WO2014148520A1 - Préparation solide - Google Patents

Préparation solide Download PDF

Info

Publication number
WO2014148520A1
WO2014148520A1 PCT/JP2014/057444 JP2014057444W WO2014148520A1 WO 2014148520 A1 WO2014148520 A1 WO 2014148520A1 JP 2014057444 W JP2014057444 W JP 2014057444W WO 2014148520 A1 WO2014148520 A1 WO 2014148520A1
Authority
WO
WIPO (PCT)
Prior art keywords
salt
tablet
mass
sucrose
tablets
Prior art date
Application number
PCT/JP2014/057444
Other languages
English (en)
Japanese (ja)
Inventor
亜矢 桑田
孝文 湊
智宏 浜下
Original Assignee
大正製薬株式会社
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 大正製薬株式会社 filed Critical 大正製薬株式会社
Priority to JP2015506812A priority Critical patent/JP6341196B2/ja
Publication of WO2014148520A1 publication Critical patent/WO2014148520A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445—Non condensed piperidines, e.g. piperocaine
    • A61K31/4523—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems
    • A61K31/4545—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems containing a six-membered ring with nitrogen as a ring hetero atom, e.g. pipamperone, anabasine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/16—Amides, e.g. hydroxamic acids
    • A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/167—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid 
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/365—Lactones
    • A61K31/375—Ascorbic acid, i.e. vitamin C; Salts thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4402—Non condensed pyridines; Hydrogenated derivatives thereof only substituted in position 2, e.g. pheniramine, bisacodyl
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445—Non condensed piperidines, e.g. piperocaine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/46—8-Azabicyclo [3.2.1] octane; Derivatives thereof, e.g. atropine, cocaine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/54—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame
    • A61K31/5415—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame ortho- or peri-condensed with carbocyclic ring systems, e.g. phenothiazine, chlorpromazine, piroxicam
    • 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
    • A61K9/2013—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
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin

Definitions

  • the present invention relates to a solid preparation that can be rapidly disintegrated or easily chewed in the oral cavity, and has a moderate hardness and is excellent in ingestibility and can be taken without water, including orally disintegrating tablets or chewable tablets About.
  • Orally disintegrating tablets are defined as tablets that can be dissolved or disintegrated rapidly in the oral cavity, and have appropriate disintegrating properties, and chewable tablets are chewable tablets (Non-patent Document 1). Since it is a formulation that can be taken without any, there is an advantage that it can be taken even in situations where there is no water, regardless of the scene.
  • Known orally disintegrating tablets include those formed by freeze-drying in a container using a substance such as gelatin, and those obtained by wet compression of a wet powder or granulated product. However, these tablets often break and chip during transport, and it is difficult to say that they have sufficient hardness, and the manufacturing method is complicated.
  • Patent Document 1 starch powder and gelatinized starch, water-soluble excipient containing mannitol, orally disintegrating tablet containing sodium stearyl fumarate and medicinal ingredients
  • Patent Document 2 low moldability saccharide and high moldability saccharide Orally-dissolved, orally-dissolved compression-molded product
  • Patent Document 3 mannitol, disintegrant, celluloses, lubricants, and starches and lactose
  • Patent Document 3 A method for producing an orally disintegrating tablet containing one kind (Patent Document 3) has been reported.
  • Patent Document 3 when starch powder and starch that has been gelatinized are used, sticking to a manufacturing apparatus or the like is likely to occur, and handling in manufacturing is difficult.
  • Patent Document 3 is an orally disintegrating tablet based on mannitol and substantially containing a super disintegrant such as crospovidone or croscarmellose. Is not preferable because of concern.
  • Japanese Patent No. 4435424 Japanese Patent No. 3212141 JP 2000-273039 A
  • An object of the present invention is a solid preparation that can be rapidly disintegrated or chewed in the oral cavity, and has a suitable hardness and can be taken without water, including an orally disintegrating tablet or chewable tablet that is excellent in dosing. Is to provide.
  • the inventors of the present invention contain mannitol, sucrose, and starch, and the mannitol content is 10 parts by mass or more per 1 part by mass of sucrose.
  • the formulation was found to be an orally disintegrating tablet or chewable tablet having an appropriate hardness while exhibiting rapid disintegration in the oral cavity, and having excellent dosing properties, thereby completing the present invention.
  • the present invention comprises (1) mannitol, sucrose and starch, wherein the content of mannitol is 10 parts by mass or more with respect to 1 part by mass of sucrose, (2) The preparation according to (1), which is an orally disintegrating tablet or chewable tablet, (3) The preparation according to (1) or (2), wherein the starch content is 0.01 parts by mass or more with respect to 1 part by mass of sucrose.
  • the drug is acetaminophen, scopolamine or a salt thereof, chlorpheniramine or a salt thereof, carbinoxamine or a salt thereof, belladonna total alkaloid, loratadine, fexofenadine or a salt thereof, mequitazine, loxoprofen or a salt thereof, meclizine or a salt thereof , Ibuprofen, caffeine, ascorbic acid, pseudoephedrine or a salt thereof, the preparation according to any one of (1) to (4), It is.
  • an orally disintegrating tablet or chewable tablet that disintegrates in the oral cavity without using special equipment, a manufacturing method, and an excipient, has a desired appropriate hardness, and is excellent in taking ability. It has become possible.
  • the orally disintegrating tablet of the present invention means a tablet having an extremely fast disintegration time in the oral cavity under normal chewing conditions.
  • the chewable tablet of the present invention means a tablet that is chewed and taken. Since orally disintegrating tablets or chewable tablets do not require water when taking them, they are suitable dosage forms for, for example, disasters and sudden onsets where it is difficult to take ordinary tablets.
  • the content of mannitol contained in a preparation that can be taken without water according to the present invention, including an orally disintegrating tablet and a chewable tablet is 10 parts by mass or more per 1 part by mass of sucrose. This is because if it is less than 10 parts by mass, it is difficult to achieve both oral disintegration time, tablet hardness, and dosage.
  • the content of mannitol contained in the preparation that can be taken without water according to the present invention including the orally disintegrating tablet and the chewable tablet is preferably 950 parts by mass or less, and 100 parts by mass or less based on 1 part by mass of sucrose. More preferred, particularly preferred is 50 parts by mass or less.
  • the mannitol content contained in the preparations that can be taken without water according to the present invention, including orally disintegrating tablets and chewable tablets is preferably 95% by mass from the viewpoint of tablet physical properties and compression moldability. .
  • starch of the present invention examples include corn starch, potato starch, rice starch, wheat starch, sweet potato starch, mung bean starch, tapioca starch and the like, preferably corn starch and potato starch.
  • corn starch contained in powdered sugar is contained in the starch of this invention.
  • the starch content contained in preparations that can be taken without water according to the present invention, including orally disintegrating tablets and chewable tablets is preferably 0.01 parts by mass to 20.0 parts by mass with respect to 1 part by mass of sucrose. From the viewpoint of the effect of the present invention, 0.01 to 15.0 parts by mass is more preferable.
  • the upper limit of the starch content contained in the preparation of the present invention is preferably 70% by mass from the viewpoint of tablet physical properties and compression moldability.
  • sucrose contained in the preparation that can be taken without water according to the present invention including the orally disintegrating tablet and the chewable tablet contains powdered sugar in the preparation
  • the sucrose contained in the powdered sugar is Included in sucrose.
  • the content of the sucrose of the present invention is usually 0.01 to 30% by mass, preferably 0.1 to 30% by mass, more preferably 0.1 to 20% by mass, and still more preferably 1% with respect to the total mass of the preparation. 0.0 to 20% by mass, more preferably 2.0 to 10% by mass.
  • a drug can be mix
  • a drug that can be incorporated into a preparation that can be taken without water according to the present invention, including an orally disintegrating tablet and a chewable tablet it may be solid or crystalline, such as antipyretic analgesic anti-inflammatory drugs, nourishing tonic health drugs, Hypnotic sedatives, antispasmodics, gastrointestinals, antacids, antitussives, antiemetics, respiratory stimulants, bronchodilators, allergic agents, antihistamines, central nervous stimulants, vitamins, oral and oral medicines, antispasmodics One or more components selected from agents, etc.
  • Examples include caffeine, ascorbic acid, pseudoephedrine or a salt thereof.
  • the content of the drug is usually 0.01 to 90% by mass, preferably 0.01 to 80% by mass, more preferably 0.1 to 80% by mass, and further preferably 0.1 to 70% by mass with respect to the total mass of the preparation. %, More preferably 0.5 to 50% by mass.
  • compositions that can be taken without water according to the present invention including orally disintegrating tablets and chewable tablets, are generally used in the production of orally disintegrating tablets or chewable tablets as long as the effects of the present invention are not hindered. May be included.
  • additives include excipients, disintegrants, binders, sour agents, foaming agents, sweeteners, fragrances, lubricants, and coloring agents.
  • the size and shape of preparations that can be taken without water according to the present invention, including orally disintegrating tablets and chewable tablets are not particularly limited, and may be divided tablets having a score line.
  • the granulation method is not particularly limited, and may be produced by either a wet granulation method or a dry granulation method. You may dry suitably after a granulation process or granulation manufacture. Examples of the wet granulation method include a fluidized bed granulation method, an agitation granulation method, a kneading granulation method, a rolling granulation method, and a molten solvent method.
  • the dry granulation method includes a slug method, a roller method, and the like. Although a compactor method is mentioned, it is preferable to manufacture by a fluidized-bed granulation method and a stirring granulation method.
  • a formulation that can be taken without water according to the present invention, including orally disintegrating tablets and chewable tablets, is obtained by adding a suitable additive to the resulting granulated product and performing general compression molding such as tableting. can get.
  • the granulation solvent is preferably water or an aqueous solution containing at least one of mannitol, low-substituted hydroxypropyl cellulose, and light anhydrous silicic acid, and in particular, a granulation solvent containing mannitol. Is more preferable because the hardness of the tablet and the ingestibility, which are the effects of the present invention, are further improved.
  • the tableting device a device generally used for tablet formation is used, and for example, a single-shot tableting machine, a rotary tableting machine, or the like is used.
  • the orally disintegrating tablet or chewable tablet thus obtained exhibits excellent disintegration properties in the oral cavity, and preferably disintegration time is within 60 seconds in the disintegration test by the Japanese Pharmacopoeia or the oral disintegration test by humans. Preferably, it is within 30 seconds. In addition, it has a moderate strength that is not damaged in the preparation process and further in the distribution process, and has a tablet hardness of 0.7 MPa or higher in terms of tableting strength in terms of tensile strength.
  • Table 1 shows the disintegration time, tensile strength, and dosing results of each tablet.
  • Examples 1 to 8 which are solid preparations containing mannitol, sucrose and starch, and containing 10 parts by mass or more of mannitol with respect to 1 part by mass of sucrose, are disintegrated. It showed excellent disintegration for less than 30 seconds, and all showed good values in tensile strength and ingestibility.
  • Comparative Example 1 in which sucrose was not blended in the formulation could not produce a tablet having a hardness of 0.7 MPa or more even when it was produced at a high tableting pressure, and was not satisfactory in dosage.
  • Comparative Example 2 in which corn starch was not blended in the formulation and in Comparative Example 3 in which mannitol was 10 parts by mass or less with respect to 1 part by mass of sucrose, either disintegration time or ingestion was not satisfactory.
  • Example 9 Using acetaminophen as a drug, the granulated granule components shown in Table 4 were weighed and mixed, and a granulated product was produced with a fluidized bed granulator (trade name: FLO-1; manufactured by Freund Corporation). After weighing and mixing the powdered ingredients shown in Table 4 into the resulting granulated product, the resulting tablet has a tensile strength of 0 using a small rotary tablet machine (trade name: VELA 5; Kikusui Seisakusho). The tableting pressure was set to 600 MPa or higher (600-1500 kgf), and tablets with a tablet diameter of 8-10 mm were obtained.
  • Example 10 Tablets were produced in the same manner as in Example 9 using scopolamine hydrobromide hydrate and chlorpheniramine maleate as drugs.
  • Example 11 Tablets were produced in the same manner as in Example 9 using belladonna total alkaloid and chlorpheniramine maleate as drugs.
  • Example 12 Tablets were produced in the same manner as in Example 9 using loratadine as a drug.
  • Example 13 Tablets were produced in the same manner as in Example 9 using belladonna total alkaloid and carbinoxamine maleate as drugs.
  • Example 14 Tablets were produced in the same manner as in Example 9 using scopolamine hydrobromide hydrate and meclizine hydrochloride as drugs.
  • Example 15 Using loxoprofen sodium dihydrate as a drug, tablets were produced in the same manner as in Example 9.
  • Example 17 Tablets were produced in the same manner as in Example 16 using caffeine as a drug.
  • Example 18 Tablets were produced in the same manner as in Example 16 using ascorbic acid as a drug.
  • Example 19 Using fexofenadine hydrochloride as a drug, tablets with a tablet mass of 150 mg were produced in the same manner as in Example 16.
  • Example 20 Tablets were produced in the same manner as in Example 16 using mequitazine as a drug.
  • Example 21 Tablets were produced in the same manner as in Example 16 using pseudoephedrine hydrochloride as the drug.
  • ⁇ Evaluation method 2> For the orally disintegrating tablets of Examples 16 to 21, the disintegration time was measured by the following test methods, and the ingestibility (roughness, powderiness) was evaluated according to the following evaluation criteria and scored.
  • Hardness test It carried out similarly to the evaluation method 1.
  • Disintegration test oral disintegration test
  • Two healthy adult panelists measured the time until the tablet completely disintegrated in the oral cavity, and determined the average value.
  • Ingestion test 1 Roughness It was carried out in the same manner as in the evaluation method 1 by two healthy adult panelists.
  • Ingestion test 2 powdery The same as evaluation method 1 was conducted by two healthy adult panelists.
  • Table 5 shows the disintegration time, tablet hardness, and dosing results of the tablets obtained in Examples 16-21. Also in the solid preparations (Examples 16 to 21) containing the drugs shown in Table 5, all the results satisfying the standard values in the disintegration time, the tensile strength, and the ingestibility were obtained.
  • an orally disintegrating tablet that rapidly disintegrates or dissolves in the oral cavity without using special equipment, a manufacturing method, and an excipient, has a desired appropriate hardness, and is excellent in dosage.
  • a chewable tablet can be provided.

Landscapes

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

Abstract

La présente invention concerne une préparation solide contenant du mannitol, du saccharose, et de l'amidon ; la teneur en mannitol étant d'au moins 10 parties en masse par rapport à 1 partie en masse de saccharose et la teneur en amidon étant de préférence d'au moins 0,01 partie en masse par rapport à 1 partie en masse de saccharose ; la préparation solide contenant en outre, de préférence, un médicament tel que l'acétaminophène, la scopolamine ou un sel de celle-ci, la chlorphéniramine ou un sel de celle-ci, la carbinoxamine ou un sel de celle-ci, un alcaloïde total de belladone, la loratadine, la fexofénadine ou un sel de celle-ci, la méquitazine, le loxoprofène ou un sel de celui-ci, la méclizine ou un sel de celle-ci, l'ibuprofène, la caféine, l'acide ascorbique ou la pseudoéphédrine ou un sel de celle-ci ; et la préparation solide étant un comprimé à désintégration orale ou un comprimé à mâcher présentant des performances de désintégration rapide dans la cavité buccale tout en ayant une dureté élevée et une excellente dosabilité. Ce comprimé à désintégration orale ou comprimé à mâcher peut être fabriqué sans utiliser un équipement, des procédés de fabrication, ou des excipients spéciaux.
PCT/JP2014/057444 2013-03-21 2014-03-19 Préparation solide WO2014148520A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2015506812A JP6341196B2 (ja) 2013-03-21 2014-03-19 固形製剤

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2013-057659 2013-03-21
JP2013057659 2013-03-21

Publications (1)

Publication Number Publication Date
WO2014148520A1 true WO2014148520A1 (fr) 2014-09-25

Family

ID=51580195

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2014/057444 WO2014148520A1 (fr) 2013-03-21 2014-03-19 Préparation solide

Country Status (3)

Country Link
JP (1) JP6341196B2 (fr)
TW (1) TW201532634A (fr)
WO (1) WO2014148520A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2017002045A (ja) * 2015-06-12 2017-01-05 ゼリア新薬工業株式会社 口腔内崩壊錠
JP2021004193A (ja) * 2019-06-25 2021-01-14 小林製薬株式会社 アセトアミノフェン含有顆粒剤

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2000515535A (ja) * 1996-08-07 2000-11-21 パーク―デイヴィス トリメブチンマレエートのコーティング錠
WO2006123678A1 (fr) * 2005-05-18 2006-11-23 Dainippon Sumitomo Pharma Co., Ltd. Comprimé stable contenant de la droxidopa
WO2011071139A1 (fr) * 2009-12-11 2011-06-16 大日本住友製薬株式会社 Comprimé enrobé à sec à désintégration orale

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH11116464A (ja) * 1997-10-09 1999-04-27 Ss Pharmaceut Co Ltd 迅速溶解性固形製剤およびその製造法
EP1620075B1 (fr) * 2003-05-07 2020-06-24 Samyang Biopharmaceuticals Corporation Granules a teneur elevee en plastique, destines a la fabrication de comprimes a dissolution rapide
WO2005037254A1 (fr) * 2003-10-15 2005-04-28 Fuji Chemical Industry Co., Ltd. Comprime se desintegrant rapidement dans la cavite buccale

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2000515535A (ja) * 1996-08-07 2000-11-21 パーク―デイヴィス トリメブチンマレエートのコーティング錠
WO2006123678A1 (fr) * 2005-05-18 2006-11-23 Dainippon Sumitomo Pharma Co., Ltd. Comprimé stable contenant de la droxidopa
WO2011071139A1 (fr) * 2009-12-11 2011-06-16 大日本住友製薬株式会社 Comprimé enrobé à sec à désintégration orale

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2017002045A (ja) * 2015-06-12 2017-01-05 ゼリア新薬工業株式会社 口腔内崩壊錠
JP2021004193A (ja) * 2019-06-25 2021-01-14 小林製薬株式会社 アセトアミノフェン含有顆粒剤

Also Published As

Publication number Publication date
JPWO2014148520A1 (ja) 2017-02-16
TW201532634A (zh) 2015-09-01
JP6341196B2 (ja) 2018-06-13

Similar Documents

Publication Publication Date Title
JP5583012B2 (ja) 口腔内速崩壊錠及びその製造方法
JP5702305B2 (ja) 有核型の口腔内崩壊錠
JPWO2007018192A1 (ja) 口腔内崩壊錠剤
JP2001278812A (ja) 錠剤用崩壊剤及びこれを用いた錠剤
JP2003034655A (ja) 速崩壊性固形製剤
JP4438121B2 (ja) 口腔内速崩錠及びその製造方法
JP3884056B1 (ja) 口腔内速崩錠の製造方法
TWI673069B (zh) 超高速崩解錠劑及其製造方法
JP6341196B2 (ja) 固形製剤
JP6513702B2 (ja) 超速崩壊錠剤及びその製造方法
JP6262490B2 (ja) 口腔内速崩壊性錠剤用組成物
JP2008037853A (ja) イソマルトを含有する速崩壊性医薬品固形製剤
JP6469234B2 (ja) 超速崩壊錠剤及びその製造方法
JP6863401B2 (ja) 固形製剤
JP6476122B2 (ja) 二段階の湿式造粒工程で製造される崩壊性粒子組成物及び該組成物を含む口腔内崩壊錠剤
JP2021105057A (ja) 固形製剤
JP5490691B2 (ja) 炭酸カルシウム含有速崩壊性製剤
JP3967767B1 (ja) 口腔内速崩錠の製造方法
JP2008208078A (ja) 分割錠剤
JP2005029557A (ja) 口腔内速崩壊性錠剤およびその製造方法
JP2016117652A (ja) 小児への投与に適した速崩壊錠とその簡便な製造方法
JP6438547B2 (ja) 口腔内速崩壊性錠剤用組成物
TWI650142B (zh) 口腔内崩解錠添加用組成物
JP2016190794A (ja) 錠剤およびその製造方法
JP2024050466A (ja) 固形組成物

Legal Events

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

Ref document number: 14768357

Country of ref document: EP

Kind code of ref document: A1

ENP Entry into the national phase

Ref document number: 2015506812

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: 14768357

Country of ref document: EP

Kind code of ref document: A1