WO2007029376A1 - Comprimé se désintégrant rapidement dans la bouche - Google Patents

Comprimé se désintégrant rapidement dans la bouche Download PDF

Info

Publication number
WO2007029376A1
WO2007029376A1 PCT/JP2006/309706 JP2006309706W WO2007029376A1 WO 2007029376 A1 WO2007029376 A1 WO 2007029376A1 JP 2006309706 W JP2006309706 W JP 2006309706W WO 2007029376 A1 WO2007029376 A1 WO 2007029376A1
Authority
WO
WIPO (PCT)
Prior art keywords
weight
parts
granulated particles
magnesium
rapidly disintegrating
Prior art date
Application number
PCT/JP2006/309706
Other languages
English (en)
Japanese (ja)
Inventor
Tadashi Fukami
Yoshiro Nagai
Kanemasa Takado
Hitoshi Machimura
Original Assignee
Fuji Chemical Industry Co., Ltd.
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 Fuji Chemical Industry Co., Ltd. filed Critical Fuji Chemical Industry Co., Ltd.
Priority to JP2007534257A priority Critical patent/JP5074190B2/ja
Publication of WO2007029376A1 publication Critical patent/WO2007029376A1/fr

Links

Classifications

    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2009—Inorganic compounds
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin

Definitions

  • the present invention relates to an intraoral rapidly disintegrating tablet having rapid and powerful disintegration property and appropriate hardness in the oral cavity, and a method for producing the same with high productivity.
  • the intraoral rapidly disintegrating tablet of the present invention can be used in the field of medicine.
  • Intraoral rapidly disintegrating tablets have a disintegration time of about 60 seconds or less in the oral cavity, and need to have a certain degree of hardness so that the tablets are not chipped or pulverized during manufacture or transportation. Hardness and disintegration time are contradictory elements. If disintegration time is increased, the hardness decreases, and if the hardness is increased, the disintegration time decreases. In order to solve the problem of disintegration time and hardness, several methods are known for producing a rapidly disintegrating tablet in the oral cavity, including a wet tableting method, a tableting warming method, and a direct tableting method.
  • the usual preparation equipment for compression molding cannot be used, and a heating device, a humidifying device, and a drying device are required, and special equipment is required.
  • the process involves processes such as humidification, warming, and drying in addition to normal compression molding, so there is a problem in productivity and it is not suitable for water-soluble active ingredients.
  • a method for producing an orally rapidly disintegrating tablet by the direct tableting method can use a normal preparation facility.
  • the direct tableting method it is difficult to have both moldability, moderate hardness and disintegration while increasing the content of the active ingredient, and methods for improving these are known.
  • an active ingredient, spray-dried mannitol, crospovidone, and excipients that can be used for pharmaceuticals are dry mixed and then compression molded to produce an orally rapidly disintegrating tablet (see Patent Document 1). .
  • Tablets made by using spray-dried mannitol suitable for direct compression and crospovidone, a super disintegrant, have moderate moldability and disintegration, but can be used as an orally rapidly disintegrating tablet.
  • the tolerance between the oral disintegration time and the hardness of the obtained tablets was not always sufficient.
  • Patent Document a composition for a rapidly disintegrating tablet in the oral cavity, wherein a disintegrant and an inorganic substance are uniformly dispersed in water in saccharide composite particles (Patent Document).
  • Patent Documents These are granulated particles that have been spray-dried, so that they have good meterability in a compression molding machine and are particles in which disintegrants and inorganic substances are homogeneously dispersed. Indicated.
  • tablets obtained by mixing and compressing active ingredients and spray-dried granules in Examples of Patent Documents 3 and 4 can obtain the desired disintegration but have insufficient hardness (30-40N), and tablet manufacture
  • problems such as chipping and powdering of tablets occurred during transportation.
  • the active ingredient content is high, tableting troubles such as sticking to the bag may occur.
  • Patent document 1 International publication 00Z57857 pamphlet
  • Patent Document 2 Japanese Patent Laid-Open No. 2001-58944
  • Patent Document 3 International Publication 2005Z037319 Pamphlet
  • Patent Document 4 International Publication 2005Z037254 Pamphlet
  • the present invention eliminates problems that occur when the content rate of the active ingredient is high compared to the above-described prior art oral disintegrating tablets, and has sufficient hardness that does not cause problems during production and transportation and the oral cavity. It is an object of the present invention to provide an intraoral rapidly disintegrating tablet having good disintegration property and a method for producing an intraoral rapidly disintegrating tablet having high productivity.
  • the "orally-fast disintegrating tablet” in the present invention means a tablet that can disintegrate rapidly in the oral cavity, for example, within 40 seconds, more preferably within 30 seconds, and even more preferably within 20 seconds.
  • the oral disintegration time here is the time obtained by the conditions of the intraoral quick disintegrating tablet described later and the methods of the examples.
  • the disintegration time in the oral cavity varies depending on the tablet size and tablet shape, and this is also included in the present invention.
  • the tablet obtained by using the composition for rapidly disintegrating tablets in the oral cavity of the present invention has a higher active ingredient content than conventional quick disintegrating tablets, causing problems during production and transportation. It has the feature of having a good disintegration time in the oral cavity despite having a sufficient hardness. Therefore, the intraoral rapidly disintegrating tablet of the present invention obtained by blending a medicinal component with the composition is suitable for a pharmaceutical product that requires rapid or powerful disintegration in the oral cavity.
  • the rapidly disintegrating tablet in the oral cavity of the present invention is (a) a structure in which an inorganic substance and a disintegrant are homogeneously dispersed in a composite particle of two or more saccharides, and further contains an active ingredient.
  • B Lubricant,
  • an orally rapidly disintegrating tablet comprising an active ingredient is there.
  • the granulated particles used in the present invention are described below.
  • the granulated particle used in the present invention is a granulated particle in which an inorganic substance and a disintegrant are homogeneously dispersed in a composite particle having mannitol and other saccharide power, or further containing an active ingredient.
  • These granulated particles can be obtained by spray-drying (i) saccharides, (mouth) disintegrants, and (c) inorganic substances in water and then spray-drying, or further dispersing active ingredients and spray-drying.
  • the method described in International Publication 2005Z 037319 or International Publication 2005Z037254 Therefore, it is a composition for intraoral rapidly disintegrating tablets manufactured.
  • Several types of these compositions are manufactured and sold by Fuji Chemical Industry Co., Ltd. as F-M ELT [trademark], and any type can be used.
  • the saccharide refers to sugar and sugar alcohol.
  • the saccharide contained in the granulated particles used in the present invention is a combination of mannitol and saccharides other than mannitol.
  • the saccharides other than mannitol are at least one or more selected from forces such as xylitol, sorbitol, erythritol, maltitol, lactose, sucrose, glucose, fructose, maltose, trehalose, palatinit and palatinose.
  • these saccharides those having an average particle size that are readily soluble in water can be used.
  • a pharmaceutically acceptable inorganic acid containing at least one of aluminum, magnesium and strength aluminum is preferred.
  • magnesium aluminate metasilicate, magnesium aluminate, calcium hydrogen phosphate, anhydrous calcium hydrogen phosphate, anhydrous calcium hydrogen phosphate granule, hydrated talcite, calcium carbonate, calcium silicate and dried At least one selected from hydroxyaluminum gel strength, more preferably at least one selected from magnesium aluminate metasilicate, hydrated talcite, anhydrous calcium hydrogen phosphate and calcium carbonate.
  • the average particle diameter of these inorganic substances is 0.1 to 100 / ⁇ ⁇ , preferably 1 to 60 / ⁇ ⁇ , and more preferably 1 to 40 m. In order to obtain a desired average particle size, a product pulverized by a conventional method can be used!
  • the disintegrant contained in the granulated particles of the present invention at least one selected from crospovidone, croscarmellose sodium, low-substituted hydroxypropylcellulose, and crystalline cellulose strength is preferred. May be used alone, but it is more preferable to use them as a mixture. Of these, crospovidone and crystalline cellulose are more preferably used. When using crospovidone and crystalline cellulose, the weight ratio of crospovidone and crystalline cellulose is 5-15: 8-22, preferably 5-14: 10-22, more preferably 6-13: 12-21. Ah.
  • the above disintegrant preferably has an average particle size of 0.1 to: LOO / zm, more preferably 1 to 1 in order to prevent uniform dispersibility in the composition of the present invention and roughness in the oral cavity.
  • the thickness is 60 ⁇ m, more preferably 1 to 40 ⁇ m. In order to obtain a desired average particle size, those obtained by pulverization by a conventional method can be used.
  • the blending amount of each component of the granulated particle of the present invention is 40 to 90 parts by weight of saccharide, 1 to 30 parts by weight of an inorganic substance, and 5 to 40 parts by weight of a disintegrant with respect to 100 parts by weight of the entire granulated particle.
  • the amount is 50 to 80 parts by weight of saccharide, 2 to 15 parts by weight of an inorganic substance, and 10 to 36 parts by weight of a disintegrant with respect to 100 parts by weight of the whole granulated particles. More preferably, it is 62 to 78 parts by weight of saccharide, 3 to 8 parts by weight of an inorganic substance, and 18 to 34 parts by weight of a disintegrant with respect to 100 parts by weight of the whole granulated particles.
  • the granulated particles of the present invention have a structure in which a disintegrant and an inorganic substance are homogeneously dispersed in composite particles having man-tol and saccharide power other than man-tol.
  • a disintegrant and an inorganic substance are homogeneously dispersed in composite particles having man-tol and saccharide power other than man-tol.
  • the granulated particles used in the present invention can contain an active ingredient described later and other ingredients that can be added to a pharmaceutical within a range not impairing the disintegration property described later.
  • the amount is 0.01 to 80 parts by weight, preferably 0.05 to 70 parts by weight, more preferably 0.1 to 60 parts by weight, based on 100 parts by weight of the saccharide, inorganic substance and disintegrant. It is.
  • the active ingredient is not contained in the granulated particles. Good.
  • the granulated particles used in the present invention can be produced by a production method capable of obtaining desired physical properties. Commonly used methods such as a spray drying method, a fluidized bed granulation drying method, and a stirring granulation method are used. It can be produced by a wet granulation method such as a wet extrusion granulation method.
  • the spray drying method is preferred from the standpoint of ease of production and easy acquisition of desired physical properties.
  • the spray drying method will be specifically described below. It can be produced by spray-drying an aqueous solution or dispersion containing a saccharide, an inorganic substance and a disintegrant according to a conventional method. More specifically, after a saccharide is previously dissolved or dispersed in an aqueous solvent, a dispersion obtained by uniformly dispersing a disintegrant and an inorganic substance can be produced by spray drying.
  • those containing an active component may optionally contain an active component, and are one of the other components that can be added to the pharmaceuticals described below as long as they do not impair disintegration. It can be produced by spray-drying a dispersion in which more than seeds are added and homogeneously dispersed.
  • Examples of the solvent include water, ethanol, methanol and the like as long as they are pharmaceutically acceptable solvents without affecting the characteristics of the granulated particles.
  • the dispersion can be prepared by a known method, and examples thereof include ordinary stirring, colloid mill, high-pressure homogenizer, ultrasonic irradiation, etc., but a method capable of highly dispersing particles in an aqueous dispersion. If it is.
  • the concentration in the dispersion is not particularly limited as long as it can be spray-dried with clay of the dispersion, that is, 5 to 50% by weight, preferably 10 to 45% by weight, more preferably 25 to 45% by weight. .
  • the conditions for spray drying are not particularly limited, but it is preferable to use a disk-type or nozzle-type spray dryer as the spray dryer.
  • the inlet temperature is preferably about 120 to 220 ° C, and the outlet temperature is preferably about 80 to 130 ° C.
  • the concentration of the solid matter in the aqueous dispersion during spray drying may be in a range that allows spray drying.
  • the average particle size of the granulated particles used in the present invention thus obtained can be appropriately adjusted depending on the concentration of the aqueous solution or dispersion, the spray drying method, the drying conditions, and the like. m, preferably 5 to 300 ⁇ m, more preferably 10 to 200 ⁇ m, even more preferred 30 to 200 ⁇ m is preferable because it can prevent roughening in the oral cavity! /.
  • the static specific volume of the granulated particles is preferably 1.5 to 4. Og / ml, more preferably 1.
  • the granulated particles have such a static specific volume, they can be easily filled into a mortar when they are formed into tablets, so that the formulation process proceeds smoothly, the tablets are uniformly compressed, and excellent punching is achieved. Can show lockability.
  • the static specific volume can be measured according to standard methods.
  • the particles have good fluidity, excellent tableting properties can be shown in the formulation process.
  • Examples of the lubricant used in the present invention include gum arabic powder, cacao butter, carnauba roux, carmellose calcium, carmellose sodium, caropeptide, hydrous carbon dioxide, dry hydroxide-aluminum gel, Glycerin, magnesium silicate, light anhydrous carboxylic acid, light liquid paraffin, crystalline cellulose, hydrogenated oil, synthetic aluminum silicate, sesame oil, wheat starch, white beeswax, magnesium oxide, dimethylpolysiloxane, sodium tartrate, sucrose fatty acid ester , Glycerin fatty acid ester, silicone resin, aluminum hydroxide gel, stearyl alcohol, stearic acid, aluminum stearate, calcium stearate, polyoxyl stearate, magnesium stearate, cetanol, zera Chin, Talc, Magnesium carbonate, Precipitated calcium carbonate, Corn starch, Lactose, No, Dop fat, Sucrose, Potato tempo, Hydroxy
  • stearic acid magnesium stearate, calcium stearate, sucrose fatty acid ester, polyethylene glycol, sodium stearyl fumarate, talc
  • the excipient, disintegration aid, and binder in the present invention are components that can improve the disintegration and moldability of the rapidly disintegrating tablet in the oral cavity of the present invention.
  • Binder it is not particularly limited to these applications.
  • the excipient in the present invention includes, for example, starch acrylate, L-aspartic acid, aminoethinolesnorephonic acid, aminoacetic acid, candy (powder), gum arabic, gum arabic powder, anoregic acid, sodium alginate, alpha-1 Modified starch, inositol, ethyl cellulose, ethylene acetate butyl copolymer, erythritol, sodium chloride, olive oil, kaolin, strength kaolin, casein, fructose, pumice grains, carmellose, carmellose sodium, hydrous diacid Yeast, dry hydroxyaluminum gel, dry sodium sulfate, dry magnesium sulfate, agar, agar powder, xylitol, citrate, sodium citrate, disodium citrate, glycerin, calcium glycephosphate, sodium dalconate, L- Dartami , Clay, clay grains, croscarmel
  • disintegration aid in the present invention examples include adipic acid, alginic acid, sodium alginate, alpha-monoized starch, erythritol, fructose, carboxymethyl starch sodium, carmellose, carmellose calcium, carmellose sodium, hydrous silicon dioxide, Kantene, Xylitol, Guar gum, Calcium citrate, Croscarmellose sodium, Crospovidone, Synthetic aluminum silicate, Magnesium aluminate, Low-substituted hydroxypropinolecellulose, Crystalline cellulose, Crystalline cellulose 'Power normelose sodium, Wheat starch , Rice starch, cellulose acetate phthalate, dioctyl sodium sulfosuccinate, sucrose fatty acid ester, hydroxyalumina magnesium, calcium stearate , Polyoxyl stearate, sorbitan sesquioleate, gelatin, cerac, sorbitol, sorbitan fatty acid ester, talc, sodium
  • the binder in the present invention includes, for example, ethyl acrylate 'methyl methacrylate copolymer emulsion, acetyl glycerin fatty acid ester, aminoalkyl methacrylate copolymer E, aminoalkyl methacrylate copolymer RS, aminoethyl sulfonic acid, candy ( Flour), gum arabic, gum arabic powder, sodium alginate, propylene glycol alginate, alpha starch starch, ester gum H, ethyl cellulose, ovata powder, hydrolyzed gelatin powder, sodium caseinate, fructose, caramel, carragham powder, carboxy Bull polymer, carboxymethylethyl cellulose, carboxymethyl starch sodium, carmellose, carmellose sodium, hydrous silicon dioxide, agar, ume powder, xanthan gum, beef tallow Oil, Guar gum, Glycerin, Synthetic aluminum silicate, Light anhydrous carboxylic acid, Hydroxy
  • Polyoxypropylene Glycol, Polysorbate, Polybulacetal Jetylaminoacetate, Polybulu alcohol ( Completely saponified product), polyvinyl alcohol (partially saponified product), polyvinyl pyrrolidone, polybutene, sodium polyphosphate, D-manntol, starch, light anhydrous caustic acid, magnesium metasilicate aluminate, etc. Any of these may be used alone, but two or more of them may be blended.
  • the active ingredient used in the present invention is not particularly limited, and is a central nerve agent such as a peripheral nerve agent, an antipyretic analgesic / antiinflammatory agent, a hypnotic sedative, or a neuropsychiatric agent; a skeletal muscle relaxant, an autonomic god Peripheral nerve drugs such as transdermal drugs; Cardiovascular drugs such as cardiotonic drugs, arrhythmia drugs, diuretics, vasodilators; respiratory drugs such as bronchodilators and antitussives; Digestives such as digestives, intestinal drugs, and antacids Tube drugs; metabolic drugs such as hormones, antihistamines and vitamins; anti-ulcer agents; antibiotics; chemotherapeutic agents; herbal extracts;
  • a central nerve agent such as a peripheral nerve agent, an antipyretic analgesic / antiinflammatory agent, a hypnotic sedative, or a neuropsychiatric agent
  • a skeletal muscle relaxant an autonomic god
  • the active ingredient those processed by a known method such as coating can be used for the purpose of concealing bitterness and controlling release. Moreover, in order to release in the digestive tract, the release may be controlled by a known method. If the active ingredient is rough in the oral cavity, it can be blended in order to enhance the feeling of taking, and an average particle size of 0.1 to LOO m is preferred.
  • the active ingredient should be contained in either or both of the above and outside of the granulated particles. If not included in the granulated particles, (a) the granulated particles, (b) the lubricant, and ( c) What is necessary is just to mix
  • the rapidly disintegrating tablet in the oral cavity of the present invention comprises (a) granulated particles 1 to 98 with respect to 100 parts by weight of the whole tablet. Parts by weight, (b) lubricant 0.01 to 5 parts by weight, (c) at least one selected from excipients, disintegration aids and Z or binders 1 to 98 parts by weight, (d) active ingredient 0. Consists of 01-60 parts by weight.
  • the whole tablet More preferably, for 100 parts by weight of the whole tablet, (a) 5 to 90 parts by weight of granulated particles, (b) 0.1 to 3 parts by weight of lubricant, (c) excipient, disintegration aid and At least one selected from Z or a binder is 5 to 90 parts by weight, and (d) the active ingredient is 0.1 to 50 parts by weight.
  • the intraoral rapidly disintegrating tablet of the present invention can be blended with other components that can be blended with pharmaceuticals as long as the disintegration property is not impaired.
  • Surfactants that do not impair disintegration that can be incorporated into the rapidly disintegrating tablet of the present invention include surfactants (for example, polyoxyethylene hydrogenated castor oil, polyoxyethylene polyoxypropylene glycol, sorbitan fatty acid ester, Polysorbate, glycerin fatty acid ester, sodium lauryl sulfate, etc.)
  • Acidulants eg, citrate, tartaric acid, malic acid, ascorbic acid
  • foaming agents eg, sodium bicarbonate, sodium carbonate
  • sweeteners sodium saccharin, dipotassium glycyrrhizinate, aspartame, stevia, thaumatin
  • flavoring E.g. lemon oil, orange oil, menthol, etc.
  • colorants e.g. edible red No. 2, edible blue No. 2, edible yellow No. 5, edible lake dye, ferric trioxide, etc.
  • stabilizers e.g. Edetate sodium, tocopherol, cyclodextrin, etc.
  • the rapidly disintegrating tablet in the oral cavity of the present invention is at least one or more selected from (a) granulated particles, (b) a lubricant, (c) an excipient, a disintegration aid and Z or a binder. And (d) It can be produced by mixing the active ingredient and other ingredients that can be blended with pharmaceuticals, followed by compression molding.
  • the compression molding is preferably performed by the direct tableting method.
  • the tableting pressure at that time depends on the size of the tablet and can be selected within the range of tableting pressure that can be formulated.
  • the other production methods include (a) granulated particles, (b) lubricant, (c) excipient, disintegration aid and at least one selected from Z or binder, and d)
  • the active ingredient may be subjected to compression molding after wet granulation.
  • wet granulation methods include spray drying, fluidized bed granulation drying, stirring granulation, and wet extrusion granulation.
  • aging such as heating and humidification can be performed according to a conventional method to impart desired hardness' disintegration property.
  • the lubricant may be mixed with other ingredients and then mixed with other ingredients, and then compression molded.
  • the other It is possible to manufacture by the method of pre-coating and compression molding (external lubrication method) on the surface of the punch and the wall of the mortar without mixing with the ingredients of the mold, giving the desired hardness and disintegration can do.
  • the method of applying the lubricant to the mortar can be performed by a conventionally known method or machine.
  • the intraorally rapidly disintegrating tablet of the present invention has a hardness of usually 40 to 200N, preferably 40 to 150N, more preferably 40 to 120N.
  • the tableting pressure can be adjusted as appropriate to achieve the above-mentioned hardness.
  • a 200 mg tablet is compressed using a 8 mm diameter punch, it has a hardness of 40 to 70 N when the tableting pressure is 300 to 2400 kgf.
  • the drug content has sufficient hardness, good disintegration property, and good moldability, but the properties (structure and shape) of the granulated particles are maintained. And the synergistic effect with the granulated particles due to the characteristics of certain excipients, disintegration aids and Z or the binder itself.
  • the rapidly disintegrating tablet in the oral cavity of the present invention can also be used as other solid preparations such as molding into tablets other than those intended for rapid disintegrating (for example, tabletable tablets).
  • the rapidly disintegrating tablet in the oral cavity of the present invention disintegrates immediately with a small amount of water, it can be used not only for pharmaceuticals but also for foods, health foods, specific function foods, pet foods, feeds and agricultural chemicals.
  • Spray-dried granulation D-Mann-Toll (Pearlitol 200 SD, Roquette) 51.2 parts by weight, Xylitol (Xylit XC, Towa Kasei Kogyo Co., Ltd.) 3.2 parts by weight, Crospovidone (Coridon CL, BASF Takeda Vitamin Co., Ltd.] 7.2 parts by weight, crystalline cellulose (Ceras PH-101, manufactured by Asahi Kasei Co., Ltd.) 13.6 parts by weight, magnesium aluminate metasilicate (Neusilin UFL2, manufactured by Fuji Chemical Industry Co., Ltd.) ] 4.
  • Mantol (Mannit p, manufactured by Towa Kasei Kogyo Co., Ltd.) 64 parts by weight, 4 parts by weight of xylitol, 9 parts by weight of crospovidone, 17 parts by weight of crystalline cellulose, 6 parts by weight of magnesium metasilicate aluminate in water And then spray-dried at an outlet temperature of 90 ° C using a spray dryer (L-8 type, manufactured by Okawara Kako Co., Ltd.). Good fluidity! White spherical granulated particles Got.
  • the tablet After mixing 5 parts by weight of aspirin with 95 parts by weight of the granulated particles obtained in Reference Example 1, and then mixing an appropriate amount of magnesium stearate, the tablet was tableted with a set hardness of 50 N using a rotary tableting machine, weight 200 mg, diameter 8mm, 9R tablets were obtained.
  • the tablet After mixing 20 parts by weight of aspirin with 80 parts by weight of the granulated particles obtained in Reference Example 1, and mixing an appropriate amount of magnesium stearate, the tablet was tableted with a set hardness of 50 N using a rotary tableting machine, and the weight was 200 mg, diameter. 8mm, 9R tablets were obtained.
  • the tablet is tableted with a rotary tableting machine with a set hardness of 50N to obtain tablets with a weight of 200mg and a diameter of 8mm ⁇ 9R. It was.
  • the tablet was tableted with a set hardness of 50 N using a rotary tableting machine, weight 200 mg, diameter 8mm, 9R tablets were obtained.
  • Comparative Example 1 caused tableting trouble and was unable to obtain a tablet, it can be seen that the granulated particles used in the present invention play an important role. From Examples 1 to 7 and Comparative Examples 2 to 4, by adding at least one or more selected from excipients, disintegration aids and Z or binders in the present invention, good disintegration and good molding The higher the hardness and the higher the hardness.
  • Mantol 65 parts by weight, xylitol 4 parts by weight, crospovidone 9 parts by weight, crystal cell port 17 parts by weight and 5 parts by weight of anhydrous calcium hydrogen phosphate were uniformly dispersed in water, and then the outlet temperature was 90 ° using a spray dryer (L-8 type, manufactured by Okawara Chemical Co., Ltd.). Spray drying with C gave white spherical granulated particles with good fluidity.
  • 70 parts by weight of the granulated particles obtained in Reference Example 2 are mixed with 10 parts by weight of aspirin and 20 parts by weight of low-substituted hydroxypropyl cellulose, mixed with an appropriate amount of magnesium stearate, and then set using a rotary tableting machine. Tableting was performed with a hardness of 50 N, and tablets with a weight of 200 mg, a diameter of 8 mm, and 9R were obtained.
  • Croscarmellose sodium (Ac-D To Sol, manufactured by Asahi Kasei Co., Ltd.) 50 g and light anhydrous caeic acid (Fad Solida 101, manufactured by Freund Sangyo Co., Ltd.) 50 g were kneaded in a mortar while adding an appropriate amount of water. . This was granulated with a 22 mesh sieve, dried at 60 ° C. for 18 hours, and then granulated with a 22 mesh sieve to obtain granules A.
  • the tablet After mixing 20 parts by weight of aspirin with 80 parts by weight of the granulated particles obtained in Reference Example 2 and mixing an appropriate amount of magnesium stearate, the tablet was tableted with a set hardness of 50 N using a rotary tableting machine, and the weight was 200 mg, diameter. 8mm, 9R tablets were obtained.
  • 60 parts by weight of the granulated particles obtained in Reference Example 2 are mixed with 20 parts by weight of aspirin and 20 parts by weight of carmellose (NS-300, manufactured by Gotoku Pharmaceutical) and mixed with an appropriate amount of magnesium stearate, followed by rotary tableting. Tableting was performed using a machine with a set hardness of 50 N, and tablets with a weight of 200 mg, a diameter of 8 mm, and 9R were obtained.
  • the tablet After mixing 70 parts by weight of the granulated particles obtained in Reference Example 2 with 30 parts by weight of aspirin and mixing an appropriate amount of magnesium stearate, the tablet is tableted with a set hardness of 50 N using a rotary tableting machine, weight 200 mg, diameter 8mm, 9R tablets were obtained.
  • the tablet After mixing 50 parts by weight of the granulated particles obtained in Reference Example 2 with 40 parts by weight of aspirin and 10 parts by weight of crospovidone, and mixing an appropriate amount of magnesium stearate, the tablet is tableted with a set hardness of 50 N using a rotary tableting machine. A tablet having a weight of 200 mg, a diameter of 8 mm, and 9R was obtained.
  • Mantol (Mannit p, manufactured by Towa Kasei Kogyo Co., Ltd.) 65 parts by weight, xylitol 5 parts by weight, crospovidone 8 parts by weight, crystalline cellulose 15 parts by weight, magnesium metasilicate aluminate 7 parts by weight in water And then spray-dried at an outlet temperature of 80 ° C using a spray dryer (L-8 type, manufactured by Okawahara Kako Co., Ltd.). Good fluidity! White spherical granulated particles Got.
  • the tablet was tableted with a set hardness of 50 N using a rotary tableting machine, A tablet having a weight of 200 mg, a diameter of 8 mm, and 9R was obtained.
  • the tablet was tableted with a set hardness of 50 N using a rotary tableting machine to obtain tablets with a weight of 200 mg, a diameter of 8 mm, and 9R.
  • the rotary tableting machine After mixing 50 parts by weight of acetaminophen with 50 parts by weight of the granulated particles obtained in Reference Example 3 and mixing an appropriate amount of magnesium stearate, the rotary tableting machine sets the hardness to 50 N, weight 200 mg, diameter. Force to try tableting as 8mm, 9R The upper limit pressure of the tableting machine exceeded 2400k gf, and the machine stopped, so it was impossible to obtain tablets.
  • Tableting was performed using a tableting machine with a set hardness of 50 N, and tablets with a weight of 200 mg and a diameter of 8 mm ⁇ 9R were obtained.
  • the content of the drug can be increased by adding at least one selected from the group consisting of excipient, disintegration aid and Z or binder force to the granulated particles in the present invention. It can be seen that good disintegration and good moldability can be obtained with higher hardness.
  • spray dryer [L — 8 type, manufactured by Okawara Chemical Industries Co., Ltd.] was spray-dried at an outlet temperature of 80 ° C. to obtain white spherical granulated particles with good fluidity.
  • the tablet was tableted with a set hardness of 50 N using a rotary tableting machine, A tablet having a weight of 200 mg, a diameter of 8 mm, and 9R was obtained.
  • the granulated particles obtained in Reference Example 4 are mixed with 64 parts by weight of acetaminophen 20 parts by weight and a crystal cell port. After mixing 16 parts by weight of the cellulose and an appropriate amount of magnesium stearate, the tablet was tableted with a set hardness of 50 N using a rotary tableting machine to obtain tablets with a weight of 200 mg, a diameter of 8 mm, and 9R.
  • the tablet After mixing 70 parts by weight of the granulated particles obtained in Reference Example 4 with 30 parts by weight of acetaminophen and mixing an appropriate amount of magnesium stearate, the tablet is tableted with a set hardness of 50 N using a rotary tableting machine, A tablet having a weight of 200 mg, a diameter of 8 mm, and 9R was obtained.
  • the set hardness is set to 50 N using a rotary tableting machine. As a result, tablets with a weight of 200 mg, a diameter of 8 mm, and 9R were obtained.
  • the tablet was tableted with a set hardness of 50 N using a rotary tableting machine, A tablet having a weight of 200 mg, a diameter of 8 mm, and 9R was obtained.
  • 35 parts by weight of the granulated particles obtained in Reference Example 4 and 40 parts by weight of acetaminophen 25 parts by weight of the mixture was mixed with an appropriate amount of magnesium stearate, and then tableted with a rotary tableting machine with a set hardness of 50 N to obtain tablets with a weight of 200 mg, a diameter of 8 mm, and 9R.
  • the hardness is set to 50 N with a rotary tableting machine, weight 200 mg, diameter. Force to try tableting as 8mm and 9R The upper limit pressure of the tableting machine exceeded 2400kgf and the machine stopped, so it was impossible to obtain tablets.
  • Tableting was performed with a tableting machine with a set hardness of 50 N, and tablets with a weight of 200 mg and a straightness of 8 mm 9 R were obtained.
  • a spray dryer L 8 type, manufactured by Okawahara Chemical Co., Ltd.
  • the granulated particles obtained in Reference Example 5 were mixed with an appropriate amount of magnesium stearate, and then tableted with a rotary tableting machine with a set hardness of 50N to obtain tablets with a weight of 200 mg, a diameter of 8 mm, and 9R.
  • the tablet After mixing 20 parts by weight of hydroxypropyl starch with 80 parts by weight of the granulated particles obtained in Reference Example 5 and mixing an appropriate amount of magnesium stearate, the tablet is tableted with a set hardness of 50 N using a rotary tableting machine, and the weight is 200 mg. A tablet with a diameter of 8 mm and 9R was obtained.
  • Tableting was performed using a rotary tableting machine with a set hardness of 50 N, and tablets with a weight of 200 mg, a diameter of 8 mm, and 9R were obtained.
  • Crospovidone (50 g) and maltitol (manufactured by Towa Kasei Kogyo Co., Ltd.) (10 g) were kneaded in a mortar while preparing an appropriate amount of ethanol (99.5%). This was granulated with a 22 mesh sieve, dried at 60 ° C. for 18 hours, and then granulated with a 22 mesh sieve to obtain granules C.
  • the tablet was tableted with a set hardness of 50 N using a rotary tableting machine, weight 200 mg, diameter 8mm, 9R tablets were obtained.
  • magnesium stearate was mixed with granule D, it was tableted with a rotary tableting machine with a set hardness of 50N to obtain tablets with a weight of 200 mg, a diameter of 8 mm, and 9R.
  • the tablet After mixing 1 part by weight of granule El with 89 parts by weight of the granulated particles obtained in Reference Example 5 and mixing an appropriate amount of magnesium stearate, the tablet was tableted with a set hardness of 50 N using a rotary tableting machine, and the weight was 200 mg. Tablets with a diameter of 8 mm and 9R were obtained.
  • Crospovidone (5 g), maltitol (20 g), magnesium metasilicate aluminate (5 g) and hydroxypropyl starch (70 g) were mixed with an appropriate amount of ethanol (99.5%) in a mortar. This was granulated with a 22 mesh sieve, dried at 60 ° C for 18 hours, and then granulated with a 22 mesh sieve to obtain granules F.
  • Mantol (Mannit p, manufactured by Towa Kasei Kogyo Co., Ltd.) 63 parts by weight, 6 parts by weight of xylitol, 7 parts by weight of crospovidone, 19 parts by weight of crystalline cellulose, 5 parts by weight of magnesium metasilicate aluminate in water And then spray-dried at an outlet temperature of 90 ° C using a spray dryer (L-8 type, manufactured by Okawara Kako Co., Ltd.). Good fluidity! White spherical granulated particles Got.
  • the tablet After mixing 70 parts by weight of the granulated particles obtained in Reference Example 6 with 30 parts by weight of ascorbic acid and mixing an appropriate amount of magnesium stearate, the tablet is tableted with a set hardness of 50 N using a rotary tableting machine, and the weight is 200 mg. A tablet with a diameter of 8 mm and 9R was obtained.
  • a tableting machine (compact high-speed rotary tableting machine VIRGO, Kikusui Manufacturing Co., Ltd.) To obtain a tablet with a tablet weight of 200 mg, a diameter of 8 mm and a flat corner.
  • oral disintegrating tablets that were tableted by the external lubrication method obtained good moldability and disintegration, and were rapidly mixed with the lubricant and tableted in advance. It can be seen that the disintegration time is shorter than tablets, and the disintegration is superior.
  • It can be provided as a tablet having sufficient hardness and good disintegration property in the oral cavity.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Zoology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

La présente invention concerne la création d’un comprimé qui se dissout rapidement dans la bouche et qui a un niveau suffisant de dureté et une capacité suffisante à être moulé pour ne pas causer de problèmes tels qu’un effritement ou de la poudre lors du procédé de production ou de transport et qui fait également preuve d’un bon niveau de dissolution dans la cavité orale, tout en maintenant un niveau élevé d’ingrédient actif ; et un procédé de production d’un comprimé se désintégrant rapidement dans la bouche comprenant un moulage sous compression qui utilise un établissement conventionnel de préparation de médicaments. Pour résoudre le problème, les ingrédients suivants (a) à (d) sont mélangés l’un à l’autre : (a) une particule granulée comprenant (i) une substance inorganique et (ii) un agent de désintégration dispersés de manière homogène dans (iii) une particule composite faite d’au moins deux saccharides, qui contient en option un ingrédient actif, (b) un lubrifiant, (c) au moins un ingrédient sélectionné à partir d’un agent de désintégration auxiliaire, un excipient et/ou un liant et (d) l’ingrédient actif, le mélange résultant est formé sous compression en utilisant un établissement de préparation de médicament conventionnel ou en utilisant un procédé dans lequel un lubrifiant est préalablement enduit sur les surfaces d’un mortier ou d’un pilon (procédé de lubrification externe). Il est ainsi possible de préparer un comprimé qui se dissout rapidement dans la bouche et qui a des propriétés de moulage excellentes, un bon niveau de désintégration et un niveau satisfaisant de dureté même si la quantité d’ingrédient actif est élevée.
PCT/JP2006/309706 2005-09-02 2006-05-16 Comprimé se désintégrant rapidement dans la bouche WO2007029376A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2007534257A JP5074190B2 (ja) 2005-09-02 2006-05-16 口腔内速崩壊性錠剤

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
JP2005254478 2005-09-02
JP2005-254478 2005-09-02
JP2005-364009 2005-12-16
JP2005364009 2005-12-16
JP2006-042944 2006-02-20
JP2006042944 2006-02-20

Publications (1)

Publication Number Publication Date
WO2007029376A1 true WO2007029376A1 (fr) 2007-03-15

Family

ID=37835510

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2006/309706 WO2007029376A1 (fr) 2005-09-02 2006-05-16 Comprimé se désintégrant rapidement dans la bouche

Country Status (2)

Country Link
JP (1) JP5074190B2 (fr)
WO (1) WO2007029376A1 (fr)

Cited By (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2008285434A (ja) * 2007-05-16 2008-11-27 Taisho Pharm Ind Ltd 口腔内速崩壊錠
JP2010143836A (ja) * 2008-12-16 2010-07-01 Nichi-Iko Pharmaceutical Co Ltd 口腔内崩壊錠用組成物
WO2010092828A1 (fr) 2009-02-12 2010-08-19 富士化学工業株式会社 Composition de particule se désintégrant et matériau moulé par compression se désintégrant rapidement comprenant celle-ci
JP2010241695A (ja) * 2009-04-01 2010-10-28 Teika Seiyaku Kk 口腔内速崩壊性錠剤およびその製造方法
JP2011026311A (ja) * 2009-06-29 2011-02-10 Fuji Chem Ind Co Ltd 口腔内速崩壊錠の製造方法
WO2011019043A1 (fr) 2009-08-11 2011-02-17 大日本住友製薬株式会社 Comprimé qui se délite rapidement en bouche et qui contient deux types ou plus de particules
WO2011019046A1 (fr) 2009-08-11 2011-02-17 富士化学工業株式会社 Composition de particules se désintégrant et comprimé se désintégrant rapidement dans la cavité buccale
WO2011019045A1 (fr) 2009-08-11 2011-02-17 富士化学工業株式会社 Composition de particules se désintégrant et comprimé se désintégrant rapidement dans la cavité buccale
JP2011513194A (ja) * 2008-02-29 2011-04-28 大塚製薬株式会社 口腔内崩壊錠
JP2011524386A (ja) * 2008-06-20 2011-09-01 メルク パテント ゲゼルシャフト ミット ベシュレンクテル ハフツング 直接圧縮性および迅速崩壊性錠剤マトリックス
US8613950B2 (en) 2005-03-01 2013-12-24 Bayer Intellectual Property Gmbh Pharmaceutical forms with improved pharmacokinetic properties
WO2014014010A1 (fr) 2012-07-20 2014-01-23 大塚製薬株式会社 Tablette ayant un film d'encre sèche sur la surface de celle-ci, et encre pour imprimante à jet d'encre
US8841446B2 (en) 2002-07-16 2014-09-23 Bayer Intellectual Property Gmbh Medicaments containing vardenafil hydrochloride trihydrate
US9284490B2 (en) 2010-10-28 2016-03-15 National Institute For Materials Science Organic/inorganic hybrids, and process of producing them
JP5897196B1 (ja) * 2015-10-05 2016-03-30 大同化成工業株式会社 糖又は糖アルコール、膨潤型結合剤、崩壊剤及び高吸収性賦形剤を含む複合化造粒物及びその製造方法
CN115486543A (zh) * 2022-10-09 2022-12-20 江苏天美健大自然生物工程有限公司 一种高浓度螺旋藻片及其制备方法

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000078292A1 (fr) * 1999-06-18 2000-12-28 Takeda Chemical Industries, Ltd. Preparations solides a desintegration rapide
WO2002069934A1 (fr) * 2001-03-06 2002-09-12 Kyowa Hakko Kogyo Co., Ltd. Préparations se délitant rapidement dans la bouche
WO2005037319A1 (fr) * 2003-10-15 2005-04-28 Fuji Chemical Industry Co., Ltd. Composition de comprime se desagregeant rapidement dans la bouche
WO2005037254A1 (fr) * 2003-10-15 2005-04-28 Fuji Chemical Industry Co., Ltd. Comprime se desintegrant rapidement dans la cavite buccale

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000078292A1 (fr) * 1999-06-18 2000-12-28 Takeda Chemical Industries, Ltd. Preparations solides a desintegration rapide
WO2002069934A1 (fr) * 2001-03-06 2002-09-12 Kyowa Hakko Kogyo Co., Ltd. Préparations se délitant rapidement dans la bouche
WO2005037319A1 (fr) * 2003-10-15 2005-04-28 Fuji Chemical Industry Co., Ltd. Composition de comprime se desagregeant rapidement dans la bouche
WO2005037254A1 (fr) * 2003-10-15 2005-04-28 Fuji Chemical Industry Co., Ltd. Comprime se desintegrant rapidement dans la cavite buccale

Cited By (26)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8841446B2 (en) 2002-07-16 2014-09-23 Bayer Intellectual Property Gmbh Medicaments containing vardenafil hydrochloride trihydrate
US8613950B2 (en) 2005-03-01 2013-12-24 Bayer Intellectual Property Gmbh Pharmaceutical forms with improved pharmacokinetic properties
JP2008285434A (ja) * 2007-05-16 2008-11-27 Taisho Pharm Ind Ltd 口腔内速崩壊錠
JP2011513194A (ja) * 2008-02-29 2011-04-28 大塚製薬株式会社 口腔内崩壊錠
US11166917B2 (en) 2008-06-20 2021-11-09 Merck Patent Gmbh Direct injection moldable and rapidly disintegrating tablet matrix
JP2011524386A (ja) * 2008-06-20 2011-09-01 メルク パテント ゲゼルシャフト ミット ベシュレンクテル ハフツング 直接圧縮性および迅速崩壊性錠剤マトリックス
JP2010143836A (ja) * 2008-12-16 2010-07-01 Nichi-Iko Pharmaceutical Co Ltd 口腔内崩壊錠用組成物
WO2010092828A1 (fr) 2009-02-12 2010-08-19 富士化学工業株式会社 Composition de particule se désintégrant et matériau moulé par compression se désintégrant rapidement comprenant celle-ci
JP2010241695A (ja) * 2009-04-01 2010-10-28 Teika Seiyaku Kk 口腔内速崩壊性錠剤およびその製造方法
JP2011026311A (ja) * 2009-06-29 2011-02-10 Fuji Chem Ind Co Ltd 口腔内速崩壊錠の製造方法
WO2011019045A1 (fr) 2009-08-11 2011-02-17 富士化学工業株式会社 Composition de particules se désintégrant et comprimé se désintégrant rapidement dans la cavité buccale
US8591955B2 (en) 2009-08-11 2013-11-26 Dainippon Sumitomo Pharma Co., Ltd. Orally rapidly disintegrating tablet that contains two or more types of particles
US9446055B2 (en) 2009-08-11 2016-09-20 Fuji Chemical Industry Co., Ltd. Disintegrating particle composition and orally rapidly disintegrating tablet
WO2011019046A1 (fr) 2009-08-11 2011-02-17 富士化学工業株式会社 Composition de particules se désintégrant et comprimé se désintégrant rapidement dans la cavité buccale
US8900602B2 (en) 2009-08-11 2014-12-02 Fuji Chemical Industry Co., Ltd. Disintegrating particle composition and orally rapidly disintegrating tablet
JP5674667B2 (ja) * 2009-08-11 2015-02-25 富士化学工業株式会社 崩壊性粒子組成物及び口腔内速崩壊錠
JP5674666B2 (ja) * 2009-08-11 2015-02-25 富士化学工業株式会社 崩壊性粒子組成物及び口腔内速崩壊錠
WO2011019043A1 (fr) 2009-08-11 2011-02-17 大日本住友製薬株式会社 Comprimé qui se délite rapidement en bouche et qui contient deux types ou plus de particules
US9284490B2 (en) 2010-10-28 2016-03-15 National Institute For Materials Science Organic/inorganic hybrids, and process of producing them
WO2014014010A1 (fr) 2012-07-20 2014-01-23 大塚製薬株式会社 Tablette ayant un film d'encre sèche sur la surface de celle-ci, et encre pour imprimante à jet d'encre
WO2017061426A1 (fr) * 2015-10-05 2017-04-13 大同化成工業株式会社 Produit composite granulé comprenant du sucre ou un alcool de sucre, un liant gonflant, un agent délitant et un excipient hautement absorbant, et procédé de fabrication dudit produit composite granulé
JP2017071561A (ja) * 2015-10-05 2017-04-13 大同化成工業株式会社 糖又は糖アルコール、膨潤型結合剤、崩壊剤及び高吸収性賦形剤を含む複合化造粒物及びその製造方法
US10632074B2 (en) 2015-10-05 2020-04-28 Daido Chemical Corporation Composite granulated product including sugar or sugar alcohol, swelling binder, disintegrating agent and highly absorbent excipient, and method for manufacturing composite granulated product
JP5897196B1 (ja) * 2015-10-05 2016-03-30 大同化成工業株式会社 糖又は糖アルコール、膨潤型結合剤、崩壊剤及び高吸収性賦形剤を含む複合化造粒物及びその製造方法
CN115486543A (zh) * 2022-10-09 2022-12-20 江苏天美健大自然生物工程有限公司 一种高浓度螺旋藻片及其制备方法
CN115486543B (zh) * 2022-10-09 2024-02-23 江苏天美健大自然生物工程有限公司 一种高浓度螺旋藻片及其制备方法

Also Published As

Publication number Publication date
JP5074190B2 (ja) 2012-11-14
JPWO2007029376A1 (ja) 2009-03-12

Similar Documents

Publication Publication Date Title
JP5074190B2 (ja) 口腔内速崩壊性錠剤
JP3841804B2 (ja) 口腔内速崩壊性錠剤用の組成物
EP2218443B1 (fr) Comprimé se désintégrant oralement
JP4706785B2 (ja) 経口投与用粒子状医薬組成物
JP4920798B2 (ja) ２種以上の粒子を含有する口腔内速崩壊錠
EP1980272B1 (fr) Comprimé se délitant en bouche et son procédé de fabrication
JP4802436B2 (ja) 口腔内崩壊型組成物及び口腔内崩壊型製剤
WO2005037254A1 (fr) Comprime se desintegrant rapidement dans la cavite buccale
CN1225017A (zh) 可迅速崩解的压模物质及其生产方法
WO2007074856A1 (fr) Procede de production de preparation solide se desintegrant dans la cavite orale
JP2009114113A (ja) 口腔内崩壊錠及びその製造方法
KR20030094272A (ko) 구강내 급속 붕괴성 정제
JP5534004B2 (ja) 口腔内崩壊錠
JP5342028B2 (ja) 口腔内崩壊錠
JP2016174616A (ja) 崩壊性組成物及び易崩壊性圧縮成型物
JP2004315483A (ja) 口腔内崩壊錠剤
JP3900245B2 (ja) 口腔内速崩壊型錠剤及びその製造方法
JP5835875B2 (ja) 口腔内速崩壊錠の製造方法
JPH1143429A (ja) 固形製剤
JP5572321B2 (ja) 被覆微粒子含有口腔内崩壊錠
JP6513702B2 (ja) 超速崩壊錠剤及びその製造方法
EP2433652A1 (fr) Comprimé à désintégration orale et enrobé à sec
JP2002308760A (ja) 圧縮成型用組成物及びその利用
JP4601271B2 (ja) 圧縮成形製剤およびその製造方法
JP2005029557A (ja) 口腔内速崩壊性錠剤およびその製造方法

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application
ENP Entry into the national phase

Ref document number: 2007534257

Country of ref document: JP

Kind code of ref document: A

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 06746420

Country of ref document: EP

Kind code of ref document: A1