CN1069191A - 药用组合制剂 - Google Patents
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Abstract
一种固态口服剂型,它包括受控释放型的硫氮
酮(或其药学上可接受的盐)和正常释放型的双氢氯
噻嗪。优选的受控释放组分包括许多球体,该球体包
括硫氮酮和成球剂。
Description
本发明提供一种固态口服剂型,它包括受控释放型的硫氮 酮或其在药学上可接受的盐以及直接释放型的双氢***。
本发明剂型应用受控释放型的硫氮
酮或其在药学上可接受的盐。可用于本发明的已知受控释放***包括扩散、侵蚀或渗透受控传送***。溶解可以通过控制屏障速率或形成基质***。还介绍过能改良活性成分穿越屏障扩散的含可溶胀聚合物的受控释放基质。
侵蚀受控释放***通过缓慢溶解或分解基质传送活性成分。可以加入适宜的辅药,例如亲水凝胶型辅药或疏水辅药。在亲水基质中,活性成分的释放由与水或消化液接触形成的凝胶层所控制。此外,可使用疏水辅药即经其侵蚀控制释放速率。
在渗透***中,活性成分的传送由膜的渗透性以及核心基质产生的渗透压所控制。
此外,活性成分的释放还可受PH值或时间控制。
含于复控释放基质中的适宜材料包括:例如:
(a)亲水或疏水聚合物,例如树胶、纤维素酯、纤维素醚、蛋白质衍生的材料、尼龙、丙烯酸树脂、多元乳酸、聚氯乙烯、淀粉、聚乙烯吡咯烷酮、乙酸酞酸酯纤维素。这些聚合物中,纤维素醚最好是取代的纤维素醚,例如烷基纤维素和丙烯酸树脂(例如甲基丙烯酸酯,如甲基丙烯酸共聚物)是优选的。该受控释基质一般可含有1%至80%(重量)的亲水或疏水聚合物。
(b)可消化的长链(C8-C50,尤其是C8-C40)被取代的和未被取代的烃,例如脂肪酸、氢化植物油(如商标为Cutina)、脂肪醇、脂肪酸甘油酯如单硬脂酸甘油脂矿物油和蜡(例如蜂蜡、甘蜡、蓖麻蜡或巴西棕榈蜡)。以熔点为25℃至90℃的烃为优选。这些长链材料中,以脂肪(脂族的)醇为佳。该基质可含达60%(重量)至少一种可消化长链烃。
(c)聚二醇。该基质可含达60%(重量)至少一种聚二醇。
适宜的基质包括一种或多种纤维素醚或丙烯酸树脂,一种或多种C12-C36(优选C14-C22)脂族醇和/或一种或多种氢化植物油。
特别适宜的基质包括一种或多种烷基纤维素,一种或多种C12-C36(优选C14-C22)脂族醇和任意的一种或多种聚二醇。
纤维素醚最好是一种取代的纤维素醚,例如烷基纤维素,并且最好是一种取代的烷基纤维素,如乙基纤维素或羟基(C1至C6)烷基纤维素,例如羟丙基纤维素、羟丙基甲基纤维素酞酸酯和特别是羟乙基纤维素。该基质含有纤维素醚的量,优选2%至60%(重量),尤以3%至50%(重量)为佳。
丙烯酸树脂最好是一种甲基丙烯酸树脂,例如甲基丙烯酸共聚物USNF A型(商标为Eudragit L)、B型(商标为Eudragit S)、C型(商标为Eudragit L 100-55)、Eudragit NE 300、Eudragit E、Eudragit RL和Eudragit RS。该基质含丙烯酸树脂的量优选2%至60%(重量),以30%至50%(重量)为佳。
脂族醇可以是例如十二烷基醇、十四烷基醇、或十八烷基醇、但是最好为十六烷基醇或十八醇十六醇混合物。脂族醇或氢化植物油的量由硫氮)酮释放所需的精确速率以及聚二醇是否存在来确定。当聚二醇不存在时,该基质含脂族醇优选8%至40%,尤以12%至36%(重量)为佳。当口服剂型中存在聚二醇时,那么脂族醇和聚二醇的组合重量占基质的2%至40%(重量)为好,最好为8%至36%(重量)。
聚二醇可以是例如聚丙二醇,或最好是聚乙二醇。至少一种聚二醇的数均分子量优选200至1500,尤以400至12000为佳。
除上述成分之外,受控释放基质还可含适量的其它材料,例如稀释剂、润滑剂、粘合剂、成粒辅剂、着色剂、表面活化剂、抗粘剂、香味剂和助流剂,这些是药学中的常规成分。
在本发明最佳实施例中,受控释放组分包括许多小珠,该小珠包含硫氮)酮或其药学上可接受的盐还可包含小珠成形剂。
术语“小珠”在制药技术中是常用的,意思是指直径为0.1至2.5毫米、尤其是0.5至2毫米的球形颗粒,其内所包含的是由涂覆活性成分的赋形剂组成的惰性核。适宜的惰性赋形剂包括蔗糖、淀粉和微晶纤维素,然而,优选的小珠包括由活性成分和可选的成球剂组成的球体。
所述小珠含硫氮
酮及其在药学上可接受盐的量优选为40%至98%,较好为60%至85%,最好为70%至85%。
成球剂可以是任意适宜的药学上可接受的材料,它可与活性成分一起成球,形成球状核。优选的成球剂是微晶纤维素,所用的微晶纤维素可以是,例如阿维塞尔PH 101或阿维塞尔PH102(商品名,FMC公司)。一般来说,当存在成球剂时,它占球状核的1%至60%(重量),最好为15%至40%(重量)。
此外,所述球体还可含有粘合剂。可以采用的适宜粘合剂是众所周知的,它包括亲水聚合物或水解胶体。例如纤维素聚合物,尤其是纤维素醚、丙烯酸树脂和树胶。水溶性羟基低级烷基纤维素(例如羟丙基纤维素)是最佳的。粘合剂存在的量最好占球状核的1%至40%(重量)。
球状核还可含有其它药学上可接受赋形剂和稀释剂。使之易于成球,例如用糖(如蔗糖、右旋糖、麦芽糖或乳糖)或糖醇(例如甘露醇、木糖醇或山梨糖醇)。在球状核中还可含有着色剂。
球状核最好是涂覆允许硫氮
酮在水性介质中控制速率释放的膜,适宜的涂膜材料可包括水不溶蜡和聚合物,例如聚甲基丙烯酸酯(例如商标为Eudragit的聚合物)或优选水不溶纤维素,特别是乙基纤维素。这膜涂层还可含水溶性聚合物,例如聚乙烯吡咯烷酮或最好是水溶性纤维素,例如羟丙基甲基纤维素和羟丙基纤维素。应当理解,水不溶材料与水溶性材料的比率取决于所要求的释放速度和所选材料的溶解度,水溶性聚合物与水不溶聚合物的比率以1∶20至1∶2为佳。受控释放涂层优选包括一种或多种本领域的常规增塑剂,例如酞酸二乙酯,但最好是癸二酸二丁酯;表面活性剂,例如山梨聚糖三油酸酯山梨聚糖单月桂酸酯或优选多乙氧基醚80(商标为Tween80)和胶粘改性剂,例如滑石粉或优选胶质无水硅石。
当存在增塑剂时,其含量将取决于所选的特定增塑剂,一般,增塑剂的量为受控释放膜涂层的1%至25%(重量)。当存在表面活性剂时,其适宜存在量为受控膜涂层的1%至25%(重量)当存在胶粘改性剂时,其存在量也以受控释放膜涂层的1%至25%(重量)为宜。
优选的受控释放膜涂层包括50%至95%乙基纤维素,5%至15%胶质无水硅石,5%至15%癸二酸二丁酯和5%至15%多乙氧基醚80(商标为Tween 80)。
采用传统涂覆方法例如流化床或槽式涂覆,可在含硫氮
酮的球状核的表面形成受控释放涂膜层。该涂层材料可应用溶液或悬浮液,适宜的溶剂***包括水、二氯甲烷、乙醇、甲醇、异丙醇和丙酮及其混合物。涂覆溶液或悬浮液优选含2%至60%(重量)、最好含2%至20%(重量)涂覆材料。
受控释放涂覆材料的用量取决于所要求的释放速率,但是一般为受控释放涂覆球体的1%至25%(重量),最好为2%至8%(重量)。
(b)挤压成粒混合物,得到挤出物;
(c)将挤出物成球,直至形成球状核;
(d)干燥球状核,并且可选地
(e)膜涂敷球状核。
通常,双氢***外涂层包括水溶性亲水聚合物,例如纤维素醚(例如羟丙基纤维素或羟丙基甲基纤维素)、聚乙烯吡咯烷酮或合成生物聚合胶。聚合物与双氢***的比率优选10∶1至1∶10。还可选用其它涂覆赋形剂,例如增塑剂、表面活性剂、胶粘改性剂、遮光剂和着色剂。双氢***与赋形剂的比例最好为10∶1至1∶10。
采用传统的涂覆技术,例如流化床涂覆或槽式涂覆,可在含硫氮
酮的受控释放球体上形成含双氢***的外涂层。用于涂覆溶液的适宜溶剂包括水、乙醇、甲醇、异丙醇或二氯甲烷。应当理解,在涂覆溶液中涂覆材料的量取决于药物与聚合物的比率以及该溶液的粘度,通常,所述涂覆溶液含涂覆材料为1%至60%(重量)。
本发明的剂型中,硫氮
酮与双氢***的重量比一般约为30∶1至4∶1,最好为20∶1至6∶1。本发明的剂型适合于每天1次或2次给药。一般每天一次给药,所述剂型含120-480毫克硫氮
酮或其药学上可接受的盐(优选硫氮 酮盐酸盐)和6.25-25毫克双氢***。本发明优选的剂型为每天一次给药,它含有150毫克硫氮 酮盐酸盐和12.5毫克双氢***。
就每天2次给药而言,该剂型一般含60-240毫克硫氮
酮或其药学上可接受的盐(优选硫氮
酮盐酸盐)和3.125-12.5毫克双氢***。用于每天2次给药的优选剂型含有75毫克硫氮
酮盐酸盐和6.25毫克双氢***。
采用传统制药技术可将本发明组合物填充制成胶囊或压制成片剂。
为了更好地理解本发明,给出下述实施例,仅为说明而已。
实施例1
制备具有下述配方的胶囊
材料 毫克
微晶纤维素E.P(Avicel PH101) 37.5
蒸馏水E.P 适量
187.5
受控释放膜涂层
材料 毫克
乙基纤维素N10 U.S.N.F 9.225
胶质无水硅石E.P.(Aerosil 130) 1.235
癸二酸二丁酯U.S.N.F. 0.928
多乙氧基醚80 E.P.(Tween80) 0.989
二氯甲烷BS 1994 适量
甲醇B.P.1973 适量
200
双氢***膜涂层
材料 毫克
硫氮
酮盐酸盐受控
释放涂膜球体 200
双氢***E.P. 12.5
羟丙基甲基纤维素5 CPS E.P.
(Methocel E5) 2.5
蒸馏水 适量
215
采用高剪切混合器混合硫氮
酮和微晶纤维素,该混合是湿式成粒,挤压后得到 挤出物,成粒并置于流化床干燥器中干燥,所得球体过筛,得到粒经为0.85-1.7毫米。
将受控释放涂膜成分分散在二氯甲烷/甲醇溶剂体系中,应用到流化床涂敷器内的硫氮
酮球状核上,得到的涂膜球体过筛,然后,在流化床涂覆器中,将含硫氮
酮受控释放球体用双氢***和羟丙基甲基纤维素的分散体涂膜。
通过EP篮式装置(100转/分),用PH4.5EP磷酸盐缓冲液测定所得产品的溶解度。所得结果如下:
双氢***溶解度
10分钟 100%
时间(小时) 双氢***球体(%)
1 8
2 20
3 32
4 41
5 50
6 57
8 66
10 73
12 77
15 83
实施例2
还制备了具有下述配方的受控释放硫氮
酮核芯。
(ⅰ)材料 毫克
乳糖 E.P. -
羟乙基纤维素 E.P. 45.0
聚乙烯吡咯烷酮K25 B.P. 10.0
蒸馏水 E.P. N.D
十八醇十六醇混合物B.P. 30.0
纯滑石粉 E.P. 6.0
硬脂酸镁 E.P. 6.0
总重量(mg) 217.0
材料 毫克
微晶纤维素 E.P. 44.5
胶质无水硅石 E.P. 20.0
Eudragit NE400 80.0*
十八醇十六醇混合物B.P. 52.5
硬脂酸镁 E.P. 3.0
总重量(mg) 320.0
*毫克固体
Claims (15)
1、一种固态口服剂型,它包括受控释放型的硫氮
酮或其药学上可接受的盐;直接释放型的双氢***。
4、根据权利要求2或3的任一项剂型,其中,所述受控释放组分包括许多球体,所述球体包括硫氮
酮或其药学上可接受的盐和成球剂。
5、根据权利要求4的剂型,其中,所述成球剂包括微晶纤维素。
6、根据权利要求4或5的剂型,其中,所述成球剂的量为球状核的15%至40%(重量)。
7、根据权利要求4至6的任一项剂型,所述球体用受控释放涂膜材料涂覆。
8、根据权利要求7的剂型,其中,所述涂膜材料包括水不溶性聚合物。
9、根据权利要求7或8的剂型,其中,所述涂膜材料包括乙基纤维素。
10、根据权利要求7至9的任一项剂型,所述涂膜材料还包括一种或多种增塑剂、表面活性剂和胶粘改性剂。
11、根据权利要求10的剂型,其中,所述涂膜材料包括50%至95%乙基纤维素,5%至15%胶质无水硅石,5%至15%癸二酸二丁酯和5%至15%多乙氧基醚80。
13、根据权利要求1至12任一项的剂型,其特征在于所述硫氮 酮式其药学上可接受的盐与双氢***的重量比为30∶1至4∶1。
15、一种胶囊,它包含权利要求1至14任一项的剂型。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
GB9117361.7 | 1991-08-12 | ||
GB919117361A GB9117361D0 (en) | 1991-08-12 | 1991-08-12 | Oral dosage form |
Publications (1)
Publication Number | Publication Date |
---|---|
CN1069191A true CN1069191A (zh) | 1993-02-24 |
Family
ID=10699854
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN92109398A Pending CN1069191A (zh) | 1991-08-12 | 1992-08-12 | 药用组合制剂 |
Country Status (14)
Country | Link |
---|---|
US (1) | US5508044A (zh) |
EP (1) | EP0527638A1 (zh) |
JP (1) | JPH05201866A (zh) |
KR (1) | KR930003905A (zh) |
CN (1) | CN1069191A (zh) |
AU (1) | AU658209B2 (zh) |
CA (1) | CA2075355A1 (zh) |
FI (1) | FI923581A (zh) |
GB (1) | GB9117361D0 (zh) |
IL (1) | IL102777A (zh) |
IN (2) | IN173839B (zh) |
NO (1) | NO300797B1 (zh) |
PH (1) | PH30666A (zh) |
ZA (2) | ZA926020B (zh) |
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CN1103592C (zh) * | 1996-05-22 | 2003-03-26 | 永光制药有限公司 | 含有2-(苯基亚氨基)-3-苯基-1,3-全氢噻嗪的药物组合物及其应用和制备方法 |
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JPH08143450A (ja) * | 1994-11-14 | 1996-06-04 | Taiyo Yakuhin Kogyo Kk | 徐放化製剤 |
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FR2771291B1 (fr) * | 1997-11-21 | 2000-02-25 | Ethypharm Lab Prod Ethiques | Spheroides, procede de preparation et compositions pharmaceutiques |
PT1041987E (pt) | 1997-12-22 | 2006-07-31 | Euro Celtique Sa | Forma farmaceutica de dosagem oral, compreendendo uma combinacao de um agonista de opioide e naltrexona |
US6375957B1 (en) | 1997-12-22 | 2002-04-23 | Euro-Celtique, S.A. | Opioid agonist/opioid antagonist/acetaminophen combinations |
US6524620B2 (en) | 1998-07-20 | 2003-02-25 | Andrx Pharmaceuticals, Inc. | Diltiazem controlled release formulation and method of manufacture |
US6039979A (en) * | 1999-01-13 | 2000-03-21 | Laboratoires Prographarm | Multiparticulate pharmaceutical form with programmed and pulsed release and process for its preparation |
FR2794646B1 (fr) * | 1999-06-09 | 2001-09-21 | Ethypharm Lab Prod Ethiques | Microgranules de sulfate de morphine, procede de preparation et composition les contenant |
US6569456B2 (en) * | 2000-01-13 | 2003-05-27 | Osmotica Corp. | Osmotic device containing diltiazem and an ACE inhibitor or diuretic |
GB0007419D0 (en) † | 2000-03-27 | 2000-05-17 | Smithkline Beecham Gmbh | Composition |
GB0025208D0 (en) * | 2000-10-13 | 2000-11-29 | Euro Celtique Sa | Delayed release pharmaceutical formulations |
EP1387673B1 (en) | 2001-05-11 | 2010-12-29 | Endo Pharmaceuticals Inc. | Abuse-resistant controlled-release opioid dosage form |
ES2733051T1 (es) * | 2002-04-05 | 2019-11-27 | Euro Celtique Sa | Matriz para liberación sostenida, invariable e independiente de compuestos activos |
AU2003225102A1 (en) * | 2002-04-23 | 2003-11-10 | Bristol-Myers Squibb Company | Modified-release vasopeptidase inhibitor formulation, combinations and method |
WO2004112756A1 (en) | 2003-06-26 | 2004-12-29 | Isa Odidi | Proton pump-inhibitor-containing capsules which comprise subunits differently structured for a delayed release of the active ingredient |
SI21637A (sl) * | 2003-12-23 | 2005-06-30 | LEK farmacevtska dru�ba d.d. | Farmacevtska oblika z nadzorovanim sproščanjem |
EP1604666A1 (en) | 2004-06-08 | 2005-12-14 | Euro-Celtique S.A. | Opioids for the treatment of the Chronic Obstructive Pulmonary Disease (COPD) |
US8394409B2 (en) | 2004-07-01 | 2013-03-12 | Intellipharmaceutics Corp. | Controlled extended drug release technology |
US10624858B2 (en) | 2004-08-23 | 2020-04-21 | Intellipharmaceutics Corp | Controlled release composition using transition coating, and method of preparing same |
US20080096979A1 (en) * | 2004-11-08 | 2008-04-24 | Rubicon Research Pvt. Ltd. | Aqueous Pharmaceutical Coating |
EP1702558A1 (en) | 2005-02-28 | 2006-09-20 | Euro-Celtique S.A. | Method and device for the assessment of bowel function |
US10064828B1 (en) | 2005-12-23 | 2018-09-04 | Intellipharmaceutics Corp. | Pulsed extended-pulsed and extended-pulsed pulsed drug delivery systems |
CA2648280C (en) * | 2006-04-03 | 2014-03-11 | Isa Odidi | Controlled release delivery device comprising an organosol coat |
US10960077B2 (en) | 2006-05-12 | 2021-03-30 | Intellipharmaceutics Corp. | Abuse and alcohol resistant drug composition |
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CA2703365A1 (en) * | 2007-10-25 | 2009-04-30 | Yuka Yamanouchi | Nifedipine-containing press coated tablet and method of preparing the same |
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-
1991
- 1991-08-12 GB GB919117361A patent/GB9117361D0/en active Pending
-
1992
- 1992-08-04 KR KR1019920013983A patent/KR930003905A/ko not_active Application Discontinuation
- 1992-08-05 IN IN476MA1992 patent/IN173839B/en unknown
- 1992-08-05 CA CA002075355A patent/CA2075355A1/en not_active Abandoned
- 1992-08-05 IN IN475MA1992 patent/IN173847B/en unknown
- 1992-08-06 AU AU20879/92A patent/AU658209B2/en not_active Ceased
- 1992-08-10 IL IL10277792A patent/IL102777A/en not_active IP Right Cessation
- 1992-08-10 PH PH44789A patent/PH30666A/en unknown
- 1992-08-10 JP JP4234294A patent/JPH05201866A/ja active Pending
- 1992-08-11 EP EP19920307334 patent/EP0527638A1/en not_active Ceased
- 1992-08-11 ZA ZA926020A patent/ZA926020B/xx unknown
- 1992-08-11 NO NO923127A patent/NO300797B1/no unknown
- 1992-08-11 ZA ZA926019A patent/ZA926019B/xx unknown
- 1992-08-11 FI FI923581A patent/FI923581A/fi not_active Application Discontinuation
- 1992-08-12 CN CN92109398A patent/CN1069191A/zh active Pending
-
1994
- 1994-07-22 US US08/279,062 patent/US5508044A/en not_active Expired - Fee Related
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1103592C (zh) * | 1996-05-22 | 2003-03-26 | 永光制药有限公司 | 含有2-(苯基亚氨基)-3-苯基-1,3-全氢噻嗪的药物组合物及其应用和制备方法 |
Also Published As
Publication number | Publication date |
---|---|
ZA926020B (en) | 1993-03-10 |
IN173847B (zh) | 1994-07-23 |
EP0527638A1 (en) | 1993-02-17 |
NO923127L (no) | 1993-02-15 |
US5508044A (en) | 1996-04-16 |
CA2075355A1 (en) | 1993-02-13 |
NO300797B1 (no) | 1997-07-28 |
FI923581A (fi) | 1993-02-13 |
PH30666A (en) | 1997-09-16 |
GB9117361D0 (en) | 1991-09-25 |
IL102777A (en) | 1996-05-14 |
AU2087992A (en) | 1993-02-18 |
NO923127D0 (no) | 1992-08-11 |
KR930003905A (ko) | 1993-03-22 |
JPH05201866A (ja) | 1993-08-10 |
IN173839B (zh) | 1994-07-23 |
FI923581A0 (fi) | 1992-08-11 |
AU658209B2 (en) | 1995-04-06 |
ZA926019B (en) | 1993-03-10 |
IL102777A0 (en) | 1993-01-31 |
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