Topical Pharmaceutical Foam Composition

a technology of pharmaceutical foam and composition, applied in the direction of drug composition, aerosol delivery, plant/algae/fungi/lichens ingredients, etc., can solve the problems of difficult to provide reproducible performance of reformulated aerosols for pharmaceutical use, few pharmaceutical foams are commercially available, etc., and achieve the effect of reducing the intensity of odor and/or color

Inactive Publication Date: 2007-07-05
PRECISION DERMATOLOGY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0012] It is a further object of the invention to provide keratolytic topical foam formulations

Problems solved by technology

However, as yet, only a few pharmaceutical foams are commercially available.
Although hydrocarbon propellants, such as propane and butane, can be used in the manufacturing of pharmaceutical foams, these propellants are not suited for human use since they are flammable.
Since replacing a component of any formulation means introducing new properties, and HFAs differ in their solvating power from CFCs and hydrocarbons, providing reproducible performance of reformulated aerosols for pharmaceutical uses represents a challenging task.
Such formulations, however, have a number of undesirable aspects.
Alcohol co-solvents can dry and irritate the skin.
U.S. Pat. No. 6,126,920 suggests that the use of alcohol co-solvents can lead to burning, itching, and irritation observed in the use of topical foam for delivering betametha

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

Reduced Odor Topical Formulation Containing Sulfur and Sodium Sulfacetamide

[0074] A topical formulation containing sulfur and sodium sulfacetamide was prepared wherein the formulation exhibited diminished color. The composition of the formulation and the physical and mechanical properties of the formulation are shown in Table 1.

[0075] The formulation was prepared by mixing the water and propylene glycol together and adding the methylparaben, propylparaben and sodium sulfacetamide to form a uniform solution. The solution was heated to 70° C. and the sulfur was dispersed in the solution with moderate stirring. Separately, cetyl alcohol, emulsifying wax, and BRIJ 76 were melted together and heated to 70° C. The water and oil phases were combined and mixed for 10 minutes at high shear to form the emulsion. The emulsion was allowed to cool to 45° C. with moderate stirring at which time trolamine was added to the formulation and the formulation was adjusted to 100% with water.

[0076] Th...

example 2

Reduced Odor Topical Formulation Containing Urea

[0077] A topical formulation containing urea was prepared, wherein the formulation exhibited diminished odor. The composition of the formulation and the physical and mechanical properties of the formulation are shown in Table 1.

[0078] The formulation was prepared by mixing the water and propylene glycol together and adding the methylparaben, propylparaben and urea to form a uniform solution. The solution was heated to 70° C. with moderate stirring. Separately the cetyl alcohol, emulsifying wax and BRIJ 76 were melted together and heated to 70° C. The water and oil phases were combined and mixed for 10 minutes at high shear to form the emulsion. The emulsion was allowed to cool to 45° C. with moderate stirring at which time the trolamine was added and the formulation was adjusted to 100% with water.

[0079] The final formulation consisted of 91% by weight emulsion concentrate and 9% by weight HFC 134a propellant.

TABLE 1Formulation Co...

example 3

Organoleptic Analysis of Formulation Odor and Color

[0080] The odor and color of the formulations outlined in Table 1 were measured. Samples of the sulfur and urea aerosol foams were dispensed into weighing boats in a manner similar to that used to dispense the product for use. The samples of sulfur and urea emulsion concentrates were observed for color and odor in bulk packaging under conditions similar to that in which currently marketed products are used. Panelists were asked to rate on a scale of 0 to 5 each sample for the attributes of color and odor. In the scale, 0 corresponded to no detectable odor or color and 5 corresponded to strong odor or color. The results are shown in Table 2.

TABLE 2Organoleptic Analysis of Formulation Odor and ColorSulfacetamide / SulfurUreaFoamConcentrateFoamConcentrateOdorColorOdorColorOdorOdorScoreScoreScoreScoreScoreScoreAverage0.71.52.03.90.14.3Std Dev0.80.81.21.10.31.3p Value0.00050.0001n / an / a≦0.0001n / an101010101010

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Abstract

A stable topical alcohol-free aerosol foam containing one or more keratolytic agents is provided. The foam-forming formulation is an emulsion which contains an HFA propellant and one or more keratolytic agents. The emulsion has an oil phase and an aqueous, i.e. water-containing, phase. The active agent(s) may be present in either phase of the emulsion or dispersed in the emulsion. The oil phase may consist at least in part of the HFA propellant. Either or both of the oil phase and the aqueous phase may contain one or more surfactants, emulsifiers, emulsion stabilizers, buffers, and/or other excipients. The foam is stable on the skin, for example, for at least 5 minutes at body temperature, preferably at least 20 minutes at body temperature, and disappears into the skin upon rubbing or after prolonged standing. In one embodiment, the formulation contains an HFA propellant which does not contain additional co-solvents or co-propellants. The formulations demonstrate reduced intensity of the odor and/or color associated with the keratolytic agent(s) as compared to conventional formulations containing keratolytic agents.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This invention claims the benefit of the priority of U.S. Ser. No. 60 / 729,788, filed Oct. 24, 2005.FIELD OF THE INVENTION [0002] This invention is generally in the field of pharmaceutical compositions, specifically pharmaceutical foam compositions containing keratolytic agents intended for topical administration. BACKGROUND OF THE INVENTION [0003] Pharmaceutical foams are pressurized dosage forms containing one or more active ingredients that, upon valve actuation, emit a fine dispersion of liquid and / or solid materials in a gaseous medium. Foam formulations are generally easier to apply, are less dense, and spread more easily than other topical dosage forms. Foams may be formulated in various ways to provide emollient or drying functions to the skin, depending on the formulation constituents. Accordingly, this delivery technology is a useful addition to the spectrum of formulations available for topical use. However, as yet, only a few...

Claims

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Application Information

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IPC IPC(8): A61K38/46A61K9/12A61K31/19A61K31/203A61K36/18A61K31/17
CPCA61K9/0014A61K9/06C12Y304/22002A61K47/18A61K45/06A61K38/4873A61K31/203A61K9/12A61K9/122A61K9/124A61K31/17A61K31/19A61K2300/00A61P17/10A61P29/00A61P31/00A61P31/04A61P31/10A61P31/12A61P33/02A61P39/06
Inventor TRUMBORE, MARK W.GURGE, RONALD M.HIRSH, JANE C.
Owner PRECISION DERMATOLOGY
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