Dissolution Methods Search Page

 1.   What is the purpose of the Dissolution Methods Database?
2.   How can I search the Dissolution Methods Database?
3.   How are drug names listed in the search results?
4.   What is a "Dosage Form"?
5.   Where can I find a detailed description of each "USP Apparatus"?
6.   Where can I find a detailed description of each "Medium"?
7.   What do the numbers in the "Recommended Sampling Times" column mean?
8.   What is the meaning of the date in the last column?
9.   What should I do if I can't find a Dissolution Method for a particular drug?
10.  How often do you update the Dissolution Methods Database?
11.  How can I get further assistance?
12.  Are there any related resources on the FDA Web site?

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 Biopharmaceutics, Office of Pharmaceutical Quality. We are providing the Dissolution Methods Database to aid industry personnel in developing generic drug products. Dissolution Database Disclaimer

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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]

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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").

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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.

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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).

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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.

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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.

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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.

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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 Biopharmaceutics (HFD-003)
Office of New Drug Products
Office of Pharmaceutical Quality
10903 New Hampshire Ave
Silver Spring, MD 20993

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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.

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11.   How can I get further assistance?

The Division of Biopharmaceutics in the Office of Pharmaceutical Quality can provide you with more specialized searches of the Dissolution Methods Database. For assistance, you can mail questions concerning dissolution methods to:

Division of Biopharmaceutics (HFD-003)
Office of New Drug Products
Office of Pharmaceutical Quality
10903 New Hampshire Ave
Silver Spring, MD 20993

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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