The draft reflection paper defines immediate release as a product where at least 75% of the active substance is dissolved within 45 minutes. This derives from the Ph. Eur. (5.17.1) recommendation for conventional release dosage forms.

The paper discusses the suitability of the dissolution method and the specifications for in vitro dissolution of orally administered generics with immediate release characteristics. It is intended to ensure batch-to-batch consistency and, ideally, signal potential problems with in vivo bioavailability. It should also be read in connection with the principles of relevant guidelines.

Reflection paper on the dissolution specification for generic oral immediate release products
EMA/332805/2016
Date: 13 May 2016
End of consultation: 13 August 2016
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2016/05/WC500206407.pdf

The reflection paper does not, however, discuss the dissolution tests in three different buffers required as complementary to bioequivalence studies.

EMA has released the draft reflection paper for a three-month public consultation period. Feedback on the draft reflection paper can be submitted to EMA until 13 August 2016. Comments should be submitted to QWP@ema.europa.eu using the template provided by EMA.

Related article
Bioequivalence testing for generics

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