WO2019180604A1 - A set of dispersible formulations for training to use a potty or a dry bottom toilet for excretion - Google Patents

Abstract

A set of dispersible formulations as a didactic tool for training of small children to use a potty through targeted motivation (subconscious habit) remove strong habit of children to use diapers which occurs with children already since 17 months of age. Due to their composition and size, it motivates a child to use a potty instead of diapers and this way, it fixes its required hygienic habits. Dispersible formulations are loose powders or tablets that are health-safe and contain spectacular substances selected in the group containing colouring agents, effervescent substances or cracking sugar which attract a child at any relieve.

Description

A Set of dispersible formulations for training to use a potty or a dry bottom toilet for excretion Field of Application

The subject of the invention applies to a didactic tool for training of body hygiene of small children using quickly dispersing health-safe formulations.

State of the Art

Almost any parent has met the challenge how to train his/her child in proper body hygiene during its growth. Parents of small children have tried various ways how to motivate their children to do so. The biggest limits or faults that the parents have committed and that are, according to observation, caused by wrong or no idea about feel of children during satisfaction of call of nature into a potty instead of diapers have three basic reasons:

1) inability to fix the child in a potty /dry bottom toilet - comfort, wrong size, stability

2) inability to understand behaviour and recognize the child's maturity - physical, physiological and psychical aspects

3) inability to motivate the child and to keep its attention - motivation

Instead considering this process comprehensively and concurrently from the view of the child, the children have been frequently demotivated or directly dissuaded from using the potty/dry bottom toilet.

Motivation of the child to perform the bodily need / behaviour and to understand the maturity of the child

Concerning the neurological aspect, a child is ready for training at the age of 18 to 21 months when it is able to keep urine or stool willingly. This age is suitable, because the child is ready to train to use a potty at the moment when prerequisites of physical nature are met (the child can walk, is able to go to the loo, can put down its trousers), of physiological nature (it understands that it urinates) and of psychological nature (it does not like diapers, does not feel well, if being polluted). Because of brain development, also emotional experiences of a child become deeper, the child understands what is "right" and "wrong" and it has prerequisites for training of social behaviour. Under right motivation it is able to keep clean. Training of cleanness is the key task what a child should master during this toddler period. It is also an expression of training of social behaviour in a broader sense. For example, Freud has attributed the effect on development of required properties like diligence and exactness to training of cleanness. This way it can get into dangerous situations. Children of this age touch everything and want to taste it. Some parents limit the investigative activities of the child with series of bans, orders, and possibly punishments to prevent such risks. But parents do not realize that the child just passes a fragile period of development of its personality and any inhibition of its independence can disturb its development. It is more advisable if parents do not prevent their child in increasing independence but they adopt measures that facilitate the investigative effort of the child and also limit occurrence of injuries.

The runaway development of cognitive, emotional and locomotor capacity in this period is determined by maturation of brain tissue. This is also a prerequisition for training of cleanness, one of the key tasks of a child in this development stage.

Toddlers feel full rectum and urinary bladder and they are able to control activity of anal sphincter. If being positively motivated, they are happy with their success in cleanness keeping.

Bad experience with a potty, negative reaction of parents if an“accident” has occurred, or hurrying in satisfaction of the need can result in aversion to the potty. Stubborn, headlong and potty -rejecting due to timidity children require special attention. The positive motivation in children’s training gives best results in all these cases.

Recognition of efficient motivation itself plays a key role. For example, conscious external motivation specified as a goal - the child gets something for relieving but it does not care about relieving itself and soon it looses motivation and concern for the not-changed award. In most cases, with permanent effect or“award“, it is only a timely effect and the child rejects the training later. The child is not adequately motivated again and again, and the stereotypes of hygienic behaviour are not fixed.

The outcome of this process is a wrong idea that the child is not ready even in the higher toddler age and the training is postponed for later. Quite frequently we can see children using diapers all the day even till four years of age.

Motivation of child and keeping its attention

Sitting the child on a potty and its motivation to relieve is the first step to successful training. But the rise of the habit is important. A habit is a relation of a man to something or his way of action risen due to regular repetition, it is an issue of longer and more demanding effort. A well fixed habit facilitates the situation. It works itself without major effort, everything is fixed in subconsciousness. The habits start regardless of being good or bad. Unsuitable habits should be eliminated and disposed. In acquiring habits, it is advisable to proceed slowly and systematically. Most of child’s training is done based on conscious activity without effect in subconsciousness.

The perception of consciousness means vigilance, oriented attention, work (operation) memory or memories and self-awareness and personality, as well. But awareness has only limited capacity and the subconscious alias the unconscious operates at the moment when consciousness is overloaded with stimulation from neighbourhood. It sends to consciousness some information or signals, possibly warning and negative ones, or pleasant and positive ones which we can sometimes mark as the so called sixth sense, thus ability to perceive and assess inconspicuous or hidden facts. Thus not-all information and experience are controlled consciously, a man is not aware of overwhelming majority of experience and knowledge in his unconscious. But the unconscious keeps the information only till the time when he notices something known consciously. At this moment the unconscious provides all the information somehow related to this stimulus for the conscious. Mostly it is so much that there is no chance to realize it consciously, and thus only some part of it is selected and the conscious operates with it. Thus the subconscious operates in the principle, what we have learnt and experienced. So that the conscious activities could pass into the subconscious particularly in small children and become a habit, this requires frequent repetition with strong external and internal motivation. In the broad meaning, the motivation means a complex of factors, phenomena and processes that stimulate, regulate, maintain and target human behaviour. It consists of instincts, needs, interests, goals, aspirations, ideals, values and philosophy of life.

The learning itself is purposeful, and therefore it cannot exist without psychical activity of the learning person. Such an activity follows from the motivation above all.

External motivation in learning is understood to be such a state when a person does not learn from its interest but under effect of external motivation factors - awards, orders, threats and the like. It is evident that external motivation in learning has less value than the internal motivation. In small children, the training runs frequently under effect of the external one, and the external motivation frequently results in a situation when the activity that should be managed is very disliked, and this way happens that it causes a frustrating barrier. When overcoming a frustrating barrier, the pleasant experience does not result from the training process but from the goal achieving. In this case, it may happen that second time a“smart” child evades the learning process and tries to achieve the goal through“cheating”, the child for example sits on a potty but relieves elsewhere, it runs away permanently and the like. Or the child loses interest in the goal and thus also the attention.

The internal motivation is understood to be a state when the state“forces” the person to do something or to learn something for his/her own satisfaction, for own experience. A person that is motivated for learning internally learns willingly because he/she likes the learning and he/she is satisfied with its outcome. The internal motivation is much more important for learning because the stimulus for learning comes directly from the child learning and so it is more interesting for him/her, thus the child has more patience and determination.

In spite of the higher value of the internal motivation, we may not neglect the external motivation in learning. This is in the parent’s hands. For majority of children we can achieve that the need to learn would rise under effect of the internal motivation but there are such children where external motivation is necessary. The external motivation can turn into the internal one.

Internalisation of the external motivation requires some prerequisites:

1. Development particularities of the children: motivation and development particularities must be harmonised. If a task is beyond child’s forces, if the target is too far, the external motivation will not fix.

2. Past experience: learning is most affected through previous experience, failing to respect means failing to motivate the child for further training.

3. Self fulfilment: the child cannot be motivated for further learning without respecting the self fulfilment ambitions.

4. Aspiration level: under this notion, we understand what a person expects in learning in the field of his/her success.

5. Interest: recognition of interest of the child provides important tools for motivation. Children are better motivated in learning things they are interested in.

6. Knowledge of results of the performance in training: if children know the achieved level, this knowledge becomes a strong motivation factor for further stages.

7. Setting of goals: precise and clear partial goals that the child strives to achieve become strong motivation.

8. Trend to finish the task: within addressing the task,“a strained system" rises in the person that is oriented on achieving the goal. When the goal is reached, the strain relieves.

9. Award and punishment: they used to be a traditional educational tools. Recently there have been trends among experts to re-assess the current position. They have concluded that neither punishment, nor award are the right motivation for a child and that it is much more efficient to work with opportunities provided by moral development when we guide the child to the required behaviour through awakening its own conscience. Only positive motivation is applied particularly in case of small children training. Negative motivation is quite undesirable with regard to the development of child’s character.

10. Success and failure: success experience in learning motivates the child to pass over failure, and thus it spends more effort to learn.

Currently dispersible formulations are marketed in the form of tablets or grained powders with medical substances, used for treatment of patients in the pharmaceutical or food industries in production of food supplements in the form of effervescent tablets and some types of sweets. In that case the formulations and tablets serve for direct consumption. In some variations they also are used in cosmetics for manufacturing relaxation baths which serve to induce pleasant sense on the body above all due to aromatic (scented) components, hydration components and the like. However, in the current form and composition they are not applicable to the smallest children. Several available formulations of tablets designed to dissolve or disintegrate (breakdown) in fluid are used in the pharmacy above all in the form of orally dispersing tablets and films which dissolve/disintegrate quickly after administration into a mouth cavity and easy-to-swallow solution/suspension is formed. Above all, they are used for patients with problems in swallowing (for example children, elder persons, psychiatric patients, patients with dysphagia and the like). Orodispersible tablets or ODT (EL:“Tablets breaking down in mouth before swallowing“) are uncoated tablets that disperse quickly after insertion into mouth even before being swallowed. They must pass the pharmacopoeial test on breakdown of a tablet within 3 minutes.

Further there are several tools marketed in the field related to this problem, and they treat training of body hygiene of children using a potty or a loo. Various tools are applied into the loo or potty which can produce sounds or move. Particularly for boys, for example a hoop like for basket-ball is applied into a bowl or a free flowing picture is inserted and it moves in the urine flow to attract attention of the child. Most documents describe self-sticking papers or various pads to stick to the bottom of a potty or a wall of a loo. They can have several layers, for one or several use instances.

Available training tablets - Whiz Kids Potty Training Tablets , they are intended for use by children from 3 years up. According to their description, presented by the manufacturer, this are compacted effervescent tablets with small size, approximately 8 mm which are thrown in a toilet bowl or in a potty and they start fizzling under contact with water immediately and they paint the water. A marketed formulation has this composition: sodium carbonate, sodium bicarbonate, lactose, citric acid, mineral oils, colouring agents and PEG 3350 (polyethylene glycol). In case of mineral oils, it is a mixture of fluid hydrocarbons that is acquired through refining and cleaning of petrolic mineral oils. The substance is labelled as a dangerous one and is banned in the EU. However, the producer does not present the precise shares of the components. Moreover, appearance of the tablets recalls available sweets strikingly which increases the risk of being consumed by a child. After being accidentally consumed by a child, the child can experience laxative effects and because of small size it can be inspired by small children. Substances contained in tablets from the view of accidental consumption by a child:

FD&C Blue #1 (Brilliant blue - Brilliant blue FCF (Cl blue for use in food 2) - El 33, manufactured synthetically of coal tar, unsuitable for children, the colouring agent is fully harmless for other applications than in food. Studies on rats have found occurrence of malign tumours in points of injection or after consumption. Cases of toxic nature of the colouring agent with patients have been registered - in the cases when the colouring agent should serve for diagnosing aspiration functions of patient, it has been established that it colours urine, fecal solids and skin. This has been related to other negative effects like decrease of blood pressure, occurrence of metabolic acidosis or death. D&C Red 33, also known as Acid Red 33 or Red 33 is a red azo-colouring agent, in the USA only permitted in cosmetic products used far from eyes - H319: causes serious irritation of eye [Warning serious impairment of eye / irritation of eye ] - it is used for example as a colouring agent into non oxidation colouring shampoos, content of heavy metals is familiar: antimony, arsenic, mercury <5 ppm, cadmium <10 ppm, lead <20 ppm, cosmetic colouring agent Cl 17200, banned completely in the EU since 2009, in the food industry formerly as a food red 12 - currently banned in all countries; FD&C Yellow #5 (tartrazine - Cl food yellow 4) - food industry E102 - it is manufactured synthetically of coal tar, unsuitable for children, research results of Washington University indicate that tartrazine is a possible agent of dermal tumours. Another possible outcome of consuming tartrazine is rise of children’s hyperactivity. In individual persons, symptoms similar to hay fever (cold, cough, headaches, and the like) can occur after its intake. The research has shown that some people suffer from nettlerash, asthma, allergic reactions or acne in case of tartrazine consumption. Current knowledge inclines to limit it but it is permitted in most countries.

PEG 3350 - it is used as laxative in pharmacy. PEGs are polymers of ethylene oxide and water and they are marked according to their molecular weight. A request to approve their use as a part of coat for food supplements has been submitted for six PEGs in food quality (PEG 400, PEG 3000, PEG 3350, PEG 4000, PEG 6000 and PEG 8000).

Mineral oils - it is a mixture of fluid hydrocarbons that is acquired through refining and cleaning of petrolic mineral oils. It can limit absorption of vitamins soluble in fat (vitamins D, E and K, and some essential fat acids) and it accumulates in an organism. Studies with animals have proved persistence of these substances in organs and they have caused inflammatory reactions. This substance is not allowed in the CR (throughout the EU) in the food industry.

Use of the above commercial products, as common bath mixtures is deleterious, the appearance of the tablets recalls sweets and children could eat them, or inspire them. Laxative symptoms can occur after consumption by children.

US 6811403 has described chemically treated biodegradable material with an impregnated picture - a self-sticking sheet where an indicator in the self-sticking sheet or pad reacts with urine and gets coloured after urination. A luminous picture appears for the child after relieving. The child can see the picture again after each urination, or if the stick is changed, it can see another picture. But using this tool does not cause internalisation of the motivation for the child, and the provided external motivation effect is only temporary. Thus the child is not motivated any more to sit on a potty and to relieve and the habit is not fixed. US 7435867 has described the whole training packet for training of children’s urination. There are bags with urine indicators and a powder mixture, game cards, self-stick sheets and a reward in a gold bag. The content of the bag is poured into a toilet or a potty, it consists of powder with colouring agent and pieces of a cellulose sponge of various shapes. The cellulose sponge expands after urination, and thus the whole content of the bag expands and colouring agents disperse in urine and get the urine coloured. The child is given a sticker after each urination and it can stick it to a card. The child gets award after finishing the whole“training process”. This tool, however, brings too many stimuli for the child together and the child is completely overwhelmed.

US 2013/0157236 has described inflatable pads of various shapes, inserted into a toilet that consists of a cavity, consisting of two sewn plates, and there is loose powder inside. The powder is of citric acid, sodium bicarbonate, sodium carbonate and colour pigments. The pad can be designed shaped like various animals and it can have an internal membrane that separates the internal part in two. Each part can contain different colour. The pad is of biodegradable, hydrophilic material which can be non- woven fabric, polymer fibres or cellulose. After being inserted into water, gas start releasing from a hole on the pad back, the pad starts moving and starts releasing colour flow upstream. Several holes can be in the pad, it is possible that different colours will leave different holes. Release of gas generates bubbles in water and we can hear specific sound which will attract children. Move of the pad will start on putting into water and it lasts for 1-5 minutes depending on quantity of powder. Cover of the pad is insoluble and then it can be washed into sink. The functionality of this tool in a potty is, however, very limited because of the size of the potty and quantity of urine that a child is able to produce in this age. So the necessary motivation would not occur, and on the other hand the child can be disgusted and discouraged from further attempts by a bad function. Moreover, a motivation element for the child is lacking because the colour starts releasing from the pad immediately on contact with water, without the child getting urinated.

Document US 6 648 650 Bl describes a powder including water soluble color additive and a salt. Salt is presented to help the color additive to uniformly disperse. Powder in a potty or a training toilet changes its color from white to non-white since urine or water is present. Document describes a content of chemicals, defines salts and another additives, but the color additive is not specified by its color. Claims describes using the same powder with the same content - the same color many times to induce positive mental association for using a toilet. We found out, that after repeated use child is bored by the same effect - the same color over and over and the positive association is gone. So that, this document is considered to be a part of the state of art, but it not solves the problem at all. No known tool can keep attention of a child for the matter, not even to motivate it to go on and on in the activity, therefore, the training of body hygiene is without any result.

Description of the Invention

A set of dispersible formulations for training to use a potty or a dry bottom toilet for excretion represents an efficient system in the form of dispersible formulations to train right habits in body hygiene of small children already from 17 months of age. The dispersible formulation is thrown or poured into a potty or a dry bottom toilet and the child uses it subsequently to relieve. The child can feel some effects that occur on contact with the fluid, like fizzling or cracking in the dispersible formulation, already during excretion. Having finished, a child usually stands up from the potty to investigate the work. It observes colour of the fluid or fizzling or cracking of the dispersible formulation. When the child needs to relieve next time, it itself reports that it wants to get the dispersible formulation into the potty and it looks forward that as soon as it urinates, there will be a surprise in the form of a colour or a visual/sound effect.

The basic necessary composition of the dispersible formulation consists of the spectacular component and/or the colouring agent. The spectacular component is a fizzling pair or cracking sugar. The colouring agent is any natural colouring agent or any mixture of them. The spectacular component can be mixed arbitrarily together with the colouring agents. The fizzling pair consists of food acid and food salt of weak acid and cracking sugar is oligosaccharide containing carbon dioxide, it is advantageous if this is monosaccharide or disaccharide.

The set of dispersible formulations for training of body hygiene of excretion utilises children’s curiosity and quest to discover. It was found that children’s motivation can only be kept in relation with a moment of surprise. That means the set for training to use a potty or a dry bottom toilet for excretion must provide for various effects within and/or after relieving, namely without possibility for the child to find in advance what effect will follow relieving. The nursing person/parent will provide for the moment of surprise that is oriented on internal motivation of a child through selection of a piece with adequate effect from the set. The parent can select once the fizzling effect, in another case some colour, next time another colour, then cracking and a third colour, and the like. This way a period of time of several weeks of child’s interest, enough long, is maintained that is necessary for forming the habit that will pass into the subconscious due to repeated attempts and the child will report the need to relieve automatically and it will not recall the joy with surprise with the dispersible formulation any more.

Dispersible formulations fit for a child with their size and they present no risk for a child^'s health. A dispersible formulation consists of a loose mixture or a tablet containing quickly soluble basic substances with additives, as filling, bonding and colouring agents approved by the relevant authority, taste and aromatic additives and the like. A dispersible formulation will dissolve in fluid (urine) without residues in less than 5 minutes with a sound and/or optic effect that will attract the child. The set contains more pieces of a dispersible formulation of a different composition which provides different effects in the applications according to the used spectacular component or the colouring agent in that piece of the dispersible mixture or tablet. The set contains a tablet or powder mixtures of two, at least, different compositions of the dispersible mixture, particularly with a different spectacular component and/or a colouring agent. The set combines for example only visual components, thus various types of colours of the colouring agents in the individual tablets, two, at least, colours, or sound components are necessary to provide for the moment of surprise, thus for example a fizzling effect in half of the tablets and a cracking effect in the other half of the tablets. Or it is advantageous if the set combines tablets containing various colours of colouring agents together with a fizzling of cracking effect of sound components. In this case, a child still relieves and it can already hear fizzling cracking of a dispersible formulation and as soon as it finishes relieving and stands up from the potty, a coloured fluid awaits it with a decaying fizzling or cracking effect. The set, however, always contains powders or tablets of two, at least, kinds of dispersible formulations secured with one, at least, spectacular component and/or a colouring agent to provide for a moment of surprise.

Review of benefits of dispersible formulations:

- Special formulation of composition in food and paediatric pharmaceutical quality

- The tool can be used for a small child without age limitation

- Its composition does neither harm a child in case of accidental consumption of the tool nor in case of touch with skin

- the formulations produce less CO2, compared with the state of the art, which results in weaker reactions and lesser percolation of the substances in environment and skin

- Within the reaction no contact of suspension with children’s skin occurs

- The tool is activated with small amount of liquid (2 ml) - better application in a potty which is used most frequently for education of toddlers

- It dissolves without residuum

- Simple application

- Size adapted to the child’s age

The dispersible formulation contains generally substances selected in the following groups: filling, bonding, disintegrating and slide agents, food acids, bitter food alkaloids - corrigents, wetting agents, food colouring agents and spectacular substances. A fizzling pair and cracking sugar are classified among spectacular substances. The fizzling pair consists of carbonate salt and food acid. The substances are quickly dispersible with added spectacular substances which induce an optical or sound sensation to attract a child. It is evident that any given substance can have more than single function, for example it can serve as a filling, bonding and disintegrating agent and also as a slide agent.

Loose dispersible mixtures consist of one, at least, spectacular substance and/or a colouring agent and it is advantageous if any substance as above can be added to it. Tablets of a dispersible mixture consist of three, at least, substances, namely of any spectacular substance and/or a colouring agent or their mixture, a bonding agent and wetting substance. The tablets are produced of loose mixtures, using several methods, for example lyophilisation, shaping, direct compacting or compacting tablets with subsequent sublimation.

Suitable representatives of filling and bonding agents are for example disaccharides (saccharose, lactose), monosaccharides (mannitol), sodium chloride, glucose, gelatine, starch, starch derivatives, cellulose, cellulose derivatives, PVP (polyvinylpyrrolidon), crosscarmellose, aspartame, potassium acesulfame, saccharine and sodium cyclamate. Also mixtures of them can be used. Polymers and crystallic substances like gelatine (hydrogel 4%), starch (hydrogel 10%), cellulose and cellulose derivatives - methylcellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose, sodium salt of carmellose (carboxymethylether of cellulose), synthetic polymers (soluble), lactose, a - lactose monohydrate, lactinol, lactitol monohydrate or b-galactosido-sorbitol, sorbitol, maltitol, xylitol, dry lactitol, dry b-lactose, starches, gelatine, saccharose, glucose, natural gel-forming substances (e.g. tragant), pectin, gum acacia, microcrystalline cellulose, ethers of cellulose, inorganic calcium salts (dicalcium phosphate, tricalcium phosphate, calcium sulphate, calcium carbonate and calcium silicate), povidone, polyvinylalcohol, acrylic polymers and combinations of them are used as bonding agents. Preferably, if saccharides, sweeteners, cellulose and its derivatives, natural gel-forming substances, inorganic calcium salts, gelatine (hydrogel 4%), starch (hydrogel 10%), independently or combined. 10-90 per cent of weight of filling agents is added into the dispersible formulations. Substances that swell, as for example starch, formaldehydcasein, sodium carbonate, hydrogen sodium carbonate, calcium salt of carboxymethylcellulose, sodium salt of carboxymethylcellulose, carbonate salts and salts of acids, microcrystalline cellulose, arbocel, cross-linked PVP, pre-gelatinesed starch and guma guar are used as disintegrating agents. The advantage in using disintegrating agents is such that they serve to speed up granulate breakdown. They are contained extra-granularly that means outside grain and they can be used in range 0.5-99.5 per cent of weight.

Slide substances improve flowability and decrease friction between particles. They are added extra- granularly with weight 0.1-5 per cent of weight. The following appropriate representatives can be mentioned: soap-stone, talc, solid and liquid paraffin, stearin, macrogols, silicon dioxide, magnesium stearate, syolide, calcium silicate, starch, magnesium and calcium stearate, aluminium stearate or calcium stearate, stearic acid and calcium, magnesium and zinc salts of stearic acid (for example magnesium stearate), sodium stearyl fumarate, soap-stone (hydrated magnesium silicate), starches, waxes, glyceryl-monofatty acid, glycerylmonostearate, glycerylpalmitostearate, hydrogenated plant oils (for example cotton oil), plant oil, saccharate esters, glyceryl dibehenate, DL-leucine, glyceryltriacetate, magnesium laurylsulphate, macrogols 4000 and 6000, sodium chloride, adipic acid, sodium acetate, maltitol. Preferably, magnesium stearate is used at level 0.25 - 0.5%, either independently or combined.

As food acids, among other things, it can be mentioned tartaric acid, citric acid, malic acid, ascorbic acid (C vitamin), lactic acid and fumaric acid at level 0.5-99.5 per cent of weight. Preferably tartaric acid, ascorbic acid and citric acid are used.

Bitter food alkaloids - corrigents adjust taste properties of a tablet so that it induces unpleasant bitter feel in mouth for the children after accidental licking off a tablet. This way the tablet becomes untastefull and discourages the child from further consumption. It is advantageous if bitter food alkaloids can be used, selected in the group consisting of derivatives of floroglucinol (1,3,5- benzentriol), iso/a/p-bitter acids (homologues of humulone, lupulone), quinoline alkaloids, tonics, caffeine (protoalkaloids, purine alkaloids, neohesperidine, naringin, terpenes at level 0.1 to 15 per cent of weight.

Suitable representatives of spectacular substances are aromatic (flavouring) substances as etheric oils, effervescent components, polishing substances, salts, fizzling pair (source of acid and carbonate salt in ratio 0.5 to 99.5% of one or another component in the pair), sugar containing carbon dioxide so called cracking sugar - produced of dissolved saccharides, as for example saccharose, lactose or glucose syrup, where carbon dioxide was incorporated, waxes under low temperature. It is preferred if the quantity of the used effect substances is 0.05 to 15 per cent of weight.

The preferred colouring agents are natural ones soluble in water.

Also hygroscopic substances can be added into loose mixtures, they prevent overdrying of granulate. The optimum moisture level of granulate is from 4 to 8%. For example starches, glycerol and propyleneglycol are used.

One or more substances as below can be used as wetting substances. Alkyl sulphates, esthers of propyleneglycol, lecithin, water, de-mineralized water, ethanol (alcohol with various concentration), glycerol, solutions of polymers, like starch hydrogel, solution of gelatine, of polyvinylpyrolidon, solutions of cellulose ethers (methylcellulose, hydroxymethylcellulose), esters of sorbitol. The benefit in using wetting substances is that they belong among indispensable additives for formulation of tablets with quick breakdown in fluid. Moreover, they take part in keeping stability of mixture consisting of immiscible substances.

It is advantageous if the individual component of these substances are ground and sieved through a special mesh. This way the equal size of particles is acquired, and this way a dispersible loose mixture is created. It is advantageous if the mixture is then sterilised. Granulate can be produced for example by sieving and mashing, grinding, aggregation. Dispersible loose mixtures are then packed into various packages, for example capsules, pots, bags and the like. They can be produced as single-dose (split) or multi-dose (not-split) preparations. A single dose in case of a multi-dose preparation is administered with a measure or another tool allowing to measure the required quantity. These mixtures are ready for use, they are poured into a dry potty after the package is opened. Loose mixtures have breakdown time less than 5 minutes in fluid, and it is advantageous if they breakdown in less than 1 minute in 200 ml of liquid.

Further dispersible tablets can be produced of loose mixtures, and they can be produced in several methods: for example using lyophilisation, shaping, direct compacting or compacting tablets with subsequent sublimation. It is advantageous if direct compacting or shaping is used for their production The tablets can be either homogeneous and/or heterogeneous. The term“homogeneous“ means a tablet produced by compacting a single mixture of particles which need not have the same composition. The term“heterogeneous“ means a tablet composed of series of separate areas, for example layers, inserts or coats, and each of them is acquired through compaction of a mixture of particles. The tablets must have the optimum strength (0.06-1.7 MPa) and porosity so that quick dissolution is achieved, and therefore compacting runs under small pressing force, which ranges from 7 to 35 kN. Dispersible tablets can be produced in any shape and size. The tablets use to have cylindrical shape, flat or lens-shaped, edges can be tapered. They can have grooves to facilitate their separation and they can be fitted with a legend or labels. Dispersible tablets usually have the following dimensions: diameter 9 mm to 39.9 mm, height 2 to 10 mm and weight 1.1 to 10 g. 30 mm tablets with height 2 mm to 10 mm are intended for children under 3 years of age, and 17 to 18 mm tablets with height 5 mm are for children elder than 3 years. The manufactured tablets also can be coated to improve their properties. Coated or uncoated tablets are finally packed for example in blisters, PVC tubes, bags and the like. After opening the package, a tablet is thrown into a dry potty.

The tablets are designed in such a way that they get loose and disperse quickly. The optimum porosity enables water to enter the tablets which is the core of dispersion. Higher mechanic strength of a tablet, and thus low porosity result usually in slowing dissolution. Tablets are dissolved using just a little amount of liquid, approximately 1-2 ml, at temperature 1 to 93°C, it is advantageous if at l5°C to 45°C. Quick loosening of a tablet results in quicker absorption and release of colouring agent, aromas or other added components. This differences are given by using various added substances and differences in manufacturing processes.

The whole tablet or powder is activated at the moment when the child relieves. The change of the state just at this moment is one of the key motivation factors. In case of these quickly dispersible formulations, we have the opportunity to catch this moment precisely which facilitates attracting attention of the child and also a pleasant feel of the child is induced. The child will recall this acquired subconscious feel later, whenever it sits down on a potty again.

The set of dispersible formulations for training to use a potty or a dry bottom toilet for excretion thus consists of two pieces of a dispersible formulation, and a dispersible formulation contains a colouring agent or a spectacular component where the colouring agent is selected in these groups of shades of colouring agents or their mixture, a spectacular component is selected in the group of a fizzling pair and cracking sugar and the fizzling pair consists of food acid and food salt of weak acid, cracking sugar is oligosaccharide containing carbon dioxide, and the set contains two types, at least, of a dispersible formulation that differ one from another in one , at least, spectacular component and/or a food colouring agent.

This means that the set can involve any amount of pieces of tablets or packets of powders of various kinds, concerning used colouring agents, types of fizzling pairs or types of cracking sugars. However, concerning the spectacular component, thus the cracking sugar or the fizzling pair, the child cannot distinguish the difference in the qualitative composition, while qualitative change is visible for the used colouring agents, other used colouring agents cause other colour effects in urine. Thus it is enough to change for example only the colouring agent.

It is advantageous if the set dispersible formulations for training to use a potty or a dry bottom toilet for excretion contains one, at least, type of a dispersible formulation containing a fizzling pair and one type of a dispersible formulation containing cracking sugar or one, at least, type of a dispersible formulation containing a fizzling pair and one type of a dispersible formulation containing a colour shade of a colouring agent or one, at least, type of a dispersible formulation containing cracking sugar and one type of a dispersible formulation containing a colour shade of a colouring agent or it contains two, at least, types of a dispersible formulation containing various colouring agents when, for example, one type of a dispersible formulation contains a blue colouring agent and one type of a dispersible formulation contains a mixture of a blue colouring agent and a red colouring agent or any other combination of colours distinguishable by eye as different ones. A dispersible formulation is in the form of tablets or the form of powder, it is advantageous if it contains 10-90 per cent of weight of bonding agents and/or filling agents and a wetting substance, and the bonding agent and/or the filling agent are selected in the group consisting of saccharides, sweeteners, cellulose and its derivatives, natural gel-forming substances, inorganic calcium salts, PVP or their mixture.

It is advantageous if a dispersible formulation contains 0.05 to 15 per cent of weight of a slide agent that is selected in the group consisting of soap-stone, talc, paraffin, wax, stearin, macrogols, syolid, silicon dioxide, silicates, starch, stearic acid and its salts and derivatives, derivatives of glyceric acid, plant oil, saccharate esthers, glyceryl dibehenate, DL-leucine, glyceryltriacetate, magnesium laurylsulphate, macrogols 4000 and 6000, sodium chloride, adipic acid, sodium acetate, maltitol and/or their mixture.

It is advantageous if a dispersible formulation contains a disintegrating agent that is selected in the group consisting of formaldehydcasein, carbonate, salt of carboxymethylcellulose, microcrystalline cellulose, arbocel, cross-linked PVP, guar gum, starch, pre-gelatinezed starch and/or their mixture. The wetting substance in a dispersible formulation is selected in the group consisting of alkyl sulphates, esters of propyl enegly col, lecithin, water, de-mineralized water, ethanol, glycerol, solution of starch hydrogel, gelatine, polyvinylpyrolidon, cellulose ethers, esters of sorbitol.

It was advantageous if the tablets were compacted with the press force 5, 6 and 7 kN, and also stability of tablets thus the necessary destructive force 62 N, at least, increased with increasing press force, and it is advantageous if tensile strength of tablets is 0.75 MPa, at least, and it is advantageous if solubility of tablets is 0.44 min or less.

The tablets have these advantageous parameters:

applied press force 7 to 35 kN, necessary destructive force 11 to 157 kN, tensile strength of tablets 0.078 to 1.838 MPa, crumbliness less than 0.1 to 0.3 % for tablets without starch and gelatine.

Examples of Invention Execution

Example 1

Grainy Powder

Ascorbic acid and sodium bicarbonate were used; the latter was adjusted thermally so that the external surface of particles would turn into sodium carbonate (calcination process). Ascorbic acid and sodium bicarbonate were mixed manually. Preparation of samples was carried out in environment with controlled temperature and low relative moisture, to prevent untimely start of the effervescent reaction because of capture of moisture in raw materials.

In order to achieve the optimum ratio of effervescent components, where the adequate reaction occurs within dispersion, the following ratios of components of acid were tested: salts from approximately 1 : 1.2 to approximately 1 :6. It was found that it is advantageous if the ratio of acid to salt is from 1 :3 to 1 :4. One advantageous configuration has the ratio of acid to salt approximately 1 :3. The optimum ratio of components in the mixture was determined as follows: citric acid 20-25%, sodium bicarbonate adjusted by calcination 75-80%. Finally colouring agent E lOO-curcumin was added into the mixture in amount 1-10 %.

Then the powder mixture was separated into parts of 3 g and packed in plastic capsules with size 2 x 3 cm.

The breakdown time of powder mixtures in ml of liquid was less than 30 seconds.

Example 2

Dispersible Tablet Produced of Grainy Powder

Croscarmellose and colloidal silicon dioxide were filtered and stirred for 30 minutes in a mixer with one cubic double agitator (stirring rate 24 rpm), then ascorbic acid (Northeast General Pharmaceutical Factory, China), citric acid, sodium carbonate and colouring agent in shade Chabrowy (blue) by manufacturer : FoodColours, Poland, were added.

The mixture was stirred for other 20 minutes and then transferred into a drying vessel. The mixture was dried to low percentual relative moisture in such a way that pressure air was driven through round bars placed in the mixtures overnight. After drying-up the mixtures were compacted using 20position tablet press (Fette l200i) fitted with upper and bottom plungers with diameter 16 mm.

The target weight of a tablet was 665 mg ± 3 %; the target strength of a tablet was 70 N; The production rate of a tablet was 20,000 tablets per hour; filling rate : 30 rpm; allowed load: 80 kN; main pressure force was kN: 30 kN; depth of tablet filling: 6.40mm; main compression of height of tablet cylinder: 3.0 mm; pre-compression of height of tablet cylinder: 3.00 mm.

The resulting ratio of acid to salt was 1 :2.

Properties of tablets:

Example 3

Dispersible tablet - Direct Compaction

Preparation of the mixture was divided into three stages. First excipients of stage II for 10 minutes, the resulting mixture was added to stage I and the resulting mixture was stirred for the same period of time. Then stage III was added to the powder mixture of stages I and II. The resulting mixture was stirred for 3 minutes.

The resulting powder mixture was inserted and compacted using a round matrix with diameter 16 mm which resulted in average weight 665 mg ± 3% and average strength 32 N ± 3 N.

Properties of tablet:

Example 4

Directly Compacted Tablet with Effervescent Components Added

Additives 1-5 were mixed in advance and sieved through a wire mesh with mesh size 1 mm and inserted in a mixer. Component 7 was sieved extra through a 0.5 mm wire mesh and inserted in a mixer. The additives were stirred for 25 minutes at rate 20 rpm/60“. Components 6 and 8 were sieved through a 0.2 mm wire mesh and inserted in a mixer. Stirring continued with other additives for 5 minutes at rate 20 rpm/60“. Powder was inserted and compacted using a round matrix with diameter 16 mm which gives average weight 665 mg ± 3% and average strength 35 N ± 3 N

Ratio of acid to salt was 1 :5,25.

Properties of tablet:

Example 5

Tablets Produced by Lyophilization

a) Tablets based on starch:

Modified starch Amylogum™, by manufacturer Avebe, Ltd, U.K. was used for production. It is starch the hydroxyl groups of which have been esterified. Further PEARLITOL® BioPharma, by manufacturer Roquette, France, was used. It is mannitol - low endotoxin, USP, EP, JP. Powder dye in shade Chabrowy (blue) by manufacturer FoodColours, Poland, was used as a colouring agent. The colouring agent was mixed in advance in small quantity of refined water.

Suspension with the colouring agent was added into refined water and starch was added and the mixture was heated under concurrent stirring to temperature of 60°C. The acquired mixture was kept for 10 minutes at 60°C to facilitate dissolution and then it was cooled to room temperature. Mannitol was added after adequate cooling of the mixture and the mixture was stirred to till mannitol completely dissolved. The mixture was batched in 500 mg (± 2%) into PVC/PVdC blistered packages. Finally, the mixture was frozen in flow of cool nitrogen and then lyophilization was carried out at temperature rising from -l0°C to + 20°C at pressure 50 Pa.

Tablets had quick breakdown, in average < 10 seconds in 200 ml of liquid. b) Tablets based on gelatine:

Gelatine, mannitol and colouring agent were added under intensive stirring into refined water and heated to 60°C. Before batching the mixture was cooled to 25°C, then the mixture was batched in 500 mg (± 2%) into PVC/PVdC blister packages with diameter 16 mm. Unsealed blister packages were frozen in flow of cool nitrogen and then the mixture was lyophilised at temperature rising from -l0°C to + 20°C at pressure 50 Pa.

Blistered packages filled with mixtures were unsealed placed into stabilisation boxes and kept there at 40°C and at relative air moisture 75% for 20 hours. Then diameters of individual dried fillings of blisters were measured.

Comparison:

In case of preparations based on modified starch, only 50% shrinking occurs compared with preparations containing gelatine.

Further, the tablets were subjected to a test, whether preparations based on gelatine or modified starch containing colour agent can be prepared without their spontaneous breakdown in the air and rise of cracks would occur (loss of strength due to absorption of water vapours).

Mixtures a) and b) were prepared and after lyophilization each package was subjected to inspection, that investigated occurrence of cracks in the individual blisters. The occurrence of cracks can be established visually, 90% of blisters filled with mixture b) (gelatine) showed cracks, while no cracks were found in blisters filled with mixture a) (modified starch).

For comparison, the same mixtures were prepared with the difference that the fill of one blister was increased to 750 mg. No cracks were found in any sample after lyophilization was completed.

This way it was established that for preparation of a dispersible tablet in case using gelatine with colouring agent is necessary that weight of a single dose of a tablet was higher than in case of modified starch.

The breakdown time was approximately the same in all tablets, < 10 seconds.

The marked disadvantages of lyophilization are high finance and time requirements, fragility, low weight and the sensitivity of tablets to external environment, therefore packages of high quality must be used. Example 6

Dispersible Tablet Produced using Shaping Method

Corn starch, lactose and colloidal silicon dioxide were filtered and stirred for 30 minutes in a mixer with 1 cubic double agitator (stirring rate 24 rpm), then citric acid, sodium bicarbonate, naringin and colouring agent E l60a-carotene were added. The mixture was stirred for a further 20 minutes. Then, wetting of the powder mixture with refined water followed. Refined water was sprayed under permanent stirring on the powder mixture for the period of 3 minutes.

After wetting the mixture was compacted using 20-position tablet press (Fette l200i) fitted with upper and bottom plungers with diameter 16 mm. The main pressure force was 12 kN; depth of tablet filling: 7 mm; main compression of height of tablet cylinder: 3.6 mm; pre-compression of height of tablet cylinder: 4 mm. Speed of movement of the upper compacting plug (compacting speed) was 40 mm. min ¹, pre-load was 2 N and pre-load speed 2 mm.s ¹. The target weight of a tablet 665 ± 3%. The target strength of tablets: 25 N ± 5%.

Then the drying stage followed at 30°C in vacuum overnight.

Properties of tablet:

Example 7

Tablets Produced by Shaping without Compaction Machine

Dispersible tablets were produced manually without using a compaction machine. Corn starch, citric acid, sodium bicarbonate, naringin and colouring agent E 172-iron oxide and hydroxide were mixed manually. Then plant oil and refined water were mixed into the mixture under permanent stirring. Then the resulting wetted mixture was manually pressed into round forms of PVC with size 18 mm and depth 5 mm. Then solvent in the form of cleaned water was removed through drying at common room temperature for 24 hours. Then the tablets were taken from the form.

Properties of tablets:

Example 8

Dispersible Tablet Produced by Compacting from Pharmaceutical Mixed Dry Bonding Agent

Prosolv® ODT G2 (JRS PHARMA GmbH & Co. KG, Germany) is a mixed dry bonding agent containing: MCC (21.6%), colloidal silicon dioxide (2.0%), mannitol (67.3%), fructose (4.9%), crospovidone (4.3%), average size of particles: 59 pm, apparent density: 0.64 g/ml, tap density: 0.76 g/ml, moisture: 0.8%. It was mixed with magnesium stearate (Acros organics, US) in a mixing cube for 2.5 min and with colouring agent E l40-chlorophyl. Then tablets were compacted. Pre-load was 2 N, pre-load speed was 2 mm/s, speed of movement of the upper compacting plug was 40 mm/min. Tablets were compacted with force of 7 kN. The breakdown time of the tablets was < 45 seconds.

Example 9

Example on Comparison of Effect of Compacting Force

Further, the effect of compacting force on stability, strength and solubility of tablets was observed. A tablet mixture was prepared according to procedure in Example 8. The tablets were compacted with compacting force 5, 6 and 7 kN. 6 tablets were prepared with each compacting force.

Comparison:

The tests confirmed positive effect of compacting force on improved stability, strength and solubility of dispersible tablets.

Example 10

Comparison of Properties of Dispersible Tablets Produced in Different Procedures

The instruments as below were used for the measurements: Schleuniger’s instrument for measurement of strength and dimensions of tablets Tablet Tester M8 by manufacturer K. Schleuniger, Switzerland - instrument for measurement dimensions of tablets and force for destruction of a radially positioned tablet under constant load rate.

Instrument for determination of breakdown time of tablets and capsules Erweka ZT 301 by manufacturer Erweka, Germany. Tablets were dissolved always in approximately 200 ml water. Strength of tablets ranged mostly within the optimum range of tensile strength of tablets which is 0.56 - 1.12 MPa. Breakdown times, as well as times to release colouring agent, suit to requirements on quickly dispersible formulations serving as an education tool for training of body hygiene of children using a potty/toilet.

In spite that dispersible tablets with added effervescent components achieved the best average results, it was established that dispersible formulations according to the invention can be produced in various methods and using various excipients. Their resulting properties then can be supported by suitably selected packages, they also can be coated, and the like.

Also it was checked that it is possible to base on pharmaceutical or food-processing approaches and compositions in production of dispersible formulations as education tools for training of body hygiene using a potty/toilet. This way tools can be produced that respect common behaviour of the smallest children which taste everything and for which the subject of the invention has been designed.

Example 11

Study of Disintegration of Dispersible Tablets as Effected by Fluid Temperature

Directly compacted dispersible tablets with effervescent components added achieved the best results in the tests. Because a compacted tablet enables reaction just on its surface, thus where the reactants touch directly water which breaks up the original layer and the reaction passes into deeper layers, it is necessary to also check behaviour of tablets at lower temperatures with regard to possible application of dispersible tablets in a toilet bowl as well. On the other hand, when using it in a potty it is necessary to check the behaviour of the dispersible tablet at higher temperature taking into account urine temperature.

And also acid carbonates and citric acid are not the only components of a tablet as they only are additives facilitating quick dissolution of a tablet. Even though the tablets should have adequately uniform content, actual placement of all the substances in them and actual way of compacting the tablet will be always stochastic to some extent, and this can play a role in quicker or slower dissolution of the tablet. The rate of dissolution also is affected by the moment when a bubble layer adjacent to the tablet is able to generate such force that would bring the tablet to the surface, because as soon as the tablet flows on the surface, the rate of dissolution can decrease because of lesser contact with water. Dispersible tablets according to Example 2 were used for the experiment. They were always dissolved in approximately 200 ml of water. Several tablets in series were weighted within the experiment and this way it was checked that they had similar weight. Water temperature was measured using sealed digital temperature sensors. Time was measured with a stop-watch, and two seconds were considered as measurement uncertainty due to problems to determine the moment a tablet is completely dissolved.

Times for dissolution of tablets at more than twenty various temperatures in range from approximately 1 C to 93 C were measured. The tablets have very small volume compared with water, and therefore they pass to temperature of water without major effect on results. Boiling water from a kettle, cold tap water, water at room temperature and ice, combined one with another in various ratios were used for the measurements, so that we could have approximately uniform distribution of measured temperatures. Always we let ice thaw completely (residua, if any, were taken away), so that pieces of ice would not affect the dissolution of the tablet.

A temperature sensor was inserted in a pot and we waited till the recorded temperature became stabilised. Then we threw a tablet in water, started the stopwatch and registered the temperature, we stopped time measuring when the tablet dissolved and again registered the temperature. The difference between the temperature measured at start and at the end of the measurement due to thermal exchange with environment was negligible. The initial temperature was regarded to be the measurement temperature and its variability was included into the uncertainty in temperature determination, which amount to ±2 ^°C for this reason.

Table 1: Times tfor dissolution of tablets for room temperature T

Select standard deviation ø 5.88 s was calculated from times for dissolution for room temperature extended uncertainty pro 95% probability interval amounted to approximately 14 s.

A surprising finding was that a transition occurs approximately from temperature of 20^°C and rate of dissolution increases with temperature more slowly, first it even decreases, this slower increase of dissolution rate passes away approximately at range 60^°C-70^°C. This condition can be explained most likely that the reaction releases bubbles of carbon dioxide and that we have reactants in the form of compacted tablets, and thus the whole process does not follow kinetics of chemical reactions only but that it also depends on the way how dissolution and disintegration of the whole tablet occurs. The problem is that dissolution of tablets has not the equal character for various temperatures.

When we dissolve a tablet in water of low temperature, thus approximately 0^°C - l9^°C, the whole process runs relatively slowly, this way also the bubbles of carbon dioxide release more slowly, and thus they do not accumulate enough for the tablet to lift it to the surface. Therefore the tablet keeps at bottom completely surrounded with water for an important part of its dissolution process, and this is a factor which facilitates its dissolution significantly. Bubbles raise to the surface only a small, macerated residuum and there is no problem to "dissolve it up".

For dissolution of tablets in water of medium temperature, approximately 20^°C - 60^°C, the reaction rate increased that much that there were bubbles of carbon dioxide enough after a while, so the tablet was raised to the surface in relatively shorter time. However, the reaction was not still extremely intense and the tablet did not manage to soak more water, and so it dissolved on the surface for rather long time because the dissolution rate was markedly decreased as dissolution and reactivity were markedly decreased from one side of the tablet.

In tablets dissolution at high temperature, thus approximately 70^°C - 90^°C, it occurred that tablets floated up very quickly or even almost instantly but the reaction is so turbulent that it markedly facilitates quick disintegration of a tablet. The tablet itself on the surface almost could not be distinguished through a fizzling foam layer, the tablet moved on the surface very quickly and impinged pot walls which likely facilitated its breakdown. Because the tablet reacted quite violently at these temperatures, the "float-up" effect did not brake it so markedly as at medium temperatures. The differences in dissolution were already observed within the tests but another additional experiment was performed where both the total time for dissolution of a tablet and the time till a tablet floats-up to the surface were measured. Its result is that in water with temperature about 90^°C a tablet floats-up almost immediately but it reacts really quite violently. In water with temperature about 3 l^°C a tablet is fully immersed for only 19% of the time for dissolution. But there is a surprising finding that a tablet will stay sunk for 77% of the time for dissolution in water with temperature about l2^°C which is a marked difference. Further we tested a change of temperature as a result of the chemical reaction. A vacuum mug was used as a vessel for dissolution, a temperature sensor was inserted through its drinking hole, it was slightly jammed by closing the mug, so that the system would be well thermally insulated. Only some 44 g of water of room temperature was in the mug, and 5 tablets were thrown inside at the same time. Immediately, we closed the mug cap properly and we followed how water temperature changed as outcome of the chemical reaction under way, thus what its thermodynamics will be like.

We observed that first it is necessary to provide energy in the system for dissolution of a tablet and initiation of the subsequent chemical reaction, thus water temperature markedly drops from room temperature. But then higher amount of energy releases than it was necessary to add at the start. Thus it is an exothermic reaction, without doubts, which supplies heat in the system.

The difference between water temperature in the initial and final state was approximately 3^°C, water weight is about 44 g and its specific heat capacity is about 4,200 J kg^-1 K ^_1, therefore we can determine that the total heat supplied to the water is about 550 J, that means one tablet releases approximately 110 J of heat.

Dissolution of a single tablet in approximately 200 g of water will have only negligible effect on its temperature, possible increase is approximately 0. l^°C, even though, first water next to the tablets will heat locally.

In finding time dependence for dissolution of effervescent tablets on water temperature, no surprising finding was that the dependence is mostly decreasing, thus mostly tablets dissolve quicker at higher temperature. However, the surprising fact is that simple exponential dependence which follows from the theory of kinetics of chemical reactions does not apply for this type of tablets. Slowed dissolution of tablets, which is evident at a certain temperature, can be explained as a result of different course of dissolution of tablets, above all of different relative time after which a tablet is carried up to the surface due to carbon dioxide bubbles.

The tests have shown that tablets are soluble for approximately the same time irrespective of fluid temperature but their behaviour within dissolution is different. In case of using quickly dispersing tablet in a toilet it is therefore necessary to consider in relation to lower temperature that they keep submerged for the most time for dissolution which can have an adverse effect on the subject of invention usage.

Example 12

Production of Set from Dispersible Formulations.

A set for training to use a potty or a dry bottom toilet for excretion was produced. The set consisted of 25 pieces, five pieces of each kind, and four kinds of dispersible tablets were wrapped in colour, marked paper and one type of loose dispersible mixture which was packed in sealable zippered bags. 1. The tablet was manufactured according to Example 2 - it fizzles in fluid and the liquid is blue coloured,

2. The tablet was manufactured according to Example 3 - it fizzles in fluid and the liquid is green coloured,

3. The tablet was manufactured according to Example 6 - it fizzles in fluid and the liquid is red coloured and

4. The tablet was manufactured according to Example 8 - the liquid cracks and the liquid is green coloured,

5. The loose dispersible mixture was manufactured according to Example 1 - it fizzles in fluid.

The whole set was inserted in a marked paper box.

Example 13

Study on Use Efficiency

Sets of dispersible formulations for training to use a potty or a dry bottom toilet for excretion.

Six healthy children in average age of 20 months were included in the test sample within tests of using the A set of dispersible formulations as an education tool for training of body hygiene with a potty. Traditional motivation tools in the form awards - stickers were used for two children (A;C). Other three children (B;D;E) got available a potty with dispersible tablets and powders from the set according to Example 12 for training to use a potty or a dry bottom toilet for excretion regularly for 3 weeks. The last child (F) got available a potty with blue fizzling dispersible tablets from the set according to Example 2 for training to use a potty or a dry bottom toilet for excretion regularly for 3 weeks.

Diapers were withdrawn to all the children during a day. The children were instructed by their parents to use a potty regularly in hour intervals for the first two test weeks. The third week the activity was left to the children without parents’ attendance.

The parents were given test sets together with the tools. Then the parents recorded all the activities carefully. Dispersible powders and tablets from Example 12 were used, awards were common stickers with children’s motives, blue fizzling dispersible tablets from Example 12 were used.

We followed the number of so called accidents (relieving during a play and the like when the child was busy), number of relieving willingly outside the destination (the child was seated on a potty but it postponed relieving till it left the potty), interest of children for the performed activity (when the children wanted to have a tablet or an award), number of potty using, number of reporting the need. Table 2: Test week 1

Table 3: Test week 2

Table 4: Test week 3

This study established that children best respond to motivation formed as the A set ofquickly dispersing tablet or powders from the A set of dispersible formulations for training to use a potty or a dry bottom toilet for excretion, compared with awards or only one type of dispersing tablet. Parents of children B, D and E varied sequence of tablets or powders during a day, the child did not know which dispersible formulation awaits it in a potty. Sometimes they even used the same dispersible formulation twice one after another which also was a surprise for the children. Even though during the first two weeks it seemed that children are interested more in the awards, the last test week showed that children without instructions of the parents were more interested in training with dispersible tablets or powders from the Set and also reflected it better. In two cases the children asked for insertion of a dispersible tablet or powder after each reporting of the need. Also the number of so called accidents decreased with the children where dispersing tablets or powders were used for the training steadily and they did not in any case relieved willingly outside the destination.

Thus the last test week showed that application of the A set of dispersing tablet for training to use a potty or a dry bottom toilet for excretion as a tool for training achieved stable results with the children.

Applicability in Industry

Set for training of small children to use a potty or a dry bottom toilet for excretion which serves for making training of small children in using a potty more efficient.

Claims

PATENT CLAIMS

1. A Set of dispersible formulations for training to use a potty or a dry bottom toilet for excretion, containing a colouring agent or a spectacular component, where the spectacular component consists of a fizzling pair or a cracking sugar, the fizzling pair consists of food acid and food salt of weak acid, the cracking sugar is oligosaccharide containing carbon dioxide characterized by the fact that it consists of at least two pieces of at least two types of a dispersible formulation where the types of the dispersible formulations differ one from another in a colouring agent and/or a spectacular component.

2. The set of dispersible formulations according to claim 1, char act eri zed by the fact that it contains, at least, a dispersible formulation containing a fizzling pair and a dispersible formulation containing cracking sugar.

3. The set of dispersible formulations according to claim 1, characterized by the fact that it contains, at least, a dispersible formulation containing a fizzling pair and a dispersible formulation containing a colour shade of a colouring agent.

4. The set of dispersible formulations according to claim 1, char act eri zed by the fact that it contains, at least, a dispersible formulation containing cracking sugar and a dispersible formulation containing a colour shade of a colouring agent.

5. The set of dispersible formulations according to claim 1, characterized by the fact that it contains two, at least, types of a dispersible formulations containing various colouring agents.

6. The set of dispersible formulations according to claim 5, char act eri zed by the fact that one type of the dispersible formulation contains a blue colouring agent and one type of the dispersible formulation contains a mixture of a blue colouring agent and of a red colouring agent.

7. The set of dispersible formulations according to claim 2, char act eri zed by the fact that the dispersible formulation containing cracking sugar contains a colouring agent of one shade and the dispersible formulation containing a fizzling pair contains a colouring agent of another shade.

8. The set of dispersible formulations according to claim 1, char act eri zed by the fact that the dispersible formulation is in a form of tablets.

9. The set of dispersible formulations according to claim 1, char act eri zed by the fact that the dispersible formulation is in a powder form.

10. The set of dispersible formulations according to claim 7, char act eri zed by the fact that the dispersible formulation contains 10-90 per cent of weight of bonding agents and/or filling agents and a wetting substance.

11. The set of dispersible formulation according to claim 10, characterized by the fact that the bonding agent and/or the filling agent is selected in the group of saccharides, sweeteners, cellulose and its derivatives, natural gel-forming substances, inorganic calcium salts, PVP or their mixture.

12. The set of dispersible formulations according to claim 10, characteri zed by the fact that the dispersible formulation contains 0.05 to 15 per cent of weight of a slide agent that is selected in the group containing soap-stone, talc, paraffin, wax, stearin, macrogols, syolide, silicon dioxide, silicates, starch, stearic acid and its salts and derivatives, derivatives of glyceric acid, plant oil, saccharate esters, glyceryl dibehenate, DL-leucine, glyceryltriacetate, magnesium laurylsulphate, macrogols 4000 and 6000, sodium chlorid, adipic acid, sodium acetate, maltitol, or their mixture.

13. The set of dispersible formulations according to claim 10, characteri zed by the fact that the dispersible formulation contains a disintegrating agent selected in the group containing formaldehyde cassein, carbonate, salt of carboxymethylcellulose, microcrystalline cellulose, arbocel, cross-linked PVP, guar gum, starch, pregelatinized starch or their mixture.

14. The set of dispersible formulations according to claim 1, characteri zed by the fact that the dispersible formulation contains bitter food alkaloids at level 0.1 to 15 per cent of weight.

15. The set of dispersible formulations according to claim 10, char acteri zed by the fact that the wetting substance is selected in the group containing alkyl sulphates, esters of propyleneglycol, lecithin, water, de-mineralized water, ethanol, glycerol, solution of starch hydrogel, gelatine, polyvinylpyrolidon, cellulose ethers, esters of sorbitol.

16. The set of dispersible formulations according to claim 1 characterized by the fact that the food acid is selected in the group containing tartaric, citric, malic, ascorbic, lactic and fumaric acids.

17. The set of dispersible formulations according to claim 1 characterized by the fact that the oligosaccharide is saccharose, lactose, glucose, glucose syrup.

18. The set of dispersible formulations according to claim 1 characterized by the fact that the food salt of weak acid is carbonate salt.