Diclofenac Potassium Powder for Oral Solution [Regulatives / Guidelines]

posted by Dr_Dan  – Germany, 2014-08-16 09:47 (2841 d 11:44 ago) – Posting: # 13395
Views: 4,928

Dear Ahmed Al Habashi
In general the impact of excipients on bioavailability of completely absorbable drug substances like diclofenac is considered rather unlikely but it can not be completely excluded. Therefore, even in the case of solid oral formulations with class I drugs it is advisable to use similar amounts of the same excipients in the composition of test like in the reference product. 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. Luckily you have two advantages: 1. your drug substance is already in solution (=no exipient's influence on solubility) and 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.
I hope this helps.
Kind regards

Kind regards and have a nice day

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