AU2005200277A1 - A process for producing starch and gelatin - containing edible products using a novel flow depositor - Google Patents

Description

AUSTRALIA

Patents Act 1990 COMPLETE SPECIFICATIONS STANDARD PATENT A PROCESS FOR PRODUCING STARCH AND GELATIN PRODUCTS USING A NOVEL FLOW DEPOSITOR The following statement is a full description of this innovation, including the best method of performing it known to us.

2- A PROCESS FOR PRODUCING STARCH AND GELATIN PRODUCTS USING A NOVEL FLOW DEPOSITOR FIELD OF THE INVENTION The present invention relates to a flow depositing process whereby a product is produced using the present invention comprised of a mixing product tank, that mixes the ingredients of the product, a valve, that allows product to flow at a controlled rate, a product distributor head, that ensures the continuous even spread of product across a number of moulds, other than moulding starch moulds, and scrapers that leave the mould upper surface clean and relatively free of product residue and ensure that each mould is accurately filled.

BACKGROUND TO THE INVENTION Injector-type depositors are presently used to deposit measured amounts of material into moulds to produce a range of gelatin products including confectionery and medications, such as cough lollies and vitamin jelly chews. The moulds are usually made from recyclable moulding starch but other materials such as silicon rubber or metal are also used. These depositors use a number of injectors that are designed to place a measured volume of material into the moulds. The material is usually a hot liquid of low viscosity that sets on cooling because of its gelatin content.

APV Baker of Peterborough in the United Kingdom manufacture such a depositor machine for extruding product called a "J-RAC Depositor". This machine is a soft mix depositor which handles a wide range of products including slurries, creams, jellies and fondants. It allows exact flow and quantity deposits, using the peristalsis principle.

This machine can be used to accurately deposit a pourable mix directly into moulds as they pass below the multi-head depositor.

New ingredients and technologies make injector-type depositors unsuitable where cold materials or materials of high or variable viscosity are required to be deposited. In such cases, these depositors are unable to consistently and accurately deposit specific quantities of material into each mould.

3- Cold starch and gelatin based products are examples of products that may be unsuitable for injector type depositors. However, there is a need for such products that contain a wide variety of physiologically active agents, typically referred to as drugs, medicaments, therapeutic or nutraceutical substances, that are used to treat or prevent diseases of people or animals. Physiologically active agents also include analgesics, tranquilizers, cardiovascular products, antibiotics, and stimulants such as caffeine, vitamins, minerals, herbal extracts, probiotics, bacteria and others.

Nougat-type confectionery or chewing gum compositions containing medicaments are described in some published patent specifications. For example WO 01/21156 describes a chewing gum containing a medicament, but it is not finally swallowed and therefore there is no certainty of the actual dosage absorbed. The manufacture of these products can require the use of elevated temperatures, often above 1250C, during the manufacturing process. Many physiologically active agents are deactivated or denatured by exposure to such elevated temperatures, and therefore such products cannot be prepared for many physiologically active agents.

The use of the flow depositing process using cold starch or gelatin based products to carry the physiologically active agents is a major attraction for the process.

4- SUMMARY OF THIE INVENTION In a first aspect, the present invention provides a flow depositing process that consists of a mixing tank, which incorporates a mechanical stirrer and into which components of the product is added and stirred. The product then flows through a control valve that regulates the flow of product into a product distributor head and ensures that the flow distributor head is kept filled, but not overfilled. The product distributor head ensures the continuous even supply and spread of product across the entire width of a number of moulds, other than moulding starch moulds. The moulds are carried continuously on a variable speed conveyor, the speed of which can be adjusted to allow for the particular viscosity of the product being deposited, as this may vary during the depositing process, particularly in the case of cold deposited starch based products. The conveyor is located beneath the product flow distributor head and extends through until other processes detailed below are completed, as necessary.

In a second aspect, surplus product is removed from the upper surface of the moulds by a primary scraper which is located after the product flow distributor head and leaves the mould upper surface clean and relatively free of product residue and ensures that each mould is accurately filled. Other scrapers may be placed behind the primary scraper to further clean the mould surface, as necessary, depending on the product being deposited. These scrapers ensure that each mould is accurately filled and the mould upper surfaces are clean and free of surplus product.

In a third aspect, the moulds can be of any shape or size that can be fed by the distributor head and carried by the variable speed conveyor, so that novelty or specially shaped moulds can be used.

In a fourth aspect, an oiling roller may be fitted before the product flow distributor head to coat the surface of the moulds with a small deposit of an edible vegetable oil, such as canola oil, facilitating further the cleaning action of the scrapers. When the full surface of the moulds requires a thin oil coating, such as in the case of gelatin based products, the oiling roller can be replaced with an oil misting chamber which allows the upper surface of the moulds to pass through a fine mist of oil prior to the deposit of the product into the moulds. This is required with some products to obtain easy release of the product from the moulds. Where necessary, the rate of oiling supplied can be adjusted to ensure the most suitable deposit of oil on the moulds.

In a fifth aspect, a particular advantage of the flow depositor is that some products can be deposited directly into moulds consisting of plastic blisters. As the upper surface of the plastic blister moulds are scraped clean of product by the scrapers, the plastic blisters can be immediately sealed using conventional foil sealing equipment commonly used in the pharmaceutical industry. Where the product requires drying prior to such sealing, the plastic blisters can be passed through a standard drying tunnel, prior to the foil sealing process.

In a sixth aspect, the present invention provides a method for producing starch or gelatin based products containing physiologically active agents, a method comprising mixing a syrup phase, a cold hydrating starch or gelatin and a physiologically active agent to form a chewable composition in a pourable or extrudable form, and depositing the chewable composition using the flow depositing process, allowing it to set to form the product in the desired shape.

In a seventh aspect, the method of the present invention can be carried out at room temperatures when the physiological active agent is mixed into form the chewable composition and deposited using the flow depositing process. The method can therefore be carried out without exposing the physiologically active agent to elevated temperatures during the preparation of the product. Accordingly, the method of the invention can be used to produce chewable compositions containing physiologically active agents which are adversely affected by exposure to elevated temperatures.

Typically, after cooling the syrup phase, the method of the invention is carried out at about room temperature, for example at a temperature between about 5C to about 50C, typically between about 15 0 C and about In an eighth aspect, the chewable compositions, when deposited using the flow depositing process can have a chewing resilience similar to that of a gelatine chew or to that of a hard boiled sweet that can be sucked and dissolved.

As used herein, the phrase "chewable composition" refers to a composition having a consistency that enables it to be chewed multiple times before the composition is dissolved or broken into small components and swallowed or sucked until dissolved, and which, when chewed, sucked or swallowed, has an effect on the physiology of a human or animal body. Such compositions include, for example, compositions having a texture and consistency similar to nougat, a gel-type confectionery or a boiled sweet 6- STARCH AND GELATIN BASED PRODUCTS THE SYRUP PHASE The syrup phase gives the end product a viscosity that enables the mixture to be extruded or poured prior to the mixture setting to form the product, thereby assisting in the formation of discrete sized units of the desired shape. The syrup phase also influences the cohesion of the resultant product, and therefore the release characteristics of the composition from any mould in which the composition is formed. In order for the syrup phase to be suitable for use in the present invention it must set into a gel within a required time period to allow depositing of the batch in a period of between 15 and 120 minutes and release easily from the blister pack or other mould The syrup phase can be based on sugar syrups such as glucose, sucrose, fructose or mixtures thereof. Alternatively, the syrup phase can be based on non-sugars such as polyols, such as Maltisweet 3145HS supplied by Nutrinova. A sugar-free chewable pharmaceutical composition can therefore be produced if a non-sugar liquid such as a polyol is used in the syrup phase instead of a sugar syrup.

In some embodiments of the invention, ingredients such as colours and flavours are added to the syrup phase prior to mixing the syrup phase with the cold hydrating starch or gelatin and a physiologically active agent.

A suitable syrup phase can be prepared using the following procedure: Mix glucose syrup, dextrose monohydrate, water, sweeteners, and any other soluble, heat resistant ingredients, such as Inulin, preservatives or vitamins, together.

Typical proportions of the first three ingredients are about 20% glucose syrup, about 33% dextrose monohydrate and about 12% water, by weight of the finished product.

Heat the mixture to between 70 and 80°C, depending on the ingredients added while stirring, until the mixture is almost clear and smooth. Whilst sugars are clear in solution, other additives can make the solution cloudy.

Allow the mixture to cool to ambient temperature.

Add any colorants and flavourings, whether in liquid or powder format, to the mixture once it has cooled (thereby avoiding bum-off of any alcohol present in many of these types of liquid ingredients or of natural flavours that could possibly be degraded by high temperatures).

7- Typically, the syrup phase constitutes about 65% to 85% by weight of the total weight of the end product. Preferably, the dissolved solids content of the syrup phase is about by weight of the syrup phase. It has been found that a high dissolved solids content in the syrup phase improves the stability of the composition, as, typically, confections with moisture content above 20% are less stable.

COLD HYDRATING STARCH BASED PRODUCTS Products are prepared by combining the syrup phase, as described above, with a coldhydrating starch phase.

A cold hydrating starch is one that only requires the presence of water (not heat) to set at ambient temperatures. These starches harden in ambient temperatures, of up to degrees centigrade, without the use of heat and set as a gel in a time frame of 15 to 120 minutes, depending on the combination of starches used and also release easily from a mould. It is the starch which causes liquids containing additives to thicken at room temperatures rather than the application of heat.

Cold hydrating starches exhibit similar properties and characteristics to modified cookup starches, but without requiring cooking. Examples of suitable cold hydrating starches for use in the present invention include the hydrated modified food starches, such as Mira-thik 468, Mira-thik 469, Mira-gel 463 and Mira-sperse 2000 produced by A. E. Staley Manufacturing Company of Illinios, USA. Mixtures of these or other cold hydrating starches can be used.

Mira-thik 468 is a cold water hydrating food starch that exhibits the properties and characteristics of a modified cook-up starch, but without requiring cooking. It is produced from common (dent) corn starch, modified and then processed in a unique manufacturing system. It is marketed as a thickener/stabiliser for acidic foods, generally in the range of 3.0 to 4.5 pH. It is a free flowing powder that is easily blended with other dry ingredients and outperforms pregelatinized starches by extending storage times without breakdown or thinning. It is identified as "Food Starch-Modified" as defined in CFR 172.892, Title 21 of the US Food Code and meets the standards of the National Food Processors Association for canners starch.

Mira-thik 469 is similar to Mira-thik 468, except in the degree to which it is modified, as it is marketed for use in foods having a neutral to mildly acidic pH, generally in the range of 4.0 to 7.0 pH.

8- Mira-gel 463 is a cold water swelling, granular corn starch that differs significantly from the traditional pregelatinized starches commonly used in "instant mix" food products. It is similar to both Mira-thik 468 and Mira-thik 469 except in the degree to which it is modified as it is marketed for use in foods requiring a gel, having a gel strength of 90-140g and generally in the acidic range of 3.5 to 5.5 pH. It is identified as "Food Starch-Modified" as defined in CFR 182.1, Title 21 and meets the standards of National Food Processors Association for canners starch in the USA.

Mira-sperse 2000 is a cold water swelling, granular corn hydrating starch similar to the other starches cited above, except that it has a delayed thickening effect. This delay in setting time is important when a longer term of pot life is required in the manufacturing process or while the product is being deposited. It is marketed for use in foods requiring a gel generally in the acidic range of 5.0 to 6.8 pH. It is identified as "Food Starch-Modified" as defined in CFR 172.892, Title 21 and meets the standards of National Food Processors Association for canners starch in the USA.

When hydrated in water at ambient temperatures, the above starches first form a thick smooth consistency and then set to a resilient, colloidal gel structure, typically in times ranging from 15 to 120 minutes, depending on the starch(es) used, at room temperature.

The structure then resists flow when exposed to high heat, retaining form and firmness, even when heated to temperatures of 350°C for 7 to 8 minutes. The type and amount of the cold hydrating starch used influences the cohesion and mouth-feel of the end product.

Immediately upon mixing the cold hydrating starch with the syrup phase, the setting process commences. Accordingly, it is important that, the cold hydrating starch is mixed with the syrup phase and the physiologically active agent as a final step before the mixture is deposited using the flow depositing process.

As the syrup is cooled before the addition of the cold setting starches, this process can, for the first time, allow for heat sensitive physiologically active agent(s) or other ingredients to be used without heat degradation Typically, the cold hydrating starch constitutes about 6% to 15% by weight of the total weight of the mixture of the end product.

9- GELATIN BASED PRODUCTS Products are prepared by combining the syrup phase, as described above, with a gelatin phase.

The gelatin used in this phase is one that only requires the addition of water (not heat) to set at ambient temperatures. These gelatins harden in ambient temperatures, of up to about forty (40) degrees centigrade, without the use of heat and set as a gel in a time frame of 10 to 45 minutes, depending on the combination of gelatins used and also release easily from a mould. It is the gelatin which causes liquids containing additives to thicken at room temperatures rather than the application of heat.

An example of such a gelatin for use in the present invention include Gelcosol produced by Gelita Australia Pty Limited.

The gelatin is mixed with the syrup phase, which, as it contains water, starts the gelling or setting process. At ambient room temperatures, the gelatin first forms a thick smooth consistency and then sets to a resilient, colloidal gel structure, typically in times ranging from 10 to 45 minutes, depending on the gelatin(s) used. The structure then resists flow when exposed to high heat, retaining form and firmness, even when heated to temperatures of up to 50'C for 10 to 30 minutes. The type and amount of the gelatin used influences the cohesion and mouth-feel of the end product.

It is obviously important that the gelatin is mixed with the syrup phase and the physiologically active agent as a final step before the mixture is deposited, using the flow depositing process, to avoid the gelling process commencing prematurely.

As the syrup is cooled before the addition of the gelatin, this process can, for the first time, allow for heat sensitive physiologically active agents or other ingredients to be used without heat degradation.

Typically, the gelatin constitutes about 5% to 15% by weight of the total weight of the mixture of the end product.

THE PHYSIOLOGICALLY ACTIVE AGENT The physiologically active agent may be any agent that has an effect on the physiology of a human or animal body when absorbed through the oral mucosa or when swallowed.

Typically, the quantity of physiologically active agent in the chewable composition does not exceed 25% by weight of the composition, otherwise it may become too thick to work and too hard in texture. Typically, the physiologically active agent constitutes about 5% to 20% by weight of the mixture comprising the syrup phase, the cold hydrating starch or gelatin and the physiologically active agent.

Examples of classes of physiologically active agents include drugs such as analgesics, tranquillisers and antibiotics, and bioactive products such as antacids, vitamins, minerals and herbal extracts. Mixtures of physiologically active agents can also be used in the method of the present invention.

Examples of particular physiologically active agents include the following: Antacids: calcium carbonate, sodium bi-carbonate, aluminium magnesium hydroxy sulphate.

Analgesics: Paracetamol, Aspirin, Ibuprofen, Pseudoephedrine sulphate or hydrochloride, Dexchlorpheniramine maleate, Triprolidine hydrochloride.

Therapeutic drugs: antibiotics, Atorvastatin, Verapamil hydrochloride, Irbesartan hydrochloro thiazide and other common drugs currently available in tablet or capsule format.

Vitamins: vitamin A, B group (Bl, B2, B3, B5, B6, B12), C, D, E, H and K, folic acid.

Minerals: calcium, magnesium, potassium, sodium, zinc, glucosamine sulphate, and manganese gluconate.

Herbal extracts: Lycopene, Echinacea, Andrographis, Gingko Biloba, Evening Primose and other common extracts currently available in tablet or capsule format.

Preferably, the physiologically active agent is an agent capable of being absorbed through the oral mucosa but is not limited to such agents as long as it is capable of having a physiological effect on a human or animal body when swallowed.

11- FURTHER INGREDIENTS In some embodiments, the mixture comprising the syrup phase, the cold hydrating starch or gelatin and the physiologically active agent further comprises a frappe phase.

The inclusion of a frappe phase in the mixture can enhance the mouth feel and texture of the resultant chewable composition.

The frappe phase can be made using any method known in the art. Typically, a frappe phase is made by adding icing sugar to water with stirring until the icing sugar is dissolved. Hyfoama DSN, a hydrolised milk protein made by Quest International, Nederland BV, is then slowly added, whilst the mixture is continuously whipped, until peaks in the frappe form from the whipping motion, stand up.

A typical frappe phase consists of 36% water, 61% icing sugar and 3% Hyfoama, by weight of the frappe and typically constitutes about 3% to about by weight of the mixture used to form the chewable composition.

When the syrup phase has cooled to about 30 degrees centigrade and is ready for the addition of the flavour, the frappe is mixed with the syrup into which it readily dissolves.

Many physiologically active agents have an unpleasant or bitter taste. Accordingly, in some embodiments, masking agents are included in the mixture to mask both or either of the initial or after taste of the physiologically active agent(s). Examples of masking agents that can be used include high intensity sweeteners, such as Sucralose, Acesulfam K or Stevia.

In some embodiments the mixture further comprises flavourings, colorants and sweeteners. In some embodiments, these agents are added to the mixture formed by mixing the syrup phase, the cold hydrating starch or gelatin and the physiologically active agent. In other embodiments these agents may be incorporated into the syrup phase or mixed with the cold hydrating starch or gelatin or the physiologically active agent, prior to the syrup phase, the cold hydrating starch or gelatin and the physiologically active agent being mixed together.

12- Flavourings that can be used include Strawberry Colorite (73.820-01), Banana Colorite(73.715-01), White Chocolate Colorite (73.973-01) and Vanilla or Spearmint Flavours, amongst others supplied by Australian Food Ingredient Suppliers Pty Ltd.

Colorants that can be used include strawberry, banana and white chocolate colorite and food grade dyes such as blue, red or other colours to match the intended flavour.

Non-sugar sweeteners that can be used include: Sucralose, Inulin, Stevia and Acesulfam

K.

Further ingredients that are likely to be used in any commercial product include.

preservatives, such as Potassium Sorbate, a food acid such as Malic acid and also Vitamin D3, when calcium is included as it further assists in the absorption of the calcium, particularly where exposure to good sunlight is not available.

METHOD FOR PREPARING THE CHEWABLE COMPOSITION The method of preparing the chewable composition ready for depositing comprises mixing the syrup phase, prepared separately, as described earlier, with the cold hydrating starch or gelatin, the physiologically active agent and any further ingredients of the chewable composition. Typically the ingredients are mixed at about room temperature. The ingredients can be mixed using standard methods used in the pharmaceutical or confectionery industry for mixing or blending liquid and powder ingredients, or carried out in the mixing tank of the present invention.

Some physiologically active agent are mixed with the cold hydrating starch or gelatin before mixing those ingredients with the syrup phase, others are mixed with the syrup phase before mixing those ingredients with the cold hydrating starch or gelatin. If there are two or more physiologically active agents, these can be mixed together and added to one or more of the other ingredients, before mixing all of the ingredients.

Similarly, flavouring, colorants, or sweeteners can be added to the syrup phase or to the cold hydrating starch or gelatin before mixing the syrup phase or the cold hydrating starch or gelatin with the other ingredients.

13 Once the mixing or blending of all the components is completed, the mixture is then deposited into moulds using the flow depositing process of the invention to form discrete chewable dosage units, for example, in the form of soft chewable tablets, where each dosage unit contains a suitable dose of the physiologically active agent.

Advantageously, the mixture can be deposited directly into inverted plastic blister moulds and sealed with foil, after being passed through a standard drying tunnel if required. The mixture sets in the blister pack, and the blister pack may then be used to store and display the chewable composition prior to use.

For all physiologically active agents, the type and amounts of the syrup phase, the cold hydrating starch or gelatin, and the other components of the chewable composition (if any) can be selected such that the chewable composition has a texture and cohesion so that it is readily releases from the blister pack as a cohesive unit by applying pressure to the portion of the blister pack containing the composition. Suitable proportions of the syrup phase, cold hydrating starch and physiologically active agent to produce such a chewable composition are 75:15:10 By way of example only, the following illustrates the manufacture of an actual chewable composition containing a physiological active agent of calcium made using the process.

EXAMPLE

All of the percentages of the components referred to in this example relate to their percentage by weight of the final chewable composition.

Step 1 Prepare the syrup phase by blending together: 0 21 to 25% of glucose syrup, 33 to 55% of dextrose monohydrate, 11.47% water and 9 sweeteners (2.73% Inulin, 0.10% Acesulam K and 0.05% Sucralose).

Heat the mixture to 700C and maintain until all ingredients are dissolved and then allow the mixture to cool.

Step 2 When the syrup phase of Step 1 has cooled to an ambient temperature, add 1.25% Strawberry colorite, 50 microns per chew of Vitamin D3 and 0.10% Potassium Sorbate and mix.

14- Step 3 Add 19.50 of the physiologically active agent Alumin 996, a whey mineral concentrate of calcium, to the mixture of Step 2 and mix.

Step 4 Separately dry blend 5.00% Mira-thik and 5.00% Mira-gel 463 or Mira-sperse 2000 at the respective levels required to match the actives to achieve the right mouth feel and chewability. That is, to achieve the desired or right mouth feel and chewyness of the mixture, different amounts of the various starches are used.

Step 5 Mix the cold hydrating starches of Step 4 with the mixture of Step 3, and immediately start dispensing the mixture through the flow depositor process directly into blister packs.

Step 6 Seal the blister packs. This composition is readily released from a blister pack as a cohesive unit.

Although the example has been described with reference to a particular product, it will be appreciated that the chewable composition can contain many other physiologically active agents.

Claims (23)

1. A flow depositing process that allows consistent and accurate quantities of product to be deposited into moulds, the process comprising a mixing tank, a control valve, a product distributor head, scrapers, a variable speed conveyor, moulds and, where required, an oiling roller or misting chamber, a drying tunnel and a foil sealing unit.

2. The process according to claim 1 wherein the mixing tank has a standard internal mixer that continuously mixes the product in the mixing tank, which helps to stop it gelling or setting prematurely.

3. The process according to claim 1 wherein the control valve regulates the flow of product from a mixing tank into a product distributor head and ensures that the distributor head is kept filled, but not overfilled.

4. The process according to claim 1 wherein the product distributor head ensures the continuous even supply and spread of product across the entire width of a number of moulds, other than moulding starch moulds.

The process according to claim 1 wherein surplus product is removed from the upper surface of the moulds by a primary scraper which is located after the product flow distributor head and leaves the mould upper surface clean and relatively free of product residue and ensures that each mould is accurately filled.

6. The process according to claim 1 and 4 wherein other scrapers are placed behind the primary scraper to further clean the mould surface. These scrapers ensure that each mould is accurately filled and the mould upper surfaces are clean and free of surplus product.

7. The process according to claim 1 wherein the moulds are carried continuously on a variable speed conveyor, the speed of which is adjusted to allow for the particular viscosity of the product being deposited, as this may vary during the depositing process. The conveyor is located beneath the product flow distributor head and extends through until other processes are completed.

8. The process according to claim 1 wherein the moulds are made of plastic blisters, silicon rubber, metal or other materials, but not recyclable moulding starch. -16-

9. The process according to claim 1 and 8 wherein the moulds are of any shape or size so that novelty or specially shaped products are made using the moulds.

The process according to claim 1, 8 and 9 wherein consistent and accurate quantities of product are deposited into moulds.

11. The process according to claim 1, 8, 9 and 10 wherein once the moulds consisting of plastic blisters have the product deposited into them, they are immediately sealed using conventional foil sealing equipment commonly used in the pharmaceutical industry.

12. The process according to claim 1, 8, 9, 10 and 11 wherein, once the moulds consisting of plastic blisters have the product deposited into them and the product requires drying prior to sealing, the plastic blisters are passed through a standard drying tunnel, prior to the foil sealing process.

13. The process according to claim 1, 8, 9, 10, 11 andl2 wherein the consistency of the product, when set, enables it to be released as a cohesive unit from a mould.

14. The process according to claim 1 wherein an oiling roller is fitted before the product flow distributor head to coat the surface of the moulds with a small deposit of an edible vegetable oil, such as canola oil, facilitating further the cleaning action of the scrapers.

The process according to claim 1 wherein an oil misting chamber is fitted before the product flow distributor head to coat all the upper surface of the moulds, by passing the moulds through a fine mist of oil prior to the deposit of the product into the moulds.

16. The process according to claim 1 wherein the process is carried out with product at a temperature of between about 5°C and about 50'C and typically between about 15°C and about

17. The process according to claim 1 wherein the process is carried out with product that includes heat sensitive physiologically active agents.

18. The process according to claim 1 wherein the process is carried out with product with variable viscosity. 17-

19. The process according to claim 1 wherein hydrating cold starch or gelatin based products are deposited and allowed to set to form the product in the desired shape.

20. The process according to claim 1 and 19 wherein hydrating cold starch or gelatin based products, with the addition of a physiologically active agent, is deposited and allowed to set to form a chewable composition in the desired shape.

21. The process according to claim 1, 19 and 20 wherein hydrating cold starch or gelatin based products is carried out at room temperatures when a physiologically active agent is mixed into form the chewable composition and is deposited using the flow depositing process.

22. The process according to claim 1, 19, 20 and 21 wherein the process is carried out without exposing the physiologically active agent to elevated temperatures during the preparation of the chewable composition.

23. The process according to claim 1 wherein the chewable compositions have a chewing resilience between that similar to a gelatine chew or to a hard boiled sweet that can be sucked and dissolved. Dated at Sydney this4 day of January, 2005. ADVANCED NUTRITIONAL FOODS PTY LIMITED R rt Bucknell, Director Maxwel Strong, Directo