Table 4

Results from the investigation of possible precipitation and emulsion stability following the mixing of drug and total parenteral nutrition (TPN) (n ≥3), V.W. MDD (volume weighted mean droplet diameter) and % size fractions: n=1 with multiple runs. Mix ratios denotes drug + TPNaq or drug + TPN, respectively. Shaded areas highlight values that might indicate an incompatible mix

DrugMix ratio Drug+TPN/TPNaq Investigation of possible formation of precipitation with TPNaq Testing of emulsion stability with TPN
*Particles/ml ≥0.5 µmTurbidity (FNU)Visible particles and/or Tyndall effect (+/−)pHLight obscurationLaser diffractionpH
PFAT5% <500 nm% <
1 µm
V.W. MDD
0h4h0h4h0h4h24 hours0h4h0h4h4h4h4h0h4h
Baseline (TPNaq/TPN)17±15136±400.32±0.170.86±0.50+/−+/−5.895.890.11±0.010.18±0.02821003755.895.89
 Ampicillin 50 mg/mL†1+10336±219113±980.28±0.040.23±0.06+++6.916.810.07±0.000.10±0.01821003746.926.77
1+1100±361932±2000.45±0.170.67±0.06+++7.957.920.08±0.010.04±0.01831003738.037.92
2+186±42287±5910.96±0.101.03±0.16+++8.168.190.07±0.000.04±0.01851003708.238.16
 Ceftazidime
 40 mg/mL‡
1+1055±1612±60.10±0.020.20±0.02+6.046.000.09±0.010.23±0.02831003696.006.04
1+119±518±20.12±0.020.12±0.036.486.420.12±0.070.04±0.03871003606.636.71
1+227±1213±60.10±0.010.10±0.01+/−6.336.280.09±0.020.14±0.02831003706.366.45
 Fluconazole
 2 mg/mL§
1+10381±190180±120.16±0.040.12±0.01++/−5.855.860.14±0.020.30±0.06821003785.845.85
1+1360±16585±190.14±0.020.09±0.00++/−5.865.870.12±0.010.29±0.04811003825.855.89
9+192±477±260.08±0.020.07±0.015.855.870.10±0.010.32±0.28801003855.885.90
 Fosphenytoin
 10 mg/mL‡
1+50135±1933±40.10±0.010.10±0.015.945.960.11±0.010.15±0.04821003745.915.92
1+1132±1427±100.09±0.020.18±0.08+/−+/−+7.477.440.09±0.000.04±0.00831003757.347.23
5+154±2052±250.08±0.010.11±0.018.218.250.09±0.010.08±0.01821003788.148.07
 Furosemide
 2 mg/mL†
1+100436±215105±310.14±0.050.10±0.015.875.900.13±0.030.24±0.02831003735.845.85
1+1561±31939±160.13±0.040.08±0.00+/−+/−+/−5.945.980.10±0.010.04±0.01831003725.905.93
2+1518±28451±260.12±0.020.09±0.01+/−+/−+/−5.996.020.09±0.010.04±0.02831003745.975.98
 Metronidazole
 5 mg/mL§
1+10312±82218±260.26±0.140.27±0.16+/−+/−5.845.850.17±0.030.35±0.08821003745.815.83
1+1302±81118±280.18±0.090.10±0.02+/−5.635.650.16±0.010.29±0.05821003775.605.62
5+1252±25109±850.10±0.010.10±0.015.295.280.15±0.050.27±0.10821003775.275.29
 Paracetamol¶
 10 mg/mL§
1+1040±142±90.14±0.010.13±0.025.705.710.08±0.000.20±0.01801003795.755.76
1+113±112±40.35±0.010.36±0.02+++5.305.310.09±0.010.15±0.01831003745.335.33
1+225±628±120.26±0.010.26±0.01+++5.395.380.12±0.020.36±0.15831003745.405.42
  • *Particle counts above 10 and 25 µm are not shown as the Ph.Eur. limits were not exceeded in any of the samples.

  • †Diluted in 9 mg/mL NaCl.

  • ‡Diluted in 50 mg/mL glucose.

  • §Undiluted.

  • ¶All tests were performed with paracetamol from B. Braun, except for laser diffraction measurements where the paracetamol was from Fresenius Kabi.