Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Cosmetic – antiperspirant – dentifrice
Patent
1996-08-26
1997-08-05
Page, Thurman K.
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Cosmetic, antiperspirant, dentifrice
424405, 424450, 424455, 514941, 514943, 514937, A61K 748
Patent
active
056539894
DESCRIPTION:
BRIEF SUMMARY
The present invention concerns a new type of lotion containing a corticosteroid as active ingredient.
Use is often made of creams as therapeutic vehicles containing corticosteroids. These creams incorporate either oil-in-water or water-in-oil emulsion systems.
For example, EP-A-0 217 146 discloses an oil-in-water cream containing a hydrocortisone diester. However, oil-in-water creams play a minor role in corticosteroid therapies, since most inflammatory processes are triggered when skin is dry. Accordingly, oil-in-water emulsions (containing water in the external phase of the emulsion) lend themselves to this application only in a limited manner.
Use is more often made of water-in-oil creams (containing oil in the external phase of the emulsion). Because of their thick consistency and, consequently, of the difficulty with which they are spread, they have the disadvantage of being unsuited to application on large surface areas. In addition, they leave an unctuous film on the skin, a cosmetically-adverse phenomenon. A water-in-oil emulsion-based cream containing hydrocortisone diester as active ingredient is, for example, described in Patent No. EP-A-0 217 141. "Stabilized" creams (water-in-oil emulsions) containing corticosteroids are described, for example, in U.S. Pat. No. 4,284,630.
These two problems, i.e., poor spreadability on large surface areas and cosmetic unacceptableness, also apply to a greater degree to a third type of topical preparation, i.e., creams such as ointments having a vaseline/paraffin base (fatty ointments). In addition to these problems, these preparations soil linen and clothing that has come into contact with skin treated with them.
A fourth type of vehicle intended for corticosteroid therapy consists of liquid oil-in-water liquid emulsions, and thus, lotions. The scope of application of these products is similar to that of oil-in-water creams. Oil-in-water lotions nevertheless exhibit the same basic problem as oil-in-water creams. They are not suitable for use on dry skin, which is most often encountered when these products are indicated. Consequently, the field of application of these lotions is extremely limited, despite their general aptitude for application on large surface areas.
Tinctures and tinctures solidified using gelling agents form a fifth type of base for corticosteroids. In this case, these tinctures are solutions, most often ethanol-, isopropanol/propylene glycol-, or polyethylene glycol/water-based. They are often, but erroneously, termed lotions, even though they are not constituted by emulsion systems. While these lotions contain, in addition, a surface-active substance, this substance is used only to solubilize the minimally-soluble corticosteroid. Such a tincture, is, for example, described (as a "lotion") in patent EP-A-0 292 893.
The preceding description shows that, to date, there is no vehicle for corticosteroids which meets the following requirements:
Water-in-oil lotions alone lend themselves to these purposes. To date, they have not been used in corticosteroid therapy. Even in the cosmetic industry, water-in-oil lotions tend to separate during storage into an oil and an aqueous phase. Consequently, they cannot be produced by "diluting" a water-in-oil cream with water. To obtain a water-in-oil lotion, a complex combination of multiple emulsifiers with specially-adapted lipophilic compounds proves necessary.
Use must be made of combinations of emulsifiers, because it is hardly possible to produce a stable water-in-oil lotion based on only one of the emulsifiers indicated above. Water-in-oil emulsifiers (or mixtures thereof) constitute new substances that are particularly well-adapted to water-in-oil lotions. They are not identical to the emulsifiers widely used in water-in-oil creams, such as sorbitan oleates and sorbitan stearates (Span (R) products). The latter (see U.S. Pat. No. 4,284,630) can be used solely for preparing water-in-oil creams.
As regards a water-in-oil lotion of this kind containing a corticosteroid as active ingredient, consideration
REFERENCES:
patent: 4252796 (1981-02-01), Yu et al.
patent: 4347238 (1982-08-01), Hollingsbee
patent: 4464389 (1984-08-01), Dawson
patent: 4879274 (1989-11-01), Kamiya et al.
patent: 5190936 (1993-03-01), Laugier et al.
Faulkner Diedra
Galderma S.A.
Page Thurman K.
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