Miconazole Nitrate Cream

Specifications:
Composition:
Miconazole Nitrate I.P.

2% w/w

Chlorocresol I.P. (As preservative) 0.1% w/w

Cream Base

Q.S.

Presentation 20x 15g x 48 Box in a shipper

Miconazole Cream
(2%)
1. Formulation
I. Cetylstearyl alcohol...................................7.0 g
Cremophor A 6 [1] ....................................1.5 g
Cremophor A 25 [1] ..................................1.5 g
Liquid paraffin ........................................12.0 g
Parabene(s)..............................................0.1 g
II. Water .....................................................67.8 g
III. Propylene glycol [1] ..................................8.0 g
Miconazole nitrate ....................................2.0 g
2. Manufacturing
Heat the mixture I and the water II separately to about 80 C. Add the
water II to the obtained solution I with rigorous stirring. Heat III until the
active ingredient is dissolved, mix with I/II and continue to stir during
cooling to room temperature.
3. Properties
White cream.
4. Physical stability
N
o change of appearance or crystallization were observed during 6 weeks
at 45 C.
5. Remark
This formulation could be used for other active ingredients too.

Miconazole Mouth Gel

(2%)
1. Formulation
I. Miconazole nitrate (Sigma) ........................2.0 g
Orange flavour..........................................0.1 g
II. Lutrol F 127 [1] .......................................20.0 g
Cremophor RH 40 [1]..............................10.0 g
Propylene glycol [1].................................10.0 g
III. Kollidon 90 F [1] .......................................5.0 g
Saccharine sodium ...................................0.3 g
W
ater.....................................................52.6 g
2. Manufacturing
Dissolve I in the molten mixture II. Heat solution III to 90 C and mix
slowly with I/II. Let cool to room temperature when the air bubbles

escaped.
3. Properties of the gel
A colourless, clear and soft gel was obtained having a orange like taste
and a slightly bitter after taste.