US20060240094A1 - Masticatable capsule and process for producing the same - Google Patents

Masticatable capsule and process for producing the same Download PDF

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Publication number
US20060240094A1
US20060240094A1 US10/566,541 US56654104A US2006240094A1 US 20060240094 A1 US20060240094 A1 US 20060240094A1 US 56654104 A US56654104 A US 56654104A US 2006240094 A1 US2006240094 A1 US 2006240094A1
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Prior art keywords
capsule
drying
shell
chewable
humidity
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US10/566,541
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Inventor
Yuzo Asano
Kyoichi Oshida
Takanori Kobayashi
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Morinaga Milk Industry Co Ltd
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Individual
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Assigned to MORINAGA MILK INDUSTRY CO., LTD. reassignment MORINAGA MILK INDUSTRY CO., LTD. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: ASANO, YUZO, KOBAYASHI, TAKANORI, OSHIDA, KYOICHI
Publication of US20060240094A1 publication Critical patent/US20060240094A1/en
Priority to US12/422,717 priority Critical patent/US8414917B2/en
Abandoned legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4833—Encapsulating processes; Filling of capsules
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23P—SHAPING OR WORKING OF FOODSTUFFS, NOT FULLY COVERED BY A SINGLE OTHER SUBCLASS
    • A23P10/00—Shaping or working of foodstuffs characterised by the products
    • A23P10/30—Encapsulation of particles, e.g. foodstuff additives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4816—Wall or shell material
    • A61K9/4825—Proteins, e.g. gelatin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/06—Antigout agents, e.g. antihyperuricemic or uricosuric agents

Definitions

  • the present invention relates to a capsule which is suitable for chewing to eat, known as a chewable soft capsule and a production method thereof.
  • Patent document 1 Japanese Unexamined Patent Application, First Publication No.2001-89362
  • Patent document 2 Japanese Unexamined Patent Application, First Publication No. H10-273436
  • Patent document 3 Japanese Unexamined Patent Application, First Publication No.2001-161306
  • Patent document 4 Japanese Unexamined Patent Application, First Publication No.2000-136127
  • Patent document 5 Japanese Unexamined Patent Application, First Publication No. H11-266804
  • Patent document 1 discloses reduction of adherance of capsules to each other by precipitating saccharides, such as a xylitol contained in the gelatin shell.
  • Example 1 a method for producing a soft capsule by molding a solution of a packing material which contains gelatin into the shape of a capsule, while filling it with a filling, and solidifying it, and thereafter drying it with rotating, is disclosed.
  • Patent document 2 (Chewable Soft Capsule, TOKAI CAPSULE Co., Ltd.) discloses blending a plasticizer into a gelatin shell to soften it and blending a crystalline cellulose into reduce adhering of capsules to each other.
  • Patent document 3 Provides for Producing Gelatin Capsule which Excels in Palatability, EZAKI GLYCO Co., Ltd. discloses giving a good flavor to a soft capsule by blending an emulsified flavour highly efficiently into a gelatin shell.
  • Patent document 4 discloses a soft capsule having a 15% to 80% of water content in the soft encapsulating shell, and 10% to 70% of soft encapsulating shell mass to total mass of the soft capsule, the soft encapsulating shell of which dissolves very rapidly.
  • Patent document 5 (Royal Jelly Oily Suspension and Rroyal Jelly Capsule, SANSHO-IYAKU Co., Ltd.) discloses a royal jelly oily suspension in which discoloration is controlled, and a royal jelly soft capsule which is filled with 450 mg of the royal jelly oily suspension as filling and sealed.
  • patent document 6 Hyperlithuria-Disease-Prophylactic Remedy, MORINAGA MILK INDUSTRY Co., Ltd. discloses a Hyperuricemia-prophylactic remedy which contains a substance having 20 carbon atoms or a derivative thereof, and a monounsaturated fatty acid having 22 carbon atoms or a derivative thereof as an active ingredient.
  • An encapsulated formulation is illustrated as an example of a dosing form.
  • Patent document 6 Japanese Unexamined Patent Application, First Publication No.2001-278786
  • the present invention is made under these circumstances, and it is an object of the present invention to provide a capsule which is suitable for chewing to be eaten, and a process for producing such a capsule.
  • the chewable capsule of the present invention includes an encapsulating shell and a filling contained in the encapsulating shell, and is characterized by having the following properties (a), (b), (c), and (d):
  • the outer diameter of the encapsulating shell ranges from 14 mm to 25 mm
  • the mass of the encapsulating shell ranges from 10% to 20% of the total mass of the capsule
  • the quantity of the content contained in the encapsulating shell ranges from 1400 mg to 3000 mg
  • the encapsulating shell contains gelatin.
  • the above encapsulating shell preferably contains glycerin in an amount of 30 to 200 mass parts and a crystal precipitating agent in an amount of 1 to 200 mass parts, per 100 mass parts of gelatin.
  • At least a part of the above crystal precipitating agent is exposed to a surface of the shell as a crystal.
  • the above content is a liquid fat-soluble substance having a viscosity of not more than 2 Pa ⁇ s at 25° C.
  • the above content contains one or more selected from the group consisting of an animal-or-vegetable oil, a phospholipid, and a ceramide.
  • the above content preferably contains one or more selected from the group consisting of a monounsaturated fatty acid having 20 carbon atoms and/or a derivative thereof, and one or more selected from the group consisting of a monounsaturated fatty acid having 22 carbon atoms and/or a derivative thereof.
  • a process for producing the chewable capsule of the present invention includes: a step of molding a capsule-like molded product with a shell material liquid which contains gelatin, and a step of drying the molded product, in which in said step of drying, a first drying for 10 to 12 hours is performed in an atmosphere in which humidity is controlled to be within a range of ⁇ 5% and temperature is controlled to be within a range of ⁇ 2° C. with respect to first conditions of a humidity of 30% to 50% and a temperature of 20° C. to 30° C., respectively.
  • aging for 2 to 3 hours is performed in an atmosphere in which humidity is controlled to be within a range of 70% ⁇ 5% and temperature is controlled to be within a range of 25° C. ⁇ 2° C.
  • a second drying for 35 to 70 hours is performed in an atmosphere in which humidity is controlled to be within a range of ⁇ 5% and a temperature is controlled to be within a range of ⁇ 2° C. with respect to second conditions of a humidity of 30% to 50% and temperature of 20° C. to 30° C., respectively.
  • a chewable capsule which has a size large enough so that the capsule cannot be swallowed wholly, a high hardness but thin shell, easiness of chewing, and tastiness upon being eaten can be obtained.
  • the chewable capsule of the present invention has a large outer diameter and a low percentage of the shell mass to total mass of the capsule. Because the shell is thin, the shell dissolves rapidly in the mouth, thereby causing no feeling of remaining shell. In addition, it has a size which makes it easy to eat with the fingers.
  • the shape is of a capsule (i.e., double structure), it is possible to fill it with a filling larger than those of a gummi candy or tablet sweet, etc. Because the filling is covered with a shell, the filling is not substantially oxidized. The effect of protecting the filling is high, and storage stability is excellent.
  • the viscosity of the content is not more than 2Pa ⁇ s at 25° C., then flowability of the content is excellent, and the content in the capsule is likely to spread in the mouth when it is eaten.
  • the exterior shape of the encapsulating shell is not particularly limited.
  • it can be molded to have various shapes, such as an approximately spherical shape, a spherical and an ellipse, or an approximate cube, approximate parallelopipedon, etc.
  • a spherical shape or approximately spherical shape is preferable.
  • the value of the outer diameter of the encapsulating shell in this specification is the greater axis of the capsule, and for example, it can be measured with rulers, such as slide calipers. Moreover, in the case in which the capsule is spherical, it can be also measured by general methods, such as volume conversion.
  • the outer diameter of the encapsulating shell of the chewable capsule of the present invention ranges from 14 mm to 25 mm. By setting the diameter to be within this range, excellent feeling at the time of consumption can be obtained, such as easiness to eat, easiness to chew, and excellent spreadability (diffusibility) in the mouth when eating.
  • the percentage of mass of the encapsulating shell to the total mass of the capsule ranges from 10% to 20%. If the percentage is less than the above range, then there is a possibility that breaking strength may be insufficient, or the content may leak when storing under high temperature or change of ambient temperature. Moreover, if the percentage exceeds the above range, then feeling of melting in the mouth may deteriorate. Moreover, as the percentage increases, the capsule tends to be less crunchable. Moreover, if the percentage is too large or too small, then it will lose balance with quantity of the content, and as a result, comfortable feeling when eating becomes insufficiently obtainable.
  • the amount of the filling contained in the encapsulating shell is within a range of 1400 mg to 3000 mg.
  • the amount of the filling is preferably within the above range. If the amount of the filling exceeds the above range, then it becomes difficult to chew the capsule.
  • gelatin which is a base material for forming the encapsulating shell is contained as an essential ingredient.
  • the gelatin may be one which is derived from any of cow, pig, chicken, and fish.
  • the production method thereof may be any method, such as an alkali extracting method or acid extracting method, etc., and the jelly strength etc., of the gelatin is not limited.
  • glycerin it is preferable to blend glycerin as a plasticizer apart from the base material.
  • the blending amount of glycerin into an encapsulating shell is preferably 30 to 200 mass parts to 100 mass parts of gelatin, and more preferably 50 to 100 mass parts. If the blending amount of glycerin is too much or too little, then processability when molding capsules deteriorates, resulting in no comfortable feeling of chewing. Moreover, as the blending amount of glycerin increases, the capsules are more likely to adhere to each other.
  • the blending amount of the crystal precipitating agent preferably ranges from 1 to 200 mass parts to 100 mass parts of gelatin, and more preferably 1 to 50 mass parts. As the blending amount of crystal precipitating agent increases, cooling feeling obtained when eating the capsule becomes better, and adherance among capsules becomes infrequent. However, if the blending amount of the crystal precipitating agent is too much, then processability when molding capsules will become worse.
  • the crystal precipitating agent which is blended into the encapsulating shell precipitate as a crystal to be exposed to the encapsulating shell surface.
  • a state that the precipitant of the crytal precipitating agent is exposed a state that the above precipitant (crystal) is adhered to the outer surface of the encapsulating shell may be, or a state that a part of the precipitating agent is embedded in the encapsulating shell may be.
  • sugar alcohols such as xylitol, erythritol, trehalose, and D-sorbitol
  • xylitol is particularly preferable, because it excels in properties, such as precipitating performance of crystal, cooling feeling, and degree of sweetness, etc.
  • An encapsulating shell may suitably contain flavoring material, such as sweetener, etc.
  • a sweetener for example, artificial sweeteners, such as a suclarose, acesulfame potassium, stevia, and aspartame, and a saccharide such as cane sugar or fruit sugar, can be used.
  • additives such as colorants, corrigents, and flavours, can be included.
  • the filling is preferably a liquid, and the viscosity at 25° C. is preferably not more than 2 ⁇ PaS. If it becomes higher than this value, then the spreadability (diffusibility) of the content in the mouth at the time of eating deteriorates.
  • the viscosity is preferably approximately 0.5 Pa ⁇ S.
  • Viscosity of the filling can be adjusted by adding a thickener, if necessary.
  • the thickener is not particularly limited, as long as it can be added to food, but, for example, beeswax, glycerin fatty acid ester, etc. can be used.
  • a liquid filling is a hydrophilic substance, the filling is likely to react with gelatin, which is a base material of the encapsulating shell to cause change over time
  • the filling is preferably an fat-soluble substance.
  • “fat-soluble substance” indicates a substance which has a fat-solubleity (hydrophobicity) of a grade which does not cause effects over time on the encapsulating shell which contains gelatin as a base material.
  • oily substances such as an animal or vegetable oil or its powdery suspensions can be used.
  • one or more selected from an animal or vegetable oil, phospholipid, and a ceramide are exemplary.
  • an animal or vegetable oil safflower oil, olive oil, fish oil, etc. are exemplary.
  • one or more selected from a monounsaturated fatty acid having 20 carbon atoms and/or derivative thereof, and one or more selected from a monounsaturated fatty acid having 22 carbon atoms and/or derivative thereof can be preferably used.
  • a chewable capsule which contains the above components within the content can be administered orally to a human or an animal as a preservative curing agent or a nutritional composition for the use of a dietetic treatment for a lifestyle-related illness of which hyperuricemia is representative.
  • the above monounsaturated fatty acid having 20 carbon atoms and/or derivative thereof and the monounsaturated fatty acid having 22 carbon atoms and/or derivative thereof are icosenoic acids (eicosenoic acid), such as gondoic acid having 20 carbon atoms, gadoleic acid, 5-icosenoic acid, etc., and/or derivative thereof, and a docosenoic acid, such as erucic acid (erucine acid) having 22 carbon atoms, cetoleic acid, and 5-docosenoic acid, etc., and/or derivative thereof.
  • the monounsaturated fatty acid having 20 carbon atoms and the monounsaturated fatty acid having 22 carbon atoms to be used are not particularly limited, as long as they are acceptable medicinally or as a food.
  • Natural fats and oils having a high content of these long chain monounsaturated fatty acids such as shark liver oil, whale oil, cod liver oil, rape oil, mustard oil, cabbage seed oil, jojoba oil, meadowfoam seed oil, etc. can be used alone or in combination.
  • an icosene acid or docosenoic acid which is obtained by extracting and refining these natural fats and oils through a normal method, for example, fractional distillation, crystallization, solvent extraction, urea clathration, or chromatography.
  • a commercially available gondoin acid or erucic acid (all of these are produced by SIGMA Co., Ltd.) can be used as an easy method.
  • Derivatives of these long chain monounsaturated fatty acids include derivatives like various esters, in addition to salts of long chain monounsaturated fatty acids.
  • a salt with an alkali metal, such as sodium, potassium, etc., or an ester with a lower aliphatic alcohol, such as methanol, ethanol, etc., and mono-, di-, or triglyceride, etc. is exemplary.
  • the amount of the monounsaturated fatty acid having 22 carbon atoms and/or derivative thereof is preferably 0.1 to 17 mass parts of the amount of the monounsaturated fatty acid having 20 carbon atoms and/or derivative thereof, because this percentage excels in preventive and curative effects on lifestyle-related illnesses, of which hyperuricemia is representative, compared to the case in which the percentage is outside the above range.
  • an effective dosage is 5 to 400 mg/kg in terms of body weight/day, based on the quantity of the active ingredient which consists of the monounsaturated fatty acid with carbon number 20 or its derivative, and the monounsaturated fatty acid with carbon number 22 or its derivative (referred to as “long chain monounsaturated fatty acids” below). Therefore, it is preferable to set the content of the long chain monounsaturated fatty acid in the filling contained in the chewable capsule so that an effective dosage can be taken by way of one or a few dosagings.
  • the amount of contents per capsule can be increased, and hence the chewable capsule of the present invention is very much suitable for encapsulating long chain monounsaturated fatty acids, which become more effective as intake increases, for the prevention and treatment of a lifestyle-related diseases.
  • the contents of the chewable capsule may contain surface active agents, such as glycerin fatty acid esters and cane sugar fatty acid esters, various hydrogenerated oils, and waxes, etc.
  • surface active agents such as glycerin fatty acid esters and cane sugar fatty acid esters, various hydrogenerated oils, and waxes, etc.
  • suitable additives such as flavour, sweetener, and colorant
  • flavour various natural or synthetic flavours can be used, corresponding to purpose.
  • sweetener an artificial sweetener, saccharides, sugar alcohol, etc. can be used.
  • colorant a synthetic colorant, a natural colorant, etc. can be used.
  • the chewable capsule of the present invention can be produced by way of the step of forming a capsule-like molded product using a shell material liquid which contains gelatin, and the step of drying the above molded product.
  • the method for molding the shell material liquid which contains gelatin into the shape of a capsule is not limited, and various well-known methods can be used.
  • various well-known methods can be used.
  • a method for molding an encapsulating shell using a rotary type automatic soft capsule producing apparatus while providing the filling can be suitably used.
  • FIG. 1 is a schematic view showing an example of a rotary type automatic soft capsule producing apparatus which is suitably used in this embodiment.
  • the constitutional component of the shell is dissolved into a proper quantity of water to prepare a shell material liquid. If necessary, it is heated to dissolve the mixture uniformly. Since molding becomes difficult if the quantity of gelatin is too large or too small, the quantity of gelatin should be within a range so that the shell material liquid can be molded into a desired shaped.
  • the quantity of gelatin in the shell material liquid ranges from approximately 20 to 45 mass % and, more preferably ranges from approximately 30 to 40 mass %.
  • FIG. 1 two pieces of shell sheet 1 which is molded into the shape of a belt are sent between a pair of rotating cylindrical metallic dies 2 .
  • a fillings 4 are pressed between a pair of the shell sheets 1 by the pump 3 which interlocks with this, while the rotating cylindrical metallic dies 2 are rotated.
  • the shell sheet 1 is heated by a segment 5 to a temperature suitable for performing heat sealing, and the bonded portion 6 is heat sealed by pressing and contact of gibbous tooth formed on the surface of the rotating cylindrical die 2 , thereby producing a capsule like molded product 7 .
  • the method for forming the shell sheet 1 is not particularly limited, the shell sheet 1 in a gel form can be produced by, for example, spreading the shell material liquid into a shape of a sheet, and controlling the temperature so that the gelatin gels.
  • the resultant capsule molded product 7 is dried to produce a chewable capsule.
  • drying step first, primary drying is performed, that is, drying for 10 to 12 hours is performed in an atmosphere in which the humidity is controlled to within ⁇ 5% and the temperature is controlled to within ⁇ 2° C. with respect to the first condition of a range of humidity of 30% to 50% and a temperature of 20 to 30° C., respectively.
  • the primary drying is preferably performed using a rotating drying method.
  • the rotating drying method is a method that includes putting a non-dried capsule into a hollow and air-permeable container having a bottom (for example, a cylindrical cage), and then flowing dehumidified air into the container, while rotating the container, thereby drying the capsule.
  • a rotating air-blowing drying apparatus which is equipped with a container, a means for rotating the container, and a means for blowing air.
  • aging is performed for 2 to 3 hours in an atmosphere in which the humidity is controlled to within 70% ⁇ 5% and the temperature is controlled to within 25° C. ⁇ 2° C.
  • the aging is preferably performed in a state in which the capsule is stationary placed. A more preferable time for aging is approximately 3 hours.
  • secondary drying is performed, that is, drying for 35 to 70 hours is performed in an atmosphere in which the humidity is controlled to within ⁇ 5% and the temperature is controlled to within ⁇ 2° C. with respect to the second condition of a range of humidity of 30% to 50% and a temperature of 20 to 30° C., respectively, thereby making a chewable capsule.
  • a more preferable drying time is approximately 40 to 60 hours.
  • the secondary drying is preferably performed using a rotating drying method, similarly to the primary drying.
  • the water content of the capsule shell immediately after the completion of aging is preferably approximately 10 to 20 mass %, in view of chewability and self-deformation. A more preferable range is 13 to 17 mass %. It should be noted that the water content of the capsule shell can be measured using a drying reduction method.
  • a conventional and ordinary internally-soft-capsule is ordinary molded into a capsule, and thereafter dried for approximately 20 hours in an atmosphere in which the humidity is 30 to 50% and the temperature is approximately 20 to 30° C., using a rotating air-blowing drying apparatus.
  • the chewable capsule of the present invention is produced to have an external diameter which is far larger than that of an ordinary internal capsule, and a thin (low percentage of shell) capsule shell so that it can be easily chewed. For this reason, if the chewable capsule of the present invention is produced using a conventional method of finishing in one step of drying, then the capsule will be broken by the self-weight during the rotating drying.
  • the humidity and the temperature during the primary drying and the second drying are strictly controlled (i.e. the tolerance for temperature control is ⁇ 2° C., and the tolerance for humidity is ⁇ 5%), and during this, aging is performed under high humidity (the humidity is approximately 70%).
  • the humidity is approximately 70%.
  • the crystals will precipitate efficiently due to the crystal precipitating agent contained in the shell material liquid.
  • the drying rate should be strictly controlled. In accordance with this embodiment, it is possible to obtain a chewable capsule having a uniform quality, on the surface of which the crystal is precipitated uniformly.
  • the filling and the capsule shell material liquid prepared as above were used with a rotary type soft capsule filling apparatus to mold a spherical capsule-molded-product having a mass of capsule filling of 1500 mg.
  • the resultant molded product was allowed to stand in an air atmosphere in which the humidity was 70% and the temperature was 25° C. for 3 hours (i.e. aging). It was controlled so that the humidity was within a range of 70% ⁇ 5%, and the temperature was within a range of 25° C. ⁇ 2° C.
  • the resultant molded product was dried in an air atmosphere in which the humidity was 50% and the temperature was 25° C. for 35 hours, using a rotating type air-blowing drying apparatus, thereby obtaining a spherical chewable capsule (the secondary drying). It was controlled so that the humidity was within a range of 50% ⁇ 5%, and the temperature was within a range of 25° C. ⁇ 2° C. Moreover, the rotating rate of the rotating type air-blowing drying apparatus was set to 15 r.p.m. The water content of the capsule shell immediately after finishing secondary drying was 14 mass %.
  • the chewable capsule i.e. spherical chewable soft capsule
  • the chewable capsule had an external diameter of the shell (spherical diameter) of 16 mm, a total mass of 1750 mg, and a mass of the capsule shell of 250 mg (it was approximately 14.3% of the total mass of the capsule).
  • Example 2 a capsule molded product having a mass of the capsule filling of 3000 mg was molded, using the filling and the capsule shell material liquid prepared as above.
  • Example 2 This was immediately dried similarly to in Example 1 to produce a chewable capsule (a spherical chewable soft capsule).
  • the water content of the capsule shell immediately after finishing the secondary drying was 14 mass %.
  • the chewable capsule i.e. a spherical chewable soft capsule
  • the chewable capsule had an external diameter of the shell (spherical diameter) of 20 mm, a total mass of 3600 mg, and a mass of the capsule shell being 600 mg (it was approximately 16.7% of the total mass of the capsule).
  • crystals of xylitol were uniformly precipitated, and it turned out that it was a capsule with a high quality.
  • test Example 1 sample chewable capsules were produced in the same way as in Example 1, with the exception of varying the external diameter (spherical diameter) of the capsule shell within a range of 10 to 30 mm, as shown in Table 1 below. It should be noted that the shell percentage was standardized at 15% by varying the amount of the filling, corresponding to the spherical diameter.
  • a sensory test was performed on the resultant samples.
  • the sensory test was performed by 20 panelists, who ate each sample to evaluate 3 items of easiness to eat, easiness to chew, and diffusibility of the filling, through a scoring method, based on the following evaluation scale.
  • Sample chewable capsules were produced in the same way as in Example 1, with the exception of varying the capsule shell percentage within a range of 8% to 25%, as shown in Table 2 and Table 3. It should be noted that the shell percentage was controlled by standardizing the total mass of the capsule 3600 mg and varying the thickness of the capsule shell and the quantity of the filling, as well as standardizing the external diameter (spherical diameter) of the capsule shell 20 mm.
  • Example 2 A sensory test was performed on the resultant samples in the same way as in Example 1. The sensory test was performed by 20 panelists, who ate each sample to evaluate 3 items of easiness to crunch, easiness to dissolve in the mouth, and quantity of the filling, similarly to in the method in Test Example 1. The results are shown in Table 2 below.
  • the capsule shell percentage is within the range of 10 to 20%, then it becomes possible to make feeling of eating, such as easiness to crunch, easiness to melt in the mouth, and quantity of the filling, etc., compatible with stability against external force to the capsule or environmental change.
  • chewable capsules were produced in the same way as in Example 1, with the exception of varying the blending amount of xylitol to 100 mass parts of gelatin within a range of 0.5 to 250 mass parts, as shown in the following Table 5. At that time, the blending amount of glycerin was standardized at 60 mass parts to 100 mass parts of gelatin.
  • the sensory test was performed by 20 panelists, who ate each sample to evaluate the goodness of feeling in chewing as to samples of which glycerin content differed, and the degree of cooling feeling as to samples of which xylitol content differed, similarly to the method in Test Example 1.
  • Chewable capsules were produced in the same way as in Example 1, with the exception of varying the blending amount of beeswax (thickener) in the composition of the filling shown in Example 1 to vary the viscosity of the filling at 25° C. into 6 levels of 0.1, 0.5, 1.0, 2.0, 2.5, and 3.0 Pa ⁇ s, as shown in the following Table 6.
  • a sensory test was performed on the resultant samples. The sensory test was performed by 20 panelists, who ate each sample to evaluate the easiness to spread of the filling in the mouth (diffusibility) through a scoring method, similarly to in Test example 1. The results are shown in Table 6 below. TABLE 6 Test Item Sample No.
  • Chewable capsules were produced by changing the drying method into the following 5 methods with respect to each size of capsule, as well as varying the mass of the filling of the capsule into the 6 levels of 1,000 mg, 1,400 mg, 2,000 mg, 2,500 mg, 3,000 mg, and 3,500 mg, in Example 1, in order to examine the preferable drying conditions when producing the chewable capsules. It should be noted that a rotating type air-blowing drying apparatus was used for drying, and the rotating rate was set to 10 r.p.m.
  • Drying method 1 A method for drying an ordinary soft capsule (the humidity of 30 to 50%, temperature of 20 to 30° C., and drying time of 20 hours).
  • Drying method 2 A drying method for drying an ordinary soft capsule in which the drying time is extended (humidity of 30 to 50%, temperature of 20 to 30° C., and drying time of 45 hours).
  • Drying method 3 A drying method similar to drying method 2, but in which drying is divided into 2 periods between which aging operation is inserted (humidity of 40 ⁇ 5%, temperature of 25 ⁇ 2° C., and drying time of 45 hours).
  • Drying method 4 A drying method similar to drying method 2, but in which drying is divided into 2 periods between which aging operation is inserted (humidity of 30 to 50%, temperature of 20 to 30° C., and drying time for the primary drying of 10 hours, and then aging at a humidity of 70% for 3 hours, and thereafter performing the secondary drying for 35 hours under the same conditions as in the primary drying).
  • Drying method 5 A drying method similar to drying method 4, in which the temperature and humidity are strictly controlled (performing primary drying under conditions in which the humidity is 40 ⁇ 5% and the temperature is 25 ⁇ 2° C. for 10 hours, and then aging with a humidity of 70 ⁇ 5% for 3 hours, and thereafter performing secondary drying for 35 hours under the same conditions as in the primary drying).
  • Drying method 6 Drying for 5 hours under conditions in which the humidity is 30%, and the temperature is 31° C., and then allowing to stand for 3 hours under conditions in which the humidity is 80% and the temperature is 28° C., and thereafter drying for 12 hours under conditions in which the humidity is 30% and the temperature is 31° C.
  • the present invention can be applied to a chewable capsule, which is utilized for foods, particularly health foods, specified healthcare foods, pharmaceuticals, quasi drugs, etc., known as a chewable soft capsule, and a process for producing such a capsule.

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US10/566,541 2003-07-31 2004-07-30 Masticatable capsule and process for producing the same Abandoned US20060240094A1 (en)

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CN102813275A (zh) * 2011-06-10 2012-12-12 杭州养生堂保健品有限公司 一种咀嚼型软胶囊皮和咀嚼型软胶囊

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CN101721931B (zh) * 2009-11-26 2012-08-08 广州普正生物科技有限公司 一种多相混悬系统及其制备方法与应用
US8323702B2 (en) * 2010-01-28 2012-12-04 Okoro Chuks I Composition and method for treating ulcers
JP5618402B2 (ja) * 2010-06-24 2014-11-05 三生医薬株式会社 咀嚼性ソフトカプセル剤の製造方法
JP5723403B2 (ja) * 2013-03-01 2015-05-27 アール．ピー． シェーラー テクノロジーズ エルエルシー 被包囲粒状物の製造方法、皮膜材料の乾燥方法、及び、流動層乾燥機
CN104606678B (zh) * 2015-01-06 2017-09-01 韩山师范学院 一种软质软胶囊及其制备方法
CN107613918B (zh) 2015-04-07 2021-03-09 丘奇和德怀特有限公司 具有硬核的多组分软糖组合物
TW202500124A (zh) * 2023-06-27 2025-01-01 日商三生醫藥股份有限公司 軟膠囊

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US20110092605A1 (en) * 2009-10-15 2011-04-21 Appleton Papers Inc. Encapsulation
WO2011046609A3 (en) * 2009-10-15 2011-08-18 Appleton Papers Inc. Encapsulation
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CN102813275A (zh) * 2011-06-10 2012-12-12 杭州养生堂保健品有限公司 一种咀嚼型软胶囊皮和咀嚼型软胶囊
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JPWO2005011402A1 (ja) 2006-09-14
HK1087893A1 (en) 2006-10-27
KR100732199B1 (ko) 2007-06-25
CN1829449A (zh) 2006-09-06
EP1649758A1 (en) 2006-04-26
AU2004261113A1 (en) 2005-02-10
JP4364869B2 (ja) 2009-11-18
CA2533906C (en) 2010-02-09
CN100399935C (zh) 2008-07-09
CA2533906A1 (en) 2005-02-10
US20090194893A1 (en) 2009-08-06
DE602004028373D1 (enrdf_load_stackoverflow) 2010-09-09
US8414917B2 (en) 2013-04-09
EP1649758B1 (en) 2010-07-28
AU2004261113B2 (en) 2007-12-13
KR20060035779A (ko) 2006-04-26
WO2005011402A1 (ja) 2005-02-10

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