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    • 1. 发明申请
    • TRANSORAL DOSAGE FORMS COMPRISING SUFENTANIL AND NALOXONE
    • 包含SUFENTANIL和NALOXONE的转运剂型
    • WO2008100434A1
    • 2008-08-21
    • PCT/US2008/001711
    • 2008-02-08
    • DURECT CORPORATIONYUM, Su IISHAH, JayminKWON, Sung YunSONG, Xiaoping
    • YUM, Su IISHAH, JayminKWON, Sung YunSONG, Xiaoping
    • A61K31/4535A61K9/00
    • A61K31/4535A61K9/0056A61K9/006A61K9/06A61K9/2009A61K9/2063A61K9/7007A61K31/485A61K2300/00
    • The invention pertains to methods that include administering to a subject a transoral dosage form comprising a pharmaceutical carrier and sufentanil, and maintaining a mean pH ranging from about 3.5 to about 5.5 during a dosing period after administration of the transoral dosage form as determined using an in vitro donor media test. Related dosage forms are also disclosed. Also disclosed are transoral dosage forms and related methods, wherein a transoral dosage form may comprise: (1) about 5 to about 1000 micrograms of sufentanil; (2) about 50 micrograms to about 100 milligrams of naloxone; and (3) acidifying material in an amount sufficient to provide a mean pH ranging from about 3.5 to about 5.5 during a dosing period after administration of the transoral dosage form as determined using an in vitro donor media test; wherein the dosing period begins no earlier than about 1 minute after administration of the transoral dosage form, and ends no later than about 120 minutes after administration of the transoral dosage form.
    • 本发明涉及包括向受试者施用包含药物载体和舒芬太尼的经口给药形式的方法,并且在给予经口给药后的给药期间保持约3.5至约5.5的平均pH,所述给药期间使用 体外供体介质试验。 还公开了相关的剂型。 还公开了经口给药剂型和相关方法,其中经口剂型可包含:(1)约5至约1000微克的舒芬太尼; (2)约50微克至约100毫克的纳洛酮; 和(3)足量的酸化材料,其在施用经口给药形式后的给药期间提供约3.5至约5.5的平均pH,使用体外供体培养基测试确定; 其中给药期在给予经口给药后不早于约1分钟开始,并且在给予经口给药后不迟于约120分钟结束。