Dissolution References for Everyone

Dissolution References for Everyone

Dissolution is often misunderstood, and a lot of questions I get are about where you can learn the basics of dissolution. Below are some references that I find helpful, or I've have had some involvement in making to help dissolution chemists.

USP - Chapters <711> Dissolution, <724> Drug Release, and <1092> Dissolution Method Development and Validation

There are the basic texts for Dissolution Apparatus 1-7, and contain specifications and other relevant information. The Dissolution Method Development and Validation chapter is a great primer and touches on many of the questions I'm most frequently asked.

USP Monographs for individual drugs are helpful as well, but keep in mind that many of these methods may be older and not reflect current technology or your particular dosage form.

FDA Dissolution Method Database

The Dissolution Method Database is a useful resource to find information on accepted methods for a wide variety of dissolution products. These methods aren't complete - they don't describe filters, sinkers, degassing, and other critical method components - but they are a great starting point.

Dissolution Discussion Group

www.dissolution.com

This is a free forum for dissolution users to talk about just about anything related to dissolution. Post a question, answer one, or just search in the forum. There are over 15,000 posts archived here - so if you have a question - that's an excellent place to start your search.

Dissolution Technologies

https://www.dissolutiontech.com/

This is a free publication, and the only one dedicated to dissolution. The back issues are especially helpful, and there have been issues dedicated to specific dissolution subjects. I frequently refer people to articles here. Subscriptions are free - or you can view articles online.

There are some dissolution books for sale here as well that are good texts to refer to.

Agilent Dissolution Exchange

Agilent offers a free Dissolution 1-on-1 Fundamentals Class here. You can take the class free, and if you'd like - there's an exam available from a 3rd party to show completion. This gives a great overview on the basics of dissolution.

Also available here is a long list of recorded webinars covering a variety of dissolution topics. Some of them are product specific, but there are also several covering basic dissoluton topics that I put together and presented. If you find my short articles informative, I think you'll like these as well.

Google (or whatever your preferred search engine is)

It's amazing what you can find out with a search. If you're faced with a new product you need to develop a method for, simply putting "drug name dissolution" into a search engine usually will pull up at least a few articles to help you get some helpful hints in the right direction.

Are there any resources I missed? Please let me know in the comments.




Bernie Vellón

R&D Pharmaceutical Scientist

6 年

Great reading material for anyone that performs dissolution testing. Thanks for sharing!

Anastasia Angelova

Senior Expert Analytical Development at Teva Pharmaceuticals

6 年

Ph. Eur. 5.17.1 Recommendations for dissolution testing is a very good reference as well.

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