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 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:
Some files may require
Adobe Acrobat Reader.
|