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    • 1. 发明授权
    • Vaginal progesterone tablet
    • 阴道孕酮片
    • US5116619A
    • 1992-05-26
    • US238535
    • 1988-08-30
    • John C. GrecoJames W. McGinity
    • John C. GrecoJames W. McGinity
    • A61K9/00A61K31/57
    • A61K31/57A61K9/0034Y10S514/843Y10S514/935Y10S514/967
    • A vaginal progesterone suppository is provided in the form of a tablet which delivers biologically effective amounts of progesterone for at least about 48 hours, and blood amounts above basal levels for 72 hours. The tablet is formulated to preferably have a hardness on its edge of 8-13 kg, and disintegrates from its surface to form a milky suspension in 6-8 hours after it is inserted in the vaginal vault. The tablet contains, by weight, about 13-20% progesterone, 65-85% lactose, 2-10% corn starch paste binder, 3-10% corn starch disintegrant, and 0.1-0.9% magnesium stearate as a lubricant. The ratio by weight of progesterone to lactose is preferably 1:6, and the ratio of starch paste binder to starch disintegrant is preferably 1:1. This dosage form is an effective treatment for many progesterone deficiency conditions, and provides enhanced bioavailability.
    • 提供阴道孕酮栓剂,其片剂形式将生物有效量的孕酮输送至少约48小时,血液量高于基础水平72小时。 将片剂配制成优选具有8-13kg边缘的硬度,并且在将其插入阴道穹顶后6-8小时内从其表面分解形成乳状悬浮液。 片剂含有约13-20%孕酮,65-85%乳糖,2-10%玉米淀粉糊粘合剂,3-10%玉米淀粉崩解剂和0.1-0.9%硬脂酸镁作为润滑剂。 孕酮与乳糖的重量比优选为1:6,淀粉糊粘合剂与淀粉崩解剂的比例优选为1:1。 该剂型是许多孕激素缺乏症的有效治疗方法,并提供增强的生物利用度。
    • 3. 发明授权
    • Hot-melt extrusion of modified release multi-particulates
    • 改性释放多颗粒的热熔挤出
    • US09192578B2
    • 2015-11-24
    • US12544963
    • 2009-08-20
    • James W. McGinitySandra U. Schilling
    • James W. McGinitySandra U. Schilling
    • A61K9/16A61K9/20A61K31/522B29C47/00B29K105/00
    • A61K9/2077A61K9/1641A61K9/1694A61K9/2081A61K31/522B29C47/00B29C47/0014B29K2105/0035
    • 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.
    • 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。
    • 8. 发明授权
    • Effervescent granules and methods for their preparation
    • 泡腾颗粒及其制备方法
    • US06488961B1
    • 2002-12-03
    • US09468513
    • 1999-12-21
    • Joseph R RobinsonJames W. McGinity
    • Joseph R RobinsonJames W. McGinity
    • A61K946
    • A61K9/0007A61K9/1694
    • 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).
    • 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
    • Method for improving the dispersion of redispersible polymer powders
    • 改善可再分散聚合物粉末分散性的方法
    • US06169130A
    • 2001-01-02
    • US09316815
    • 1999-05-21
    • Roland BodmeierJames W. McGinity
    • Roland BodmeierJames W. McGinity
    • C08K716
    • A61K9/5161A61K9/2866A61K9/2893C08J3/05C08J2301/08
    • The method according to the present invention includes the step of adding sufficient amounts of an alkalinizing agent to an aqueous solution into which a redispersible polymer powder will be dispersed or to an aqueous dispersion which will be dried to form a redispersible polymer powder. The method of the invention is particularly well suited for nonionic polymers. A surfactant, plasticizer and/or preservative can also be used in addition to the alkalinizing agent. Redispersible polymer powders processed according to the invention form acceptable tablet coatings which are comparable in quality to those coatings formed from aqueous polymer dispersions that have not been dried into redispersible polymer powders.
    • 根据本发明的方法包括向待分散的可再分散聚合物粉末的水溶液中加入足量的碱化剂或将其干燥以形成可再分散聚合物粉末的水分散体的步骤。 本发明的方法特别适用于非离子聚合物。 除了碱化剂之外,还可以使用表面活性剂,增塑剂和/或防腐剂。 根据本发明加工的可再分散聚合物粉末形成可接受的片剂涂层,其质量与由尚未干燥成可再分散聚合物粉末的水性聚合物分散体形成的涂层相当。