Diclofenac Potassium Powder for Oral Solution [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2014-08-16 11:00 (2437 d 18:37 ago) – Posting: # 13396
Views: 4,501

Dear Dan & Ahmed,

» […] The effect of mannitol on gastro-intestinal motility is often due to concentration and a possible overlap of multiple mechanistic pathways of the excipient’s influence on drug absorption. In order to discuss the magnitude of this influence of mannitol in your formulation you could study biowaiver monographs and other scientific publications.

In the biowaiver monograph we find:

“Although data in humans are lacking, data in rabbits suggest that high concentrations of os­mo­tically active excipients such as mannitol may have an impact on the tmax of acet­amino­phen.”

The monograph is from 2005; maybe newer data exist.

» 2. diclofenac is a completely absorbable drug substances. If there is an influence (if any) this will only affect the rate but not the amount of absorption.

Correct. I guess it depends on the indication. If used as an antiinflammatory I would not bother. If used as an analgetic rapid onset of effect is important, right? That’s why according to EMA’s BE-GL in vivo studies may be required even for oral solutions.

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Helmut Schütz

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