Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Cosmetic – antiperspirant – dentifrice
Reexamination Certificate
1999-09-27
2001-08-28
Dudash, Diana (Department: 1619)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Cosmetic, antiperspirant, dentifrice
C424S078020, C424S078030, C424S078060, C424S731000, C424S489000, C514S844000, C514S944000, C549S408000, C106S287130, C554S219000
Reexamination Certificate
active
06280752
ABSTRACT:
TECHNICAL FIELD
The present invention relates in general to a formulation for topical use and, in particular, to a vitamin E acetate-based hydrophobic gel preparation.
BACKGROUND OF THE INVENTION
Vitamin E and its derivatives are substances which by virtue of their presumed properties as antioxidants and removers of free radicals, are widely used in the pharmaceutics and cosmetics industry in the preparation of formulations for treating skin diseases, or for combating or preventing unsightly skin conditions.
For these reasons, vitamin E and its derivatives are often present in cosmetic formulations as “active” components in variable concentrations ranging between 1% and 25%, although the antioxidant and anti-ageing action of vitamin E at a skin level has never been scientifically proved.
On the contrary, it has recently been experimentally proved (see patent application WO 98/10793 by the same Applicant) that vitamin E acetate has physical-chemical properties such as to make it suitable for use as main component of the lipophilic phase of ointments.
In fact, vitamin E acetate is particularly easy to spread, is absorbed surprisingly quickly, produces no unpleasant thermal sensations, leaves the skin shiny only for a few minutes, and then leaves it soft, elastic and not sticky; in addition, it resists to cleansing with water or detergents.
In addition, since vitamin E acetate is not a molecule foreign to the human organism, it can easily integrate with the lipids present in the cornified layer, thus facilitating absorption through the skin of substances dispersed into it.
Among the other formulations for topical use, the above patent application disclosed and claimed a hydrophobic gel preparation comprising a cyclomethicone and dimethiconol mixture, preferably having a 8:2 weight ratio.
Two examples of said formulation had been provided, too, in which vitamin E acetate made up 20% and 30% respectively of the total weight of the composition, the rest of which comprised a 8:2 cyclomethicone/dimethiconol mixture and, optionally, 5% of hydrogenated castor oil.
These hydrophobic gels actually proved excellent formulations for cosmetic use when used as they are, and very good carriers of pharmaceutically active substances.
Nevertheless, it has been observed that hydrophobic gels thus formulated in the end showed a certain tendency to separate a liquid phase, i.e. a certain tendency to syneresis.
SUMMARY OF THE INVENTION
The problem underlying the present invention was that of providing a vitamin E acetate-based hydrophobic gel that could overcome the inconveniences shown by the hydrophobic gels that were already known from previous patent application WO 98/10793, while at the same time keeping unchanged the excellent properties as cosmetics and as carriers for active principles of the latter.
According to the invention, such a problem has been solved by a hydrophobic gel formulation for topical use comprising, in weight percentages on the total weight of the formulation, 20 to 70% of vitamin E acetate, 20 to 70% of a volatile silicone chosen from the group comprising pentamer cyclomethicone (or decamethylcyclopentasiloxane), tetramer cyclomethicone (or octamethylcyclotetrasiloxane), hexamer cyclomethicone and mixtures thereof, hexamethyldisiloxane, and 7 to 13% of hydrogenated castor oil.
The content of vitamin E acetate is preferably comprised between 30 and 60%.
Preferably, the formulation according to the invention also comprises 7 to 15% of an oily component chosen among vegetal oils and esters of fatty acids such as octyl palmitate, isopropyl myristate and ethyl oleate or mixtures thereof, for the purpose of further incrementing the gel stability and ensuring that no phase separation at all occurs in time.
In addition, the formulation can also comprise 2 to 3% of dimethiconol for the purpose of increasing the tactile sensation of silkiness of the skin that is felt during and after the application of the gel.
The hydrophobic gel according to the invention is characterised by absolute stability over the time and towards high and low temperatures in terms of viscosity and of rheological features and it does not show the slightest phenomenon of syneresis not even several months after the preparation.
The gel according to the invention can be very easily spread over the skin, and it is of absolutely pleasant application since it does not produce any thermal sensation on the skin and is absorbed with great rapidity.
The application of the gel according to the invention causes the formation of a thin film on the skin, which is absolutely invisible since it is not shiny. This film protects the skin for a long time against any aggression by external, atmospheric, physical and chemical agents avoiding the removal of the hydrolipidic film naturally occurring on the skin. In fact, it integrates the above film by bringing in a significant amount of vitamin E acetate.
After application of the hydrophobic gel according to the invention, the skin is extremely soft and silky.
The hydrophobic gel according to the invention is remarkably suitable to be used as a base ointment in which pharmaceutically active substances can be dissolved or suspended, also thanks to its easy applicability and to its rapid absorption by the skin.
Some examples of active principles that can be carried in the hydrophobic gel according to the invention comprise antibiotics, such as gentamicin, neomycin, clindamycin, and tetracyclines, corticosteroids, such as hydrocortisone acetate or butyrate, diflucortolone valerate, methylprednisolone aceponate, mometasone furoate and the esters of betametasone, trans-retinoic acid, synthetic retinoids, calcipotriol, vitamins such as retinol and its derivatives (retinol acetate and palmitate), lipophilic derivatives of ascorbic acid, such as palmitoylascorbic acid, vitamin K, vitamin D, vasoprotectants such as flavonoids and topical anti-inflammatory agents.
DETAILED DESCRIPTION OF THE INVENTION
For the purpose of further illustrating the present invention, the following general example shows a way to prepare a hydrophobic gel according to the invention.
REFERENCES:
patent: 4410517 (1983-10-01), Stillman et al.
patent: 4551332 (1985-11-01), Stillman et al.
patent: 6013270 (1998-08-01), Hargraves et al.
patent: 6146664 (1998-07-01), Siddiqui et al.
patent: WO 98 10793 (1998-03-01), None
Dudash Diana
Haghighatian Mina
Panin Giorgio
Sughrue Mion Zinn Macpeak & Seas, PLLC
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