Others titles
- FDA Dissolution Methods Database
- FDA Recommended Dissolution Methods Database
Keywords
- Dissolution Methods
- Dissolution Test Method
- FDA Drug Products
- United States Pharmacopeia
- Generic Drug Products
- Chemical Generic Names
- Drugs Database
FDA Drug Dissolution Methods
For a drug product that does not have a dissolution test method in the United States Pharmacopeia (USP), the Food and Drug Administration (FDA) Dissolution Methods Database provides information on dissolution methods presently recommended by the Division of Bioequivalence, Office of Generic Drugs.
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Description
The Food and Drug Administration (FDA) is providing the Dissolution Methods Database to aid industry personnel in developing generic drug products.
All drug products are listed alphabetically by non-proprietary (generic) names. For combination products, the active drug components appear in alphabetical order of their chemical generic names.
For most of the drugs in the database, the preparation of the recommended dissolution medium is described in the United States Pharmacopeia (USP). Under normal circumstances, the dissolution testing should be conducted at 37° C unless otherwise noted.
About this Dataset
Data Info
Date Created | 2015-03 |
---|---|
Last Modified | 2021-04-22 |
Version | 2021-04-22 |
Update Frequency |
Quarterly |
Temporal Coverage |
N/A |
Spatial Coverage |
United States |
Source | John Snow Labs; U.S. Food and Drug Administration (FDA); |
Source License URL | |
Source License Requirements |
N/A |
Source Citation |
N/A |
Keywords | Dissolution Methods, Dissolution Test Method, FDA Drug Products, United States Pharmacopeia, Generic Drug Products, Chemical Generic Names, Drugs Database |
Other Titles | FDA Dissolution Methods Database, FDA Recommended Dissolution Methods Database |
Data Fields
Name | Description | Type | Constraints |
---|---|---|---|
Drug_Name | Drug non-proprietary name | string | required : 1 |
Dosage_Form | Dosage Form of the drug | string | required : 1 |
USP_Apparatus | Related USP Apparatus, A description of each official apparatus appears in the United States Pharmacopeia (USP) | string | - |
Speed_RPMs | Speed in RPMs | string | - |
Medium | Dissolution medium of USP | string | required : 1 |
Volume_ml | Volume in ml | string | - |
Recommended_Sampling_Times_Minutes | Times recommended for taking dissolution samples for a particular drug product to generate a dissolution profile | string | - |
Date_Updated | Last Update Date | date | - |
Data Preview
Drug Name | Dosage Form | USP Apparatus | Speed RPMs | Medium | Volume ml | Recommended Sampling Times Minutes | Date Updated |
Balsalazide Disodium | Tablet | II (Paddle) | 100.0 | Water (degassed) | 1000.0 | 10, 20, 30, 45, 60, 75, 90 and 120Â | 2013-07-31 |
Balsalazide Disodium | Capsule | II (Paddle) with sinker | 50.0 | pH 6.8 buffer | 900.0 | 10, 20, 30, and 45 | 2006-01-26 |
Cobicistat/Elvitegravir/Emtricitabine/Tenofovir Disoproxil Fumarate | Tablet | II (Paddle) with sinker | 100.0 | 0.01 N HCl with 2% w/w Polysorbate 80 | 1000.0 | 5, 10, 15, 20 and 30 | 2015-06-25 |
Disopyramide Phosphate | Capsule (Extended Release) | Refer to USP | 2008-11-04 | ||||
Efavirenz/Lamivudine/Tenofovir Disoproxil Fumarate | Tablet | II (Paddle)Â | 75.0 | 2% SLS in Water | 1000.0 | 5, 10, 15, 20 and 30 | 2021-08-19 |
Tafamidis | Capsule | II (Paddle) with sinker | 75.0 | Tier 1 Medium: 0.05M Sodium Phosphate Buffer, pH 6.8 with 1.0% Tween 80; Tier II Medium: 0.05M Sodium Phosphate Buffer, pH 6.8 with 1.0% Tween 80 and enzyme with protease activity as per USP | 900.0 | 5, 10, 15, 20, 30 and 45 | 2021-04-22 |
Tafamidis Meglumine | Capsule | II (Paddle) with sinker | 75.0 | Tier 1 Medium: 0.05M Sodium Phosphate Buffer, pH 6.8. Tier 2 Medium: 0.05M Sodium Phosphate Buffer, pH 6.8, and pancreatin with protease activity as per USP | 900.0 | 5, 10, 15, 20, 30 and 45 | 2021-04-22 |
Abacavir Sulfate | Tablet | Refer to FDA's Dissolution Guidance, 2018 | 2020-07-02 | ||||
Abacavir Sulfate/Dolutegravir Sodium/Lamivudine | Tablet | II (Paddle) | 85.0 | 0.01 M Phosphate Buffer with 0.5% sodium dodecyl sulfate (SDS), pH 6.8 | 900.0 | Abacavir and lamivudine: 10, 15, 20, 30 and 45; Dolutegravir: 5,15, 25, 35 and 45. | 2015-05-28 |
Abacavir Sulfate/Lamivudine | Tablet | II (Paddle) | 75.0 | 0.1 N HCl | 900.0 | 10, 20, 30, and 45Â | 2007-01-03 |