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
Brincidofovir Tablet I (Basket) 50 50 mM sodium phosphate buffer, pH 6.4 + 0.3% SDS 900 5, 10, 15, 20, 30, 45, 60, 75 and 90 2023/07/07
Brincidofovir Suspension II (Paddle) 50 0.05 M Sodium Phosphate Monobasic, Monohydrate Buffer, pH 6.4 + 0.05% Tween 80 900 5, 10, 15, 20, 30, 45, 60, 75 and 90 2023/07/07
Brinzolamide Ophthalmic Suspension Develop a method to characterize in vitro release 2011/09/01
Brivaracetam Tablet II (Paddle 50 Phosphate Buffer, pH 6.4 2.5 and 5 mg tablets: 500 mL; 10, 25, 50, 75 and 100 mg tablets: 900 mL 5, 10, 15, 20 and 30 2016/07/28
Bromocriptine Mesylate Tablet Refer to USP 2007/07/25
Budesonide Tablet (Extended Release) II (Paddle) 100 Acid Stage: 0.1 M HCl containing 0.5% Macrogol Cetostearyl Ether; Buffer Stage: pH 7.2 phosphate buffer containing 0.5% Macrogol Cetostearyl Ether. Acid Stage: 500 mL ; Buffer Stage: 1000 mL Acid Stage: 2 hours; Buffer Stage: 1, 2, 4, 6, 8 and 10 hours 2015/04/02
Budesonide Capsule II (Paddle) with sinker 75 Acid stage: 0.1 N HCl; Buffer stage: Phosphate Buffer, pH 7.5 Acid stage: 1000; Buffer stage: 1000 Acid stage: 2 hours; Buffer stage: 0.25, 0.5, 1, 2, 4, 6 and 8 hours 2015/02/25
Budesonide Suspension II (Paddle) 50 0.25% SDS in 0.009 N HCl 500 5, 10, 15, 20, 30, 45 and 60 2026/01/28
Bumetanide Tablet Develop a dissolution method 2024/01/03
Bupivacaine Solution (Extended Release), Infiltration II (Paddle) 50 0.025 M Sodium Phosphate Buffer with 0.03% Sodium Dodecyl Sulfate (SDS), pH 7.4 900 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours 2022/07/07
Bupivacaine; Meloxicam Solution, Extended Release Develop a method to characterize in vitro release 2025/09/08
Buprenorphine Solution, Extended Release Develop a dissolution method 2026/03/25
Buprenorphine Film, Transdermal (Extended Release) VI (Cylinder) with adapter, if needed 50 0.9% Sodium Chloride at 32°C 600 0.5,1, 2, 4, 6, 8,12, 16 and 24 hours 2013/05/09
Buprenorphine (64 mg, 96 mg, and 128 mg) Solution, Extended Release I (Basket) 50 100 mM Citric Acid Buffer, pH 4.0 500 1, 2, 4, 6, 10, 12, 24, 48, 72 and 96 hours 2026/03/25
Buprenorphine (8 mg, 16 mg, 24 mg, and 32 mg) Solution, Extended Release I (Basket) 50 100 mM Citric Acid Buffer, pH 3.0 900 1, 2, 4, 6, 10, 12, 24, 48, 72, 96, 168 and 192 hours 2026/03/25
Buprenorphine HCl Film (Buccal) I (Basket)  100 mL round bottom vessel 100 0.05M NaH2PO4.H2O Phosphate Buffer, pH 4.5 60 10, 15, 20, 30, 45 and 60 2016/10/20
Buprenorphine HCl Implant II (Paddle) 50 Water 900 1, 4, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours 2016/07/28
Buprenorphine HCl Tablet (Sublingual) Develop a dissolution method 2023/09/15
Buprenorphine HCl/Naloxone HCl Tablet (Sublingual) Develop a dissolution method 2023/09/15
Buprenorphine HCl/Naloxone HCl Film (Sublingual) V (Paddle over Disk) with 56 mm, 40 mesh stainless steel disk. 100 Acetate Buffer, pH 4.0 (12.5mM Sodium acetate trihydrate and 60mM glacial acetic acid. Adjust the pH with glacial acetic acid or ammonium hydroxide). 900 1, 2, 3, 5, 7 and 10 2013/10/31

数据库说明:

当前数据更新日期:2026年04月15日。
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