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WO2007111375A1 - Comprime a desintegration rapide par voie intra-orale - Google Patents

Comprime a desintegration rapide par voie intra-orale Download PDF

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Publication number
WO2007111375A1
WO2007111375A1 PCT/JP2007/057007 JP2007057007W WO2007111375A1 WO 2007111375 A1 WO2007111375 A1 WO 2007111375A1 JP 2007057007 W JP2007057007 W JP 2007057007W WO 2007111375 A1 WO2007111375 A1 WO 2007111375A1
Authority
WO
WIPO (PCT)
Prior art keywords
tablet
weight
starch
parts
rapidly disintegrating
Prior art date
Application number
PCT/JP2007/057007
Other languages
English (en)
Japanese (ja)
Inventor
Masatsugu Nozaki
Sachio Motegi
Kana Matsumoto
Original Assignee
Kowa Company, 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 Kowa Company, Ltd. filed Critical Kowa Company, Ltd.
Priority to JP2008507527A priority Critical patent/JP5100634B2/ja
Priority to CN2007800106678A priority patent/CN101410127B/zh
Publication of WO2007111375A1 publication Critical patent/WO2007111375A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/66—Microorganisms or materials therefrom
    • A61K35/74—Bacteria
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/66—Microorganisms or materials therefrom
    • A61K35/74—Bacteria
    • A61K35/741—Probiotics
    • A61K35/744—Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
    • A61K35/745—Bifidobacteria
    • 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
    • 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
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/14—Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents

Definitions

  • the present invention relates to a rapidly disintegrating tablet in the oral cavity that rapidly disintegrates in the presence of saliva in the oral cavity or in the presence of a small amount of water. More specifically, the present invention contains useful bacteria and is excellent in long-term storage stability. Orally disintegrating tablets. Background art
  • Intestinal bacteria are present in the intestines of baboons.
  • Enterobacteriaceae include useful bacteria such as bifidobacteria lactic acid bacteria or good bacteria and bad bacteria such as large intestinal bacteria welsh bacteria.
  • useful bacteria such as bifidobacteria lactic acid bacteria or good bacteria
  • bad bacteria such as large intestinal bacteria welsh bacteria.
  • Disturbances of the intestinal flora are not only caused by the situation that modern people often fall into, such as stress, disorder of eating habits, fatigue, lack of sleep, etc.Aging also causes disturbance of the intestinal flora etc. It is a symptom that can happen to anyone.
  • viable cell preparations such as bifidobacteria is provided powder as ethical drugs, generally pharmaceuticals or supplements, tablets agent, to a patient in the form of a force capsule agents I.
  • Orally disintegrating tablets should not be taken anywhere, even in patients with low swallowing ability, such as elderly people, children, or general adults.
  • the development of these products is desired, and several such preparations have already been developed.
  • Known literatures disclosing such preparations include: (1) a method of tableting and drying a drug, a saccharide, and a mixture containing moisture to such an extent that the particle surface of the saccharide is wet (see JP-A-5-27 1054).
  • a tablet produced by a method in which a drug, a water-soluble excipient and an amorphous saccharide are compressed and then aged see JP-A-11-12161
  • 3) A tablet see Japanese Patent Laid-Open No. 2000-273038) characterized by containing a certain ratio of drug, lactose, crystalline cellulose, and light anhydrous key acid, and further containing a disintegrating agent such as crospopidone. It has been.
  • the tablet (1) compresses the wet mixture, and it is difficult to apply it to useful bacteria that are unstable to moisture, and the tablet (2) is bare under conditions of constant temperature and humidity.
  • the tablets need to be aged, which has the disadvantage of increasing the loss on drying of the tablets and reducing the storage stability of useful bacteria.
  • the tablet of (3) has a different tablet composition from that of the present invention, the crystalline cellulose and light anhydrous anhydrous used in the present invention are not used, and any useful bacterial preparation and its storage stability are described. Not.
  • (4) shows an example in which crystalline cellulose and light anhydrous carboxylic acid are applied to useful bacteria such as bifidobacteria, and it is possible to reduce the loss of the number of viable bacteria during tableting. Is also shown. However, (4) does not describe the storage stability and rapid disintegration property of the obtained viable bacterial preparation. Disclosure of the invention
  • the object of the present invention is to break down rapidly in the oral cavity of useful bacteria, have an appropriate strength, can be produced by a very simple method using a normal compression molding machine, and contain useful bacteria
  • the purpose of this study is to develop an orally rapidly disintegrating tablet with excellent long-term storage stability.
  • an orally rapidly disintegrating tablet containing useful bacteria, crystalline cellulose, light anhydrous anhydrous caustic acid and starch-containing saccharide, and having a moisture content of 3.2% by weight or less.
  • the intraorally rapidly disintegrating tablet wherein the useful bacteria are bifidobacteria or lactic acid bacteria.
  • the intraorally rapidly disintegrating tablet having a tablet hardness of 30N to 60N.
  • the inventors of the present invention use a combination of crystalline cellulose, light anhydrous keyic acid and starch-containing saccharides in a useful bacterium.
  • a useful bacterium By tableting with pressure, it rapidly disintegrates in the oral cavity, has an appropriate strength, has a low kill rate when tableting useful bacteria, and has excellent long-term storage stability. It was found that an internal fast disintegrating tablet was obtained.
  • the present invention was completed by further research based on such knowledge.
  • Any useful bacteria can be used in the present invention as long as they are useful for human digestive activity.
  • Bifidobacterium Bactetrachlorobacterium
  • Bifidobacterium longum, Bifidobacterium infant is, Bifidobacterium bifidunu Bif idobacterium breve, etc.
  • Lactobacillus Lactobacillus casei, Lactobac i 1 lus gasseri, Lactobacillus acidophilus, Streptococcus faecal is, ept be able to.
  • Preferable examples include bifidobacteria such as Bifidobacterium longum, Bifidobacterium longum, and Bifidobacterium infantis. Two or more useful bacteria can be used in combination as appropriate.
  • Useful bacteria used in the present invention may be in the form of, for example, viable powder or lyophilized product.
  • the blending amount can be 0.03 to 30 parts by weight with respect to 100 parts by weight of the tablet, and 0.1 to 20 parts by weight, particularly 0.5 to 10 parts by weight, in order to obtain better moldability. I like it.
  • the number of mixed bacteria is not particularly limited, but considering its effectiveness, the number of viable bacteria is 10 5 to 10 ⁇ / tablet, preferably 10 6 to 10 9 / tablet.
  • Crystalline cellulose used in the present invention is an excipient manufactured by spray drying after mixing crystalline cellulose and a small amount of light anhydrous key acid in a slurry state. The method is shown. This can be used as: "Prosolv (PR0S0LV)" (registered trademark) from TRS PHARMA.
  • the crystalline cellulose / light anhydrous caustic anhydride is used in an amount of about 35 to 70 parts by weight, preferably 40 to 70 parts by weight, based on 100 parts by weight of the tablet.
  • the starch-containing saccharides used in the present invention may be those containing at least starch, may be starch alone, or may be a mixture of starch and one or more other saccharides in an appropriate ratio. Or they may be granulated.
  • the starch-containing sugar is usually one containing 40 parts by weight or more, preferably 70 parts by weight or more of starch.
  • the method for granulating the starch-containing saccharide is not particularly limited, and examples thereof include spray drying, stirring granulation, fluidized bed granulation, and extrusion granulation.
  • the origin of starch is not particularly limited. Examples include corn starch, wheat starch, and potato starch.
  • saccharides examples include lactose, lactulose, sucrose, maltose, flour, glucose, fructose, maltitol, mannitol, sorbitol, xylitol, and erythritol.
  • the amount of starch-containing saccharide used varies depending on the content of starch contained in the starch-containing saccharide, but is usually 25 to 60 parts by weight per 100 parts by weight of the tablet.
  • a starch-lactose granulation mixture containing starch and lactose in a ratio of about 7: 3 is used as the starch-containing saccharide, about 25-60 parts by weight, preferably 30 parts per 100 parts by weight of the tablet. ⁇ 60 parts by weight are used.
  • the tablet of the present invention may be blended with various additives commonly used in tablet production.
  • additives can be used alone or May be mixed and used at an appropriate ratio.
  • additives include disintegrants, binders, acidulants, foaming agents, artificial sweeteners, flavoring agents, flavoring agents, fluidizing agents, lubricants, coloring agents, stabilizers, excipients, and the like.
  • a disintegrant is usually added.
  • these disintegrants include crospovidone, low-substituted hydroxypropylcellulose, carmellose strength, croscarmellose sodium, carboxymethyl sulfate sodium, and the like.
  • crospopidone is widely used.
  • the rapidly disintegrating tablet in the oral cavity of the present invention disintegrates rapidly in the oral cavity without adding a disintegrating agent.
  • Production of the rapidly disintegrating tablet in the oral cavity according to the present invention is carried out by compressing in a dry state a useful fungus, crystalline cellulose-light anhydrous caustic acid and starch-containing saccharide, and optionally adding other additives. This is done by obtaining a tablet of 2% by weight or less.
  • the particle diameter of the additive such as useful bacteria is not particularly limited, but the use of a particle having a small particle provides an excellent feeling of dosing. If desired, other additives excluding useful bacteria may be used after being subjected to a wet granulation step and then dried.
  • crystalline cellulose, light anhydrous galeic acid, starch-containing saccharides, and the like are mixed by a conventional method, followed by spray drying, stirring granulation, fluidized bed granulation, extrusion granulation, and the like.
  • an apparatus generally used for tablet formation is used, and for example, a mouth-and-mouth tableting machine can be used.
  • the tableting pressure in order to avoid the killing of useful bacteria at the time of tableting, it is preferable to set the tableting pressure to be relatively low and to perform tableting so as to obtain a hardness that does not damage the tablet.
  • the tableting pressure is usually preferably about 1 ton or less.
  • the oral disintegrating tablet of the present invention thus obtained is disintegratable in the oral cavity.
  • the disintegration time in the oral cavity is usually 5 to 50 seconds, preferably 5 to 40 seconds, and more preferably 5 to 30 seconds.
  • the tablet hardness is preferably about 30 N to 60 N, and more preferably about 30 N to have a strength that prevents the tablet from being damaged in the distribution process, and a short disintegration time. Has a hardness of 50N.
  • the water content in the tablet significantly affects the long-term storage stability of useful bacteria. Therefore, in the present invention, it is necessary to reduce the water content of the rapidly disintegrating tablet in the oral cavity as much as possible. In the present invention, the water content is kept at 3.2% by weight or less, preferably at 2.5% by weight or less. In addition, for storage of tablets, it is usually preferable to store the tablets in a glass bottle containing a desiccant, or SP packaging in which the tablets are completely sealed with an aluminum packaging material.
  • the bifidobacteria powder used in the following examples and comparative examples is A powder obtained by cultivating Idobacteria longum and Bifidobacterium infant is and then freeze-drying it, and having about 1X 10 1 Q / g of living bacteria It is.
  • the time until the tablet disintegrates only with the saliva in the oral cavity was measured. The test was performed three times and the average value was shown.
  • Each tablet was packaged in aluminum, and stored at 40 ° C (:, 75% relative humidity for 1 week or 2 weeks. During this period, the number of bacteria was reduced using Pifidobacterium differentiation medium (with horse defibrinated blood added). The survival rate of bifidobacteria was determined from the viable cell count before storage and the viable cell count after storage Examples 1-3
  • the rapidly disintegrating tablet in the oral cavity of the present invention has an appropriate strength.
  • the rapidly disintegrating tablet in the oral cavity of the present invention exhibits excellent disintegration in the disintegration test and also has an excellent survival rate of bifidobacteria.
  • tablets that do not contain starch-containing saccharides corn starch / lactose granulation mixture
  • have a longer disintegration time due to the fact that small pieces of the tablets remain in the basket, resulting in a lower survival rate.
  • the rapidly disintegrating tablet in the oral cavity of the present invention exhibits an excellent disintegrating property in the oral cavity while having an appropriate strength, and also has an excellent survival rate of bifidobacteria.
  • the tablet produced without blending crystalline cellulose / light anhydrous anhydrous silicic acid and starch has significantly low storage stability.
  • a rotary tableting machine PI CC0M, manufactured by RI VA. S.A
  • Tablets with a loss on drying of 2.2 to 7.3 wt% were produced.
  • the obtained tablets were subjected to a disintegration test, an oral disintegration time measurement, and a storage stability test (storage period 1 week). The results are shown in Table 4.
  • PI CC0RA manufactured by RIM. S.A
  • 1 tablet 280 mg, 9 ⁇ ⁇ , hardness of about 30, 40, 50, 60 ⁇ Tableted The obtained tablets were subjected to a disintegration test and an oral disintegration time measurement. The results are shown in Table 5.
  • Table 5 Table 5
  • the hardness of the intraoral quick disintegrating tablet of the present invention is preferably about 30 N or more and about 60 N or less in order to make the disintegration time within about 40 seconds.
  • Powdered bifidobacteria powder, crystalline cellulose ⁇ light anhydrous key acid (Prosolv 90; manufactured by TRS PHARMA), corn starch and lactose granulation mixture were added, and then stearic acid Mg was added and mixed again to obtain a tableting powder. .
  • a lipstick type tableting machine PI CC0RA RIVA. S. A
  • tableting was performed with a sugar-coated scissors so that 1 tablet was 280 mg 9 ⁇ ⁇ and the hardness was 30 40 ⁇ .
  • a tablet was prepared containing about 987 parts by weight of crystalline cellulose / light anhydrous caustic anhydride and about 987 parts by weight of the corn starch / lactose granulation mixture in the tablet.
  • the obtained tablets were subjected to a disintegration test, an oral disintegration time measurement, a tableting stability test, and a storage stability test. The results are shown in Table 6. Table 6
  • the blending amount of crystalline cellulose ⁇ light anhydrous caustic acid is about 35 to 70 parts by weight in the tablet, starch-containing sugar (corn starch ⁇ It is found that the blending amount of the lactose granulated mixture) is preferably about 25 to 60 parts by weight in the tablet. Also, the amount of crystalline cellulose / light anhydrous galeic acid is low at 9.6 parts by weight, and the starch-containing saccharide is 87 parts by weight. A large amount of tablets (Comparative Example 7) is not preferable because the disintegration property is remarkably deteriorated. On the other hand, a tablet (Comparative Example 9) containing 87 parts by weight of light anhydrous hydrous carboxylic acid and 9.6 parts by weight of starch-containing saccharide is not preferable because of low storage stability. Industrial applicability
  • the rapidly disintegrating tablet in the oral cavity of the present invention exhibits an excellent disintegrating property in the oral cavity while having an appropriate strength, and has excellent tableting stability and storage stability of useful bacteria. Therefore, patients with low swallowing ability such as elderly people and children or It can be provided to patients who want to improve the disturbance of the gut microbiota balance or maintain the gut microbiota balance as a tablet that can be taken without water even in general adults regardless of the location.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
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Abstract

L'invention concerne un comprimé à désintégration rapide par voie intra-orale de bactéries utiles, telles que les bifidobactéries et les bactéries lactiques, ayant d'excellentes propriétés de stabilité à la compression et de stabilité au stockage, par le moulage par compression d'un mélange pulvérulent de bactéries utiles, de cellulose cristalline/acide silicique anhydre léger (véhicule produit par le mélange de cellulose cristalline avec une petite quantité d'acide silicique anhydre léger sous forme de bouillie puis le séchage par pulvérisation du mélange) et de sucres contenant de l'amidon (poudre d'amidon, amidon granulé, mélange amidon granulé/lactose, entre autres) à l'état sec, en un comprimé d'une dureté de comprimé allant de 30 à 60 N et d'une teneur en eau de 3,2 % en poids ou moins.
PCT/JP2007/057007 2006-03-24 2007-03-23 Comprime a desintegration rapide par voie intra-orale WO2007111375A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
JP2008507527A JP5100634B2 (ja) 2006-03-24 2007-03-23 口腔内速崩壊性錠剤
CN2007800106678A CN101410127B (zh) 2006-03-24 2007-03-23 口腔速崩片

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2006083857 2006-03-24
JP2006-083857 2006-03-24

Publications (1)

Publication Number Publication Date
WO2007111375A1 true WO2007111375A1 (fr) 2007-10-04

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JP (1) JP5100634B2 (fr)
KR (1) KR101470483B1 (fr)
CN (1) CN101410127B (fr)
MY (1) MY149923A (fr)
SG (1) SG170766A1 (fr)
WO (1) WO2007111375A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2017006935A1 (fr) * 2015-07-07 2017-01-12 東亜薬品工業株式会社 Comprimé à désintégration orale rapide contenant des bactéries
WO2021212000A1 (fr) * 2020-04-17 2021-10-21 Evelo Biosciences, Inc. Formes pharmaceutiques solides à profils de désintégration améliorés

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JP2000063289A (ja) * 1998-08-20 2000-02-29 Morinaga Milk Ind Co Ltd 生理活性物質含有製剤
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Cited By (4)

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WO2017006935A1 (fr) * 2015-07-07 2017-01-12 東亜薬品工業株式会社 Comprimé à désintégration orale rapide contenant des bactéries
JPWO2017006935A1 (ja) * 2015-07-07 2018-04-26 東亜薬品工業株式会社 菌含有口腔内速崩壊性錠剤
EP3320908A4 (fr) * 2015-07-07 2019-03-13 Toa Pharmaceutical Co., Ltd. Comprimé à désintégration orale rapide contenant des bactéries
WO2021212000A1 (fr) * 2020-04-17 2021-10-21 Evelo Biosciences, Inc. Formes pharmaceutiques solides à profils de désintégration améliorés

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CN101410127B (zh) 2011-08-31
KR101470483B1 (ko) 2014-12-08
CN101410127A (zh) 2009-04-15
JPWO2007111375A1 (ja) 2009-08-13
JP5100634B2 (ja) 2012-12-19
SG170766A1 (en) 2011-05-30
KR20080111014A (ko) 2008-12-22

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