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公开(公告)号：US20130011543A1
公开(公告)日：2013-01-10
申请号：US13603813
申请日：2012-09-05
IPC分类号： B05D5/00
CPC分类号： A61K9/5026 , A61K9/2081 , A61K31/485
摘要： A method for preparing a solid oral dosage form comprising up to about 160 mg of oxycodone or a salt thereof to control pain in substantially all patients is disclosed. The method comprises forming spheroids comprising a spheronising agent and oxycodone or a salt thereof, and coating the spheroids with a controlled-release film coat. Repeated “q12h” (i.e., every 12 hour) administration of the dosage form through steady-state conditions results in a mean maximum plasma concentration of oxycodone up to about 240 ng/ml from a mean of about 2 to about 4.5 hours after administration, and a mean minimum plasma concentration up to about 120 ng/ml from about 10 to about 14 hours after administration.
摘要翻译： 公开了一种制备固体口服剂型的方法，其包含至多约160mg的羟考酮或其盐以控制基本上所有患者的疼痛。 该方法包括形成包含球形化剂和羟考酮或其盐的球体，并用控释膜包衣涂覆球体。 通过稳态条件重复给药剂量q12h（即每12小时）导致给予后平均约2至约4.5小时的羟考酮的平均最大血浆浓度高达约240ng / ml， 在给药后约10至约14小时，平均最小血浆浓度高达约120ng / ml。
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公开(公告)号：US20100034876A1
公开(公告)日：2010-02-11
申请号：US12579781
申请日：2009-10-15
CPC分类号： A61K31/485 , A61K9/2081
摘要： A method for substantially reducing the range in daily dosages required to control pain in approximately 90% of patients is disclosed whereby an oral solid controlled release dosage formulation having from about 10 to about 40 mg of oxycodone or a salt thereof is administered to a patient. The formulation provides a mean maximum plasma concentration of oxycodone from about 6 to about 60 ng/ml from a mean of about 2 to about 4.5 hours after administration, and a mean minimum plasma concentration from about 3 to about 30 ng/ml from about 10 to about 14 hours after repeated “q12h” (i.e., every 12 hour) administration through steady-state conditions. Another embodiment is directed to a method for substantially reducing the range in daily dosages required to control pain in substantially all patients by administering an oral solid controlled release dosage formulation comprising up to about 160 mg of oxycodone or a salt thereof, such that a mean maximum plasma concentration of oxycodone up to about 240 ng/ml from a mean of up to about 2 to about 4.5 hours after administration, and a mean minimum plasma concentration up to about 120 ng/ml from about 10 to about 14 hours after repeated “q12h” (i.e., every 12 hour) administration through steady-state conditions are achieved. Controlled release oxycodone formulations for achieving the above are also disclosed.
摘要翻译： 公开了一种用于大大减少约90％患者中控制疼痛所需的日剂量范围的方法，其中向患者施用具有约10至约40mg羟可待酮或其盐的口服固体控释剂量制剂。 所述制剂提供给药后平均约2至约4.5小时约6至约60ng / ml的羟考酮的平均最大血浆浓度，并且平均最小血浆浓度为约3至约30ng / ml，约10 通过稳态条件重复“q12h”（即每12小时）至约14小时。 另一个实施方案涉及通过施用包含高达约160mg羟考酮或其盐的口服固体控制释放剂量制剂来显着降低在基本上所有患者中控制疼痛所需的日剂量范围的方法，使得平均最大值 在给药后平均高达约2至约4.5小时，羟考酮的血浆浓度高达约240ng / ml，重复“q12h”后约10至约14小时的平均最小血浆浓度高达约120ng / ml “（即每12小时一次）通过稳态条件实现。 还公开了用于实现上述目标的控释羟考酮制剂。
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公开(公告)号：US20100092570A1
公开(公告)日：2010-04-15
申请号：US12579805
申请日：2009-10-15
CPC分类号： A61K9/5026 , A61K9/2081 , A61K31/485
摘要： A method for substantially reducing the range in daily dosages required to control pain in approximately 90% of patients is disclosed whereby an oral solid controlled release dosage formulation having from about 10 to about 40 mg of oxycodone or a salt thereof is administered to a patient. The formulation provides a mean maximum plasma concentration of oxycodone from about 6 to about 60 ng/ml from a mean of about 2 to about 4.5 hours after administration, and a mean minimum plasma concentration from about 3 to about 30 ng/ml from about 10 to about 14 hours after repeated “q12h” (i.e., every 12 hour) administration through steady-state conditions. Another embodiment is directed to a method for substantially reducing the range in daily dosages required to control pain in substantially all patients by administering an oral solid controlled release dosage formulation comprising up to about 160 mg of oxycodone or a salt thereof, such that a mean maximum plasma concentration of oxycodone up to about 240 ng/ml from a mean of up to about 2 to about 4.5 hours after administration, and a mean minimum plasma concentration up to about 120 ng/ml from about 10 to about 14 hours after repeated “q12h” (i.e., every 12 hour) administration through steady-state conditions are achieved. Controlled release oxycodone formulations for achieving the above are also disclosed.
摘要翻译： 公开了一种用于大大减少约90％患者中控制疼痛所需的日剂量范围的方法，其中向患者施用具有约10至约40mg羟可待酮或其盐的口服固体控释剂量制剂。 所述制剂提供给药后平均约2至约4.5小时约6至约60ng / ml的羟考酮的平均最大血浆浓度，并且平均最小血浆浓度为约3至约30ng / ml，约10 通过稳态条件重复“q12h”（即每12小时）至约14小时。 另一个实施方案涉及通过施用包含高达约160mg羟考酮或其盐的口服固体控制释放剂量制剂来显着降低在基本上所有患者中控制疼痛所需的日剂量范围的方法，使得平均最大值 在给药后平均高达约2至约4.5小时，羟考酮的血浆浓度高达约240ng / ml，重复“q12h”后约10至约14小时的平均最小血浆浓度高达约120ng / ml “（即每12小时一次）通过稳态条件实现。 还公开了用于实现上述目标的控释羟考酮制剂。
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公开(公告)号：US5656295A
公开(公告)日：1997-08-12
申请号：US618344
申请日：1996-03-19
IPC分类号： A61K9/20 , A61K9/22 , A61K31/485 , A61K9/26
CPC分类号： A61K9/2013 , A61K31/485 , A61K9/2027 , A61K9/2054
摘要： A method for substantially reducing the range in daily dosages required to control pain in approximately 90% of patients is disclosed whereby an oral solid controlled release dosage formulation having from about 10 to about 40 mg of oxycodone or a salt thereof is administered to a patient. The formulation provides a mean maximum plasma concentration of oxycodone from about 6 to about 60 ng/ml from a mean of about 2 to about 4.5 hours after administration, and a mean minimum plasma concentration from about 3 to about 30 ng/ml from about 10 to about 14 hours after repeated "q12h" (i.e., every 12 hour) administration through steady-state conditions. Another embodiment is directed to a method for substantially reducing the range in daily dosages required to control pain in substantially all patients by administering an oral solid controlled release dosage formulation comprising up to about 160 mg of oxycodone or a salt thereof, such that a mean maximum plasma concentration of oxycodone up to about 240 ng/ml from a mean of up to about 2 to about 4.5 hours after administration, and a mean minimum plasma concentration up to about 120 ng/ml from about 10 to about 14 hours after repeated "q12h" (i.e., every 12 hour) administration through steady-state conditions are achieved. Controlled release oxycodone formulations for achieving the above are also disclosed.
摘要翻译： 公开了一种用于大大减少约90％患者中控制疼痛所需的日剂量范围的方法，其中向患者施用具有约10至约40mg羟可待酮或其盐的口服固体控释剂量制剂。 所述制剂提供给药后平均约2至约4.5小时约6至约60ng / ml的羟考酮的平均最大血浆浓度，并且平均最小血浆浓度为约3至约30ng / ml，约10 通过稳态条件重复“q12h”（即每12小时）至约14小时。 另一个实施方案涉及通过施用包含高达约160mg羟考酮或其盐的口服固体控制释放剂量制剂来显着降低在基本上所有患者中控制疼痛所需的日剂量范围的方法，使得平均最大值 在给药后平均高达约2至约4.5小时，羟考酮的血浆浓度高达约240ng / ml，重复“q12h”后约10至约14小时的平均最小血浆浓度高达约120ng / ml “（即每12小时一次）通过稳态条件实现。 还公开了用于实现上述目标的控释羟考酮制剂。
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公开(公告)号：US20130012533A1
公开(公告)日：2013-01-10
申请号：US13604066
申请日：2012-09-05
IPC分类号： A61K31/485 , A61P25/04
CPC分类号： A61K31/485 , A61K9/2081
摘要： A method for preparing a solid oral dosage form comprising up to about 160 mg of oxycodone or a salt thereof to control pain in substantially all patients is disclosed. The method comprises wet granulating at least one hydrophilic or hydrophobic polymer, preferably a hydroxyalkyl cellulose or an alkyl cellulose, with oxycodone or a salt thereof to form a controlled-release matrix. Repeated “q12h” (i.e., every 12 hour) administration of the dosage form through steady-state conditions results in a mean maximum plasma concentration of oxycodone up to about 240 ng/ml from a mean of about 2 to about 4.5 hours after administration, and a mean minimum plasma concentration up to about 120 ng/ml from about 10 to about 14 hours after administration.
摘要翻译： 公开了一种制备固体口服剂型的方法，其包含至多约160mg的羟考酮或其盐以控制基本上所有患者的疼痛。 该方法包括用羟考酮或其盐将至少一种亲水或疏水聚合物，优选羟烷基纤维素或烷基纤维素湿法造粒以形成控释基质。 通过稳态条件重复给药剂量q12h（即每12小时）导致给予后平均约2至约4.5小时的羟考酮的平均最大血浆浓度高达约240ng / ml， 在给药后约10至约14小时，平均最小血浆浓度高达约120ng / ml。
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