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1. 发明申请

WO2017190036A1 PACKAGING SYSTEM FOR STORAGE AND SHIPMENT OF SOLIDS 审中-公开
标题翻译：用于储存和装运固体的包装系统
公开(公告)号：WO2017190036A1
公开(公告)日：2017-11-02
申请号：PCT/US2017/030169
申请日：2017-04-28
申请人： AVANTOR PERFORMANCE MATERIALS, LLC , FARINA, James , DEORKAR, Nandu
发明人： FARINA, James , DEORKAR, Nandu
IPC分类号： B65D81/26 , B65D65/38 , B65D75/38 , B65D77/04
摘要： A packaging system that maintains the free flowing characteristic of solid materials contained therein. The packaging system includes a container, a cover, a vapor permeable bag, a vapor impermeable liner and at least two desiccant snakes. The vapor permeable bag has an opening for receiving solid materials and is formed from cloth or continuous fibers of high- density polyethylene that are randomly distributed and non-directional. The vapor impermeable liner surrounds the vapor permeable bag and provides a moisture barrier. The desiccant snakes are disposed between the vapor permeable bag and the liner. Each snake includes two or more desiccant packages formed from a vapor permeable material through which moisture can freely pass. The desiccant packages contain clay, silica, or molecular sieves.
摘要翻译：保持包含在其中的固体材料的自由流动特性的包装系统。包装系统包括容器，盖子，蒸气可渗透袋，蒸气不可渗透的衬垫和至少两个干燥剂蛇。蒸气可渗透袋具有用于接收固体材料的开口，并且由布料或高密度聚乙烯的连续纤维形成，所述纤维是随机分布的和非定向的。蒸汽不可渗透的内衬围绕蒸气可渗透袋并提供防潮层。干燥剂蛇布置在蒸汽可渗透袋和衬里之间。每条蛇包括两个或更多个干燥剂包装，由湿气可以自由通过的蒸气可渗透材料形成。干燥剂包装包含粘土，二氧化硅或分子筛。

2. 发明申请

WO2011008674A1 MATERIAL AND PROCESS FOR INCORPORATION OF LOW DOSAGE ACTIVE PHARMACEUTICAL INGREDIENTS AND USE THEREOF 审中-公开
标题翻译：合并低剂量活性药物成分的材料和方法及其用途
公开(公告)号：WO2011008674A1
公开(公告)日：2011-01-20
申请号：PCT/US2010/041665
申请日：2010-07-12
申请人： MALLINCKRODT BAKER, INC. , FARINA, James , DEORKAR, Nandu , MIINEA, Liliana
发明人： FARINA, James , DEORKAR, Nandu , MIINEA, Liliana
IPC分类号： A61K9/14 , A61K9/16 , A61K9/20 , A61K31/19 , A61K31/44 , A61K31/5415
CPC分类号： A61K9/2054 , A61K9/146 , A61K9/167 , A61K9/2095 , A61K31/19 , A61K31/44 , A61K31/5415
摘要： A low dose API pharmaceutical tablet having excellent content uniformity is provided. The tablet is formed by spray coating a support excipient with the API. The resulting composition is suitable for direct compression tablet formulation without the need for an additional granulation step to uniformly coat the API onto the support excipient. The support excipient comprises microcrystalline cellulose, a binder and a disintegrant, and is formed by spraying a homogeneous slurry of the support excipient components.
摘要翻译：提供了具有优异的均匀性的低剂量API药片。片剂通过用API喷涂载体赋形剂而形成。所得组合物适用于直接压制片剂制剂，而不需要另外的制粒步骤将API均匀地涂覆在支持赋形剂上。支持赋形剂包括微晶纤维素，粘合剂和崩解剂，并且通过喷洒支持赋形剂组分的均匀浆液形成。

3. 发明申请

WO2010059534A2 DIRECTLY COMPRESSIBLE GRANULAR MICROCRYSTALLINE CELLULOSE BASED EXCIPIENT, MANUFACTURING PROCESS AND USE THEREOF 审中-公开
标题翻译：直接可压缩颗粒状微晶纤维素制品，制造工艺及其用途
公开(公告)号：WO2010059534A2
公开(公告)日：2010-05-27
申请号：PCT/US2009/064498
申请日：2009-11-16
申请人： MALLINCKRODT BAKER, INC. , DEORKAR, Nandu , FARINA, James , MIINEA, Liliana , RANDIVE, Sameer
发明人： DEORKAR, Nandu , FARINA, James , MIINEA, Liliana , RANDIVE, Sameer
IPC分类号： A61K9/22 , A61K47/38
CPC分类号： A61K9/2054 , A61K9/2027 , A61K9/2095 , A61K47/38
摘要： An improved excipient comprising substantially homogeneous particles of a compressible, high functionality granular microcrystalline cellulose based excipient is provided. The improved excipient comprises microcrystalline cellulose and a binder, and optionally a disintegrant, and is formed by spraying a homogeneous slurry of the components. The excipient provides enhanced flowability/good flow properties, excellent/high compactibility, and increased API loading and blendability as compared to the individual components, and as compared to conventional excipients formed from the same materials. The improved excipient has strong intraparticle bonding bridges between the components, resulting in a unique structural morphology including significant open structures or hollow pores. The presence of these pores provides a surface roughness that is the ideal environment for improved blending with an API.
摘要翻译：提供了包含基本上均匀的可压缩，高功能性颗粒状微晶纤维素基赋形剂颗粒的赋形剂。改进的赋形剂包括微晶纤维素和粘合剂，以及任选的崩解剂，并且通过喷涂组分的均匀浆料而形成。与各种组分相比，赋形剂与由相同材料形成的常规赋形剂相比，提供增强的流动性/良好的流动性能，优异的/高紧密性和增加的API负载量和混合性。改进的赋形剂在组分之间具有强烈的颗粒内键合桥，导致独特的结构形态，包括显着的开放结构或中空孔。这些孔的存在提供了表面粗糙度，这是改进与API混合的理想环境。

4. 发明申请

WO2009048557A1 DIRECTLY COMPRESSIBLE HIGH FUNCTIONALITY GRANULAR MICROCRYSTALLINE CELLULOSE BASED EXCIPIENT, MANUFACTURING PROCESS AND USE THEREOF 审中-公开
标题翻译：直接可控的高功能颗粒状微晶纤维素制品，制造工艺及其使用
公开(公告)号：WO2009048557A1
公开(公告)日：2009-04-16
申请号：PCT/US2008/011555
申请日：2008-10-07
申请人： MALLINCKRODT BAKER, INC. , DEORKAR, Nandu , FARINA, James , MIINEA, Liliana , RANDIVE, Sameer
发明人： DEORKAR, Nandu , FARINA, James , MIINEA, Liliana , RANDIVE, Sameer
IPC分类号： A61K9/16 , A61K9/20
CPC分类号： A61K9/1635 , A61K9/1652 , A61K9/2027 , A61K9/2054
摘要： An improved excipient comprising substantially homogeneous particles of a compressible, high functionality granular microcrystalline cellulose based excipient is provided. The improved excipient comprises microcrystalline cellulose, a binder and a disintegrant, and is formed by spraying a homogeneous slurry of the components. The excipient provides enhanced flowability/good flow properties, excellent/high compactibility, and increased API loading and blendability as compared to the individual components, and as compared to conventional excipients formed from the same materials. The improved excipient has strong intraparticle bonding bridges between the components, resulting in a unique structural morphology including significant open structures or hollow pores. The presence of these pores provides a surface roughness that is the ideal environment for improved blending with an API.
摘要翻译：提供了包含基本上均匀的可压缩，高功能性颗粒状微晶纤维素基赋形剂颗粒的赋形剂。改进的赋形剂包括微晶纤维素，粘合剂和崩解剂，并且通过喷涂组分的均匀浆料形成。与各种组分相比，赋形剂与由相同材料形成的常规赋形剂相比，提供增强的流动性/良好的流动性能，优异的/高紧密性和增加的API负载量和混合性。改进的赋形剂在组分之间具有强烈的颗粒内键合桥，导致独特的结构形态，包括显着的开放结构或中空孔。这些孔的存在提供了表面粗糙度，这是改进与API混合的理想环境。

5. 发明申请

WO2010059506A1 DIRECTLY COMPRESSIBLE HIGH FUNCTIONALITY GRANULAR DIBASIC CALCIUM PHOSPHATE BASED CO-PROCESSED EXCIPIENT 审中-公开
标题翻译：直接可控的高功能颗粒碳酸钙基磷酸钙加工方法
公开(公告)号：WO2010059506A1
公开(公告)日：2010-05-27
申请号：PCT/US2009/064289
申请日：2009-11-13
申请人： MALLINCKRODT BAKER, INC. , DEORKAR, Nandu , FARINA, James , MIINEA, Liliana , RANDIVE, Sameer
发明人： DEORKAR, Nandu , FARINA, James , MIINEA, Liliana , RANDIVE, Sameer
IPC分类号： A61K9/16 , A61K9/20 , A61K31/196
CPC分类号： A61K31/00 , A61K9/2009 , A61K9/2095 , A61K31/196 , A61K47/02
摘要： An improved excipient comprising substantially homogeneous particles of a compressible, high functionality granular dibasic calcium phosphate based excipient is provided. The improved excipient comprises dibasic calcium phosphate, a binder and a disintegrant, and is formed by spraying a homogeneous slurry of the components. The improved excipient provides enhanced flowability/good flow properties, an increased API loading and blendability and higher compactibility as compared to the individual components, and as compared to excipients formed from the same materials by conventional methods. [0083] The improved excipient has strong intraparticle bonding bridges between the components, resulting in a unique structural morphology including significant open structures or hollow pores. The presence of these pores provides a surface roughness that is the ideal environment for improved blending with an API.
摘要翻译：提供了一种改进的赋形剂，其包含基本上均匀的可压缩，高官能度的基于磷酸钙的磷酸钙基赋形剂的颗粒。改进的赋形剂包括磷酸氢钙，粘合剂和崩解剂，并且通过喷涂组分的均匀浆料而形成。与单独组分相比，改进的赋形剂提供了增强的流动性/良好的流动性能，增加的API负载量和可混合性，并且与通过常规方法由相同材料形成的赋形剂相比具有更高的紧实性。改进的赋形剂在组分之间具有强的内部颗粒结合桥，导致独特的结构形态，包括显着的开放结构或中空孔。这些孔的存在提供了表面粗糙度，这是改进与API混合的理想环境。

6. 发明申请

WO2010017358A1 SUSTAINED RELEASE COMPOSITIONS COMPRISING GUMS AND SUGAR ALCOHOLS 审中-公开
标题翻译：持续发行包含食品和糖酒的组合物
公开(公告)号：WO2010017358A1
公开(公告)日：2010-02-11
申请号：PCT/US2009/052956
申请日：2009-08-06
申请人： MALLINCKRODT BAKER, INC. , DUMBRE, Nilesh, Tanhaji , AVACHAT, Amelia, Makarand , DEORKAR, Nandu , FARINA, James , MIINEA, Liliana
发明人： DUMBRE, Nilesh, Tanhaji , AVACHAT, Amelia, Makarand , DEORKAR, Nandu , FARINA, James , MIINEA, Liliana
IPC分类号： A61K31/16 , A61K31/20 , A61K31/135 , A61K31/137 , A61K31/196
CPC分类号： A61K9/1623 , A61K9/1652 , A61K9/2018 , A61K9/205 , A61K9/2054 , A61K31/09 , A61K31/135 , A61K31/137 , A61K31/167 , A61K31/196
摘要： A sustained release composition comprising spray dried particles of at least one polysaccharide gum and at least one polyhydric sugar alcohol, as well as methods of making the sustained released composition are provided. A sustained release pharmaceutical solid dosage form, and a method of making the solid dosage form by compression are also provided.
摘要翻译：提供包含至少一种多糖胶和至少一种多羟基糖醇的喷雾干燥颗粒的持续释放组合物，以及制备持续释放的组合物的方法。还提供了缓释药物固体剂型，以及通过压缩制备固体剂型的方法。

7. 发明申请

WO2015148916A2 PACKAGE SYSTEM AND METHOD FOR INHIBITING MOISTURE ENTRY 审中-公开
标题翻译：用于抑制水分进入的包装系统和方法
公开(公告)号：WO2015148916A2
公开(公告)日：2015-10-01
申请号：PCT/US2015/022981
申请日：2015-03-27
申请人： AVANTOR PERFORMANCE MATERIALS, INC. , FARINA, James , BOLESSA, Evon, A. , DEORKAR, Nandu
发明人： FARINA, James , BOLESSA, Evon, A. , DEORKAR, Nandu
IPC分类号： C12M3/04
CPC分类号： B65D81/266 , B65D31/12 , B65D41/02 , B65D65/38 , B65D75/38 , B65D75/522 , B65D75/56 , B65D75/5872 , B65D81/268 , B65D2205/00
摘要： A package system for maintaining the physicochemical integrity of the contents of the package system that includes: an inner bag formed from a gas and/or moisture permeable material, an outer bag formed from an impermeable polymer material, a discharge port that provides access to the interior of the outer bag; and a desiccant or gas scavenging material. The first end of the outer bag sealingly surrounds the exterior wall of the discharge port. The second end of the inner bag is sealed closed and the desiccant or gas scavenging material is disposed in an isolated compartment. The second end of the outer bag is sealed closed to isolate the interior from the environment exterior to the package system.
摘要翻译：一种用于保持包装系统的内容物的物理化学完整性的包装系统，包括：由气体和/或透湿材料形成的内袋，由不可渗透的聚合物材料形成的外袋，排出口，外袋内部; 和干燥剂或气体清除材料。外袋的第一端密封地包围排出口的外壁。内袋的第二端密封封闭，干燥剂或气体清除材料设置在隔离隔间中。外袋的第二端密封封闭，以将内部与包装系统外部的环境隔离。

8. 发明申请

WO2008020990A1 NEW DIRECT COMPRESSIBLE EXCIPIENT BLEND 审中-公开
标题翻译：新的直接可压缩的特殊混合
公开(公告)号：WO2008020990A1
公开(公告)日：2008-02-21
申请号：PCT/US2007/017039
申请日：2007-07-30
申请人： MALLINCKRODT BAKER, INC. , FARINA, James , BRITTAIN, Harry, G.
发明人： FARINA, James , BRITTAIN, Harry, G.
IPC分类号： A61K9/20
CPC分类号： A61K9/2095 , A61K9/2054 , A61K9/2059
摘要： A method for making a pharmaceutically acceptable tablet utilizing a pre-mixed excipient blend is provided. A universal, pre-mixed excipient blend is mixed with an active pharmaceutical ingredient to form an active pharmaceutical ingredient blend. The resulting blend is then tableted to form a pharmaceutically acceptable tablet. The pre-mixed excipient blend includes at least one diluent, at least one binder and at least one disintegrant. The pre-mixed excipient blend has a particle size of about 80 to 150 micrometers.
摘要翻译：提供了使用预混合赋形剂混合物制备药学上可接受的片剂的方法。将通用的预混合赋形剂混合物与活性药物成分混合以形成活性药物成分混合物。然后将所得混合物压片以形成药学上可接受的片剂。预混合赋形剂混合物包括至少一种稀释剂，至少一种粘合剂和至少一种崩解剂。预混合赋形剂共混物具有约80至150微米的粒度。

9. 发明申请

WO2007015724A1 TROMETHAMINE SALT OF VALPROIC ACID 审中-公开
标题翻译：硫酸钡盐酸盐
公开(公告)号：WO2007015724A1
公开(公告)日：2007-02-08
申请号：PCT/US2006/023106
申请日：2006-06-11
申请人： MALLINCKRODT BAKER, INC. , FARINA, James , BRITTAIN, Harry, G.
发明人： FARINA, James , BRITTAIN, Harry, G.
IPC分类号： C07C53/128 , C07C211/03 , C07C311/63 , A61K31/19 , A61P25/08
CPC分类号： C07C53/128 , C07C215/10
摘要： An improved valproic acid salt, the tromethamine salt of valproic acid (TRIS-valproate) is disclosed. TRIS-valproate provides superior stability, storage, tableting and patient tolerance. A crystalline form of TRIS-valproate, a method of making TRIS-valproate, as well as pharmaceutical dosage forms and methods of treating patients comprising TRIS-valproate are also disclosed.
摘要翻译：公开了一种改进的丙戊酸盐，丙戊酸（TRIS-丙戊酸盐）的氨基丁三醇盐。 TRIS-valproate提供卓越的稳定性，储存，压片和耐受性。还公开了TRIS-丙戊酸盐的结晶形式，制备TRIS-丙戊酸盐的方法，以及药物剂型和治疗包含TRIS-丙戊酸盐的患者的方法。

10. 发明申请

WO2006014225A1 APPARATUS AND METHOD FOR DISPENSING HIGH PURITY MATERIALS 审中-公开
标题翻译：用于分配高纯度材料的装置和方法
公开(公告)号：WO2006014225A1
公开(公告)日：2006-02-09
申请号：PCT/US2005/021234
申请日：2005-06-15
申请人： MALLINCKRODT BAKER, INC. , FARINA, James
发明人： FARINA, James
IPC分类号： B65D83/14
CPC分类号： B65D83/48 , B01L3/00 , B01L3/0293 , B01L2200/16 , B01L2300/049 , B01L2400/0487 , G01N35/1002 , G01N2001/2238
摘要： This invention relates to a system or apparatus (10) and a method for dispensing a material (16) from a pressurized container (12) while maintaining product integrity. The system or apparatus comprises a pressurized container for holding the material and having a dispensing valve (20) provided with a dispensing conduit or stem (26) for dispensing the material from the container at the appropriate time, a syringe (42) equipped with an on/off locking mechanism (48) for permitting or preventing flow of the material into and out of the syringe by way of a stem or conduit (50) attached to the locking mechanism, and a removable adaptor (34) for connecting the stem of the syringe to the stem of the dispensing valve of the pressurized container for permitting flow of material from the pressurized container into a chamber of the syringe upon actuation of the dispensing valve.
摘要翻译：本发明涉及一种系统或装置（10）以及用于在保持产品完整性的同时从加压容器（12）分配材料（16）的方法。系统或装置包括用于保持材料的加压容器，并且具有分配阀（20），该分配阀（20）设置有用于在适当的时间从容器分配材料的分配导管或杆（26）;装备有开/关锁定机构（48），用于允许或防止材料通过连接到锁定机构的杆或导管（50）流入和流出注射器;以及可拆卸适配器（34），用于将杆注射器到加压容器的分配阀的杆部，用于允许在致动分配阀时材料从加压容器流入注射器的腔室。

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