CN1173327A - 固体药物剂型的生产 - Google Patents
固体药物剂型的生产 Download PDFInfo
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- CN1173327A CN1173327A CN97115459.7A CN97115459A CN1173327A CN 1173327 A CN1173327 A CN 1173327A CN 97115459 A CN97115459 A CN 97115459A CN 1173327 A CN1173327 A CN 1173327A
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Abstract
固体药物剂型通过在不含溶剂情况下将至少一种药理学上可接受的聚合粘合剂和至少一种药物活性组分与或不与常规药物添加剂一起混合并熔融,得到塑性混合物,和通过挤出将该混合物成型为所需要的药物形式而制备,其中通过两步进行成型,在第一步中将挤出物切割成成型制品,在第二步中将这些成型制品在塑性状态下弄圆。
Description
本发明涉及一种生产固体药物剂型的方法,它包括在不含溶剂情况下,将至少一种药理学上可接受的聚合粘合剂和至少一种药物活性组分与或不与常规药物添加剂一起混合并熔融,得到塑性混合物,和将混合物成形为所需要的药物形式。
生产固体药物剂型,特别是片剂的传统方法是分批进行并且包含许多步骤。药物颗粒代表了其中重要的中间体。因此,例如,由Bauer,Frommig和Fuhrer教授编辑的书“Pharmazeutische Technologie(药物技术)”(Thieme Verlag)第292页及以下中公开了可通过干法成粒从熔体得到药物剂型。描述了怎样通过熔化和冲击固化,通过浇铸和粉碎或通过在喷粉塔中喷淋固化来生产熔体固化颗粒。该生产方法所存在的一个问题是准确成型,这是生产药品中所必需的。在生产中经常有不规则颗粒或碎颗粒存在,这使得产生的形状与常规药物剂型不符,因此颗粒本身作为药物剂型具有很小的重要性。生产所需固体药物剂型要求使用其它工艺步骤,如在压片机中压缩。这是耗费时间和成本的(time-andcost-intensive)。
生产固体药物剂型的一种更简单的连续方法已知有一段时间并且包括将包含活性组分而不含溶剂的聚合粘合剂熔体挤出,并且例如在带有成型辊的压延机上,将挤出物成型为所需要的药物剂型,参见EP-A-240904,EP-A-240906和EP-A-337256和EP358105。尽管用该方法可获得特异性成型,但该方法具有很大的不利之处,即在片剂之间或片剂上存在溢料,并且在后续工艺步骤中必须将其除掉。这种类型的方法是复杂的并且在很多情况下,涉及破坏的片剂形式的 产品损失,由于各种原因,这些损失的产品并不能总是再循环到生产方法中。
本发明的一个目的是提供一种简单并且费用实际的生产固体药物剂型,特别是确定形状片剂的方法。
业已发现,通过在两个单独的步骤中将挤出的塑性混合物成形,即将挤出物切割并在塑性状态下将得到的坯料弄圆来实现该目的。
因此,本发明涉及一种生产固体药物剂型的方法,它包括在不含溶剂情况下,将至少一种药理学上可接受的聚合粘合剂和至少一种药物活性组分与或不与常规药物添加剂一起混合并熔融,得到塑性混合物,和通过挤出将混合物成形为所需要的药物剂型,其中分两步进行成形,第一步是将挤出物切割成成形制品,第二步是在塑性状态下,将这些成形制品弄圆。
按照本发明,首先用适宜的模头将塑性混合物挤成连续的挤出物。模头的形状依赖于所需要的药物剂型。适宜的实例为圆形截面的模头或共挤塑模头如环形模头。共挤塑模头用于生产至少有两层的开放或封密式药物剂型。这些层中之一包含活性组分,另一层可不包含活性组分或包含另一种活性组分。进一步的详细说明见DE19539361.9。
然而,优选使用圆形截面的模头,在该种情况下,塑性混合物转变为具有圆形横截面的挤出物。
模头的设计依赖于所使用的聚合粘合剂和所需要的药物剂型。优选将模头放置在水平线上,各孔之间的距离通常为其直径的倍数。从模头出来后,优选通过切割将挤出物切开。切割时间的选择依赖于挤出速率和所需要的药物剂型。在从模头出来后,通过机械方法支撑挤出物在这方面是有利的,例如通过水平板或循环带。由此形成具有确定长度L和确定直径D的圆柱体。L/D比值可依赖于所需药物剂型而变化。如果比值>1(例如≥2),那么得到椭圆形片剂,并且当比值≤1时,可得到球形片剂。
优选地,分别控制各挤出物的切割装置。例如,可通过光学系统来测定成形制品的所需长度。当达到所需要的长度(距破料板的距离)时,该光学系统发出信号给在每一情形下设置在一个孔上并独立于其它切割装置的切割装置,该切割装置切割挤出物并摆动回到其初始位置。
按照本发明,在第二步中将得到的成形制品弄圆。在这方面,弄圆是指将成形制品的边和角弄圆,其重量变化可忽略不计。将挤出物弄圆通过使成形制品与一种或多种弄圆工具接触而进行。在该过程中,或者成形制品或弄圆工具运动,而另一个保持静止状态。在某些情况下,两者同时运动可能也是有利的,从而可获得特定成形。例如,通过将成形制品放在静止的和运动的表面之间,优选在两个板之间或一个板和一个运动带之间,可获得成形制品的运动,例如滚动。用常规方法可获得弄圆工具的运动。
优选使用的弄圆工具为曲线形,尤其为半圆形颚板,尤其是在面向圆柱体截面的一侧基本上为凹面形状的金属部件。
进行弄圆步骤的前提条件是成形制品处在塑性状态。例如,这可通过延迟成形制品的冷却步骤和/或使挤出物从模头出来和弄圆之间的时间尽可能短来达到。另一种可能是控制弄圆工具的温度,例如通过加热,这样使得当弄圆工具与成形制品接触时,后者具有适宜的塑性。
成形步骤之后,将药物剂型冷却并固化,例如在冷却带上进行。
本发明生产固体药物剂型的方法也包括在不含溶剂的情况下将至少一种药理学上可接受的聚合粘合剂和至少一种药物活性组分与或不与常规药物添加剂一起混合并熔融,得到塑性混合物。
这些工艺步骤可通过常规方法进行,如EP-A-240904,EP-A-337256和EP-A-358105中所述,其内容引入本文供参考。
可首先将各组分混合,然后熔化和均化。然而,已证明,尤其在使用敏感的活性组分时,优选首先将聚合粘合剂与或不与常规药物添加剂一起熔融并预混合,合适的话交替地操作搅拌的容器,搅拌器,固体混合器等,然后在强力混合器中在塑性状态下用很短的停留时间将敏感的活性组分混入(均化)。活性组分可以固体形式或以溶液或分散体来使用。
在通常用于该目的的装置中进行熔融和混合。特别适宜的为挤出机或带有搅拌器的可加热罐,例如捏合机(如下文所提到的类型)。
也可以使用在塑料技术中用于混合的各类混合装置。合适装置的实例描述于“Mischen beim Herstellen und Verarbeiten vonKunststoffen”,H.Pahl,VDI-Verlag,1986。尤其适于混合的是挤出机及动态和静态混合器,以及搅拌的容器,带有脱模装置的单螺杆搅拌器,尤其是浆料搅拌器,多螺杆搅拌器,尤其是PDSM混合器,固体混合器和优选混合/捏合反应器(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),双槽捏合机(槽式混合器)和密炼机或转子/定子系统(例如由IKA提供的Dispax)。
在敏感的活性组分情况下,优选首先将聚合粘合剂在挤出机中熔化,然后在混合/捏合反应器中将活性组分混入。另一方面,在不太敏感的活性组分情况下,可使用转子/定子系统将活性组分充分分散。
取决于混合装置的设计,可以常规方式连续或分批地加料。可通过自由流动方式加入粉状组分,例如通过差示定重喂料机加料。可通过挤出机直接加入塑性组合物或通过齿轮泵加入,后者对于高粘度和高压力尤其有利。液体介质可通过适宜的泵装置定量供给。
通过将粘合剂和活性组分与或不与添加剂混合并熔融得到的混合物是浆糊状的或粘稠的(热塑性)并因此也是可挤出的。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该是可溶解或可溶胀的。适宜的粘合剂实例为:
聚乙烯基吡咯烷酮(PVP),N-乙烯基吡咯烷酮(NVP)和乙烯基酯,特别是乙酸乙烯酯的共聚物,乙酸乙烯酯和丁烯酸的共聚物,部分水解的聚乙酸乙烯酯,聚乙烯醇,聚(丙烯酸羟烷基酯),聚(甲基丙烯酸羟烷基酯),聚丙烯酸酯和聚甲基丙烯酸酯(Eudragit类),甲基丙烯酸甲酯和丙烯酸的共聚物,纤维素酯类,纤维素醚类,特别是甲基纤维素和乙基纤维素,羟烷基纤维素,特别是羟丙基纤维素,羟烷基烷基纤维素,特别是羟丙基乙基纤维素,邻苯二甲酸纤维素,特别是乙酸邻苯二甲酸纤维素和邻苯二甲酸羟丙基甲基纤维素,和甘露聚糖,特别是半乳甘露聚糖。聚合物的K值(H.Fikentscher的方法,Cellulose-Chemie 13(1932),58-64和71-74)在10-100之间,优选为12-70,特别为12-35,并且对于PVP来说>17,特别在20-35之间。
优选的聚合粘合剂为聚乙烯基吡咯烷酮,N-乙烯基吡咯烷酮和乙烯基酯的共聚物,聚(丙烯酸羟烷基酯),聚(甲基丙烯酸羟烷基酯),聚丙烯酸酯,聚甲基丙烯酸酯,烷基纤维素和羟烷基纤维素。
在50-180℃,优选在60-130℃下,在所有组分的完全混合物中聚合粘合剂必须软化或熔化。因此,混合物的玻璃化转变温度必须低于180℃,优选低于130℃。如果需要,可通过常用的药理学上可接受的增塑辅助物质来降低该玻璃化转变温度。增塑剂的量不超过粘合剂和增塑剂总重量的30%,以便形成在贮存过程中稳定并且不表现冷流现象的药物剂型。然而,优选混合物不含增塑剂。
该种增塑剂的实例为:
长链醇类,乙二醇,丙二醇,甘油,三羟甲基丙烷,三甘醇,丁二醇类,戊醇类如季戊四醇,己醇类,聚乙二醇类,聚丙二醇类,聚乙二醇/丙二醇,聚硅氧烷,芳族羧酸酯(例如,邻苯二甲酸二烷基酯,1,2,4-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,柠檬酸酯和酒石酸酯),脂肪酸酯如甘油一-,二-或三乙酸酯或磺基琥珀酸二乙酯钠。增塑剂的浓度通常为混合物总重量的0.5-15%,优选0.5-5%。
总量可达到聚合物重量100%的常用药物辅助物质的实例为增量剂和填充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,蔗糖,乳糖,谷类或玉米淀粉,马铃薯粉,聚乙烯醇,尤其是浓度为混合物总重量的0.02-50%,优选0.20-20%;
润滑剂如硬脂酸铝和钙,滑石和聚硅氧烷,其浓度为混合物总重量的0.1-5%,优选0.1-3%;
助流剂如动物或植物脂肪,尤其是氢化形式的动植物脂肪和在室温下为固体的那些。优选这些脂肪的熔点为50℃或50℃以上。C12,C14,C16和C18脂肪酸的甘油三酯是优选的。也可以使用蜡如巴西棕榈蜡。这些脂肪和蜡可有利地单独或与甘油单酯和/或甘油二酯或磷脂,尤其是卵磷脂一起混合。优选甘油单酯和甘油二酯是由上述类型的脂肪酸衍生的。脂肪,蜡,甘油单酯和甘油二酯和/或卵磷脂的总量为各层组合物总重量的0.1-30%,优选0.1-5%;
染料如偶氮染料,有机或无机颜料或天然染料,浓度为混合物总重量的0.001-10%,优选0.5-3%的无机颜料是优选的;
稳定剂如抗氧剂,光稳定剂,氢过氧化物消除剂,自由基清除剂,抗微生物侵独的稳定剂。
可进一步加入湿润剂,防腐剂,崩解剂,吸附剂和脱膜剂与发泡剂(例如,参见H.Sucker等人的Pharmazeutische Technologie,Thieme-Verlag.Stuttgart 1978)。
本发明所使用的辅助物质也是指生产含药物活性组分的固体溶液的物质。这些辅助物质的实例为季戊四醇和四乙酸季戊四醇酯,聚合物如聚氧乙烯和聚氧丙烯及其嵌段共聚物(Poloxamers),磷脂如卵磷脂,乙烯基吡咯烷酮的均聚物和共聚物,表面活性剂如聚氧乙烯40硬脂酸酯和柠檬酸与琥珀酸,胆汁酸,甾醇和其它物质,例如在J.L.Ford,Pharm.ActaHelv.61,(1986),69-88中所描述的那些。
可认为药物辅助物质包括加入其中以控制活性组分的溶解度的酸和碱(例如见K.Thoma等人,Pharm.Ind.51,(1989)98-101)。
适用于作为辅助物质的唯一条件是它们具有足够的热稳定性。
本发明药物活性组分是指具有药物作用和最小副作用的所有物质,只要它们在加工条件下不分解。依赖于活性和释放速率,每个剂量单位中活性组分的量和浓度可以在宽范围内变化。唯一的条件是它们足以获得所需要的作用。因此,活性组分的浓度可以为0.1-95wt%,优选20-80wt%,特别优选30-70wt%。也可以组合使用活性组分。本发明活性组分也可以是维生素和矿物,作物治疗剂和杀虫剂。维生素包括A组维生素,B组维生素,B组维生素不仅指B1,B2,B6和B12,及烟酸和烟酰胺,而且指具有维生素B性质的化合物如腺嘌呤,胆碱,泛酸,生物素,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,以及维生素C,D组维生素,E组维生素,F组维生素,H组维生素,I和J组维生素,K和P组维生素。本发明活性组分也包括肽治疗剂。
例如,本发明方法适用于加工下列活性组分:
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,氨碘酮,阿米替林,氨氯地平,羟氨苄青霉素,氨苄青霉素,抗坏血酸,阿司帕坦,阿司咪唑,阿替洛尔,氯地米松,苄丝肼,苯扎氯铵,苯佐卡因,苯甲酸,倍地米松,苯扎贝特,生物素,比哌立登,比索洛尔,溴西泮,溴己新,溴隐亭,布地苯德,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(cefachlor),头孢氨苄,头孢吡硫(cefatroxil),头孢唑啉,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-非尼那敏,氯噻酮,胆碱,环孢菌素,西司他丁,西咪替丁,环丙氟哌酸,西沙必利,顺铂,克红霉素,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,二氢麦角碱,地尔硫,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,Eucalyptus globulus,法莫替丁,非洛地平,非诺贝特,非诺特罗,芬太尼,flavin mononucleotide,氟康唑,氟桂利嗪,氟尿嘧啶,氟西汀,氟比洛芬,呋噻米,加洛帕米,吉非贝齐,庆大霉素,Gingkobiloba,格列本脲,格列吡嗪,氯氮平,Glycyrrhiza glabra,灰黄霉素,愈创甘油醚,氟哌啶醇,肝素,玻璃糖醛酸,氢氯噻嗪,氢可酮,氢化可的松,氢吗啡酮,氢氧化异丙托品,布洛芬,亚胺培南,吲哚美辛,碘海醇,碘帕醇,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,复合维生素混合物及无机盐, N-甲基麻黄碱,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,尼唑替丁,炔诺酮,诺氟沙星,炔诺孕酮,去甲替林,制霉菌素(nystatin),氧氟沙星,奥美拉唑,奥丹亚龙,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,苯氧甲基青霉素,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,溴隐亭,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,昔伐司丁,生长激素,索他洛尔,螺内酯,硫糖铝,舒巴坦,磺胺噁唑,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,曲安萘德,氨苯蝶啶,甲氧苄啶,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。
优选的活性组分为布洛芬(外消旋体,对映体或浓缩的对映体),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。
在特定情况下可能形成固体溶液。术语“固体溶液”是技术工人熟知的,如开始引入的文献中所述。活性组分以在聚合物中的分子分散体形式存在于药物活性组分的聚合物固体溶液中。
所得到的混合物不含溶剂,即该混合物既不含水也不含有机溶剂。
可通过本发明方法生产的固体药物剂型尤其为片剂,优选椭圆形片剂,糖包衣片剂,锭剂和丸剂。最后,也可以以常规方式给所得到的药物剂型提供膜包衣以控制活性组分的释放或掩盖味道。此类包衣的合适材料为聚丙烯酸酯如Eudragit类,纤维素酯如邻苯二甲酸羟丙基甲基纤维素,和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。
因此,通过本发明方法生产具有特别精确尺寸的药物剂型是可能的。令人吃惊的是,该方法是经济的,每单位时间可得到大量产品并且避免任何浪费。
下列实施例用于说明而不是限制本发明。图1-7叙述实施例并被简要描述如下。
在图中:
图1显示在本发明方法第一步骤中所使用的挤出机装置的纵截面;
图2显示图1中挤出机的变体;
图3显示用于挤出的成形制品的收集器;
图4显示在本发明方法第二步骤中所使用的弄圆工具的第一实施方案的横截面;
图5显示图4中弄圆工具沿V-V线的纵截面;
图6显示在本发明方法第二步骤中所使用的弄圆工具的第二实施方案的视图;
图7显示图6中弄圆工具沿VII-VII线的横截面。
图1描述的是挤出机10,它通过模头11将塑性组合物以产品挤出物的形式挤出,产品挤出物通过循环运输带15收集。将切割装置安装在模头11的出口处,并且在图1中的挤出机情况下,该切割装置为刀12,它将产品挤出物切成圆柱形制品13。通过传感器14来确定该成形制品的长度,传感器14安装在每一挤出物通路的上方,并且其距刀12的距离与圆柱形制品13的长度相符。
图2中所描述的挤出机与图1中挤出机的不同之处在于前者具有可加热的金属丝16,它作为切割装置代替图1中的刀12,并被安装在金属丝支架17中且可上下移动。
通过传感器14控制在图1装置中的刀12和在图2装置中的切割金属丝16。传感器14记录产品挤出物的前端,然后将控制脉冲传递给切割装置,该切割装置开动刀12或金属丝16以便产生圆柱形制品13的后切割表面。
图3描述的是收集器18,它收集已切割成段的挤出成形制品13。收集器18可设计为具有上端漏斗形进料口和下端出料口的收集容器。然而,在特别简单的收集器18实例中,它也可以由两个导料板19组成,该两板基本平行放置并且其间距略大于圆柱形制品13的直径。在所描述的实例中,导料板19形成进料口,它的上部延伸为漏斗形。圆柱形制品13一个叠一个地以单排排列在图3的收集器中,其长轴与导料板19平行。在关闭状态下,收集器18的下端出料口由多孔滑门20封闭。如果要放出单个的成形制品13,那么稍稍移动一下多孔滑门20,使得存在于滑门中并且其尺寸与成形制品13的长和宽基本相符的伸长孔移动到收集器18的出料口下,这样使得单个的成形制品能够通过伸长孔落下。
将排放出来的成形制品13加到弄圆工具21中。
图4和5描述的是弄圆工具21的第一实施方案,在该实施方案中,弄圆工具由弧形的可移动驱动器22和固定的滚筒23组成。弧形驱动器22的内表面与滚筒23的外表面之间的距离精确地与圆柱形制品13的直径相符。将待弄圆的成形制品13放置在驱动器22和固定的滚筒23之间,使得其长轴与弧形驱动器的转动轴基本平行,该弧形驱动器至少可以扇形角度沿固定的滚筒23中心转动。驱动器22的内表面与圆柱形制品13的外表面摩擦接合,使得当驱动器22运动时,成形制品13在固定的滚筒23上滚动。
图5描述的是图4中弄圆工具21沿V-V线的纵截面。显然,方形颚板24安置在圆柱形制品两端的附近,并且在面向成形制品13的表面上具有凹穴25。优选颚板24由金属构成并且可加热。它们可沿圆柱形制品的长轴移动,并且凹穴的中心位于该长轴上。为了弄圆,将方形金属颚板不停地向圆柱形制品13两端的光滑切割表面运动,同时,弧形驱动器22将圆柱形制品13在固定的滚筒23上来回滚动。当金属颚板与成形制品13端面外部边缘接触时,这些切割表面逐渐变圆。这两个相对的颚板24彼此靠近直至成形制品13的两个端面完全变圆。
图6和7描述的是弄圆工具21的第二个实施方案。如图4和5的实例中所述,将圆柱形制品13的切割边在加热的方形颚板24上来回移动。将在两个相对颚板24中的凹穴基本设计成半圆柱体形,在成形制品13运动方向上成锥形渐变。为了使挤出的成形制品13在图6和7的实施方案中滚动,将它们在运输带15上旋转90°,所述运输带将它们运输到弄圆工具21中,使得它们的长轴垂直于运输方向。或者,也可以使用第二个(未示出)运输带,它以所需要的取向从第一个运输带接收成形制品。将静止的板26放置在运输带上并与成形制品13摩擦接触并使其旋转,这些成形制品在板26下面运输。实际上,成形制品在静止的板26上滚动并因此到达方形的成锥形渐变的弄圆颚板的接合面。
通过下文的两个实施例来说明本发明方法。
实施例1:
利用双螺杆挤出机来制备椭圆形片剂
用螺杆直径为57mm的啮合,自动清洗同向旋转双螺杆挤出机来制备聚合物/活性组分混合物(300kg K值为30的聚乙烯基吡咯烷酮,6kgAerosil 90,54kg麦芽糖糊精,240kg布洛芬)。将塑性组合物以100Kg/h的输出量通过10个排成一排且各自直径为8mm的模头11挤出并通过循环运输带15接收。运输带以挤出物出现的速度移动。在该情况中,在挤出物密度为~1g/cm3时,速度大约为0.85m/min。将传感器14安置在各挤出物通道的上方,并且它距模头的距离与椭圆形片剂的长度相符。当传感器位于挤出物的开始部位时,它发出脉冲给切割装置,并开动该切割装置,以便于进行切割。也可以使用刀12(图1)作为切割工具,它在切割后立即返回开始的位置,或使用金属丝16(图2)作为切割工具,它可加热并且既可在向下运动也可在向上运动中进行切割。对于长度大约为2cm的椭圆形片剂来说,切割速度为~50/min。
将在运输带上冷却了的圆柱形制品13暂时贮存在收集器18中(图3)并随后通过多孔的滑门20单个地加到弄圆工具21中(图4)。在此期间,弧形驱动器22支撑并移动成形制品13,并因此使它围绕其长轴旋转,与固定的滚筒23接触。在成形制品进行旋转运动的同时,它的扁平端被加热的弄圆工具通过(图5)。弄圆工具包括成对安置并且在朝向成形制品13的各侧具有凹穴25的金属颚板。两个金属颚板可沿成形制品13的长轴移动,并且球缺形凹穴的中心位于该长轴上。如上所述,将成形制品13弄圆,随着金属颚板的不断运动,成形制品的边缘圆周不断地减少。当边缘圆周为0时,金属颚板24的运动停止,并且作为结果,被弄圆的制品13的整个横截面与至少部分球缺形凹穴接触。
没有产生任何浪费便得到椭圆形片剂。在弄圆步骤结束时,将片剂从工艺中排出。
可将该方法中得到的椭圆形片剂接着加工处理,例如进行包衣步骤,或直接进行包装。
实施例2:
利用共捏合机(ko-kneader)来制备椭圆形片剂
用直径为70mm的共捏合机来代替实施例1中所使用的双螺杆挤出机。该共捏合机能产生特别剧烈的混合步骤,因为在旋转运动上叠加了前后运动。所制备的塑性组合物以100kg/h的输出量由齿轮泵并通过模头排出,所述齿轮泵可确保均匀排料。如实施例1所述切割圆形挤出物。在运输带15上,将成形制品13旋转90℃,使得它们在运输带和固定带26之间进行垂直于其长轴的平移运动,该运动与运输带(图6)的运动方向相同。在此过程中,成形制品13也围绕其长轴旋转。用与实施例1类似的方法,在具有半圆柱形的锥形渐变凹穴25(图7)的弄圆颚板24上将扁平面弄圆。
弄圆步骤完成后,可将椭圆形片剂接下来再进行包衣步骤或直接包装。
Claims (7)
1.一种生产固体药物剂型的方法,它包括在不含溶剂情况下,将至少一种药理学上可接受的聚合粘合剂和至少一种药物活性组分与或不与常规药物添加剂一起混合并熔融,得到塑性混合物,和通过挤出将该混合物成形为所需要的药物形式,其中,通过两步进行成形,在第一步中将挤出物切断成为成形制品,在第二步中将这些成形制品在塑性状态下弄圆。
2.如权利要求1所述的方法,其中,将塑性混合物挤出成具有圆形横截面的挤出物。
3.如权利要求2所述的方法,其中,成形制品为圆柱体,其长度/直径比大于1。
4.如权利要求1-3中任一项所述的方法,其中通过切割将塑性混合物断开。
5.如权利要求1-4中任一项所述的方法,其中通过将成形制品与至少一种可被加热的弄圆工具接触而进行弄圆。
6.如权利要求5所述的方法,其中将成形制品和/或弄圆工具移动。
7.如权利要求1-6中任一项所述的方法,其中将混合物成形为椭圆形片剂。
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PE20131126A1 (es) | 2010-09-02 | 2013-10-21 | Gruenenthal Chemie | Forma de dosificacion resistente a alteracion que comprende un polimero anionico |
US9149959B2 (en) | 2010-10-22 | 2015-10-06 | Monosol Rx, Llc | Manufacturing of small film strips |
DK2736497T3 (da) | 2011-07-29 | 2017-11-13 | Gruenenthal Gmbh | Stød-resistent tablet, der tilvejebringer en øjeblikkelig frigivelse af et lægemiddel. |
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LT2838512T (lt) | 2012-04-18 | 2018-11-12 | GrĆ¼nenthal GmbH | Pažeidimui atspari ir dozės atpalaidavimo nuokrypiui atspari farmacinė vaisto forma |
US10064945B2 (en) | 2012-05-11 | 2018-09-04 | Gruenenthal Gmbh | Thermoformed, tamper-resistant pharmaceutical dosage form containing zinc |
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US10154966B2 (en) | 2013-05-29 | 2018-12-18 | Grünenthal GmbH | Tamper-resistant dosage form containing one or more particles |
KR20160031526A (ko) | 2013-07-12 | 2016-03-22 | 그뤼넨탈 게엠베하 | 에틸렌-비닐 아세테이트 중합체를 함유하는 템퍼 내성 투여형 |
CA2931553C (en) | 2013-11-26 | 2022-01-18 | Grunenthal Gmbh | Preparation of a powdery pharmaceutical composition by means of cryo-milling |
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EP3142646A1 (en) | 2014-05-12 | 2017-03-22 | Grünenthal GmbH | Tamper resistant immediate release capsule formulation comprising tapentadol |
US9872835B2 (en) | 2014-05-26 | 2018-01-23 | Grünenthal GmbH | Multiparticles safeguarded against ethanolic dose-dumping |
WO2016170097A1 (en) | 2015-04-24 | 2016-10-27 | Grünenthal GmbH | Tamper-resistant dosage form with immediate release and resistance against solvent extraction |
WO2017042325A1 (en) | 2015-09-10 | 2017-03-16 | Grünenthal GmbH | Protecting oral overdose with abuse deterrent immediate release formulations |
WO2017192921A1 (en) | 2016-05-05 | 2017-11-09 | Monosol Rx, Llc | Enhanced delivery epinephrine compositions |
US11273131B2 (en) | 2016-05-05 | 2022-03-15 | Aquestive Therapeutics, Inc. | Pharmaceutical compositions with enhanced permeation |
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Publication number | Priority date | Publication date | Assignee | Title |
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US1419147A (en) * | 1921-10-27 | 1922-06-13 | Charles A Kloepping | Machine for making pastils |
DE957875C (de) * | 1952-08-30 | 1957-02-07 | Carl Goebel | Maschine zum Herstellen von Pillen |
JPS5839870Y2 (ja) * | 1976-09-14 | 1983-09-08 | 花王株式会社 | 棒状樹脂の先端加工装置 |
DE3612211A1 (de) * | 1986-04-11 | 1987-10-15 | Basf Ag | Kontinuierliches verfahren zum tablettieren |
DE3612212A1 (de) * | 1986-04-11 | 1987-10-15 | Basf Ag | Verfahren zur herstellung von festen pharmazeutischen formen |
GB2192128A (en) * | 1986-07-03 | 1988-01-06 | Fa Ez Khan | Production of pharmaceutical unit dosage forms |
DE3812567A1 (de) * | 1988-04-15 | 1989-10-26 | Basf Ag | Verfahren zur herstellung pharmazeutischer mischungen |
DE3830353A1 (de) * | 1988-09-07 | 1990-03-15 | Basf Ag | Verfahren zur kontinuierlichen herstellung von festen pharmazeutischen formen |
DE19539361A1 (de) * | 1995-10-23 | 1997-04-24 | Basf Ag | Verfahren zur Herstellung von mehrschichtigen, festen Arzneiformen zur oralen oder rektalen Verabreichung |
-
1996
- 1996-07-23 DE DE19629753A patent/DE19629753A1/de not_active Withdrawn
-
1997
- 1997-07-01 US US08/886,286 patent/US6051253A/en not_active Expired - Fee Related
- 1997-07-08 CA CA002209943A patent/CA2209943A1/en not_active Abandoned
- 1997-07-22 CN CN97115459.7A patent/CN1173327A/zh active Pending
- 1997-07-22 JP JP9195390A patent/JPH1057450A/ja not_active Withdrawn
- 1997-07-22 EP EP97112548A patent/EP0820753A3/de not_active Withdrawn
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN114290746A (zh) * | 2021-12-31 | 2022-04-08 | 山东旭日石墨新材料科技有限公司 | 一种油管式加热双层石墨电极挤出模具 |
CN114290746B (zh) * | 2021-12-31 | 2023-12-05 | 山东旭日石墨新材料科技有限公司 | 一种油管式加热双层石墨电极挤出模具 |
Also Published As
Publication number | Publication date |
---|---|
CA2209943A1 (en) | 1998-01-23 |
DE19629753A1 (de) | 1998-01-29 |
EP0820753A2 (de) | 1998-01-28 |
JPH1057450A (ja) | 1998-03-03 |
EP0820753A3 (de) | 1998-06-10 |
US6051253A (en) | 2000-04-18 |
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