Important applications of the invention will be to various food products but the invention also extends to other applications wherein the additive is an active -medical or pharmaceutical ingredient and the creamy base acts as an effective carrier.

BACKGROUND TO THE INVENTION The inventor's own prior patent specification PCT/AU95/00259 (now Australian patent No. 691,282 and US patent No. 5,939,126) discloses a range of embodiments in which a creamy base is aerated and a hot aqueous solution of gelatin is rapidly and intimately mixed through the creamy base whereby the gelatin is effectively dispersed.

The amount of gelatin, its concentration in the solution and the temperature of the solution needs to be selected relative to the aerated creamy base such that effective and intimate rapid distribution of the gelatin occurs whereby the base has a range of advantageous characteristics. The inventors'prior patent discloses products which can have excellent freeze/thaw stability and/or products which have an extraordinary capacity to be intimately mixed with oily products, acidic products, fruit components containing enzymes and products having an alcoholic base. These additives generally are difficult to mix intimately with a cream based food product to produce a combination for use e. g. as a sauce, mayonnaise, dessert or similar product.

The use of gelatin in the food industry is used in a wide range of applications but the particular applications

the inventors prior patent offers new and useful applications. This specification is directed to additional significant new application and production methods extending to further uses of the creamy base.

The use of gelatin is also known in the pharmaceutical industry as a coating of pharmaceutical products. One recent patent in this field is US5,614,219 (Wunderlich et al) which discloses, for oral administration, peptidic medicaments such as insulin distributed in a gelatin or gelatin derivative matrix.

US5,928,664 is a further disclosure for medicament carriers using a gelatin matrix and a glycerol matrix and other gummy delivery systems.

Thus, gelatin is well established as an acceptable food component and component for use in the pharmaceutical industry.

SUMMARY OF THE INVENTION The present invention is directed to a range of new applications all based on new and useful applications derived from a creamy base product produced from any one of the forms of the inventor's prior patent specification or adaptations, improvements or modifications, and whereby novel combinations and/or novel processing conditions are proposed for additional steps so that new and useful products are derived. A major application of products of the inventor's prior patent are products which have been allowed to at least set and cool and may then either be cold-stored for good shelf life or frozen to provide extended shelf life. It is to be understood that the present invention includes applications where the creamy base product is not necessarily allowed to cool and set before additional components, as required by aspects of the present invention, are introduced.

The creamy base product together with the hot aqueous gelatin solution mixed into the base product can be further processed at elevated temperature with additional

components and otherwise treated in accordance with aspects of the further present invention. Alternatively, the cold, set creamy base according to the prior patent specification may be a starting ingredient for new methods and products.

According to the first aspect of the present invention, there is provided a method of producing a food product including: (a) taking a creamy base component (as defined hereinafter); (b) mixing in a further food product before, during or after mixing in gelatin solution; (c) establishing and maintaining elevated temperature conditions: (i) to cause intimate distribution of the further food product substantially uniformly with the cream base component and (ii) to provide increased shelf life to the product when cooled and packaged; (d) allowing the composite product to cool and then providing suitable storage for supply of the food product.

For the purpose of this specification, the creamy base component is defined as that derived from: a cold base ingredient selected from the group consisting of cream, artificial cream, thickened cream, cream cheese, and mixtures thereof and mixtures with compatible incidental ingredients, the ingredient being aerated to produce an overrun and intimately mixing into the ingredients a hot aqueous solution of gelatin providing: (A) sufficient thermal load to maintain the gelatin solution and the cold base ingredient with low enough viscosity to permit rapid and substantially uniform distribution during the mixing step;

(B) sufficient gelatin to provide the stability required in the product; and (C) sufficient gelatin to substantially obviate breakdown or collapse of the aerated base ingredient during or after the mixing step, whereby the product has freeze/thaw stability.

Examples of compatible incidental ingredients are sugar and sweetened condensed milk.

Preferably, but not necessarily the method of producing the creamy base is characterised by one or more of the following conditions: (a) the gelatin solution is at greater than 48°C and preferably at about 80°C ; (b) the gelatin solution causes 1%-3% by weight of gelatin in the creamy base; (c) the aeration is to an overrun in the range of 10%-40% ; (d) the ingredient is at about 4°C and after mixing the gelatin solution raises the product temperature to about 10°C ; (e) mixing is conducted rapidly using a wire whisk.

One important application is where by mechanical mixing, the creamy base component is substantially de- aerated before or during mixing in the further food component.

Important embodiments of the invention are those in which an elevated temperature around the boiling point of the product is sustained for a period of the order of one minute and typically in the range 30 seconds to 5 minutes and preferably in the range 30 seconds to 2 minutes. In some embodiments, additional water is added to ensure that suitable product characteristics are maintained.

One example of the food product is where the product is maintained at 90°C for about 1 minute and then hot filled into a suitable container which is closed before cooling and shipment of the product.

Another example is where the product is canned and

then heated to a temperature of around 120°C and held for around 1 minute to achieve the processing whereby long life can be established.

Another application is for the final product to be frozen and stored in a frozen condition.

A further application is where the product is freeze- dried and packaged suitably for longer shelf life.

In one form, the invention has a minor proportion of the creamy base relative to the major component which is a formulated product which may have higher acidity e. g. in the range of pH 3.0 to 4.2 and may be selected from a wide range of products.

In another range of products embodying a second aspect of the invention, the product is primarily the creamy base with the minor component comprising flavouring ingredients and surprisingly, it has been found that mixing in the products into the base in a method in which the base is substantially de-aerated compared with its original form produces a stable product which can readily be formed into suitable shapes and frozen for long-term storage.

When applied to the medical field, the present invention can be applied by mixing in an active ingredient such as insulin which becomes encapsulated in the base material to facilitate effective ingestion in tablet form and absorption to the bloodstream and this is believed to be a new and useful alternative to known proposals. This approach may permit many medicaments to be administered orally rather than by the much less preferred injection method.

More broadly, this medical application aspect can be defined as a method of producing an oral pharmaceutical comprising taking a creamy base product resulting from a process which includes taking an ingredient selected from the group consisting of cream, artificial cream, thickened cream, cream cheese, and mixtures thereof and mixtures with compatible incidental ingredients, the ingredients

when cold being aerated to produce an overrun and intimately mixing into the ingredient a hot aqueous solution of gelatin providing: (A) sufficient thermal load to maintain the gelatin solution and the cold creamy base product with low enough viscosity to permit rapid and substantially uniform distribution during the mixing step; (B) sufficient gelatin to provide the stability required in the product; and (C) sufficient gelatin to substantially obviate breakdown or collapse of the aerated base product during or after the mixing step; mixing in as a minor proportion of the final product an active pharmaceutical agent before, during or after mixing in the gelatin solution; forming a stable powder from the product and forming pharmaceutical doses therefrom.

Although not intended to be bound by any particular theory, the inventor suggests that the various embodiments of the present invention exploit a distinct characteristic arising from the particular use of the gelatin solution with the creamy base. It is thought that the method forms a continuous three-dimensional gelatin network which surrounds gas bubbles in the aerated product and that this can be achieved by the hot aqueous gelatin solution which is greater than 50°C (and typically higher in temperature) followed by suitable rapid mixing.

Many embodiments of the present invention provide surprisingly good shelf life even as a refrigerated product due to the combination of processing conditions.

For example, tests have been conducted with examples based on fetta cheese and spinach, parmesan cheese and herbal additives and surprisingly it is found that by pursuing standard tests coliform of less then 10 per gram have been found along with a standard plate count cfu per gram (30°C/72 hours) of less than 10.

In the following examples the gelatin used is Type B

(115-135 bloom) but the invention is not so limited and other types of gelatin may be useable.

DESCRIPTION OF EXAMPLES Example 1 An example of a creamy base is one having the following ingredients: Cream Cheese; Sugar; Sweetened Condensed Milk; Thickened Cream (0.4% gelatin and 35% milk fat); Type B Gelatin (115-135 Bloom); and Water.

The ingredients provide added gelatin of 1.16% so that the resultant product would have a total of approximately 1.5% gelatin. The cream was thickened by conventional thickening. The manufacturing methodology used a Hobart mixer with a wire whisk agitator. The method was as follows: 1. Cream cheese and sugar was blended to a smooth paste at mixer speed 2 for approximately 3 minutes and then for a 30 second mixing at speed 3.

2. Sweetened condensed milk was added with agitation at speed 3 for approximately 90 seconds.

3. The thickened cream was added and beating occurred in the mixer on speed 3 for approximately 2 minutes and this achieved a 25% increase in volume.

4. The gelatin was formed in solution in water at near boiling point and allowed to cool to approximately 80°C. The cream pre-mix at about 10°C then received the gelatin solution, which was poured slowly into the mixer on speed 2 with the solution directed into the spinning

whisk. It was distributed in approximately 10 to 15 seconds and then the mixer speed increased to speed 3 for a few seconds. The product was then available for use, including freezing and when desired thawing and mixing with other materials.

The creamy base may then be used as a starting point for various applications within the teaching of the present invention. In this particular example, the mixture was brought close to its boiling point and held for approximately one minute and then allowed to cool and set. Desirable characteristics including texture and freeze/thaw stability are believed to occur in the product.

Example 2 The creamy base of Example 1, modified by the omission of sugar and sweetened condensed milk, was produced and then heated to at or near its boiling point, at which time fragments of cheese were stirred in until dissolved and uniformly distributed. The product was allowed to cool and then packaged for storage and distribution.

Example 3 A creamy base was produced as in Example 2 and using a high speed mixer with a whisk, a further food component mixture was whisked into the base at high speed to cause substantially de-aeration and uniform intimate distribution of the added food component. An example of the added food component is a mixture of equal parts of ham and a Bechamel sauce (based on flour, margarine and water).

Example 4 A ganache product is usually formed by a mixture of

very hot dairy cream and chocolate. Traditionally the ratio of ingredients is chosen to suit the application.

By the present example, however, a ganache product has been produced which has been shown to be capable of extensive storage under ambient conditions.

In this example, a creamy base in accordance with Example 1 was formed and the method comprised the following additional steps: (a) the creamy base material was heated to in excess of 85°C ; (b) chocolate in finely divided form was added to the creamy base, the ingredients comprising 1/3 creamy base and 2/3 chocolate; (c) the mixture was agitated and held in the range of 60-70°C ; (d) the product was hot packed at 65°C ; and (e) the product was cooled to ambient temperature for storage and distribution.

It has been found that the risk of product spoilage is well addressed when water activity is below 0.85 and atmospheric contamination, eg due to yeast or moulds, is obviated by appropriate air filtration systems in the process environment coupled with the heating regime of the method.

The use of the creamy base in its original finished and aerated form, coupled with processing through to hot filling at greater than 60°C, are believed to be important factors leading to the success of the product and its shelf life.

The term"water activity"is used herein and understood in the art to mean activity referring to "unbound water", ie water which is not bound to food molecules and can support the growth of bacteria, yeast and moulds. It is believed that the use of the present creamy base in this example in the process described ensures a substantial amount of the water present is bound into the product, yet the physical characteristics of the

product are of the nature of a semi-moist food product.

Tests have been conducted on samples produced by the present method and with a water activity of 0.83, long shelf life at ambient conditions has been found. It is believed that the process of heating the creamy base together with the hot filling step are effective at killing any organisms which might otherwise adversely affect the product. The product is filled into a container which is sealed. Once the container is opened, it will require refrigeration. The applicant's experiments have shown shelf life in excess of 15 weeks can be obtained and greater shelf lives occur if the water activity is lowered to about 0.81.

Example 5 The cream base in accordance with example 2 was formed and the method of Example 4 was effected with the additional step of adding an alcoholic liquid was added at step (c). The product exhibited excellent qualities with enhanced shelf life compared to Example 4.

Example 6 A creamy base is prepared from thickened dairy cream which is chilled to about 4°C. 5Kg of cream cheese is dissolved in 1 litre of hot water (about 90°C) and mixed into the cream base, and the mixture whipped with a wire whisk to an overrun of about 25%. A typical batch comprises 50 litres of cream with or without incidental ingredients and with or without artificial cream.

Approximately 900gm of gelatin is dissolved in 5 litres of hot water (about 90°C) and poured steadily into the cream base while stirring and vigorous distribution with a wire whisk is effected for 10-15 seconds.

The mixture is brought to a temperature of close to or at the boiling point of the mixture and held at that temperature for about 60 seconds.

The resultant product was allowed to cool and set. A

texture similar to butter (but of a distinct cream cheese character) resulted with extended storage time at refrigeration temperature. Furthermore, the product had freeze/thaw stability and in the frozen state indefinite shelf life could be obtained.

Example 7 The product mixture was produced in accordance with Example 6; at the product boiling temperature, hard cheese fragments were stirred in until dissolved and uniformly distributed. The product was allowed to cool, was packaged and provided for storage and distribution. The product can be frozen or stored at refrigeration temperatures.

It is believed that the heat treatment significantly reduces microbe population and free water is essentially absent whereby a long shelf life in a refrigerated product is obtained with a pleasing buttery texture of a cheese flavoured spread is obtained.

Example 8 A creamy base made in accordance with Example 6 was prepared and then cooled and allowed to set.

A pharmaceutical agent in a fluid form was mixed into the base by rapid whisking for approximately 1 minute to distribute the agent intimately and uniformly through the creamy base and substantially removing the aeration of the product. The product was then freeze-dried and tablets formed to provide dosage units.

Example 9 A creamy base was made in accordance with Example 6 and including an additional component/a pharmaceutical agent in fluid form which was added prior to mixing with hot gelatin solution. Freeze drying was effected followed by formation of dosage units.

Example 10 10 parts by weight of creamy base was made in accordance with Example 6. A mixture comprising five parts by weight of ham and five parts by weight of a Bechamel sauce (based on flour, margarine and water) is formed and the mixture rapidly whisked into the base at high speed in a manner to cause substantially de-aeration and uniform intimate distribution of the added materials to the cream base.

The resultant product is a sauce for cooking which can be formed into suitable units which are frozen and packaged for distribution and supply.

In a modified version the creamy base incorporates a Camembert style cheese. There is no heating step of the creamy base after the addition of the gelatin solution in this example.

Example 11 A creamy base is prepared in accordance with Example 6 but after incorporation of the gelatin solution, no heating is effected. In this example approximately 3kg of a flavouring agent, e. g. garlic salt, is added together with approximately 6kg of food acid (preferably in liquid phase such as lemon juice) together with a large volume of water (50kg in this example) following by rapid further mixing, typically at the same speed of mixing as that in which the original aeration is effected, i. e. speed 4 on a Tonelli food mixer or speed 3 on a Hobart mixer.

The effect of this mixing is to de-aerate the product and provide a smooth creamy sauce with sufficiently low viscosity so that it is easily poured at normal refrigeration temperatures of about 4°C.

Example 12 This example is a modification of the previous example in that the flavouring agent and food acid are added quickly just before the gelatin solution is mixed

into the product. After completion of the distribution of the gelatin solution, the final quantity of water is added and mixed in. Providing the food acid is rapidly mixed in and there is no delay in applying the gelatin solution it has been found that a product similar to that of the previous example is achieved.