Abstract: PO1134
Compatibility Study of Patiromer with Juices/Liquids and Soft Foods
Session Information
- Salt, Potassium, and Water Balance: Clinical
November 04, 2021 | Location: On-Demand, Virtual Only
Abstract Time: 10:00 AM - 12:00 PM
Category: Fluid, Electrolyte, and Acid-Base Disorders
- 902 Fluid, Electrolyte, and Acid-Base Disorders: Clinical
Authors
- Khoeiklang, Martin, Vifor International AG, Saint Gallen, Saint Gallen, Switzerland
- Wilhelm, Maria, Vifor International AG, Saint Gallen, Saint Gallen, Switzerland
- Li, Lingyun, Vifor Pharma Group, Redwood City, California, United States
- Moreno Quinn, Carol Patricia, Vifor International AG, Saint Gallen, Saint Gallen, Switzerland
- Popov, Tamara, Vifor International AG, Saint Gallen, Saint Gallen, Switzerland
Background
Patiromer is a novel, once-daily, sodium-free K+-binder approved for treatment of hyperkalemia. The drug–a tasteless, odorless powder–is administered orally suspended in water. Recently, the FDA approved apple or cranberry juice as suspension vehicles. As patients may prefer to take patiromer with alternative liquids/foods, the ability to mix patiromer with small amounts (per allowed dietary intake recommendations) of various liquids and foods may improve palatability and medication adherence. This in vitro study assessed the compatibility of patiromer with six different juices/nectars and six soft foods or other liquids (Table).
Methods
For all mixtures, compatibility was assessed at two ratio levels: low (8.4 g patiromer in 40 mL of vehicle, ~1/6 cup); high (12.7 g patiromer in 20 mL of vehicle, ~1/12 cup), equivalent to patiromer doses of 8.4 g and 25.2 g per 80 mL (1/3 cup), respectively. Mixtures with soft foods were spoon stirred for 30 s; juices were stirred for 5 min on a magnetic stirrer. After a 45-min rest period, suspensions were diluted with 50 mL (juices) or 100 mL of water (soft foods) and centrifuged at 1000 rpm for 30 s. Residues were washed, vacuum filtered, and dried. Total potassium binding capacity (TKEC) was tested (acceptance criterion: 8.4–10 mmol/g).
Results
Mean TKEC for patiromer mixed with juices/nectars were 8.7–8.9 mmol/g for the low ratio and 8.5–8.6 mmol/g for the high ratio (Table). For soft foods or other liquids, the mean TKEC at low and high ratios was 8.5–8.7 mmol/g (reference: 9.2 mmol/g); exchange capacity for tested vehicles was within the prespecified range.
Conclusion
Mixing of patiromer with small amounts of juices/nectars, soft foods, and other liquids does not adversely affect the drug’s potassium-binding capacity. Use of different vehicles for mixing patiromer may improve palatability and reduce the risk of nonadherence.
Mean total potassium binding capacity (TKEC) after mixing of patiromer with juices and soft foods. RSD, relative standard deviation
| Juice/nectar vehicle | Low ratio | TKEC, RSD [%] | mmol/g High ratio | RSD [%] | Soft food vehicle | Low ratio | TKEC, RSD [%] | mmol/g High ratio | RSD [%] |
| Pineapple juice | 8.9 | 1.5 | 8.5 | 0.8 | Yoghurt | 8.7 | 0.4 | 8.6 | 0.4 |
| Orange juice | 8.8 | 2.0 | 8.5 | 0.7 | Milk | 8.6 | 0.9 | 8.5 | 1.2 |
| Grape juice | 8.8 | 2.0 | 8.6 | 0.8 | Apple sauce | 8.6 | 0.9 | 8.7 | 1.6 |
| Apricot nectar | 8.8 | 0.4 | 8.6 | 0.5 | Thickener | 8.6 | 0.4 | 8.6 | 0.6 |
| Peach nectar | 8.7 | 0.7 | 8.5 | 0.5 | Vanilla pudding | 8.5 | 1.2 | 8.6 | 0.6 |
| Pear juice | 8.7 | 1.6 | 8.5 | 0.4 | Chocolate pudding | 8.5 | 0.8 | 8.6 | 0.7 |
Funding
- Commercial Support – Vifor Pharma