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21. 发明申请

US20050281806A1 Compositions for topical enzymatic debridement 审中-公开
标题翻译：用于局部酶清创的组合物
公开(公告)号：US20050281806A1
公开(公告)日：2005-12-22
申请号：US11147567
申请日：2005-06-08
申请人： Mark Trumbore , Roman Rariy , Mark Hirsh , Jane Hirsh , Julie Saunders
发明人： Mark Trumbore , Roman Rariy , Mark Hirsh , Jane Hirsh , Julie Saunders
IPC分类号： A61K9/00 , A61K9/12 , A61K33/18 , A61K33/36 , A61K33/38 , A61K36/48 , A61K38/46 , A61K38/48 , A61K47/44 , A61K35/78
CPC分类号： A61K9/0014 , A61K9/12 , A61K33/18 , A61K33/38 , A61K36/48 , A61K38/482 , A61K38/4826 , A61K38/4873 , A61K38/4886 , A61K47/44 , A61L15/34 , A61L15/38 , A61L15/48 , A61K2300/00
摘要： Formulations are described for the treatment by enzymatic debridement of wounds and ulcers. The formulations have a clear, transparent composition that allows for easy visualization of the wound, and are non-staining for easy clean up. These formulations can also exhibit increased enzymatic debridement activity, improved post-treatment lubricity and coating occlusivity, and stability. The formulations, optionally containing non-animal source biologics, may be in the form of lotions, aerosols to provide a spray, or a foam. A non-reactive substrate may be used as a composition carrier. A non-aqueous lotion formulation having improved enzymatic activity is provided. The non-aqueous lotion viscosity is adjusted to achieve high enzymatic activity while maintaining the application benefits of high viscosity non-aqueous lotions. The lotion formulation may be delivered in a patch.
摘要翻译：描述了用于通过创伤和溃疡的酶清除治疗的制剂。制剂具有清晰，透明的组合物，其允许容易地观察伤口，并且是无污染的以便于清洁。这些制剂还可以表现出增加的酶清除活性，改善的后处理润滑性和涂层封闭性以及稳定性。任选地含有非动物源生物制剂的制剂可以是洗剂，提供喷雾剂或泡沫剂的气溶胶的形式。非反应性底物可以用作组合物载体。提供了具有改善的酶活性的非水性乳液制剂。调节非水性乳液粘度以达到高酶活性，同时保持高粘度非水性乳液的应用益处。洗剂制剂可以在贴剂中递送。

22. 发明申请

US20080014169A1 Compositions for Topical Enzymatic Debridement 审中-公开
标题翻译：局部酶清创组成
公开(公告)号：US20080014169A1
公开(公告)日：2008-01-17
申请号：US11843158
申请日：2007-08-22
申请人： Mark Trumbore , Roman Rariy , Mark Hirsh , Jane Hirsh , Julie Saunders
发明人： Mark Trumbore , Roman Rariy , Mark Hirsh , Jane Hirsh , Julie Saunders
IPC分类号： A61K31/74 , A61K33/38 , A61K35/00 , A61K38/43 , A61P17/00
CPC分类号： A61K9/0014 , A61K9/12 , A61K33/18 , A61K33/38 , A61K36/48 , A61K38/482 , A61K38/4826 , A61K38/4873 , A61K38/4886 , A61K47/44 , A61L15/34 , A61L15/38 , A61L15/48 , A61K2300/00
摘要： Formulations are described for the treatment by enzymatic debridement of wounds and ulcers. The formulations have a clear, transparent composition that allows for easy visualization of the wound, and are non-staining for easy clean up. These formulations can also exhibit increased enzymatic debridement activity, improved post-treatment lubricity and coating occlusivity, and stability. The formulations, optionally containing non-animal source biologics, may be in the form of lotions, aerosols to provide a spray, or a foam. A non-reactive substrate may be used as a composition carrier. A non-aqueous lotion formulation having improved enzymatic activity is provided. The non-aqueous lotion viscosity is adjusted to achieve high enzymatic activity while maintaining the application benefits of high viscosity non-aqueous lotions. The lotion formulation may be delivered in a patch.
摘要翻译：描述了用于通过创伤和溃疡的酶清除治疗的制剂。制剂具有清晰，透明的组合物，其允许容易地观察伤口，并且是无污染的以便于清洁。这些制剂还可以表现出增加的酶清除活性，改善的后处理润滑性和涂层封闭性以及稳定性。任选地含有非动物源生物制剂的制剂可以是洗剂，提供喷雾剂或泡沫剂的气溶胶的形式。非反应性底物可以用作组合物载体。提供了具有改善的酶活性的非水性乳液制剂。调节非水性乳液粘度以达到高酶活性，同时保持高粘度非水性乳液的应用益处。洗剂制剂可以在贴剂中递送。

23. 发明申请

US20070036731A1 Topical Delivery with a Carrier Fluid 审中-公开
标题翻译：带载体流体的局部输送
公开(公告)号：US20070036731A1
公开(公告)日：2007-02-15
申请号：US11464100
申请日：2006-08-11
申请人： Jane Hirsh , Ronald Gurge , Mark Hirsh , Mark Trumbore
发明人： Jane Hirsh , Ronald Gurge , Mark Hirsh , Mark Trumbore
IPC分类号： A61K31/7034 , A61K9/14 , A61K31/496 , A61K31/4178 , A61K31/4196
CPC分类号： A61K47/34 , A61K9/0014 , A61K9/12 , A61K31/4178 , A61K31/4196 , A61K31/496 , A61K31/7034 , A61K47/02
摘要： Aerosol spray formulations capable of delivering high concentrations of active agent-containing materials and/or excipient are described herein. The formulation contains a carrier fluid, a propellant, and a therapeutic, prophylactic, consmeticeutical and/or inert solid suspended, dissolved, or dispersed in the formulation. The active ingredient may be any pharmaceutically active agent, but is preferably an antibiotic, an antihistamine, an anesthetic, an anti-inflammatory, and/or an astringent. In one embodiment, the active agent is an antifungal agent. In another embodiment, the active agent is a consmeticeutical. The active agent can optionally be dispersed on, or associated with, a carrier powder. The carrier fluid is a highly volatile silicone liquid, which evaporates in less than 10 minutes, preferably less than 5 minutes, after application of the formulation to the patient's skin. The formulation may also contain one or more pharmaceutically acceptable excipients such as antioxidants, stabilizers, perfumes, colorants, viscosifiers, emulsifiers, surfactants, and combinations thereof. The formulation can be packaged in a conventional aerosol spray can.
摘要翻译：本文描述了能够递送高浓度的含活性剂的物质和/或赋形剂的气溶胶喷雾制剂。制剂含有悬浮，溶解或分散在制剂中的载体流体，推进剂和治疗性，预防性，依赖性和/或惰性固体。活性成分可以是任何药物活性剂，但优选为抗生素，抗组胺剂，麻醉剂，抗炎剂和/或收敛剂。在一个实施方案中，活性剂是抗真菌剂。在另一个实施方案中，活性剂是一种辅助药。活性剂可以任选地分散在载体粉末上或与载体粉末相关联。载体流体是高度挥发性的有机硅液体，其在将制剂施用于患者皮肤后在少于10分钟，优选少于5分钟内蒸发。制剂还可以含有一种或多种药学上可接受的赋形剂，例如抗氧化剂，稳定剂，香料，着色剂，增粘剂，乳化剂，表面活性剂及其组合。该制剂可以包装在常规的气溶胶喷雾罐中。

24. 发明申请

US20050153946A1 Temperature-stable formulations, and methods of development thereof 审中-公开
标题翻译：温度稳定的配方及其开发方法
公开(公告)号：US20050153946A1
公开(公告)日：2005-07-14
申请号：US11014636
申请日：2004-12-16
申请人： Jane Hirsh , Donald Tibbetts
发明人： Jane Hirsh , Donald Tibbetts
IPC分类号： A61K9/00 , A61K31/56
CPC分类号： A61K9/0043 , A61K31/56
摘要： One embodiment of the present invention relates to a method of preparing a concentrated pharmaceutical formulation, comprising the steps of: combining in a container a therapeutic agent, a solvent and at least one pharmaceutically acceptable excipient to give a solution; adding to said solution a seed crystal of said compound to give a heterogeneous mixture; and observing the stability of said heterogeneous mixture.
摘要翻译：本发明的一个实施方案涉及制备浓缩药物制剂的方法，其包括以下步骤：在容器中混合治疗剂，溶剂和至少一种药学上可接受的赋形剂，得到溶液; 向所述溶液中加入所述化合物的晶种，得到非均相混合物; 并观察所述不均匀混合物的稳定性。

25. 发明申请

US20090010869A9 Compositions for Topical Enzymatic Debridement 审中-公开
标题翻译：局部酶清创组成
公开(公告)号：US20090010869A9
公开(公告)日：2009-01-08
申请号：US11843158
申请日：2007-08-22
申请人： Mark Trumbore , Roman Rariy , Mark Hirsh , Jane Hirsh , Julie Saunders
发明人： Mark Trumbore , Roman Rariy , Mark Hirsh , Jane Hirsh , Julie Saunders
IPC分类号： A61K31/74 , A61K33/38 , A61K35/00 , A61K38/43 , A61P17/00
CPC分类号： A61K9/0014 , A61K9/12 , A61K33/18 , A61K33/38 , A61K36/48 , A61K38/482 , A61K38/4826 , A61K38/4873 , A61K38/4886 , A61K47/44 , A61L15/34 , A61L15/38 , A61L15/48 , A61K2300/00
摘要： Formulations are described for the treatment by enzymatic debridement of wounds and ulcers. The formulations have a clear, transparent composition that allows for easy visualization of the wound, and are non-staining for easy clean up. These formulations can also exhibit increased enzymatic debridement activity, improved post-treatment lubricity and coating occlusivity, and stability. The formulations, optionally containing non-animal source biologics, may be in the form of lotions, aerosols to provide a spray, or a foam. A non-reactive substrate may be used as a composition carrier. A non-aqueous lotion formulation having improved enzymatic activity is provided. The non-aqueous lotion viscosity is adjusted to achieve high enzymatic activity while maintaining the application benefits of high viscosity non-aqueous lotions. The lotion formulation may be delivered in a patch.
摘要翻译：描述了用于通过创伤和溃疡的酶清除治疗的制剂。制剂具有清晰，透明的组合物，其允许容易地观察伤口，并且是无污染的以便于清洁。这些制剂还可以表现出增加的酶清除活性，改善的后处理润滑性和涂层封闭性以及稳定性。任选地含有非动物源生物制剂的制剂可以是洗剂，提供喷雾剂或泡沫剂的气溶胶的形式。非反应性底物可以用作组合物载体。提供了具有改善的酶活性的非水性乳液制剂。调节非水性乳液粘度以达到高酶活性，同时保持高粘度非水性乳液的应用益处。洗剂制剂可以在贴剂中递送。

26. 发明申请

US20070116757A1 Methylene Blue Derivatives 审中-公开
标题翻译：亚甲基蓝衍生物
公开(公告)号：US20070116757A1
公开(公告)日：2007-05-24
申请号：US11557889
申请日：2006-11-08
申请人： Roman Rariy , Jane Hirsh
发明人： Roman Rariy , Jane Hirsh
IPC分类号： A61K31/5415 , C07D279/24 , A61K9/64 , A61K9/20
CPC分类号： C07D279/18 , A61K9/1617 , A61K31/5415 , C07D265/38 , C07D279/20
摘要： Pharmaceutical compositions comprising a fatty acid salt, a dicarboxylic acid salt, an alkyl sulfate salt, an aryl sulfate salt or an alkyl aryl sulfonate salt of methylene blue or a derivative of methylene blue are described herein. The compositions are preferably administered orally and can be administered as tablets, soft or hard shell capsules (e.g. soft gelatin capsules), suspensions or solutions. The composition can also be formulated as a suppository or enema or rectal administration. The compositions further comprise a pharmaceutically acceptable carrier and optionally one or more pharmaceutically acceptable excipients. Suitable excipients include diluents, binders, plasticizers, lubricants, disintegrants, colorants, stabilizers, surfactants, and combinations thereof. The fatty acid salts, alkyl sulate salts, aryl sulfate salts or alkyl aryl sulfonate salts can be co-mixed or co-melted with one or more fatty acids to make more hydrophobic compositions, which may result in less staining formulations. The compositions can be formulated for immediate release, controlled release such as extended release, delayed release, and pulsatile release, or combinations thereof. In one embodiment, the derivative of methylene blue is methylene dodecylsulfate.
摘要翻译：本文描述了包含脂肪酸盐，二羧酸盐，烷基硫酸盐，芳基硫酸盐或亚甲基蓝或亚甲基衍生物的烷基芳基磺酸盐的药物组合物。组合物优选口服施用，并且可以片剂，软或硬壳胶囊（例如软明胶胶囊），悬浮液或溶液给药。组合物也可以配制成栓剂或灌肠剂或直肠给药。组合物还包含药学上可接受的载体和任选的一种或多种药学上可接受的赋形剂。合适的赋形剂包括稀释剂，粘合剂，增塑剂，润滑剂，崩解剂，着色剂，稳定剂，表面活性剂及其组合。脂肪酸盐，烷基磺酸盐，芳基硫酸盐或烷基芳基磺酸盐可以与一种或多种脂肪酸共混或共熔，以制备更疏水的组合物，这可能导致较少的染色制剂。组合物可以配制成立即释放，控制释放，例如延长释放，延迟释放和脉动释放，或其组合。在一个实施方案中，亚甲基蓝的衍生物是十二烷基硫酸亚甲酯。

27. 发明申请

US20060188449A1 Topical aerosol foams 审中-公开
标题翻译：局部气溶胶泡沫
公开(公告)号：US20060188449A1
公开(公告)日：2006-08-24
申请号：US10565346
申请日：2004-10-04
申请人： Jane Hirsh , John Willis , Mark Hirsh
发明人： Jane Hirsh , John Willis , Mark Hirsh
IPC分类号： A61K31/573 , A61L9/04 , A61K31/56 , A61K31/24
CPC分类号： A61K31/24 , A61K9/0014 , A61K9/122 , A61K9/124 , A61K31/56 , A61K31/573
摘要： A stable topical aerosol foam is provided. The foam-forming formulation includes a HFA propellant and an active agent in an emulsion. The emulsion has an oil phase and an aqueous, i.e. water-containing, phase. The active agent may be present in either phase or dispersed in the emulsion. The oil phase may consist at least in part of the HFA propellant. Either or both of the oil phase and the aqueous phase may contain one or more surfactants, emulsifiers, emulsion stabilizers, buffers, and other excipients. In an alternative embodiment, the aqueous phase contains a water-soluble active agent, for example, a local anesthetic, and the oil phase contains a water-insoluble second active agent. The foam is stable on the skin, for example for at least 10 minutes at body temperature, and will disappear into the skin upon rubbing or after prolonged standing. The formulation has the advantage of an inert non-flammable hydrofluorocarbon propellant without requiring the use of additional co-solvents or co-propellants. The composition is administered to the skin or mucous membranes.
摘要翻译：提供稳定的局部气溶胶泡沫。泡沫形成制剂包括HFA推进剂和乳液中的活性剂。乳液具有油相和含水相，即含水相。活性剂可以以任一相存在或分散在乳液中。油相可以至少部分地由HFA推进剂组成。油相和水相中的任一种或两者可以含有一种或多种表面活性剂，乳化剂，乳液稳定剂，缓冲剂和其它赋形剂。在另一个实施方案中，水相含有水溶性活性剂，例如局部麻醉剂，油相含有水不溶性第二活性剂。泡沫在皮肤上是稳定的，例如在体温下至少10分钟，并且在摩擦或长时间放置后将消失在皮肤中。该配方具有惰性不易燃氢氟烃推进剂的优点，而不需要使用额外的共溶剂或共推进剂。将组合物施用于皮肤或粘膜。

28. 发明申请

US20060024366A1 Modified release compositions of milnacipran 审中-公开
标题翻译：米那普仑的改性释放组合物
公开(公告)号：US20060024366A1
公开(公告)日：2006-02-02
申请号：US11192885
申请日：2005-07-29
申请人： Jane Hirsh , Roman Rariy , Shubha Chungi , Srinivas Rao , Michael Heffernan
发明人： Jane Hirsh , Roman Rariy , Shubha Chungi , Srinivas Rao , Michael Heffernan
IPC分类号： A61K9/22
CPC分类号： A61K9/2054 , A61K9/2846
摘要： A once-a-day oral milnacipran modified release formulation has been developed. The formulation comprises an extended release dosage unit (optionally containing the immediate release portion) coated with delayed release coating. The milnacipran composition, when administered orally, first passes through the stomach releasing from zero to less than 10% of the total milnacipran dose and then enters the intestines where drug is released slowly over an extended period of time. The release profile is characterized by a 0.05-4 hours lag time period during which less than 10% of the total milnacipran dose is released followed by a slow or extended release of the remaining drug over a defined period of time. The composition provides in vivo drug plasma levels characterized by Tmax at 4-10 hours and an approximately linear drop-off thereafter and Cmax below 3000 ng/ml, preferably below 2000 ng/ml, and most preferably below 1000 ng/ml. The composition provides a therapeutic effect over approximately 24 hours, when administered to a patient in need, resulting in diminished incidence or decreased intensity of common milnacipran side effects such as sleep disturbance, nausea, vomiting, headache, tremulousness, anxiety, panic attacks, palpitations, urinary retention, orthostatic hypotension, diaphoresis, chest pain, rash, weight gain, back pain, constipation, vertigo, increased sweating, agitation, hot flushes, tremors, fatigue, somnolence, dyspepsia, dysoria, nervousness, dry mouth, abdominal pain, irritability, and insomnia.
摘要翻译：已经开发了一天一次的口服米那普仑改性释放制剂。该制剂包含用延迟释放包衣涂覆的延长释放剂量单位（任选地含有速释部分）。当口服给药时，米那普仑组合物首先通过胃从零释放至总的米那普仑剂量的10％，然后进入肠道，药物在较长时间内缓慢释放。释放曲线的特征在于0.05-4小时的滞后时间，在此期间，释放总的米那普仑总量的不到10％，然后在规定的时间段内缓慢或延长释放剩余的药物。该组合物在4-10小时时提供特征为T max max的体内药物血浆水平，此后大约线性下降，低于3000ng / ml，优选低于 2000ng / ml，最优选低于1000ng / ml。当给予需要的患者时，该组合物在约24小时内提供治疗效果，导致常见的米那普仑副作用的发生率降低或强度降低，例如睡眠障碍，恶心，呕吐，头痛，惊恐，焦虑，惊恐发作，心悸，尿潴留，直立性低血压，尿频，胸痛，皮疹，体重增加，背痛，便秘，眩晕，出汗增加，激动，潮红，震颤，疲劳，嗜睡，消化不良，呕吐，紧张，口干，腹痛，烦躁不安和失眠。

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