美国FDA药品溶出方法数据库

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
Omega-3-Acid Ethyl Esters Type A	Capsule			Develop an in vitro release method using USP IV (Flow-Through Cell), and, if applicable, Apparatus II (Paddle) or any other appropriate pharmacopoeial apparatus, for comparative evaluation by the Agency.			2025/09/08
Omeprazole	Capsule (Delayed Release)			Refer to USP			2007/06/18
Omeprazole	OTC Tablet (Delayed Release)	II (Paddle)	100	Tablets are pre-exposed to 750 ml of 0.1M HCL for 2 hrs and then 250 ml of 0.2M Na3PO4 is added to the medium to give 1000 ml with pH 6.8	Acid stage: 750; Buffer stage: 1000	Acid stage: 120; Buffer stage: 10, 20, 30, 45 and 60	2013/02/28
Omeprazole (Orally Disintegrating)	OTC Tablet (Delayed Release)	II (Paddle)	100	Tablets are pre-exposed to 500 ml of 0.1M HCL for 2 hrs and then 400 ml of 0.235M Na2HP04 is added to the medium. Adjust if necessary with 2 N HCI or 2 N NaOH to a pH of 6.8	Acid stage: 500; Buffer stage: 900	Acid stage: 120; Buffer stage: 10, 20, 30, 45 and 60	2018/02/08
Omeprazole Magnesium	For suspension (Delayed Release)	II (Paddle)	100	Pre-exposed to 300 mL of 0.1M HCl for 2 hrs and then 700 mL of 0.086 M Na2HPO4 is added to the medium to give 1000 mL with pH 6.8	Acid stage: 300; Buffer stage: 1000	Acid stage: 120; Buffer stage: 10, 20, 30, 45 and 60	2019/02/07
Omeprazole Magnesium	OTC Tablet (Delayed Release)	II (Paddle)	100	Tablets are pre-exposed to 300 mL of 0.1M HCL for 2 hrs and then 700 mL of 0.086 M Na2HPO4 is added to the medium containing the capsule to give 1000 mL with pH 6.8	300 ml for the acid stage; 1000 ml for the buffer stage	Sampling started at the buffer stage 10, 20, 30, 45 and 60	2007/01/03
Omeprazole Magnesium	Capsule, Delayed Release	II (Paddle)	100	Acid stage: 0.1 N HCl (deaerated) for 2 hrs; Buffer stage: Phosphate buffer (deaerated), pH 6.8		Acid stage: 120; Buffer stage: 10, 20, 30 and 45	2023/03/30
Omeprazole Sodium Bicarbonate	Capsule	II (Paddle)	75	Phosphate Buffer, pH 7.4	900	15, 30, 45 and 60	2008/07/14
Omeprazole Sodium Bicarbonate	Powder for suspension (Immediate Release)	II (Paddle)	50	0.25 mM Sodium Phosphate Buffer, pH 7.4	900	5, 10, 15, and 30	2007/06/20
Ondansetron	Tablet (Orally Disintegrating)			Refer to USP			2007/06/18
Ondansetron	Film (Oral)	V (Paddle over Disk) with a stainless steel disk (120 mesh screens)	50	0.1 N HCl	900	5, 10, 15, 20 and 30	2012/01/26
Ondansetron HCl	Tablet			Refer to FDA's Dissolution Guidance, 2018			2020/07/02
Opicapone	Capsule	I (Basket with sinker)	100	Tier 1: 0.05 M Phosphate Buffer, pH 6.8 with 1% cetrimide; Tier 2: Stage 1: 0.05 M Phosphate Buffer, pH 6.8 with pancreatin (1750 USP units/L); Stage 2: after 10 minutes of Stage 1, add 100 mL of 10% cetrimide.		5, 10, 15, 20, 30 and 45	2022/05/12
Orlistat	Capsule	II (Paddle)	75	3% SLS in 0.5% Sodium Chloride, pH 6.0	900	10, 20, 30, 45 and 60	2004/02/12
Orphenadrine Citrate	Tablet (Extended Release)			Develop a dissolution method			2024/01/03
Oseltamivir Phosphate	Capsule			Refer to FDA's Dissolution Guidance, 2018			2020/07/02
Oseltamivir Phosphate	Oral Suspension	II (Paddle)	25	0.1 N HCl	900	5, 10, 15, 20 and 30	2009/07/15
Osilodrostat Phosphate	Tablet			Refer to FDA's Dissolution Guidance, 2018			2021/08/19
Osimertinib Mesylate	Tablet			Refer to FDA's Dissolution Guidance, 2018			2020/07/02
Ospemifene	Tablet			Develop a dissolution method			2023/09/15