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New EMA reflection paper on setting dissolution specifications Posted 08/09/2017

The European Medicines Agency (EMA) released a reflection paper on 15 August 2017 which will help generic drugmakers to set specifications for the in vitro dissolution of immediate-release oral drugs.

Dissolution specification describes the quantity of active substance dissolved in a specified time, expressed as a percentage of the content stated on the product label.

Dissolution specification should ensure batch-to-batch consistency and highlight possible problems with in vivo bioavailability.

This latest guidance was released following discussions on the suitability of dissolution specifications in marketing authorization procedures, and a number of referrals raised through the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), which deals with marketing authorization of human medicines in the European Union.

The guidelines relate to solid immediate release drug products with systemic action, characterized as having at least 75% dissolution within 45 minutes, which derives from the European Pharmacopoeia Ph. Eur. (5.17.1) recommendation for conventional release dosage forms.

EMA says specification should be based on the quality of the batches of drugs used in bioequivalency testing or clinical studies. It also says a similar approach could be used to develop innovator products.

The paper provides guidance on developing a dissolution method, test conditions, batches with differentin vivobehaviour, and setting specifications. It also provides a decision tree to make the evaluation process more transparent, although this is not applicable for drugs with narrow therapeutic ranges or where there is no prior knowledge of critical dissolution behaviour.

The paper also does not discuss dissolution tests in three different buffers required as complementary to bioequivalence studies, or tests required in support of biowaiver of strengths or Biopharmaceutics Classification System (BCS)-based biowaivers. EMA says it should be read alongside relevant guidelines, include European Pharmacopoeia Recommendations on Dissolution Testing and Guidelines on the Investigation of Bioequivalence.

This is the final version of the paper, put together based on various feedbacks from stakeholders.

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Source: EMA

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