JP7239119B2 - 賦形剤及び錠剤 - Google Patents
賦形剤及び錠剤 Download PDFInfo
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- JP7239119B2 JP7239119B2 JP2022008665A JP2022008665A JP7239119B2 JP 7239119 B2 JP7239119 B2 JP 7239119B2 JP 2022008665 A JP2022008665 A JP 2022008665A JP 2022008665 A JP2022008665 A JP 2022008665A JP 7239119 B2 JP7239119 B2 JP 7239119B2
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- crystalline cellulose
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- 229920002472 Starch Polymers 0.000 claims description 18
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- 239000008107 starch Substances 0.000 claims description 17
- 239000003795 chemical substances by application Substances 0.000 claims description 13
- SERLAGPUMNYUCK-DCUALPFSSA-N 1-O-alpha-D-glucopyranosyl-D-mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO[C@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O SERLAGPUMNYUCK-DCUALPFSSA-N 0.000 claims description 8
- 239000000905 isomalt Substances 0.000 claims description 8
- 235000010439 isomalt Nutrition 0.000 claims description 8
- HPIGCVXMBGOWTF-UHFFFAOYSA-N isomaltol Natural products CC(=O)C=1OC=CC=1O HPIGCVXMBGOWTF-UHFFFAOYSA-N 0.000 claims description 8
- OWEGMIWEEQEYGQ-UHFFFAOYSA-N 100676-05-9 Natural products OC1C(O)C(O)C(CO)OC1OCC1C(O)C(O)C(O)C(OC2C(OC(O)C(O)C2O)CO)O1 OWEGMIWEEQEYGQ-UHFFFAOYSA-N 0.000 claims description 7
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 claims description 7
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims description 7
- GUBGYTABKSRVRQ-PICCSMPSSA-N Maltose Natural products O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@@H](CO)OC(O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-PICCSMPSSA-N 0.000 claims description 7
- GUBGYTABKSRVRQ-QUYVBRFLSA-N beta-maltose Chemical compound OC[C@H]1O[C@H](O[C@H]2[C@H](O)[C@@H](O)[C@H](O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@@H]1O GUBGYTABKSRVRQ-QUYVBRFLSA-N 0.000 claims description 7
- 239000008101 lactose Substances 0.000 claims description 7
- 239000000845 maltitol Substances 0.000 claims description 7
- VQHSOMBJVWLPSR-WUJBLJFYSA-N maltitol Chemical compound OC[C@H](O)[C@@H](O)[C@@H]([C@H](O)CO)O[C@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O VQHSOMBJVWLPSR-WUJBLJFYSA-N 0.000 claims description 7
- 235000010449 maltitol Nutrition 0.000 claims description 7
- 229940035436 maltitol Drugs 0.000 claims description 7
- 239000002994 raw material Substances 0.000 claims description 7
- 229920002261 Corn starch Polymers 0.000 claims description 3
- 239000008120 corn starch Substances 0.000 claims description 3
- 229940100486 rice starch Drugs 0.000 claims description 3
- 235000010980 cellulose Nutrition 0.000 description 36
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 17
- 238000000034 method Methods 0.000 description 13
- 239000003814 drug Substances 0.000 description 7
- 229940079593 drug Drugs 0.000 description 6
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- 238000006460 hydrolysis reaction Methods 0.000 description 4
- 239000002245 particle Substances 0.000 description 4
- 229920001592 potato starch Polymers 0.000 description 4
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 description 3
- 240000003183 Manihot esculenta Species 0.000 description 3
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- 239000000314 lubricant Substances 0.000 description 2
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 2
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- 229940016286 microcrystalline cellulose Drugs 0.000 description 2
- 239000010902 straw Substances 0.000 description 2
- 241000609240 Ambelania acida Species 0.000 description 1
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- 235000017491 Bambusa tulda Nutrition 0.000 description 1
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- 229920000742 Cotton Polymers 0.000 description 1
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- 102000004190 Enzymes Human genes 0.000 description 1
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- 229920002488 Hemicellulose Polymers 0.000 description 1
- 240000000797 Hibiscus cannabinus Species 0.000 description 1
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- CJZGTCYPCWQAJB-UHFFFAOYSA-L calcium stearate Chemical compound [Ca+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O CJZGTCYPCWQAJB-UHFFFAOYSA-L 0.000 description 1
- 239000008116 calcium stearate Substances 0.000 description 1
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- 230000000052 comparative effect Effects 0.000 description 1
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- AQEDFGUKQJUMBV-UHFFFAOYSA-N copper;ethane-1,2-diamine Chemical compound [Cu].NCCN AQEDFGUKQJUMBV-UHFFFAOYSA-N 0.000 description 1
- 238000007907 direct compression Methods 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 230000001747 exhibiting effect Effects 0.000 description 1
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- 238000013095 identification testing Methods 0.000 description 1
- 239000012535 impurity Substances 0.000 description 1
- 229920005610 lignin Polymers 0.000 description 1
- 235000019359 magnesium stearate Nutrition 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 239000010445 mica Substances 0.000 description 1
- 229910052618 mica group Inorganic materials 0.000 description 1
- 230000000704 physical effect Effects 0.000 description 1
- 239000004848 polyfunctional curative Substances 0.000 description 1
- 229940114930 potassium stearate Drugs 0.000 description 1
- ANBFRLKBEIFNQU-UHFFFAOYSA-M potassium;octadecanoate Chemical compound [K+].CCCCCCCCCCCCCCCCCC([O-])=O ANBFRLKBEIFNQU-UHFFFAOYSA-M 0.000 description 1
- 239000000047 product Substances 0.000 description 1
- 235000009566 rice Nutrition 0.000 description 1
- RYYKJJJTJZKILX-UHFFFAOYSA-M sodium octadecanoate Chemical compound [Na+].CCCCCCCCCCCCCCCCCC([O-])=O RYYKJJJTJZKILX-UHFFFAOYSA-M 0.000 description 1
- 235000014347 soups Nutrition 0.000 description 1
- 230000003068 static effect Effects 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 238000005406 washing Methods 0.000 description 1
- 229940100445 wheat starch Drugs 0.000 description 1
- 239000002023 wood Substances 0.000 description 1
Classifications
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- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
- C08L3/00—Compositions of starch, amylose or amylopectin or of their derivatives or degradation products
- C08L3/02—Starch; Degradation products thereof, e.g. dextrin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- 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
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L29/00—Foods or foodstuffs containing additives; Preparation or treatment thereof
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- A23L29/00—Foods or foodstuffs containing additives; Preparation or treatment thereof
- A23L29/20—Foods or foodstuffs containing additives; Preparation or treatment thereof containing gelling or thickening agents
- A23L29/206—Foods or foodstuffs containing additives; Preparation or treatment thereof containing gelling or thickening agents of vegetable origin
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
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- A23L29/00—Foods or foodstuffs containing additives; Preparation or treatment thereof
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- A23L5/00—Preparation or treatment of foods or foodstuffs, in general; Food or foodstuffs obtained thereby; Materials therefor
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- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08K—Use of inorganic or non-macromolecular organic substances as compounding ingredients
- C08K5/00—Use of organic ingredients
- C08K5/04—Oxygen-containing compounds
- C08K5/15—Heterocyclic compounds having oxygen in the ring
- C08K5/151—Heterocyclic compounds having oxygen in the ring having one oxygen atom in the ring
- C08K5/1535—Five-membered rings
- C08K5/1539—Cyclic anhydrides
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
- C08L1/00—Compositions of cellulose, modified cellulose or cellulose derivatives
- C08L1/02—Cellulose; Modified cellulose
-
- C—CHEMISTRY; METALLURGY
- C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
- C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
- C11D17/00—Detergent materials or soaps characterised by their shape or physical properties
- C11D17/0047—Detergents in the form of bars or tablets
- C11D17/0065—Solid detergents containing builders
- C11D17/0073—Tablets
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- C—CHEMISTRY; METALLURGY
- C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
- C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
- C11D17/00—Detergent materials or soaps characterised by their shape or physical properties
- C11D17/04—Detergent materials or soaps characterised by their shape or physical properties combined with or containing other objects
- C11D17/041—Compositions releasably affixed on a substrate or incorporated into a dispensing means
- C11D17/042—Water soluble or water disintegrable containers or substrates containing cleaning compositions or additives for cleaning compositions
- C11D17/044—Solid compositions
-
- C—CHEMISTRY; METALLURGY
- C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
- C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
- C11D3/00—Other compounding ingredients of detergent compositions covered in group C11D1/00
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- C11D3/22—Carbohydrates or derivatives thereof
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- C—CHEMISTRY; METALLURGY
- C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
- C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
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- C11D3/221—Mono, di- or trisaccharides or derivatives thereof
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- C—CHEMISTRY; METALLURGY
- C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
- C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
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- C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
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- A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
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- Engineering & Computer Science (AREA)
- Medicinal Chemistry (AREA)
- Organic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Wood Science & Technology (AREA)
- Molecular Biology (AREA)
- Polymers & Plastics (AREA)
- Emergency Medicine (AREA)
- Food Science & Technology (AREA)
- Nutrition Science (AREA)
- Dispersion Chemistry (AREA)
- Biophysics (AREA)
- Medicinal Preparation (AREA)
- Detergent Compositions (AREA)
- General Preparation And Processing Of Foods (AREA)
Description
マルチトール、イソマルト、マルトース及びラクトースからなる群から選ばれた一種以上の硬化剤と、
でんぷんと、
結晶セルロースとを含有することを特徴とする。
でんぷんとして、タピオカでんぷん、とうもろこしでんぷん、じゃがいもでんぷん及び米でんぷんと、結晶セルロースとして、結晶セルロース1(旭化成ケミカルズ社製 商品名「セオラス」)、結晶セルロース2(栄研商事社製 商品名「ヘヴァテン101」)及び結晶セルロース3(栄研商事社製 商品名「ヘヴァテン102」)と、硬化剤として、イソマルト、マルチトール、マルトース及びラクトースとを表1及び表2に示した所定量ずつを攪拌機に供給し、均一に混合して賦形剤を製造した。
得られた錠剤を24.9℃の水1リットル中に投入した。錠剤を静止状態の水中に投入し、錠剤がその体積の2/3崩壊した時点から60rpmの回転数で水を攪拌し、錠剤が完全に崩壊するまで攪拌した。錠剤を静止状態の水中に投入してから錠剤が完全に崩壊するまでの時間を測定した。錠剤を静止状態の水中に投入してから300秒経過しても崩壊しなかった場合は「Bad」とした。
得られた錠剤の硬度を硬度計(藤原製作所社製 商品名「木屋式硬度計」)を用いて測定した。
本出願は、2016年6月28日に出願された日本国特許出願第2016-128150号に基づく優先権を主張し、この出願の開示はこれらの全体を参照することにより本明細書に組み込まれる。
Claims (4)
- マルチトール、イソマルト、マルトース及びラクトースからなる群から選ばれた一種以上の硬化剤0.2~3質量部と、とうもろこしでんぷん及び/又は米でんぷんを含むでんぷん100質量部と、結晶セルロース8~12質量部とを含有することを特徴とする賦形剤。
- 粉末の錠剤化に用いられることを特徴とする請求項1に記載の賦形剤。
- 請求項1に記載の賦形剤と、原料となる粉末とを含有していることを特徴とする錠剤。
- 粉末の含有量と賦形剤の含有量との比(粉末の含有量/賦形剤の含有量)が6.4以下であることを特徴とする請求項3に記載の錠剤。
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WO2004064810A1 (ja) | 2003-01-21 | 2004-08-05 | Nippon Shinyaku Co., Ltd. | 口腔内速崩性錠剤 |
WO2007114376A1 (ja) | 2006-03-30 | 2007-10-11 | Nippon Zoki Pharmaceutical Co., Ltd. | 固形医薬製剤 |
WO2008018371A1 (fr) | 2006-08-08 | 2008-02-14 | Kissei Pharmaceutical Co., Ltd. | Comprimé à désagrégation orale ayant un goût amer masqué et son procédé de production |
WO2010092828A1 (ja) | 2009-02-12 | 2010-08-19 | 富士化学工業株式会社 | 崩壊性粒子組成物及びそれを用いた速崩壊性圧縮成型物 |
WO2012001977A1 (ja) | 2010-06-29 | 2012-01-05 | 富士化学工業株式会社 | 崩壊性組成物及び易崩壊性圧縮成型物 |
WO2013054872A1 (ja) | 2011-10-14 | 2013-04-18 | 大塚製薬株式会社 | 7-[4-(4-ベンゾ[b]チオフェン-4-イル-ピペラジン-1-イル)ブトキシ]-1H-キノリン-2-オン又はその塩を含む錠剤 |
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