Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution... – Containing or obtained from aloe
Reexamination Certificate
2000-07-19
2002-04-02
Weber, Jon P. (Department: 1651)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
Containing or obtained from aloe
C424S728000, C424S725000
Reexamination Certificate
active
06365200
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention relates generally to the field of chemical aphrodisiacs, and more particularly to a topical medicament which is applied to sensitive tissue areas to produce increased sensitivity to physical contact.
Internally taken aphrodisiacs are well-known in the art as is the resultant psychological effect of using the same. The use of such preparations, in many cases, is accompanied by some disadvantages, including time delay before taking effect, various side effects resulting from ingestion, and often, the lack of useful effect.
The use of benzalkonium chloride as a virucidal agent in the treatment of AIDS and related disease is known, as is the use of this compound as a spermicidal agent when incorporated into a suppository. It is also known to use this composition in aqueous, Quaternary ammonium antiseptics, and disinfectants.
In the composition described in our prior U.S. Pat. Nos. 5,902,593 and 5,976,561, a small amount of propylene glycol is employed as a gel thickener, which has now been found to be unnecessary. As a preservative, use is made of methylchloroisothiazolinone and methylisothiazoline, both of which have tended to cause irritation during use, as well as affect the complete clarity of the gel.
The improved composition disclosed herein has eliminated these components. The use of dmdm hydantoin has provided substantial decrease in the irritation rate of the original composition without affecting its primary effect as a topical aphrodisiac. We have also provided additives to improve texture of the composition to retard evaporative drying and effect healing of irritated tissues.
SUMMARY OF THE INVENTION
Briefly stated, the invention contemplates the use of benzalkonium chloride as a skin and tissue sensitizer, particularly effective when manually applied in a gel vehicle to vaginal areas, wherein the thinly spread gel also serves as an effective lubricant. The product may be applied immediately before intercourse, and will remain effective for a substantial period of time thereafter.
As contrasted with our earlier composition, we have provided an improved preservative in the form of dmdm hydantoin to result in decreased tissue irritation without any adverse effect. In addition, we have incorporated additional ingredients which improve the texture and surface spreading of the composition, namely aloe and vitamin E, which stabilizes the ionic environment of nerve endings in the skin and facilitates their re-polarization.
DETAILED DESCRIPTION OF THE DISCLOSED EMBODIMENT
In accordance with the invention, the disclosed embodiment is in the form of a water soluble gel. As in our prior composition, the principal effective ingredient is benzalkonium chloride in a spreadable vehicle, which may include other known ingredients to provide desirable characteristics in terms of odor, spreadability, adherence to the applied area, and chemical stability. A suitable gel includes water, glycerin, hydroxyethylcellulose, aloe barbadensis gel and/or vitamin E. These ingredients improve the texture and surface spreading of the composition in a noticeable way. Aloe is well known in the art for its anti-inflammatory and wound healing properties, and is a component in a cosmetic skin cleaner described in the Menzel, et al., U.S. Pat. No. 5,993,857. Recent works have also suggested that substances can be purified from aloe with anti-oxidant and antiviral properties, as disclosed in the patent to Yu, et al., U.S. Pat. No. 5,939,395. The Shand, et al., U.S. Pat. No. 5,902,796, discloses certain bioactive factors of aloe vera plants. The formulation may include cyclomethicone, dimethicone, dimethicone copolyol or related substances in order to retard lost lubricity with drying of the gel.
The subject of ion channels in the function of sensory nerves is reviewed by the Hahn U.S. Pat. No. 5,958,436, and is pertinent to the effect of benzalkonium chloride in the present preparation. We have selected the anti-oxidant vitamin E for stabilizing the ionic environment of the nerve endings in the skin, and facilitating their re-polarization.
The present composition has been tested using high resolution ultrasound imaging and one and two dimensional Doppler ultrasound techniques and impedance plethysmographY (“Registran”) to study arousal in both men and women before and after application of the composition. As impressive as blood flow changes and local firmness of the penis and clitoris are with use in a laboratory setting, we are aware that they do not represent the subjective and satisfaction components of sexual activity in privacy. To this end, we have continued to rely upon questionnaires, diaries, and comments of users.
We have begun to use the composition as a coupling agent for ultrasound scanning, in particular endovaginal and endorectal studies and for volume image reconstruction (3D ultrasound). The lubricant facilitates probe (transducer) placement and scanning motion, the anti-microbial properties of the present formulation decrease interpersonal disease transmission, and the anti-inflammatory properties of the aloe decrease the possibility of post-scan irritation. The following examples are illustrative. Parts are by weight.
REFERENCES:
patent: 6080707 (2000-06-01), Glenn, Jr. et al.
patent: 6083932 (2000-07-01), Pang et al.
Birnholz Jason C.
Kent Frances B.
Patton Patricia
Temko Charles E.
Weber Jon P.
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