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Opioid formulation for pain management

机译:阿片类药物用于疼痛管理

摘要

Oral sustained release opioid formulation comprises: an opioid analgesic, a retardant material to cause the opioid analgesic to be released at a rate to provide an analgesic effect after oral admin. to a human patient for 24 hrs, the formulation when administered in humans providing an initially rapid rate of rise in the plasma conc. of the opioid characterised by providing an absorption half-life of 1-8 hrs. in the fastened state. Method for titrating human patients with a sustained release oral opioid formulation comprises: 1) administering to a human patient on a once-a-day basis a unit dose of an oral sustained release formulation comprising a dose of an opioid analgesic and a retardant material as described above, 2) monitoring pharmacokinetic and pharmacodynamic parameters elicited by the formulation in the human patient and determining whether the pharmacokinetic and/or pharmacodynamic parameters are appropriate to treat the patient on a repeated basis, 3) titrating t he patient by adjusting the dose of the opioid analgesic administered to the patient by administering a unit dose of the sustained release opioid analgesic formulation if it is determined that the pharmacokinetic and/or the pharmacodynamic parameters are not satisfactory or maintaining the dose of the opioid analgesic in the unit dose at a previously administered amt. if the pharmacokinetic and/or pharmacodynamic parameters are deemed appropriate, 4) continuing the step 3 titration by adjusting the dose of the opioid analgesic until appropriate steady state pharmacokinetic and/or pharmacodynamic parameters are achieved in the patient, and 5) continuing the admin. of the dose of the opioid analgesic in the oral sustained release formulation on a once-a-day basis until treatment is terminated.
机译:口服持续释放的阿片样物质制剂包括:阿片样物质镇痛剂,一种使阿片样物质镇痛剂以在口服给药后提供镇痛作用的速率释放的阻滞材料。对于人类患者24小时,当在人类中施用时,该制剂提供了血浆浓度最初快速升高的速率。阿片样物质的特征在于提供1-8小时的吸收半衰期。在紧固状态。用持续释放的口服阿片样物质制剂滴定人类患者的方法包括:1)每天一次向人类患者给药单位剂量的口服持续释放制剂,该制剂包含一定剂量的阿片类镇痛药和阻滞剂,如如上所述,2)监测该制剂在人类患者中引起的药代动力学和药效学参数,并确定该药代动力学和/或药效学参数是否适合于重复治疗该患者,3)通过调整剂量来滴定该患者如果确定药代动力学和/或药效学参数不令人满意或将阿片类镇痛剂的剂量维持在先前的单位剂量,则通过给予单位剂量的持续释放阿片类镇痛剂向患者给药的阿片类镇痛药行政管理如果认为药代动力学和/或药效学参数合适,则4)通过调整阿片类镇痛剂的剂量继续进行步骤3的滴定,直到在患者体内达到适当的稳态药代动力学和/或药效学参数为止,以及5)继续给药。每天一次口服持续释放制剂中阿片类镇痛剂的剂量,直至治疗终止。

著录项

  • 公开/公告号DK1470815T3

    专利类型

  • 公开/公告日2006-10-02

    原文格式PDF

  • 申请/专利权人 EURO-CELTIQUE S.A.;

    申请/专利号DK20040009845T

  • 申请日1994-11-22

  • 分类号A61K9/52;A61K9/54;A61K9/22;A61K9/50;A61K9/62;A61K31/137;A61K31/485;A61K45;A61K47/32;A61K47/38;A61K47/42;A61K47/44;A61K47/46;A61P25/04;

  • 国家 DK

  • 入库时间 2022-08-21 21:39:43

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