JPH0653658B2 - 安定な錠剤の製造法 - Google Patents

安定な錠剤の製造法

Info

Publication number
JPH0653658B2
JPH0653658B2 JP59265888A JP26588884A JPH0653658B2 JP H0653658 B2 JPH0653658 B2 JP H0653658B2 JP 59265888 A JP59265888 A JP 59265888A JP 26588884 A JP26588884 A JP 26588884A JP H0653658 B2 JPH0653658 B2 JP H0653658B2
Authority
JP
Japan
Prior art keywords
pressure
molding
present
tablet
tablet manufacturing
Prior art date
Legal status (The legal status 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 status listed.)
Expired - Lifetime
Application number
JP59265888A
Other languages
English (en)
Other versions
JPS61143316A (ja
Inventor
隆 寺薗
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Chugai Pharmaceutical Co Ltd
Original Assignee
Chugai Pharmaceutical Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Chugai Pharmaceutical Co Ltd filed Critical Chugai Pharmaceutical Co Ltd
Priority to JP59265888A priority Critical patent/JPH0653658B2/ja
Priority to AU50762/85A priority patent/AU579431B2/en
Priority to CA000497114A priority patent/CA1255227A/en
Priority to ZA859390A priority patent/ZA859390B/xx
Priority to AR85302556A priority patent/AR241515A1/es
Priority to SU853993193A priority patent/RU1811401C/ru
Priority to DE8585116032T priority patent/DE3578373D1/de
Priority to PT81680A priority patent/PT81680B/pt
Priority to IE317685A priority patent/IE59158B1/en
Priority to DK583385A priority patent/DK167171B1/da
Priority to EP85116032A priority patent/EP0185347B1/en
Priority to KR1019850009452A priority patent/KR930007251B1/ko
Priority to AT85116032T priority patent/ATE54050T1/de
Priority to NO855048A priority patent/NO171826C/no
Priority to HU854801A priority patent/HU195731B/hu
Priority to FI855032A priority patent/FI84781C/fi
Priority to CN85109190A priority patent/CN1007209B/zh
Priority to YU1973/85A priority patent/YU45292B/xx
Priority to MX000985A priority patent/MX166095B/es
Publication of JPS61143316A publication Critical patent/JPS61143316A/ja
Priority to US07/147,129 priority patent/US4803213A/en
Priority to SG52493A priority patent/SG52493G/en
Priority to HK654/93A priority patent/HK65493A/xx
Publication of JPH0653658B2 publication Critical patent/JPH0653658B2/ja
Priority to BA980214A priority patent/BA98214B1/bs
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • 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
    • A61K9/02—Suppositories; Bougies; Bases therefor; Ovules
    • 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
    • A61K31/455—Nicotinic acids, e.g. niacin; Derivatives thereof, e.g. esters, amides
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • 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
    • 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
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer

Description

【発明の詳細な説明】 本発明は加圧成型圧に対し不安定な薬物、中でも医薬品
の製剤化方法に関する。更に詳しくは本発明は、微粉砕
された糖類を賦形剤として含有する加圧成型圧に対し安
定な錠剤の製造方法に関する。
医薬品の安定性は種々の因子、例えば温度，湿度，光，
酸素などに影響される。従って安定な医薬品製剤を製造
するために従来から種々の製剤化法が見い出されてき
た。また錠剤を製造する際の打錠による成型圧に対しあ
る種の医薬品製剤は不安定になり含量低下を来すことも
しられている。この解決策としては、ワックス成分を添
加する方法やポリエチレングリコールを添加する方法等
が知られている。
本発明者等はある種の医薬品、例えば酵素を含有する製
剤等における成型圧に対するより簡便な安定化方法につ
き鋭意研究した結果、賦形剤として微粉砕した糖を用い
ることによりその安定性が著しく向上することを見いだ
し本発明を完成した。
本発明の方法において医薬品としては特に制限はないが
本発明の安定化方法が特に効果をあげるものであり、例
えばストレプトコッカスフェカリス、ラクトバシルスア
シドフィリスおよびビフィズス菌等の乳酸菌、パンクレ
アチン、ジアスターゼ、リパーゼ、アシラーゼ、ペプシ
ン等の消化酵素、セクレチン、グルカゴン等の消化管ホ
ルモン、塩化リゾチームなどのポリペプチドおよび生物
製剤等が挙げられる。またこれらの他に打錠の際の成型
圧に不安定な医薬品としては、例えば循環器疾患治療剤
として知られているＮ−（２−ヒドロキシエチル）ニコ
チン酸アミド硝酸エステル（一般名ニコランジル）があ
る。本発明の方法において糖類としてはマンニトール，
乳糖，庶糖，ブドウ糖，ガラクトースおよびマルトース
等の一般によく食品又は医薬品の分野で使用されている
ものである。また本発明の方法においてこれらの糖類は
微粉砕されて用いられるが、特に好ましい結果を与える
のは平均粒子径が10μｍ以下のものを用いた場合であ。
粉砕化方法としては例えばジェット粉砕機による方法が
ある。この微粉砕された糖類は例えば湿式製法により造
粒され主剤と配合される。糖類の配合比は錠剤中の主剤
の量および打錠圧等の関係で適宜調節されるが例えば、
通常医薬品の製剤において賦形剤として使用される範囲
であれば本発明の安定化効果は充分に得られる。なお本
発明の方法により得られる錠剤には他に崩壊剤，結合剤
および滑沢剤等を適宜添加することができる。
実施例１． Ｎ−（２−ヒドロキシエチル）ニコチン酸アミド硝酸エ
ステル（ニコランジル）１部とジェット粉砕機で粉砕し
平均粒子径３μｍとしたマンニトールを湿式製法にて製
造した造粒物９部を均一に混和し静圧成型機にて直径10
mm，重量300mg，錠剤硬度約10Kg（岡田精工製自動硬度
計にて測定）の錠剤を得た。粉砕していないマンニトー
ル粉末を用いて同じ操作を行い錠剤を得た。この２種の
錠剤を５０℃（乾燥剤添加）下で加速した時の結果を表
Ｉに示す。なお表中の数値は錠剤中のニコランジルの残
存率（％）である。
実施例２． 乳酸菌であるストレプトコッカスフェカリス１部、微粉
砕し平均粒子径８μｍ以下とした乳糖８．４部を用い以
下実施例１に記載の方法と同様の処理を行った後カルボ
キシメチルセルロース０．５部、ステアリン酸マグネシ
ウム０．１部を配合し単発打錠機を用いて打錠し直径８
mm，重量２２０mgの本発明の錠剤を得た。対照として用
いた錠剤は乳糖を微粉砕しないで用いた点を除き同様の
操作を行い製造したものである。
本発明の錠剤および対照の錠剤は各々、加圧成型圧を約
700,1400,2100kgと変えて打錠した。このときの錠剤中
の残存活性酵素量（％）を表IIに示す。

Claims (3)

    【特許請求の範囲】
  1. 【請求項１】加圧成型圧に対し不安定な有効成分と平均
    粒子径が１０μｍ以下に微粉砕された糖類の１種または
    ２種以上の混合物を加圧成型して得られる安定な固形製
    剤。
  2. 【請求項２】加圧成型に対し不安定な有効成分がＮ−
    （２−ヒドロキシエチル）ニコチン酸アミド硝酸エステ
    ルである特許請求の範囲第１項記載の製剤。
  3. 【請求項３】糖類がマンニトール、乳糖、蔗糖、ブドウ
    糖、ガラクトースおよびフルクトースの群から選ばれる
    ものである特許請求の範囲第１項または第２項記載の製
    剤。
JP59265888A 1984-12-17 1984-12-17 安定な錠剤の製造法 Expired - Lifetime JPH0653658B2 (ja)

Priority Applications (23)

Application Number Priority Date Filing Date Title
JP59265888A JPH0653658B2 (ja) 1984-12-17 1984-12-17 安定な錠剤の製造法
AU50762/85A AU579431B2 (en) 1984-12-17 1985-12-04 Method for production of stable nicorandil preparation
CA000497114A CA1255227A (en) 1984-12-17 1985-12-06 Method for production of stable nicorandil preparation
ZA859390A ZA859390B (en) 1984-12-17 1985-12-09 Method for production of stable nicorandil preparation
AR85302556A AR241515A1 (es) 1984-12-17 1985-12-12 Procedimiento de preparacion de composiciones farmaceuticas estables que contienen nicorandil.
NO855048A NO171826C (no) 1984-12-17 1985-12-16 Fremgangsmaate for fremstilling av et stabilt nicorandilholdig preparat
DE8585116032T DE3578373D1 (de) 1984-12-17 1985-12-16 Herstellungverfahren fuer stabile nicorandilpraeparate.
PT81680A PT81680B (pt) 1984-12-17 1985-12-16 Processo para a preparacao de uma composicao farmaceutica estavel de nicorandil
IE317685A IE59158B1 (en) 1984-12-17 1985-12-16 Method for production of stable nicorandil preparation
DK583385A DK167171B1 (da) 1984-12-17 1985-12-16 Fremgangsmaade til fremstilling af et stabilt nicorandilholdigt farmaceutisk praeparat
EP85116032A EP0185347B1 (en) 1984-12-17 1985-12-16 Method for production of stable nicorandil preparation
KR1019850009452A KR930007251B1 (ko) 1984-12-17 1985-12-16 안정한 니코란딜 제제의 제조방법
AT85116032T ATE54050T1 (de) 1984-12-17 1985-12-16 Herstellungverfahren fuer stabile nicorandilpraeparate.
SU853993193A RU1811401C (ru) 1984-12-17 1985-12-16 Способ получени таблеток никорандила
HU854801A HU195731B (en) 1984-12-17 1985-12-16 Process for production of preparatives of stabil n-/hydroxi-ethil/-nicotinamid-nitrate
CN85109190A CN1007209B (zh) 1984-12-17 1985-12-17 生产稳定的尼可地尔制剂的方法
FI855032A FI84781C (fi) 1984-12-17 1985-12-17 Foerfarande foer produktion av en stabil nikorandilprodukt.
YU1973/85A YU45292B (en) 1984-12-17 1985-12-17 Process for stabilizing nicorandyl compound
MX000985A MX166095B (es) 1984-12-17 1985-12-17 Metodo para la produccion de una preparacion estable de nicorandil
US07/147,129 US4803213A (en) 1984-12-17 1988-01-21 Method for production of stable nicorandil preparation
SG52493A SG52493G (en) 1984-12-17 1993-04-23 Method for production of stable nicorandil preparation
HK654/93A HK65493A (en) 1984-12-17 1993-07-08 Method for production of stable nicorandil preparation
BA980214A BA98214B1 (bs) 1984-12-17 1998-04-27 Postupak za stabilizaciju nikorandil preparata

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
JP59265888A JPH0653658B2 (ja) 1984-12-17 1984-12-17 安定な錠剤の製造法
JP14968885 1985-07-08
JP21327785 1985-09-26

Publications (2)

Publication Number Publication Date
JPS61143316A JPS61143316A (ja) 1986-07-01
JPH0653658B2 true JPH0653658B2 (ja) 1994-07-20

Family

ID=27319808

Family Applications (1)

Application Number Title Priority Date Filing Date
JP59265888A Expired - Lifetime JPH0653658B2 (ja) 1984-12-17 1984-12-17 安定な錠剤の製造法

Country Status (23)

Country Link
US (1) US4803213A (ja)
EP (1) EP0185347B1 (ja)
JP (1) JPH0653658B2 (ja)
KR (1) KR930007251B1 (ja)
CN (1) CN1007209B (ja)
AR (1) AR241515A1 (ja)
AT (1) ATE54050T1 (ja)
AU (1) AU579431B2 (ja)
BA (1) BA98214B1 (ja)
CA (1) CA1255227A (ja)
DE (1) DE3578373D1 (ja)
DK (1) DK167171B1 (ja)
FI (1) FI84781C (ja)
HK (1) HK65493A (ja)
HU (1) HU195731B (ja)
IE (1) IE59158B1 (ja)
MX (1) MX166095B (ja)
NO (1) NO171826C (ja)
PT (1) PT81680B (ja)
RU (1) RU1811401C (ja)
SG (1) SG52493G (ja)
YU (1) YU45292B (ja)
ZA (1) ZA859390B (ja)

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US8945618B2 (en) 1996-06-14 2015-02-03 Kyowa Hakko Kirin Co., Ltd. Intrabuccally rapidly disintegrating tablet and a production method of the tablets
US9040086B2 (en) 2001-10-04 2015-05-26 Aptalis Pharmatech, Inc. Timed, sustained release systems for propranolol
US9161918B2 (en) 2005-05-02 2015-10-20 Adare Pharmaceuticals, Inc. Timed, pulsatile release systems
US9233105B2 (en) 2009-12-02 2016-01-12 Adare Pharmaceuticals S.R.L. Fexofenadine microcapsules and compositions containing them
US9884014B2 (en) 2004-10-12 2018-02-06 Adare Pharmaceuticals, Inc. Taste-masked pharmaceutical compositions
US10471017B2 (en) 2004-10-21 2019-11-12 Adare Pharmaceuticals, Inc. Taste-masked pharmaceutical compositions with gastrosoluble pore-formers

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KR100481583B1 (ko) * 1996-06-14 2005-07-12 교와 핫꼬 고교 가부시끼가이샤 구강내에서빠르게붕괴하는정제
CA2258159C (en) 1996-06-14 2006-03-21 Kyowa Hakko Kogyo Co., Ltd. Intraorally rapidly disintegrable tablet
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KR100483080B1 (ko) * 2001-09-21 2005-04-14 한인규 염산·베타인(betaine·HCl), 판크레아틴, 제2인산 칼슘, 크롬 피콜리네이트, 락토바실러스속·비피도박테리아속·스트렙토코커스속·프럭토 올리고당, 비타민, 미네랄을 유효성분으로 구성된 것을 특징으로 하는 증체개선용 영양강화 사료첨가제
US8367111B2 (en) * 2002-12-31 2013-02-05 Aptalis Pharmatech, Inc. Extended release dosage forms of propranolol hydrochloride
JP4235149B2 (ja) 2004-07-02 2009-03-11 インターナショナル・ビジネス・マシーンズ・コーポレーション ノートブック型コンピュータ
US8747895B2 (en) * 2004-09-13 2014-06-10 Aptalis Pharmatech, Inc. Orally disintegrating tablets of atomoxetine
US20060105038A1 (en) * 2004-11-12 2006-05-18 Eurand Pharmaceuticals Limited Taste-masked pharmaceutical compositions prepared by coacervation
CN100417381C (zh) * 2006-02-09 2008-09-10 西安力邦医药科技有限责任公司 尼可地尔冻干粉的制备方法
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GB0720516D0 (en) * 2007-10-18 2007-11-28 Cadbury Schweppes Plc Comestible products
UY33173A (ja) * 2010-01-08 2011-07-29 Eurand Inc
CN111606847B (zh) * 2020-05-26 2021-12-31 中国科学院上海药物研究所 尼可地尔与1-羟基-2-萘甲酸的共晶及其制备方法和应用
CN114732792A (zh) * 2022-03-25 2022-07-12 北京诺康达医药科技股份有限公司 一种尼可地尔口腔崩解片及其制备方法
CN115317456A (zh) * 2022-08-17 2022-11-11 北京科源创欣科技有限公司 一种尼可地尔片组合物及其制备方法
CN115282123B (zh) * 2022-09-13 2023-11-03 南京比逊医药科技有限公司 一种稳定的尼可地尔制剂的制备方法

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US8956650B2 (en) 1996-06-14 2015-02-17 Kyowa Hakko Kirin Co., Ltd. Intrabuccally rapidly disintegrating tablet and a production method of the tablets
US8945618B2 (en) 1996-06-14 2015-02-03 Kyowa Hakko Kirin Co., Ltd. Intrabuccally rapidly disintegrating tablet and a production method of the tablets
US9040086B2 (en) 2001-10-04 2015-05-26 Aptalis Pharmatech, Inc. Timed, sustained release systems for propranolol
US9358214B2 (en) 2001-10-04 2016-06-07 Adare Pharmaceuticals, Inc. Timed, sustained release systems for propranolol
US10130580B2 (en) 2004-10-12 2018-11-20 Adare Pharmaceuticals, Inc. Taste-masked pharmaceutical compositions
US11452689B2 (en) 2004-10-12 2022-09-27 Adare Pharmaceuticals, Inc. Taste-masked pharmaceutical compositions
US10568832B2 (en) 2004-10-12 2020-02-25 Adare Pharmaceuticals, Inc. Taste-masked pharmaceutical compositions
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US10471017B2 (en) 2004-10-21 2019-11-12 Adare Pharmaceuticals, Inc. Taste-masked pharmaceutical compositions with gastrosoluble pore-formers
US9579293B2 (en) 2005-05-02 2017-02-28 Adare Pharmaceuticals, Inc. Timed, pulsatile release systems
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US9161919B2 (en) 2005-05-02 2015-10-20 Adare Pharmaceuticals, Inc. Timed, pulsatile release systems
US11147772B2 (en) 2005-05-02 2021-10-19 Adare Pharmaceuticals, Inc. Timed, pulsatile release systems
US9161918B2 (en) 2005-05-02 2015-10-20 Adare Pharmaceuticals, Inc. Timed, pulsatile release systems
US10166220B2 (en) 2009-12-02 2019-01-01 Adare Pharmaceuticals S.R.L. Fexofenadine microcapsules and compositions containing them
US9233105B2 (en) 2009-12-02 2016-01-12 Adare Pharmaceuticals S.R.L. Fexofenadine microcapsules and compositions containing them

Also Published As

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YU197385A (en) 1988-04-30
EP0185347A3 (en) 1987-04-22
HK65493A (en) 1993-07-16
SG52493G (en) 1993-08-06
HU195731B (en) 1988-07-28
EP0185347B1 (en) 1990-06-27
EP0185347A2 (en) 1986-06-25
MX166095B (es) 1992-12-18
DK583385A (da) 1986-06-18
ATE54050T1 (de) 1990-07-15
NO171826B (no) 1993-02-01
KR860004633A (ko) 1986-07-11
FI855032A (fi) 1986-06-18
AR241515A1 (es) 1992-08-31
PT81680B (pt) 1988-11-30
FI84781B (fi) 1991-10-15
US4803213A (en) 1989-02-07
NO855048L (no) 1986-06-18
AU5076285A (en) 1986-06-26
CN85109190A (zh) 1986-07-16
IE59158B1 (en) 1994-01-12
CA1255227A (en) 1989-06-06
CN1007209B (zh) 1990-03-21
FI84781C (fi) 1992-01-27
YU45292B (en) 1992-05-28
RU1811401C (ru) 1993-04-23
FI855032A0 (fi) 1985-12-17
AU579431B2 (en) 1988-11-24
ZA859390B (en) 1986-08-27
BA98214B1 (bs) 1999-08-02
KR930007251B1 (ko) 1993-08-04
DK167171B1 (da) 1993-09-13
HUT40567A (en) 1987-01-28
JPS61143316A (ja) 1986-07-01
DK583385D0 (da) 1985-12-16
PT81680A (en) 1986-01-01
DE3578373D1 (de) 1990-08-02
NO171826C (no) 1993-05-12
IE853176L (en) 1986-06-17

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