Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Good afternoon,
We filed an IND for one of our development drug products. The team plans to file an NDA and the commercial product would be a debossed and scored tablet. A question came up from the team about whether the appearance of the tablet once broken in half matters. The FDA guidance on Tablet Scoring isn't clear on whether the appearance of the split tablet is important. The guidance discusses the criteria that the scored tablets will be evaluated against and appearance isn't one of the criteria. Wanted to get some thoughts on the importance of the appearance of the split tablet. Thank you.

This message was posted by a user wishing to remain anonymous

The guidance rightfully mentions "be evaluated" because that's the only thing matters in terms of quality (i.e. before being broken and after broken) more specifically its' bioavailability! Scientifically the appearance is irrelevant after broken into half! Its the bioavailability via in vivo and dissolution testing one could evaluate.....!
Original Message:
Sent: 08-Sep-2021 16:10
From: Anonymous Member
Subject: Tablet scoring and appearance

This message was posted by a user wishing to remain anonymous

Good afternoon,
We filed an IND for one of our development drug products. The team plans to file an NDA and the commercial product would be a debossed and scored tablet. A question came up from the team about whether the appearance of the tablet once broken in half matters. The FDA guidance on Tablet Scoring isn't clear on whether the appearance of the split tablet is important. The guidance discusses the criteria that the scored tablets will be evaluated against and appearance isn't one of the criteria. Wanted to get some thoughts on the importance of the appearance of the split tablet. Thank you.

This message was posted by a user wishing to remain anonymous

Bioavailability would be more important than how the tablet appears after the tablet is broken so the FDA guidance is focusing on evaluation to assess the performance of the tablet via dissolution and or BA in vivo study.
Original Message:
Sent: 08-Sep-2021 16:10
From: Anonymous Member
Subject: Tablet scoring and appearance

This message was posted by a user wishing to remain anonymous

Good afternoon,
We filed an IND for one of our development drug products. The team plans to file an NDA and the commercial product would be a debossed and scored tablet. A question came up from the team about whether the appearance of the tablet once broken in half matters. The FDA guidance on Tablet Scoring isn't clear on whether the appearance of the split tablet is important. The guidance discusses the criteria that the scored tablets will be evaluated against and appearance isn't one of the criteria. Wanted to get some thoughts on the importance of the appearance of the split tablet. Thank you.