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 + TPN_aq or drug + TPN, respectively. Shaded areas highlight values that might indicate an incompatible mix

Drug	Mix ratio Drug+TPN/TPN_aq	Investigation of possible formation of precipitation with TPN_aq									Testing of emulsion stability with TPN
		*Particles/ml ≥0.5 µm		Turbidity (FNU)		Visible particles and/or Tyndall effect (+/−)			pH		Light obscuration		Laser diffraction			pH
		*Particles/ml ≥0.5 µm		Turbidity (FNU)		Visible particles and/or Tyndall effect (+/−)			pH		PFAT5		% <500 nm	% < 1 µm	V.W. MDD	pH
		0h	4h	0h	4h	0h	4h	24 hours	0h	4h	0h	4h	4h	4h	4h	0h	4h
Baseline (TPN_aq/TPN)	–	17±15	136±40	0.32±0.17	0.86±0.50	+/−	+/−	−	5.89	5.89	0.11±0.01	0.18±0.02	82	100	375	5.89	5.89
Ampicillin 50 mg/mL†	1+10	336±219	113±98	0.28±0.04	0.23±0.06	+	+	+	6.91	6.81	0.07±0.00	0.10±0.01	82	100	374	6.92	6.77
	1+1	100±36	1932±200	0.45±0.17	0.67±0.06	+	+	+	7.95	7.92	0.08±0.01	0.04±0.01	83	100	373	8.03	7.92
	2+1	86±4	2287±591	0.96±0.10	1.03±0.16	+	+	+	8.16	8.19	0.07±0.00	0.04±0.01	85	100	370	8.23	8.16
Ceftazidime 40 mg/mL‡	1+10	55±16	12±6	0.10±0.02	0.20±0.02	−	−	+	6.04	6.00	0.09±0.01	0.23±0.02	83	100	369	6.00	6.04
	1+1	19±5	18±2	0.12±0.02	0.12±0.03	−	−	−	6.48	6.42	0.12±0.07	0.04±0.03	87	100	360	6.63	6.71
	1+2	27±12	13±6	0.10±0.01	0.10±0.01	−	−	+/−	6.33	6.28	0.09±0.02	0.14±0.02	83	100	370	6.36	6.45
Fluconazole 2 mg/mL§	1+10	381±190	180±12	0.16±0.04	0.12±0.01	+	+/−	−	5.85	5.86	0.14±0.02	0.30±0.06	82	100	378	5.84	5.85
	1+1	360±165	85±19	0.14±0.02	0.09±0.00	+	+/−	−	5.86	5.87	0.12±0.01	0.29±0.04	81	100	382	5.85	5.89
	9+1	92±4	77±26	0.08±0.02	0.07±0.01	−	−	−	5.85	5.87	0.10±0.01	0.32±0.28	80	100	385	5.88	5.90
Fosphenytoin 10 mg/mL‡	1+50	135±19	33±4	0.10±0.01	0.10±0.01	−	−	−	5.94	5.96	0.11±0.01	0.15±0.04	82	100	374	5.91	5.92
	1+1	132±14	27±10	0.09±0.02	0.18±0.08	+/−	+/−	+	7.47	7.44	0.09±0.00	0.04±0.00	83	100	375	7.34	7.23
	5+1	54±20	52±25	0.08±0.01	0.11±0.01	−	−	−	8.21	8.25	0.09±0.01	0.08±0.01	82	100	378	8.14	8.07
Furosemide 2 mg/mL†	1+100	436±215	105±31	0.14±0.05	0.10±0.01	−	−	−	5.87	5.90	0.13±0.03	0.24±0.02	83	100	373	5.84	5.85
	1+1	561±319	39±16	0.13±0.04	0.08±0.00	+/−	+/−	+/−	5.94	5.98	0.10±0.01	0.04±0.01	83	100	372	5.90	5.93
	2+1	518±284	51±26	0.12±0.02	0.09±0.01	+/−	+/−	+/−	5.99	6.02	0.09±0.01	0.04±0.02	83	100	374	5.97	5.98
Metronidazole 5 mg/mL§	1+10	312±82	218±26	0.26±0.14	0.27±0.16	+/−	+/−	−	5.84	5.85	0.17±0.03	0.35±0.08	82	100	374	5.81	5.83
	1+1	302±81	118±28	0.18±0.09	0.10±0.02	+/−	−	−	5.63	5.65	0.16±0.01	0.29±0.05	82	100	377	5.60	5.62
	5+1	252±25	109±85	0.10±0.01	0.10±0.01	−	−	−	5.29	5.28	0.15±0.05	0.27±0.10	82	100	377	5.27	5.29
Paracetamol¶ 10 mg/mL^§	1+10	40±1	42±9	0.14±0.01	0.13±0.02	−	−	−	5.70	5.71	0.08±0.00	0.20±0.01	80	100	379	5.75	5.76
	1+1	13±1	12±4	0.35±0.01	0.36±0.02	+	+	+	5.30	5.31	0.09±0.01	0.15±0.01	83	100	374	5.33	5.33
	1+2	25±6	28±12	0.26±0.01	0.26±0.01	+	+	+	5.39	5.38	0.12±0.02	0.36±0.15	83	100	374	5.40	5.42

*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.