Excipient in risk assesment for worst case identification

Hi everybody,

I want to know if excipient are include in the worst case rating/risk assessment or you focus only on actives. For example in my matrix, i have some product with many excipients and only one active, and an other product with less excipients and 2 or 3 actives, and finally products with more excipient is the worst case. When I exclude excipients, products with more actives are wort case.

What it your point of view and advices

Thank you

What causes the products with more excipients to be worst case? What is your evaluation criteria.

Hi JaredCroft,

I have 5 evaluation criteria for worst case determination : solubility, toxicity, amount and type of of every ingredient (if it is actif or excipient) and finally the cleanability of finish product.
For every ingredient and every criteria i assign rating numbers. And addition of all rating number give the score of the product. This procedure is done for every products and the product with high score is selected as worst case. That is why if there is more ingredients, the score of the product is greater.

I don’t know if this is a scientific rating strategy . if i’m not right, please tell me what is your rating procedure or strategy.

That you

I like your evaluation criteria. But I wouldn’t sum the various calculations for each finished product, I would take the worst case for each finished product.

That way if you have something with a lot of ingredients it doesn’t become your worst case finished product by default even if it really isn’t your worst case.

I don’t use excipients in a ‘risk assessment’ matrix since many of them are GRAS (generally regarded as safe) by the FDA. The FDA has a database of GRAS excipients (IIIS?).