Problem of the Month: March 2026
What Does a Bisect (“Breakline”) in a Scored Tablet Mean?
If you look closely at the photos above you will notice both tablets have a bisect. But they are different. Is there any reason for this?
Actually there are functional bisects and then aesthetic bisects. But more importantly, if they are functional, then is there a further obligation to ensure that (within a small error) there is an equal distribution of the drug on each side of the bisect?
Not so fast! If you look in the package insert for patients, companies say different things. Sometimes NOTHING!, “may be conveniently divided”, “divide the tablet into two”, etc. And in countries where the drug is dispensed in a bottle, the label instructions may be different than the insert!
Question. If you in fact have a score/bisect/breakline do you have to prove equal drug content on each side? Well it depends upon the drug, the country in which the drug is sold, and also what kind of instruction you place on the patient insert.
See you in Pune, Hyderabad, Bangaluru and Goa very soon!
Jakarta and Manila also!