Stable gel mixture in the form of a mixture of oleogel and...

Details Stable gel mixture in the form of a mixture of oleogel and... Stable gel mixture in the form of a mixture of oleogel and...

1998-12-03

2001-02-13

Page, Thurman K. (Department: 1615)

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Cosmetic, antiperspirant, dentifrice

C424S443000, C424S447000, C424S449000, C424S078020

Reexamination Certificate

active

06187323

ABSTRACT:

The present invention relates to a stable gel mixture in the form of a mixture of oleogel and aqueous gel, to a process for preparing this stable gel mixture, to a pharmaceutical composition comprising this stable gel mixture, to the use of this composition as a reservoir of active ingredients in a transdermal release system and, lastly, to a cosmetic composition comprising this stable gel mixture.
It is known to prepare oleogels, in particular by gelling a synthetic, semisynthetic or natural oil, in order to combine the relatively solid consistency of a gel with the total transparency of an oil.
However, oleogels have the drawback of feeling greasy and unpleasant, on account of the presence of the oily compound. This unpleasant feel very often discourages users, in particular in the case of dermatological and cosmetic applications.
It is thus desirable, for example, to be able to give a bodycare oil a relatively solid consistency but with a non-greasy, fresh and pleasant feel, while at the same time keeping the original appearance of the oil. The reason for this is that oils are difficult for users to control because of their excessive fluidity. In particular, the use of bath oils makes the bath slippery and accounts for approximately 3% of the serious accidents in bathrooms.
It has now been found, entirely surprisingly and unexpectedly, that the mixture of a certain type of oleogel with an aqueous gel makes it possible to obtain a gel of substantially uniform appearance, which is remarkably stable and has a fresh and pleasant feel.
Thus the subject of the present invention is a stable gel, substantially uniform appearance, that comprises a mixture, of at least one oleogel and at least one aqueous gel, the oleogel comprising at least one oily agent gelled with at least one cellulose polymer.
According to the invention, the expression “mixture of substantially uniform appearance” is understood to mean an intimate mixture, and not an emulsion, of the oleo and aqueous gels, that is, a uniform dispersion of one in the other, such that, when inspected visually, only a single gel can be distinguished, and when applied to the skin, no separation of the two aqueous gel and oleogel phases is detected.
The intimate nature of the mixture of the two types of gel can be controlled, for example, by introducing a dye substance into the oily or aqueous gel, before forming the mixture, in order to visually observe the uniform dispersion of this dye substance after forming the mixture, even though the dye is present in only one of the two types of gel—oily or aqueous—of the stable gel mixture formed.
According to the invention, the term “stable gel” is understood to mean the stable mixture of oily and aqueous gels of a uniform appearance without any demixing on storage.
In particular, the cellulose polymer is chosen from ethylcellulose, non-sodium containing carboxymethylcellulose, and mixtures thereof.
The oily agent is chosen in particular from mono-, di-, and triglycerides of synthetic, semisynthetic and natural origin, and mixtures thereof.
As synthetic mono-, di- or triglycerides, reference is made in particular to Miglyol 810 and 812, as sold by the company Dynamit Nobel.
As semisynthetic mono-, di- or triglycerides, reference is made in particular to propylene glycol isostearate, such as the product sold under the name “hydrophilol isostéarique” by the company Gatefossé, and the polyglycolysed glyceride “Labrafil® M 1944 Cs” as sold by the company Gatefossé.
Labrafil® M 1944 CS is a mixture of polyoxyethylenated oleic glycerides obtained by alcoholysis of natural plant oil (French Pharmacopoeia, 8th edition). It is an oily liquid whose properties are presented in Table 1 below.
Lastly, as mono-, di- or triglycerides of natural origin, reference is made in particular to oils of plant origin, such as sweet almond oil, argan oil and palm oil.
According to a preferred embodiment of the present invention, the cellulose polymer is ethyl-cellulose, present in a proportion of between about 1 and about 10% by weight, and the oily agent comprises Labrafil® M 1944 CS, present in a proportion of between about 5 and about 90% by weight, relative to the total weight of the oleogel, the ratio of the weight of oleogel to the weight of aqueous gel being between about 10:90 and about 90:10.
Preferably, the oily agent further comprises propylene glycol isostearate, in a proportion of between about 5 and about 90% by weight, relative to the total weight of the oleogel.
TABLE 1
Chemical name
Polyglycolysed oleic glyceride
(cores)
Trade name
Labrafil M 1944 CS
Drop point ° C.
Liq.
Saponification number
1451175
Acid number
<2
Iodine number
60/90
Oral acute toxicity/rat
OLD >20 ml/kg
LOP
0
HLB
314
The aqueous gel present in the stable gel mixture according to the invention comprises at least one gelling agent preferably chosen from carbomers, poloxamers, sodium carboxymethylcellulose and mixtures of the latter, the gelling agent being present in a proportion of between about 0.1 and about 10% by weight, relative to the total weight of the aqueous gel, the ratio of the weight of oleogel to the weight of aqueous gel formed being between about 10:90 and about 90:10.
More particularly, the gelling agent for the aqueous gel is the carbomer Carbopol 974, present in a proportion of between about 0.1 and about 5% by weight, relative to the total weight of the aqueous gel.
Needless to say, the oleogel and the aqueous gel can, respectively, further comprise standard ingredients for a gel, such as texture agents, antioxidants such as butylated hydroxyanisole (BHA) or butylated hydroxytoluene (BHT), dyes or fragrances.
The subject of the present invention is also a process for the preparation of the stable gel mixture as defined above, this process being characterized in that it comprises the steps consisting of:
a) separately forming the oleogel and the aqueous gel, the viscosity of the oleogel formed being adjusted, where necessary by heating preferably to temperature of not more than 50° C., to a value of between about 20 and about 40 Pa.s, and the viscosity of the aqueous gel formed being adjusted, where necessary by heating preferably to a temperature of not more than 50° C.; to a value of between about 10 and about 30 Pa.s, and
b) incorporating the oleogel into the aqueous gel or, vice versa, with non-shear stirring, until a mixture of substantially uniform appearance, as already defined above, is obtained.
The respective formations of the oleogel and of the aqueous gel in step a) are carried out according to operating conditions known to those skilled in the art. Reference will be made in particular to the examples below.
According to the invention, the expression “non-shear stirring”, for the incorporation of the oleogel into the aqueous gel, or vice versa, in accordance with step b) of the present process, is understood to refer in particular to a non-destructive stirring of the respective gels of oily and aqueous types, for the formation of a mixture of substantially uniform appearance.
Preferably, a planetary mixer is used, such as those sold by the companies Hobart or Kenwood, set to a maximum speed of about 5 revolutions/minute for about 10 to 20 minutes.
In general, the settings for the other operating conditions in order to carry out the present process are within the scope of those skilled in the art.
The subject of the present invention is also a stable pharmaceutical composition, which can be administered topically, orally or parenterally, characterized in that it comprises a stable gel mixture as defined above, and at least one of the oleogel or the aqueous gel components further comprises at least one active ingredient(s).
Needless to say, depending on the route of administration envisaged, the viscosity of the composition is adjusted to an appropriate value, in particular by adapting the proportions of gelling agents in the aqueous gel phase or in the oleogel phase, or both.
In particular, given its biodegradable nature, the composition according to the invention can be administered as an injec

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