FDA药品溶出方法数据库
(FDA-Recommended Dissolution Methods Database)
药品通用名称 剂型 USP溶出装置 速度 溶出介质 介质体积 建议取样时间(分钟) 更新日期
Methocarbamol Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Methotrexate Sodium Tablet Develop a dissolution method 2024/01/03
Methoxsalen Capsule Develop a dissolution method 2024/01/03
Methscopolamine Bromide Tablet Refer to USP 2018/02/15
Methyldopa Tablet II (Paddle) 50 0.1 N HCl 900 10, 15, 30 and 45 2025/01/17
Methylergonovine Maleate Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Methylnaltrexone Bromide Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Methylphenidate Tablet (Extended Release, Orally Disintegrating ) II (Paddle) 75 Acid Stage: 0.1 N HCl; Buffer Stage: Phosphate Buffer, pH 6.8 Acid Stage: 900 mL; Buffer Stage: 1000 mL Acid Stage: 15, 30, 60, 120 minutes; Buffer Stage: 1, 2, 3, 4, 6 and 8 hours 2017/11/16
Methylphenidate Capsule (Extended Release) Develop a dissolution method 2023/09/15
Methylphenidate Transdermal Patch VI (Cylinder) 50 0.01 N HCl at 32ºC 900 0.5, 1.5, 3, 4 hours and until at least 80% released 2008/04/15
Methylphenidate Tablet (Extended Release) Develop a dissolution method 2024/01/03
Methylphenidate (BX) Capsule (Extended Release) I (Basket) 75 0-2 hrs:0.01 N HCl. 2-10 hrs: Phosphate Buffer, pH 6.8. 0-2 hrs: 500. 2-10 hrs:500 0.5, 1, 3, 6, 8 and 10 hours 2007/07/25
Methylphenidate HCl Powder for Suspension (Extended Release) II (Paddle) 75 0.4 M Phosphate Buffer, pH 4.5 900 0.25, 0.5, 1, 2, 3, 4, 6 and 8 hours 2016/06/02
Methylphenidate HCl Tablet (Extended Release, Chewable) II (Paddle) 75 0.4M KH2PO4 solution (degas) 900 0.25, 0.5, 1, 2, 3, 4, 6, 8 hours 2016/03/17
Methylphenidate HCl Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Methylphenidate HCl Capsule (Extended Release) I (Basket) 100 Acid Stage:(First 2 hours) 0.01 N HCl; Buffer Stage (2-10 hours): Phosphate Buffer, pH 6.0 Acid: 500 mL; Buffer: 500 mL 0.5, 1, 2, 4, 6, and 10 hours 2016/10/20
Methylphenidate HCl Tablet (Chewable) Develop a dissolution method 2023/09/15
Methylphenidate HCl (25 mg, 35 mg, 45 mg, 55 mg, 70 mg and 85 mg) Capsule (Extended Release) II (Paddle) with sinker 75 Acid Stage:(0-6 hours) Simulated Gastric Fluid [SGF, pH 1.2] without enzyme; Buffer Stage (after six hours in acid stage): Phosphate Buffer, pH 7.4 Acid Stage: 0.5, 1, 2, 4, 6 hours; Buffer Stage: 1, 2, 4, 6, 8 and 10 hours 2020/04/02
Methylprednisolone Tablet Develop a dissolution method 2024/01/03
Methylprednisolone Acetate Injectable Suspension IV (Flow-Through Cell-Open system) 0.55 % SDS 15, 30, 45, 60, 90 and 120 2009/10/08

数据库说明:

当前数据更新日期:2025年12月20日。
©2006-2025 DrugFuture->FDA-Recommended Dissolution Methods Database