Lacosamide ER Capsules, 200 mg, was used as 200 mg was the highest strength with the highest risk of forming occlusions. Different sizes of nasogastric (NG) tubes and gastrostomy (G) tubes with 2 types of extension set were evaluated. Suitable dispersion medium, distilled water, volume of water for dispersion, soaking time of beads dispersed in water, detailed preparation for dispersion including proposed administration instructions through the tubes, flush volume used before and after drug administration were determined. Testing of recovery, sedimentation volume, dispersibility and in-use stability for Lacosamide ER beads soaked in water were performed. Dissolution testing for initial and 5-minute soaking time of ER beads in water at room temperature was performed after administering through an oral syringe and an enteral tube in dissolution media. The above tests were only performed on the smallest tubing diameter suitable, 16 Fr (Fr = French, 3 Fr = 1 millimeter) for NG tubes and 18 Fr for G tubes, as the successful testing on the smallest tubing diameter obviated the need to perform testing through tubing with larger diameters.

The study demonstrated that Lacosamide ER Capsules can be adequately delivered via enteral feeding tubes through 16 Fr or above for nasogastric tubes and 18 Fr or above for gastrostomy tubes. This proposed alternative administration method via feeding tube in addition to the approved labeling preserves the correct dose and the expected safety and effectiveness.