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1. 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。

2. 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。

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。

5. 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。

6. 发明授权

US09192578B2 Hot-melt extrusion of modified release multi-particulates 有权
标题翻译：改性释放多颗粒的热熔挤出
公开(公告)号：US09192578B2
公开(公告)日：2015-11-24
申请号：US12544963
申请日：2009-08-20
申请人： James W. McGinity , Sandra U. Schilling
发明人： James W. McGinity , Sandra U. Schilling
IPC分类号： A61K9/16 , A61K9/20 , A61K31/522 , B29C47/00 , B29K105/00
CPC分类号： A61K9/2077 , A61K9/1641 , A61K9/1694 , A61K9/2081 , A61K31/522 , B29C47/00 , B29C47/0014 , B29K2105/0035
摘要： The present invention includes compositions and methods of making a modified release pharmaceutical formulation and a method of preparation for the embedding of modified release multi-particulates into a polymeric or wax-like matrix. The modified release multi-particulates comprise an effective amount of a therapeutic compound having a known or desired drug-release profile. Modified release multi-particulates may include a polymeric coat or may be incorporated into particle or core material. The polymer matrix comprises a thermoplastic polymer or lipophilic carrier or a mixture thereof that softens or melts at elevated temperature and allows the distribution of the modified release multi-particulates in the polymer matrix during thermal processing. Formulation compounds and processing conditions are selected in a manner to preserve the controlled release characteristics and/or drug-protective properties of the original modified release multi-particulates.
摘要翻译：本发明包括制备改性释放药物制剂的组合物和方法以及将改性释放多颗粒包埋在聚合物或蜡状基质中的制备方法。改性释放多颗粒包含有效量的具有已知或期望的药物释放曲线的治疗化合物。改性释放多颗粒可以包括聚合物涂层或可以结合到颗粒或芯材料中。聚合物基质包括在高温下软化或熔化的热塑性聚合物或亲脂性载体或其混合物，并且允许在热加工期间将改性释放多颗粒分布在聚合物基质中。选择配制化合物和加工条件以保持原来的改性释放多颗粒的控制释放特性和/或药物保护性质。

7. 发明授权

US06488963B1 Hot-melt extrudable pharmaceutical formulation 有权
标题翻译：热熔可挤出药物制剂
公开(公告)号：US06488963B1
公开(公告)日：2002-12-03
申请号：US09260694
申请日：1999-03-02
申请人： James W. McGinity , Feng Zhang
发明人： James W. McGinity , Feng Zhang
IPC分类号： A61K910
CPC分类号： A61K9/2031 , A61K9/2095 , Y10S514/953
摘要： The present invention relates to pharmaceutical formulations comprising a hot-melt extrudable mixture of a therapeutic compound and a high molecular weight poly(ethylene oxide) in an essentially non-film like preparation. In some embodiments, the formulation further comprises poly(ethylene glycol). The present invention also includes efficient methods for hot-melt extruding pharmaceutical formulations in essentially non-film preparations.
摘要翻译：本发明涉及包含基本上非膜状制剂中治疗化合物和高分子量聚（环氧乙烷）的热熔可挤出混合物的药物制剂。在一些实施方案中，制剂还包含聚（乙二醇）。本发明还包括在基本上非薄膜制剂中热熔挤出药物制剂的有效方法。

8. 发明授权

US4537689A Oral lubricant for athletic mouth protector 失效
标题翻译：口腔润滑剂用于运动口保护器
公开(公告)号：US4537689A
公开(公告)日：1985-08-27
申请号：US563239
申请日：1983-12-19
申请人： Robert M. Morrow , William A. Kuebker , James W. McGinity
发明人： Robert M. Morrow , William A. Kuebker , James W. McGinity
IPC分类号： A61K8/02 , A61Q11/00 , A63B71/08 , C10M169/00 , C10M5/00 , C10M1/06
CPC分类号： A61Q11/00 , A61K8/02 , A63B71/085
摘要： An oral lubricant effective in reducing the discomfort associated with the wearing of a mouth protector during periods of activity consisting essentially of a thickening agent, a preservative, a flavoring agent, a sweetener, an emulsifier, if needed, and a liquid diluent.
摘要翻译：一种口服润滑剂，其有效地减少了在活性期间与口罩保护剂相关的不适，基本上由增稠剂，防腐剂，调味剂，甜味剂，乳化剂（如果需要）和液体稀释剂组成。

9. 发明授权

US06488961B1 Effervescent granules and methods for their preparation 有权
标题翻译：泡腾颗粒及其制备方法
公开(公告)号：US06488961B1
公开(公告)日：2002-12-03
申请号：US09468513
申请日：1999-12-21
申请人： Joseph R Robinson , James W. McGinity
发明人： Joseph R Robinson , James W. McGinity
IPC分类号： A61K946
CPC分类号： A61K9/0007 , A61K9/1694
摘要： Disclosed here are effervescent granules having a controllable rate of effervescence. In some embodiments, the such granules comprise an acidic agent, an alkaline agent, a pharmacologically active agent, hot-melt extrudable binder capable of forming a eutectic mixture with the acidic agent and, optionally, a plasticizer. The effervescent granules are made by a hot-melt extrusion process. The present invention also provides a thermal heat process for preparing a pharmacologically active agent containing effervescent granule. In certain aspects, the granules contain pharmacologically active agents such as narcotics, antidiarrheal agents, antiviral agents, anxiolytic agents, a cholesterol lowering agent, an alpha adrenergic blocking agent, a phenanthrene derivative. By way of example, some of the narcotics that may be included in the granules and in the process of preparing the granules include, by way of example: phenanthrene derivatives (e.g., morphine sulfate), and morphine derivatives (e.g., hydromorphone hydrochloride).
摘要翻译：这里公开了具有可控的泡腾速率的泡腾颗粒。在一些实施方案中，这种颗粒包含酸性试剂，碱性试剂，药理学活性剂，能够与酸性试剂形成共晶混合物的热熔可挤出粘合剂和任选的增塑剂。泡腾颗粒通过热熔挤出方法制成。本发明还提供了制备含有泡腾颗粒的药理活性剂的热加工方法。在某些方面，颗粒含有药理学活性剂如麻醉剂，止泻药，抗病毒剂，抗焦虑剂，降胆固醇剂，α肾上腺素能阻断剂，菲衍生物。作为实例，可以包括在颗粒中和在制备颗粒的过程中的一些麻醉剂包括例如：菲衍生物（例如硫酸吗啡）和吗啡衍生物（例如盐酸氢吗啡酮）。

10. 发明授权

US5597849A Stick formulations for topical drug delivery of therapeutic agents and uses thereof 失效
标题翻译：用于局部药物递送治疗剂的制剂及其用途
公开(公告)号：US5597849A
公开(公告)日：1997-01-28
申请号：US345051
申请日：1994-11-14
申请人： James W. McGinity , Thomas G. Gerding , Roland Bodmeier
发明人： James W. McGinity , Thomas G. Gerding , Roland Bodmeier
IPC分类号： A61K8/63 , A61K9/02 , A61K9/06 , A61K31/135 , A61K31/138 , A61K31/16 , A61K31/167 , A61K31/57 , A61Q15/00 , A61Q19/00 , A61K7/32
CPC分类号： A61K31/135 , A61K31/138 , A61K31/167 , A61K31/573 , A61K8/0229 , A61K8/63 , A61K9/06 , A61Q15/00 , A61Q17/00 , A61Q19/00 , A61K2800/75 , Y10S514/817
摘要： Stick formulations for topical delivery of water soluble and/or water insoluble agents are disclosed. The stick formulations may contain steroids, antibiotics, antifungals, antihistamines anti inflammatories or local anesthetics. The vehicles comprise a combination of waxes and oils and a surfactant in embodiments involving water soluble agents. Methods for preparing the various stick formulations are also disclosed.
摘要翻译：公开了用于局部递送水溶性和/或水不溶性试剂的粘合剂制剂。棒剂可能含有类固醇，抗生素，抗真菌剂，抗组胺药物抗炎剂或局部麻醉剂。车辆包括蜡和油的组合以及涉及水溶性试剂的实施方案中的表面活性剂。还公开了制备各种棒剂制剂的方法。

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