Recovery and Stability of Omadacycline 150-mg Crushed Tablets Dispersed in Food or Water and Administered via Nasogastric Tube.

BACKGROUND

Omadacycline, an aminomethylcycline tetracycline available orally and intravenously, is approved for the treatment of patients with acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia, some of whom have difficulty swallowing tablets. The objective of this study was to assess the stability and recovery of crushed omadacycline 150-mg tablets.

METHODS

The recovery and stability of crushed omadacycline 150-mg tablets was assessed using 3 crushing methods (pill crusher, mortar/pestle, and sandwich bag method) and 3 dispersal products (water, vanilla syrup, or applesauce) over 24 hours at room temperature and administered via nasogastric tube. Omadacycline and its epimer (OMC-4-epimer) concentrations were assessed via liquid chromatography tandem mass spectrometry.

RESULTS

There was no significant difference in recovery of omadacycline or OMC-4-epimer proportion based on crushing technique. There were significantly higher proportions of OMC-4-epimer in applesauce experiments than in water or vanilla syrup experiments, regardless of crushing methods. All experiments had significantly less recovery of omadacycline and increased proportions of OMC-4-epimer at 24 hours compared with earlier time points. There was no significant difference in recovery of omadacycline or OMC-4-epimer proportion using either type of nasogastric tube with omadacycline recovery above 91%.

CONCLUSIONS

The optimal method for recovery and stability of crushed omadacycline was to rinse the crushing device thoroughly into the collection container and disperse it into water, with consumption immediately or after no more than 4 hours. Vanilla syrup may be used as an alternative dispersal vehicle to be consumed immediately if used.