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11. 发明授权

US06358533B2 Pharmaceutical excipient having improved compressibility 失效
公开(公告)号：US06358533B2
公开(公告)日：2002-03-19
申请号：US09754760
申请日：2001-01-04
申请人： Bob E. Sherwood , John H. Staniforth , Edward A. Hunter
发明人： Bob E. Sherwood , John H. Staniforth , Edward A. Hunter
IPC分类号： A61K914
CPC分类号： A61K9/2054 , A61K9/2009 , A61K9/2013 , A61K9/2018 , A61K9/2036 , A61K9/205 , Y10S977/727 , Y10S977/773 , Y10S977/775 , Y10S977/801 , Y10S977/89 , Y10S977/896 , Y10S977/904 , Y10S977/906 , Y10S977/915 , Y10T428/2982
摘要： A microcrystalline cellulose-based excipient having improved compressibility, whether utilized in direct compression, dry granulation or wet granulation formulations, is disclosed. The excipient is an agglomerate of microcrystalline cellulose particles and from about 0.1% to about 20% silicon dioxide particles, by weight of the microcrystalline cellulose, wherein the microcrystalline cellulose and silicon dioxide are in intimate association with each other. The silicon dioxide utilized in the novel excipient has a particle size from about 1 nanometer to about 100 microns. Most preferably, the silicon dioxide is a grade of colloidal silicon dioxide.

12. 发明授权

US6103219A Pharmaceutical excipient having improved compressibility 失效
公开(公告)号：US6103219A
公开(公告)日：2000-08-15
申请号：US992073
申请日：1997-12-17
申请人： Bob E. Sherwood , John H. Staniforth , Edward A. Hunter
发明人： Bob E. Sherwood , John H. Staniforth , Edward A. Hunter
IPC分类号： A61K9/20 , A61K9/26 , A61K47/02 , A61K47/04 , A61K47/38 , A61K7/16 , A61K9/16 , A61K9/32
CPC分类号： A61K9/2054 , A61K9/2009 , A61K9/2013 , A61K9/2018 , A61K9/2036 , A61K9/205 , Y10S977/727 , Y10S977/773 , Y10S977/775 , Y10S977/801 , Y10S977/89 , Y10S977/896 , Y10S977/904 , Y10S977/906 , Y10S977/915 , Y10T428/2982
摘要： A microcrystalline cellulose-based excipient having improved compressibility, whether utilized in direct compression, dry granulation or wet granulation formulations, is disclosed. The excipient is an agglomerate of microcrystalline cellulose particles and from about 0.1% to about 20% silicon dioxide particles, by weight of the microcrystalline cellulose, wherein the microcrystalline cellulose and silicon dioxide are in intimate association with each other. The silicon dioxide utilized in the novel excipient has a particle size from about 1 nanometer to about 100 microns. Most preferably, the silicon dioxide is a grade of colloidal silicon dioxide.

13. 发明授权

US5965166A Directly compressible high load acetaminophen formulations 失效
标题翻译：直接可压缩的高负荷对乙酰氨基酚制剂
公开(公告)号：US5965166A
公开(公告)日：1999-10-12
申请号：US964917
申请日：1997-11-05
申请人： Edward A. Hunter , Joseph A. Zeleznik , Bob E. Sherwood
发明人： Edward A. Hunter , Joseph A. Zeleznik , Bob E. Sherwood
IPC分类号： A61K9/20 , A61K31/165 , A61K31/167 , A61K47/04 , A61K47/12 , A61K47/38 , A61P29/02 , A61K9/14
CPC分类号： A61K9/2009 , A61K31/167 , A61K9/2054 , A61K9/2095 , Y10S977/904 , Y10S977/906 , Y10S977/915
摘要： Direct compressed solid pharmaceutical dosage forms containing:a) from about 40 to about 95% by weight acetaminophen;b) from about 1 to about 60% by weight of a direct compression vehicle comprising microcrystalline cellulose; andc) from about 0.01 to about 4.0% by weight of a pharmaceutically-acceptable lubricant are disclosed. The acetaminophen and direct compression vehicle are combined under high shear conditions which are sufficient to transform acetaminophen and direct compression vehicle into a homogenous granulate without degradation. In preferred aspects of the invention, the lubricant is also combined with the acetaminophen and direct compression vehicle under high shear conditions. Methods of preparing the directly compressed solid pharmaceutical dosage forms and methods of treatment with the dosage forms are also disclosed. The methods are particularly well suited for preparing directly compressed dosage forms containing high load (i.e., up to 80% or greater) amounts of acetaminophen based on the weight of the total tablet.
摘要翻译：直接压缩固体药物剂型，其含有：a）约40至约95重量％的对乙酰氨基酚; b）约1至约60重量％的包含微晶纤维素的直接压缩载体; 和c）约0.01至约4.0重量％的药学上可接受的润滑剂。对乙酰氨基酚和直接压缩载体在高剪切条件下组合，足以将对乙酰氨基酚和直接压缩载体转化成均匀的颗粒而不降解。在本发明的优选方面，润滑剂还在高剪切条件下与对乙酰氨基酚和直接压缩载体组合。还公开了制备直接压片的固体药物剂型的方法和剂型的治疗方法。该方法特别适用于制备基于总片剂重量的含有高负荷量（即高达80％或更多）量的对乙酰氨基酚的直接压缩剂型。

14. 发明授权

US5866166A Pharmaceutical excipient having improved compressibility 失效
公开(公告)号：US5866166A
公开(公告)日：1999-02-02
申请号：US660553
申请日：1996-06-10
申请人： John N. Staniforth , Bob E. Sherwood , Edward A. Hunter
发明人： John N. Staniforth , Bob E. Sherwood , Edward A. Hunter
IPC分类号： A61K20060101 , A61K9/20 , A61K9/22 , A61K47/04 , A61K47/14 , A61K47/18 , A61K47/20 , A61K47/30 , A61K47/38 , A61K47/42 , A61K9/14
CPC分类号： A61K9/2009 , A61K9/2013 , A61K9/2018 , A61K9/2036 , A61K9/205 , A61K9/2054 , A61K9/2095 , Y10S977/904 , Y10S977/906 , Y10S977/915
摘要： A composition, comprising (a) microcrystalline cellulose; and (b) a compressibility augmenting agent which (i) physically restricts the proximity of the interface between adjacent cellulose surfaces; or (ii) inhibits interactions between adjacent cellulose surfaces; or (iii) accomplishes both (i) and (ii) above, is disclosed. The composition is in the form of agglomerated particles of microcrystalline cellulose and the compressibility augmenting agent in intimate association with each other.

15. 发明授权

US06471994B1 Pharmaceutical excipient having improved compressibility 失效
标题翻译：药物赋形剂具有改善的压缩性
公开(公告)号：US06471994B1
公开(公告)日：2002-10-29
申请号：US09384130
申请日：1999-08-27
申请人： John N. Staniforth , Bob E. Sherwood , Edward A. Hunter
发明人： John N. Staniforth , Bob E. Sherwood , Edward A. Hunter
IPC分类号： A16K914
CPC分类号： A61K9/2013 , A61K9/2009 , A61K9/2018 , A61K9/2036 , A61K9/205 , A61K9/2054 , Y10S977/906
摘要： A microcrystalline cellulose-based excipient having improved compressibility, whether utilized in direct compression, dry granulation or wet granulation formulations, is disclosed. The excipient is an agglomerate of microcrystalline cellulose particles and from about 0.1% to about 20% silicon dioxide particles, by weight of microcrystalline cellulose, wherein the microcrystalline cellulose and silicon dioxide are in intimate association with each other. The silicon dioxide utilized in the novel excipient has a particle size from about 1 nanometer to about 100 microns. Most preferably, the silicon dioxide is a grade of colloidal silicon dioxide. An extra low moisture excipient is provided which exhibits improved compressibility as compared to conventional microcrystalline cellulose, while providing a moisture content of from about 0.5 to 2.5% LOD, preferably between about 0.5 and about 1.8%, more preferably between 0.8 and 1.5%, and most preferably between about 0.8 and about 1.2 %.
摘要翻译：公开了具有改进的压缩性的微晶纤维素基赋形剂，无论是用于直接压片，干法制粒还是湿法制粒。赋形剂是微晶纤维素颗粒的聚集物和约0.1％至约20％的微晶纤维素重量的二氧化硅颗粒，其中微晶纤维素和二氧化硅彼此紧密结合。新型赋形剂中使用的二氧化硅具有约1纳米至约100微米的粒度。最优选地，二氧化硅是胶体二氧化硅的等级。提供了与常规微晶纤维素相比显示出改进的可压缩性的超低水分赋形剂，同时提供约0.5至2.5％的LOD，优选约0.5至约1.8％，更优选0.8至1.5％的水分含量，以及最优选在约0.8至约1.2％之间。

16. 发明授权

US5948438A Pharmaceutical formulations having improved disintegration and/or absorptivity 失效
标题翻译：具有改善的崩解和/或吸收性的药物制剂
公开(公告)号：US5948438A
公开(公告)日：1999-09-07
申请号：US868744
申请日：1997-06-04
申请人： John N. Staniforth , Bob E. Sherwood , Edward A. Hunter
发明人： John N. Staniforth , Bob E. Sherwood , Edward A. Hunter
IPC分类号： A61K9/20 , A61K9/14
CPC分类号： A61K9/2013 , A61K9/2009 , A61K9/2018 , A61K9/2036 , A61K9/2054 , Y10S977/801 , Y10S977/906 , Y10S977/915
摘要： An oral solid dosage form, comprising a compressed tablet including an excipient comprising (a) microcrystalline cellulose; and (b) a compressibility augmenting agent which (I) physically restricts the proximity of the interface between adjacent cellulose surfaces (e.g., silicon dioxide); or (ii) inhibits interactions between adjacent cellulose surfaces (e.g., sodium lauryl sulfate); or (iii) accomplishes both (i) and (ii) above; together with an active agent, is disclosed which provides improved disintegration and/or absorptivity to the oral solid dosage form when orally administered to human patients. The excipient comprises agglomerated particles of said microcrystalline cellulose and said compressibility augmenting agent in intimate association with each other.
摘要翻译：一种口服固体剂型，其包含压片，其包含赋形剂，所述赋形剂包含（a）微晶纤维素; （b）压缩性增强剂，其（I）物理地限制相邻的纤维素表面（例如二氧化硅）之间的界面的接近度; 或（ii）抑制相邻纤维素表面（例如月桂基硫酸钠）之间的相互作用; 或（iii）完成上述（i）和（ii）与活性剂一起被公开，其当口服施用于人类患者时提供口服固体剂型的改善的崩解和/或吸收性。赋形剂包括所述微晶纤维素的凝聚颗粒和所述压缩性增强剂彼此紧密结合。

17. 发明授权

US5741524A Sustained-release formulations utilizing pharmaceutical excipient having improved compressibility 失效
标题翻译：使用具有改善的压缩性的药物赋形剂的持续释放制剂
公开(公告)号：US5741524A
公开(公告)日：1998-04-21
申请号：US676654
申请日：1996-07-08
申请人： John N. Staniforth , Bob E. Sherwood , Edward A. Hunter
发明人： John N. Staniforth , Bob E. Sherwood , Edward A. Hunter
IPC分类号： A61K20060101 , A61K9/20 , A61K9/22 , A61K47/04 , A61K47/14 , A61K47/18 , A61K47/20 , A61K47/30 , A61K47/38 , A61K47/42 , A61K9/14
CPC分类号： A61K9/2009 , A61K9/2013 , A61K9/2018 , A61K9/2036 , A61K9/205 , A61K9/2054 , A61K9/2095 , Y10S977/904 , Y10S977/906 , Y10S977/915
摘要： Sustained release formulations include an augmented microcrystalline cellulose, an active agent, and a sustained release carrier and methods for making same are disclosed.
摘要翻译：持续释放制剂包括增强的微晶纤维素，活性剂和缓释载体及其制备方法。

18. 发明授权

US5733578A Directly compressible high load acetaminophen formulations 失效
公开(公告)号：US5733578A
公开(公告)日：1998-03-31
申请号：US558335
申请日：1995-11-15
申请人： Edward A. Hunter , Bob E. Sherwood , Joseph A. Zeleznik
发明人： Edward A. Hunter , Bob E. Sherwood , Joseph A. Zeleznik
IPC分类号： A61K9/20 , A61K31/165 , A61K31/167 , A61K47/04 , A61K47/12 , A61K47/38 , A61P29/02 , A61K9/14
CPC分类号： A61K9/2009 , A61K31/167 , A61K9/2054 , A61K9/2095 , Y10S977/904 , Y10S977/906 , Y10S977/915
摘要： Direct compressed solid pharmaceutical dosage forms containing: a) from about 40 to about 95% by weight acetaminophen; b) from about 1 to about 60% by weight of a direct compression vehicle comprising microcrystalline cellulose; and c) from about 0.01 to about 4.0% by weight of a pharmaceutically-acceptable lubricant are disclosed. The acetaminophen and direct compression vehicle are combined under high shear conditions which are sufficient to transform acetaminophen and direct compression vehicle into a homogenous granulate without degradation. In preferred aspects of the invention, the lubricant is also combined with the acetaminophen and direct compression vehicle under high shear conditions. Methods of preparing the directly compressed solid pharmaceutical dosage forms and methods of treatment with the dosage forms are also disclosed. The methods are particularly well suited for preparing directly compressed dosage forms containing high load (i.e., up to 80% or greater) amounts of acetaminophen based on the weight of the total tablet.

19. 发明授权

US5725884A Pharmaceutical excipient having improved compressibility 失效
公开(公告)号：US5725884A
公开(公告)日：1998-03-10
申请号：US724613
申请日：1996-09-30
申请人： Bob E. Sherwood , Edward A. Hunter , John H. Staniforth
发明人： Bob E. Sherwood , Edward A. Hunter , John H. Staniforth
IPC分类号： A61K9/20 , A61K9/26 , A61K47/02 , A61K47/04 , A61K47/38 , A61K9/14
CPC分类号： A61K9/2054 , A61K9/2009 , A61K9/2013 , A61K9/2018 , A61K9/2036 , A61K9/205 , Y10S977/727 , Y10S977/773 , Y10S977/775 , Y10S977/801 , Y10S977/89 , Y10S977/896 , Y10S977/904 , Y10S977/906 , Y10S977/915 , Y10T428/2982
摘要： A microcrystalline cellulose-based excipient having improved compressibility, whether utilized in direct compression, dry granulation or wet granulation formulations, is disclosed. The excipient is an agglomerate of microcrystalline cellulose particles and from about 0.1% to about 20% silicon dioxide particles, by weight of the microcrystalline cellulose, wherein the microcrystalline cellulose and silicon dioxide are in intimate association with each other. The silicon dioxide utilized in the novel excipient has a particle size from about 1 nanometer to about 100 microns. Most preferably, the silicon dioxide is a grade of colloidal silicon dioxide.

20. 发明授权

US5725883A Pharmaceutical excipient having improved compressibility 失效
标题翻译：药物赋形剂具有改善的压缩性
公开(公告)号：US5725883A
公开(公告)日：1998-03-10
申请号：US486183
申请日：1995-06-07
申请人： John N. Staniforth , Bob E. Sherwood , Edward A. Hunter
发明人： John N. Staniforth , Bob E. Sherwood , Edward A. Hunter
IPC分类号： A61K9/20 , A61K9/26 , A61K47/02 , A61K47/04 , A61K47/38 , A61K9/14
CPC分类号： A61K9/2054 , A61K9/2009 , A61K9/2013 , A61K9/2018 , A61K9/2036 , A61K9/205 , Y10S977/727 , Y10S977/773 , Y10S977/775 , Y10S977/801 , Y10S977/89 , Y10S977/896 , Y10S977/904 , Y10S977/906 , Y10S977/915 , Y10T428/2982
摘要： A microcrystalline cellulose-based excipient having improved compressibility, whether utilized in direct compression, dry granulation or wet granulation formulations, is disclosed. The excipient is an agglomerate of microcrystalline cellulose particles and an effective amount of a surfactant, which, in preferred embodiments is an anionic surfactant present in amounts ranging from about 0.1% to about 0.5%, by weight of the microcrystalline cellulose, wherein the microcrystalline cellulose and surfactant are in intimate association with each other. One preferred anionic surfactant utilized in the novel excipient is sodium lauryl sulfate.
摘要翻译：公开了具有改进的压缩性的微晶纤维素基赋形剂，无论是用于直接压片，干法制粒还是湿法制粒。赋形剂是微晶纤维素颗粒和有效量的表面活性剂的附聚物，其在优选的实施方案中是以微晶纤维素重量计约0.1％至约0.5％的量存在的阴离子表面活性剂，其中微晶纤维素和表面活性剂彼此紧密结合。在新型赋形剂中使用的一种优选的阴离子表面活性剂是月桂基硫酸钠。

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