic compositions of the invention comprise an excipient which when administered to the intradermal compartment of skin in accordance with the invention demonstrate adjuvant activity. The immunogenic compositions of the invention have enhanced efficacy as the excipients of the composition cause an asymptomatic skin irritation and recruit antigen presenting cells to the intradermal compartment and thus enhance presentation and/or availability of the antigenic or immunogenic agent to the antigen presenting cells. The enhanced efficacy of the immunogenic compositions of the invention may result in a therapeutically effective immune response after a single intradermal dose, with lower doses of antigenic or immunogenic agent than conventionally used, and without the need for booster immunizations
摘要翻译：本发明涉及用于皮内递送抗原性或免疫原性试剂与一种或多种赋形剂组合的免疫原性组合物。本发明的免疫原性组合物包含抗原或免疫原性试剂和至少一种充当佐剂的赋形剂，即一旦递送到受试者的皮肤的真皮内隔室，则增强对抗原或免疫原性试剂的免疫应答。本发明的免疫原性组合物包含赋形剂，其当根据本发明施用于皮肤的皮内隔室时显示佐剂活性。本发明的免疫原性组合物具有增强的功效，因为组合物的赋形剂引起无症状的皮肤刺激并将抗原呈递细胞募集到皮内区室，从而增强抗原呈递细胞的抗原或免疫原性的呈递和/或可用性。本发明的免疫原性组合物的增强的功效可以在单次真皮内剂量之后产生治疗有效的免疫应答，具有比常规使用的更低剂量的抗原性或免疫原性试剂，并且不需要加强免疫

10. 发明申请

WO2005086773A2 A METHOD FOR DELIVERING THERAPEUTIC PROTEINS TO THE INTRADERMAL COMPARTMENT 审中-公开
标题翻译：将治疗性蛋白质递送到内脏室的方法
公开(公告)号：WO2005086773A2
公开(公告)日：2005-09-22
申请号：PCT/US2005/007412
申请日：2005-03-08
申请人： BECTON DICKINSON AND COMPANY , MIKSZTA, John, A. , DEKKER, III, John, P.
发明人： MIKSZTA, John, A. , DEKKER, III, John, P.
IPC分类号： A61K38/21 , G01N33/53
CPC分类号： A61K38/212 , A61K9/0021 , A61K38/215 , A61K38/217
摘要： The present invention relates to methods and devices for intradermal delivery of substances, preferably therapeutic substances by targeting the substance to the intradermal compartment of a subject's skin. Substances delivered in accordance with the methods of the invention have an improved clinical utility and therapeutic efficacy relative to other drug delivery methods including intramuscular, and subcutaneous delivery. The present invention provides benefits and improvements over conventional drug delivery methods including but not limited to, improved pharmacokinetics and bioavailability.
摘要翻译：本发明涉及用于皮内递送物质的方法和装置，优选通过将物质靶向受试者皮肤的皮内隔室来治疗物质。根据本发明的方法递送的物质相对于包括肌内和皮下递送的其它药物递送方法具有改进的临床效用和治疗功效。本发明提供了优于常规药物递送方法的益处和改进，包括但不限于改善的药代动力学和生物利用度。

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