Dissolution Method Development for Generic Products – Helpful Tips to Get You Started

Dissolution method development on a new formulation or product is a challenging process filled with trial and error. For generic products that have existed for years, you might think this is an easier endeavor; but that’s not always the case. In this post, Agilent’s Ken Boda offers guidance on how to begin the method development process and where to find useful resources.

Tips from Ken - Method Development for Generics

(Credit: Information contained in this post was originally published by Ken Boda on LinkedIn.)

Starting dissolution method development on a new product can be challenging. There are many factors to consider when developing methods, and a lot of trial and error. Luckily, there are some places to start your research to help point you in the right direction when working on generics.

Both the USP and FDA have Dissolution Method Databases showing methods which have been accepted by each:

  • US FDA Dissolution Method Database
    • Purpose: 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.
    • Disclaimer: The dissolution methods included in the database reflect methods used for quality control testing in approved applications that have been previously found acceptable by the FDA, USP methods, and methods recommended in FDA guidance(s) (e.g., Guidance for Industry, Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility Drug Substances). These dissolution methods are not required to be used by applicants; FDA will consider alternate methods instead of those listed in the database, the acceptability of which will be determined based on whether the method is supported by appropriate data. It is important to note that the database contains a large amount of material, and methods and acceptance criterion/criteria may change over time. Methods used in more recently approved submissions may differ from methods currently reflected in the database. We welcome comments or suggested changes to the database. We plan to revise this web site on an ongoing basis.
  • USP Dissolution Methods Database
    • Terms of Use: Copyright the United States Pharmacopeial Convention (USP). All rights reserved. The database content is not intended to and does not constitute legal advice and is not warranted or guaranteed by USP. Your use of database content is at your own risk. USP accepts no responsibility or legal liability for the use and/or accuracy of the database or for decisions made based on this data.
    • Applications and Use: The database allows you to search by monograph name, dissolution medium, apparatus type, test duration, and analytical finish. It is a useful tool to answer questions such as:

While these methods are considered accepted, don't assume that the method(s) shown for the drug you are working with will match your method. It's also important to know that these methods are far from complete - they do not include specific information on filters, sinkers, deaeration, and several other variables.

The information contained in the online databases remains a good starting point to consider and test. Since your formulation is not the exact same formulation as the one the method was accepted for, your method may vary. You might find an immediate release method, but your product is delayed- or modified-release, for example. The accepted method might be for a tablet and you're working with a capsule. So, while the information is useful and may be applied, it isn’t the end of your development. Even if the method in the USP or FDA database is perfect for your product - you still need to validate it.

Just Google It

Another important reference for you is an online search engine (e.g., Google). I've been able to find so much good information for people needing support by searching "drug name dissolution method" or "drug name solubility" or other similar terms. There are plenty of good, helpful hints to get you on your way.

For more information and support, check out the following resources from Agilent’s Dissolution Team:

Thank you for reading!


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