Patent Application
20080027026
The present invention provides a novel treatment for topical inflammatory conditions such as acne, eczema, shingles, psoriasis, insect bites and hives. The treatment consists of the application of a cream or ointment which incorporates micronized hydroxypropyl methylcellulose acetate succinate (“HPMCAS”). The cream or ointment is applied to the effected area on the skin.
The inventive cream is prepared by making a suspension of HPMCAS (either alone or with other ingredients, as described below) in water and mixing the two together. The weight percent of HPMCAS in the invention formulation (in the prepared suspension) is between about 15% and 50%, and more preferably between 15% and 25% by weight.
In addition to HPMCAS, the inventive cream or ointment formulation may also include one or more thickeners for the formulation to become thickened before application and to also prevent settling of the mixture. Suitable thickeners include polyethylene glycol and glycerol. The thickener should be present in the inventive formulation by weight in an amount between about 1.0% and 20%. The thickener should be one that maintains a relatively low pH (4.5-5.5) for the composition.
In addition, the inventive cream or ointment formulation should also include a bio-adhesive agent so that the formulation, when applied, sticks to the treated area. Suitable bio-adhesive agents include ethers of cellulose, such as hydroxypropyl methylcellulose and methyl cellulose. The bio-adhesive agent is present in the inventive composition in an amount between 1% and 3% by weight.
The inventive formulation also must include water in an amount between about 50% and 85% based on the total weight of the formulation.
The inventive formulation may also include one or more preservatives in an amount between about 0.02% and 0.1% based on the weight of the formulation. Examples of suitable preservatives include methyl paraben, propyl paraben, benzoic acid, sorbic acid and potassium sorbate.
It is important that the HPMCAS component of the inventive formulation be micronized so that it makes intimate contact with the skin. The HPMCAS should have a particle size of between about 0.1 microns and 10 microns in micronized form, preferably from 0.1 microns to 1.0 microns. A good source for HPMCAS to be used in the inventive formulation is AQOAT of the Japanese company Shin-etsu.
One advantage of the inventive formulation is that it incorporates HPMCAS, a high molecular weight and water insoluble polymer, in topical form. As a result, the HPMCAS does not penetrate into the skin cells of the patient.
The inventive formulation is prepared as follows:
The components listed below are added together and slowly mixed until they are hydrated. Thereafter, the components are rapidly mixed until a homogenous mixture is obtained.
An example of the inventive formulation is identified below:
In tests, 16 patients were treated with a daily application of pharmaceutical creams containing HPMCAS in order to treat various inflammatory conditions, including eczema, psoriasis, acne, shingles, insect bites and other assorted skin condition. The results demonstrated that the patients exhibited substantially reduced symptoms; in some cases, the symptoms were totally eliminated.
It will thus be seen that the objects set forth above, and those made apparent from the preceding description are efficiently attained. Moreover, certain changes may be made to the inventive formulation without departing from the spirit and scope of the invention. It is intended that all matter contained in the above description shall be interpreted as illustrative and not in a limiting sense.
It will also be understood that the following claims are intended to cover all the generic and specific features of the invention herein described, and all statements of the scope of the invention which, as a matter of language, might be said to fall therebetween.
