Stable sulfide compositions uses and process for preparation the

Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai

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514880, 536 56, 536 84, 536124, 536127, 8161, 8 9416, A61K 31715, C14C 106, C07H 106

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057705836

DESCRIPTION:

BRIEF SUMMARY
This application is a 371 of PCT/US94/00435 which was filed Jan. 25, 1994.


BACKGROUND

Sulfides, such as sodium sulfide nonahydrate (hereinafter referred to as sodium sulfide), are effective keratolytic agents useful for softening nails and as depilatory agents for removing unwanted hair. Cosmetics, Science and Technology, Edward Sagarin (Ed.) Interscience Publishers, a division of John Wiley & Sons, New York, (1957) in the Chapter 20 Depilatories by Richard H. Barry, on pages 457-478 provides an historical renew on the use of sulfide-containing depilatories. A long-standing problem exists in this art, however, Sulfides tend to be extremely unstable during storage and numerous attempts have been made to stabilize this class of compounds. For example, there are numerous references which teach allegedly stabilized sulfide compositions, such as U.S. Pat. No. 1,379,855 (1921) to J. Donner, U.S. Pat. No. 2,031,489 (1936) to F. Koenigsberger and U.S. Pat. No. 2,487,558 (1949) to J. Kamlet. French Patent Document 1,170,558 (1959) discloses that adding sugars, such as maple sugar, to preparations containing metal sulfides, will improve the shelf life and stability of the preparation by rendering the preparation nonhydrolyzable. However, none of these references provides a process for effectively carrying out the preparation of a sulfide-containing composition in the substantial absence of decomposing or oxidizing agents such as oxygen, carbon dioxide and various metallic impurities which can rapidly decompose the sulfide in the composition during preparation, storage or use. Thus, the decomposition renders the sulfide-containing compositions ineffective for their Intended uses. Accordingly, a different approach was needed to provide truly stable, sulfide-containing compositions.


SUMMARY OF THE INVENTION

The present Invention is directed toward a stable sulfide-containing composition comprising: alkaline earth metal; and which the sulfide is dissolved or dispersed; wherein the composition has a substantial absence of agents which decompose the sulfide in the composition, such that after maintaining the sulfide-containing composition at a temperature of about 37.degree. to about 50.degree. Celsius for about 2 weeks to one month, the sulfide content remaining in the sulfide-containing composition is about 90% or greater of the initial sulfide content.
Preferably the sulfide is a sulfide of an alkali earth metal, most preferably sodium sulfide. Also preferred is that the carrier for the sulfide is a gel which is a high-viscosity aqueous formulation of water soluble polymers. More preferably the gel contains a non-ionic cellulosic material, such as hydroryethyl cellulose.
The present invention is also directed toward a process for preparing the stable sulfide-containing composition of claim 1, comprising contacting, in the substantial absence of agents which can decompose the sulfide in the composition and in the presence of an inert atmosphere, a sulfide, a polysulfide or mixtures thereof, of an alkali or an alkaline earth metal, with a suitable carrier. Preferably, the removal of agents which can decompose the sulfide in the composition is performed by removing gases in water by using a vacuum and by introducing an inert atmosphere, prior to addition of the sulfide. The mixing of the sulfide with any other ingredients in the composition is also conducted under an inert atmosphere. The present invention is also directed toward a medicament for softening nails or for treating ingrown toenail. The medicament comprises or is made of the stable sulfide composition as described above.
The present invention is also directed toward the use of a stable sulfide containing composition as described above, for the manufacture of a medicament for softening nails or for treating ingrown toenail.
The present invention is also directed towards a method for softening nails or for treating ingrown toenail. The method comprises contacting the nail with our stable sulfide composition as described above, for a time effective to softe

REFERENCES:
patent: 1379855 (1921-05-01), Donner
patent: 2031489 (1936-02-01), Koenigsberger
patent: 2487558 (1949-11-01), Kamlet
patent: 3864294 (1975-02-01), Busch, Jr.
patent: 4073887 (1978-02-01), McLean, Sr.
patent: 4110230 (1978-08-01), Hessert et al.
patent: 4854333 (1989-08-01), Inman et al.
The Merck Index, 10th Edition, Merck & Co., Rahway, N.J., Entry 8527. Sodium Sulfide, p. 8526 (1983).
Cosmetics, Science & Technology, Edward Sagarin (ed.) Interscience Publishers, New York, 1957, Chapter 20-Depilatories, pp. 457-478.
H.M. Fishman, "Depilatories," HAPPI, Feb. 1989, pp. 34-35.
Aqualon Technical Bulletin Natrosol.RTM.Hydroxyethylcellulose, Aqualon Company, 1313 North Market Stree, Willmington, DE, (rev. Jul. 1987) 22 pages.
M. DeLa Guardia, "Facial depilatories on black skin", Cosmetics and Toiletories, vol. 91, Jul. 1976, pp. 37-38.

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