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1. 发明授权

US5393765A Pharmaceutical compositions with constant erosion volume for zero order controlled release 失效
标题翻译：具有恒定侵蚀体积的药物组合物，用于零级控制释放
公开(公告)号：US5393765A
公开(公告)日：1995-02-28
申请号：US166123
申请日：1993-12-13
申请人： Martin H. Infeld , A. Waseem Malick , Navnit H. Shah , Wantanee Phuapradit
发明人： Martin H. Infeld , A. Waseem Malick , Navnit H. Shah , Wantanee Phuapradit
IPC分类号： A61K9/20 , A61K9/22 , A61K31/425 , A61K47/38 , A61K47/00
CPC分类号： A61K31/425 , A61K9/2018 , A61K9/2054
摘要： An erodible pharmaceutical composition providing a unique zero order controlled release profile is herein described. The erodible composition contains a therapeutically active substance having a solubility not greater than 80 mg/mL, a hydroxypropyl methylcellulose derivative and erosion modifiers depending on drug solubility and drug loading, such as lactose and polyoxyalkylene derivatives of propylene glycol, as well as other inert materials such as binders and lubricants. The hydroxypropyl methylcellulose derivative is most preferably a hydroxy-propylmethyl having a methoxy content of about 19-30% and hydroxypropyl content of 7-12%, a methoxy degree of substitution from 1.1 to 2.0, a molecular weight of approximately 20,000 to 26,000 daltons and a viscosity of a 2% w/w polymer solution at 25.degree. C. ranging from 50 to 100 cps. The composition erodes with a constant erosion volume for a desired time period. When ingested, the matrix forms two layers, an outer layer of hydrated matrix which is eroding and an inner core of unchanged matrix. The composition provides a zero order release profile in part because the diffusion rate of the drug from the matrix is either negligible or is comparable to the erosion rate of the matrix and the drug concentration in the hydrated layer remains constant.
摘要翻译：这里描述了提供独特的零级控制释放曲线的可侵蚀的药物组合物。可溶性组合物含有不大于80mg / mL的溶解度的治疗活性物质，羟丙基甲基纤维素衍生物和取决于药物溶解度和药物负荷的侵蚀改性剂，例如丙二醇的乳糖和聚氧化烯衍生物以及其它惰性物质如粘合剂和润滑剂。羟丙基甲基纤维素衍生物最优选甲氧基含量为约19-30％，羟丙基含量为7-12％，甲氧基取代度为1.1至2.0，分子量为约20,000至26,000道尔顿的羟基丙基甲基和 25℃下2％w / w聚合物溶液的粘度为50至100cps。组合物以恒定的侵蚀体积侵蚀所需时间段。当摄取时，基质形成两层，即水分基质的外层是侵蚀的，内层是不变的基体。该组合物提供了零级释放曲线，部分原因是药物从基质的扩散速率可以忽略不计，或与基质的侵蚀速度相当，并且水合层中的药物浓度保持恒定。

2. 发明申请

US20100310659A1 Compositions and Uses Thereof 有权
标题翻译：组合及用途
公开(公告)号：US20100310659A1
公开(公告)日：2010-12-09
申请号：US12752035
申请日：2010-03-31
申请人： Dipen Desai , Ralph Diodone , Zenaida Go , Prabha N. Ibrahim , Raman Iyer , Hans-Juergen Mair , Harpreet K. Sandhu , Navnit H. Shah , Gary Visor , Nicole Wyttenbach , Stephan Lauper , Johannes Pudewell , Frank Wierschem
发明人： Dipen Desai , Ralph Diodone , Zenaida Go , Prabha N. Ibrahim , Raman Iyer , Hans-Juergen Mair , Harpreet K. Sandhu , Navnit H. Shah , Gary Visor , Nicole Wyttenbach , Stephan Lauper , Johannes Pudewell , Frank Wierschem
IPC分类号： A61K9/14 , C07D471/04 , A61K31/437
CPC分类号： C07D471/04 , A61K9/0014 , A61K9/0019 , A61K9/10 , A61K9/1635 , A61K9/1652 , A61K31/437 , C07B2200/13
摘要： Provided are solid dispersions, solid molecular complexes, salts and crystalline polymorphs involving propane-1-sulfonic acid {3-[5-(4-chloro-phenyl)-1H-pyrrolo[2,3-b]pyridine-3-carbonyl]-2,4-difluoro-phenyl}-amide.
摘要翻译：提供的是固体分散体，固体分子复合物，盐和结晶多晶型物，其涉及丙烷-1-磺酸{3- [5-（4-氯 - 苯基）-1H-吡咯并[2,3-b]吡啶-3-羰基] -2,4-二氟 - 苯基} - 酰胺。

3. 发明授权

US5482718A Colon-targeted delivery system 失效
标题翻译：结肠靶向递送系统
公开(公告)号：US5482718A
公开(公告)日：1996-01-09
申请号：US217344
申请日：1994-03-23
申请人： Navnit H. Shah , Wantanee Phuapradit , Aruna Railkar
发明人： Navnit H. Shah , Wantanee Phuapradit , Aruna Railkar
IPC分类号： A61K9/00 , A61K9/20 , A61K9/22 , A61K9/28 , A61K9/30 , A61K9/32 , A61K9/34 , A61K9/36
CPC分类号： A61K9/2886
摘要： A novel delivery system for targeting drugs to the colon is disclosed. The delivery system is a tablet comprised of three parts: (1) an enteric coating to prevent penetration of gastric fluid into the delivery system, thereby preventing any drug release in the stomach; (2) an erodible polymer layer which is exposed and gradually erodes during transit through the upper intestinal tract, and (3) a core, which is a conventional tablet or beadlet containing an active ingredient(s), which readily disintegrates and subsequently releases the drug to the target site, the colon, after erosion of the erodible polymer layer. The erodible polymer layer prevents drug release in the upper portion of the intestinal tract for 4-6 hours after gastric emptying, representing the amount of time needed for the delivery system to reach the colon.
摘要翻译：公开了一种用于将药物靶向结肠的新型递送系统。递送系统是由三部分组成的片剂：（1）肠胃衣，以防止胃液渗透到输送系统中，从而防止任何药物在胃中释放; （2）在通过上肠道过渡期间暴露并逐渐侵蚀的可侵蚀聚合物层，和（3）核心，其是含有活性成分的常规片剂或珠粒，其容易崩解并随后释放药物到目标部位，结肠，侵蚀后的可溶性聚合物层。侵蚀性聚合物层在胃排空后防止药物在肠上部释放4-6小时，代表输送系统到达结肠所需的时间。

4. 发明授权

US4892742A Controlled release compositions with zero order release 失效
标题翻译：具有零级释放的控释组合物
公开(公告)号：US4892742A
公开(公告)日：1990-01-09
申请号：US799229
申请日：1985-11-18
申请人： Navnit H. Shah
发明人： Navnit H. Shah
IPC分类号： A61K9/20 , A61K9/22 , A61K9/28 , A61K9/36
CPC分类号： A61K9/2054 , A61K9/2013 , A61K9/2866
摘要： Pharmaceutical compositions for controlled release of water soluble drugs are disclosed. The compositions comprise a tablet core containing the drug and a water insoluble polymeric matrix surrounded with a rate controlling membrane coating.
摘要翻译：公开了用于控制释放水溶性药物的药物组合物。组合物包含含有药物的片芯和用速率控制膜包被的水不溶性聚合物基质。

5. 发明授权

US4310543A Prostaglandin compositions 失效
标题翻译：前列腺素组合物
公开(公告)号：US4310543A
公开(公告)日：1982-01-12
申请号：US195575
申请日：1980-10-09
申请人： Hugo E. Gallo-Torres , Navnit H. Shah
发明人： Hugo E. Gallo-Torres , Navnit H. Shah
IPC分类号： A61K31/20 , A61K9/48 , A61K31/23 , A61K31/557 , A61K47/34 , A61K31/215 , A61K31/19
CPC分类号： A61K9/4858 , A61K31/557
摘要： Orally administrable pharmaceutical compositions in the form of a soft gelatin capsule containing a prostaglandin and ascorbic acid or ascorbyl palmitate which are dissolved in polyethylene glycol or polyoxyethylene sorbitan esters of fatty acids or combinations thereof. The compositions are especially useful in improving bioavailability and stability of the prostaglandin in pharmaceutical dosage form.
摘要翻译：口服给药的药物组合物，其为含有前列腺素和抗坏血酸或抗坏血酸棕榈酸酯的软明胶胶囊形式，其溶解于聚乙二醇或脂肪酸的聚氧乙烯脱水山梨糖醇酯或其组合。组合物特别可用于改善药物剂型中前列腺素的生物利用度和稳定性。

6. 发明申请

US20120213827A1 PROCESS FOR CONTROLLED CRYSTALLIZATION OF AN ACTIVE PHARMACEUTICAL INGREDIENT FROM SUPERCOOLED LIQUID STATE BY HOT MELT EXTRUSION 审中-公开
标题翻译：通过热熔融挤出从超级液体状态控制活性药物成分的结晶过程
公开(公告)号：US20120213827A1
公开(公告)日：2012-08-23
申请号：US13398902
申请日：2012-02-17
申请人： Ashish Chatterji , Dipen Desai , Dave Alan Miller , Harpreet K. Sandhu , Navnit H. Shah
发明人： Ashish Chatterji , Dipen Desai , Dave Alan Miller , Harpreet K. Sandhu , Navnit H. Shah
IPC分类号： A61K31/265 , B29C47/00 , A61K31/405 , A61K31/167 , A61K9/14 , A61K31/192
CPC分类号： A61K9/146 , A61K31/167 , A61K31/192 , A61K31/265 , A61K31/405 , B29B7/488 , B29B7/726 , B29B7/82 , B29C48/03 , B29C48/875
摘要： A process for controlling the crystallization of certain hydrophobic active pharmaceutical ingredients (APIs) from a supercooled liquid state by hot-melt extrusion processing is described. Also described is a pharmaceutical composition comprising a solid crystalline dispersion of a cholesterol ester transfer protein inhibitor in a hydrophilic excipient matrix. In the process of the present invention, the API is fed to an extrusion system in a crystalline state contemporaneously with carrier excipients where it is first converted to a non-crystalline state by the application of heat and then subsequently recrystallized in-situ by the removal of heat and application of shear. Recrystallization of the API is controlled by carrier formulation design and the hot-melt extrusion process parameters; i.e. barrel temperature profile, feed rate, etc.
摘要翻译：描述了通过热熔挤出处理从过冷液体状态控制某些疏水性活性药物成分（API）的结晶的方法。还描述了一种药物组合物，其包含亲水性赋形剂基质中的胆固醇酯转移蛋白抑制剂的固体结晶分散体。在本发明的方法中，将API以与载体赋形剂同时的结晶状态进料至挤出系统，其中首先通过施加热量将其转化为非结晶状态，然后通过去除原位再结晶的热量和应用的剪切。 API的重结晶由载体配方设计和热熔挤出工艺参数控制; 即桶温度分布，进料速率等

7. 发明授权

US09447089B2 Compositions and uses thereof 有权
标题翻译：组合物及其用途
公开(公告)号：US09447089B2
公开(公告)日：2016-09-20
申请号：US12752035
申请日：2010-03-31
申请人： Dipen Desai , Ralph Diodone , Zenaida Go , Prabha N. Ibrahim , Raman Iyer , Hans-Juergen Mair , Harpreet K. Sandhu , Navnit H. Shah , Gary Visor , Nicole Wyttenbach , Stephan Lauper , Johannes Pudewell , Frank Wierschem
发明人： Dipen Desai , Ralph Diodone , Zenaida Go , Prabha N. Ibrahim , Raman Iyer , Hans-Juergen Mair , Harpreet K. Sandhu , Navnit H. Shah , Gary Visor , Nicole Wyttenbach , Stephan Lauper , Johannes Pudewell , Frank Wierschem
IPC分类号： A61K9/14 , C07D471/04 , A61K31/437 , A61K9/10 , A61K9/16 , A61K9/00
CPC分类号： C07D471/04 , A61K9/0014 , A61K9/0019 , A61K9/10 , A61K9/1635 , A61K9/1652 , A61K31/437 , C07B2200/13
摘要： Provided are solid dispersions, solid molecular complexes, salts and crystalline polymorphs involving propane-1-sulfonic acid {3-[5-(4-chloro-phenyl)-1H-pyrrolo[2,3-b]pyridine-3-carbonyl]-2,4-difluoro-phenyl}-amide.
摘要翻译：提供的是固体分散体，固体分子复合物，盐和结晶多晶型物，其涉及丙烷-1-磺酸{3- [5-（4-氯 - 苯基）-1H-吡咯并[2,3-b]吡啶-3-羰基] -2,4-二氟 - 苯基} - 酰胺。

8. 发明申请

US20150335753A1 SUPERSATURATED STABILIZED NANOPARTICLES FOR POORLY SOLUBLE DRUGS 审中-公开
标题翻译：用于不溶性药物的超级稳定纳米颗粒
公开(公告)号：US20150335753A1
公开(公告)日：2015-11-26
申请号：US14653061
申请日：2013-12-19
申请人： Dipen DESAI , Wantanee PHUAPRADIT , Anekant JAIN , Atsawin THONGSUKMAK , Navnit H. SHAH , KASHIV PARMA, LLC
发明人： Dipen Desai , Wantanee Phuapradit , Anekant Jain , Atsawin Thongsukmak , Navnit H. Shah
IPC分类号： A61K47/32 , A61K31/421 , A61K31/5377 , A61K38/08 , A61K31/496 , A61K38/07 , A61K31/57 , A61K31/58
CPC分类号： A61K47/32 , A61K9/1635 , A61K9/1676 , A61K31/421 , A61K31/496 , A61K31/5377 , A61K31/57 , A61K31/58 , A61K38/07 , A61K38/08 , A61K2800/5424 , A61K2800/5426
摘要： A pharmaceutical composition and method of producing supersaturated stabilized nanoparticles of poorly soluble drugs having average sizes less than 1 μm, or less than 800 nm, or less than 500 nm, comprising at least one pharmaceutically active ingredient, a hydrophilic polymer, a water-soluble surfactant, and subsequently stabilized by ionic polymers.
摘要翻译：一种药物组合物和方法，其制备平均粒度小于1μm，或小于800nm，或小于500nm的难溶性药物的过饱和稳定纳米颗粒，其包含至少一种药物活性成分，亲水性聚合物，水溶性表面活性剂，随后通过离子聚合物稳定。

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