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Table 6 Results on emulsion stability

From: Development and evaluation of a test program for Y-site compatibility testing of total parenteral nutrition and intravenous drugs

TPN

Drug

Time after mixing h

Laser diffraction

Dynamic light scattering

Light obscuration

ζ (mV)

pH d

a% < 500 nm b

a% < 1 μm c

a% > 5 μm c

a% > 10 μm b

V.W. MDD nm

I.W. MDD nm

PI

PFAT2

PFAT5

PFAT10

Olimel® N5E

Fresh without drug

-

91

100

0

0

330 ± 0

273 ± 2

0.05 ± 0.03

0.04 ± 0.01

0.02 ± 0.01

0.01 ± 0.01

−38 ± 3

6.38

Heated 2 days (45 °C)

-

89

100

0

0

344 ± 2

266 ± 2

0.06 ± 0.01

5.43 ± 0.24

4.47 ± 0.22

1.17 ± 0.08

−38 ± 1

6.27

Heated 4 days (45 °C)

-

68

75

9

5

1531 ± 25

275 ± 2

0.09 ± 0.03

5.60 ± 2.60

4.55 ± 2.26

2.19 ± 1.26

−41 ± 4

6.17

Ampicillin

0

91

100

0

0

326 ± 1

272 ± 3

0.05 ± 0.02

0.05 ± 0.02

0.03 ± 0.02

0.02 ± 0.02

−51 ± 1

7.95

4

92

100

0

0

326 ± 15

270 ± 1

0.05 ± 0.02

0.04 ± 0.02

0.02 ± 0.02

0.02 ± 0.02

−53 ± 2

7.83

Ondansetron

0

90

100

0

0

325 ± 1

273 ± 2

0.06 ± 0.02

0.05 ± 0.00

0.03 ± 0.00

0.01 ± 0.01

−35 ± 2

6.17

4

91

100

0

0

322 ± 0

272 ± 3

0.06 ± 0.02

0.04 ± 0.00

0.02 ± 0.01

0.01 ± 0.01

−41 ± 1

6.16

Paracetamol

0

90

100

0

0

322 ± 0

274 ± 2

0.09 ± 0.01

0.04 ± 0.00

0.02 ± 0.00

0.01 ± 0.00

−43 ± 2

6.21

4

91

100

0

0

318 ± 0

274 ± 7

0.06 ± 0.01

0.04 ± 0.01

0.02 ± 0.01

0.01 ± 0.00

−38 ± 2

6.20

Kabiven®

Fresh without drug

-

82

100

0

0

365 ± 0

287 ± 11

0.11 ± 0.04

0.22 ± 0.04

0.12 ± 0.03

0.05 ± 0.03

−37 ± 2

5.55

Heated 2 days (45 °C)

-

76

100

0

0

393 ± 0

287 ± 2

0.10 ± 0.01

6.35 ± 1.25

5.06 ± 1.04

1.65 ± 0.32

−39 ± 2

5.40

Heated 4 days (45 °C)

-

66

81

9

5

1616 ± 27

316 ± 19

0.25 ± 0.10

6.67 ± 0.22

5.48 ± 0.42

3.01 ± 0.89

−38 ± 3

5.48

Ampicillin

0

83

100

0

0

353 ± 0

275 ± 2

0.07 ± 0.03

0.12 ± 0.01

0.06 ± 0.01

0.02 ± 0.01

−51 ± 1

7.92

4

83

100

0

0

359 ± 0

278 ± 1

0.09 ± 0.01

0.10 ± 0.02

0.06 ± 0.02

0.04 ± 0.02

−51 ± 3

7.82

Ondansetron

0

83

100

0

0

355 ± 0

280 ± 2

0.07 ± 0.01

0.11 ± 0.01

0.06 ± 0.01

0.02 ± 0.00

−37 ± 1

5.55

4

84

100

0

0

346 ± 0

280 ± 2

0.09 ± 0.02

0.13 ± 0.00

0.06 ± 0.00

0.02 ± 0.00

−37 ± 1

5.55

Paracetamol

0

82

100

0

0

364 ± 0

277 ± 1

0.09 ± 0.02

0.11 ± 0.00

0.05 ± 0.00

0.02 ± 0.00

−38 ± 2

5.63

4

83

100

0

0

357 ± 0

281 ± 2

0.07 ± 0.00

0.13 ± 0.00

0.07 ± 0.02

0.03 ± 0.01

−40 ± 2

5.60

SmofKabiven®

Fresh without drug

-

89

100

0

0

326 ± 0

248 ± 1

0.06 ± 0.01

0.31 ± 0.13

0.22 ± 0.11

0.06 ± 0.04

−34 ± 2

5.43

Heated 2 days (45 °C)

-

66

84

5

2

980 ± 11

279 ± 4

0.15 ± 0.03

5.65 ± 1.07

4.51 ± 1.01

1.79 ± 0.81

−33 ± 3

5.39

Heated 4 days (45 °C)

-

22

41

30

14

4083 ± 75

342 ± 10

0.29 ± 0.03

8.69 ± 0.97

6.97 ± 0.84

3.21 ± 0.45

−38 ± 3

5.36

Ampicillin

0

89

100

0

0

324 ± 0

242 ± 2

0.08 ± 0.02

0.35 ± 0.25

0.27 ± 0.22

0.10 ± 0.10

−48 ± 2

7.52

4

90

100

0

0

317 ± 0

242 ± 1

0.08 ± 0.01

0.22 ± 0.10

0.14 ± 0.08

0.04 ± 0.02

−49 ± 2

7.34

Ondansetron

0

89

100

0

0

324 ± 0

249 ± 1

0.08 ± 0.01

0.37 ± 0.16

0.27 ± 0.14

0.08 ± 0.05

−37 ± 2

5.54

4

89

100

0

0

330 ± 1

247 ± 1

0.08 ± 0.02

0.57 ± 0.08

0.39 ± 0.07

0.11 ± 0.05

−34 ± 1

5.56

Paracetamol

0

89

100

0

0

324 ± 0

242 ± 2

0.08 ± 0.02

0.38 ± 0.27

0.28 ± 0.25

0.12 ± 0.13

−39 ± 2

5.34

4

90

100

0

0

325 ± 1

244 ± 7

0.11 ± 0.04

0.83 ± 0.58

0.44 ± 0.22

0.12 ± 0.08

−40 ± 4

5.34

  1. a: volume weighted % of oil droplets; b: standard deviation 0–2 c: standard deviation 0–1; d: standard deviation 0.00-0.06
  2. V.W. MDD volume weighted mean droplet diameter, I.W. intensity weighted, PI, polydispersity index, Mean ± standard deviation: n = ≥ 3, dynamic light scattering, n = 2 with multiple runs, laser diffraction, n = 1 with multiple runs