We have an API compound which exhibits a bimodal particle size distribution. The drug product is an immediate release solid oral with limited solubility.
The proposal is to have no particle size distribution specifications. Has anyone had success with this tactic? If so and you are willing/able to share, what was the overall strategy?
Assuming a particle size specification is required (far more likely in my opinion), does anyone have advice on how to approach this and what items would be used to justify such an approach?
We have already considered DP manufacturability (doesn't seem to be a problem there), any suggestions or past experiences that folks are able to share would be helpful.
Thanks for the input.
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Karen Fleshman PhD
Dir
Bellevue WA
United States
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