DESCRIPTION

The present invention relates to cosmetic or pharmaceutical preparations intended for application to human or animal skin as a freshly prepared emulsion, which can take the form of a cream or lotion.

Conventional pharmaceutical or cosmetic creams or lotions, of the type which comprise both lipophilic and aqueous phases, generally, are supplied ready for use in the form of stable emulsions. Such preparations include conventional moisturising creams, lotions, gels and the like. In these preparations, the lipophilic or non-polar phase usually consists of a mineral oil, such as paraffin oil or another synthetically derived material. Both the lipophilic and aqueous phases can contain small quantities of pharmaceutically active or nutrient components. Naturally sourced oils and fats,

such as animal or vegetable oils and fats or lipids, are not used in such preparations, except in trace amounts, since they would rapidly degrade and become rancid, if present in a significant quantity. Notwithstanding the substantial absence of natural or unsaturated oils, most conventional preparations still require the presence of preservatives for preventing both degradation of the lipophilic, or non-polar phase and the growth of mould or other organisms in the emulsion. It is an object of the present invention to provide a method of preparing a pharmaceutical or cosmetic emulsion in which the lipophilic phase comprises a significant proportion of a non-mineral oil or fat, without requiring the presence of significant quantities of preservative or stabilizer.

According to a first aspect of the present invention there is provided a a method of preparing a pharmaceutical or cosmetic composition, comprising an emulsion of a lipophilic or non-polar phase and an aqueous phase, wherein a separately prepared lipophilic component is mixed with an aqueous component, to form the emulsion, immediately prior to use.

By the term "immediately prior to use" it is herein meant that the emulsion is not stored after preparation for more than one week and, preferably, is used within less than 1 day and, more preferably, within less than one hour of preparation.

In a second aspect, the invention provides a pharmaceutical or cosmetic composition comprising an aqueous component and a lipophilic or non-polar component, wherein the lipophilic component is isolated from the aqueous component but dispensable, for mixing with the aqueous component, to provide an emulsion suitable for external application to human or animal skin.

In a further aspect, the invention provides a packaged pharmaceutical or cosmetic composition, comprising a lipophilic component in an openable container, suitable for use in a method in accordance with the first aspect of the invention, or in a composition in accordance with the second aspect of the invention.

Preferred embodiments and further aspects of the invention are defined and described in the subsidiary claims attached hereto.

Preferably, the emulsion is in the form of a cream or lotion. Also, it is preferred that at least one of the two phases, preferably the lipophilic or non-polar component, should include an emulsifying agent.

In embodiments, the aqueous component contains at least one water soluble or miscible nutrient or pharmaceutically active substance. Suitable such nutrients and active substances include vitamin C, carotenoids and panthenols. The aqueous phase can also contain a small amount of hydrolysed vegetable protein or an amino acid or acids derived therefrom, which are known for their moisture retention and skin firming properties. Also, the lipophilic component can include an oil soluble or miscible nutrient, or pharmaceutically active substance.

Preferably, the lipophilic component is characterised by a substantial absence of mineral oil and, in embodiments, the lipophilic or non-polar component comprises a natural or non-mineral oil which, preferably, is an animal or vegetable oil or fat. The most preferred oil is a self emulsifying oil, such as wheatgerm oil, which will form an emulsion with water, without requiring the presence of a separate emulsifying agent. The emulsifying agent, or agents (when used), preferably, are derived from natural sources,- such as purified lecithin, which is rich in phospholipids, or a glucose derivative.

Unlike the mineral oils, usually employed in ready formed emulsions, the natural oil or fat, used in the present invention, is more readily absorbed into the skin and, therefore, can carry nutrient or pharmaceutically active material deeper and more rapidly into the stratum corneum. Also, the material can provide a softer and smoother texture to the hydrophilic keratin layer of the skin. The phospholipids in lecithin can help reduce the loss of water from the epidermis. When anti-oxidant nutrients, such as vitamins

A, C and E, carotenoids and amino acids, are included in either phase of the emulsion, these can behave as free radical scavengers and, therefore, can prevent cellular DNA damage and retard the ageing process of the skin.

The two components may be provided in separate containers, or in two separate compartments of a single container. In an embodiment, the two components or phases are each contained in separate openable containers or capsules, either or both of which contain measured amounts of said components and, preferably, at least one of the components includes a measured amount of a nutrient or a pharmaceutically active component. In preferred embodiments the lipophilic component is provided in a measured amount contained in an openable gelatin capsule and the aqueous component is provided either in an ampule or a larger dispenser. A plurality of such capsules or ampules can be packaged together with appropriate mixing instructions. Most preferably, neither phase includes a preservative, stabilizing or antibacterial agent.

The invention also extends to the use of a cosmetic or pharmaceutical preparation, in accordance with the invention, in the preparation of an emulsion suitable for application to human or animal tissue.

It is because the aqueous and lipophilic components can be kept separate from one another, up until the time when it is wished to apply the emulsion, that a majority of the lipophilic component may comprise a natural or unsaturated oil, without there being any significant risk of this component becoming rancid, during storage. This risk is minimized when the lipophilic component is packed in a sealed capsule, or container, preferably under a nitrogen atmosphere. A further effect, also derived from the fact that the two phases need not be mixed until the emulsion is required for use, is that there is no need for any preservative or stabilizer to be included therein.

The advantage of avoiding the use of preservatives, synthetic chemical additives, synthetic emulsifiers and mineral oil derived components is that certain harmful effects, which these substances may have and which are

not generally associated with naturally derived substances, may be avoided. For example, skin allergies, contact dermatitis and subjective irritation can be caused by contact with mineral oil or certain preservatives and these are less likely to be provoked by contact with natural oils and nutrients.

A preparation in accordance with the present invention can be supplied in a pack of two containers, one containing the aqueous component and the other containing the lipophilic component, so that an emulsion of the two may be freshly prepared for immediate application to the skin. Alternatively, the two phases may be supplied in two separately encapsulated portions which can be opened and mixed together to provide a single dose or application. It is intended that the two components should be mixed by the consumer and it is preferred that such mixing should take place freshly before each application of the preparation. Mixing can be carried out in a container, or in the palm of one hand using the finger tips of the other, or by rubbing two palms together.

The proportion of the two components used by an individual may be varied in a way which was not possible with conventionally preprepared and preformed emulsion creams or lotions.

The emulsifying agent or agents, as aforementioned, is preferably of a natural origin and can be a lecithin, or a derivative (which are rich in phospholipid) , can be synthesized or derived from a natural source, such as glucose, or can be a modified starch emulsifier produced by a reaction between starch and a long chain fatty acid. The emulsion may be a water in oil, or oil in water emulsion. The emulsifying agent may comprise between 0.1% and 40% of the oily phase.

The final emulsion may comprise between 1 and 99% aqueous phase and between 99 and 1% lipophilic phase.

Most preferably, the composition provides a cosmetic, such as a moisturising cream or lotion, preferably for application to hands, face or body.

Example .

Lipophilic component batches 1-4 are suitable for use in a composition or method in accordance with the present invention. Each is prepared by admixing the listed ingredients and stirring the resulting mixture until it becomes homogeneous and, where possible, a solution.

1. Vit. E acetate 10 Gm Vit. A palmitate 2 Gm

Ascorbyl palmitate 5 Gm

Purified Lecithin 10 Gm

Lanolin 2 Gm

Olive Oil 6 Gm Wheat Germ Oil 60 Gm

Natural Fregrance q.s. to 100 Gm

2. Vit. E acetate 12 Gm Vit. A palmitate 3 Gm Ascorbyl palmitate 6 Gm

Purified lecithin 9 Gm Wheat Germ Oil 70 Gm

Vit. E acetate 10 Gm

Vit. A palmitate 2 Gm

Bovine thymus extract 1 Gm

Purified lecithin 15 Gm

Evening Primrose Oil 7 Gm

Avocado Oil 3 Gm

Sun Flower Oil 5 Gm

Wheat Germ Oil 50 Gm

Natural Fragrance q.s. to 100 Gm

4. Vit. E acetate 20 Gm

Vit. A palmitate 3 Gm

Ascorbyl palmitate 6 Gm

Purified lecithin 8 Gm Almond Oil 5 Gm

Macadamia nut oil 5 Gm

Jojoba Oil 3 Gm

Olive Oil 5 Gm

Wheat Germ Oil 45 Gm Natural Fragrance q.s. to 100 Gm

Aqueous component batches 1-4 are also suitable for use in compositions and methods in accordance with the present invention. These batches are prepared in the same manner as the lipophilic components 1-4.

1. Panthenol 10 Gm Hydrolysed oat protein 3 Gm Aloe Vera gel 10% concentrate 1 Gm Ascorbic acid 2 Gm Spring mineral water 84 Gm

2. Panthenol 15 Gm Hydrolysed Wheat protein 3 Gm Demineralised water 87 Gm

3. Panthenol 7 Gm Ascorbic acid 3 Gm Magnesium Sulphate 0.3 Gm Zinc Sulphate 0.3 Gm Sodium Chloride 0.17 Gm

Potassium Chloride 0.2 Gm

Copper sulphate 0.02 Gm

Spring Mineral Water 92 Gm

β-Carotene 0.01 Gm

Pectin 0.5 Gm

4. Panthenol 12 Gm Ascorbic acid 1 Gm

Hydrolysed Soya Protein 4 Gm

Modified Starch Emulsifier 2 Gm

Spring Mineral Water 81 Gm

Each batch of the lipophilic components 1-4 can be packed into a single container or into 10 - 20 separate containers, each containing a measured amount of lipophilic component (10 - 5 Gms) . The aqueous batches 1-4 can be packaged in a similar manner. The containers can be glass or thermoplastic ampules or, in the case of the lipophilic components, gelatin capsules. The containers can be packed in lots of 10 or 20 of each component into a larger container or box. Whenever it is wished to prepare an emulsion for use, one container of each component should be opened and the contents of both mixed, to form an emulsion, which can then be applied to the skin. The lipophilic and aqueous components can be prepared in larger batches than

aforesaid, simply by scaling up the quantities of ingredients used.