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Neglect Excipients at Your Own Risk

Inert ingredients are still pharma’s stepchild, even though they can be a key source of quality and manufacturing problems. At IFPAC 2013 Brian Carlin, Director of Open Innovation at FMC, emphasized the importance of considering excipients' properties and variability.
27/02/2013 | 2 comments
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Brian Carlin
Brian Carlin  
3/5/2013 11:31:36 AM
User Rank Blogger
Re: Criticality and CMC relation
The choice of excipient, as reported in the CMC, is a matter of development pharmaceutics, and will be dependent on the intended role of the excipient in that specific application. If a property or attribute of the excipient governs its performance in that application, then that attribute should be focused upon in the CMC, and specified accordingly. However the attribute may be something other than a pharmacopoeial parameter reported on the CoA.

2/27/2013 3:37:18 PM
User Rank Survivor (White Belt)
Criticality and CMC relation
How does the CMC can relate to the choice of excepient to be used dependent which properties of the excipient? can you name the properties of excipients to be focused upon critically during CMC considerations as mentioned in the video???


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