Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Cosmetic – antiperspirant – dentifrice
Reexamination Certificate
1999-09-24
2001-08-21
Dudash, Diana (Department: 1619)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Cosmetic, antiperspirant, dentifrice
C424S400000, C424S486000, C424S677000, C424S070110, C424S078010, C424S078030, C524S832000, C524S505000
Reexamination Certificate
active
06277388
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a stable gelled composition, in particular a topical composition, which contains a large amount of electrolyte or a primary alcohol and to its use, treatment, protection and/or care of the skin, scalp, mucous membranes, nails and/or hair.
2. Discussion of the Background
Gelling agents are frequently used for topical application in the cosmetic, dermatological and pharmaceutical fields in the form of gels or emulsions for improving the consistency of the composition. The majority of gelling agents conventionally used are aqueous gelling agents and in particular carboxyvinyl polymers, which are neutralized with a base. However, some compounds cannot be used in these compositions because they are incompatible with gelling agents. For example, electrolytes, e.g., inorganic and organic salt, are incompatible with carboxyvinyl polymer gelling agents because they “break down” and liquify emulsions gelled with carboxyvinyl polymers. Thus, compositions containing carboxyvinyl polymers and electrolytes are often devoid of a good consistency.
Electrolytes are particularly desirable components of thickened, topical gel compositions where they have a beneficial effect on the skin or hair and are used in combination with cosmetic, dermatological, and/or pharmaceutical active agents.
Polysaccharide-type gelling agents, such as guar gums, xanthan gums and cellulose derivatives, have been used in place of carboxyvinyl polymers. EP-A-654270 describes a topical composition intended for the treatment of acne and seborrhoeic dermatitis containing a mixture of salts and hydroxyethyl cellulose as the gelling agent. However, these compositions, especially aqueous gels containing no oily phase, have an unsightly lumpy appearance. In addition, they leave the skin “wet looking” after application because these compositions do not penetrate sufficiently into the skin. Therefore, these materials have limited use as cosmetic and/or dermatological agents, where product appearance is critical. The combination of these cellulose derivatives with another thickening agent, such as silicate as described in WO-A-93/8230, provides compositions with the same disadvantages.
Furthermore, the incorporation of primary alcohol and in particular of ethanol into gelled compositions result in the same problems of stability. It is important to be able to use gelled compositions comprising a primary alcohol because the primary alcohol is often needed as solvent for solubilization of active agents.
Therefore, the need remains for gel compositions which overcome the disadvantages of known gelling agents: lack of consistency, instability, lumpy appearance, unpleasant sensation to the touch and incompatibility with electrolytes.
The present inventor has now unexpectedly found a class of associative polymers, in combination with an oxyalkylenated polymer, that stabilize compositions containing a high content of electrolyte and/or of primary alcohol.
SUMMARY OF THE INVENTION
An object of the present invention is to provide a stable gelled composition containing a cosmetic, dermatological, and/or pharmaceutical active agent and electrolyte which is useful for the treatment, protection and/or care of the skin, mucous membranes, scalp, nails, and hair.
Another object of the present invention is to provide a stable gelled composition containing a large quantity of electrolyte.
Another object of the invention is to provide a method of treating, protecting, and/or caring for the skin, mucous membranes, scalp, nails, and hair.
These objects and others may be accomplished with a composition containing at least one electrolyte and/or at least one primary alcohol, at least one associative polyurethane, at least one oxyalkylentated polymer, and water.
The above objects may also be accomplished by a method of treating, protecting, and/or caring for the skin, mucous membranes, scalp, nails, and hair of a subject, where the composition contains at least one cosmetic, dermatological, and/or pharmaceutical active agent, at least one electrolyte and/or at least one primary alcohol, at least one associative polyurethane, at least one oxyalkylentated polymer, and water.
The above objects may also be accomplished with a process of manufacturing a composition by combining at least one cosmetic, dermatological, and/or pharmaceutical active agent, at least one electrolyte and/or at least one primary alcohol, at least one associative polyurethane, at least one oxyalkylentated polymer, and water to produce a gel.
DETAILED DESCRIPTION OF THE INVENTION
A more complete appreciation of the invention and many of the attendant advantages thereof will be readily obtained as the same becomes better understood by reference to the following detailed description.
The present composition can be used in all areas where it is desired to obtain a thickened composition in the presence of electrolytes and/or alcohol. In particular, the present composition may be used in the cosmetic, dermatological and pharmaceutical fields. The present invention is directed to a composition for topical care, protection or treatment. The composition must comprise a topically acceptable medium, that is to say compatible with the skin, mucous membranes, nails, scalp and/or hair. It can be provided in any pharmaceutical dosage form appropriate for topical application and in particular in the form of a water-in-oil (W/O), oil-in-water (O/W), triple (W/O/W) or (O/W/O) dispersion or emulsion. The composition according to the invention may also contain ionic and/or nonionic lipid vesicles. The composition can constitute, for example, a cream or an ointment. The amounts of the various constituents of the composition are those conventionally used in the cosmetic, dermatological and/or pharmaceutical fields.
The present composition may have any viscosity ranging from 0.1 to 50 Pa·s (1 to 500 poises) and preferably from 0.5 to 10 Pa·s (5 to 100 poises). The viscosity is measured with a Rhéomat 180 viscometer at 25° C., at a shear rate of 200 s
−1
.
The associative polyurethanes are nonionic sequential copolymers containing in a chain, both hydrophilic sequences of generally polyoxyethylenated nature and hydrophobic sequences which can be aliphatic linkages alone, cycloaliphatic and/or aromatic liikages.
Preferably, these polymers contain at least two alkyl chains having from 6 to 30 carbon atoms, separated by a hydrophilic sequence. The alkyl chains may be pendant chains or chains at the end of the hydrophilic sequence. Preferably, the polymers may contain one or more pendant chains and alkyl chain at one end or at both ends of a hydrophilic sequence. The polymers can be sequential in triblock or multiblock form. The hydrophobic sequences can therefore be at each end of the chain, e.g., triblock copolymer with a hydrophilic central sequence, or distributed both at the ends and in the chain, e.g., multisequential copolymer. The polymers can also be grafted polymers or star polymers. Preferably, the polymers are triblock copolymers, the hydrophilic sequence of which is a polyoxyethylenated chain containing from 50 to 1000 oxyethylenated groups.
Associative polyurethanes generally contain a urethane bond between the hydrophilic sequences. Therefore, associative polyurethanes also include polymers, the hydrophilic sequences of which are bonded via other chemical bonds to the lipophilic sequences. Particularly preferred and commercially available sources of associative polyurethanes are the C
16
—OE
120
—C
16
polymer available from Hüls under the name Sérad FX1100 (molecule with urethane functional group and average molecular weight of 1300, OE being an oxyethylenated unit), Rhéolate 205 with a urea functional group, Rheolate 208, or Rhéolate 204 available from Rheox.
The polymers may be in solutions or dispersions, in particular in water or in an aqueous/alcoholic medium. Preferred and commercially available polymers in solution or dispersions are Sérad FX1010 (available from Hüls), Sérad 1035 (available from H
Dudash Diana
Haghighatian Mina
L'Oreal
Oblon & Spivak, McClelland, Maier & Neustadt P.C.
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