Frequently Asked Questions (FAQ)

Dissolution Methods Search Page

1. What is the purpose of the Dissolution Methods Database?

For a drug product that does not have a dissolution test method in the United States Pharmacopeia (USP), the FDA Dissolution Methods Database provides information on dissolution methods presently recommended by the Division of Bioequivalence, Office of Generic Drugs. We are providing the Dissolution Methods Database  to aid industry personnel in developing generic drug products.    Dissolution Database Disclaimer

back to top

2.  How can I search the Dissolution Methods Database?

You can search the Dissolution Methods Database by entering any part of the generic name of a drug. You must enter at least three characters.

To find all products, click on the link "Printable List of all Drugs in the Database" on the Search Page.

When searching combination products, enter the component ingredients in alphabetical order, separated by a slash (/), but  with no spaces before or after the slash.   You can also search each ingredient individually if you are not sure of the correct way to type the search terms.

Example: To find Betaxolol HCl/Chlorthalidone,

You could enter:

• Betaxolol HCl/Chlorthalidone   [no spaces around the slash]
• betaxolol
• betaxolol HCl
• chlorthalidone

but not

• Betaxolol HCl  /  Chlorthalidone     [spaces around the dash]
• Chlorthalidone/Betaxolol     [not in alphabetical order]
• betaxolol  chlorthalidone   [slash is missing]

back to top

3. How are drug names listed in the search results?

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 example, "sulfamethoxazole/trimethoprim").

back to top

4. What is a "Dosage Form"?

A "Dosage Form" is the form in which a drug is produced and dispensed, for example, tablet, capsule,  or suspension.

back to top

5. Where can I find a detailed description of each "USP Apparatus"?

A description of each official apparatus appears in the United States Pharmacopeia (USP).

back to top

6. Where can I find a detailed description of each "Medium"?

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.

back to top

7. What do the numbers in the "Recommended Sampling Times" column mean?

The "Recommended Sampling Times" field specifies the times recommended for taking dissolution samples for a particular drug product to generate a dissolution profile.  The times are given in minutes, unless the word "hours" appears after a number.  FDA generally recommends that by the last sampling time, at least 70-85% (Q) of the labeled content of the active drug should be dissolved, depending upon the specific drug product.

back to top

8. What is the meaning of the date in the last column?

The "Date Updated" field contains the date of the latest dissolution information used to recommend a test for a particular drug product.

back to top

9.  What should I do if I can't find a Dissolution Method for a particular drug?

Mail questions about dissolution methods to:

Division of Bioequivalence (HFD-650)
Office of Generic Drugs
7500 Standish Place
Rockville, MD 20855

back to top

10.  How often do you update the Dissolution Methods Database?

We update the database quarterly, by the fifth working day of April, July, October, and January.  The date of the latest database update appears at the bottom of each page.

back to top

11.  How can I get further assistance?

The Division of Bioequivalence of the Office of Generic Drugs (OGD) can provide you with more specialized searches of the Dissolution Methods Database.  For assistance, you can mail questions concerning dissolution methods to:

Lizzie Sanchez
Office of Generic Drugs
Division of Bioequivalence HFD-650
7500 Standish Place
Rockville MD 20855

back to top

12. Are there any related resources on the FDA Web site?

The following documents are available on the FDA Web site:

• Dissolution Testing of Immediate Release Solid Oral Dosage Forms
• Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations
• Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System
• SUPAC-IR: Immediate-Release Solid Oral Dosage Forms: Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation
• SUPAC-MR: Modified Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution
• SUPAC-SS: Nonsterile Semisolid Dosage Forms; Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation

Some files may require Adobe Acrobat Reader.
 

Back to Top     Back to Dissolution Methods Search

Date created: November 2, 2005

CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | Privacy | Accessibility | HHS Home Page

FDA/Center for Drug Evaluation and Research