WO2008059186A1

WO2008059186A1 - Soluble film dose delivery system for thaumatin

Info

Publication number: WO2008059186A1
Application number: PCT/GB2006/004276
Authority: WO
Inventors: Vivienne Smith
Original assignee: Overseal Natural Ingredients Ltd.
Priority date: 2006-11-16
Filing date: 2006-11-16
Publication date: 2008-05-22

Abstract

An edible cold water soluble film comprises thaumatin as the only active agent. In this way, small accurate amounts of thaumatin can be delivered into a batch or continuous mix during the manufacturing process of ingredients and/ or finished products within the food and beverage industry.

Description

Soluble film dose delivery system for Thaumatin

Field of the invention

The present invention relates to an edible cold water soluble film which comprises Thaumatin as the only active agent. More particularly the present invention provides a way to deliver small, accurate amounts of Thaumatin via a cold water soluble film, into a batch or continuous mix comprising an aqueous phase, during the manufacturing process of ingredients and/or finished products within the food and beverage industry.

Background of the invention

Water soluble films have been used in industrial and domestic applications for a number of years. A good example is the use of hot water soluble films to hold a single dose of detergent which is added directly to a domestic washing machine. The packaging ruptures and dissolves when the washing cycle reaches a certain temperature and the detergent is released; see for instance, GB 2358191 A (Robert McBride Ltd), US 2006/148668 A1 (Verral et al.), US 2003/0114332 A1 (Ramcharan et al.). Also, document WO 2004/016724 A1 (Colgate-Palmolive Company) discloses a unit dose detergent film which can be used in an automatic dishwasher or a washer for cleaning fabrics.

Patent documents US 6,419,903 B1 (Xu et al.), WO 2005/000254 A2 (Colgate- Palmolive Company) and US 2006/013779 A1 (Dodds et al.) among others, describe examples of breath freshening strips which dissolve on the tongue to release a flavour.

In the last ten years water soluble films have developed greatly and these days they can be designed adequately with its use in mind by controlling the composition and/or the variables during the production process. For instance, document US 2004/0204543 A1 (Thomas P. Yang) describes water-soluble films having the characteristics of rapid cold water solubility, even at O⁰C. Several patent documents describe disintegrating films for delivery of pharmaceutical or cosmetic agents, for instance WO 2005/039499 A2 (Adhesive Research, Inc.), WO 00/42992 A2 (Lavipharm Laboratories, Inc), US 4,136,162 (Schering Aktiengesellschaft, Germany). Patent document US 2003/0107149 A1 discloses film products and methods of their preparation that demonstrate a non-self- aggregating uniform heterogeneity, disintegrate in water and may be formed by a controlled drying process. Films that by controlling the process should maintain the required uniformity of the film are adequate to be used for mucosal delivery, as described in WO 00/42992 A2 (Lavipharm Laboratoires, Inc.) which discloses compositions and methods for mucosal delivery including an effective dose of sildenafil citrate, nicotine and hydromorphone among others. Document US 2003/0068378 A1 (Chen et al.) describes mucosal surface-coat-forming film dosage units containing a water-soluble hydrocolloid, an effective dose of a sexual disfunction active agent and a mucosal adhesion enhancer. Patent document WO 03/031637 A1 (Arrow Coated Product Limited) describes a water-soluble film system with actives embedded/entrapped therein such as to provide a desired release of said actives, which include a variety of substances such as detergents, enzymes, softeners, perfumes, pesticides, fungicides, dyes, pigments, active agents for cleaning laundry, dishes, floorings, walls, furniture, etc.

Natraceutical SA has an ingredient in their portfolio called Talin®, the brand name for Thaumatin (Talin® from now on). It is a naturally derived protein extracted from the Katemfe Fruit (Thaumatococcus danielli) which is harvested from the African rainforest. From a health perspective Talin® is a natural protein metabolised by the body, non cariogenic, not calorific at the low dose level typically used and suitable for diabetics.

Eight disulphide bridges within Thaumatin's structure confer to this protein thermal stability, resistance to denaturation and maintenance of the tertiary structure of the polypeptide chain. The maintenance of tertiary structure is critical to Thaumatin' s technical function as cleavage of just one disulfide bridge results in a loss of sweet taste. Stability to heat and pressure is also important as it is stable through processes such as UHT, pasteurization, retorting, baking and extrusion at pH ranges between 2 and 8. It is soluble in aqueous alcohol, glycerol, propylene glycol and sugar alcohols. It is freely soluble in water based solutions. Talin® has a characteristic sweetness profile with a slow onset and long lasting effect. It has the ability to work in a variety of food and beverage applications and flavour systems where it can act as a sweetener, a flavour enhancer or a bitterness masking agent

Patent document WO 03/030883 A1 (Kosmos Pharma) describes a film drug delivery composition comprising (i) a flowable water-soluble film forming matrix; (ii) a particulate bioeffecting agent uniformly stationed therein; and (Hi) a taste-masking agent coated or intimately associated with the particulate to provide taste-masking of the bioeffecting agent. Thaumatin is only mentioned as an optional ingredient within a long list of sweeteners. Also, in JP 59125846 (Kanebo Foods) Thaumatin is mentioned within a list of possible sweeteners in a chewing gum cake composed of chewing gum and small pieces of a film having high sweetness, having extremely long durability of the taste and flavour. When the taste of the main chewing gum is lost by chewing, the film pieces are put into the mouth, and chewed together with the chewing gum giving the enjoyable taste and flavor for a longer period.

Talin® is used at very low dosages being freely soluble in cold water.

Controlling the dosage of this product is essential as the effective range is quite narrow. Additionally, the pure form of Talih® can cause a sensitization_/ reaction to handlers who are exposed to the powder, in particular when the free flowing particles become airborne, this can result in severe irritation to the upper respiratory tract and eyes.

Therefore, it is desirable that a dosage unit should provide an effective means to deliver Talin® to the target site in such a form that the persons are not exposed to its powder when handling it, especially within the food or beverages industry.

In order to avoid the possible above mentioned problems, the present invention uses water soluble films to accurately control the dosage of Thaumatin into a master mix. The water soluble film is formed into a continuous strip which contains clearly defined units of Thaumatin of a controlled concentration. The cutting or removal of an exact unit of film via perforations or defined printed markings will deliver an exact weight of active ingredient. It can then be added into the aqueous phase of a mix during which time this cold water soluble film dissolves and Thaumatin is released. Summary of the invention

In one aspect of the present invention, there is provided a water-soluble film comprising Talin® as the only active agent which can be divided into equally sized dosage units having substantially equal amounts of the active and a method of forming the same. This delivery form is particularly advantageous because it permits large areas of film to be initially formed and subsequently cut into individual dosages units without concern during the handling. In the second aspect of the invention, there are provided some examples of its use within the food and beverage industry.

The use of this invention, as applied to Talin®, would allow customers to accurately dose this compound into their product by cutting or tearing off a measured length of water soluble film at clearly indicated intervals.

The ingredient is further protected within the matrix and would thus enable operators to safely handle this material. The concentration of Talin® added to the film can be varied subject to customer requirements and is homogeneous throughout the film. Application quantities can be controlled through changes to the width and length of the film. This would be of critical importance as the weights required to be measured are generally very small.

Detailed description of the invention

The present invention provides an edible cold water soluble film characterized because it comprises Thaumatin (Talin®) as the only active agent and the use of such film in the food and beverage industry. Being Talin® the only active, the main concern is the forming of the film matrix containing it distributed in a uniform way, that is, the composition of the film and the different steps during the processing which can influence the results of the end product.

One of the most important ingredients of the film forming composition is water.

When the active is combined with the polymer in the solvent, the type of matrix that is formed depends on the solubilities of the active and the polymer. If the active and the polymer are soluble in the selected solvent, this may form a solution. However, if the components are not soluble, the matrix may be classified as an emulsion, a colloid, or a suspension.

The film matrix material comprises as film forming material one or more water soluble polymers. The polymer may include cellulose or a cellulose derivative, selected but not limited to the cellulose ethers group encompassing hydroxypropylmethyl cellulose, methyl cellulose, ethyl cellulose, hydroxyethy! cellulose, hydroxypropyl cellulose, carboxymethy! cellulose, polyvinyl alcohol, polyethylene glycol, and combinations thereof. Further, it may include modified starches, and water soluble gums such as, natural gums, edible polymers, alginates, carrageenans and corresponding derivatives, like tragacanth gum, guar gum, xanthan gum, acacia gum, Arabic gum. A preferred example of the film forming material is hydroxypropylmethyl cellulose.

Other ingredients present in the water soluble film of the present invention are the plasticizers. Examples of suitable plasticizing agents include but are not limited to glycerin, polyethylene glycols, polypropylene glycols, monopropylene glycerol, glycerol monoacetin, diacetin, or triacetin, polyethylene glycol and sorbitol. The preferred plasticizer is glycerin, which ensures optimum release of the active from the belt and maintains a smooth product appearance absent from any defects such as pinholes.

Also, optionally some coloring agents could be added to impart the film with a colour coded to distinguish the formulation without imparting any undesirable flavour taints.

Further, it should be known that with reference to specific technological applications of the delivery system, three examples have been selected based on the multi functional properties that Talin® can offer i.e. flavour enhancement within a beverage system, an alternative sweetener within confectionary and finally bitterness masking within a bakery system.

Preferred formulation of the invention

Taking into consideration the special situation of creating a water soluble film with only one active ingredient and considering its uses, the preferred film composition according to the present invention comprises: a) 1 to 41% by weight of Thaumatin (Talin®), b) 31 to 94 % by weight of hydroxypropylmethyl cellulose, c) 1 to 21 % by weight of glycerin, and d) 4 to 9% by weight of water.

And within these selected components the preferred range of each one is:

a) 5 to 15% by weight of Thaumatin (Talin®), b) 64 to 86 % by weight of hydroxypropylmethyl cellulose, c) 5 to 15% by weight of glycerin, and . d) 4 to 6% by weight of water.

The ranges provided herein are percentages by weight of the composition (wt.%), once dried, as shown in Table 1.

TABLE 1

Inclusion of Talin® 1 to 41% 5 to 15%

Inclusion of HPMC 31 to 94% 64 to 86%

Inclusion of Glycerin 1 to 21% , 5 to 15%

Moisture Content 4 to 9% 4 to 6 %

Film Thickness 20 to 150 microns 40 to 75 microns

With these selected ingredients and the processing steps as explained below, a water soluble film impregnated with Tafin®, which has a final substantially uniform thickness within the range of 20 to 150 microns, preferably within the range of 40 to 75 microns, is obtained. The shelf life of the film is at least 12 months and normally 18 months if the customer storage conditions are adequate.

Process description

The first point to consider with the mixing phase is the size of the mixer in relation to the batch size. There is the risk that if the batch size is too small then air will be incorporated into the mix. If this occurs then further processing problems could result during the casting and drying stages resulting in excessive bubbles in the finished film giving a non uniform appearance. Generally, the mixer specification must be sufficient to form a homogenous solution without the inclusion of air bubbles. Heating is required to ensure dissolution of the hydroxypropyfmethyl cellulose in water prior to addition of Talin® and glycerin.

Hydroxypropylmethyl cellulose (HPMC) is prepared as a 10% solution (10g

HPMC / 9Og water), heated gently to 9O⁰C for minimum 3 minutes to fully dissolve the particles and optimize ease of mixing. Afterwards the solution is allowed to cool to ambient temperature, preferably 17 to 24⁰C after which Talin® is added at the required amounts. The actual range at which Talin® can be added to the liquid phase is 0.1 to 11.0 % with a preferred range of 0.5 to 2.3 %. Glycerin is similarly added at this stage from 0.1 to 5.5 % within the actual range and 0.5 to 2.3 % in the preferred range.

The solution is finally pH adjusted to ensure optimum performance, typically to a pH between 2.5 and 5.0.

Casting and drying phase.

After the desired components are combined to form the matrix, including the polymer, water, the active and the other components as desired, the combination is formed into a sheet or film, by any method known in the art such as extrusion, coating or casting. It is important to select ^a method that will provide a flexible film. The films of the present invention must be formed into a sheet prior to drying. Coating or casting methods are particularly useful for the purpose of forming the films of the present invention.

Solution casting is a technique known by those skilled in the art of the processing of thin soluble films and fully applies to this invention. Although processes may vary in their technical design and absolute control in obtaining a final product specification, the individual process steps are aligned. The following process description provides a generic overview of the phases involved in the film formation containing Talin®. Further to this, additional detail will be given on the handling of the film with reference to specific examples of food and beverage applications where differences in process technologies are indicated

The stable solution is further cast on to a stainless steel belt within 24 hours of mixing via a pressurized nozzle injection system. The solution is further dried to form a flexible film; during which the temperature and time of the drying process can be adjusted to give the required thickness and moisture content. The temperature of drying can range from 40 to 85⁰C. Drying above 85⁰C could form patches of discolouration. The process is also influenced by humidity conditions particularly at the end of the drying stage where the product could absorb or lose moisture.

The final combination of thickness and moisture, as shown in Table 1 is fundamental to ensure that the final flexible film is strong enough to withstand further processing. A moisture content of less than 4% or thickness of less than 20 microns can result in a more brittle film prone to cracking and in extreme cases breakage; alternatively a higher moisture content film of greater than 8% could result in a reduced shelf life. This is more applicable to final storage conditions where poor temperature control may result in softening of the film and mould growth. Generally preservatives are not required if the end moisture is adhered to. In addition the pH of the solution, typically 2.5 to 5, will assist in maintaining a low risk environment.

Printing

The film can be further printed at regular unit intervals to display instructions for use e.g. 'cut here' with marking lines and infoπriation relating/ to a known quantity of

Talin®. It is also possible to use perforations to allow ease of release into the mixing vessel and also in a manufacturing environment where scissors are not permitted.

Further the film can be colour coded to distinguish the formulation without imparting any undesirable flavour taints

Film reels and storage

The final continuous sheet of film can be of variable length and width however the length is dependent on the mix size and also governed by safety restrictions on the weight of individual reels which should not exceed 25kg. The finished reels are then rolled on to spools and can be protected by a food grade outer film. The reels can be further stacked on a separate pallet, shrink wrapped and, afterwards delivered to the customer. The film should not be exposed to excessive heat or light which could have a detrimental effect on the product shelf life. Processing of water soluble film strips impregnated with Talin®

As disclosed before, the strips of film can be printed with information of use to the operator e.g. level of Talin® within the unit section which can correspond with the quantity per mix. In some cases this may correspond to multiple units pending mix size. In addition the use of perforations will facilitate the release of individual units or alternatively small dotted printed lines to indicate position of cutting. Each individual section will have a known concentration of Talin® which can be varied according to customer requirements.

The cold water soluble film will fully solubilise up to temperatures of 45⁰C within an aqueous environment of a preferred optimum range of 15° to 25⁰C. Minimum time of dissolution is 4 minutes without the requirement of any mixing. Shear does not offer a faster rate of dissolution. If shear is applied it will only ensure ease of dispersion and produce a more homogenous mix.

The features and advantages of the present invention are more fully shown by the following examples which illustrate liquid and finished film compositions of the actual and preferred range, and are not to be construed as limiting the invention in any way.

Examples

All the formulations are based on a 10% HPMC solution (10% HPMC + 90% water).

Actual Range

Examples 1 - 6 include the upper and lower limits of Talin®, Glycerin and moisture within the liquid and film composition. It also highlights glycerin at intermediate levels.

Ex.1: Film containing approximately 4% moisture level, 1%Talin® and 1% Glycerin

Ex. 2: Film containing approximately 4% moisture level, 40%Talin® and 1 % Glycerin

Ex. 3: Film containing approximately 8% moisture level, 1%Talin® and 20% Glycerin

Ex.4: Film containing approximately 8% moisture level, 40% Talin® and 20% Glycerin

Ex. 5: Film containing approximately 8% moisture content, 40% Talin® and 6% Glycerin

Ex. 6: Film containing approximately 4% moisture content, 1 % Talin® and 9% Glycerin

Preferred Range

Examples 7 - 12 include the upper and lower limits of Talin®, Glycerin and moisture within the liquid and film composition. It also includes glycerin at intermediate levels.

Ex.7: Film containing approximately 4% moisture level, 5%Talin® and 5% Glycerin

Ex. 8: Film containing approximately 4% moisture level, 15%Talin® and 15% Glycerin

Ex. 9: Film containing approximately 6% moisture level, 5%Talin® and 5% Glycerin,

Ex. 10: Film containing approximately 6% moisture level, 15%Talin® and 15% Glycerin

Ex. 11: Film containing approximately 6% moisture content, 5%Talin® and 8% Glycerin

Ex. 12: Film containing approximately 4% moisture content, 15%Talϊn® and 9% Glycerin

Concentration levels within unit sections of fifm

The following provide examples of different inclusion levels per a known unit section. The examples clearly highlight how the same concentration can be achieved on changes to the individual unit length and width. The examples are based on the extreme values of the actual and preferred range.

A film manufactured under a typical film casting production process as discussed earlier, with a thickness within the range 20 - 150 microns will have a surface area of 15/3 m²per kg of film. The concentration of Talin® can be varied within a known surface area.

Actual range

Example 1: From an inclusion level of 1%.

This is equivalent to 10g / 15.3m² Thus 66mg is present in 0.102 m² 0.102 m²is equivalent to 10.2 cm x 1m.

Example 2: Doubling the width and decreasing the length by 50% will still contain the same level of Talin®, that is, from an inclusion level of 1% 66mg is present in 20.4cm x 0.5m. Example 3: From an inclusion level of 40%.

This is equivalent to 40Og /15.3 m² Thus 2.6g is present in 10.2cm x 1m.

Example 4: Reducing the width by 50% and doubling the length. Thus 2.6g is present in 5.1cm x 2m.

Preferred range

From known data 15.3m² /kg of film can contain varying inclusion levels of Talin®, in this case 5 to 15%.

Example 5: From an inclusion level of 5%.

This is equivalent to 5Og / 15.3m² Thus 0.33g is present in 10.2cm x 1m.

Example 6: Doubling the width and reducing the length by 50%. From an inclusion level of 5%. Thus 0.33g is present in 20.4cm x 0.5m.

Example 7: From an inclusion level of 15%.

This is equivalent to 15Og / 15.3 m² Thus 1g is present in 10.2cm x 1m.

Example 8: Doubling the width and reducing the length by 50%. From an inclusion level of 15%. Thus 1g is present in 20.4cm x 0.5m. Use of the water soluble film comprising Talin® within the food and beverage industry

The following examples have been selected to illustrate the different properties and application rates of Talin® delivered via a thin strip of film into three main applications, namely; (i) flavour enhancement within a soft drink beverage at O.δppm;

(ii) alternative sweetener in confectionary at 26ppm; and (Hi) bitterness masking within bread at 5ppm.

The examples also highlight the potential differences in permutations of strip dimensions and number of strips which can be added.

It should be noted that due to the properties of the film it must currently be manually transferred to the aqueous phase of the mix and does not include interference from any other ingredients during the dissolution stage. The two preferred routes for the handling of this film are thus:

(i) a batch mixer where the lid can be easily opened and the strip(s) added directly to the pre delivered water by the operator

or in the case of continuous mixing,

(ii) preparation of a stock solution of the Talin® in water which can then be metered into an enclosed mixer as required

With reference to the following specific examples each mixing phase has been trialed separately with the given recommendations. The rate of dissolution in this patent is described as the time taken for the piece or pieces of film to fully disintegrate within the aqueous phase at a preferred temperature. The minimum dissolution time recorded is 4 minutes without shear within an optimum temperature range of 15 to 25⁰C. If the temperature falls outside these limits then the rate of dissolution will start to reduce.

Further the temperature of the water should not exceed 45⁰C or the film will only start to disintegrate very slowly and have a detrimental effect on the time for further processing.

The requirement for mixing is not essential as the film will fully dissolve in water without shear, however the advantage of mixing is that it will allow thorough dispersion throughout the aqueous phase. Example 1 : Flavour enhancement within a carbonated soft drink

The carbonated drink industry has grown considerably over the last 10 years and, as such, the level of technology has progressed from batch to continuous mixing. In the case of the latter it is important to note that if the mixer cannot be accessed manually by the operator then a separate mixing tank for a stock solution is made available. The following is based on manual access to a premix tank.

Objective: To ultimately enhance the flavour of a carbonated soft drink through the application of O.δppm of Talin®; delivered via a cold water soluble thin film. The chosen batch size is 100kg.

Calculation: O.δppm = 0.00005% = 50mg / 100kg

According to Example 1 of "Concentration levels within unit sections of film":

66mg is present in 1m x 10.2cm, thus 50mg can be added in 1m x 7.7cm or 0.5m x 15.4 cm (twice the width and half the length delivers the same quantity)

The strip of dimensions 0.5m x 15.4cm containing 50mg Talin® was dissolved in 30kg of water as part of Pre Mix 1.

The application of low shear is utilized in this example and has the advantage of ensuring even dispersion of Talin® throughout the mix.

In order to manufacture 100kg of carbonated soft drink Pre-mix 1 & 2 are prepared according to the amounts in the Tables below and further diluted using the following process:

(i) Deliver the water into the mixer.

(ii) Set the water temperature between 15 and 25⁰C.

(iii) Open the mixer and add the film containing O.δppm Talin® of 0.5m x 15.4cm. (iv) Set the mixer on low speed for minimum 4 minutes to ensure dissolution of the film.

(v) Once the film has been fully dissolved the remainder of the minor ingredients are added and mixed in.

(vi) Once Pre-mix 1 is fully mixed it is transferred to Pre-mix 2 which contains liquid sugar and citric acid. (vii) After mixing of Pre-mix 1&2, the composite mix is further diluted with the remainder of water.

(viii) Finally the composite mix can be carbonated, (ix) Pasteurization of the carbonated mix is the final stage prior to packing .

Pre-mix 1

Pre-mix 2

Mix stage 3: Dilution with water

Pre Mix 1 & 2 combined 39.89 Water 60.11

Example 2: Alternative sweetener within sugar free confectionary

Objective: To provide an alternative sweetener within sugar free confectionary through the application of 26ppm of Talin® delivered via a water soluble thin film, after using a separate holding tank for the dissolution of the strips without application of shear. The chosen batch size is ITonne.

Calculation: 26ppm = 0.0026% Talin® = 26g / 1 Tonne batch

According to Example 3 of "Concentration levels within unit sections of film":

2.6g can be added to a strip size of 1m x 10.2cm. Thus 26g can be added as either 10 strips of 1m x 10.2cm or 5 strips of 1m x 20.4cm

In this example, 5 strips of 1m x 20.4cm will be dissolved in 300kg of water as part of Pre-mix 1 , clearly shown below in the process diagram

Note the time taken to dissolve 1 piece, 5 or 10 pieces of an identical total length is exactly the same.

Composition of 1 Tonne batch

1 Tonne of Talin® in Sugar - Free Confectionary is prepared using the following steps of the process:

(i) Deliver the water at ambient temperature into a separate holding vessel.

(ii) Set the water temperature between 15 and 25⁰C.

(iii) Add the 5 strips of film containing Talin®

(iv) Allow minimum 4 minutes to ensure dissolution within the aqueous phase.

(v) After transfer to the main mixer return to step (i) and repeat as necessary. (vi) The solution can be stored only for 24 hours prior to its use and should be discarded after this time to prevent any potential micro activity.

Solution No.2 (vii) In a separate mixing vessel prepare 50% acid solution (either lactic, malic or citric acid).

(viii) Add flavour and colour to 50% acid solution, (ix) Blend all ingredients on low shear until fully mixed.

Manufacture of Hard Boiled Sweets

(x) Deliver the pre manufactured Taiin® Solution into the mixing pan complete with heating elements.

(xi) After adding the Talin® solution, low shear is applied for 2 minutes prior to adding the isomalt to ensure complete dispersion,

(xii) Add the required amount of isomalt (xiii) Heat the Talin® solution and isomalt slowly with continuous mixing until the solution reaches 16O⁰C and maintain for 5 minutes.

(xiv) Allow the solution to cool to 130⁰C and add Solution No.2 with continuous mixing.

(xv) Maintain temperature at 130⁰C and while free flowing deposit into moulds, (xvi) Allow to set for minimum 30 minutes prior to packing into appropriate film /wrapper.

(See process outline in next page)

Process outline for the manufacture of hard boiled sugar- Free Confectionary

Isomalt

Example 3: Bitterness masking of a soya based improver within bread

Objective: To mask the bitterness /off notes imparted from a soya based flour improver in a traditional white pan bread formulation through the application of 5ppm Talin®; delivered via a water soluble thin film. The chosen batch size is 220kg based on a batch system.

Calculation: 5ppm = 0.0005% = 5mg /kg According to Example 7 of "Concentration levels within unit sections of film":

1g is present in 1m x 10.2cm. Thus 1.1g can be added as 1 strip of 1m x 11.22cm or

1.1g can be added as 2 strips of 0.5m x 11.22cm

In this example, 2 strips of 0.5m x 11.22cm will be added. These strips will be dissolved in 78kg of water and low shear will be applied as clearly shown in the process outline

Formulation

Key process steps to manufacture 220kg of bread dough are the following:

(i) Deliver the 78kg water into the spiral mixer prior to adding 1.1g Talin® in 2 strips of film (0.5m x 11.22cm) (ii) Set the water temp to between a preferred range of 15 to 25⁰C (it should not exceed 45⁰C for optimum dissolution)

(iii) Open the mixer lid and add the 2 strips of film (0.5m x 11.22cm) (iv) Set the mixer on low speed for minimum 4.0 minutes to ensure uniform dissolution of the film into the aqueous phase (v) Once the film has been fully dissolved, the remainder of the ingredients can be added, (vi) Next add the pre-weighed salt, flour improver and yeast (pre dispersed in 3 kg of water).

(vii) No intermediate mixing is required at this stage, (viii) Next transfer the 132kg wheat flour into the mixer, (ix) Set the Spiral mixer on slow speed for 3.5 minutes to gradually incorporate the flour and minor ingredients. (x) Further set the mixer on fast speed for δminutes to allow full gluten development as shown by elasticity and smooth surface of the final dough.

Proving and baking stages

(i) Allow the dough to rest for 3 minutes prior to removal from the mixing bowl, (ii) Divide the dough into smaller manageable blocks of approx. 10kg. (iii) Transfer the dough to a divider and former where they are formed into 1 kg uniform shapes to fit the base of the baking tins.

(iv) Stack the baking tins on to vertical racks and then transfer to the prover to initiate the dough development process. Target proving conditions are Relative Humidity of 80% (+/- 5%) and temperature of 4O⁰C (+/- 5⁰C) for 45mins (+/- 5mins). (v) After proving remove the racks and position in the ovens, the target baking conditions are 180⁰C (+/- 5⁰C) for 25minutes (+/-5mins) (vi) Once baked remove the racks form the ovens and place in a cooling tunnel for minimum 30minutes.

(vii) After cooling remove the loaves from the tins prior to packing in the appropriate film.

(see process outline in next page).

Process outline of the key manufacturing steps

Key advantages of delivering Talin® in an edible water soluble film within the food and beverage industry

The advantages of this invention encompass all the aforementioned examples and can be attributed to general processing within the food and beverage industry, where there is an aqueous phase separate to the interference of any other ingredients.

1. Removal of a need to weigh small amounts of pure Talin® , variations in the concentration of which can have a dramatic impact on the final product.

2. Protection of operators from a potential sensitization reaction to pure Talin® as it will be entrapped within a soluble film and not need to be weighed.

3. The specification (film dimensions. Concentration of Talin® , number of strips) can be designed to fit the requirements of the customer and thus work within the confines of their process technology.

4. The film can be perforated as an alternative to cutting particularly where the use of scissors and knives are not permitted. This will facilitate ease of tearing and addition of the strip(s) to the mixing vessel. Further the film can be clearly printed with food grade ink with ppm per unit section.

5. Further the film can be colour coded to illustrate the concentration level and particularly useful if there is a requirement to use more than one specification at site

6. The strip(s) of film can fully dissolve in an aqueous phase without the requirement of shear thus if the process cannot be accessed manually then a separate holding tank can be utilized to allow free dissolution of Talin®.

7. Further to point 6, it is recommended that on transfer to the mixing vessel low shear is applied to ensure uniform dispersion within the mix and final film. This should be done prior to the addition of secondary ingredients

Claims

1. An edible cold water soluble film characterized because it comprises Thaumatin (Talin®) as the only active agent.

2. A film according to claim 1, which comprises as film forming material one or more water soluble polymers selected but not limited to the cellulose ethers group encompassing hydroxypropylmethyJ cellulose, methyl cellulose, ethyl cellulose, hydroxyethyl cellulose, carboxymethy! cellulose, derivatives thereof and combinations thereof.

3. A film according to claims 1-2, wherein the film forming material is hydroxypropylmethyl cellulose.

4. A film according to claims 1-3, which further comprises an effective amount of one or more compounds selected from the group of modified starches, natural gums, edible polymers, alginates, carrageenans and corresponding derivatives.

5. A film according to claims 1-4, which comprises an effective amount of one or more plasticizing agents selected but not limited to glycerin, monopropylene glycerol, propylene glycol, triacetin, monoacetin, diacetin, polyethylene glycol and sorbitol.

6. A film according to claims 1-5, wherein the plasticizing agent is glycerin.

7. A film according to claims 1-6, which comprises Thaumatin (Talin®), hydroxypropylmethyl cellulose, glycerin and water.

8. A film according to claims 1-7, which comprises 1 to 41% by weight of

Thaumatin (Talin®), 31 to 94 % by weight of hydroxypropylmethyl cellulose, 1 to 21 % by weight of glycerin and 4 to 9% by weight of water.

9. A film according to claim 8, which comprises 5 to 15% by weight of Thaumatin (Talin®), 64 to 86 % by weight of hydroxypropylmethyl cellulose, 5 to 15% by weight of glycerin and 4 to 6% by weight of water.

10. A film according to claims 1-9, wherein said film has a final thickness within the range of 20 to 150 microns.

11. A film according to claim 10, wherein said film has a final thickness within the range of 40 to 75 microns.

12. A film according to claims 10-11, which has a substantially uniform thickness.

13. A film according to claims 1-12, wherein said film can be delivered as a tape on a reel which has substantially homogeneous Talin® concentration.

14. A film according to claims 1-12, wherein said film can be delivered as individual precut strips of defined Talin® concentrations

15. A film according to claim 14, wherein said film is divided into dosage forms of variable lengths and widths to deliver substantially the same concentrations of Talin®.

16. A film according to claim 15, wherein said dosage forms in any predetermined shape are perforated to deliver known equal quantities of Talin®.

17. A film according to claims 1-16, which can be overprinted with marks, divisions, concentration levels or any other required information using food grade ink.

18. A film according to claims 1-16, which could be colour coded with pigments to distinguish different concentrations at a level which would not impart colour or any secondary flavour to the final product.

19. Use of an edible cold water soluble film according to claims 1-18, to deliver small accurate amounts of Talin® into a batch or continuous mix comprising an aqueous phase, during the manufacturing process of ingredients and/or finished products within the food and beverage industry.

20. Use of a film according to claim 19, to deliver Talin® to the aqueous phase where it is freely soluble at an ideal temperature range of 5 to 25⁰C for optimum dissolution.

21. Use of a film according to claims 18-19, to deliver Talin® to the aqueous phase where it fully disintegrates without low shear.

22. Use of a film according to claims 1-21, to deliver Talin® to the aqueous phase providing protection to the operators of the food and beverage industry from exposure to the potentially sensitizing effects of handling pure Talin® in powder form.

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