CN1200663A - 模塑带式压延机 - Google Patents
模塑带式压延机 Download PDFInfo
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- CN1200663A CN1200663A CN96197806A CN96197806A CN1200663A CN 1200663 A CN1200663 A CN 1200663A CN 96197806 A CN96197806 A CN 96197806A CN 96197806 A CN96197806 A CN 96197806A CN 1200663 A CN1200663 A CN 1200663A
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- A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
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Abstract
一种自含有活性成分的产物组合物通过熔体压延生产平面模制品,特别是片的机器及方法。在此,一加料装置供应产物组合物到至少一对由二个相反转动的压延辊构成的辊。此机器包括一循环模塑带,此模塑带通过二辊之间并在其表面具有凹座以接受产物组合物。
Description
本发明涉及用含有活性成分的产物组合物生产平面模制品,特别是片的机器及方法。
已知的生产片的方法是熔体压延。例如,于DE-A 17 66 546及美国专利4,880,585即说明过此类型的方法。此方法的原理是将活性成分嵌入载体熔体内,例如嵌入脂肪物质或水溶性热塑性聚合物内。熔体由活性成分及聚合物和适宜时其他助剂的混合物,例如在挤压机内熔融,并作为熔体在下游(down-stream)模塑压延机内成形为片,并将此片冷却硬化而生产的。此模塑压延机包括一对反向转动的模塑辊,此模塑辊表面有刻纹(凹陷),相当于所需片的一半的形状。通过一个辊的凹陷内的片组合物与另一辊的凹陷内的片组合物合并,在二个辊的接触区进行片的模塑。
但此种生产片的方法有缺点。例如,辊的构造非常复杂。凹陷是刻于辊内,多数情形下都必须加以磨光才能使片表面达到最大限度的平滑。此辊的制造成本昂贵,因为凹陷的制造必须极准确。这是因为必须将二辊调整到其凹陷恰恰相反。当凹陷很小时,要调整到这样的程度极为困难。
此外,这种机器是不具有灵活性的,因为例如,如果要以同一机器生产不同形状和/或大小的片时,唯一的可能就是完全换装辊并重新仔细调整。但生产片时需要机器在生产各种不同大小及形状的片时有很大的灵活性,尤其在制药业中。
本发明的目的在于制造片的机器,一方面其成本较已知的机器低,另一方面能具有较大的灵活性。本发明另一目的在于提供一种简单且灵活的生产片的方法。
发明人等已发现,此目的可由用含有活性成分的产物组合物生产平面模制品的机器达到,此机器有至少一个供应产物组合物的加料装置,至少一对由二个反向转动的压延机辊构成的辊,且此机器包括一循环模塑带,优选是连续带,此模塑带通过一对辊的二个辊之间,模塑带表面有凹陷以接受产物组合物。
辊是这样安排的,使在其外表面间有一裂缝状(slit-like)通路。而且,一对辊外表面间的最小距离必须对应于模塑带的厚度。产物组合物优选作为宽产物带与模塑带向二辊间的槽状间隙运动的方向相平行供应。模塑带与产物组合物进一步进入压延机辊间的逐渐变窄的区域,将产物组合物送入模塑带的凹座内。二辊间的空间设定主要决定给予产物组合物的压力,于是也由此决定了模制品的厚度。
模塑带的使用在片的生产上导致相当大的灵活性。可仅仅改变机器的模塑带就可生产不同形状或大小的片,而同一压力辊可用于不同大小的片。而且,此机器可以较低成本制造,因为模塑带的凹座不再须高准确度,而这是因为每一片只需一凹座。不需对向反方向转动的组件作仔细的调整。
以塑料制成的模塑带更为经济,可由模塑的方法在其中制成凹座。自然,此时须注意塑料必须是在生产片的各种温度下其尺寸是稳定的。以此法制造的模制品具有由压力辊形成的平表面,而相反的表面决定于模塑带中凹座的形状。
在特别简单及经济的具体实施例中,此凹座在模塑带上为连续的孔隙。在此具体实施例中,孔隙优选是以冲孔制成,根据所用冲孔工具,几乎可制出任何需要的片形。此具体实施例中,在片生产过程中送入模内的产物组合物与一对压延辊的两个外表面接触,所以于此例中生产出的片有二个平表面。
明显的是,模塑带的凹座或孔隙的制造是使能转化成产物模制品的产物组合物有最少的损失。
较常用的凹座或孔隙,从上向下看时,为圆、椭圆或六角形。
孔隙也可,例如,于其周边表面有小条,此小条是由冲孔形状的对应的槽形成,这样可生产有刻痕的片。
模塑带可由任何需要的材料构成,但优选是金属,特别是钢,塑料或橡胶构成。如果使用较刚性的材料,带的厚度必须对应于片的所需厚度。所以,较厚的片形需较厚的带,此带在适宜时可为绞接式带,以便于绕过机器的折向辊。但也可用弹性材料制成的模塑带,此模塑带可此所需片的厚度厚。在此情形时,模塑带比压延机辊间的裂缝厚。当于辊间送料时,模塑带所受压力逐渐增大,以致使片模制品因与压延机辊的距离不同而受到不同的压力。
压延机辊优选是有平滑的外表面。但是,如果需要有大表面积的片模制品时,可以使压延机辊例如有一定程度的粗糙表面。
优选是用可控制温度的压延机辊。这是因为,如果所用产物组合物在高温时是可塑的,而在冷却时变成固体时,优选是使用冷却的压延机辊。另一方面,已知有些产物组合物在潮湿状态时是可塑的,而在干燥状态时是固体,此时优选使用可加热的压延机辊。因此可用辊冷却或干燥产物组合物。视辊的直径而定,产物组合物与辊的热接触有时间长短的不同。压力辊为适合于各种目的工具,优选是导热的,对压力稳定的,对所使用的物质是惰性的。辊间的距离可作调整以产生不同的接触压力。
在一简单具体实施例中,此机器只有一个产物组合物加料装置。但也可能需要生产例如多层片,所以其他具体实施例中可有多个加料装置,用以生产多种产物带。此产物带可同时供应给一对辊。但也可能使模塑带通过多对辊,在此情形时,不同的产物带相继在各对辊中供应。在此情形下,各对辊间的距离优选作调整,使第一对辊的接触压力最低,最后一对辊的接触压力最高。以此法生产的片是多层片。
但也可以用薄保护膜涂覆片,例如涂覆抗扩散聚合物,以使活性成分作特别释放。也可能生产保护性膜,此膜只在特定环境条件(如特定pH或温度)下溶解并释出活性成分。此涂层也可用以掩盖味道或用作光稳定剂。如果整个片都要用保护膜涂覆,一般是于另一工序中以已知方法完成。但根据本发明,也可将一或二种膜板与熔体一起送入辊装置内,送入方法是使熔体位于二膜板之间。这样可使片于其上和/或下边包以适宜的保护膜。上、下二边的保护膜并不必须相同。如为多层片,保护膜可以,例如,导致活性成分的不同释出。
挤压机和/或可加热的送料楔是优选的使用的加料装置。
根据本发明的机器可用以连续生产片或丸状模制品。此机器非常适于各种用途的,因为基础辊装置是未改变的,只须改换模塑带。视所用模塑带及凹座或孔隙的大小而异,可生产的产物的范围可由极小的丸状产物至重1克以上的片。此模制品的边缘角为90℃或更小,这有益于片去除边料,特别是对易碎产物组合物生产的片而言。模塑带上的孔隙优选是互相分离的,这样在生产时不会产生相连的片。是以不需再将片一个个分开。
用压力辊驱动作磨擦偶合意谓着不需另外的模塑带驱动。模塑带的长度可在大范围内变化。这样做的最大优点是可使片停留于模内的时间作所需要的延长,以避免尚未冷却(未硬化)的片由模排出。
离开压延机辊后,可简单地通过使辊偏离的方式,或在适合时使用有齿的辊而从模塑带取出产物。这一方式特别适于具有连续孔隙的模塑带,因为在此情形下片接近上边或下边,很易将片从带中推出。
用模塑带式压延机制得的平面模制品特别适于用作片。这一方面特别适宜的是IR片,即迅速释出活性成分的片,SR片,即缓慢释出活性成分的片,延时作用的片,即延时释出活性成分的片,舌下片,其活性成分经由口腔粘膜吸收,是以是在“舌下”溶解,软片剂或可溶的片剂。
以此法所制造的片自然可用于医药业或食品业(例如维生素片的形式),但也可用于作物(crop)保护及工业界。
本发明还涉及用含活性成分的产物组合物制造平面模制品的方法,其中是将有凹座的模塑带通过反向转动的一对辊的辊间,至少形成一条由含有活性成分的组合物构成的产物股料,优选是宽带,此产物股料供应至成对的辊,在送至一对辊的辊间时,产物组合物压入凹座内,在通过此对辊后模制品即由凹座取出。用以将产物组合物压入所需的接触压力是由调整二辊间的距离事先固定的。二辊间的距离,即其外表面间最小的距离,优选应不大于所用模塑带的厚度。如果是特别具有弹性的模塑带,带间的裂缝可选择为明显小于带的厚度,这样可使产物组合物受到较高的压力。
在本发明方法另一具体实施例中,产物带通过多个连续辊对。也可形成许多不同的产物股料,此产物股料同时供应至一对辊或相继供应至多对辊。此具体实施例的一个变化是,可以共挤压的方式生产有最后片中各层所需顺序的多层熔体。
视所需片而异,产物组合物在热或潮湿时是可塑的。视生产的型式而异,辊对可加热或冷却以制得固体的、尺寸稳定的片。
片是用含一或多种医药活性成分和一或多种常用助剂的混合物制成,此混合物由于至少一种成分熔化或软化,会变成糊状或有粘性,所以是可挤压的。
这特别地包括含有医药上可接受的聚合物的混合物(混合物的玻璃转变温度低于混合物中所有成分的分解温度),例如,聚乙烯吡咯烷酮(PVP),N-乙烯基吡咯烷酮(NVP)与醋酸乙烯酯的共聚物,醋酸乙烯酯与巴豆酸的共聚物,部分水解的聚醋酸乙烯酯,聚乙烯醇,乙烯/醋酸乙烯酯共聚物,聚甲基丙烯酸羟基乙基酯,甲基丙烯酸甲酯与丙烯酸的共聚物,纤维素酯,纤维素醚,聚乙二醇或聚乙烯。聚合物的K值(根据H.Fikentscher,Cellulose-Chemie 13(1932),58-64及71-74)在10至100,优选是12至70,特别是12至35的范围内,以PVP而言,优选是12至35,特别是12至17。
聚合物粘合剂必须是于50至180,优选是60至130℃在整个所有成分的混合物内是软化或熔化的,这样才能使组合物被挤压。所以混合物的玻璃转变温度必须低于180,优选是低于130℃。如有必要,可用常用的医药上可接受的塑化助剂,如长链醇,乙二醇,丙二醇,三羟甲基丙烷,三乙二醇,丁烷二醇,戊醇,己醇,聚乙二醇,硅氧烷,芳香族羧酸酯(例如邻苯二甲酸二烷基酯,偏苯三酸酯,苯甲酸酯,对苯二酸酯)或脂肪族二羧酸酯(如己二酸二烷基酯,癸二酸酯,壬二酸酯,柠檬酸及酒石酸酯)或脂肪酸酯,降低此温度。
其总用量可达聚合物重量的100%的常用的医药助剂的例子是:
增量剂,如硅酸盐或硅藻土,氧化镁,氧化铝,二氧化钛,硬脂酸或其盐,例如其镁盐或钙盐,甲基纤维素,羧甲基纤维素钠,滑石粉,蔗糖,乳糖,谷类淀粉或玉米淀粉,马铃薯粉,聚乙烯醇,特别是其浓度为此混合物总重量的0.02至50,优选是0.20至20%。
润滑剂,如硬脂酸铝及钙,滑石粉及硅氧烷,其浓度为混合物总重量的0.1至5,优选是0.1至3%。
染料,如偶氮染料,天然的有机或无机颜料或染料,无机颜料的存在浓度为混合物总重的0.001至10,优选是0.5至3%.
流动助剂,如动物或植物脂肪,特别是其加氢的形式,以及于室温为固体的脂肪。这些脂肪优选是其熔点为50℃或以上。优选是C12,C14,C16及C18的脂肪酸甘油三酯。也可使用蜡,如巴西棕榈蜡。这些脂肪及蜡优选是单独或与单和/或二甘油酯或磷脂,特别是卵磷脂相混合。此单-及二甘油酯优选衍生自上述形式的脂肪酸。脂肪,蜡,单-和二甘油酯和/或卵磷脂的总量优选是每一层中组合物总重量的0.1至30,优选是0.1至5%.
稳定剂,如抗氧化剂,光稳定剂,氢过氧化物破坏剂,自由基消除剂及抗微生物用的稳定剂。
还可加湿润剂,防腐剂,崩解剂,吸附剂,脱模剂及推进剂(参考,例如,H.Sucker等,Pharmazeutische Technologie,Thieme-Verlag,Stuttgart 1978)。
本发明所谓的助剂也可意谓着与医药活性成分生产固体溶液的物质。这些助剂的例子是季戊四醇及四醋酸季戊四醇酯,聚合物,如聚氧乙烯及聚氧丙烯,及其嵌段共聚物,磷脂,如卵磷脂,乙烯基吡咯烷酮的均聚物或共聚物,表面活性剂,如聚氧乙烯40硬脂酸酯,及柠檬酸与丁二酸,胆汁酸,固醇及,例如,在J.L.Ford,Pharm,Acta Helv.61(1986)69-88所示的其它物质。
用以控制活性成分的溶解度的碱及酸的加成物也可看作是医药助剂(见,例如K.Thoma等,Pharm.Ind.51(1989)98-101)。
助剂合适性的唯一先决条件是其适宜的热稳定性。
本发明的医药活性成分是指所有具有医药效果及最小副作用的物质,只要在加工条件下不分解即可。每一剂量单位的活性成分的量及浓度,视释出的效率及速度而定,可在大范围内变化。唯一的条件是需达到所需效果。因此,活性成分的浓度可在0.1至95,优选是20至80,优选是30至70%重量范围内。也可使用活性成分混合物,例如异丁苯丙酸/咖啡因。本发明的活性成分也可以是维生素及矿物质,以及作物处理剂及杀虫剂。维生素包括A组维生素,B组维生素,B组维生素除了B1,B2,B6及B12,烟酸及烟酰胺外,也包括有维生素B性质的化合物,如腺,嘌呤,泛酸,生物素,腺苷酸,叶酸,乳清酸,潘胺酸,肉毒碱,对一氨基苯甲酸,肌醇及硫辛酸,及维生素C,D族维生素,E族维生素,F族维生素,H族维生素,I族维生素,J族维生素,K族维生素,及P族维生素。本发明的活性成分也包括肽治疗剂。
本发明方法适于加工下述活性成分,例如:
醋丁洛尔,乙酰基半胱胺酸,乙酰基水杨酸,阿昔洛韦,阿普唑仑,阿法骨化醇,尿囊素,别嘌呤醇,氨溴索,阿米卡星,阿米洛利,氨基醋酸,胺碘酮,阿米替林,氨氯地平,阿莫西林,胺苄青霉素,抗坏血酸,阿司帕坦,阿司米唑,阿替洛尔,倍氯米松,苄丝肼,苯扎盐酸铵,苯佐卡因,苯甲酸,倍他米松,苯扎贝特,生物素,双环派丙醇,比索洛尔,溴西泮,溴苄环己烷(bromhexine),2-溴隐亭(bromocriptine),布得松奈(budesonide),丁苯羟酸(bufexamac),丁咯地尔(buflomedil),丁螺旋酮(buspirone),咖啡因,樟脑,甲巯丙脯酸,卡马西平(carbamazepine),卡比多巴(carbidopa),羰佩汀(carboplatin),头孢氯(cefachlor),塞伐列青(cefalexin),塞伐梭青(cefatroxil),硕孢唑林(cefazolin),头孢克肟(cefixime),头孢胺噻(cefotaxime),头孢噻甲羧肟(ceftazidime),头孢三肼噻肟(ceftriaxone),塞夫洛幸(cefuroxime),色力鞠林(selegiline),氯霉素,双氯苯双胍己烷,氯苯那敏(chlorpheniramine),氯噻酮(chlortalidone),胆碱,环孢霉素,西拉史达汀(cilastatin),西咪替丁(cimetidine),西波佛克辛(ciprofloxacin),西杀平(cisapride),顺铂,克雷梭霉素(clarithromycin),克列酸(clavulanic acid),克密伯胺(clomibramine),氯消西泮(clonazepam),可乐定(clonidine),克霉唑(clotrimazole),可待因,胆固胺(cholestyramine),科摩甘斯酸(cromoglycic acid),氰钴胺,环丙氯地孕酮(cyproterone),去氧孕烯(desogestrel),地塞米松(dexamethasone),泛醇(dex-panthenol),右甲吗南(dextromethorphan),右旋丙氧酚(dextropropoxiphen),安定(diazepam),二氯胺苯乙酸(diclofenac),异羟基洋地黄毒苷,二氢可待因,二氢麦角胺,二氢麦角毒(dihydroergoroxin),硫氮酮(diltiazem),苯海拉明(diphenhydramine),双嘧派胺醇(dipyridamole),二吡喃酮,二异哌酰胺(disopyramide),洞沛力酮(domperidone),多巴胺,强力霉素(doxycycline),依那普利,麻黄素,肾上腺素,麦角骨化醇,麦角胺,红霉素,雌二醇,乙炔基雌二醇,鬼臼乙叉苷(etoposide),球桉油醇(Eucalyptusglobulus),芬莫汀(famotidine),非洛伐平(felodipine),非诺代酸盐(fenofibrate),酚丙喘宁(fenoterol),芬太尼(fentanyl),黄素单核苷酸,氟康唑,氟桂肼(flunarizine),氟尿嘧啶,氟苯氧丙胺(fluoxetine),氟联苯丙酸,速尿(furosemide),勾洛帕咪(gallopamil),二甲苯氧庚酸,庆大霉素(gentamicin),银杏酚(Ginkgo biloba),优降糖(glibenclamide),吡磺环己脲,氯氮平(clozapine),甘草,灰黄霉素(griseofulvin),愈创木酚甘油醚,氟哌丁苯(haloperidol),肝素,透明质酸,双氢克尿塞(hydrochlorothiazide),二氢可待因酮,氢化可体松,氢化吗啡酮,氢氧化异丙托铵(ipratropiumhydl roxide),异丁苯丙酸,亚胺配(imipenem),消炎痛(indomethacin),碘己醇(iohexol),碘异酞醇,二硝酸异山梨醇,单硝酸异山梨醇,异维甲酸(isotretinoin),酮替芬,酮康唑,苯酮苯丙酸(ketoprofen),酮列(ketorolac),柳安心定(labetalol),乳果糖,卵磷脂,左旋肉毒碱(levocarnitine),左旋多巴(levodopa),左旋杀酰胺,左旋乙基炔诺酮(levonorgestrel),左旋甲状腺素,利多卡因(lidocaine),脂酶,丙咪肼(imipramine),力辛皮(lisinopril),氯苯呱酰胺(loperamide),氯羟取甲安定(lorazepam),洛伐他汀,甲羟孕酮,薄荷,甲胺蝶呤,甲基多巴,甲基强的松龙,灭吐灵(metoclopramide),美多心安(metoprolol),双氯苯咪唑(miconazole),米大连(midazolam),二甲胺四环素,长压定(minoxidil),米异波透(misoprostol),吗啡,多种维生素混合物或矿物盐混合物,N-甲基麻黄素,那汀左呋喃(naftidrofuryl),甲氧萘丙酸,新霉素,尼卡汀平(nicardipine),麦角溴菸脂,菸酰胺,菸碱,菸酸,硝苯吡啶,尼莫代平(nimodipine),硝基安定(nitrazepam),硝代平(nitrendipine),尼那啶(nizatidine),炔诺酮(norethisterone),诺福克辛(norfloxacin),18-甲炔诺酮(norgestrel),去甲替林(nortriptyline),制霉菌素(nystatin),欧福克辛(ofloxacin),欧眉婆柔(omeprazole),翁大西左(ondansetron),胰酶,泛醇,泛酸,醋胺酚(paracetamol),青霉素G,青霉素V,苯巴比妥,己酮可可碱,苯氧甲基青霉素,脱羟肾上腺素,去甲麻黄碱,苯妥英(phenytoin),吡氧噻肼(piroxicam),多粘菌素B,聚烯吡酮磺,帕凡他汀(pravastatin),环丙二氮单,哌唑胼(prazosin),泼尼松龙(prednisolone),泼尼松(prednisone),溴麦角环肽(bromocriptine),丙芬诺(propafenone),萘心市(propranolol),丙羟茶碱,假麻黄素,吡多醇(pyridoxine),奎尼丁(quinidine),那力皮(ramipril),那尼丁啶(ranitidine),利血平(reserpine),视黄醇,核黄素,利福平(rifampicin),芸香苷,糖精,舒喘宁(salbutamol),杀卡宁(salcatonin),水杨酸,辛凡大汀(simvastatin),生长激素,甲磺胺心定(sotalol),螺内酯(spironolactone),硫糖铝,舒巴坦,磺胺甲基异噁唑,柳胺磺胺吡啶(sulfasalazine),舒宁(sulpiride),三苯氧胺(tamoxifen),喃氟啶(tegafur),替普瑞酮,特柔辛(terazosin),叔丁喘宁(terbutaline),特非那定(terfenadine),四环素,茶碱,硫胺,血小板抑制剂(ticlopidine),噻吗心安(timolol),反克米酸(tranexamic acid),全反维生素A酸(tretinoin),丙酮缩去炎松(triamcinolone acetonide),胺苯喋啶(triamterene),甲氧苄胺嘧啶(trimethoprim),曲克芦丁,尿嘧啶,丙戊酸,万古霉素,藜帕咪(verapamil),维生素E,亚叶酸,日多啶(zidovudine)。
优选的活性成分是异丁苯丙酸(外消旋物,对映体或浓缩对映体),苯酮苯丙酸,氟联苯丙酸,乙酰基水杨酸,藜帕咪(verapamil),醋胺酚,硝苯吡啶(nifedipine)或甲巯丙脯酸。
在一些情况下,会形成固体溶液。“固体溶液”一词是技术人员所熟知的,例如开始时所述文献所叙。于医药活性成分在聚合物内的固体溶液中,活性成分是在聚合物内以分子分散体存在。
然后以常用方法将医药混合物熔化,优选是在挤压机内熔化,然后如美国专利4,880,585所述方法供应至模塑带式压延机。如有必要,经压延后可将片于空气或冷浴内冷却。
在物料粘性太大时,会难以从模中取下或根本不能取下,此时可用脱模剂,例如硅油或硅氧烷涂料。
下面今以附图说明根据本发明的机器的优选具体实施例。其中:
-图1为本发明模塑带式压延机的示意图,
-图2为模塑带第一具体实施例的纵断面详图,此模塑带通过图1所示机器的压延辊之间,
-图3为模塑带的第二具体实施例的如图2的详图。
图1表示本发明模塑带式压延机10,模塑带12通过压延机辊14及16间,此二压延辊位于折向辊18之上。挤压机20用以生产可塑产物组合物,此产物组合物优选是以宽产物带22形式生产。压延机辊14,16,模塑带12及产物带22优选是基本同一宽度。模塑带12的循环方向及辊14与16的旋转方向如箭头所示。产物带22以平行于模塑带12运动的方向送入辊14与16间的楔状凹陷26内。
模塑带12的表面有凹陷24或裂缝30,特别如图2及3所示。
图2表示本发明机器的第一具体实施例,其中模塑带12有凹陷24。模塑带12及产物组合物22一起进入辊14与16间的逐渐变窄的缝隙内,产物组合物22被挤入模塑带12的凹座24内。例如如果产物组合物以热的可塑的状态供应,至少辊14与16之一可被冷却,这样可使产物组合物在通过辊时在凹座24内变冷,形成固体模制品28,然后由凹座取出。
图3表示如图2所示的本发明图1模塑带式压延机的详情,在图3中,根据本发明另一具体实施例,模塑带12有连续裂缝30,产物组合物22在通过机器的辊14与16间时被挤入其中。此情形下所生产的模制品28有二个平滑表面。模塑带12的裂缝30优选是对模塑带冲孔产生的。由图3可了解到,所形成的模制品28有近90°的边缘角。任何突出的产物组合物可从以此方法模塑的片上轻易磨去。
Claims (20)
1.一种自一含有活性成分的产物组合物(22)生产平面模制品(28)的机器,此机器具有至少一加料装置(20)以供应产物组合物,至少一对由反向转动的压延机辊组成的辊(14,16),其中机器包括循环模塑带(12),此模塑带通过二辊(14,16)之间,并在此模塑带表面具有凹座(24,30)以接受产物组合物。
2.根据权利要求1的机器,其中凹座是模塑带(12)中的连续裂缝(30)。
3.根据权利要求2的机器,其中裂缝(30)为圆、椭圆或六角形。
4.根据权利要求2或3的机器,其中裂缝(30)在其周边具有条,此条向内伸出以形成模制品中的刻痕。
5.根据权利要求1至4任一项的机器,其中模塑带(12)由金属、塑料或橡胶材料构成。
6.根据权利要求1至5任一项的机器,其中模塑带(12)的厚度至少与模制品(28)所需的厚度一样大。
7.根据前述权利要求任一项的机器,其中压延机辊(14,16)具有平滑外表面。
8.根据前述权利要求任一项的机器,其中压延机辊(14,16)的温度可以控制。
9.根据前述权利要求任一项的机器,其中一对辊的辊(14,16)间距可以改变,以便产生不同的接触压力。
10.根据前述权利要求任一项的机器,其中此机器(10)具有多个加料装置(20),以供应不同的产物组合物。
11.根据权利要求10的机器,其中由不同产物组合物构成的产物股料(22)同时供应至一对辊。
12.根据权利要求10的机器,其中由不同产物组合物构成的产物股料(22)供应至连续的各对辊。
13.根据前述权利要求任一项的机器,其中加料装置(20)是挤压机和/或可加热的装料楔。
14.一种自一含有活性成分的产物组合物生产平面模制品的方法,其中
-将具有凹座的模塑带通过反向转动的一对压延机辊间,
-设定二辊间所需的接触压力,
-至少形成由含有活性成分的产物组合物所构成的产物股料,
-此产物股料供应至一对辊,将产物组合物挤入凹座内,
-将模制品由凹座取出。
15.根据权利要求14的方法,其中产物带通过多个对辊之间。
16.根据权利要求14或15的方法,其中形成多个产物股料,将它们同时供应至一对辊或相继供应至多对辊。
17.根据权利要求14至16任一项的方法,其中供应的产物组合物在加热时为可塑的,冷却时则变成固体。
18.根据权利要求17的方法,其中至少冷却一对辊。
19.根据权利要求14至16任一项的方法,其中使用的产物组合物在潮湿时为可塑的,在干燥时则变成固体。
20.根据权利要求19的方法,其中加热至少一对辊。
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CN102421298A (zh) * | 2009-03-26 | 2012-04-18 | 马雷尔汤森深加工公司 | 物块分配设备和包括这种物块分配设备的模制设备 |
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DE19751330A1 (de) * | 1997-11-19 | 1999-05-20 | Hosokawa Bepex Gmbh | Formgebungsverfahren für bei Raumtemperatur knetbare, insbesondere zähelastische, klebrige Massen |
DE19901383A1 (de) | 1999-01-15 | 2000-07-20 | Knoll Ag | Verfahren zur Herstellung unterschiedlicher fester Dosierungsformen |
ATE266996T1 (de) * | 1999-10-13 | 2004-06-15 | Novo Nordisk As | Verfahren zum herstellung von medizinische formkörpern |
DE10007560C2 (de) * | 1999-12-14 | 2002-09-26 | Alexanderwerk Ag | Vorrichtung zum Kompaktieren von kleinen Mengen pulverförmigen Materials |
DE10038571A1 (de) * | 2000-08-03 | 2002-02-14 | Knoll Ag | Zusammensetzungen und Dosierungsformen zur Anwendung in der Mundhöhle bei der Bhandlung von Mykosen |
WO2012004408A2 (en) * | 2010-07-09 | 2012-01-12 | Research Center Pharmaceutical Engineering | Multi-layer tablet formation by adhering tablet bodies together |
WO2014139803A1 (en) * | 2013-03-15 | 2014-09-18 | AbbVie Deutschland GmbH & Co. KG | Process and apparatus for metering a plasticized formulation |
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US2157570A (en) * | 1937-01-19 | 1939-05-09 | Atlantic Coast Fisheries Co | Apparatus for making tablets |
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CN102421298A (zh) * | 2009-03-26 | 2012-04-18 | 马雷尔汤森深加工公司 | 物块分配设备和包括这种物块分配设备的模制设备 |
CN102421298B (zh) * | 2009-03-26 | 2015-07-29 | 马雷尔汤森深加工公司 | 物块分配设备、包括物块分配设备的模制设备及操作方法 |
CN105165997A (zh) * | 2009-03-26 | 2015-12-23 | 马雷尔汤森深加工公司 | 用于操作模制设备的方法 |
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HUP9900734A3 (en) | 2000-07-28 |
CZ109698A3 (cs) | 1999-07-14 |
EP0957884A1 (de) | 1999-11-24 |
AU705657B2 (en) | 1999-05-27 |
SI9620112A (sl) | 1998-08-31 |
DE19539359A1 (de) | 1997-04-24 |
ZA968848B (en) | 1998-04-22 |
TW343920B (en) | 1998-11-01 |
NO981795L (no) | 1998-04-23 |
BR9611239A (pt) | 1999-03-30 |
AU7491196A (en) | 1997-05-15 |
WO1997015268A1 (de) | 1997-05-01 |
NO981795D0 (no) | 1998-04-22 |
CA2232353A1 (en) | 1997-05-01 |
KR19990066977A (ko) | 1999-08-16 |
MX9802985A (es) | 1998-09-30 |
SK50698A3 (en) | 1999-01-11 |
HUP9900734A2 (hu) | 1999-10-28 |
JPH11514275A (ja) | 1999-12-07 |
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