Dear All,
We have one modified release dosage form:
3 parts of beads filled in capsule.
1 part is uncoated.
2 and 3 part is enteric coated.
Now for 2nd part of bead we want to slow down dissolution by changing enteric polymer quantity.
As per Supac MR 5% change in Total controlled release polymer annual reportable.
This 5% change will be applicable to only 2nd part beads or fda will consider it as a whole quantity of polymer (2+3 )filled in entire capsule.
please suggest.
Regards,
Sapna
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sapna rathi
Regulatory specialist
AHME
India
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