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. 2009 May 22;10(2):684–691. doi: 10.1208/s12249-009-9256-8

Table II.

Composition and Evaluation of Fluconazole Sprays Based on 32 Full Factorial Design

Ingredient (% w/w) Batch Code
B7 B8 B9 B10 B11 B12 B13 B14 B15 B16
Fluconazole 0.5 0.5 0.5 0.5 0.5 0.5 0.5 0.5 0.5 0.5
Ethyl cellulose 7.5 5 3 7.5 5 3 7.5 5 3 5.25
Eudragit® RS100 15 15 15 10 10 10 5 5 5 10.6
PEG 400 0.25 0.25 0.25 0.25 0.25 0.25 0.25 0.25 0.25 0.25
Eutectic blend 10 10 10 10 10 10 10 10 10 10
Alcohol and acetone blend (q.s.) 100 100 100 100 100 100 100 100 100 100
Tests Average results (n = 3)
Viscosity (a ± 2.7 cPs) 128.3 92.8 70.8 69.7 48.9 38.1 52.5 34.0 23.7 52.9
Volume of solution delivered upon each actuation (b ± 0.03 ml) 0.14 0.18 0.2 0.21 0.26 0.31 0.26 0.3 0.33 0.24
Spray angle (c ± 0.4o) 91.5 88.2 83.8 84.2 81.8 80.6 82.6 79.8 78.7 82.6
Ex–in vivo film formation timea (d ± 35 sec) 532 435 390 372 328 287 340 282 249 335
Feeling of warmth and subsequent cooling sensationa (e ± 1 min) 19 18 17 18 16 15 17 13 13 17
Appearance of the filma +++ ++ ++ ++ ++ + ++ + + ++
Dermal adhesion and flexibility of the filma +++ +++ +++ +++ +++ +++ +++ ++ ++ +++
Water washabilitya + + ++ ++ ++ ++ ++ ++ ++ ++

aMeasured for placebo batches replacing fluconazole with blend of alcohol and acetone