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公开(公告)号：US08986280B2
公开(公告)日：2015-03-24
申请号：US13866425
申请日：2013-04-19
发明人： Ronald J. Pettis , James A. Down , Noel G. Harvey
CPC分类号： A61M5/46 , A61K38/28 , A61K38/29 , A61M5/158 , A61M5/32 , A61M5/3286 , A61M5/3291 , A61M5/3295 , A61M37/0015 , A61M2037/0038 , A61M2037/0061
摘要： The present invention provides improved methods for ID delivery of drugs and other substances to humans or animals. The methods employ small gauge needles, especially microneedles, placed in the intradermal space to deliver the substance to the intradermal space as a bolus or by infusion. It has been discovered that the placement of the needle outlet within the skin and the exposed height of the needle outlet are critical for efficacious delivery of active substances via small gauge needles to prevent leakage of the substance out of the skin and to improve absorption within the intradermal space. The pharmacokinetics of hormone drugs delivered according to the methods of the invention have been found to be very similar to the pharmacokinetics of conventional SC delivery, indicating that ID administration according to the methods of the invention is likely to produce a similar clinical result (i.e., similar efficacy) with the advantage of reduction or elimination of pain for the patient. Delivery devices which place the needle outlet at an appropriate depth in the intradermal space and control the volume and rate of fluid delivery provide accurate delivery of the substance to the desired location without leakage.
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公开(公告)号：US20130237960A1
公开(公告)日：2013-09-12
申请号：US13866425
申请日：2013-04-19
发明人： Ronald J. Pettis , James A. Down , Noel G. Harvey
CPC分类号： A61M5/46 , A61K38/28 , A61K38/29 , A61M5/158 , A61M5/32 , A61M5/3286 , A61M5/3291 , A61M5/3295 , A61M37/0015 , A61M2037/0038 , A61M2037/0061
摘要： The present invention provides improved methods for ID delivery of drugs and other substances to humans or animals. The methods employ small gauge needles, especially microneedles, placed in the intradermal space to deliver the substance to the intradermal space as a bolus or by infusion. It has been discovered that the placement of the needle outlet within the skin and the exposed height of the needle outlet are critical for efficacious delivery of active substances via small gauge needles to prevent leakage of the substance out of the skin and to improve absorption within the intradermal space. The pharmacokinetics of hormone drugs delivered according to the methods of the invention have been found to be very similar to the pharmacokinetics of conventional SC delivery, indicating that ID administration according to the methods of the invention is likely to produce a similar clinical result (i.e., similar efficacy) with the advantage of reduction or elimination of pain for the patient. Delivery devices which place the needle outlet at an appropriate depth in the intradermal space and control the volume and rate of fluid delivery provide accurate delivery of the substance to the desired location without leakage.
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公开(公告)号：US20160051807A1
公开(公告)日：2016-02-25
申请号：US14929945
申请日：2015-11-02
发明人： Ronald J. Pettis , Noel G. Harvey , Barry Ginsberg
IPC分类号： A61M37/00
CPC分类号： A61M37/0015 , A61M5/3291 , A61M2037/0023 , A61M2037/0061
摘要： Methods and devices for administration of substances into at least two compartments of skin for systemic absorption and improved pharmacokinetics, based on biphasic or bimodel kinetic profiling.
摘要翻译： 基于双相或双模动力学分析，将物质施用至至少两个皮肤区域以进行全身吸收和改善的药代动力学的方法和装置。
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4.发明申请Method for Altering Drug Pharmacokinetics Based on Medical Delivery Platform 有权基于医疗交付平台改变药物药代动力学的方法公开(公告)号：US20140200547A1
公开(公告)日：2014-07-17
申请号：US14215271
申请日：2014-03-17
发明人： Ronald J. Pettis , Noel G. Harvey , James A. Down
IPC分类号： A61M5/158
CPC分类号： A61M5/46 , A61K38/28 , A61K38/29 , A61M5/158 , A61M5/32 , A61M5/3286 , A61M5/3291 , A61M5/3295 , A61M37/0015 , A61M2037/0038 , A61M2037/0061
摘要： A method for directly delivering whereby a substance is introduced into an intradermal space within mammalian skin which involves administering the substance through at least one small gauge hollow needle having an outlet with an exposed height between 0 and 1 mm. The outlet is inserted into the skin to a depth of between 0.3 mm and 2 mm such that the delivery of the substance occurs at a depth between 0.3 mm and 2 mm.
摘要翻译： 一种用于直接递送的方法，其中物质被引入到哺乳动物皮肤内的真皮内空间，其涉及通过至少一个具有暴露高度在0和1mm之间的出口的小规模中空针管来施用该物质。 将出口插入到皮肤中至0.3mm至2mm之间的深度，使得物质的输送发生在0.3mm和2mm之间的深度。
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公开(公告)号：US10322272B2
公开(公告)日：2019-06-18
申请号：US14929945
申请日：2015-11-02
发明人： Ronald J. Pettis , Noel G. Harvey , Barry Ginsberg
IPC分类号： A61M37/00
摘要： Methods and devices for administration of substances into at least two compartments of skin for systemic absorption and improved pharmacokinetics, based on biphasic or bimodel kinetic profiling.
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公开(公告)号：US20130245601A1
公开(公告)日：2013-09-19
申请号：US13866381
申请日：2013-04-19
发明人： Ronald J. Pettis , James A. Down , Noel G. Harvey
IPC分类号： A61M5/158
CPC分类号： A61M5/46 , A61K38/28 , A61K38/29 , A61M5/158 , A61M5/32 , A61M5/3286 , A61M5/3291 , A61M5/3295 , A61M37/0015 , A61M2037/0038 , A61M2037/0061
摘要： The present invention provides improved methods for ID delivery of drugs and other substances to humans or animals. The methods employ small gauge needles, especially microneedles, placed in the intradermal space to deliver the substance to the intradermal space as a bolus or by infusion. It has been discovered that the placement of the needle outlet within the skin and the exposed height of the needle outlet are critical for efficacious delivery of active substances via small gauge needles to prevent leakage of the substance out of the skin and to improve absorption within the intradermal space. The pharmacokinetics of hormone drugs delivered according to the methods of the invention have been found to be very similar to the pharmacokinetics of conventional SC delivery, indicating that ID administration according to the methods of the invention is likely to produce a similar clinical result (i.e., similar efficacy) with the advantage of reduction or elimination of pain for the patient. Delivery devices which place the needle outlet at an appropriate depth in the intradermal space and control the volume and rate of fluid delivery provide accurate delivery of the substance to the desired location without leakage.
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公开(公告)号：US08998877B2
公开(公告)日：2015-04-07
申请号：US13866446
申请日：2013-04-19
发明人： Ronald J. Pettis , James A. Down , Noel G. Harvey
CPC分类号： A61M5/46 , A61K38/28 , A61K38/29 , A61M5/158 , A61M5/32 , A61M5/3286 , A61M5/3291 , A61M5/3295 , A61M37/0015 , A61M2037/0038 , A61M2037/0061
摘要： The present invention provides improved methods for ID delivery of drugs and other substances to humans or animals. The methods employ small gauge needles, especially microneedles, placed in the intradermal space to deliver the substance to the intradermal space as a bolus or by infusion. It has been discovered that the placement of the needle outlet within the skin and the exposed height of the needle outlet are critical for efficacious delivery of active substances via small gauge needles to prevent leakage of the substance out of the skin and to improve absorption within the intradermal space. The pharmacokinetics of hormone drugs delivered according to the methods of the invention have been found to be very similar to the pharmacokinetics of conventional SC delivery, indicating that ID administration according to the methods of the invention is likely to produce a similar clinical result (i.e., similar efficacy) with the advantage of reduction or elimination of pain for the patient. Delivery devices which place the needle outlet at an appropriate depth in the intradermal space and control the volume and rate of fluid delivery provide accurate delivery of the substance to the desired location without leakage.
摘要翻译： 本发明提供了将药物和其它物质的ID递送给人或动物的改进方法。 该方法使用放置在皮内空间中的小规格针，特别是微针，以将物质作为推注或通过输注递送至皮内空间。 已经发现，针出口在皮肤内的放置和针出口的暴露高度对于通过小规格针有效递送活性物质是至关重要的，以防止物质从皮肤泄漏并改善吸收在 皮内空间。 已经发现根据本发明的方法递送的激素药物的药代动力学与常规SC递送的药代动力学非常相似，表明根据本发明的方法的ID给药可能产生类似的临床结果（即， 具有类似功效），具有减少或消除患者疼痛的优点。 将针头出口放置在皮内空间内的适当深度并控制流体输送的体积和速率的输送装置能够将物质精确地输送到期望的位置而不泄漏。
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公开(公告)号：US09005182B2
公开(公告)日：2015-04-14
申请号：US13866381
申请日：2013-04-19
发明人： Ronald J. Pettis , James A. Down , Noel G. Harvey
CPC分类号： A61M5/46 , A61K38/28 , A61K38/29 , A61M5/158 , A61M5/32 , A61M5/3286 , A61M5/3291 , A61M5/3295 , A61M37/0015 , A61M2037/0038 , A61M2037/0061
摘要： The present invention provides improved methods for ID delivery of drugs and other substances to humans or animals. The methods employ small gauge needles, especially microneedles, placed in the intradermal space to deliver the substance to the intradermal space as a bolus or by infusion. It has been discovered that the placement of the needle outlet within the skin and the exposed height of the needle outlet are critical for efficacious delivery of active substances via small gauge needles to prevent leakage of the substance out of the skin and to improve absorption within the intradermal space. The pharmacokinetics of hormone drugs delivered according to the methods of the invention have been found to be very similar to the pharmacokinetics of conventional SC delivery, indicating that ID administration according to the methods of the invention is likely to produce a similar clinical result (i.e., similar efficacy) with the advantage of reduction or elimination of pain for the patient. Delivery devices which place the needle outlet at an appropriate depth in the intradermal space and control the volume and rate of fluid delivery provide accurate delivery of the substance to the desired location without leakage.
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公开(公告)号：US20130237961A1
公开(公告)日：2013-09-12
申请号：US13866446
申请日：2013-04-19
发明人： Ronald J. Pettis , James A. Down , Noel G. Harvey
IPC分类号： A61M5/158
CPC分类号： A61M5/46 , A61K38/28 , A61K38/29 , A61M5/158 , A61M5/32 , A61M5/3286 , A61M5/3291 , A61M5/3295 , A61M37/0015 , A61M2037/0038 , A61M2037/0061
摘要： The present invention provides improved methods for ID delivery of drugs and other substances to humans or animals. The methods employ small gauge needles, especially microneedles, placed in the intradermal space to delver the substance to the intradermal space as a bolus or by infusion. It has been discovered that the placement of the needle outlet within the skin and the exposed height of the needle outlet are critical for efficacious delivery of active substances via small gauge needles to prevent leakage of the substance out of the skin and to improve absorption within the intradermal space. The pharmacokinetics of hormone drugs delivered according to the methods of the invention have been found to be very similar to the pharmacokinetics of conventional SC delivery, indicating that ID administration according to the methods of the invention is likely to produce a similar clinical result (i.e., similar efficacy) with the advantage of reduction or elimination of pain for the patient. Delivery devices which place the needle outlet at an appropriate depth in the intradermal space and control the volume and rate of fluid delivery provide accurate delivery of the substance to the desired location without leakage.
摘要翻译： 本发明提供了将药物和其它物质的ID递送给人或动物的改进方法。 该方法使用小规格针，特别是微针，放置在皮内空间中，以将物质作为推注或通过输注将物质移入皮内空间。 已经发现，针出口在皮肤内的放置和针出口的暴露高度对于通过小规格针有效递送活性物质是至关重要的，以防止物质从皮肤泄漏并改善吸收在 皮内空间。 已经发现根据本发明的方法递送的激素药物的药代动力学与常规SC递送的药代动力学非常相似，表明根据本发明的方法的ID给药可能产生类似的临床结果（即， 具有类似功效），具有减少或消除患者疼痛的优点。 将针头出口放置在皮内空间内的适当深度并控制流体输送的体积和速率的输送装置能够将物质精确地输送到期望的位置而不泄漏。
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