Lower dosage strength imiquimod formulations and short dosing regimens for treating genital and perianal warts
a technology of genital and perianal warts and formulations, which is applied in the field of pharmaceutical formulations, can solve the problems of inconvenient regimens, high recurrence rate, pain or burning associated with therapy, and unknown clinical relevance of findings, and achieve the effect of simplified dosing regimens and low dosage strength imiquimod
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example 1
[0211]A cream according to the present invention is prepared from the following ingredients:
% by WeightAmountOil Phase1-isobutyl-1H-imidazo[4.5-c]-quinolin-4-amine1.040.0 gIsostearic acid10.0400.0 gBenzyl alcohol2.080.0 gCetyl alcohol2.288.0 gStearyl alcohol3.1124.0 gPolysorbate 602.55102.0 gSorbitan monostearate0.4518.0 gAqueous Phase Glycerin2.080.0 gMethylparaben0.28.0 gPropylparaben0.020.8 gPurified water76.483059.2 g
[0212]The materials listed above were combined according to the following procedure: The glycerin, methylparaben, propylparaben and water were weighed into a 4 liter glass beaker then heated on a hot plate with stirring until the parabens isostearic acid and 1-isobutyl-1H-imidazo[4,5-c]-quinolin-4-amine were weighed into an 8 liter stainless steel beaker and heated on a hot plate until the amine was in solution (the temperature reached 69° C.). The benzyl alcohol, cetyl alcohol, stearyl alcohol, polysorbate 60 and sorbitan monostearate were added to the isostearic a...
examples 2-9
[0213]Using the general method of Example 1, the cream formulations shown in Tables 1 and 2 are prepared.
TABLE 1% by WeightExample Example Example Example 2345Oil Phase1-isobutyl-1H-imidazo[4,5-1.01.01.01.0c]quinolin-4-amineIsostearic acid10.010.05.05.0Benzyl alcohol2.0Cetyl alcohol1.7Stearyl alcohol2.3Cetearyl alcohol6.06.06.0Polysorbate 602.552.552.552.55Sorbitan monostearate0.450.450.450.45Brij ™ 30a10.0Aqueous PhaseGlycerin2.02.02.02.0Methylparaben0.20.20.20.2Propylparaben0.020.020.020.02Purified water77.7877.7882.7872.78aBrij ™ 30 (polyoxyethylene(4) lauryl ether) is available from ICI Americas, Inc.
TABLE 2% by WeightExample Example Example Example 67 89Oil Phase1-isobutyl-1H-imidazo-[4,5-1.01.01.01.0c]quinolin-4-amineIsostearic acid10.025.010.06.0Benzyl alcohol2.02.0Cetyl alcohol2.21.7Stearyl alcohol3.12.3Cetearyl alcohol6.06.0Polysorbate 602.553.42.552.55Sorbitan monostearate0.450.60.450.45Brij ™ 30a10.0Aqueous PhaseGlycerin2.02.02.02.0Methylparaben0.20.20.20.2Propylparaben0....
example 10
[0214]A cream according to the present invention is prepared from the following ingredients in the following Table 3:
TABLE 3% by WeightAmountOil Phase1-isobutyl-1H-imidazo[4,5-1.03.00gc]quinolin-4-amineIsostearic acid5.015.0gWhite petrolatum15.045.0gLight mineral oil12.838.4gAluminum stearate8.024.0gCetyl alcohol4.012.0gWitconol ™ 14a3.09.00gAcetylated lanolin1.03.0gPropylparaben0.0630.19gAqueous PhaseVeegum ™ Kb1.03.0gMethylparaben0.120.36gPurified water49.017147.05gaWitconol ™ 14 (polyglyceryl4 oleate) is available from Witco Chemical Corp. Organics DivisionbVeegum ™ K (colloidal magnesium aluminum silicate) is available from R. T. Vanderbilt Company Inc.
[0215]The materials listed above were combined according to the following procedure: The 1-isobutyl-1H-imidazo[4,5-c]quinolin-4-amine and the isostearic acid were weighed into a glass jar and heated with occasional stirring until the amine was dissolved (the temperature reached 68° C.). To this solution was added, the petrolatum, ...
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