Pharmaceutical Manufacturing Handbook: Production and

OINTMENTS AND CREAMS 277
TABLE 3 Cream Bases Present in Some Commercial Creams
Commercial Name
Drug
Cream Base (s) Used
Dritho - Calp,
Psoriatec
Anthralin, 0.5%, 1.0% White petrolatum, cetostearyl alcohol
Temovate E Clobetasol propionate, Propylene glycol, glyceryl monostearate,
0.05%
cetostearyl alcohol, glyceryl stearate,
PEG 100 stearate, white wax
Eurax
Crotamiton, 10% Petrolatum, propylene glycol, cetyl
alcohol, carbomer - 934
Topicort
Desoximetasone, White petrolatum USP, isopropyl
0.25%
myristate NF, lanolin alcohols NF,
mineral oil USP, cetostearyl alcohol NF
Apexicon, Maxifl or, Difl orasone diacetate, Hydrophilic vanishing cream base of
Psorcon
0.05%
propylene glycol, stearyl alcohol, cetyl
alcohol
Lidex Cream, Vanos Fluocinonide, 0.05%, Polyethylene glycol 8000, propylene
0.10%
glycol, stearyl alcohol
Carac
Fluorouracil, 0.5%, Carbomer - 940, PEG 400, propylene
1.0%, 5.0%
glycol, stearic acid
Halog
Halcinonide, 0.1% Polyethylene and mineral oil gel base
with PEG 400, PEG 6000, PEG 300,
PEG 1450
Cortaid, Anusol - Hc, Hydrocortisone, 2.5% Petrolatum, stearyl alcohol, propylene
Proctosol HC water washable glycol, carbomer - 934
Monistat - Derm Miconazole nitrate, Water - miscible base consisting of pegoxol
2%
7 stearate, peglicol 5 oleate, mineral oil,
butylated hydroxyanisole
base. The fusion method is followed when the drugs and other solids are soluble in
the ointment bases. The base is liquefi ed, and the soluble components are dissolved
in the molten base. The mixture is then allowed to congeal by cooling. Fusion is
performed using steam - jacketed vessels or a porcelain dish. The congealed mixture
is then spatulated or triturated to obtain a smooth texture. Care is taken to avoid
thermal degradation of the base or other components during the fusion process.
Absorption - type ointments and creams are prepared by incorporating large
quantities of water into hydrocarbon bases with the aid of a hydrophobic emulsifying
agent. Water - insoluble drugs are added by mechanical addition or fusion methods.
As with oleaginous ointments, levigating agents are also included to improve wetting
of solids. Water - soluble or water - miscible agents such as alcohol, glycerin, or propylene
glycol are used if the drug needs to be incorporated into the internal aqueous
phase. If the drug needs to be incorporated into the external oily phase, mineral oils
are used as the levigating agent. Incorporation of water - soluble components is
achieved by slowly adding the aqueous drug solution to the hydrophobic base using
pill tile and spatula. If the proportion of aqueous phase is larger, inclusion of additional
quantities of emulsifi er and application of heat may be needed to achieve
uniform dispersion. Care must be taken to avoid excessive heating as it can result
in evaporation aqueous phase and precipitation of water - soluble components and
formation of stiff and waxy product.