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Abstract Details

Administration of Lamotrigine Formulation for Oral Suspension (ET-105) Through Gastrostomy Feeding Tubes
Epilepsy/Clinical Neurophysiology (EEG)
P11 - Poster Session 11 (8:00 AM-9:00 AM)
12-004
To determine if ET-105 (lamotrigine for oral suspension) can be effectively administered through gastrostomy feeding tubes (g-tube).
Patients with epilepsy who have difficulty swallowing may require surgical implantation of a feeding tube. As accurate dose delivery of antiepileptic medications in these patients is important to maintain seizure control, there must be minimal aggregation, clogging, or adherence of drug to the tube and syringe. Lamotrigine is a broad spectrum antiepileptic for the treatment of seizures in adults and children, although currently only available in tablet form starting at 5 mg. ET-105, a new formulation of lamotrigine for oral suspension, eliminates the need for tablet crushing and may simplify dose preparation prior to g-tube administration.
This in vitro feeding tube study evaluated the accuracy of ET-105 dose delivery from 3 g-tubes of 2 different sizes: 5 cm/18 Fr or 0.8cm/12 Fr (2 manufacturers). Using the provided feeding tube kit syringe, 5 or 6 mL of reconstituted ET-105 suspension (10 mg/mL) was passed through each g-tube, followed by 2 mL of water to washout residue. The solution was diluted and filtered through a 0.45 µm filter. Recovery was analyzed using the verified method MOA0701 Assay of suspension by high performance liquid chromatography.
A total of 12 samples were tested per g-tube. The mean recovery of ET-105 solution was ≥100% using each of the 3 g-tubes and the percent relative standard deviation (% RSD) ranged from 2.2% to 2.4%. All individual samples met the protocol-defined acceptance criteria of ≥85% recovery and % RSD of ≤5%. There was no aggregation, clogging, or adherence observed.
ET-105, lamotrigine for oral suspension, can be delivered accurately through g-tubes down to at least a minimum diameter of 0.8 cm/12 Fr.
Authors/Disclosures

PRESENTER 		No disclosure on file
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