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1. 发明授权

US09504658B2 Stabilized HME composition with small drug particles 有权
标题翻译：具有小药物颗粒的稳定的HME组合物
公开(公告)号：US09504658B2
公开(公告)日：2016-11-29
申请号：US11718620
申请日：2005-11-09
申请人： Dave A. Miller , Jason T. McConville , James W. McGinity , Robert O. Williams, III
发明人： Dave A. Miller , Jason T. McConville , James W. McGinity , Robert O. Williams, III
IPC分类号： A61K9/14 , A61K9/51 , A61K9/16
CPC分类号： A61K9/146 , A61K9/1635 , A61K9/1641 , A61K9/5138 , A61K31/496 , A61K31/55 , A61K31/58 , A61K38/13
摘要： A hot-melt extruded composition having finely divided drug-containing particles dispersed within a polymeric and/or lipophyllic carrier matrix is provided. The carrier softens or melts during hot-melt extrusion but it does not dissolve the drug-containing particles during extrusion. As a result, a majority or at least 90% wt. of the drug-containing particles in the extrudate are deaggregated during extrusion into essentially primary crystalline and/or amorphous particles. PEO is a suitable carrier material for drugs insoluble in the solid state in this carrier. Various functional excipients can be included in the carrier system to stabilize the particle size and physical state of the drug substance in either a crystalline and/or amorphous state. The carrier system is comprised of at least one thermal binder, and may also contain various functional excipients, such as: super-disintegrants, antioxidants, surfactants, wetting agents, stabilizing agents, retardants, or similar functional excipients. A hydrophilic polymer, such as hydroxypropyl methylcellulose (HPMC E15), polyvinyl alcohol (PVA), or poloxamer, and/or a surfactant, such as sodium lauryl sulfate (SLS), can be included in the composition. A process for preparing the extrudate is conducted at a temperature approximating or above the softening or melting temperature of the matrix and below the point of solubilization of drug-containing particles in the carrier system, and below the recrystallization point in the case of amorphous fine drug particles.
摘要翻译：提供了具有分散在聚合物和/或脂肪载体基质内的细分散的含药颗粒的热熔挤出组合物。载体在热熔挤出过程中软化或熔化，但在挤出过程中不溶解含药颗粒。结果，多数或至少90％重量。的挤出物中的含药颗粒在挤出过程中被解聚为基本上为初级结晶和/或无定形颗粒。 PEO是在该载体中不溶于固体的药物的合适的载体材料。载体系统中可以包括各种功能性赋形剂，以稳定药物物质在晶体和/或非晶状态下的粒度和物理状态。载体系统由至少一种热粘合剂组成，并且还可以含有各种功能赋形剂，例如：超级崩解剂，抗氧化剂，表面活性剂，润湿剂，稳定剂，阻滞剂或类似的功能赋形剂。亲水性聚合物如羟丙基甲基纤维素（HPMC E15），聚乙烯醇（PVA）或泊洛沙姆，和/或表面活性剂如十二烷基硫酸钠（SLS）可以包括在组合物中。制备挤出物的方法在接近或高于基质的软化或熔融温度的温度下进行，并且低于药物含量颗粒在载体体系中的溶解点，并且在无定形精细药物的情况下在重结晶点以下粒子。

2. 发明申请

US20080274194A1 Stabilized Hme Composition With Small Drug Particles 有权
标题翻译：用小药物颗粒稳定的Hme组合物
公开(公告)号：US20080274194A1
公开(公告)日：2008-11-06
申请号：US11718620
申请日：2005-11-09
申请人： Dave A. Miller , Jason T. McConville , James W. McGinity , Robert O. Williams
发明人： Dave A. Miller , Jason T. McConville , James W. McGinity , Robert O. Williams
IPC分类号： A61K9/14 , A61P43/00
CPC分类号： A61K9/146 , A61K9/1635 , A61K9/1641 , A61K9/5138 , A61K31/496 , A61K31/55 , A61K31/58 , A61K38/13
摘要： A hot-melt extruded composition having finely divided drug-containing particles dispersed within a polymeric and/or lipophyllic carrier matrix is provided. The carrier softens or melts during hot-melt extrusion but it does not dissolve the drug-containing particles during extrusion. As a result, a majority or at least 90% wt. of the drug-containing particles in the extrudate are deaggregated during extrusion into essentially primary crystalline and/or amorphous particles. PEO is a suitable carrier material for drugs insoluble in the solid state in this carrier. Various functional excipients can be included in the carrier system to stabilize the particle size and physical state of the drug substance in either a crystalline and/or amorphous state. The carrier system is comprised of at least one thermal binder, and may also contain various functional excipients, such as: super-disintegrants, antioxidants, surfactants, wetting agents, stabilizing agents, retardants, or similar functional excipients. A hydrophilic polymer, such as hydroxypropyl methylcellulose (HPMC E15), polyvinyl alcohol (PVA), or poloxamer, and/or a surfactant, such as sodium lauryl sulfate (SLS), can be included in the composition. A process for preparing the extrudate is conducted at a temperature approximating or above the softening or melting temperature of the matrix and below the point of solubilization of drug-containing particles in the carrier system, and below the recrystallization point in the case of amorphous fine drug particles.
摘要翻译：提供了具有分散在聚合物和/或脂肪载体基质内的细分散的含药颗粒的热熔挤出组合物。载体在热熔挤出过程中软化或熔化，但在挤出过程中不溶解含药颗粒。结果，多数或至少90％重量。的挤出物中的含药颗粒在挤出过程中被解聚为基本上为初级结晶和/或无定形颗粒。 PEO是在该载体中不溶于固体的药物的合适的载体材料。载体系统中可以包括各种功能性赋形剂，以稳定药物物质在晶体和/或非晶状态下的粒度和物理状态。载体系统由至少一种热粘合剂组成，并且还可以含有各种功能赋形剂，例如：超级崩解剂，抗氧化剂，表面活性剂，润湿剂，稳定剂，阻滞剂或类似的功能赋形剂。亲水性聚合物如羟丙基甲基纤维素（HPMC E15），聚乙烯醇（PVA）或泊洛沙姆，和/或表面活性剂如十二烷基硫酸钠（SLS）可以包括在组合物中。制备挤出物的方法在接近或高于基质的软化或熔融温度的温度下进行，并且低于药物含量颗粒在载体体系中的溶解点，并且在无定形精细药物的情况下在重结晶点以下粒子。

3. 发明申请

US20090053315A1 Thermo-Kinetic Mixing for Pharmaceutical Applications 有权
标题翻译：药物应用的热动力学混合
公开(公告)号：US20090053315A1
公开(公告)日：2009-02-26
申请号：US12196154
申请日：2008-08-21
申请人： Chris Brough , James W. McGinity , Dave A. Miller , James C. DiNunzio , Robert O. Williams
发明人： Chris Brough , James W. McGinity , Dave A. Miller , James C. DiNunzio , Robert O. Williams
IPC分类号： A61K9/14 , A61K38/02 , A61K31/7088
CPC分类号： A61K31/573 , A61J3/00 , A61J3/07 , A61J3/10 , A61K9/146 , A61K9/1694 , A61K9/2077 , A61K31/343 , A61K31/496 , A61K47/32 , A61K47/38
摘要： Compositions and methods for making a pharmaceutical dosage form include making a pharmaceutical composition that includes one or more active pharmaceutical ingredients (API) with one or more pharmaceutically acceptable excipients by thermokinetic compounding into a composite. Compositions and methods of preprocessing a composite comprising one or more APIs with one or more excipients include thermokinetic compounding, comprising thermokinetic processing the APIs with the excipients into a composite, wherein the composite can be further processed by conventional methods known in the art, such as hot melt extrusion, melt granulation, compression molding, tablet compression, capsule filling, film-coating, or injection molding.
摘要翻译：用于制备药物剂型的组合物和方法包括制备药物组合物，其包含一种或多种活性药物成分（API）与一种或多种药学上可接受的赋形剂，通过热动力学复合制成复合材料。将包含一种或多种API的复合材料与一种或多种赋形剂预处理的组合物和方法包括热动力学复合，其包括将所述API与所述赋形剂的热机械加工成复合材料，其中所述复合材料可以通过本领域已知的常规方法进一步加工，热熔挤出，熔融造粒，压缩成型，片剂压缩，胶囊填充，薄膜包衣或注塑成型。

4. 发明申请

US20140039031A1 PHARMACEUTICAL FORMULATIONS OF ACETYL-11-KETO-B-BOSWELLIC ACID, DIINDOLYLMETHANE, AND CURCUMIN FOR PHARMACEUTICAL APPLICATIONS 审中-公开
标题翻译：乙酰基-11-酮酸B-BOSWELLIC酸，DIINDOLYLMETHANE和CURCUMIN用于药物应用的药物制剂
公开(公告)号：US20140039031A1
公开(公告)日：2014-02-06
申请号：US14001098
申请日：2012-02-23
申请人： Chris Brough , Robert O. Williams, III , James W. McGinity , Dave A. Miller , Justin Hughey , Ryan Bennett
发明人： Chris Brough , Robert O. Williams, III , James W. McGinity , Dave A. Miller , Justin Hughey , Ryan Bennett
IPC分类号： A61K31/404 , A61K31/12 , A61K31/19
CPC分类号： A61K31/19 , A61K31/05 , A61K31/12 , A61K31/404
摘要： The present disclosure is directed to compositions and methods for formulating a pharmaceutical dosage form by forming a composition comprising acetyl-11-keto-β-boswellic acid, diindolylmethane, or curcumin with one or more pharmaceutically acceptable excipients for enhanced solubility to increase bioavailability and improve therapeutic efficacy. The composition can be processed by thermo-kinetic compounding along with conventional methods known in the art, such as hot melt extrusion, melt granulation, compression molding, tablet compression, capsule filling, film-coating, or injection molding.
摘要翻译：本公开涉及通过形成包含乙酰基-11-酮基-β-乳糖酸，二吲哚基甲烷或姜黄素与一种或多种药学上可接受的赋形剂的组合物来配制药物剂型的组合物和方法，以提高溶解度以提高生物利用度并提高治疗功效。组合物可以通过热动力学混合以及本领域已知的常规方法如热熔体挤出，熔融造粒，压塑，压片，胶囊填充，薄膜包衣或注射成型加工。

5. 发明授权

US08486423B2 Thermo-kinetic mixing for pharmaceutical applications 有权
标题翻译：用于药物应用的热动力学混合
公开(公告)号：US08486423B2
公开(公告)日：2013-07-16
申请号：US12196154
申请日：2008-08-21
申请人： Chris Brough , James W. McGinity , Dave A. Miller , James DiNunzio , Robert O. Williams
发明人： Chris Brough , James W. McGinity , Dave A. Miller , James DiNunzio , Robert O. Williams
IPC分类号： A61K9/00 , A61K31/50 , A01N43/58
CPC分类号： A61K31/573 , A61J3/00 , A61J3/07 , A61J3/10 , A61K9/146 , A61K9/1694 , A61K9/2077 , A61K31/343 , A61K31/496 , A61K47/32 , A61K47/38
摘要： Compositions and methods for making a pharmaceutical dosage form include making a pharmaceutical composition that includes one or more active pharmaceutical ingredients (API) with one or more pharmaceutically acceptable excipients by thermokinetic compounding into a composite. Compositions and methods of preprocessing a composite comprising one or more APIs with one or more excipients include thermokinetic compounding, comprising thermokinetic processing the APIs with the excipients into a composite, wherein the composite can be further processed by conventional methods known in the art, such as hot melt extrusion, melt granulation, compression molding, tablet compression, capsule filling, film-coating, or injection molding.
摘要翻译：用于制备药物剂型的组合物和方法包括制备药物组合物，其包含一种或多种活性药物成分（API）与一种或多种药学上可接受的赋形剂，通过热动力学复合制成复合材料。将包含一种或多种API的复合材料与一种或多种赋形剂预处理的组合物和方法包括热动力学复合，其包括将所述API与所述赋形剂的热机械加工成复合材料，其中所述复合材料可以通过本领域已知的常规方法进一步加工，热熔挤出，熔融造粒，压缩成型，片剂压缩，胶囊填充，薄膜包衣或注塑成型。

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