Ear wax solution

Details Ear wax solution Ear wax solution

2001-10-22

2002-07-09

Jarvis, William R. A. (Department: 1614)

Drug, bio-affecting and body treating compositions

Designated organic active ingredient containing

Cyclopentanohydrophenanthrene ring system doai

C424S455000

Reexamination Certificate

active

06417179

ABSTRACT:

FIELD OF INVENTION
This invention relates to treatments for ear wax, and in particular to an improved ear wax solution.
BACKGROUND OF THE INVENTION
Ear wax is produced by ceruminous glands, sebaceous glands, keratinocytes, and hair from the outer third of the human ear canal. Ear wax is composed of lipid coated epidermal cells, lipids, proteins and carbohydrates. It is very hydrophobic and not soluble in water. Ear wax functions as a protectant to the inner ear from infection, as well as a cleaning and lubricating agent for the external ear canal. However, accumulation and impaction of ear wax can cause itching, pain, hearing loss, perforated tympanum, tinnitis, dizziness, and increased risk of infection. Approximately 150,000 ear wax removals are performed weekly in America due to such otologic complications. Impaction of ear wax is the most common otologic problem encountered by physicians. It can affect up to 6% of the general population, and 20% of the geriatric population.
Excessive ear wax is often removed in physicians' offices using mechanical methods. A number of solutions have also been tried to help remove ear wax. Organic based solutions prove not to be very helpful as they appear only to soften the ear wax. Interestingly, water by itself proves to be partially effective. Alkaline solutions (e.g., solutions containing sodium bicarbonate) are somewhat more effective. However, there is still a need for an improved ear wax solution.
SUMMARY OF THE INVENTION
This invention relates to an improved ear wax solution. The ear wax solution includes a detergent which is effective to treat the ear wax by a mechanism involving at least one of dissolving the ear wax, softening the ear wax, and reducing the attachment of the ear wax to the ear. The detergent is selected from anionic detergents, cationic detergents, zwitterionic detergents, ampholytic detergents, amphoteric detergents, nonionic detergents having a steroid skeleton, or mixtures thereof. The ear wax solution also includes a solvent which is water, a hydrophilic solvent, or a mixture thereof. The ear wax solution also includes an alkaline material effective to make the solution alkaline. The ear wax solution further includes an ionic additive effective to increase the ionic strength of the solution.
In another embodiment, the ear wax solution includes a detergent comprising a salt of a bile acid, the detergent being effective to treat the ear wax by a mechanism involving at least one of dissolving the ear wax, softening the ear wax, and reducing the attachment of the ear wax to the ear. The ear wax solution also includes a solvent which is water, a hydrophilic solvent, or a mixture thereof. The ear wax solution also includes an alkaline material effective to make the solution alkaline.
In another embodiment of the invention, an ear wax formulation comprises a detergent, a polymer, and a solvent. The detergent is effective to treat the ear wax by a mechanism involving at least one of dissolving the ear wax, softening the ear wax, and reducing the attachment of the ear wax to the ear. The detergent is selected from anionic detergents, cationic detergents, zwitterionic detergents, ampholytic detergents, amphoteric detergents, nonionic detergents having a steroid skeleton, or mixtures thereof. The polymer is effective to enhance the treatment by a mechanism involving at least one of reducing the irritancy of the detergent on the ear canal, and increasing the retention of the formulation in the ear canal and thereby reducing absorption of the formulation into the epidermal tissues of the ear canal. The solvent is water, a hydrophilic solvent, or a mixture thereof.
In a preferred embodiment of the invention, the ear wax solution includes one or more materials that enhance miscelle formation by the detergent. The formation of miscelles by the detergent optimizes the effectiveness of the ear wax solution.
In another preferred embodiment of the invention, the ear wax solution contains a plurality of detergents effective to treat the ear wax by a mechanism involving at least one of dissolving the ear wax, softening the ear wax, and reducing the attachment of the ear wax to the ear. In some instances the use of two or more detergents together significantly improves the effectiveness of the ear wax solution.
The invention also relates to a method for removing ear wax from an ear. In a first step of the method, an ear wax solution is inserted into the ear in contact with the ear wax, the ear wax solution comprising: (a) a detergent effective to treat the ear wax by a mechanism involving at least one of dissolving the ear wax, softening the ear wax, and reducing the attachment of the ear wax to the ear, the detergent being selected from the group consisting of anionic detergents, cationic detergents, zwitterionic detergents, ampholytic detergents, amphoteric detergents, nonionic detergents having a steroid skeleton, and mixtures thereof, and (b) a solvent selected from the group consisting of water, hydrophilic solvents, and mixtures thereof. In a second step of the method, the ear wax solution is maintained in contact with the ear wax for a time sufficient to treat the ear wax. Preferably, the ear wax solution is held inside the ear for at least about 30 seconds, more preferably at least about 1 or 2 minutes, to increase its effectiveness. In a final step, the ear wax solution and ear wax are removed from the ear.
In another embodiment of the method, an ear wax formulation is inserted into the ear in contact with the ear wax. The ear wax formulation comprises: (a) a detergent effective to treat the ear wax by a mechanism involving at least one of dissolving the ear wax, softening the ear wax, and reducing the attachment of the ear wax to the ear, the detergent being selected from the group consisting of anionic detergents, cationic detergents, zwitterionic detergents, ampholytic detergents, amphoteric detergents, nonionic detergents having a steroid skeleton, and mixtures thereof, (b) a solvent selected from the group consisting of water, hydrophilic solvents, and mixtures thereof, and (c) a polymer effective to enhance the treatment by a mechanism involving at least one of reducing the irritancy of the detergent on the ear canal, and increasing the retention of the formulation in the ear canal and thereby reducing absorption of the formulation into the epidermal tissues of the ear canal. The ear wax formulation is maintained in contact with the ear wax for a time sufficient to treat the ear wax. Preferably, the ear wax formulation is held inside the ear for at least about 30 seconds to increase its effectiveness. Then, the ear wax formulation and the ear wax are removed from the ear.
In another embodiment of the method for removing ear wax, a first ear wax solution is inserted into the ear in contact with the ear wax. The first ear wax solution comprises: (a) a first detergent effective to loosen the ear wax, and (b) a solvent for the first detergent. The first ear wax solution is maintained in contact with the ear wax for a time sufficient to loosen the ear wax, then removed from the ear. A second ear wax solution is inserted into the ear in contact with the loosened ear wax. The second ear wax solution comprises: (a) a second detergent effective to remove the ear wax, the second detergent being different from the first detergent, and (b) a solvent for the second detergent. The second ear wax solution is maintained in contact with the ear wax for a time sufficient to enable the removal of the ear wax. Finally, the second ear wax solution and the ear wax are removed from the ear.
Various objects and advantages of this invention will become apparent to those skilled in the art from the following detailed description of the preferred embodiments.
DETAILED DESCRIPTION AND PREFERRED EMBODIMENTS OF THE INVENTION
The present invention relates to an improved ear wax solution that can be used at home or at the office of a physician or practitioner (e.g., an otologist) to improve ear hygiene and to ease ear wax removal.
The ear wax

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