KR100334707B1 - A composition of soft tablet for oral administration - Google Patents

Abstract

PURPOSE: A tablet composition obtained by blending vitamins, oligosaccharide, sugar alcohol, starch syrup and other emulsifiers is provided. The sugar free tablet composition has functional characteristics similar to conventional sugar-containing soft chewable tablets, inhibits tooth decay and has a good taste and mouth feeling. CONSTITUTION: A tablet composition comprises 5 to 15% by weight of one or more vitamins selected from lipid-soluble vitamins and water-soluble vitamins, 5 to 60% by weight of one or more oligosaccharides selected from maltooligosaccharide, isomaltooligosaccharide, fructooligosaccharide, one or more sugar alcohols selected from erythritol, ribitol, xylitol, mannitol, sorbitol, dulcitol and inositol, 10 to 60% by weight of one or more corn syrups selected from corn syrup, low sugar corn syrup, high sugar corn syrup and malt corn syrup and 0.5 to 1% by weight of one or more emulsifiers selected from glycerine monooleate, glycerine monostearate, sorbitan monostearate, glycerine monostearate and soy bean lecithin.

Description

Soft chewing tablet composition for oral administration {A composition of soft tablet for oral administration}

The present invention relates to a soft chewing tablet composition for oral administration, and more specifically, to a soft chewing tablet by combining vitamin preparation, oligosaccharide, sugar alcohol, syrup and other emulsifiers without adding sugar. The present invention relates to a soft chewing tablet composition for oral administration which can suppress corrosion and has low calories, as well as excellent sensory properties such as adhesion and texture in a soft form.

Conventional chewing tablets have been prepared by adding various additives such as sugars, excipients, disintegrants, glidants and the like to the active ingredient, which is the main ingredient, and these tablets are hard, so the tablet itself must be swallowed as it is or hard to swallow hard. Only did.

Therefore, children or the elderly had a very uncomfortable problem to take these tablets. For this reason, many products are being developed and developed so that soft tablets can be easily chewed to increase the compliance of children or the elderly with the conventional tablets, oral tablets. However, the soft tablets developed to date are still difficult to formulate due to problems such as the adhesion of the teeth at the time of taking or prosthetic stability during storage and distribution.

Conventional soft chewing tablets are mainly composed of sugars, fats and oils, anti-oral anti-sticking agent, white sugar cream, flavor, organic acid, etc., of which sugar has been used by controlling the ratio of sugar and starch syrup. In the basic soft chewing tablets, sugar is not only sweet as a basic ingredient but also sugars in the process of producing chewing tablets, which increases crystallization, resulting in a hard and tough structure, while adding sugar together. In the case of melted sugar is precipitated over time to form a stable and stable form of soft tissue is an essential ingredient affecting the viscosity of the final product. In general soft chewing tablets, the ratio of sugar and starch syrup is generally used in a ratio of sugar to syrup = 1: 11/4. Of course, it is also possible to increase the amount of starch syrup up to 3/2 to give a special effect on the tissue or crystal. In addition, in order to give a softening of chewing tablets, it is soft chewing to prepare hondant or sucrose cream (sugar: syrup = 80: 20) after condensing sugar and injecting it into a mixer to cause constant crystal precipitation (graining: crystallization). It is a basic manufacturing method of tablets.

That is, in the preparation of general soft chewing tablets, sugar and starch syrup play a complementary role, and starch syrup forms recrystallized supersaturated sugar solution and maintains the required viscosity and hardness of sugars.

The basic requirements for soft chewing tablets are low tooth adhesion, no oil separation, good texture, good shape retention during storage distribution, low mechanical attachment during molding, simple manufacturing method, and high volume production. . In order to satisfy these requirements, conventionally, vegetable oils such as palm oil, coconut oil, castor oil, cottonseed oil, olive oil, peanut oil, palm olein oil, palm stearin oil, and emulsifiers such as lecithin and glycerin fatty acid ester are added thereto, and soybean protein is added thereto. , Starch, whole milk powder, skim milk powder and the like were added in large quantities. However, these additives also did not produce satisfactory results in maintaining the above-described dental adhesion and retention of the teeth because of the excess fat component.

Currently, sugar-free hard chewing tablets are commercially available, but sugar-free soft chewing tablets are rarely available. Sugar-free hard chewing tablets, unlike soft chewing tablets, do not induce sugar crystals during the manufacturing process to give shape retention or to maintain a soft structure.They are preheated only at 110-115 ° C, then 155-165 It can be easily produced because it consists only of the final heating and concentrating process so that the moisture is 1 to 2% at ℃. However, sugar-free soft chewing tablets are difficult to manufacture in high quality products due to problems such as adhesion problems, retention of shape retention, and instability in pooling.

However, when sugar-free chewing tablets are manufactured by a general manufacturing method, chewing tablets having a certain shape due to breakage or stretching in the production process may occur because crystal precipitation rates of other sugars are too fast or too slow. Manufacturing becomes difficult and productivity is lost. In particular, formulations containing more than 7.5% of vitamin C should find a point where the rate of precipitation of vitamin C is somewhat similar to the rate of precipitation of sugar, and the viscosity of the powder is weakened due to the high amount of vitamin C powder. Severe breaks occur during the production process, and the nature of the tissues sticking together weakens. For this reason, sugar-free soft chewing tablets containing vitamin C are particularly difficult to produce.

To prepare sugar-free soft chewing tablets, it is common to use glucose, fructose or sorbitol, mannitol powder and syrup, and high fructose. However, when glucose and fructose powders are used, crystal precipitation is delayed, so that the shape retention is not maintained, and the final product, the chewing tablet, is crushed and adheres to the teeth, which is not suitable as a product. In addition, in the case of using only mannitol single component and starch syrup in sugar alcohol, too much crystallization breaks down too quickly, and mass production is not suitable.

The inventors of the present invention have studied for a long time in order to improve the above problems, and as a result, by adding a vitamin preparation, oligosaccharides, sugar alcohols, syrup and other emulsifiers without adding sugar, The invention was completed.

Therefore, the present invention exhibits a sensory property similar to that of the chewing soft chewing tablet without containing sugar and can prevent tooth corrosion, and has a lower calorie than the conventional sugar-containing chewing tablet. The purpose of the present invention is to provide a soft chewing tablet composition for oral administration that has good taste and feel, has low adhesiveness, and has excellent sensory properties such as shape retention and pooling.

In the present invention, oral soft chewing tablet composition containing vitamins, oligosaccharides, sugar alcohols and starch syrup, 5-15% by weight of vitamin preparation, 5-60% by weight oligosaccharides, 10-70% by weight sugar alcohol, and A soft chewing tablet composition for oral administration containing 10 to 60% by weight of starch syrup is characterized by its characteristics.

Referring to the present invention in more detail as follows.

The present invention does not add sugar to the soft chewing tablet composition for oral administration containing vitamin preparations, oligosaccharides, sugar alcohols, etc., thereby suppressing the generation of tooth corrosion while exhibiting the sensory characteristics of the sugar-containing soft chewing tablet. In addition, it is characterized by a soft chewing tablet composition containing vitamins improved to maintain low adhesion, softness and retention.

The vitamin preparation contained as an active ingredient in the soft chewing tablet composition for oral administration according to the present invention is one or more selected from fat-soluble vitamins, water-soluble vitamins and components containing 7.5% by weight or more of fat-soluble or water-soluble vitamins, preferably vitamins. C is contained 7.5 wt% or more. If necessary, 0.005 to 0.02% by weight of a fluorine compound selected from lithium fluoride, sodium fluoride and potassium fluoride may be included in the vitamin preparation. The use of fluoride compounds together can provide a synergistic effect to prevent tooth decay. The content of the vitamin preparation contained as the active ingredient is contained within the range of 5 to 15% by weight, preferably 5 to 10% by weight in the total chewing tablet composition. If the content is less than 5% by weight, the vitamin content of the chewing tablets is less effective when taking, and if the content exceeds 15% by weight due to the excessive content is discharged to the body.

In addition, the oligosaccharides may be included in the present invention with the vitamin preparation for the purpose of enhancing the texture, and the oligosaccharides that may be contained in the present invention include malto oligosaccharides, isomaltoligo saccharides, and fructooligosaccharides. As long as oligosaccharides used in normal tablet manufacture, etc. can be used, these can also be mixed and used suitably. Preferably, maltooligosaccharides containing at least 12% by weight of maltotriose, maltotetraose, maltopentose and maltose selected from the above oligosaccharides are used. More preferably, 12% by weight of maltotriose is used. The malto oligosaccharides contained above are used. Such oligosaccharides are contained in the total chewing tablet composition in the range of 5 to 60% by weight, preferably 10 to 30% by weight. If the content of oligosaccharide is less than 5% by weight, the crystallization rate is increased, so that breakage occurs during manufacturing. If the content of the oligosaccharide exceeds 60%, the content of starch syrup and sugar alcohol is lowered. have.

In addition, in the present invention, the sugar alcohols may be included in order to obtain a synergistic effect with the oligosaccharide in addition to the purpose of equalizing the crystal precipitation, sugar alcohols which may be contained in the present invention is a tetros derivative such as erythritol ; Pentose, such as ribitol, xylitol, and the like; Sugar alcohols used in the manufacture of conventional tablets such as hexose such as mannitol, sorbitol, dulcitol, inositol and the like can be used, and sorbitol, mannitol or xylitol is preferably used. Such sugar alcohols are contained in the total chewing tablet composition in the range of 10 to 70% by weight, preferably 25 to 65% by weight. If the content is less than 10% by weight, it is difficult to even out the crystal precipitation, and if the content exceeds 70% by weight, diarrhea may be caused by excessive intake with the problem of maintaining shape retention.

In addition, in the present invention, in order to obtain a synergistic effect with the oligosaccharides and sugar alcohols in addition to the purpose of the soft structure and viscosity of the soft chewing tablets and a certain level of hardness, it may be contained in the present invention As the starch syrup, all starch syrup used in the manufacture of conventional tablets such as general starch syrup, low sugar syrup syrup, high sugar syrup syrup and maltose syrup can be used. Such starch syrup is contained in the total chewing tablet composition in the range of 10 to 60% by weight, preferably 15 to 50% by weight. If the content is less than 10% by weight, the persistence in forming the product is not maintained, and if it exceeds 60% by weight, it is not suitable as a soft chewing tablet by forming excessively hard and tough tissue depending on the crystallization rate.

Further, in the present invention, in the chewing tablet composition containing the vitamin preparation, oligosaccharide, sugar alcohols, and starch syrup, an emulsifier is added to prevent oil segregation and tooth adhesion, and to maintain shape retention during storage. Colorants, pH adjusters, natural or artificial sweeteners may be added. The emulsifiers added to the chewing tablet composition include 0.4 to 2.0% by weight of one or more mixtures selected from glycerin monooleate, glycerin monostearate, sorbitan monostearate and soy lecithin in the whole chewing tablet composition. If it is less than 0.4% by weight, no emulsification is made, and if it exceeds 2.0% by weight, there is a problem in that a wax value becomes high.

That is, by appropriately combining these, it is possible to prevent oil separation and tooth adhesion by adding to the present soft chewing tablet composition as an emulsifier.

In addition to the composition ingredients described above, soft chewing tablets such as fruit flavors such as strawberry, orange and banana flavors, flavoring agents such as peppermint flavors, colorants such as natural and tar colors, and pH adjusters such as citric acid, tartaric acid, and succinic acid Generally, all the basic ingredients which can be added can be added.

Referring to the manufacturing process of the soft chewing tablet according to the present invention using the above components in more detail as follows.

In the present invention, starch syrup, oligosaccharides and sugar alcohols are dissolved in a relatively low temperature tank at 110 to 116 ° C. This is because the temperature range is the most suitable temperature for dissolving each sugar component. Therefore, when the dissolution temperature in the tank is less than 110 ° C., there is a problem in that dissolution is not completely performed. When it exceeds 116 ° C., the sugar is decomposed and browned. It is not preferable because it can harden or harden.

Then, emulsifiers such as glycerin monooleate, glycerin monostearate, sorbitan monostearate, and soy lecithin are added to the solution, and the mixture is sufficiently mixed to remove moisture and concentrated in a vacuum of -200 to -600 mmHg. As such, vacuum concentration at low temperature has an effect of improving glycosylation at high temperatures.

The low temperature vacuum-concentrated concentrate is passed through a steam cooling conveyor to firstly cool to 65 to 80 ° C., and the primary coolant, the flavoring agent, the colorant, and the pH regulator are put into a mixer, and then the temperature, that is, 65 to 80 ° C. Stir and mix for 30 to 60 minutes while maintaining. By maintaining a low temperature in this way, by stirring for a predetermined time and sufficiently mixed, the tablet composition according to the present invention can improve the shape retention according to the stabilization of the tissue, thereby reducing the aging process that has been required for a long time, thus causing crystal precipitation as soon as possible. By stabilizing the tissue, it can be improved to enable continuous production. However, there is a problem that the crystallization is not good when the cooling mixture is less than 65 ℃, it is not preferable because the crystal is not stabilized due to the high temperature even if it exceeds 80 ℃. In addition, if the stirring time is less than or exceeds the above range, there is a problem that the early crystallization is impossible because the stability of the mixture is not made.

The mixture thus prepared is passed through a cooling conveyor to secondary cooling to 38 to 45 ° C. The reason for the secondary cooling is that the product can be continuously produced continuously by cooling step by step together with the purpose for tableting.

Next, the secondary coolant is made into a certain thickness in the Veggie Roller and the Rob Sizer, and then compressed into a desired shape in a refiner, and passed through a cooling conveyor to form a third cooling and pillow packing at 10 to 20 ° C. of the present invention. Prepare soft chewing tablets for oral administration.

The human dose of the soft chewing tablet active ingredient of the present invention may be appropriately selected and taken according to the absorbency, inactivation rate and excretion rate of the active ingredient in the body, the age, sex and condition of the patient, and the severity of the disease to be treated.

The soft chewing tablets for oral administration of the present invention prepared as described above exhibit similar sensory characteristics as the soft chewing tablets containing sugar without containing sugar, and can prevent tooth corrosion, and the conventional sugar-containing soft chewing tablets. It has less calories than tablets, especially good taste and feel, less adhesiveness, and shows excellent effects in shaping and pooling.

Therefore, the elderly or children can take the soft chewing tablet of the present invention from time to time, which is very effective to easily take vitamins and the like.

Although this invention is demonstrated in detail based on an Example, this invention is not limited by an Example.

Examples 1-2 and Comparative Examples 1-5

According to the component contents shown in Table 1 below, the tablets of Examples 1 to 2 and Comparative Examples 1 to 5 were all prepared in the same manner as follows.

Sugars, sugar alcohols, oligosaccharides, and starch syrup are dissolved by heating to 114 ° C. Then, glycerin monooleate and cured oil are added to remove the moisture by vacuum (-400mmHg), and then passed through a steam cooling conveyor to 70 ° C. After cooling it was sent to the mixer. The flavor was then added to the mixer and stirred for 50 minutes while maintaining the temperature of the mixer at 70 ° C. to homogenize it. After sufficiently stirring and mixing in this way, the resultant was passed through a three-stage conveyor again and secondarily cooled to 40 ° C. Then, these were made into a constant thickness in the Vezi roller and the drop sizer, and tableted in a constant shape in a tablet machine, and then cooled to 15 ℃ 3 to prepare a soft chewing tablet.

TABLE 1

Experimental Example 1

Using the tablets prepared in Examples 1 and 2 and Comparative Examples 1 to 5 were subjected to sensory evaluation by the panel of 20 of the adherence and texture of the tooth when actually taken, the results are shown in Table 2 and Table 3.

TABLE 2

TABLE 3

Experimental Example 2

Using the tablets prepared in Examples 1 to 2 and Comparative Examples 1 to 5, the deformed state and the depressed state were measured visually after storage at 35 ° C. and humidity RH 77% for 48 hours, and the results are shown in Table 4 below. Indicated.

TABLE 4

Tablet Preparation Example 1

Vitamin C 500 mg

Vitamin E 50 mg

Pyridoxine hydrochloride 3 mg

Riboflavin 3 mg

Nicotinic acid 10 mg

Syrup 1,300 mg

Sorbitol 416 mg

Mannitol 416 mg

Maltooligosaccharide 800 mg

Xylitol 100 mg

Cured oil 325 mg

Lecithin 20mg

Tablet Preparation Example 2

Nicotinic acid 8 mg

Rocot pyridoxine 1.2 mg

Coated Ascorbic Acid 36.45 mg

Tocopherol Acetate 5mg

Dry cholecalciferol 4 mg

Gelatin 5mg

Cured oil 290 mg

Lecithin 10mg

1000 mg starch syrup

Sorbitol 1,250 mg

Mannitol 700 mg

Xylitol 50 mg

Maltooligosaccharide 600 mg

Tablet Preparation Example 3

Vitamin A 4 mg

Dry cholecalciferol 1.15 mg

Rocot Thiamine Nitrate 1.95 mg

Riboflavin Sodium Phosphate 0.75 mg

Rocot pyridoxine 2.7 mg

Cyanocobalamin 2 mg

Ascorbic acid 20 mg

Dry Tocopherol 10 mg

Folic acid 0.2 mg

Rocotnicotinic Acid 16.2 mg

Calcium Pantothenate 3 mg

Calcium Phosphate 20mg

1000 mg of ionic starch syrup

Sorbitol 1,250 mg

Gelatin 4mg

Mannitol 700 mg

Xylitol 60 mg

Maltooligosaccharide 20 mg

Tablet Preparation Example 4

Vitamin C 500 mg

Syrup 1,300 mg

Sorbitol 420 mg

Mannitol 420 mg

Maltooligosaccharide 900 mg

Xylitol 50 mg

Cured oil 300 mg

Lecithin 20mg

Tablet Preparation Example 5

Cyanocobalamin 20 mg

Nicotinic acid 8 mg

Pyridoxine hydrochloride 0.4 mg

Thiamine Nitrate 0.6 mg

Vitamin C 35 mg

Tocopherol Acetate 5mg

Vitamin D ₃ 4 mg

Vitamin A 6 mg

Gelatin 4mg

Cured oil 290 mg

1000 mg starch syrup

Sorbitol 1,200 mg

Xylitol 60 mg

Maltooligosaccharide 500 mg

As described above, the soft chewing tablet for oral administration according to the present invention exhibits the same sensory characteristics as the soft chewing tablet containing sugar while not containing sugar, and can prevent tooth corrosion, and the conventional sugar-containing soft tablet Not only has lower calorie than chewing tablets, it is soft and has good taste and feel, has low adhesiveness, and has excellent sensory properties such as shaping and pooling. It can be easily taken by children and elderly people when taking it and can easily take vitamins. You can get the effect.

Claims (5)

In oral soft chewing tablet composition containing vitamins, oligosaccharides, sugar alcohols and starch syrup, 5-15% by weight of one or more vitamin preparations selected from fat-soluble vitamins and water-soluble vitamins; 5 to 60% by weight of at least one oligosaccharide selected from maltooligosaccharides, isomaltoligo saccharides and fructooligosaccharides; 10 to 70% by weight of one or more sugar alcohols selected from erythritol, ribitol, xylitol, mannitol, sorbitol, dulsitol and inositol; 10 to 60% by weight of one or more starch syrup selected from ionic syrup, low sugar syrup, high sugar syrup and maltose syrup; And 0.5 to 1% by weight of one or more emulsifiers selected from glycerin monooleate, glycerin monostearate, sorbitan monostearate, and soy lecithin. The soft chewing tablet composition for oral administration according to claim 1, wherein the water-soluble vitamin contains at least 7.5% by weight of vitamin C. The soft chewing tablet composition for oral administration according to claim 1, wherein 0.005 to 0.02% by weight of the fluorine compound selected from lithium fluoride, sodium fluoride and potassium fluoride is further added to the vitamin formulation. The soft chewing tablet composition for oral administration according to claim 1, wherein the malto oligosaccharide has a maltotriose content of 12% by weight or more. The soft chewing tablet for oral administration according to claim 1, wherein the soft chewing tablet composition contains at least one selected from hardening oil, flavoring agent, coloring agent, pH adjusting agent, and natural (except sugar) or artificial sweetener . Composition.