WO2004024057A1 - Procede de production d'une capsule sans soudure se dissolvant rapidement dans la cavite orale - Google Patents

Procede de production d'une capsule sans soudure se dissolvant rapidement dans la cavite orale Download PDF

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Publication number
WO2004024057A1
WO2004024057A1 PCT/JP2003/011649 JP0311649W WO2004024057A1 WO 2004024057 A1 WO2004024057 A1 WO 2004024057A1 JP 0311649 W JP0311649 W JP 0311649W WO 2004024057 A1 WO2004024057 A1 WO 2004024057A1
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WO
WIPO (PCT)
Prior art keywords
liquid
coating
seamless capsule
seamless
film
Prior art date
Application number
PCT/JP2003/011649
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English (en)
Japanese (ja)
Inventor
Katsuhiko Suzuki
Masayuki Ikeda
Original Assignee
Freund Corporation
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Freund Corporation filed Critical Freund Corporation
Priority to AU2003268639A priority Critical patent/AU2003268639A1/en
Publication of WO2004024057A1 publication Critical patent/WO2004024057A1/fr

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    • 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

Definitions

  • the present invention relates to a method for producing a seamless capsule in which a filling substance such as a food, a health food, a medicine, a spice, a spice and the like is coated with a film substance made of gelatin, agar, or the like.
  • the present invention relates to a manufacturing method suitable for manufacturing an intra-oral rapidly soluble seamless capsule having an intra-orally rapidly dissolvable capsule capable of easily breaking the film in the oral cavity and releasing the filling substance into the oral cavity.
  • the technology for producing capsules having no coating on the coating layer that is, seamless capsules, double nozzles and triple nozzles are suitable technologies for producing capsules smaller than ordinary soft capsules and larger than microcapsules.
  • the outermost layer liquid of the multilayer droplets is brought into contact with a curing liquid and cured to form a film.
  • the following document proposes a method for obtaining a seamless capsule by coating the liquid in the inner layer, and a production apparatus suitable for the production thereof.
  • the film in the production of rapidly soluble capsules in the oral cavity, if the film is made thin or easily dissolved in the mouth to form a film that is easily broken in the oral cavity, the film does not sufficiently cure or harden during production. Also, the film strength is weak, and the capsule is easily deformed or broken when it is separated from the hardening liquid, making production difficult. On the other hand, if the film has sufficient film strength, the resulting product will not easily break the film in the oral cavity, and will not be sufficiently soluble in the oral cavity.
  • the present invention has been made in view of the above circumstances, and has an immediate oral solubility that can be easily broken in the oral cavity, and is capable of producing a product that is unlikely to cause troubles such as poor film hardening and crushing during production.
  • An object of the present invention is to provide a method for producing a seamless capsule. Disclosure of the invention
  • the method for producing a rapidly soluble seamless capsule in the oral cavity of the present invention comprises:
  • the particle size is 1 to 1 Omm
  • the mass ratio of the coating material to the filling material is 5:95 to 70:30
  • the amount of the plasticizer added is 20 to 100% of the total amount of the coating material excluding water. A 70% by mass seamless capsule is produced.
  • a method for producing a rapidly dissolving intraoral simple capsule capable of producing a product which has rapid dissolution in the oral cavity which is easily broken in the oral cavity, and which hardly causes troubles such as poor film curing or crushing during production.
  • the plasticizer may be glycerin.
  • FIG. 1 is a schematic view of a submerged nozzle type seamless capsule manufacturing apparatus that can be used in one embodiment of the present invention.
  • the present inventors have studied various capsules, for example, hard capsules, soft capsules, and seamless capsules, in order to obtain quick dissolution in the oral cavity that can be easily broken in the oral cavity.
  • Hard capsules only swell in the oral cavity and do not disintegrate and do not have rapid oral solubility. Due to the manufacturing method of soft capsules, the coating material must be at least 30% by mass of the total mass.
  • the solubility of gelatin alone decreases.
  • the capsule material mass ratio of the capsule is the least in the case of the seamless capsule, and the seamless capsule is the most suitable as a capsule that is rapidly dissolved in the oral cavity.
  • a plasticizer is added to gelatin as a film substance, and a water-soluble plasticizer is suitable as a plasticizer used in a capsule for rapid dissolution in the oral cavity.
  • the filling material is coated with a film material containing a film forming agent and a plasticizer, has a particle size of 1 to 1 Omm, and has a mass ratio of 5 to 5%. : 95 to 70: 30 and using one or more selected from the group consisting of glycerin, propylene glycol, and polyethylene glycol as the plasticizer, and adding the plasticizer to water. It was found that seamless capsules in the range of 20 to 70% by mass with respect to the total amount of the excluding shell material were particularly excellent as capsules having rapid dissolution in the oral cavity.
  • the present inventors have established a method for producing a rapidly soluble seamless capsule in the oral cavity that can produce a product that is unlikely to cause troubles such as poor film curing and crushing during production.
  • the method for manufacturing a seamless capsule of this embodiment includes the following steps.
  • a core liquid containing a filling substance and a coating liquid in which a coating substance is dissolved are prepared.
  • the core liquid is supplied to a multiple nozzle having an inner nozzle and an outer nozzle surrounding the inner nozzle such that the core liquid is discharged from the inner nozzle and the coating liquid is discharged from the outer nozzle.
  • a multilayer liquid stream is discharged from the multiple nozzles to form multilayer droplets.
  • Step C The multilayer liquid droplets are allowed to flow through a curing liquid flowing in a flow channel to cure the coating liquid, thereby forming a seamless capsule formed by coating the core liquid with a coating substance.
  • Step D> The seamless capsule is separated from the curing liquid containing the seamless capsule.
  • Step E> Remove the curing liquid attached to the surface of the seamless capsule separated from the curing liquid, and dry the surface to form a seamless capsule with substantially no mutual adhesion.
  • the filling material is coated with a film material containing a film forming agent such as gelatin and a plasticizer such as glycerin, and has a particle size of 1 to 1 O mm, and Produce a seamless capsule having a mass ratio of 5:95 to 70:30.
  • a film material containing a film forming agent such as gelatin and a plasticizer such as glycerin
  • the filling substance may be in a liquid state when it is discharged as a core liquid from the multiple nozzles in the step B.
  • the core liquid may remain liquid or may have a seamless force. It may be a gel or a solid after the formation of the capsule.
  • the fillers include the main components (active ingredients in the case of pharmaceuticals) selected according to the application of the seamless capsule, such as foods, health foods, spices, spices, pharmaceuticals, and fragrances, as well as food production.
  • various pharmaceutically acceptable additives for example, a solvent such as edible oil, a sweetener, an acidulant, a flavor, a pigment, a thickener (gelling agent), a stabilizer, and an emulsifier can be included.
  • a solvent such as edible oil
  • a sweetener an acidulant
  • a flavor a pigment
  • a thickener gelling agent
  • a stabilizer emulsifier
  • an emulsifier emulsifier
  • the filling substance can be in the form of a transparent solution, suspension, or emulsion (cream) in which the main component is dissolved in a solvent.
  • a method for preparing a liquid filler that is, a core liquid
  • a method known in the field of food production or pharmaceutical production can be used.
  • a method of weighing the main component and additives, mixing with a solvent such as edible oil, and heating and stirring as necessary to obtain a uniform solution is used.
  • a solvent such as edible oil
  • a homogenizer to produce a water-in-oil emulsion
  • high-potency sweeteners such as aspartame and sucralose can be dispersed in ethanol.
  • a method of dispersing and dissolving them in ethanol using a homogenizer and dissolving them in oil can also be used.
  • the film material is one or more film-forming agents such as gelatin and agar that are pharmaceutically acceptable or pharmaceutically acceptable, and softens the film so that the cured film can be easily broken in the oral cavity.
  • a plasticizer for reducing the strength of the membrane in the oral cavity.
  • the plasticizer one or more selected from the group consisting of glycerin, propylene glycol and polyethylene glycol is used. Glycerin is mentioned as an agent.
  • the amount of the plasticizer added is 20 to 70% by mass, preferably 30 to 65% by mass, more preferably 40 to 70% by mass based on the total amount of the film substance (the total amount of components other than water in the skin fluid). To 60% by mass.
  • the hardness of the film may be adjusted by adding to the film material, together with the plasticizer, a material that increases the hardness of the film material after curing, for example, sorbitol. Further, by adding a thickening polysaccharide, a gelling agent, a protein hydrolyzate or the like, the temporal stability of the film can be improved.
  • the coating substance can be colored to any color with a pigment, and a flavor, a sweetener, an acidulant and the like can be added.
  • These sorbitol, thickening polysaccharide, gelling agent, protein hydrolyzate and the like are usually added in an amount of 10% by mass or less, preferably 5% by mass or less based on the total amount of the film substance.
  • a film material containing at least a film forming agent and a plasticizer is heated and dissolved by adding an appropriate amount of water to prepare a film solution.
  • the amount of the coating substance in the coating liquid (that is, the total amount of components other than water) is 10 to 50% by mass, and preferably about 20 to 40% by mass, based on the total amount of the coating liquid.
  • the compounding amount of the film-forming substance is 15 to 35% by mass, preferably about 20 to 30% by mass, based on the total amount of the film solution.
  • the method of adding water to the film-forming agent and dissolving by heating is not limited.
  • a method of adding water to the film-forming agent to cause swelling and then dissolving by heating a method of adding the film-forming agent to warm water and stirring and dissolving Can be used.
  • the heating temperature is set according to the type of the film-forming agent to be used. For example, in the case of gelatin, it can be set at about 45 to 90 ° C, preferably about 45 to 55 ° C.
  • a coating solution that does not contain bubbles put the coating material and water into a reduced-pressure heating tank, heat and stir under a reduced-pressure atmosphere, and prepare the coating solution while degassing. Is desirable.
  • the core liquid and the coating liquid respectively prepared as described above are stored in appropriate containers such as separate storage tanks.
  • the coating solution must be cooled and kept warm so as not to gel.
  • the heat retention temperature of the coating solution is set according to the type of the film forming agent to be used. For example, in the case of gelatin, the temperature is 45 to 90 ° C, preferably about 45 to 55 ° C.
  • Core liquid and coating The amount of the liquid to be prepared is adjusted according to the mass ratio of the coating material and the filling material set in the range of 5:95 to 70:30 in the completed seamless capsule. Is preferred.
  • FIG. 1 is a schematic configuration diagram illustrating a manufacturing apparatus suitable for continuously performing steps B to D of the method for manufacturing a seamless capsule of the present invention.
  • a core liquid (inner layer liquid) 1 for forming a seamless capsule is stored in a core liquid tank 2, and a coating liquid for coating the core liquid 1 (Outer layer liquid) 3 is stored in a coating liquid tank 4.
  • the core liquid 1 is pumped from the core liquid tank 2 via the pipe 6 to the multiplex nozzle 7 by the pump 5, while the coating liquid 3 is pumped from the coating liquid tank 4 via the pipe 9 by the pump 8 to the multiplex nozzle. It is fed to nozzle 7.
  • the multi-nozzle 7 is inserted into the inlet portion of the flow pipe 11, that is, into the inflow portion 11 A of the curing liquid 10, and converts the core liquid 1 and the coating liquid 3 into the curing liquid in the flow pipe 11. It is configured to emit into the liquid 10 to generate multilayer droplets.
  • the curing liquid 10 cools and cures the generated multilayer droplets to form a seamless capsule SC.
  • a curing liquid when the coating liquid is cooled and cured, an edible oil, for example, medium-chain fatty acid triglyceride (MCT), and a surfactant such as lecithin added to this MCT to prevent adhesion of multilayer droplets
  • MCT medium-chain fatty acid triglyceride
  • a surfactant such as lecithin added to prevent adhesion of multilayer droplets
  • the temperature of the curing liquid is set at about 0 ° C to room temperature.
  • the flow pipe 11 is formed as a bent cylindrical body, and is slidable and sealable with the substantially J-shaped inflow section 11A and the inflow section 11A with the fitting section 11C. It consists of an inverted J-shaped outflow section 11 B fitted in a nested manner. Therefore, as will be described later, the flow pipe 11 can move the inflow section 11A and the outflow section 11B relative to each other vertically in the fitting section 11C. Is configured to move up and down.
  • a substantially funnel-shaped separator 1 2 is provided below the outlet end of the flow path pipe 11 1 1 B. Are arranged.
  • the separator 12 separates the seamless capsule SC and the curing liquid 10 that have flowed out together from the flow pipe 11 from each other, and does not allow the seamless capsule SC to pass therethrough, and A mesh 13 that allows only the curing liquid 10 to pass is stretched.
  • the separator 12 is moved up and down by a drive source 14, for example, a fluid pressure cylinder such as an air cylinder and a hydraulic cylinder, or a motor together with the outflow portion 11B of the flow path pipe 11. That is, a part of the outlet portion 11B of the flow pipe 11 is connected to the connecting rod 11D, while the separator 12 is connected to the connecting rod 12A.
  • D and 12 A are connected to each other by a connecting member 15, and the connecting member 15 is connected to a part of the horsepower source 14, for example, a piston rod of an air cylinder.
  • the height difference Ah between the liquid level of the inflow section 11A and the liquid level of the outflow section 11B of the flow pipe 11 is variably adjusted, and the curing liquid 1 in the flow pipe 11 is adjusted.
  • the flow rate of 0 is variably adjusted.
  • outflow portion 1 1B of the flow path pipe 11 and the separator 12 move up and down quickly, so that the liquid level of the curing liquid 10 in the outflow portion 11B and the separator 1 2 ( In particular, the difference in height from the mesh 13) is kept constant.
  • the curing liquid 10 separated from the seamless capsule SC by the separator 12 is collected in the lower separation tank 16.
  • the small diameter portion at the lower end of the separator 12 is fitted with the cylindrical portion at the upper end of the separation tank 16 so that the separator 12 does not come off from the separation tank 16 even if it moves up and down. .
  • the curing liquid 10 in the separation tank 16 is pumped to the cooling tank 21 via the pipe 20 by the pump 19.
  • the curing liquid 10 in the cooling tank 21 is cooled to a predetermined temperature by the cooler 22, and then returned to the flow pipe 11 through the pipe 24 by the pump 23. . Since this seamless capsule manufacturing apparatus has a submerged nozzle type structure, the multiple nozzles 7 are inserted into the inlet of a flow path pipe 11 that forms a flow path for supplying the curing liquid 10, The core liquid 1 and the coating liquid 3 are discharged into the liquid, and the latter covers the entire periphery of the former.
  • the core liquid 1 and the coating liquid 3 discharged from the multiple nozzles 7 are formed as multilayer droplets in the curing liquid 10 in the flow pipe 11 (step B).
  • it As it flows through the duct 11, it is cooled and hardened by the action of the hardening liquid 10 to form a seamless capsule SC (step C).
  • the seamless capsule SC thus formed flows down together with the curing liquid 10 from the outlet end of the outflow portion 11B of the flow path tube 11 onto the mesh 13 of the separator 12.
  • the hardening liquid 10 is separated from the hardening liquid 10 by the mesh 13 (step D), and the hardening liquid 10 passes through the mesh 13 and is collected in the separation tank 16.
  • the seamless force capsules SC collected on the mesh 13 are later collected in an unillustrated product collection container when the appropriate amount is reached.
  • the outflow section 11B of the flow pipe 11 when adjusting the height difference h of the liquid level between the inflow section 11A and the outflow section 11B of the flow pipe 11, the outflow section 11B of the flow pipe 11 is driven. Since the source 14 can move up and down with respect to the inflow portion 11A, the flow rate of the curing liquid 10 in the flow pipe 11 can be adjusted by the difference ⁇ h between the liquid level and the ascending position. It can be arbitrarily adjusted to the optimum position by arbitrarily changing between.
  • the outlet 1 1B of the flow pipe 11 and the separator 12 are moved up and down by the same distance together, so that the hardening liquid 10 at the outlet 11 B is separated from the liquid surface.
  • the height difference from the container 12 is kept constant. Therefore, the seamless capsule SC in the present embodiment can always have a desired spherical shape, and can also prevent the seamless capsule SC from being broken or scattered.
  • the particle size of the seamless capsule SC is set to 1 to 10 mm. Seamless capsules SC with a particle size in this range are easy to manufacture, easy for the user to handle the capsules, and are suitable for inclusion in the mouth.
  • the outflow portion 11B of the flow pipe 11 and the separator 12 are integrally formed by connecting the connecting rods 11D and 12A and the connecting member 15 to one another. It is moved up and down by a drive source 14 such as a fluid pressure cylinder with its integral structure, The 11B and the separator 12 are always moved up and down by the same distance without fail, and their structures are simple and inexpensive.
  • the multi-nozzle may be a triple nozzle or the like in addition to the double nozzle.
  • the ring vibrating method and the tube vibrating method required for generating the multi-layer droplets may be used.
  • Various things such as methods can be used.
  • a single nozzle that ejects droplets of only one layer may be used.
  • the multiple nozzle 7 having a tip angle (angle of the conical portion) of 90 ° or less.
  • a tip angle of the conical portion of 90 ° or less.
  • a seamless capsule SC with a uniform particle size is formed without generating turbulence in the flow of the curing liquid flowing in contact with the tips of multiple nozzles 7. can do.
  • the tips of the outer nozzle and the inner nozzle of the multi-nozzle 7 may be arranged on the same plane, or the tip of the inner nozzle projects 1 to 5 mm from the tip of the outer nozzle. It may be structured.
  • the tip position of the multiple nozzle 7 may be aligned with the axis center of the flow pipe 11 or may be arranged eccentrically from the axis center.
  • the tip position of the multi-nozzle 7 is aligned with the center of the axis of the flow pipe 11
  • the multilayer droplet discharged from the multi-nozzle 7 flows straight down along the center of the multi-nozzle 7 axis.
  • the tip position of the multiple nozzle 7 is arranged eccentrically from the center of the axis, the multilayer droplet flows down the inner wall of the flow pipe 11 along a spiral trajectory. Lower time can be extended.
  • the finished state of the seamless capsule can be adjusted, thereby preventing uneven thickness and eyes from occurring. You can get quality products. Phases are microscopic spherical vacuoles generated in the film. If the eyes are large, the skin may be perforated after drying and core fluid may leak.
  • steps B and C it is desirable to arrange a stroboscope in any one of the flow pipes 11 so as to monitor the particle size and shape of the multiple droplets flowing down in the flow pipe 11.
  • a stroboscope By monitoring multiple droplets with a stroboscopic scope in this way, the discharge conditions, vibration conditions, flow rate of the curing liquid, etc. of each liquid from the multiple nozzles 7 can be adjusted according to the particle size of the seamless capsule to be manufactured. Can be adjusted quickly and the desired grain A seamless capsule having a diameter and free from uneven thickness and eyes can be manufactured without waste.
  • a part where the curing liquid 10 flows into the flow pipe 11 is an overflow type, and the curing liquid 10 flows from the entire circumference of the end face of the flow pipe 11. It is desirable. By causing the curing liquid 10 to flow from the entire circumference of the end face of the flow pipe 11, it is possible to prevent local turbulence from being generated in the curing liquid flow in the flow pipe 11.
  • the dehydrating means any one of a water absorbing material absorbing method, a cooling trap method, a microwave heating method, and the like can be selected and used.
  • step D instead of flowing down together with the curing liquid 10 onto the mesh 13 of the separator 12 and separating the seamless capsule SC from the curing liquid 10 on the mesh 13, a mesh or cloth filter is used.
  • the belt conveyor receives the effluent from the flow pipe 11 and drops and recovers the curing liquid 10. It may be configured to transfer.
  • Step E comprises the following substeps e1 e7.
  • Step e 1 The seamless capsules separated from the curing liquid in step D are immersed as they are or in a cooling liquid made of a liquid that does not dissolve the film, and are immersed at 0 ° C to 20 ° C, preferably 1 to 10 ° C. Process to keep the cold to a certain degree and accelerate the curing of the film,
  • Step e 2 a step of centrifuging the cooled seamless capsule to remove liquid adhering to the capsule surface
  • Step e3 a step of drying the seamless capsule after centrifugation
  • Step e4 a step of washing the dried seamless capsules with an organic solvent
  • step e5 a step of drying the seamless capsules washed with an organic solvent
  • step e6 sieving the seamless capsules after the step e5
  • step e7 a step of packaging the seamless capsules after drying or sieving and sorting.
  • the method of keeping cold is not particularly limited, and a method of putting a seamless capsule separated from the curing liquid into a tray, putting a cooling liquid, putting the whole tray into a refrigerator, cooling for a certain time, and using a seamless capsule.
  • a method of keeping it cool by passing it through a tunnel type cooler while transporting it on a conveyor, or a method of bringing it into contact with a cooling plate.
  • a material that does not soften, dissolve or disintegrate the film for example, an edible oil such as medium-chain fatty acid triglyceride, or an edible oil containing a surfactant such as lecithin is preferable.
  • step e1 it is desirable to set the cooling temperature to about 2 ° C to promote the hardening of the capsule film while preventing the moisture in the capsule film from freezing.
  • step e2 the centrifugal separation is performed at such a speed and time that the liquid such as oil adhering to the film of the seamless capsule disappears while the film is not deformed or broken.
  • the oil on the film surface may be removed by rubbing the capsule with a cloth, lipophilic paper, nonwoven fabric, or the like instead of deoiling the film surface using centrifugation.
  • the drying method is not particularly limited, and the drying can be performed using a method and an apparatus conventionally used for drying granular materials.
  • ventilation drying method fluidized bed drying method
  • a drum drying method a reduced pressure drying method, and the like.
  • the seamless capsule is brought into contact with an air stream at a temperature lower than the film softening temperature, preferably 0 to 40 ° C, more preferably 10 to 30 ° C.
  • step e3 it is desirable to provide a baffle in the drum to prevent the seamless capsule from slipping. If the seamless capsule slips in the drum, the dry state will vary, which may cause undried parts.
  • the temperature of the introduced air may be the same temperature (for example, room temperature air) from the start to the end of the drying, or may be changed during the drying. Good.
  • drying may be performed by using cold air of 25 ° C or less at the beginning of drying and supplying air of 25 ° C or more after a predetermined time has elapsed.
  • the introduced air is desirably kept at a low humidity, and if necessary, dried air may be supplied through a water-absorbing material layer such as silica gel.
  • step e3 when the ventilation drying method or the drum drying method is used, it is preferable to select and use the opening of the ventilation plate or the drum on which the seamless forceps are placed according to the particle diameter of the seamless forcepsels.
  • the organic solvent used to wash the seamless capsules can dissolve the oil (hardening liquid, cooling liquid) adhering to the film of the seamless capsule, and does not soften, dissolve or disintegrate the film.
  • Hydrocarbon such as ethyl alcohol, ethyl acetate, acetone, and hexane or a mixture thereof is preferably used.
  • the method of washing the seamless capsules with an organic solvent is not particularly limited.
  • the method of immersing the seamless capsules in the organic solvent and then pulling up the capsules, the method of dropping or spraying the organic capsules on the seamless capsules A method of spraying is used.
  • the temperature of the organic solvent is about 0 to 40 ° C, preferably room temperature.
  • the number of washing and the washing time are not particularly limited, and washing may be repeated once or plural times. In the washing operation, the washing efficiency may be increased by stirring the capsule so as not to damage the film of the seamless capsule or by applying ultrasonic waves.
  • the organic solvent after washing is recovered, purified, and reused.
  • the drying (secondary drying) in step e5 is mainly performed to remove the organic solvent from the seamless capsule after washing with the organic solvent.
  • the drying method is not particularly limited, and can be carried out using a method and an apparatus conventionally used for drying granular materials.
  • ventilation drying method including fluidized bed drying method
  • drum drying method vacuum drying method
  • centrifugal drying method etc.
  • the temperature, humidity, equipment used, and the like may be substantially the same as those in the drying step of step e3.
  • the exhaust gas containing the organic solvent from the drying device is subjected to a desolvation treatment by bringing the exhaust gas into contact with a cooling trap and a suitable solvent adsorbent.
  • step e6 the method of sieving and sorting the seamless capsules after the completion of the secondary drying step (step e5) is a method conventionally used for product inspection of granular drugs, particularly capsule-like drugs such as soft capsules. Can be performed. Inspection items for seamless capsules include the size of particle size, presence or absence of abnormal shape, presence or absence of film collapse, presence of turbidity or foreign matter, presence or absence of poor appearance products (uneven thickness, eyes, etc.), multiple fused products Presence or absence. For the content, seamless capsules are extracted and subjected to various analytical tests necessary for pharmaceutical or food hygiene.
  • step e7 after the drying is completed or before the seamless capsules after sieving and sifting are packaged, they are pharmaceutically acceptable or pharmaceutically acceptable, for example, lactose, mannitol, powdered starch, starch such as corn starch, etc. An appropriate amount of powder may be sprinkled on the surface of the capsule as an anti-adhesive agent to prevent capsule blocking.
  • pharmaceutically acceptable or pharmaceutically acceptable for example, lactose, mannitol, powdered starch, starch such as corn starch, etc.
  • An appropriate amount of powder may be sprinkled on the surface of the capsule as an anti-adhesive agent to prevent capsule blocking.
  • a medium-chain fatty acid triglyceride was used as the filling liquid (core liquid), and a coating liquid obtained by mixing and heating and dissolving 30% by weight of the coating substance of each composition shown in Table 1 and 70% by weight of water as the coating substance was used.
  • Spherex registered trademark
  • the medium chain fatty acid triglyceride cooled to 7 ° C at a speed of 4 to 20 seconds from the multiple nozzles.
  • Multi-layer droplets in a curing liquid consisting of By dripping seamless capsules of each composition of Nos. 1 to 6 shown in Table 1 were produced.
  • a disintegration test was performed on each of the manufactured capsules of Nos. 1 to 6 in accordance with the JP Disintegration Test. The results are summarized in Table 1.
  • Table 1 The results are summarized in Table 1.
  • the seamless capsules of Nos. 1 to 3 according to the present invention are disintegratable (: excellent and suitable as seamless capsules with rapid dissolution in the oral cavity.

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Abstract

L'invention concerne un procédé de production de capsules sans soudure se dissolvant rapidement dans la cavité orale, consistant à préparer une solution principale (1) contenant un agent de remplissage; à préparer une solution (3) de revêtement comprenant un plastifiant tel que le glycérol et un agent filmogène dissous à l'intérieur; à utiliser la solution principale (1) et la solution (3) de revêtement avec un corps (7) à buses multiples de manière à décharger la solution principale d'une buse interne tandis que la solution de revêtement est déchargée de la buse extérieure, un courant liquide à multiples couches étant ainsi déchargé du corps (7) à buses multiples, formant ainsi des gouttes liquides à multiples couches; à mettre en contact les gouttes liquides à multiples couches avec une solution (10) de durcissement s'écoulant dans un canal, afin de faire durcir la solution(3) de revêtement pour obtenir des capsules sans soudure (SC); à séparer les capsules sans soudure (SC); et à éliminer la solucion durcie (10) collée à la surface des capsules sans soudure (SC). On obtient ainsi des capsules sans soudure (SC) ayant une dimension particulaire de 1 à 10 mm, un rapport de masse revêtement et remplissage de 5:95 à 70:30 et un contenu de plastifiant de 20 à 70% en poids basé sur l'intégrité des matériaux de revêtement sauf l'eau.
PCT/JP2003/011649 2002-09-13 2003-09-11 Procede de production d'une capsule sans soudure se dissolvant rapidement dans la cavite orale WO2004024057A1 (fr)

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Application Number Priority Date Filing Date Title
AU2003268639A AU2003268639A1 (en) 2002-09-13 2003-09-11 Process for producing seamless capsule quickly dissolving in the oral cavity

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2002268714A JP2004105282A (ja) 2002-09-13 2002-09-13 口腔内即溶シームレスカプセルの製造方法
JP2002/268714 2002-09-13

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WO2004024057A1 true WO2004024057A1 (fr) 2004-03-25

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WO2006136197A1 (fr) 2005-06-21 2006-12-28 V. Mane Fils Produit a fumer comprenant une capsule cassante, capsule cassante et procede de fabrication de cette capsule
JP2009119148A (ja) * 2007-11-16 2009-06-04 Freunt Ind Co Ltd 多色シームレスカプセルの製造装置及び製造方法
JP5293377B2 (ja) * 2009-04-23 2013-09-18 味の素株式会社 球状ゼリーの製造方法
JP2015081249A (ja) * 2013-10-24 2015-04-27 フロイント産業株式会社 シームレスカプセル及びその製造方法
JP6257344B2 (ja) * 2014-01-20 2018-01-10 株式会社三協 連球不良品の検出方法 並びにその装置
WO2016159648A1 (fr) 2015-03-31 2016-10-06 주식회사 케이티앤지 Procédé et appareil de fabrication de capsule de parfum de tabac
CN112089092B (zh) * 2015-08-06 2022-09-27 韩国烟草人参公社 香烟的香味胶囊制造方法及制造装置
JP7093973B2 (ja) * 2017-04-14 2022-07-01 富士カプセル株式会社 ソフトカプセル集合体の製造方法及びソフトカプセル集合体
JP7471651B2 (ja) * 2018-04-13 2024-04-22 富士カプセル株式会社 ソフトカプセル集合体及びこれを含む経口投与用組成物

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EP0228067A2 (fr) * 1985-12-26 1987-07-08 Taisho Pharmaceutical Co. Ltd Capsules molles sans soudure
JPH05200274A (ja) * 1991-05-29 1993-08-10 Freunt Ind Co Ltd シームレスカプセル製造装置
WO1996011053A1 (fr) * 1994-10-07 1996-04-18 Warner-Lambert Company Procede de fabrication de capsules sans soudure

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* Cited by examiner, † Cited by third party
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EP0228067A2 (fr) * 1985-12-26 1987-07-08 Taisho Pharmaceutical Co. Ltd Capsules molles sans soudure
JPH05200274A (ja) * 1991-05-29 1993-08-10 Freunt Ind Co Ltd シームレスカプセル製造装置
WO1996011053A1 (fr) * 1994-10-07 1996-04-18 Warner-Lambert Company Procede de fabrication de capsules sans soudure

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