WO2006106923A1 - Comprimé se désintégrant dans la cavité orale et méthode pour le produire - Google Patents

Comprimé se désintégrant dans la cavité orale et méthode pour le produire Download PDF

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Publication number
WO2006106923A1
WO2006106923A1 PCT/JP2006/306841 JP2006306841W WO2006106923A1 WO 2006106923 A1 WO2006106923 A1 WO 2006106923A1 JP 2006306841 W JP2006306841 W JP 2006306841W WO 2006106923 A1 WO2006106923 A1 WO 2006106923A1
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Prior art keywords
disintegrating tablet
mannitol
orally disintegrating
binder
oral cavity
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PCT/JP2006/306841
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English (en)
Japanese (ja)
Inventor
Masayo Ito
Naoko Nakamura
Nobuo Yamada
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Taiyo Yakuhin Co., Ltd.
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Publication of WO2006106923A1 publication Critical patent/WO2006106923A1/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
    • A61K9/0012—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

Definitions

  • the present invention relates to an orally disintegrating tablet, and more particularly, to an orally disintegrating tablet and a method for producing the orally disintegrating tablet capable of improving production efficiency without wear during production and transportation.
  • oral preparations such as tablets, capsules, condyles, and powders are most widely used as pharmaceutical dosage forms in terms of ease of use and ease of administration.
  • many of these oral preparations have the problem that they are difficult to take for the elderly and children who have difficulty swallowing.
  • Patent Document 1 a method for producing an orally disintegrating tablet that compresses a mixture containing water at such a level that the particle surface wets.
  • Patent Documents 2 and 3 a method for producing an orally disintegrating tablet in which an amorphous saccharide is mainly used, compression molding is performed at a low pressure, and then the tablet is placed in a humidified state and moistened, and further dried.
  • Patent Document 1 Japanese Patent Laid-Open No. 5-271054
  • Patent Document 2 Japanese Patent Laid-Open No. 11-12162
  • Patent Document 3 Japanese Patent Laid-Open No. 11-349475
  • Patent Document 4 Japanese Patent Laid-Open No. 2002-308760
  • the present inventors have reduced the compression molding time by using mannitol, which is entirely or partly a delta crystal as a carrier. Even if shortened, an orally disintegrating tablet with hardness that can withstand rapid oral disintegration, production, and transportation can be obtained, and powder scattering is suppressed by reducing the amount of fine powder during granulation. Furthermore, the present inventors have found that the damage of the preparation during production and transportation can be reduced by improving the compression moldability, thereby completing the present invention.
  • the present invention provides an orally disintegrating tablet containing mannitol, wherein all or part of the mannitol is a delta crystalline mannitol. .
  • the present invention also relates to a method for producing an orally disintegrating tablet, comprising preparing a granulated product using mannitol and a binder that dissolves or swells in water at room temperature and compresses the granulated product.
  • the present invention provides a method for producing an orally disintegrating tablet, characterized in that all or part of the mannitol is delta-type mannitol.
  • the present invention it is possible to stably tablet without causing tableting troubles such as wrinkle adhesion, cabbing, die friction and the like, and the oral cavity has quick disintegration even if the compression molding time is shortened.
  • An internally disintegrating tablet can be obtained.
  • powder scattering can be suppressed by reducing the fine powder during granulation.
  • by improving the compression moldability it is possible to reduce the breakage of the preparation during production and transportation.
  • Mantle to be used in the present invention may be a force in which all mannitol is a delta type, a part of mannitol is a delta type, and other crystal forms may be used.
  • Mantol is a type of white sugar alcohol. This product is sweet and can give a refreshing sensation in the oral cavity, and since it dissolves easily in water, it has been used in various preparations, especially intraoral quick-disintegrating tablets and troches. It is. Conventionally, however, mannitol has been considered to be susceptible to creaking between the mortars due to its poor bonding properties during compression molding. To improve this, a large amount of binder is required. However, when tableting property is increased, there is a problem that the expected disintegration property cannot be obtained. From these, it was said that some kind of technique was required for use.
  • a part or all of mannitol may be delta mannitol.
  • the compression molding preparation disintegrates rapidly in the oral cavity.
  • the amount may be such that the tableting trouble at the time of compression molding is eliminated.
  • rapid disintegration in the oral cavity means that the disintegration time in the oral cavity is preferably within 3 minutes, more preferably within 1 minute, and more preferably within 30 seconds.
  • the amount of delta mannitol that can be used in the present invention is not particularly limited as described above, but specifically, it is 3% by mass (hereinafter simply referred to as "%") of the entire man-tol. Or more, preferably 5% or more, more preferably 10% or more, and still more preferably 20% or more.
  • binder used in the present invention that dissolves or swells in water at room temperature
  • binder is dissolved or swelled in water at room temperature.
  • What is used as a binder is not particularly limited.
  • the term “dissolving in water” specifically means that it dissolves at least 1 lg per liter of purified water at room temperature, and more preferably dissolves at least 10 g.
  • Preferred examples of the binder used in the present invention include polymer compounds.
  • examples of such a high molecular weight compound include hydrolyzed starches that are soluble in water by substituting a part of cellulose with a hydrophilic substituent, Examples thereof include a compound which has been made soluble in water by being unified, or a substance obtained by chemically changing cellulose, starch or the like by a microorganism.
  • a compound obtained by synthesis is also effective for carrying out the present invention.
  • hydroxypropylcellulose hydroxychetinoresenorerose, hydroxypropinoremethinoresenellose, strength nomellose sodium, pregelatinized starch, dextrin, pullulan, polybulal alcohol, and soluble polybulur pyrrolidone.
  • starch-derived compounds that can be dissolved at room temperature or partially.
  • starches starch-derived compounds
  • Such compounds are those in which some or all of the starch, which is not normally dissolved in water, is in a state where all or part of the starch is dissolved, specifically starch alpha unification or hydrolyzate. Is mentioned.
  • alpha unification refers to a state in which water enters a crystal structure by breaking a hydrogen bond for maintaining the crystal structure by heating starch that has penetrated water.
  • the starch can be alpha-ized by suspending it in water and heating the suspension.
  • Alpha-ized starch also includes starch that is at least partially alpha-ized, i.e., substantially alpha-ized starch.
  • alpha-ized starch is commercially available as an alpha-ized compound, and this can also be used.
  • partially pregelatinized starch is commercially available as a substantially alpha-denatured starch, which may be used.
  • additives obtained by hydrolyzing starch are also "starches” and can be sufficiently used in the present invention.
  • a specific example of such a starch hydrolyzate is dextrin.
  • pullulan a natural polysaccharide with regular ⁇ -1,6-linked maltotriose obtained by culturing Aureoba sidium pullulans, a kind of black yeast. Fully demonstrate the effect of the patent.
  • the ratio of mannitol and binder in the production of the orally disintegrating tablet of the present invention is not particularly limited, but preferably 0.05 to 20% of the binder with respect to mannitol, More preferably, it is 0.1-5%, More preferably, it is 0.5-3%.
  • the granulating apparatus that can be used in this case is not particularly limited as long as it is a granulator capable of producing a granular material in the absence of fine powder.
  • the fluidized bed granulator, the stirring granulator, the extrusion granulator, the rolling granulator, the Wurster granulator or a combination of these it is preferable that the fluidized bed granulator, the stirring granulator, the extrusion granulator, the rolling granulator, the Wurster granulator or a combination of these.
  • the best granulator is a fluidized bed granulator.
  • an inorganic salt may be added.
  • the inorganic salt that can be used in the present invention is not particularly limited, but it ensures compression moldability and further reduces friction with the metal adhesion surface during tableting such as die friction. Just do it.
  • Examples of the inorganic salt satisfying such conditions include kai acids and calcium carbonate. Of these, carboxylic acids are preferred, and silicates are more preferred. Specific examples include magnesium silicate, calcium silicate, magnesium metasilicate, magnesium aluminum silicate, and light anhydrous carboxylic acid. Of these silicates, the more preferred silicate is magnesium aluminate metasilicate.
  • the addition amount of the inorganic salt is not intended to be otherwise limited, and preferably 0.5 relative mannitol 01-300 0/0, more preferably ⁇ or 0.05 to 200 0/0, more preferably ⁇ It is 0.1 to 100%.
  • the addition method of the inorganic salt is not particularly limited, for example, a method of adding together with mannitol at the time of granulation, a method of adding to the granulation liquid, a method of adding calories to the granulated granules, etc.
  • a method of coating an inorganic salt on a granulated product of mannitol and a binder that dissolves or swells in water at room temperature may be employed.
  • the preferred method is the method of adding to the granulation liquid, the method of coating the granulated granule, the method of adding to the granulated granule, and the best method is mannitol and room temperature. This is a method of coating a granulated product of a binder that dissolves or swells in water, or a method of adding after granulation.
  • physiologically active ingredient that can be blended in the orally disintegrating tablet of the present invention
  • sleep sedatives for example, sleep sedatives, anti-anxiety agents, antiepileptic agents, antipyretic analgesics, anti-parkinsonian agents, psychiatric agents, autonomic agents, antispasmodics, cardiotonic agents, arrhythmic agents, diuretics, Antihypertensive agent, vasoconstrictor, vasodilator, hyperlipidemia agent, antitussive agent, expectorant, bronchodilator, antidiarrheal agent, peptic ulcer agent, digestive stomach digester, antacid, laxative, hormone Bioactive ingredients that are active ingredients such as agents, vitamins, nourishing tonics, enzyme preparations, antidiabetic agents, antihistamines, allergic agents, antibiotic preparations, synthetic antibacterial agents, and anti-drunk agents can be used.
  • physiologically active ingredients of sleep sedatives and anxiolytics for example, alprazolam, estazolam, quazepam, triazolam, brotizolam, amobarbital, tandospirone, etc.
  • physiologically active ingredients of antiepileptic agents for example, Phytoin, carbamazepine, clonazepam, phenytoin, etc.
  • physiologically active ingredients of antipyretic analgesics such as acetaminophen, phenacetin, mefenam, aspirin, ethenzamide, isopropylantipyrine, sodium salicylate, indomethacin, diclofenac, Thiaramid, Actarit, Ampiroxicam, Ibuprofen, Etodolac, Ketoprofen, Zaltoprofen, Piroxicam, Planoprofen, Loxoprofen, etc.
  • antipyretic analgesics such as acetaminophen, phenacetin, mefenam, aspirin, ethenzamide, isopropylantipyrine, sodium salicylate, indomethacin, diclofenac, Thiaramid, Actarit, Ampiroxicam, Ibuprofen, Etodolac, Ketoprofen, Zaltoprofen, Piroxicam, Planoprofen, Loxoprofen, etc
  • bioactive component of antiparkinsonian For example, amantadine, piperidene, selegiline, trihexifere-zil, strength belgorin, pergolide, etc., as the physiologically active ingredients of the neuropsychiatric agents, for example, chlorpromadine, perphenazine, triproperazine, imipramine, etizolam, olanzapine, Quazepam, sulpiride, haloperidol, risperidone, etc. are examples of physiologically active components of autonomic nerve agents, such as calpe mouth-um, distigmine, torazoline, etc., and physiologically active components of antiseptics are butyl bromide. Examples include scopolamine, papaverine, eperisone, tizazine and nocrophene.
  • examples of the cardiotonic agent include diquitoxin, digoxin, methyldigoxin, aminophylline, caffeine, ethylephrine, ubidecarenone, and the like
  • examples of the arrhythmia agent include procainamide, atenolol, oxprenolol, carteolol, propranolol. Nord, nadolol, pindolol, bisoprolol, azimarin, pirucainide, propafenone, methiciletin, disopyramide, etc.
  • hydrothiazia thiazide for example, hydrothiazia thiazide, spirolalatone, acetazolamide, isosorbide, torasemide, furosemide, etc.
  • hydralazine, reserpine alaspril, imidapril, quinapril, captopril, cilazapril, enalapril, lisinopril, methyldonocre, efodidipine, seripro oral, dicardipine, prazosin, betaxolol, manidipine, carvedilol, metoprolol, -Dipine, ferrodipine, doxazosin, etc., as vasoconstrictors, for example, middolin, dihydroergotamine, etc.As vasodilators, isosorbide mononitrate, etafenone, diltiazem, bedipine, dip
  • antihyperlipidemic agents such as clofebrate, fenofibrate, bezafibrate, adolvastatin, elastane. , Nicomol, pravastatin, full pasta Chin, Purobukonore, simvastatin down, and the like, respectively.
  • antitussives for example, ephedrine, methylephedrine, noscalvin, benproperin and the like, such as carcistine, bromhexine, ambroxol, cherry bark, codin, dihydrocodine, tippe.
  • Pidgin is a bronchodilator such as theophylline, fenoterol, salbutamol, clenbuterol, llulobuterol, trimethoquinol, pro-powered terol, formoterol, etc.
  • stomach antiseptic for example, amylase, diastase, pancreatine, fumika tincture, carnitine, galactosidase, etc.
  • magnesium silicate magnesium oxide, sodium hydrogen carbonate, magnesium carbonate, precipitated calcium carbonate and the like.
  • laxative for example, senna extract, sennoside, magnesium sulfate, picosulfate and the like can be mentioned.
  • hormonal agent for example, levothyroxine, liothyronine, thiamazole, propylliouracil, cortisone, parameterzone, dexamethasone, betamethasone, prednisolone, testosterone, phosfestronole, estrionore, chronoremadinone, arrinole estre Nord, clomiphene, tanazol, tamsulosin, flavoxate, middolin, gal
  • vitamin A calcitriol, thiamine, fursultiamine, riboflavin, pantethine, pantothenic acid, pyridoxine, folic acid, cobamide, mecobalamin, ascorbic acid, tocopherol, phenathadione, menatetrenone, piotin
  • enzyme preparations include, for example, lysozyme, serrapeptase and the like, examples of antidiabetic
  • antihistamines include, for example, diphenhydramine, Promethazine, mequitazine, chlorpheniramine, clemastine, etc. are allergic agents such as ibudilast, azelastine, epinastine, cetirizine, sp Task door, Tiger - last, ketotifen, plan Norre cust, Bae Mirorasuto, mouth Ratajin and the like are each elevation up.
  • antibiotics include clindamycin, lincomycin, noncomycin, force namicin, amoxicillin, ampicillin, cefaclonole, cephalexin, cefixime, cefpodoxime, cefdiel, cefteram, cefpodoxime, fosfomycin, faropenem
  • examples include erythromycin, adisthromycin, clarithromycin, roxithromycin, kulam lamphenicol, tetracycline, minocycline, salazosulfaviridine, ciprofloxacin, gatifloxacin, norfloxacin, acyclovir, itraconazole, terbinafine, fluconazole, miconazole, etc. .
  • the orally disintegrating tablet of the present invention includes, in addition to the above-mentioned components, any conventionally known optional components such as various lubricants, solubilizers, buffering agents as long as the effects of the present invention are not impaired.
  • Adsorbent, Binder, Suspending agent, Antioxidant, Filler, PH adjuster, Excipient, Dispersant, Disintegrant, Disintegration aid, Dehumidifier, Preservative, Solvent, Solubilizer, Fluid An agent or the like can be used.
  • excipients include, for example, sugar alcohols such as lactose, refined sucrose, crystalline cellulose, corn starch, potato starch, mannitol, xylitol, sorbitol, erythritol, trehalose, inorganic salts, dextran, dextrin, glucose
  • examples include powdered sugar.
  • disintegrants include denpens such as corn starch and potato starch, partially alpha-monified starch, sodium carboxymethyl starch, carmellose, carmellose calcium, croscarmellose sodium, low-substituted hydroxypropyl Examples include methylcellulose, crystalline cellulose, hydroxypropyl starch and the like.
  • the binder include hydroxypropylcellulose, hydroxypropylmethylcellulose, hydroxychetylcellulose, gum arabic, alpha-unified starch, sodium alginate, carboxyvinyl polymer, agar, honey and the like.
  • Examples of the lubricant include magnesium stearate, calcium stearate, stearic acid, talc, and sucrose fatty acid ester.
  • As coating agents hydroxypropyl methylcellulose, ethyl acrylate 'methyl methacrylate copolymer, aminoacryl methacrylate copolymer E, aminoacryl methacrylate copolymer RS, hydroxypropyl methylcellulose phthalate, methacrylic acid copolymer L, methacrylic acid copolymer LD, And methacrylic acid copolymer S.
  • examples of the taste masking component include citrate, tartaric acid, malic acid and the like.
  • Examples of the foaming agent include sodium bicarbonate.
  • artificial sweeteners include saccharin sodium, dipotassium glycyrrhizin, aspanolome, stevia and thaumatin.
  • masking agent include water-insoluble polymers such as ethyl cellulose and gastric polymers such as methyl methacrylate “butyl methacrylate” and “methylaminoethyl methacrylate” copolymer.
  • the production of the orally disintegrating tablet of the present invention is not particularly limited as long as it is a general compression molding method.
  • An orally disintegrating tablet can be prepared by compression-molding the prepared granule with an ordinary tableting machine, such as a rotary tableting machine or a single tableting machine.
  • the pressure at the time of compression molding is not particularly limited as long as the disintegration time in the mouth and the tissue are appropriate, and there are no cracks at the time of production and transportation. Is compression molded at 100 to 2000 kgf, more preferably 300 to 1500 kgf.
  • One of the effects of the present invention is that, during the production of an orally disintegrating agent, no fine powder of granulated material is generated and productivity is improved. There are various methods for this index, but if the proportion of powder finer than 20 OMesh (75 ⁇ m) is 20% or less, there is no problem. it can.
  • the friability test can be used as one of the indicators for confirming the cracking and chipping during production and transportation of the orally disintegrating tablet of the present invention described above. This test is described in the 14th Amendment Japanese Pharmacopoeia. Normally, 100 tablets of compression-molded preparation were used, and the friability test was conducted for 4 minutes. It is said that there will be no cracks during production and transportation. Further, hardness can be used as another index. A very low hardness is very important as an indicator because it can lead to tablet breakage with a slight impact.
  • the hardness of the orally disintegrating tablet of the present invention is preferably 5 kg because it can be produced and transported without breakage if it is 4 kg or more.
  • a granulated liquid was prepared by dissolving 75 g of pregelatinized starch (Matsunoline CM: Matsutani Chemical Co., Ltd.) in 2500 g of purified water.
  • Delta-type Mann-Tall (Partec Delta M: Merck / Delta-type Mann-Tall power 0%, the rest is Beta-type Mann-Tall) 1700g
  • Beta-type Mann-Tall (D-Manufacturer: Towa Kasei Co., Ltd.) ) 5160 g was charged into a fluidized bed granulator, and fluidized bed granulation (FLOWCOATER: manufactured by Freund Sangyo Co., Ltd.) was performed using the previously prepared granulation liquid.
  • crospopidone Kollidon CL: BASF
  • magnesium metasilicate aluminate Nesilin UFL2: manufactured by Fuji Chemical Industry Co., Ltd.
  • aspartame PAL SWEET DIET: manufactured by Ajinomoto Co., Inc.
  • 60 g and 32 g of magnesium stearate magnesium stearate: manufactured by Taihei Chemical Co., Ltd.
  • V-type mixer V-type mixer: manufactured by Tsutsui Chemical Co., Ltd.
  • the granules were tableted using a rotary tableting machine (VIRGO 0506SS2AY-000B00: Kikusui Seisakusho) so that each tablet was 150 mg to obtain an orally disintegrating tablet.
  • An orally disintegrating tablet was produced in the same manner as in Example 1, except that gelatinized corn starch (corn starch: manufactured by Nippon Shokuhin Kako Co., Ltd.) was used instead of a starch.
  • gelatinized corn starch corn starch: manufactured by Nippon Shokuhin Kako Co., Ltd.
  • An orally disintegrating tablet was produced in the same manner as in Example 1 except that Partek Delta M in Example 1 was changed to beta-type mantol.
  • An orally disintegrating tablet was produced in the same manner as in Example 1 except that the a-modified starch in Example 1 was changed to corn starch.
  • Example 1 Example 2 Comparative Example 1 Comparative Example 2 Delta mannitol * 34 34 34 Solid mannitol 103.2 103.2 137.2 103.2 Gelatinized starch 1.5-1.5 Gelatinized corn starch-1.5
  • Corn starch (not gelatinized) ⁇ ⁇ ' ⁇ ' ⁇ :: Crospopidone 7.5 7.5 ⁇ ⁇ ' ⁇ 5 7.5 Magnesium aluminate metasilicate 1.5 1.5 1.5 1.5 Aspartame 1.5 1.5 1.5 1.5 Magnesium stearate 0.8 0.8 0.8 0.8
  • Example 2 The state of the fine powder of Example 2 and Comparative Examples 1 and 2 was confirmed. As a confirmation method, the proportion of particles of 20 OM (75 ⁇ m) or less was measured. The results are shown in Table 2.
  • Fine powder ratio of 200M or less (%) 1 3. 2 1 4. 2 2 2 2 6 2 0.2
  • the proportion of fine powder could be reduced by granulation using delta-type mannitol and alpha-ized starch. This can be expected to reduce the scattering of granulated materials and increase production efficiency.
  • Example 1 The granules obtained in Example 1 and Comparative Example 1 were tableted at a tableting pressure of 1000 kgf and a turntable speed of 20 rpm without using an external lubricant.
  • Table 3 shows the physical properties at this time. The tests described in Table 3 were conducted as follows.
  • the friability tester (tablet friability tester: Minato Medical Co., Ltd.) was used for 4 minutes, and the number of tablets used in the test was 100 tablets.
  • the tablet was put into the oral cavity, and the time until the tablet disappeared was measured.
  • Example 1 The granules obtained in Example 1 and Comparative Example 1 were tableted using an external lubricant (external lubricant spray system: manufactured by Kikusui Seisakusho) at a tableting pressure of 1000 kgf and a turntable rotation speed of 50 rpm. Table 4 shows the physical properties in this case.
  • the test method is the same as in Test Example 1.
  • Example 1 The granules obtained in Example 1 and Comparative Example 2 were tableted using an external lubricant at a tableting pressure of 1000 kgf and a turntable speed of 50 rpm. Table 5 shows the physical properties of each case.
  • the test method is the same as in Test Example 1.
  • a granulated liquid was prepared by dissolving 75 g of a starch and 225 g of magnesium aluminate metasilicate in 2500 g of purified water. 1650 g of delta-type mantol (Partec Delta M) and 5060 g of beta-type mantol were charged into a fluidized bed granulator, and fluidized bed granulation was performed using the granulation liquid prepared earlier.
  • a granulated liquid was prepared by dissolving 75 g of pregelatinized starch in 2500 g of purified water.
  • Delta type mannitol (Partec Delta M) 1650 g and beta type mannitol 5060 g were charged into a fluidized bed granulator, and fluidized bed granulation was carried out using the previously prepared granulation liquid. Further, this granulated material was coated with a suspension obtained by suspending 225 g of magnesium aluminate metasilicate in purified water lOOOOg.
  • Example 3 The granules of Examples 3 and 4 were tableted using an external lubricant at a tableting pressure of 1000 kgf and a turntable rotation speed of 50 rpm. The physical properties in this case are shown in Table 6. The test method is the same as in Test Example 1.
  • the orally disintegrating tablet of the present invention has both rapid disintegration properties in the oral cavity and hardness necessary for production, transportation, etc., and is advantageously used when orally administering various physiologically active substances. Is something that can be done.
  • tableting can be performed stably without causing tableting troubles such as wrinkle adhesion, cabbing, and die flicking, and the compression molding time can be shortened.
  • An orally disintegrating tablet having rapid disintegration even when shrunk can be obtained.
  • powder scattering can be suppressed by reducing the fine powder during granulation.
  • the method of the present invention is extremely advantageous as a method for producing an orally disintegrating tablet.

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Abstract

L’invention permet d’obtenir un comprimé se désintégrant dans la cavité orale, qui se rapidement désintègre dans la cavité orale et qui possède une dureté nécessaire pour la production, le transport ou similaire, et une technique pour améliorer la productivité du comprimé se désintégrant dans la cavité orale. Le comprimé se désintégrant dans la cavité orale contient du mannitol et est caractérisé en ce que tout ou partie du mannitol est sous forme cristalline delta. Une méthode pour produire le comprimé se désintégrant dans la cavité orale comprend les étapes de préparation d’une matière granulée qui utilise le mannitol et un liant qui se dissout ou gonfle dans l'eau à température normale, et la mise en comprimé de la matière granulée, et qui est caractérisée par le fait que tout ou partie du mannitol est sous forme cristalline delta.
PCT/JP2006/306841 2005-03-31 2006-03-31 Comprimé se désintégrant dans la cavité orale et méthode pour le produire WO2006106923A1 (fr)

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Cited By (2)

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Publication number Priority date Publication date Assignee Title
WO2007043538A1 (fr) * 2005-10-05 2007-04-19 Kyoto Pharmaceutical Industries, Ltd. Composition destinée à une administration orale
WO2010038695A1 (fr) * 2008-09-30 2010-04-08 大洋薬品工業株式会社 Préparation moulée par compression et son procédé de production

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EP3031451B1 (fr) 2009-01-26 2018-03-07 Shin-Etsu Chemical Co., Ltd Procédé de fabrication de comprimés à granulation par voie humide utilisant une dispersion aqueuse de cellulose hydroxypropyle substituée faible
JP5502358B2 (ja) * 2009-04-01 2014-05-28 テイカ製薬株式会社 口腔内速崩壊性錠剤およびその製造方法
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
JP7385367B2 (ja) * 2018-04-12 2023-11-22 東和薬品株式会社 口腔内崩壊錠

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JP5694773B2 (ja) * 2008-09-30 2015-04-01 テバ製薬株式会社 圧縮成型製剤およびその製造方法

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