Abstract Number: PB1353
Meeting: ISTH 2020 Congress
Background: Avatrombopag (AVA) is an oral thrombopoietin receptor agonist that is FDA approved for treatment of chronic immune thrombocytopenia (ITP) in adults with insufficient response to previous therapy. AVA is administered as a single tablet with food and does not interact with divalent cations. Stability data on crushed AVA is needed for patients unable to ingest whole tablets.
Aims: To evaluate the stability of crushed AVA mixed with food.
Methods: AVA stability was evaluated crushed in either whole milk yogurt or chocolate pudding. Five 20 mg AVA film-coated tablets per studied sample were crushed to a fine powder, mixed with the food vehicle in triplicate and allowed to sit at ambient temperature conditions for 30 minutes. High performance liquid chromatography was performed, and percent drug recovery was calculated. Regulatory guidance for the use of liquids and/or soft foods as vehicles for drug product administration considers drug recovery within 5% of control to be acceptable.
Results: The mean results for the percent label claim of drug product recovered from each food tested were within 5% of control, thus meeting the regulatory guidance (Table 1). Each crushed preparation had equivalent impurity results to the control whole tablet, indicating negligible degradation. The percent label claim results for the samples exposed to yogurt were all within 3% of the control (mean = 102.1% drug recovery relative to control; relative standard deviation 1.1). The percent label claim results for the pudding samples had higher variability due to the viscosity of the pudding (mean = 96.8% drug recovery relative to control, relative standard deviation 3.9).
Conclusions: These results confirm that whole milk yogurt and chocolate pudding are effective vehicles for the delivery of crushed avatrombopag for up to 30 minutes at ambient temperature after mixing. This mode of delivery could be considered in patients with ITP who cannot ingest whole tablets.
To cite this abstract in AMA style:Grace RF, Aggarwal K, Vredenburg M, Despotovic JM. Stability of Crushed Avatrombopag Tablets Demonstrated in Multiple Food Vehicles [abstract]. Res Pract Thromb Haemost. 2020; 4 (Suppl 1). https://abstracts.isth.org/abstract/stability-of-crushed-avatrombopag-tablets-demonstrated-in-multiple-food-vehicles/. Accessed March 4, 2024.
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