CN1156270C - 固体剂型的生产方法 - Google Patents
固体剂型的生产方法 Download PDFInfo
- Publication number
- CN1156270C CN1156270C CNB988134233A CN98813423A CN1156270C CN 1156270 C CN1156270 C CN 1156270C CN B988134233 A CNB988134233 A CN B988134233A CN 98813423 A CN98813423 A CN 98813423A CN 1156270 C CN1156270 C CN 1156270C
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- Prior art keywords
- acid
- ester
- vinyl
- copolymer
- desired method
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Abstract
本发明涉及通过混合至少一种聚合物粘合剂、至少一种活性成分及任选的常规添加剂形成塑料混合物并将该混合物成型得到固体剂型,使用N-乙烯基内酰胺和带有疏水基团的共聚单体的共聚物作为聚合物粘合剂制备固体剂型的方法。以简单且低成本的方法得到缓慢释放活性成分的剂型。
Description
本发明涉及通过混合至少一种聚合物粘合剂、至少一种活性成分及必要时的常规添加剂形成塑料混合物并将该混合物成型来生产固体剂型的方法。本发明特别涉及生产固体药物剂型的方法。
生产固体药物剂型,特别是片剂的经典方法是分批进行的并且包括许多步骤。因此药物颗粒代表重要的中间体。例如在Bauer,Frommig和Fuhrer的《药物技术》,Georg-Thieme-Verlag,292以后各页中显而易见药物剂型可通过干燥造粒由熔体获得。说明了通过熔融和震动凝固、通过浇铸和粉碎或者通过在喷雾塔中造粒来生产固化熔融颗粒的可能性。这些方法的一个问题是生产药物所必须的精确成型。生产出的是不规则的颗粒或碎片,以致所得形状不可能符合常规药物剂型,因此颗粒本身作为药物剂型的重要性几乎为零。生产所要求的固体药物剂型要求使用诸如在压片机中压制的进一步加工步骤。这是耗时且昂贵的。一种生产固体药物剂型的更简单的连续方法已问世有日并且要求挤塑含有活性成分的聚合物粘合剂的无溶剂熔体,将挤出物成型为所要求的药物剂型,例如在带有成型辊的压延机中,见EP-A-240904,EP-A-240 906,EP-A-337 256和EP-A-358 105(熔融挤塑)。以这种方式可以获得特殊形状。所用聚合物粘合剂特别为N-乙烯基吡咯烷酮聚合物或其与例如乙酸乙烯酯的共聚物。
基于这种聚合物的剂型的缺点是它们释放活性成分较快。因此不采取另外的方法,如施涂控制其释放的涂层是不可能生产缓释剂型的。
本发明的目的是提供可由熔融挤塑制备并且能缓慢释放活性成分的剂型。
我们发现此目的可通过使用N-乙烯基内酰胺和带有疏水基团的可共聚单体的共聚物作为聚合物粘合剂而实现。
因此本发明涉及通过混合至少一种聚合物粘合剂、至少一种活性成分及必要时的常规添加剂形成塑料混合物并将该混合物成型来生产固体剂型的方法,其中所用聚合物粘合剂是式I的N-乙烯基内酰胺和至少一种带有疏水基团的可共聚单体的共聚物:
其中n为1,2或3。
根据本发明的方法可以生产以简单且低成本方式缓慢释放(持续释放)活性成分的固体剂型。
此处剂型表示适于用作药物、植物处理组合物、人及动物食物以及释放芳香剂和芳香油的所有形式。它们包括例如任何形状的片剂、丸剂、颗粒,以及较大的剂型如立方体、块(砖)或圆筒形式,可特别用作人或动物的食物。
根据本发明可获得的剂型一般包括:
a)0.1-90wt%,特别是0.1-60wt%(基于剂型的总重量)的活性成分,
b)10-99.9wt%,特别是40-99.9wt%的聚合物粘合剂和
c)必要时的添加剂。
用作粘合剂的共聚物特别包括式II化合物的单元作为疏水共聚单体:
其中R1为氢原子或甲基,X为O,NH或NR2,R2为C1-C30-烷基,并且R3为C8-C30-烷基、C8-C30-环烷基或C8-C30-烯基。因此共聚单体包括带有疏水C8-C30-烷基、C8-C30-环烷基或C8-C30-烯基的(甲基)丙烯酸酯或(甲基)丙烯酰胺。R2优选为C1-C18-烷基而R3为C8-C18-烷基或C8-C18-烯基。
适宜的丙烯酸酯和甲基丙烯酸酯的实例为丙烯酸辛酯、丙烯酸-2-乙基己酯、丙烯酸壬酯、丙烯酸癸酯、丙烯酸月桂酯、丙烯酸肉豆蔻酯、丙烯酸鲸蜡酯、丙烯酸硬脂酯、丙烯酸油酯、丙烯酸山萮酯、甲基丙烯酸己酯、甲基丙烯酸辛酯、甲基丙烯酸壬酯、甲基丙烯酸癸酯、甲基丙烯酸月桂酯、甲基丙烯酸肉豆蔻酯、甲基丙烯酸鲸蜡酯、甲基丙烯酸硬脂酯、甲基丙烯酸油酯、甲基丙烯酸山萮酯和丙烯酸叔丁基环己酯。
可使用的丙烯酰胺和甲基丙烯酰胺的实例为N一硬脂基丙烯酰胺、N-硬脂基甲基丙烯酰胺、N-辛基丙烯酰胺、N,N-二辛基丙烯酰胺、N,N-二壬基甲基丙烯酰胺、N-鲸蜡基丙烯酰胺、N-鲸蜡基甲基丙烯酰胺、N-十二烷基丙烯酰胺、N-十二烷基甲基丙烯酰胺、N-肉豆蔻基丙烯酰胺和2-乙基己基丙烯酰胺。
特别优选的共聚物包括丙烯酸的或甲基丙烯酸乙基己基酯、月桂基酯、肉豆蔻基酯、鲸蜡基酯、硬脂基酯、油基酯或山萮基酯单元。
聚合物粘合剂还可包括脂族C8-C30-羧酸,特别是C8-C18-羧酸的乙烯基酯作为带有疏水基团的单体。可以使用例如癸酸、月桂酸、肉豆蔻酸、棕榈酸、硬脂酸、油酸和山俞酸的乙烯基酯。
聚合物粘合剂当然也可以包括任何需要的所述单体单元的混合物。
聚合物粘合剂包含50-99mol%,优选70-99mol%,且特别是90-99mol%N-乙烯基内酰胺单元。它包含1-50mol%,优选1-30mol%,且特别是1-10mol%带有疏水基团的单体单元。
此外,聚合物粘合剂还可包含用量为0.5-48wt%,优选0.5-20wt%,且特别是0.5-10wt%的其它可共聚单体(其它共单体)单元。其它适宜的共单体特别为含有3-8个碳原子的单烯键式不饱和羧酸,如丙烯酸、甲基丙烯酸、二甲基丙烯酸、ethacrylic acid、马来酸、柠康酸、亚甲基丙二酸、烯丙基乙酸、乙烯基乙酸、巴豆酸、富马酸、中康酸和表康酸,以及所述二元羧酸与C1-C18-链烷醇的单酯。丙烯酸、甲基丙烯酸、马来酸或所述羧酸的混合物是优选的。单烯键式不饱和羧酸可以游离酸及可能的酸酐或部分或完全中和的形式使用。中和反应优选与碱金属或碱土金属碱、氨或胺进行,例如氢氧化钠、氢氧化钾、碳酸钠、碳酸钾、碳酸氢钠、氧化镁、氢氧化钙、氧化钙、气态或水溶液氨、三乙胺、乙醇胺、二乙醇胺、吗啉、二亚乙基三胺或四亚乙基五胺。
适宜共单体的另外实例为上述羧酸与C1-C6-链烷醇、C1-C4-二醇、单及二-C1-C4-烷基氨基-C1-C4-链烷醇的酯,酰胺,单及二-C1-C4-烷基酰胺以及这些羧酸的腈,例如丙烯酸甲酯、丙烯酸乙酯、甲基丙烯酸甲酯、甲基丙烯酸乙酯、丙烯酸羟乙酯、丙烯酸羟丙酯、丙烯酸羟丁酯、甲基丙烯酸羟乙酯、甲基丙烯酸羟丙酯、丙烯酸羟异丁酯、甲基丙烯酸羟异丁酯、马来酸单甲酯、马来酸二甲酯、马来酸单乙酯、马来酸二乙酯、丙烯酸-2-乙基己酯、甲基丙烯酸-2-乙基己酯、丙烯酰胺、甲基丙烯酰胺、N,N-二甲基丙烯酰胺、N-叔丁基丙烯酰胺、丙烯腈、甲基丙烯腈、丙烯酸二甲基氨基乙基酯、丙烯酸二乙基氨基乙基酯、甲基丙烯酸二乙基氨基乙基酯以及上述单体与羧酸或无机酸的盐或季铵化产物。
同样适宜的共聚单体为丙烯酰氨基乙醇酸、乙烯基磺酸、烯丙基磺酸、甲代烯丙基磺酸、苯乙烯磺酸、丙烯酸3-磺基丙基酯、甲基丙烯酸3-磺基丙基酯和丙烯酰氨基甲基丙磺酸、以及含膦酰基单体如乙烯基膦酸、烯丙基膦酸和丙烯酰氨基甲基丙烷膦酸。
其它适宜的共聚单体为N-乙烯基咪唑、N-乙烯基-2-甲基咪唑、N-乙烯基-4-甲基咪唑、二烯丙基氯化铵、乙烯基酯如乙酸乙烯基酯和丙酸乙烯基酯、以及乙烯基芳族化合物如苯乙烯。当然也可以使用这些单体的混合物。
共聚物是由已知方法例如溶液、沉淀、悬浮或反相悬浮聚合法、或乳液或反相乳液聚合法,使用在聚合条件下可形成自由基的化合物制备的。
聚合通常在30-200℃,优选40-110℃进行。适宜引发剂的实例为偶氮和过氧化物、及常规氧化还原引发剂体系,如过氧化氢和还原化合物的组合物,例如亚硫酸钠、亚硫酸氢钠、甲醛次硫酸钠和肼。
共聚物的K值至少为7,优选为10-100,特别优选为10-50。K值是通过H.Fikentscher的《纤维素化学》,13(1932)58-64和71-74中的方法在水溶液或有机溶剂中于25℃以0.1-5%(取决于K值的范围)的浓度测定的。
除了上述聚合物粘合剂,还可以特别使用最多占粘合剂总重量30wt%的其它粘合剂。适宜者为聚合物、共聚物、纤维素衍生物、淀粉和淀粉衍生物,例如:
聚乙烯基吡咯烷酮(PVP)、N-乙烯基吡咯烷酮(NVP)和乙酸乙烯基酯或丙酸乙烯基酯的共聚物、乙酸乙烯基酯和巴豆酸的共聚物、部分水解的聚乙烯基乙酸酯、聚乙烯醇、聚(丙烯酸羟基烷基酯)、聚(甲基丙烯酸羟基烷基酯)、聚丙烯酸酯和聚甲基丙烯酸酯(Eudragit型)、甲基丙烯酸甲酯和丙烯酸的共聚物、聚丙烯酰胺、聚乙二醇、聚乙烯基甲酰胺(必要时可部分或完全水解)、纤维素酯、纤维素醚,特别是甲基纤维素和乙基纤维素、羟基烷基纤维素,特别是羟基丙基纤维素、羟基烷基烷基纤维素,特别是羟基丙基乙基纤维素、纤维素邻苯二甲酸酯,特别是纤维素乙酸酯邻苯二甲酸酯和羟基丙基甲基纤维素邻苯二甲酸酯、以及甘露聚糖,特别是半乳甘露聚糖。当然,聚乙烯基吡咯烷酮、N-乙烯基吡咯烷酮和乙烯基酯的共聚物、聚(丙烯酸羟基烷基酯)、聚(甲基丙烯酸羟基烷基酯)、聚丙烯酸酯、聚甲基丙烯酸酯、烷基纤维素和羟基烷基纤维素是特别优选的。
在50-180℃,优选60-130℃聚合物粘合剂在所有组分的完全混合物中必须被软化或熔融。因此该混合物的玻璃化转变温度必须在180℃之下,优选在130℃之下。如果需要,可通过常规药物上可接受的增塑助剂来降低。增塑剂的用量不超过粘合剂和增塑剂总重量的30%以形成没有冷流动的可稳定储存的药物剂型。但是,该混合物优选不含有增塑剂。
这类增塑剂的实例为:
长链醇、乙二醇、丙二醇、甘油、三羟甲基丙烷、三乙二醇、丁二醇、戊醇如季戊四醇、己醇、聚乙二醇、聚丙二醇、聚乙/丙二醇、硅酮、芳族羧酸酯(例如邻苯二甲酸二烷基酯、偏苯三酸酯、苯甲酸酯、对苯二甲酸酯)或脂族二羧酸酯(例如己二酸二烷基酯、癸二酸酯、壬二酸酯、柠檬酸和酒石酸酯)、脂肪酸酯如甘油单、二或三乙酸酯或二乙基磺基琥珀酸钠。增塑剂的浓度一般占混合物总重量的0.5-15%,优选0.5-5%。
总用量可高达聚合物重量100%的常规药物助剂为例如增容剂和增量剂如硅酸盐或硅藻土、氧化镁、氧化铝、氧化钛、硬脂酸或其盐,例如镁或钙盐、甲基纤维素、羧甲基纤维素钠、滑石粉、蔗糖、乳糖、谷类或玉米淀粉、土豆粉、聚乙烯醇,特别以占混合物总重量0.02-50%,优选0.20-20%的浓度使用。
浓度占混合物总重量0.1-5%,优选0.1-3%的润滑剂如硬脂酸铝和钙、滑石粉和硅氧烷。
流动剂如动物或植物脂肪,特别是氢化形式和室温下为固体者。这些脂肪的熔点优选为50℃或以上。C12,C14,C16和C18脂肪酸的甘油三酸酯是优选的。也可以使用蜡如巴西棕榈蜡。这些脂肪和蜡可单独有利地混合在一起或者与单和/或二甘油酯或磷脂,特别是卵磷脂混合在一起。单和二甘油酯优选衍生自上述脂肪酸类型。脂肪、蜡、单、二甘油酯和/或卵磷脂的总量占每层组合物总重量的0.1-30%,优选0.1-5%。
浓度占混合物总重量0.001-10%,优选0.5-3%的染料,如偶氮染料、有机或无机颜料或天然染料,优选无机颜料。
稳定剂如抗氧剂、光稳定剂、氢过氧化物破坏剂、自由基捕捉剂、抵抗微生物攻击的稳定剂。
还可以加入润湿剂、防腐剂、分解剂、吸收剂、脱模剂和推进剂(比较例如H.Sucker等人的《药物技术》,Thieme-Verlag,Stuttgart1978)。
用于本发明目的的助剂还包括生产活性成分固体溶液的物质。这些助剂的实例为季戊四醇和季戊四醇四乙酸酯、聚合物如聚环氧乙烷和聚环氧丙烷及其嵌段共聚物(poloxamers)、磷脂如卵磷脂、乙烯基吡咯烷酮的均聚物和共聚物、表面活性剂如硬脂酸聚氧化乙烯酯40、以及柠檬酸和琥珀酸、胆汁酸、甾醇及其它例如在J.L.FORD的Pharm.Acta Helv.
61(1986)69-88中所述者。
也可以认为助剂是加入用来控制活性成分溶解度的碱和酸(见例如K.Thoma等人的Pharm.Ind.
51(1989)98-101)。
助剂适用性的唯一先决条件是适当的热稳定性。
基于本发明目的的活性成分表示具有生理效应的所有物质,只要它们在加工条件下不分解。这些物质特别为药物活性成分(用于人类和动物)、用于植物处理的活性成分、杀虫剂、人类和动物食物的活性成分、芳香剂和芳香油。每剂量单位活性成分的量和浓度依据活性和释放速率可在很宽范围内变化。唯一的条件是它们能够达到所要求的效果。因此,活性成分的浓度可以为0.1-95wt%,优选为20-80wt%,特别为30-70wt%。也可以使用活性成分的组合物。基于本发明目的的活性成分还包括维生素和矿物质。维生素包括维生素A、B(指除B1,B2,B6和B12及烟酸和烟酰胺以外其它具有维生素B性质的化合物如腺嘌呤、胆碱、泛酸、维生素H、腺苷酸、叶酸、乳清酸、潘氨酸、肉碱、对氨基苯甲酸、肌醇和硫辛酸和维生素C、维生素D、E、F、H、I和J、K和P。基于本发明目的的活性成分还包括治疗肽。植物处理剂包括例如vinclozolin、epoxiconazole和quinmerac.
新方法例如适于加工下列活性成分:
醋丁洛尔、乙酰半胱氨酸、乙酰水杨酸、阿昔洛韦、阿普唑仑、阿法骨化醇、尿囊素、别嘌醇、氨溴索、阿米卡星、阿米洛利、氨基乙酸、胺碘酮、阿米替林、氨氯地平、阿莫西林、氨苄西林、抗坏血酸、阿司帕坦、阿司咪唑、阿替洛尔、倍氯米松、苄丝肼、苯扎铵盐酸盐、苯佐卡因、苯甲酸、倍他米松、苯扎贝特、维生素H、比哌立登、比索洛尔、溴西泮、溴己新、溴隐亭、布地奈德、丁苯羟酸、丁咯地尔、丁螺环酮、咖啡因、樟脑、卡托普利、卡马西平、卡比多巴、卡铂、头孢克洛、头孢氨苄、头孢羟氨苄、头孢唑林、头孢克肟、头孢噻肟、头孢他啶、头孢曲松、头孢呋辛、司来吉兰、氯霉素、氯己定、氯苯那敏、氯噻酮、胆碱、环孢菌素、西司他丁、西咪替丁、环丙沙星、西沙必利、顺铂、clarithromycin、克拉维酸、氯米帕明、氯硝西泮、可乐定、克霉唑、可待因、考来烯胺、色甘酸、维生素B12、环丙孕酮、去氧孕烯、地塞米松、右泛醇、右美沙芬、右丙氧芬、地西泮、双氯芬酸、地高辛、双氢可待因、双氢麦角胺、双氢麦角碱、地尔硫卓、苯海拉明、双嘧达莫、安乃近、丙吡胺、多潘立酮、多巴胺、多西环素、依那普利、麻黄碱、肾上腺素、维生素D2、麦角胺、红霉素、雌二醇、炔雌醇、依托泊甙、桉叶球剂、法莫替丁、非洛地平、非诺贝特、非诺特罗、芬太尼、黄素单核苷酸、氟康唑、氟桂利嗪、氟尿嘧啶、氟西汀、氟比洛芬、呋塞米、加洛帕米、吉非贝齐、庆大霉素、银杏biloba、格列本脲、格列吡嗪、氯氮平、Glycyrrhizaglabra、灰黄霉素、愈创甘油醚、氟哌啶醇、肝素、透明质酸、氢氯噻嗪、氢可酮、氢化可的松、氢吗啡酮、异丙托氢氧化铵、布洛芬、亚胺培南、吲哚美辛、碘海醇、碘帕醇、二硝酸异山梨酯、单硝酸异山梨酯、异维A酸、酮替芬、酮康唑、酮洛芬、酮咯酸、拉贝洛尔、乳果糖、卵磷脂、左卡尼汀、左旋多巴、左谷酰胺、左炔诺孕酮、左甲状腺素、利多卡因、脂肪酶、米帕明、赖诺普利、洛哌丁胺、劳拉西泮、洛伐他汀、甲羟孕酮、薄荷脑、甲氨蝶呤、甲基多巴、甲泼尼龙、甲氧氯普胺、美托洛尔、咪康唑、咪达唑仑、米诺环素、米诺地尔、米索前列醇、吗啡、多种维生素混合物或组合物及无机盐、N-甲麻黄碱、萘呋胺、萘普生、新霉素、尼卡地平、尼麦角林、烟酰胺、烟碱、烟酸、硝苯地平、尼莫地平、硝西泮、尼群地平、尼扎替丁、炔诺酮、诺氟沙星、炔诺孕酮、去甲替林、制霉菌素、氧氟沙星、奥美拉唑、ondansetron、胰酶、泛醇、泛酸、对乙酰氨基酚、青霉素G、青霉素V、苯巴比妥、己酮可可碱、青霉素V、苯福林、苯丙醇胺、苯妥英、吡罗昔康、多粘菌素B、聚维酮碘、普伐他汀、普拉西泮、哌唑嗪、泼尼松龙、泼尼松、普罗帕酮、普萘洛尔、丙羟茶碱、伪麻黄碱、维生素B6、奎尼丁、雷米普利、雷尼替丁、利血平、维生素A、维生素B2、利福平、芦丁、糖精、沙丁胺醇、salcatonin、水杨酸、simvastatin、生长激素、索他洛尔、螺内酯、硫糖铝、舒巴坦、磺胺甲噁唑、柳氮磺胺吡啶、舒必利、他莫昔芬、替加氟、替普瑞酮、特拉唑嗪、特布他林、特非那定、四环素、茶碱、维生素B1、噻氯匹定、噻吗洛尔、氨甲环酸、维A酸、曲安奈德、氨苯蝶啶、曲克芦丁、尿嘧啶、丙戊酸、万古霉素、维拉帕米、维生素E、亚叶酸、齐多夫定。
优选的活性成分为布洛芬(作为外消旋物或对映体或富集的对映体)、酮洛芬、氟比洛芬、乙酰水杨酸、维拉帕米、对乙酰氨基酚、硝苯地平或卡托普利。
为了生产固体剂型,制备各组分的塑料混合物(熔体)并随后进行成型步骤。有各种混合各组分并将熔体成型的方法。混合可在熔体形成之前、期间和/或之后进行。例如,可首先混合各组分然后熔融或者混合和熔融同时进行。随后经常将塑料混合物均一化以将活性成分彻底分散。
但是,特别是当使用敏感活性成分时,经证明首先将聚合物粘合剂熔融并适必要时与常规药物添加剂形成预混物,随后将敏感活性成分在转筒混合机中于很短的保留时间内(均匀)混入塑料相中是优选的。为此目的可以使用固体形式或溶液或分散体形式的活性成分。
在生产过程中各组分一般原样使用。但是,也可使用液态形式,即溶液、悬浮液或分散液。
液态形式组分的适宜溶剂基本为水或水溶性有机溶剂或其与水的混合物。但是,也可以使用不溶于水或溶于水的有机溶剂。适宜的水溶性溶剂特别为C1-C4-链烷醇如乙醇、异丙醇或正丙醇,多元醇如乙二醇、甘油和聚乙二醇。适宜的不溶于水的溶剂为烷如戊烷或己烷、酯如乙酸乙酯或乙酸丁酯、氯代烃如二氯甲烷、及芳烃如甲苯和二甲苯。另一种可用的溶剂为液态CO2。
各种情况下所用溶剂依赖于所采用的组分及其性能。例如,药物活性成分通常以一般溶于水的盐形式使用。因此水溶性活性成分可作为水溶液使用,或优选在粘合剂的水溶液或分散液中使用。如果所用组分的液态形式是基于有机溶剂的,则相应的叙述适用于可溶解在上述溶剂之一中的活性成分。
如果需要和/或必须加入适当的助剂如乳化剂,则必要时可用在上述溶剂中的溶解、悬浮或分散来替代熔融。随后一般除去溶剂以在适当的设备,例如挤出机中形成熔体。这部分将包括在随后的混合阶段。
熔融和/或混合在基于此目的的常规设备中进行。特别适宜者为挤出机或可加热(适当时)且带有搅拌器的容器,例如捏和机(如下面将要提到的类型)。
特别适宜的混合设备为塑料工艺中混合所用者。适宜的设备描述于例如“Mischen beim Herstellen und Verarbeiten vonKunststoffen”,H.Pahl,VDI-Verlag,1986。特别适宜的混和设备为挤出机和动态及静态混合机、以及搅拌容器、具有脱模功能的单轴搅拌器,特别是糊料混合机、多轴搅拌器,特别是PDSM混合机、固体混合机、以及优选的混合/捏和反应器(例如由List提供的ORP,CRP,AP,DTB或由Krauss-Maffei提供的Reactotherm或由Buss提供的Ko-Kneter)、槽式混合机和密炼机或转子/定子体系(例如由IKA提供的Dispax)。
在敏感活性成分的情况下,优选将聚合物粘合剂在挤出机中熔融并随后将活性成分在混合机/捏和机中混合。另一方面,对于较不敏感的活性成分,可以使用转子/定子体系来有力地分散活性成分。
混合设备可根据其设计以常规方式连续或分批进料。粉末组分可由分离进料,例如通过定量供给装置引入。塑料组合物可直接从挤出机或通过齿轮泵进料,如果粘度和压力都很高时,齿轮泵是特别有利的。液态介质可通过适当的泵设备计量加入。
通过混合和/或熔融粘合剂、活性成分及必要时的添加剂而获得的混合物为糊状至粘稠状(塑料)或流体,因此是可挤塑的。混合物的玻璃化转变温度低于混合物中存在的所有组分的分解温度。优选粘合剂在生理介质中应能溶解或溶胀。
在该方法中混合和熔融步骤可在同一个设备或在两个或多个分别运行的设备中进行。预混物的制备可在上述常规混合设备之一中进行。然后可将这类预混物例如直接加入到挤出机中并随后挤出,适当时可加入其它组分。
在此新方法中可以使用单螺杆机、啮合螺杆机或其它多螺杆挤出机,特别是同向旋转或反向旋转的双螺杆挤出机(适当时可装配捏和盘)作为挤出机。如果在挤出时必须蒸走溶剂,则挤出机一般装配有蒸发部分。特别优选的挤出机为来自Werner & Pfleiderer的ZKS。
根据本发明也可以通过共挤塑生产多层药物剂型,在这种情况下将上述组分的许多混合物一起加入到挤出机模具中以得到多层药物剂型所要求的层结构。优选使用不同的粘合剂作不同的层。
多层药物剂型优选包括二或三层。它们可以是开放或封闭式的,特别是开放或封闭的多层片剂。
至少一层包括至少一种药物活性成分。另一种活性成分也可以存在于另一层中。这样的优点是可加工两个互不相容的活性成分或者可以控制活性成分的释放特性。
成型是通过共挤塑即将来自各挤出机或其它设备的混合物加入到共挤塑模具中并挤塑而进行的。共挤塑模具的形状依赖于所要求的药物剂型。适宜的模具实例为具有扁平模孔的模具,即缝型模具和具有环形模孔的模具。模具的设计依赖于所用聚合物粘合剂和所要求的药物剂型。
所得混合物优选不含溶剂,即它既不含水也不含有机溶剂。
通常塑料混合物要经过最终成型。根据模具及成型模式可得到大量形状。例如,如果使用挤出机,则挤出物可在带和辊之间、两个带或两个辊之间成型,如EP-A-358 105所述,或者在带有两个模塑辊的压延机中通过压延成型,见例如EP-A-240 904。可通过挤塑并将挤出物热切或冷切而得到其它形状,例如小颗粒及均一形状的粒丸。热切造粒通常得到直径为1-10mm的透镜状剂型(片剂),而剥离造粒通常得到长径比为1-10且直径为0.5-10mm的圆筒形产物。因此可以生产单层剂型而且也可以通过使用共挤塑生产开放或封闭式多层剂型,例如长方形片剂、涂敷片剂、锭剂和丸剂。也可将所得颗粒研磨成粉末并以常规方法压成片剂。微锭剂可通过Rotoform-Sandvik方法生产。这些剂型可在后继加工步骤中通过常规方法包敷和/或包围上涂层。适于涂膜的材料实例为聚丙烯酸酯如Eudragit型、纤维素酯如羟丙基纤维素邻苯二甲酸酯、及纤维素醚如乙基纤维素、羟丙基甲基纤维素或羟丙基纤维素。
在特殊情况下可以形成固体溶液。术语固体溶液是技术工人所熟悉的,例如由开始时所引文献中可知。在活性成分溶于聚合物的固体溶液中,活性成分是以分子分散体的形式溶于聚合物中的。
下列实施例旨在说明而非限制本新方法。
实施例
实施例1
在下述条件下将520g 90wt%乙烯基吡咯烷酮和10wt%甲基丙烯酸硬脂基酯的共聚物(K值为35;水中浓度为1%)与480g维拉帕米盐酸盐一起挤塑并压延得到500mg长方形片剂。
部分1 48℃
部分2 88℃
部分3 131℃
部分4 112℃
部分5 109℃
模具 100℃
通过USP划桨方法(pH变化)研究活性成分从片剂中的释放情况。8小时后释放55%。
实施例2
在下述条件下将500g 90wt%乙烯基吡咯烷酮和10wt%甲基丙烯酸硬脂基酯的其聚物(K值为35;水中浓度为1%)与500gvinclozolin一起挤塑,并冷却造粒。
部分1 60℃
部分2 98℃
部分3 110℃
部分4 115℃
部分5 112℃
模具 100℃
得到透明的、X射线下为无定形的水分散型颗粒。
Claims (7)
2.权利要求1所要求的方法,其中使用了包括N-乙烯基吡咯烷酮单元的共聚物。
3.权利要求1所要求的方法,其中共聚物包括选自丙烯酸的或甲基丙烯酸的肉豆蔻基酯、鲸蜡基酯、硬脂基酯、油基酯或山俞酯的单体单元作为式II的化合物。
4.权利要求1所要求的方法,其中共聚物包括70-99wt%的N-乙烯基内酰胺单元。
5.权利要求1所要求的方法,其中共聚物另外包括选自α,β-烯键式不饱和C3-C8-单和二羧酸、其酸酐、与C1-C4-链烷醇、C1-C4-二醇或二-(C1-C4)-烷基氨基-C1-C4-链烷醇的二酯及单酯、这些羧酸的酰胺和腈、脂族C1-C4-羧酸的乙烯基酯及其盐或季铵化产物的其它单体单元。
6.权利要求1所要求的方法,其中塑料混合物的形成是通过在挤出机中混合和/或熔融各组分而进行的。
7.由权利要求1所要求的方法获得的固体剂型。
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-
1997
- 1997-12-01 DE DE19753298A patent/DE19753298A1/de not_active Withdrawn
-
1998
- 1998-11-30 AT AT98965716T patent/ATE220897T1/de not_active IP Right Cessation
- 1998-11-30 DK DK98965716T patent/DK1035841T3/da active
- 1998-11-30 JP JP2000522902A patent/JP2001524515A/ja not_active Ceased
- 1998-11-30 WO PCT/EP1998/007716 patent/WO1999027916A2/de active IP Right Grant
- 1998-11-30 PT PT98965716T patent/PT1035841E/pt unknown
- 1998-11-30 DE DE59804928T patent/DE59804928D1/de not_active Expired - Fee Related
- 1998-11-30 CN CNB988134233A patent/CN1156270C/zh not_active Expired - Fee Related
- 1998-11-30 US US09/555,596 patent/US6528089B1/en not_active Expired - Fee Related
- 1998-11-30 EP EP98965716A patent/EP1035841B1/de not_active Expired - Lifetime
- 1998-11-30 CA CA002311308A patent/CA2311308C/en not_active Expired - Fee Related
- 1998-11-30 ES ES98965716T patent/ES2181320T3/es not_active Expired - Lifetime
Also Published As
Publication number | Publication date |
---|---|
PT1035841E (pt) | 2002-11-29 |
DE59804928D1 (de) | 2002-08-29 |
CA2311308C (en) | 2008-01-22 |
WO1999027916A2 (de) | 1999-06-10 |
JP2001524515A (ja) | 2001-12-04 |
CA2311308A1 (en) | 1999-06-10 |
WO1999027916A3 (de) | 1999-08-12 |
ATE220897T1 (de) | 2002-08-15 |
US6528089B1 (en) | 2003-03-04 |
ES2181320T3 (es) | 2003-02-16 |
CN1283993A (zh) | 2001-02-14 |
DE19753298A1 (de) | 1999-06-02 |
EP1035841B1 (de) | 2002-07-24 |
DK1035841T3 (da) | 2002-09-02 |
EP1035841A1 (de) | 2000-09-20 |
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