JP2001517625A5 - - Google Patents

Download PDF

Info

Publication number
JP2001517625A5
JP2001517625A5 JP2000512541A JP2000512541A JP2001517625A5 JP 2001517625 A5 JP2001517625 A5 JP 2001517625A5 JP 2000512541 A JP2000512541 A JP 2000512541A JP 2000512541 A JP2000512541 A JP 2000512541A JP 2001517625 A5 JP2001517625 A5 JP 2001517625A5
Authority
JP
Japan
Prior art keywords
active ingredient
pellets
water
tablet
diffusion
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.)
Pending
Application number
JP2000512541A
Other languages
English (en)
Other versions
JP2001517625A (ja
Filing date
Publication date
Application filed filed Critical
Priority claimed from PCT/EP1998/005842 external-priority patent/WO1999015172A1/de
Publication of JP2001517625A publication Critical patent/JP2001517625A/ja
Publication of JP2001517625A5 publication Critical patent/JP2001517625A5/ja
Pending legal-status Critical Current

Links

Description

被覆活性成分ペレットの場合に、拡散ペレットは50−90%(w/w)の活性成分ペレット、好ましくは60−95%(w/w)を含む。活性成分の高用量(各用量当たりベタインの≧400mg)のために、特に好ましくは70−95%(w/w)の活性成分ペレットを含むものである。これらの活性成分ペレットは70−99.5%(w/w)の活性成分と0.5−30%(w/w)の結合剤、特に好ましくは80−99.5%(w/w)の活性成分と0.5−20%(w/w)の結合剤を含む。活性成分の高用量のために、特に好ましい例は活性成分層は90−99.5%(w/w)の活性成分と0.5−10%(w/w)の結合剤であり、そして、もし適当なら更なる添加剤(微細結晶セルロース、熱可塑性ポリマー、他の薬学的通常の助剤)を含むものである。
この方法で製造されたペレットは、5−50%(w/w)の量の拡散コートまたは拡散層でコートされる。その拡散コートまたは拡散層は、コートの量に基づくが、40−90%(w/w)、好ましくは50−85%(w/w)、特に好ましくは60−85%(w/w)のフィルム形成剤(フィルム形成ポリマー、例えばエチルセルロース(AquacoatTM またはSureleaseTM)、アクリレート(EudragitTM)、セルロースアセテート、セルロースアセテートブチレート)、0−50%(w/w)、好ましくは0−35%(w/w)、特に好ましくは0−25%(w/w)または5−25%(w/w)の範囲の細穴形成剤(可溶性ポリマー、例えば、ポリエチレングリコール、ポリビニルピロリドン、ヒドロキシプロピルメチルセルロース、カルボキシメチルセルロースまたはその塩、メチルセルロース、デキストリン、マルトデキストリン、シクロデキストリン、デキストラン、または他の可溶化物、例えば塩(普通の塩、塩化カリウム、塩化アンモニアなど)、尿素、糖(ブドウ糖、蔗糖、果糖、乳糖など)、糖アルコール(マンニトール、ソルビトール、ラクチトールなど)、そして5−50%(w/w)、好ましくは5−35%(w/w)、特に好ましくは10−35%(w/w)の範囲の可塑剤を含む。
本発明の活性成分の放出を制御する薬物製剤の更なる具体化物では、活性成分を水膨潤性ポリマーのマトリックス中に含む製剤が用いられる。この製剤は錠剤の形が好ましい。
これらの所謂マトリックス中に含む製剤は重量で30−70%、好ましくは40−60%活性成分を含む。
水膨潤性ポリマーのマトリックスの重量割合は30−50%、好ましくは30−40%である。
更に好ましくはerosion 錠剤形の本発明の薬物製剤である。この錠剤は通常の助剤、キャリアー、錠剤用助剤の他に、一定の量の水膨潤性ハイドロゲル形成ポリマー(これらのポリマーは少なくとも15、好ましくは50mPa.s(20℃で2%強度の水溶液として測定)の粘度を有していなければならない。)を含んでいることを特徴としている。
浸透圧薬物放出システム薬物製剤は好ましくは、
a) 活性成分と所望により親水性ポリマー性膨潤剤と所望により浸透(osmosis)を誘導する水溶性物質を含む核(core)、および
b) 活性成分含有核の成分にとって水浸透性および非浸透性である殻(shell)
c) 核に含まれている成分の周囲の水溶性体液への移送のためのb)への開口部からなる。

この特定の浸透圧薬物放出システムは原理的には先行技術、例えばDE−A−2328409またはUS−A−3845770に記載されている。核の成分に関しては本文で述べるEP−A−0277092、US−A−3916899とUS−A−3977404が参照される。
JP2000512541A 1997-09-25 1998-09-15 活性成分放出制御薬物製剤 Pending JP2001517625A (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE19742243 1997-09-25
DE19742243.8 1997-09-25
PCT/EP1998/005842 WO1999015172A1 (de) 1997-09-25 1998-09-15 Arzneimittelformulierung mit kontrollierter wirkstofffreisetzung

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2010058157A Division JP2010163455A (ja) 1997-09-25 2010-03-15 活性成分放出制御薬物製剤

Publications (2)

Publication Number Publication Date
JP2001517625A JP2001517625A (ja) 2001-10-09
JP2001517625A5 true JP2001517625A5 (ja) 2009-09-17

Family

ID=7843534

Family Applications (2)

Application Number Title Priority Date Filing Date
JP2000512541A Pending JP2001517625A (ja) 1997-09-25 1998-09-15 活性成分放出制御薬物製剤
JP2010058157A Withdrawn JP2010163455A (ja) 1997-09-25 2010-03-15 活性成分放出制御薬物製剤

Family Applications After (1)

Application Number Title Priority Date Filing Date
JP2010058157A Withdrawn JP2010163455A (ja) 1997-09-25 2010-03-15 活性成分放出制御薬物製剤

Country Status (37)

Country Link
US (1) US6270799B1 (ja)
EP (1) EP1017392B1 (ja)
JP (2) JP2001517625A (ja)
KR (1) KR100531065B1 (ja)
CN (3) CN1895233A (ja)
AR (3) AR013967A1 (ja)
AT (1) ATE220547T1 (ja)
AU (1) AU731693B2 (ja)
BG (1) BG64745B1 (ja)
BR (1) BR9812553B1 (ja)
CA (1) CA2304135C (ja)
CO (1) CO5011082A1 (ja)
CZ (1) CZ293062B6 (ja)
DE (1) DE59804823D1 (ja)
DK (1) DK1017392T3 (ja)
ES (1) ES2179533T3 (ja)
GT (1) GT199800152A (ja)
HK (1) HK1032010A1 (ja)
HN (1) HN1998000144A (ja)
HU (1) HU226583B1 (ja)
ID (1) ID24259A (ja)
IL (1) IL134591A0 (ja)
MY (1) MY129437A (ja)
NO (1) NO327492B1 (ja)
NZ (1) NZ503538A (ja)
PE (1) PE20000224A1 (ja)
PL (1) PL192273B1 (ja)
PT (1) PT1017392E (ja)
SI (1) SI1017392T1 (ja)
SK (1) SK283462B6 (ja)
SV (1) SV1998000119A (ja)
TR (1) TR200000752T2 (ja)
TW (1) TW523412B (ja)
UA (1) UA66812C2 (ja)
UY (1) UY25192A1 (ja)
WO (1) WO1999015172A1 (ja)
ZA (1) ZA988718B (ja)

Families Citing this family (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AR020661A1 (es) * 1998-09-30 2002-05-22 Alcon Lab Inc Una composicion farmaceutica topica oftalmica, otica o nasal y el uso de la misma para la manufactura de un medicamento
US6509327B1 (en) 1998-09-30 2003-01-21 Alcon Manufacturing, Ltd. Compositions and methods for treating otic, ophthalmic and nasal infections
US6395746B1 (en) 1998-09-30 2002-05-28 Alcon Manufacturing, Ltd. Methods of treating ophthalmic, otic and nasal infections and attendant inflammation
US6716830B2 (en) 1998-09-30 2004-04-06 Alcon, Inc. Ophthalmic antibiotic compositions containing moxifloxacin
DE10031043A1 (de) * 2000-06-26 2002-02-14 Bayer Ag Retardzubereitungen von Chinolonantibiotika und Verfahren zu ihrer Herstellung
US20030091634A1 (en) * 2001-09-14 2003-05-15 Pawan Seth Delayed release tablet of venlafaxin
EP1482910A1 (en) * 2002-03-05 2004-12-08 Ranbaxy Laboratories, Ltd. Modified release oral pharmaceutical composition
ITMI20020515A1 (it) * 2002-03-12 2003-09-12 Jagotec Ag Sistema per il rilasco controllato di uno o piu' principi attivi
US7125563B2 (en) * 2002-04-12 2006-10-24 Dava Pharmaceuticals, Inc. Sustained release pharmaceutical preparations and methods for producing the same
US20050031683A1 (en) * 2003-08-04 2005-02-10 Ashish Kapoor Solid pharmaceutical composition
ATE399536T1 (de) * 2003-12-04 2008-07-15 Pfizer Prod Inc Verfahren zur herstellung von pharmazeutischen multiteilchenförmigen produkten
GB2409204A (en) * 2003-12-19 2005-06-22 Reckitt Benckiser Nv Plasticized thermoplastic polymer
PT1868581E (pt) * 2005-04-11 2012-06-22 Abbott Lab Composições farmacêuticas que possuem perfis de dissolução melhorados para fármacos pouco solúveis
WO2007033515A1 (fr) * 2005-09-21 2007-03-29 Shenzhen Tys R & D Co., Ltd. Formulation orale contenant de la moxifloxacine et son procédé de préparation
CN1762357B (zh) * 2005-09-21 2010-12-08 深圳市天一时科技开发有限公司 一种莫西沙星口服药物制剂及其制备方法
WO2007033522A1 (fr) * 2005-09-21 2007-03-29 Shenzhen Tys R & D Co., Ltd. Formulation de gélule contenant de la moxifloxacine et son procédé de préparation
US20110293717A1 (en) 2008-12-08 2011-12-01 Ratiopharm Gmbh Compacted moxifloxacin
ITTO20110705A1 (it) * 2011-07-29 2013-01-30 Italiana Sint Spa Procedimento di preparazione della moxifloxacina cloridrato e relativi intermedi
KR20200077712A (ko) 2018-12-21 2020-07-01 한미약품 주식회사 목시플록사신 고형 제제 및 이의 제조방법

Family Cites Families (26)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3485770A (en) 1967-03-02 1969-12-23 Atlantic Richfield Co Olefin polymerization catalyst based on aluminum pyrolate
US3865108A (en) 1971-05-17 1975-02-11 Ortho Pharma Corp Expandable drug delivery device
US3845770A (en) 1972-06-05 1974-11-05 Alza Corp Osmatic dispensing device for releasing beneficial agent
US4036227A (en) 1973-04-25 1977-07-19 Alza Corporation Osmotic releasing device having a plurality of release rate patterns
US3916899A (en) 1973-04-25 1975-11-04 Alza Corp Osmotic dispensing device with maximum and minimum sizes for the passageway
US4002173A (en) 1974-07-23 1977-01-11 International Paper Company Diester crosslinked polyglucan hydrogels and reticulated sponges thereof
US3977404A (en) 1975-09-08 1976-08-31 Alza Corporation Osmotic device having microporous reservoir
US4207893A (en) 1977-08-29 1980-06-17 Alza Corporation Device using hydrophilic polymer for delivering drug to biological environment
FR2471186A1 (fr) * 1979-12-10 1981-06-19 Roussel Uclaf Nouveaux comprimes a delitescence colique, ainsi que leur procede de preparation
US4503030A (en) * 1983-06-06 1985-03-05 Alza Corporation Device for delivering drug to certain pH environments
CH668187A5 (de) 1986-08-07 1988-12-15 Ciba Geigy Ag Therapeutisches system mit systemischer wirkung.
EP0277092B1 (de) 1987-01-14 1992-01-29 Ciba-Geigy Ag Therapeutisches System für schwerlösliche Wirkstoffe
SE8704097D0 (sv) * 1987-10-22 1987-10-22 Astra Ab Oral formulation of buspirone and salts thereof
DE3906365A1 (de) 1988-07-15 1990-01-18 Bayer Ag 7-(1-pyrrolidinyl)-3-chinolon- und -naphthyridoncarbonsaeure-derivate, verfahren sowie substituierte (oxa)diazabicyclooctane und -nonane als zwischenprodukte zu ihrer herstellung, und sie enthaltende antibakterielle mittel und futterzusatzstoffe
IT1246382B (it) * 1990-04-17 1994-11-18 Eurand Int Metodo per la cessione mirata e controllata di farmaci nell'intestino e particolarmente nel colon
JPH0624959A (ja) * 1991-10-04 1994-02-01 Bayer Yakuhin Kk 胃内浮遊型薬物徐放性固形製剤
TW209865B (ja) * 1992-01-10 1993-07-21 Bayer Ag
GB9217295D0 (en) * 1992-08-14 1992-09-30 Wellcome Found Controlled released tablets
US5520920A (en) 1992-08-28 1996-05-28 Alcon Laboratories, Inc. Use of certain anionic surfactants to enhance antimicrobial effectiveness of ophthalmic compositions
JP3220331B2 (ja) 1993-07-20 2001-10-22 エチコン・インコーポレーテツド 非経口投与用の吸収性液体コポリマー類
US5662933A (en) * 1993-09-09 1997-09-02 Edward Mendell Co., Inc. Controlled release formulation (albuterol)
US5473103A (en) 1993-12-16 1995-12-05 Yissum Research Development Co. Of The Hebrew University Of Jerusalem Biopolymers derived from hydrolyzable diacid fats
IE75744B1 (en) * 1995-04-03 1997-09-24 Elan Corp Plc Controlled release biodegradable micro- and nanospheres containing cyclosporin
US5654005A (en) 1995-06-07 1997-08-05 Andrx Pharmaceuticals, Inc. Controlled release formulation having a preformed passageway
DE19546249A1 (de) 1995-12-12 1997-06-19 Bayer Ag Neue Kristallmodifikation des 1-Cyclopropyl-7-([S,S]-2,8-diazabicyclo[4,3,0]non-8-yl)-6-fluor-1,4-dihydro-8-methoxy-4-oxo-3-chinolincarbonsäure Hydrochlorid (CDCH), Verfahren zu dessen Herstellung und diese enthaltende pharmazeutische Zubereitungen
US5874418A (en) * 1997-05-05 1999-02-23 Cydex, Inc. Sulfoalkyl ether cyclodextrin based solid pharmaceutical formulations and their use

Similar Documents

Publication Publication Date Title
JP2001517625A5 (ja)
US5997905A (en) Preparation of pharmaceutically active particles
CA1334382C (en) Osmotic continuous dispensing oral delivery system containing a pharmaceutically acceptable active agent having improved core membrane adhesion properties
EP0711146B1 (en) Osmotic device having a vapor-permeable coating
JP2010163455A (ja) 活性成分放出制御薬物製剤
ES2590479T3 (es) Sistemas de administración de fármacos que comprenden fármacos débilmente básicos y ácidos orgánicos
WO2011107855A2 (en) Sustained release oral liquid suspension dosage form
AU2006233567A1 (en) Therapeutic combination in case of benign prostate hyperplasia
CA1251731A (en) Sustained release tablets and method for preparation thereof
US9463166B2 (en) Controlled release compositions comprising a combination of isosorbide dinitrate and hydralazine hydrochloride
AU2015349896B2 (en) Pharmaceutical bead formulations comprising dimethyl fumarate
EP2173329A1 (en) Tolterodine bead
Karvekar et al. A brief review on sustained release matrix type drug delivery system
US20080069870A1 (en) Controlled Release Compositions Comprising a Cephalosporin for the Treatment of a Bacterial Infection
WO2008023390A2 (en) Modified release pharmaceutical composition of bupropion hydrochloride
HRP20240303T1 (hr) Osmotski oblici doziranja koji sadrže deutetrabenazin i postupci njihove upotrebe
WO2020180690A1 (en) Liquid pharmaceutical compositions with stable drug release profiles
CA1312016C (en) Osmotic continuous dispensing oral delivery system containing a moderately water-soluble metoprolol salt having improved core composition and use thereof
US20070087056A1 (en) Pharmaceutical form with sustained pH-independent active ingredient release for active ingredients having strong pH-dependent solubility
CA2476101A1 (en) Extended-release capsules comprising venlafaxine hydrochloride
KR930003113B1 (ko) 서방성 코팅 정제의 제조방법
KR20080031050A (ko) 높은 ph-의존성 용해도를 갖는 활성 성분에 대해 활성성분이 ph-비의존적으로 지연 방출되는 제약 제제
MXPA00002929A (en) Medicament formulation with a controlled release of an active agent
HU201883B (en) Process for producing orally administerable pharmaceutical compositions consisting of composite units and having controlled release of active ingredient