It was just last month while dispensing a tablet for my wife, which was on a higher dosage, I need to adjust the dosage but realized it was rather difficult to break or split it in two pieces to get it of lower dosage as prescribed by the physician. The difficulty in breaking it was due to the fact, the tablet was not scored.
As it was also film coated, the split or broken piece was to be therefore exposed before consumption in next dosage. The dilemma remained and I tried to take precautionary measures. I knew it and so I did it, but what for those who are unaware of handling split fractions of tablets?
But my dilemma was over last week, when Ashish forwarded the new guidance for industry from FDA. This new guidance is on Tablets Scoring: its nomenclature, labeling and data for evaluation.
A good initiative as usual from the FDA. While the guidance will help people like me who may have to dispense broken tablets. The issues are related to dealing with modified released tablets, stability of split tablet, risks of impurity generation etc.
These are set of guidance’s and criteria for industry on which scored tablets characteristics will be evaluated as part of review process.
The guidance can be downloaded from the FDA site or click here.