[e-drug] Splitting of FDC tablets (2)

["Susan Walters" <susanw@netspeed.com.au>]

E-DRUG: Splitting of FDC tablets (2)
------------------------------------

Further to Chengetanai T. Mangoro's enquiry:

Even if a tablet is intended to be homogenous, there may be a problem with
content uniformity of divided tablets, and especially when one or more of
the actives is present at a low dose. 

At TGA our view was that, if a manufacturer wanted to recommend a dose that required a tablet to be divided, then (1) the tablet had to have a score line and (2) the manufacturer had to demonstrate that dividing tablets produced an accurate dose.  

Some tablets crumble rather than break cleanly. Without a score line,
the possibility of poor dose uniformity is much greater. 

regards
 
Susan Walters
Retired regulator
Australia
susanw@netspeed.com.au

 

  _____  

From: Susan Walters [mailto:susanw@netspeed.com.au] 
Sent: Thursday, 27 September 2007 9:57 AM
To: 'e-drug@healthnet.org'
Subject: Splitting of FDC tablets

 

Further to Chengetanai T. Mangoro's enquiry:

 

Even a tablet is intended to be homogenous, there may be a problem with
content uniformity of divided tablets, and especially when one or more of
the actives is present at a low dose. At TGA our view was that, if a
manufacturer wanted to recommend a dose that required a tablet to be
divided, then (1) the tablet had to have a score line and (2) the
manufacturer had to demonstrate that dividing tablets produced an accurate
dose.  Some tablets crumble rather than break cleanly. Without a score line,
the possibility of poor dose uniformity is much greater. 

 

Susan Walters

Retired regulator