Authors :
Lixin Gong, MS – Aucta Pharmaceuticals, Inc.
Kentankumar Gondalia, BS Pharm – Aucta Pharmaceuticals, Inc.
Anil Patel, MS – Aucta Pharmaceuticals, Inc.
Priti Trivedi, PhD – Aucta Pharmaceuticals, Inc.
Gloria Macalintal, BA – Aucta Pharmaceuticals, Inc.
Dhruval Patel, MS – Aucta Pharmaceuticals, Inc.
Prexa Patel, BS – Aucta Pharmaceuticals, Inc.
Ha Nguyen, MS – Aucta Pharmaceuticals, Inc.
Presenting Author: Marie Tan, MD – Aucta Pharmaceuticals, Inc.
Rationale:
Lacosamide Extended-Release Capsules, MOTPOLY XR, is an approved antiseizure medication with a novel formulation containing Lacosamide Extended-Release (ER) beads by taking whole capsules once daily with or without food. To demonstrate the suitability of alternative administration of Lacosamide ER Capsules via enteral feeding tubes to accommodate patients who cannot safely swallow or are unable to tolerate oral intake, the in vitro testing of enteral feeding tubes for Lacosamide ER Capsules was performed according to FDA draft guidance. Methods:
Lacosamide ER Capsules, 200 mg, lot # 4530661 used in bioequivalence study and stored under controlled room-temperature condition for over 36 months, was used in this study as 200 mg was the highest strength with the highest risk of forming occlusions during testing. Different sizes of nasogastric (NG) tubes and gastrostomy (G) tubes with 2 types of extension set were evaluated. Suitable dispersion medium used for Lacosamide ER beads, distilled water (water), volume of water for dispersion (15 mL), soaking time of beads dispersed in water (5 minutes), detailed preparation for dispersion including the proposed administration instructions through the tubes, flush volume used before (10 mL) and after drug administration (10 mL) were also determined. Testing of Recovery, sedimentation volume, dispersibility and in-use stability for Lacosamide ER beads soaked in water were performed with the selected NG and G tubes using applicable validated analytical methods. Refer to Table 1 for results supporting enteral tube administration. Dissolution testing for initial and 5-minute soaking time of ER beads in water at room temperature was also performed after administering through a combination of an oral syringe and an enteral tube in dissolution media. The dissolution results obtained in Table 2 demonstrated that the preparation and delivery via enteral tubes did not affect the extended release of Lacosamide ER beads. The above tests were only performed on the smallest tubing diameter suitable for Lacosamide ER beads, 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. Representative photographs taken throughout the testing including all other results were captured in the study report.Results:
Results: Table 1 Results Supporting Enteral Tube Administration
Table 2. Results of Dissolution Testing via Feeding Tubes
Conclusions:
The above study demonstrated that the entire contents inside 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 (Reference: FDA draft guidance, Oral Drug Products Administered Via Enteral Feeding Tube, effective June 2021). This proposed alternative administration method via feeding tube in addition to the approved labeling preserves the correct dose and the expected safety and effectiveness of Lacosamide ER Capsules.Funding:
This study was funded by Aucta Pharmaceuticals, Inc.