Table 3.
Physicochemical Stability Test Results for Aprepitant Injectable Emulsion (18 mL + 100 mL or 250 mL) Diluted in NSS or D5W in PVC Infusion Bags in Refrigerated Storage
| Assay (%LC), HPLCa | DEHP (µg/mL)b | Related Substances (Total Area %), HPLCa | Mean Particle Size (nm), DLSa | PDI, DLSa | Globule Size Distribution (PFAT5) (%), Light Obscurationa | |
|---|---|---|---|---|---|---|
| 100 mL Diluent | ||||||
| NSS | ||||||
| 0 hr | 98.7 ±0.18 | 2.9 ±0.05 | 0.1 | 102.4 ±0.61 | 0.14 ±0.01 | 0.00 |
| 24 hr | 98.1 ±0.06 | 23.8 ±0.98 | 0.1 | 102.4 ±0.29 | 0.15 ±0.00 | 0.00 |
| 48 hr | 98.2 ±0.09 | 50.3 ±0.17 | 0.1 | 102.5 ±0.54 | 0.15 ±0.01 | 0.00 |
| 72 hr | 98.68 ±0.12 | 84.9 ±1.97 | 0.2 | 102.5 ±0.34 | 0.15 ±0.01 | 0.00 |
| D5W | ||||||
| 0 hr | 95.7 ±1.06 | 5 ±0.73 | 0.1 | 108.5 ±0.42 | 0.17 ±0.01 | 0.00 |
| 24 hr | 96.5 ±0.58 | 23.9 ±0.69 | 0.1 | 110 ±0.52 | 0.18 ±0.01 | 0.00 |
| 48 hr | 96.8 ±0.84 | 48.8 ±2.5 | 0.1 | 110.5 ±0.28 | 0.17 ±0.01 | 0.00 |
| 72 hr | 98.1 ±0.59 | 82.21 ±1.54 | 0.1 | 109.6 ±0.46 | 0.18 ±0.00 | 0.00 |
| 250 mL Diluent | ||||||
| NSS | ||||||
| 0 hr | 90.3 ±2.7 | 4 ±0.05 | <0.1 | 86.9 ±0.24 | 0.13 ±0.01 | 0.00 |
| 24 hr | 90.1 ±2.65 | 11.8 ±0.47 | 0.1 | 87 ±0.35 | 0.13 ±0.01 | 0.00 |
| 48 hr | 90.2 ±2.74 | 18.4 ±0.67 | <0.1 | 87.1 ±0.30 | 0.14 ±0.01 | 0.00 |
| 72 hr | 90.2 ±2.72 | 25.6 ±1.26 | <0.1 | 87 ±0.38 | 0.14 ±0.01 | 0.00 |
| D5W | ||||||
| 0 hr | 93.5 ±1.7 | 3.8 ±0.04 | 0.1 | 92.1 ±0.55 | 0.17 ±0.01 | 0.00 |
| 24 hr | 88.5 ±1.23 | 11.6 ±0.43 | 0.1 | 91.7 ±0.29 | 0.17 ±0.01 | 0.00 |
| 48 hr | 90.4 ±0.91 | 19.9 ±2.99 | <0.1 | 90.8 ±0.68 | 0.17 ±0.01 | 0.00 |
| 72 hr | 90.1 ±1.3 | 23.1 ±0.7 | 0.1 | 91.8 ±0.23 | 0.17 ±0.01 | 0.00 |
Notes: aValues are the averages for two samples prepared from two bags. bValues are the averages for three samples prepared from two bags (100 mL diluent) or the averages for two samples prepared from two bags (250 mL diluent).
Abbreviations: D5W, dextrose 5% in water; DEHP, non-di-(2-ethylhexyl) phthalate; DLS, dynamic light scattering; HPLC, high-performance liquid chromatography; LC, label claim; NSS, normal saline solution; PFAT5, percent of fat globules larger than 5 μm; PVC, polyvinyl chloride; rpHPLC, reverse-phase HPLC.