Dissolution profiling in Modified Released pellet form products

Question

Hello 
 We have Modified Released pellet form products and for that QC release dissolution test is in place.We need guidance on its Dissolution profiling for Modified Released pellet form products, ,how to proceed here with time points.Anyone has expertise in this please guide us.Secondly the issue is ite RLDs.How can we get the RLDS for such Modified Released pellet form products.Is there any guidance documents please share us.

kenboda · Answer

If you are making a new formulation of a drug that already is accepted in the market, then I would first go to the USP and FDA Method Databases. These both include time points of those accepted methods. If you google the drug name and FDA Dissolution or similar terms, you can usually find additional supports. You can likely also find the acceptance criteria (or an approximate idea) of the RLD. 
 Your time points should be considered to cover the full release profile, and have adequate time points to have an understanding of the dissolution curve. Usually, you will need to demonstrate a comparison of the RLD with your product with an f2 or other metric - which would require 5 or more time points at least in the early method development stages.

lcaskey · Answer

The Agilent Technologies Dissolution Hotline may be able to help. You can email them at: dissolution.hotline@agilent.com.

Dissolution profiling in Modified Released pellet form products

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