CN1596101A - 含有糖果组分的剂型 - Google Patents
含有糖果组分的剂型 Download PDFInfo
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Abstract
由一种活性成分和一种糖果成分组成的一种剂型。在一项实施方案中,所述剂型重量的相对标准误差小于1%,且所述剂型有至少一个面。在另一项实施方案中,所述剂型由一种活性成分和一种糖果成分组成,其特征在于,所述剂型有至少一个面,而没有一个自由形态的表面,且其在最大消光角的平均偏振光传播不大于所述剂型在最大传播角的平均偏振光传播。所述活性成分可以是药物活性成分。
Description
发明背景
1.发明领域
本发明涉及一种剂型,例如含有糖果组分的药物组合物。具体而言,本发明涉及含有至少一种活性成分和糖果组分的剂型,糖果组分如脂肪、无定形冰糖(sugarglass)或软糖。
2.背景资料
在各种药用物质输送器的设计方面的一个重要目标,特别是对于供儿科和老年科的用途方面,就是要制造采用有效的药物组合物来掩蔽其不愉快口味和/或组织结构,从而具有适口性的、口味良好的各种剂型,以改善患者对于用药法方案的适应性。各种糖果组分对于获得这类理想的产品属性方面,具有很大的潜力。可是,其在药物应用方面,迄今还很有限。
在糖果企业与制药企业的管理制度方面的基本差别,造成了该两类部门之间,在设施和加工流程两个方面,都无法进行直接交流。以至制药业的开发人员,如果想要在其药物输送器中采用糖果组分的有利因素,就必须在制药业的“生产工艺规范”(GMP)以及产品品质标准等方面经受巨大的挑战。
例如在糖果生产加工设施的设计方面,并不要求如制药业那样严格控制对于其原材料的追根溯源,也并不需要象在加工多种药物活性成分时那样的严密防止交叉污染的装备。在任何制药操作过程,对于高纯度的供水源、密闭式的空气处理系统以及定点分析检验等步骤,都是严密控制的。这类系统的安装以及可靠性验证,都需要很大的代价,而且相当复杂。
当前,绝大多数的商品糖果加工过程的设计要求,都是着眼于高容量和低成本的初级目标,而对于无菌性、连贯性、一致性、计量的精确性以及一般的外观等方面,则都是次要考虑的问题。对于药物剂型,同样也需要能够可靠和可重复地生产具有高度精确剂量,并且具有一致性、连贯性和外观雅致的产品的,相对低成本、高容量的各种商品规格的加工方法。
例如在当前一般糖果生产方面,在生产过程可能会出现高比率的废次品,而不致影响其效益。因为在一批生产过程的废次产品部分,仍然能够再循环进入下一批生产程序。但是在药物生产过程中,从生产工艺规范方面考虑,在常规上就不允许将废料再加工,更不能进行各批产品的混合处理。
药用剂型在各单体的重量方面,必须只有很微小的差异,使其中的药物含量达到高度均一。由于多数糖果的生产加工过程,在设计方面就并不要求象制药过程那样高度的精确性和可重复性,其设计本身就固有其高度的可变性。例如一般的糖果拉条成型操作过程,由于随着其温度变化,其中会有空气气泡混入,且条索的拉伸强度、黏度和可塑性都会发生变化,从而使产品重量发生较大变化。常规的糖果切段和包装操作程序,会由于其条索的流动性和厚度的改变,而使产品的重量发生很大的变化。在挤压加工过程的糖果中各种组成,会由于其流动速度的改变,而使每块的重量发生变化,由于中心进料泵压操作的跳动作用,可导致其中心装料容量的变化。在糖果的浇注操作工序方面,另外还存在着固有的高度重量变化,其进料没有固定的容量。因而,糖果块的重量是由计量泵压操作的可再现性来决定的。这一操作程序则可受到因温度和各种材料因素引起的黏度变化的影响。
产品的审美问题是两类企业之间另一方面的差别。例如典型的糖果浇注操作制造的产品只在三个面有高度清晰的轮廓,而另外一面则只能是“自由形成的”表面。在这类产品中,自由形成的表面的光洁度要高于模制形成的面。至于药物制品,则一般都要求均匀一致的外观,这意味着在生产加工过程须进行严格的控制。因而,理想的是,在生产加工过程应当使剂型所有面都具有均匀而清晰的轮廓。
采用当前通用的各种糖果生产方法制造的产品,并不要求摒弃不产生大量碎屑、裂块、变形、或缺损等问题的各种常规包装操作条件。但是这对于药用剂型方面就不适用。例如在搓条成型操作过程,在其冷却和折叠操作时,会有空气混入;在搓条操作过程的机械压力也会损坏其糖衣层。这类缺陷都会在终末成品中,遗留各种扭曲的线条和空气气泡等瑕疵,从而提高了产品的脆弱性,降低了均匀性,以至损害其外观的完美性。尤其是,在其扭曲的部位,可成为其结晶形成的核心,以至影响该产品的保存期限。空气气泡的形成还可使产品的重量发生变化,从而减损产品的整体一致性和外观美感。
糖果核芯巧克力包衣的制造一般都是在冷模具中浇注巧克力外层,待其凝固,再倒去多余部分,然后注入中心充填材料;或者是将核芯材料浸入融化的巧克力以形成低层,再在其顶部和四周浇上融化的巧克力,使其整个包入巧克力中,然后倒去多余部分。这种操作方法,自然会造成明显的重量变化,因为其包衣层的份量是决定于因巧克力的原材料、温度和湿度等因素所造成的黏度。因而,这类操作条件都并不适用于药用剂型的制造。若要使巧克力这类成分有利于制药的用途,在其生产加工程序方面,就要求保证,对于任何类型的中央充填过程,能够可靠并可再现地形成精确而一致的巧克力包衣层。
本发明的一个目的是提供一种包含一种活性成分和一种糖果组分的剂型,其中,所述剂型重量的相对标准误差少于1%,且所述剂型有至少一个面。
本发明的另一个目的是提供一种包含一种活性成分和一种糖果组分的剂型,其中,所述剂型有至少一个面,所述剂型没有自由形成的表面,且所述剂型在最大消光角的平均偏振光传输不大于在最大发射角的平均偏振光传输。
本发明的还有一些目标、特色以及优势,对于本技术领域的专业人员,都可从在此提供的有关本发明的详细论述方面领略。
发明概述
在一项实施方案中,本发明的剂型包含有至少一种活性成分和一种糖果组分。所述剂型具有至少一个面,所述剂型重量的相对标准误差小于1%,较好是0.5%。
在本发明的另一项实施方案,所述种剂型包含至少一种活性成分和一种糖果组分,其中,所述剂型有至少一个面,没有自由形成的表面,且其在最大消光角的平均偏振光传输不大于所述剂型在最大发射角的平均偏振光传输。
在另一项实施方案中,所述剂型重量的相对标准误差小于0.5%。
在另一项实施方案中,所述糖果组分至少包含一种选自脂肪、无定形冰糖和软糖的成分。
在另一项实施方案中,所述糖果组分不含明胶基组分。
在另一项实施方案中,所述糖果组分不含凝胶基组分。
在另一项实施方案中,所述糖果组分包含一种无定形冰糖成分,且所述剂型不含自由形成的表面。
在另一项实施方案中,所述剂型所有的面都具有约200-300个光泽单位的表面光泽。
在另一项实施方案中,所述剂型具有两个或多个面,并且其任何两个面之间的表面光泽之差不超过约20个光泽单位。
在另一项实施方案中,其任何两个面之间表面光泽之差不超过约15个光泽单位。
在另一项实施方案中,其任何两个面之间的表面光泽之差不超过约10个光泽单位。
在另一项实施方案中,所述剂型在最大消光角的平均偏振光传输不大于所述剂型在最大发射角的平均偏振光传输。
在另一项实施方案中,所述剂型在最大消光角具有约0-40个灰度单位的平均偏振光传输。
在另一项实施方案中,所述糖果组分包含一种无定形冰糖成分,且所述剂型不含自由形成的表面。
在另一项实施方案中,所述活性成分是一种药物活性成分。
在另一项实施方案中,所述剂型包含由活性成分组成的颗粒。
在另一项实施方案中,所述颗粒的平均粒度约为50-2000微米。
在另一项实施方案中,至少一部分颗粒是包衣的颗粒。
在另一项实施方案中,所述剂型是一种完整的单体。
在另一项实施方案中,所述剂型表面上没有任何的疤痕。
在另一项实施方案中,所述剂型重量的相对标准误差小于1.0%。
在另一项实施方案中,所述糖果组分包含一种无定形冰糖成分。
在另一项实施方案中,所述剂型基本上没有直径超过0.5-5.0微米的孔。
在另一项实施方案中,本发明的剂型不含凝胶基组分或明胶基组分。
在另一项实施方案中,本发明的剂型包含有一种无定形冰糖成分,且所述剂型没有自由形成的表面。
在另一项实施方案中,所述剂型所有各面都具有约200-300个光泽单位的表面光泽。
在另一项实施方案中,所述剂型具有两个或更多的面,并且在任何两个面之间表面光泽之差不超过约20个光泽单位,较好是不超过约15个光泽单位,最好是不超过约10个光泽单位。
在另一项实施方案中,所述剂型在最大消光角具有约0-40个灰度单位的平均偏振光传输。
在另一项实施方案中,所述活性成分是一种药物活性成分。
附图简述
图1A描述的是在常偏振光下观察到的现有技术的组分以及本发明的组分。
图1B描述的是在对入射光90°过滤的偏振光下观察到的现有技术的组分以及本发明的组分。
图2A是可供本发明的剂型制造用的双片型的硬质锭剂模具的照片。
图2B是图2A描述的模具和从该模具中脱模的锭剂的照片。
图3A描述的是一种用来测量在最大发射角平均偏振光传输的仪器。
图4A描述的是,将用现有技术制造的硬糖与本发明的剂型进行比较,在最大光传输角拍摄的标准照片影象。
图4B描述的是,将用现有技术制造的硬糖与本发明的剂型进行比较,在最大光消光角拍摄的标准照片影象。
图5显示的是在最大光传输角和最大光消光角,CHLORASEPTIC润喉锭剂的灰度强度的分布状况。
图6显示的是在最大光传输角和最大光消光角,本发明的一种产品的灰度强度的分布状况。
发明详述
在此采用的术语“剂型”,是指专门设计供包含一种预定量(即剂量)的某种成分,例如一种活性成分(定义如下)的任何固体、半固体、或液态的制剂。适用的剂型可以是一类药物输送器,包括:经口施用,颊腔含服,直肠灌注,局部、经皮内、或经黏膜施用,或皮下植入,或者其他各种植入式药物输送器,或者,供输送各种无机物质、维生素和其他营养品(nutraceutical)、口腔护理用药物、食用香精等。本发明的各种剂型较好是选用固体型,不过其中仍然可以含有各种液态或半固态的成分。在特别优选的一项实施方案中,所述剂型是口服施用系统,以供输送一种活性成分进入人体的胃肠道内。在另外一项优选的实施方案中,所述剂型是经口腔施用的含有各种药物活性成分的“安慰剂”,且所述剂型设计成与专门的药用有效剂型具有相似的外观,例如在临床研究测试方面可以用于对比的目的,例如一种特定的药用有效剂型的安全性和有效性。
本发明的剂型必须是模制的。所述剂型包含至少一种活性成分和一种糖果制剂。
本发明所用的适用的活性成分包括例如药物、无机物、维生素和其他营养品、口腔护理剂、食用香精及其混合物。适用的药物包括止痛药、消炎药、治风湿药、麻醉药、抗组胺药、止咳药、抗生素类、抗感染药、抗病毒剂、抗凝血药、抗抑郁药、抗糖尿病药、止吐药、抗气胀药、抗真菌剂、镇痉药、食欲抑制药、支气管扩张药、心血管药、中枢神经系统药、中枢神经系统刺激剂、解充血药、利尿药、祛痰药、肠胃药、偏头痛药、运动病制剂、粘液溶解药、肌肉松弛药、骨质疏松制剂、聚二甲基硅氧烷类、呼吸系统药、催眠药、尿道药物及其混合物。
适用的口腔护理用药物包括呼吸清新剂、齿牙洁白剂、抗微生物剂、齿牙矿化剂、齿牙腐蚀抑制剂、局部麻醉剂、黏膜保护剂等。
适用的食用香精剂包括甲醇、薄荷、薄荷香精、水果香精、巧克力、香兰草、口香糖胶香精、液态香精及其各种制剂等。
适用的胃肠道系统药物包括抗酸剂,例如碳酸钙、氢氧化镁、氧化镁、碳酸镁、氢氧化铝、碳酸氢钠、碳酸二羟化铝钠;刺激性轻泻剂,例如比沙可啶、鼠李皮、丹蒽醌、番泻叶、酚酞、芦荟、蓖麻油、蓖麻油酸和脱氢胆酸及其混合物;H2受体拮抗剂,例如法莫替丁(famotadine)、雷尼替丁、西咪替丁(cimetadine)、尼扎替丁;质子泵抑制剂,例如奥美拉唑或兰索拉唑;胃肠道细胞防护剂,例如硫糖铝(sucraflate)和米索前列醇;胃肠道前动力剂,例如普卡比利(prucalopride);对于幽门螺杆菌的抗生素,例如克拉霉素、阿莫西林、四环素和甲硝哒唑;抗止泻药,例如苯乙哌啶和洛哌丁胺;甘吡咯溴;止吐药,例如昂丹司琼;镇痛剂,例如氨水杨酸(mesalamine)。
在本发明的一项实施方案中,其中的活性成分可选自比沙可啶、法莫替丁、雷尼替丁、甲腈咪胍、普卡比利、苯乙哌啶、洛哌丁胺、乳糖分解酶、氨水杨酸、铋、抗酸剂,和它们药学上可接受的盐、酯、异构体及其混合物。
在另一项实施方案中,其中的活性剂可选自止痛药、消炎药以及解热药:例如非类固醇型消炎药(NSAID),其中包括丙酸衍生物,例如布洛芬、萘普生、酮洛芬等;乙酸衍生物,例如消炎痛、双氯芬酸、舒林酸、托美丁等;灭酸衍生物,例如甲灭酸、氯甲灭酸、氟灭酸等;biphenylcarbodylic acid衍生物,例如二氟尼柳、氟苯柳等;以及昔康类,例如吡罗昔康、舒多昔康、伊索昔康、美洛昔康等。在一项特别优选的实施方案中,其中的活性剂选自丙酸衍生的NSAID,例如布洛芬、萘普生、氟比洛芬、芬布芬、非诺洛芬、吲哚洛芬、酮洛芬、氟洛芬、吡洛芬、卡洛芬、奥沙普秦、普拉洛芬、舒洛芬和它们的药学上可接受的盐、衍生物和组合。在本发明的另一项实施方案中,其中的活性剂可选自醋氨酚、乙酰水杨酸、布洛芬、萘普生、酮洛芬、氟比洛芬、双氯芬酸、环苯扎林、美洛昔康、罗非昔布、塞来昔布及其药学上可接受的盐、衍生物及其组合物。在本发明的另一项实施方案中,其中的活性剂可选自醋氨酚、乙酰水杨酸、布洛芬、萘普生、酮洛芬、氟比洛芬、双氯芬酸、环苯扎林、美洛昔康、罗非昔布、塞来昔布及其药学上可接受的盐、酯、异构体及其混合物。
在本发明的另一项实施方案中,其中的活性剂可选自伪麻黄素、苯丙醇胺、氯苯吡胺、右美沙芬、苯海拉明、抗敏安、阿司咪唑、特非那定、非索非那定、氯雷他定、地氯雷他定(desloratadine)、西替利嗪及其混合物及其药学上可接受的盐、酯、异构体及其混合物。
适用的聚二甲基硅氧烷,包括但是不限于二甲硅油和西甲硅油,如美国专利号4,906,478、5,275,822和5,103,260所披露。在此采用的术语“西甲硅油”所指的是,广泛范围的聚二甲基硅氧烷,包括但是不限于西甲硅油和二甲硅油。
在该类剂型中含有的一种或多种的活性成分,都是有效治疗剂量。该种剂量通过口服施用就可产生理想的治疗反应,在本领域的老资格技术人员都很容易进行确认。对于这样的剂量的确定,据本领域所熟悉的是,包括所施用的具体活性成分、该活性成分的生物利用特性、用药方案、患者的年龄和体重以及必须考虑到的其他各种因素。较好的是,所述剂型至少须包含约85重量%的活性成分。在一项优选的实施方案中,其核芯至少包含约85重量%的活性成分。
在该类剂型中可以含有任何类型的一种或多种的活性成分。例如所述活性成分可分散成为分子水平状态,例如在所述剂型内呈融化或溶解状态,或可以是颗粒状态,而且可以是有包衣或无包衣型。如果所述活性成分是颗粒型时,一般其颗粒(无论是有包衣还是无包衣)的平均粒度约为1-2000微米。在一项优选的实施方案中,其颗粒是具有平均粒度为50-2000微米的颗粒或片剂,较好是约50-1000微米,最好是约100-800微米。
如果所述活性成分具有令人不愉快的味道,而且所述剂型是供咀嚼或在口腔内溶解之后再吞咽的制品,那么,如本领域所知,该活性成分就要采用遮蔽其味道的包衣技术。适用的各种遮蔽味道的包衣技术的范例,在美国专利编号4,851,226、5,075,114和5,489,436中都有论述。也可采用商品供应的各种经过味道遮蔽处理的活性成分。例如在本发明中所采用的通过凝聚作用进行纤维素乙酯或其他各种聚合物包裹的醋氨酚颗粒。这种利用凝聚作用包裹的醋氨酚可从Eurand美国公司(Vandalia,Ohio)或Circa有限公司(Dayton,Ohio)采购。
本发明的这类剂型,还可加入药学上可接受的各种佐剂,例如防腐剂;高强度的甜味剂,例如天门冬氨酰苯丙氨酸甲酯、乙酰舒泛钾、甜蜜素、糖精、三氯半乳蔗糖等;及其他甜味剂,例如dihydroalcones类、甘草苷、MonellinTM、甜菊苷、TalinTM等;各种食用香精类;抗氧化剂;表面活性剂;以及染色剂。
在有些实施方案中,其中需要采取改变活性成分的释放过程,据本领域所知,这种活性成分可以任选包裹一种可改变释放过程的包衣技术。也可采用商品供应的各种可改变释放过程的活性成分。例如如上所述,在本发明中已经采用的通过凝聚作用进行各种可改变释放过程的聚合物包裹的醋氨酚颗粒。
一种或多种活性成分,较好是能够在接触一种液体时,例如水、胃酸、肠液等,就会溶解的制品。在一项优选的实施方案中,其中的活性成分的溶解特性,符合美国药典(USP)中关于含有该种活性成分的即释性片剂的规范。在要求所述活性成分被动物吸收进入全身循环血行的一些实施方案中,其一种或多种活性成分,较好是在接触例如水、胃酸、肠液等之类的液体时,就能够溶解的制品。在一项实施方案中,其中的活性成分的溶解特性,符合美国药典中有关含有该种活性成分的即释性片剂的规范。例如对于醋氨酚的片剂,在美国药典24中指定,在pH5.8的磷酸盐缓冲液中,采用美国药典的器械2(搅拌桨)以50转/分(rpm)测定,在用药之后30分钟内,所述剂型中含有的至少80%的醋氨酚,可以释放出来;而对于布洛芬的片剂,在美国药典24中指定,在pH7.2的磷酸盐缓冲液中,采用美国药典的器械2(搅拌桨)以50转/分测定,在用药之后60分钟内,所述剂型中含有的至少80%的布洛芬,可以释放出来。参见美国药典24的2000年修订版本,19-20和856(1999)。在另一项实施方案中,所述活性成分的溶解特性已经过改变:例如受控制的、持续性的、延展性的、迟缓性的、拖延性的、阻滞性的等。
在此采用的术语“糖果制剂”的意义是,由一种甜味成分组成的可食用制品。各种糖果制剂通常包括采用糖、糖浆、或蜂蜜等制造的各种医疗用制品。以及诸如冰糖蜜饯或糕饼之类的甜味食品。在本领域中普遍知晓的各种糖果制剂包括“糖型糖果类”,例如硬糖类(例如无定型冰糖、太妃糖、砂性软糖、微晶糖膏、果冻软糖、胶姆香糖、pasteils、饴糖、乳脂糖、果仁糖和咀嚼胶姆糖);以及“脂肪基糖果类”,例如巧克力(包括例如牛奶巧克力、黑巧克力、低糖巧克力);还有,各种涂料层,例如巧克力混合包衣层,彩色糊料混合涂料层,例如白巧克力等。
适用的甜味成分包括各种食用糖类,例如蔗糖、葡萄糖(右旋糖)、果糖;糖-醇类,例如山梨醇、甘露醇、赤藻糖醇、木糖醇、麦芽糖醇等;以及各种高强度甜味剂,天门冬氨酰苯丙氨酸甲酯、乙酰舒泛钾、甜蜜素、糖精、三氯半乳蔗糖等;及其他甜味剂,例如dihydroalcones类、甘草苷、MonellinTM、甜菊苷、TalinTM等;
在另一项实施方案中,其中的糖果制剂可选自各种脂肪基的糖果制品,例如例如巧克力、包括例如牛奶巧克力、黑巧克力、低糖巧克力;涂层夹心糖类,例如巧克力混合夹心糖类、混合彩色糊料夹心糖类,例如白巧克力等。在这类实施方案中,各种脂肪基类糖果制品,一般可以先在约25-80℃的温度下熔化,例如约25-40℃,或约34-37℃,或约40-80℃,并包含有一些低点的材料。在本领域的老资格技术人员都了解,制品的熔点可以随不同脂肪成分中的固态脂肪的指数而变动。固态脂肪指数(SFI)是一种特定的脂肪配料方法,即在不同温度条件下,脂肪配料中液态脂肪的相对比例。在IUPAC方法2.141的“各种脂肪的膨胀系数的测定”中详细论述了对于此项指数的测定方法。
在其中的糖果制品是在25-40℃的温度条件下开始融化的各项实施方案中,适用的低熔点材料包括三酸甘油酯类,例如月桂酸和非月桂酸行可可脂替代物类;月桂酸型(短链脂肪酸类)脂肪类,例如椰仁和棕榈果仁油及其衍生物;非月桂酸型(长链脂肪酸类)的脂肪类,如可可脂、棕榈仁油、豆油和棉籽油及其衍生物;可可脂同类物;单甘油酯和二甘油酯类;磷脂类;以及各种水溶性聚合物类,例如聚乙二醇。在一项实施方案中,其低熔点材料选自棕榈果仁油和椰仁油的一种经分馏处理的月桂脂。
在其中的糖果制品是在40-80℃的温度条件下开始融化的各项实施方案中,适用的低熔点材料包括各种蜡类,例如微晶体蜡类,例如巴西棕榈蜡、鲸蜡、蜂蜡、叶蜡、虫胶蜡、微晶体蜡和石蜡;以及各种水溶性聚合物类,例如聚乙二醇、聚环氧乙烷类及其衍生物和各种蔗糖酯类。
在还有一项实施方案中,其中的糖果制品可以是一种软糖。在这类实施方案中,其糖果制品中包含一种结晶性碳水化合物,其中至少有约90%的晶体的平均大小,约为2-15微米;并且一般其水分含量约为5-15%,例如约为10-12%。
在一项优选的实施方案中,其糖果制品中包含选自脂肪、无定形冰糖和软糖的至少一种成分。
本发明的这种剂型可以具有适宜于进行模制的任何形状。例如在一项实施方案中,其形状可以是一种截顶部的锥体。在另一些实施方案中,所述剂型的形状可以是各种多面体,例如立方体、棱锥体、棱柱体等;或者可以具有空间构形非平坦的若干面的几何体,例如圆锥体、圆柱体、球体、圆环面等。典型的核仁形状可采用包括由压制机形状而形成的片形,见“Elizabeth公司片剂设计手册”(Elizabeth硬质合金模具有限公司(Elizabeth Carbide Die Co.Inc.)第7页(McKeesport.Pa)纳入本文供参考)所述,有以下形状(片剂形状反向对应于压制机的形状):
1.浅凹面形。
2.标准凹面形。
3.深凹面形。
4.特深凹面形。
5.修改的球形凹面。
6.标准凹面形对开。
7.标准凹面形双对开。
8.标准凹面形欧洲式对开。
9.标准凹面形部分对开。
10.双放射形。
11.斜面形和凹面形。
12.平坦面形。
13.平面斜边形(F.F.B.E.)。
14.平面斜边形对开。
15.平面斜边形双对开。
16.环形。
17.旋涡形。
18.椭圆形。
19.卵圆形。
20.胶囊形。
21.矩形。
22.正方形。
23.三角形。
24.六角形。
25.五角形。
26.八角形。
27.菱形。
28.箭头形。
29.子弹形。
30.桶形。
31.半月形。
32.盾形。
33.心形。
34.杏仁形。
35.家用盘碟形。
36.平行四边形。
37.梯形。
38.图8/柱钟形。
39.蝴蝶结形。
40.不正三角形。
所述剂型表面可以基本是平滑的,即可以具有微观水平的凹陷或突起,其宽度、深度、或高度不超过约20微米。或者,所述剂型表面可以具有组织状态,即可以具有若干较大的凹陷或突起,其宽度、深度、或高度可超过约20微米,例如大于约50微米,或大于约100微米,甚至大于约1000微米。其凹陷或突起的宽度、深度、或高度可达到约30,000微米,例如可达到约2,000微米。在一些实施方案中,其特征在于,其内核具有结构,所述剂型的表面可以具有一种浮雕(隆起)或阴雕(凹陷)的图案。例如在核芯的外表面可以含有各种凹陷、凹雕、文字、符号,或者如图形或标帜活字的一种花纹。
在本发明的一项实施方案中,所述剂型有至少一个面,所述剂型重量的相对标准误差小于1%,较好是小于0.5%。在此采用的关于所述剂型重量的相对标准误差可按如下方法测定:利用一台分析天平,分别测定30个剂型的重量,精度达到最接近于0.1克。依在此实施例5所述的方法,计算每份样本的30次称重、其平均值、样本标准去查误差以及相对标准误差(%RSD)。在本领域中是普遍都知晓的,其相对标准误差是以平均百值来表示的标准误差。
在本发明的另一项实施方案中,所述剂型至少有一个面,所述剂型重量的相对标准误差小于1%,较好是小于0.5%。所述剂型没有自由形成的表面,而其中的糖果制品包含一种无定形的冰糖成分。
在本发明的另一项实施方案中,所述剂型至少有一个面,所述剂型重量的相对标准误差小于1%,较好是小于0.5%。所述剂型上所有面的表面光泽度,约都是200-300个光泽单位。在此采用的“表面光泽度”的意义是,按照此处实施例4所述的方法测定的反射光的量度标准。
在本发明的另一项实施方案中,所述剂型具有多于一个面,所述剂型重量的相对标准误差小于1%,较好是小于0.5%。其任何两个面之间的表面光泽度之差不超过约20个光泽单位,较好是约15个光泽单位,更好是约10个光泽单位。
在本发明的另一项实施方案中,所述剂型有至少一个面,所述剂型重量的相对标准误差小于1%,较好是小于0.5%。所述剂型在最大消光角的平均偏振光传播不大于在最大传播角的平均偏振光传播。
在此采用的“偏振光传播”是根据此处的实施例6所述的方法进行量度的。简而言之,量度其平均偏振光传播的用具,是由一个光源顺次与第一偏振过滤器、样本、第二偏振过滤器、以至一具检测器,例如一台数字摄影机所组成。
在此采用的“最大传播角”是,可使最小量光线通过样本的各偏振器的相对位置。据发现,在第一与第二偏振器之间的角度约为0度。
在此采用的“最大消光角”是,可使最大量光线通过样本的各偏振器的相对位置。据发现,在第一与第二偏振器之间的角度约为90度,并加上或减去约20度。其最大消光角,可随样本制剂的不同而有所变化。因为含糖量不同的制剂,其偏振光平面的回旋度都是不同的,对于100%的葡萄糖溶液,平均约要减去15度,相当于在第一与第二偏振器之间的最大消光角约75度。
偏振光的传播是采用对通过受检测影象的256灰度值的传播光的强度,绘制曲线图进行测定的。平均偏振光传播的定义是,在传播过程的峰强度面积中点部位的灰度值。在最大传播角的平均偏振光传播与在最大消光角的平均偏振光传播之间的差值在此就称为“相对同质性指数”。凡是没有扭曲损伤线条和空气气泡的样本,都具有高度的相对同质性指数。而具有扭曲损伤线条和空气气泡的样本,则都具有较低的相对同质性指数。
在本发明的另一项实施方案中,所述剂型有至少一个面,所述剂型重量的相对标准误差小于1%,较好是小于0.5%。所述剂型在最大消光角的平均偏振光传播不大于所述剂型在最大传播角的平均偏振光传播。所述剂型在最大消光角具有约0-40个灰度单位的平均偏振光传播。
在本发明的另一项实施方案中,所述剂型有至少一个面,没有自由形成的表面,并且在最大消光角的平均偏振光传播不大于所述剂型在最大传播角的平均偏振光传播。
在本发明的另一项实施方案中,所述剂型有至少一个面,没有自由形成的表面,并且在最大消光角的平均偏振光传播不大于所述剂型在最大传播角的平均偏振光传播。所述剂型重量的相对标准误差小于1.0%,较好是小于0.5%,更好是小于0.5%。
在本发明的另一项实施方案中,所述剂型有至少一个面,没有自由形成的表面,并且在最大消光角的平均偏振光传播不大于所述剂型在最大传播角的平均偏振光传播。其糖果制剂内不含明胶基或凝胶基组分。
在本发明的另一项实施方案中,所述剂型有至少一个面,没有自由形成的表面,并且在最大消光角的平均偏振光传播不大于所述剂型在最大传播角的平均偏振光传播。其糖果制剂内包含有一种无定形冰糖成分。
在本发明的另一项实施方案中,所述剂型具有两个或更多的面,没有自由形成的表面,并且在最大消光角的平均偏振光传播不大于所述剂型在最大传播角的平均偏振光传播。所述剂型上所有面的表面光泽度,约为200-300个光泽单位。
在本发明的另一项实施方案中,所述剂型具有两个或更多的面,没有自由形成的表面,并且在最大消光角的平均偏振光传播不大于所述剂型在最大传播角的平均偏振光传播。其任何两个面之间的表面光泽度之差不超过约20个光泽单位,较好是约15个光泽单位,最好是约10个光泽单位。
在另一项实施方案中,所述剂型包含有一种糖果制剂,是由硬质糖块,例如一种无定形冰糖所组成。在这类实施例中,所述剂型在最大消光角的平均偏振光传播不大于所述剂型在最大传播角的平均偏振光传播。
在另一项实施方案中,本发明的剂型是一种完整的单体,即是一种单一的不分开的物件或制品,例如类似一块硬糖。
在另一项优选的实施方案中,本发明的剂型的表面上没有任何瘢疵。
在另一项实施方案中,本发明的剂型基本上不含具有0.5-5.0微米直径的各种孔。“基本上没有”的含义是,所述剂型上的孔容量小于约0.02厘米3/克,较好是小于约0.01厘米3/克,更好是小于约0.005厘米3/克,孔的直径范围在0.5-5.0微米。在压制成型的各种材料上,在此直径范围的孔容量,一般可超过约0.02厘米3/克。
关于孔容量的测定,可以采用Quantachrome Instruments PoreMaster 60型汞侵入式孔隙率测定计与计算机软件配套的一种称为“Porowin”的装置来实施。在Quantachrome Instruments PoreMaster的操作手册中载有其操作程序。这种PoreMaster装置是利用无水性液体(汞)的侵入作用,来同时测定固体或粉末中的孔容量和孔直径,其中涉及,将样本放入测样小盒(透度计)中,抽成真空,再注入汞液浸没样本,使该样本盒增压,方法是:(i)压缩空气(最大为50磅/英寸2);以及(ii)液压(油)发生器(最大为60000磅/英寸2)。根据在施加的压力作用下,汞从外界侵入样本孔的容量变化,来测定其侵入容量。可直接采用所谓“Washburn公式”来计算发生侵入过程的相应孔的直径(d)大小。Washburn公式:d=-(4γ(cosθ))/P。其中,γ=液态汞的表面张力;θ=汞液与样本表面的接触角度;以及P=施加的压力。
用于测定孔容量的器材:
1.Quantachrome Instruments PoreMaster 60。
2.称量精度为0.0001克的分析天平。
3.干燥器。
供测定用的各种试剂:
1.高纯度氮。
2.三度蒸馏处理的汞液。
3.高压液(Dila AX,由壳牌化学公司供应)。
4.液态氮(用于汞蒸汽冷却捕集器)。
5.异丙醇或甲醇,供清洗样本盒之用。
6.洗涤剂液,供清洗样本盒之用。
操作程序:
各份样本保持密封包装,或者置入干燥器中,供分析用。开启真空泵,在汞蒸汽冷却捕集器中充满液态氮,将备用的压缩气体调节至55磅/英寸2,开启仪器,预热时间至少30分钟。按照仪器使用手册所述,将透度计的空盒装好,并记录其重量。小盒装入低压部位,从分析菜单上选定“只是抽真空和充填”选项,并设定如下:
精确真空时间:1分钟。
精确真空速度:10
粗略真空时间:5分钟。
再将(充满汞液的)小盒取出并称重。在汞液收集器中倒空小盒,从每份样本各取两粒片剂放入小盒中,并将小盒装入原位。再记录小盒和样本的重量。然后再将小盒装入低压部位,从菜单中选定低压选项,并设定如下参数:
状态: 低压
精确真空速度: 10
精确真空度达到:200微米汞柱
粗略真空时间: 10分钟
充装压力: 接触+0.1
最大压力: 50
指令: 侵入作用和驱除作用
重复: 0
汞液接触角度: 140
汞液表面张力: 480
开始搜集数据。在屏幕上会显示压力对累积侵入容量曲线图象。当低压分析完成之后,将小盒从低压部位取出,再称重。在汞液顶部的空隙部分,注满液压油,并将小盒装在高压部位。设定条件如下:
状态: 固定速度
发动机速率: 5
起始压力: 20
终末压力: 60000
指令: 侵入作用和驱除作用
重复: 0
注油时间长度: 5
汞液接触角度: 140
汞液表面张力: 480
然后开始搜集数据。在屏幕上会显示压力对侵入容量相比的曲线图象。当高压分析完成之后,将同一样本的低压和高压的数据资料合并一起。
现有技术与本发明之间的差别,参见图1A和1B就可进一步得以了解。在图1A中,制剂1是由Morris Plains,NJ开设的Warner-Lambert公司以商品供应的一种Halls牌硬糖制剂;制剂2是本发明的剂型,其中包含的糖果制剂是一种无定形冰糖。如图1A所示,在常态偏振光下观察时,制剂1与2并无明显区别。然而,如图1B所示,若是对于入射光以90°过滤的偏振光进行观察时,在制剂1由于在其玻璃面上残留有扭曲损伤的瘢疵,而呈现双折射现象(即折射光),而制剂2的表面则清晰均匀,毫无瘢疵。
本发明的这类剂型都是采用模制法制造的。在本领域已知有若干模制法,不过优选的是采用如下两种方法来制造这类剂型。如在待批的美国专利申请材料系列号09/966,450第57-63页所论述的热固性模制法和器材;或者,在待批的美国专利申请材料系列号09/966,497第27-51页所论述的热循环式模制法和器材;其公开论述部分都已经收录在此以供参考。
在热固性模制法方面,是将所述剂型中各种成分的原始材料注入模具腔内,模制成所需的形状。这类起始材料,除了活性成分和糖果制剂之外,最好还包含一种热固性材料,其温度条件要高于该种热固性材料的熔点,而低于所述活性成分的分解温度。该种起始材料在模具腔内冷却并固化,就可形成具有一定形状的一种片剂(即具有该种模具的形状)。
在这种方法中,其起始材料是一种流体材料。例如其中可包含悬浮在融化的基质,例如一种聚合物基质中的一种固体颗粒。该种起始材料可以是完全融化,也可以是一种糊状物。其中可以包含溶解在融化的基质中的一种活性成分。或者是,该种起始材料可以是溶解在溶媒中的一种固体物。在模制完成之后再将该种溶媒蒸发除去。
热固性材料可以是在约37-250℃的温度条件下能够流动,而在约-10-35℃的温度条件下形成固态或半固态的任何可食用物质。在有些实施方案中,其中的热固性材料可以包含所有各种或其部分的糖果制剂,因为其中有些同样的材料在两方面都可以使用。优选的各种热固性材料包括各种水溶性聚合物类,例如各种聚涯烷基二醇类、各种聚环氧乙烷类及其各种衍生物,和各种蔗糖酯类;脂肪类,例如可可脂;氢化植物油类,例如棕榈仁油、棉籽油、向日葵籽油和豆油;各种游离脂肪酸类及其盐;单甘油酯、二甘油酯、SAN三酸甘油酯;各种磷脂类;各种蜡类,例如巴西棕榈蜡、鲸蜡、蜂蜡、叶蜡、虫胶蜡、微晶蜡和石蜡;各种含混合物类,例如巧克力;无定形冰糖样的糖类,超饱和溶液性的糖类;低水分聚合物溶液类,例如用于制造“胶性软糖”类的水分含量约为30%的明胶或其他各种水性凝胶类。在特别的一项优选的实施方案中,其中的热固性材料是各种脂肪与各种单甘油酯和二甘油酯的混合物。
在根据美国专利申请材料系列号09/966,479的热循环式模制方法和器材方面,其热循环模制法所采用的模具组的基本结构如图3所示。该种热循环式模制用的模具组200包含一个转轴202,其周围设置一组单体模具204。该种热循环模制用的模具组包括一个收容器206(参见图4),供盛放制造核芯用的流体材料。此外,这种热循环模具组上还设置有一个温度监控器,能够快速调节模具单体的加热和冷却。在‘497申请材料的图55和56中描述了这种温度监控器600。
在该项实施方案中,该模具单体较好是包含一个中心模具组件底座212,一个模具组件上盖214,如美国专利申请材料系列号09/966,497中的图26C所示。两者相扣合形成具有所制造剂型的形状的一个模具腔。当转轴202转动时,相对的中心组件与上盖组件就会闭合。可流动性材料内包含剂型的各种成分,其在收容器206内被加热到流动状态,就可注入扣合而成的模具腔内。然后使该流动性材料的温度下降,并硬结成剂型。将该模具组件开启,就会弹出成型的剂型。
图2A是可用于制造本发明的剂型的两块硬质锭剂模具的照片。在图2A中的该种模具,是由第一配件块2与第二配件块4组成的2-块式的铝制模具。模具块2和4分别具有可形成内腔的部分6和8,其内面打磨成镜面。模具配件块2和4还分别设有注射口部分12和14,可形成一个注入口,专供对模具注入流体材料;还有两半通气口部分,16和18,可形成供通气用的通气口。图2B是在图2A中描述的模具与已从该模具中取出的锭剂10的照片。
本发明还将用一些实施方案来作进一步阐明,现列述如下。但是这决不意味着是对于本发明的一种限制。
实施例1:模制硬糖剂型
按如下程序制造的一批硬糖锭剂:
硬糖的预煮配方:
配方配制用的各种成分如下:
成分 | % | 毫克/片 | 克/批 |
玉米糖浆(42DE) | 45.35 | 170.06 | 498.85 |
糖(干燥颗粒) | 45.35 | 170.06 | 498.85 |
纯水,美国药典 | 9.05 | 33.93 | 99.60 |
FD&C红#40 | 0.05 | 0.20 | 0.50 |
香精 | 0.20 | 0.75 | 2.20 |
总计 | 100.00 | 375.00 | 1100.0 |
称量玉米糖浆,放入去皮重的不粘锅内。再加入纯水混合,低温加热搅拌均匀,制成稀释的玉米糖浆水。再加入干砂糖,搅拌成稀浆。
烹煮步骤:
将该种糖、水、玉米糖浆混合物放在煤气火燃器上,用旺火迅速加热,同时缓缓搅拌至混合物澄清并沸腾,直至混合物的温度达到120℃。然后调低至中等火焰,继续加热至140℃,此时其色泽加深,继续搅拌至色调分布均匀。当其温度达到145℃时,就可移开燃器,并拌入香精。随后,使该材料稍微冷却,不可再搅动,令其中的气泡消散。
模制步骤:
时而可将该混合液稍微加热,以使其保持液态。并准备将该融化的糖果基料注入用翼形螺钉将两片模具组件扣合固定而形成的金属模具腔内(如图2A和2B所示)。该铝质构成的模具,具有一个注入口和一个通气口,可利用于倒出剩余的糖果坯料。该充料腔具有所需的锭剂的形状。,其内面已经过精细打磨,可使模制成型的的剂型具有光洁平滑的表面。其注射用具是一种10厘米3的一具截去顶端的塑料注射器。用于从烹煮容器将糖果基料注入模制用具的注入口。在注满之后,就可使模具冷却至室温,约经2分钟即可将模具打开,并将成型的剂型取出,并扫清残留黏附在充填口和通气口上的剩余硬糖。
实施例2:硬糖剂型
本发明的剂型可按实施例1所述的操作程序进行制造。只是其中硬糖预先烹煮配方则按如下步骤操作:
成分 | % | 毫克/片 | 克/批 |
玉米糖浆(42DE) | 44.99 | 170.06 | 498.85 |
糖(干燥颗粒) | 44.99 | 170.06 | 498.85 |
纯水,美国药典 | 8.98 | 33.93 | 99.60 |
FD&C红#40 | 0.05 | 0.20 | 0.50 |
香精 | 0.20 | 0.75 | 2.20 |
苄达明 | 0.79 | 3.00 | 8.80 |
总计 | 100.00 | 378.00 | 1108.8 |
此处的活性成分苄达明,须在烹煮的材料移开火焰之后,与香味料一起加入。
实施例3:硬糖薄荷醇锭剂
按照本发明的一种商品规格的硬糖薄荷醇锭剂,可采用热循环式模制方法以及如下所述的配方进行制造:
硬糖的预煮配方:
配方用的有如下各种成分,包括作为活性成分的薄荷醇:
成分 | 供应商 | 百分比 | 毫克/片 | 千克/批(理论值) |
糖(干燥颗粒) | Florida Crystals,FL | 46.91 | 1407.3 | 234.6 |
玉米糖浆(42DE) | Archer Daniel Midland,CA | 38.44 | 1153.2 | 192.2 |
薄荷醇 | AlMenthol Century Int’l.CA | 0.40* | 12.0* | 2.00* |
纯水 | 14.0 | 420.0 | 70.0 | |
香精 | 0.20 | 6.00 | 1.00 | |
染料 | 0.05 | 1.5 | 0.25 | |
总计 | 100.0 | 3000 | 500.0 |
注:*包括对于加工过程损失的补偿量17%。
在批量生产方法中,蔗糖、玉米糖浆和水的配方是在真空条件下进行预先烹煮的。其他一些适用的方法,还可包括:半连续性和连续性真空烹煮法。糖果加工用的真空蒸煮器,都是由APV烘炉厂(APV Baker)(彼得波罗,联合王国)、Kloeckner-Hansel有限公司(弗罗里达州,科拉尔角)和Hosokawa Ter Braak B.V.(荷兰,鹿特丹)等地制造的。
在真空釜的糖浆烹煮平底锅内加入糖和水,加热至约110℃,直至糖晶体完全溶解。随后,再加入玉米糖浆,混合,继续煮至约138℃,并将其倒入下方在真空(620毫米)中的平底锅内。在下方平底锅内,再加入染料、香精和薄荷醇,混合成批量。在烹煮的硬糖果批还是液体状态时,就将其转移入加热的贮槽或收容器206(如待批的美国专利申请材料系列号09/966,497的图4所示)内。煮好的硬糖果批在收容器内不再搅拌,保持约120℃。将收容器206加盖,加压至约150磅/英寸2,或足以使该液态的硬糖果材料流入热循环模具的压力条件,并操作如下:
在如待批的美国专利申请材料系列号09/966,497的图26A所示的热循环模具中制造各种剂型。该种该热循环模制法的模具,包含如图26C所示的一个中心模具组件底座212,一个模具组件上盖214。两者相扣合就形成具有一种硬糖形状的一个模具腔。当转轴202转动时,该相对的中心底座组件与上盖组件就会扣合。再将煮好的液态硬糖材料注入该扣合的模具腔内。
模具组件中的热循环条件,维持在约120℃-90℃,当其循环在高温范围时,就可将煮好的硬糖材料趁热注入其中。在热料注满模具腔之后,该模具的温度又循环至低温区范围(即60-90℃),其中的材料就可冷却至足以凭其自身的重量不再流动的固结状态的温度。一旦凝结成型(即约须经1-60秒钟),就可将该模具组件开启,成型的剂型就会从该热循环模具中弹出,并由传送带送到一个冷却盘中,直至完全硬固。
当冷却至室温状态(22℃)时,已经成型的硬糖型锭剂就可准备成批输送到包装作业线。
实施例4:表面光泽度比较
对于商品供应的模制的锭剂,可采用由TriCor Systems有限公司(埃尔金,伊利诺斯州)供应的商品名为“TRI-COR 805A/806H型表面分析仪”装置,通常根据“TriCor Systems WGLOSS 3.4的805A/806H型表面分析仪参考手册”所论述的操作程序进行表面光泽度测试。其材料已经在此引为参考资料,其中修改部分如下。
该仪器配有一台具有电荷耦合装置(CCD)的摄影机检测器,采用一具平面谩射光源,对片剂样本与参考标准品进行比较,并在60度的入射角度测定其平均光泽度值。在此操作过程,该仪器可产生一种灰度影象,其特征在于,其发生的一些亮度较大的象素,表明在该指定部位的光泽度较好。
该仪器还配有一套软件,可采用对于光泽度分组定量测定的方法,即对于明亮度相似的各象素编组,求出其平均值。
“满度率”或“理想率”设定(也指“样本分组率”设定),可由用户指定用于在阈限之上的最明亮象素部分,将其分为一组,并求取该组的平均值。在此采用的“阈限”一词的定义是,不列入平均光泽度计算的最大光泽度值。从而,在进行平均光泽度值的计算方面,要排除样本的背景或无光泽区域。在2002-03-18在www.colorcon.com上提供的K.Fegley和C.Vesey的“片剂形状对于高光泽度薄膜包衣系统的感受能力的影响”中公开披露的方法,在此已经引为参考资料,可用于尽量减少因剂型的形状不同所造成的影响,并可采用有利于各企业之间进行比较的公制制来报道。(选用50%样本组的设定,可对片剂表面粗糙度的测定获得最近似的数据)。
采用标定参考板(190-228;294级标准;无遮蔽,回转度0,深度0)对于仪器进行初步标定之后,就可采用由McNEIL-PPC有限公司以商品名称“超强度泰诺凝胶包衣片类”供应的各种凝胶包衣片剂创建表面光泽度测定标准。然后测定了这类凝胶包衣片剂的112份样本的平均光泽读值,采用的是25毫米满视野屏蔽(190-280),并对该仪器设定如下条件:
回转度: 0
深度: 0.25英寸
光泽度阈限: 95
%满度(%理想):50%
折射指数: 1.57
对于参考标准品测定的表面光泽度值为269。
然后对于每份模制的锭剂的每个面,分别按照同样的操作程序进行测试。对于这类存放的样本,将其“自由形成的”面定为“面1”,其相对的面则定为“面2”。选定31×31的象素面积(相当于在样本上的约3.1毫米×3.1毫米的面积,或者是9.61毫米2),以尽量减少空气气泡的分布。选用由纽约Morris Plains的Warner-Lambert公司供应的HALLS PLUS锭剂,作为常规采用的单塑性程序生产的锭剂样本(样本A)。选用采用由Glen Rock,NJ的J.B.Williamsgyd公司供应的CepacolSole润喉锭剂,以及由Hershey,PA的Hershey食品有限公司供应的快乐牧童硬糖,作为常规采用的沉积法程序生产的锭剂样本(分别为样本B和C)。另外选用按照实施例1的方法所制造的注入式模制锭剂,定为样本D。所取得的结果如下:
样本 | 加工方法 | 光泽度-面1 | 光泽度-面2 | 光泽度差(光泽度单位) |
A(HallsPlus) | UniplastTM冲压模制法 | 225 | 210 | 15 |
B(Cepacol) | 沉积法 | 282 | 261 | 21 |
C(快乐牧童) | 沉积法 | 296 | 256 | 40 |
D(实施例1) | 注入式模制法 | 291 | 297 | 6 |
其结果表明,按照本发明的这类锭剂,其两个面之间的表面光泽度差别很小。相反,采用沉积法模制的商品供应的锭剂,在其自由形成的面上的表面光泽度,比起其模制面上的表面光泽度,至少要高出约21个光泽度单位。采用单塑冲压模制法制造的各种锭剂,在其两个主要面之间的表面光泽度差别,也要比采用沉积法制造的产品的差别小。
实施例5:比较产品的重量变化
关于各种商品供应的糖果制品个体重量的变化,采用如下方法,抽查了常规的各种糖果加工方法的代表进行检测。用分析天平检测每种产品的30份个体的重量,精度达到0.1毫克。对于每种样本的30份个体的重量,计算其均值、样本标准误差以及相对标准误差(%RSD)。须注意,据本领域所知,相对标准误差是以均数表示的标准误差。
产品 | 供应商 | 单体平均重量(克) | 单体重量标准误差(克) | 单体重量相对标准误差(%) |
Jolly Rancher硬糖 | Hersher食品有限公司,Hersher,PA | 5.9108 | 0.1972 | 3.34 |
Tootsie Roll | Tootsie RollIndustries有限公司,芝加哥,伊利诺斯州 | 6.5572 | 0.1248 | 1.90 |
Hershey之吻 | Hersher食品有限公司,Hersher,PA | 4.6323 | 0.1523 | 3.29 |
Halls锭剂 | Warner-Lambert公司,Morris Plains,NJ | 3.7859 | 0.0652 | 1.72 |
Werther原料硬糖 | Storck USA L.P.,芝加哥,伊利诺斯州 | 5.1829 | 0.1294 | 2.50 |
Draft饴糖 | Nabisco有限公司,东汉诺佛,新泽西州 | 7.9660 | 0.3844 | 4.83 |
实施例6:观察和测量冰糖型硬糖内的应力
对于冰糖型硬糖(hard candy glass)样本进行眼观检查,并在平面偏振光下照相,对冰糖内的相对应力进行定量测定。样本A是由Morris Plains,NJ的Warner-Lambert公司商品提供的HALLS PLUS锭剂;样本B是按照实施例1的方法所制造的注入式模制锭剂;样本C是由Bonita Springs,FL的Prestige Brands国际有限公司商品供应的Chloraseptic锭剂。样本A和C都是UniplastTM冲压式模制的冰糖型硬糖。通常,在应力测验仪下观察到,在注入式模制和沉积法的硬糖中都没有内部应力,而在冲压式或滚筒式模制的硬糖则残留有应力。采用的应力测验仪如下:
1)摄影机-标量袖珍数字式显微镜DG-1,配备具有C-框架适配器的1X透镜组。
2)应力测验仪-供生产过程使用的应力测验仪
—配备有瓦荧光灯的袖珍式灯箱(Apollo-LB101型,Ronkonkoma,NY11779).
—两枚5”×3”偏振滤光片,由3M公司供应,例如HN32-中性线性偏光镜或其他适用于应力分析的镜片。
据图3A和3B的描述,第一枚滤片300用玻璃纸胶带固定在灯箱302的中部,第二枚滤片304用手把持,保持位置与第一枚滤片平行,并将其转动以调节光的传播过程,如图3B所示。
或采用获自Strainoptic Technologies有限公司(108 W.Montgomery林荫大道,北威尔士,宾夕法尼亚州19454)或Sharples Stress Engineers有限公司(OliMill工业区29单元,学院巷,PR5 6SY,兰开夏郡,联合王国)的伤痕检查器。
采用数字式摄影机拍摄样本的照片。将照片在对于样本影象的最大光传播角和最小光传播角(最大消光作用)两种条件下,通过第二滤片。
图4A和4B描述的是,对于一种冲压模制的硬糖(样本A)和一种注射模制的或沉积法的硬糖(样本B),在按照最大光传播过程和最小光传播过程通过一对偏振滤光片时观察的标准照片影象。
随后,采用影象分析软件(Sigma Scan Pro 5,由SPSS有限公司供应)对于在透明硬糖中观察到的伤痕进行定量鉴定。对于彩色影象上的相当区域(没有气泡瘢疵和裂纹)换算成灰度,并以从0(黑色)到255(白色)数值范围的象素量制成立柱图来显示。为了提高分辨率,可调节样本的照明和数字影象的暴光条件,使传播过程与消光过程的分离峰值达最大程度。
如图5和6所示,显示灰度的象素形成峰形分布的转换影象。而且,一份指定的样本,当偏振滤光片在最大光传播过程(0°)对最大光消光过程(约90°)时,其最大峰值各不相同。在滴滚法或冲压法模制的各种硬糖样本方面,例如在图5中描述的Chloraceptic锭剂(样本C),当偏振过程达到最大消光点时显得明亮,并且,其灰度峰值也可提高。相反,在注射模制法和沉淀法制造的硬糖样本方面,当偏振光达到消光水平时,其影象就变暗,灰度的峰值也减小。
虽然本发明参照一些明确的实施例进行了论述,对于本领域的老资格技术人员来说,只要严格遵守本发明的专业范围,显然都能够进行各种变动和修改。
Claims (23)
1.一种剂型,所述剂型含有至少一种活性成分和一种糖果成分,其特征在于,所述剂型重量的相对标准误差小于1%,且所述剂型有至少一个面。
2.一种剂型,所述剂型含有至少一种活性成分和一种糖果成分,其特征在于,所述剂型有至少一个面,没有自由形成的表面,且其在最大消光角的平均偏振光传播不大于所述剂型在最大传播角的平均偏振光传播。
3.如权利要求2所述的剂型,其中,所述剂型重量的相对标准误差小于1%。
4.如权利要求1或3所述的剂型,其中,所述剂型重量的相对标准误差小于0.5%。
5.如权利要求1或2所述的剂型,其中,所述糖果成分包含至少一种选自脂肪、无定形冰糖和软糖的成分。
6.如权利要求1或2所述的剂型,其中,所述糖果组分中不含明胶基组分。
7.如权利要求1或2所述的剂型,其中,所述糖果组分中不含凝胶基组分。
8.如权利要求1或2所述的剂型,其中,所述糖果组分中含有一种无定形的冰糖成分,且所述剂型没有自由形成的表面。
9.如权利要求1或2所述的剂型,其中,所述剂型所有面都具有约200-300个光泽单位的表面光泽。
10.如权利要求1或2所述的剂型,其中,所述剂型具有一个或多个面,其两个面之间的表面光泽度之差不会超过约20个光泽单位。
11.如权利要求10所述的剂型,其中,任意两个面之间的表面光泽度之差不会超过约15个光泽单位。
12.如权利要求10所述的剂型,其中,任意两个面之间的表面光泽度之差不会超约10个光泽单位。
13.如权利要求1所述的剂型,其中,所述剂型在最大消光角的平均偏振光传播不大于所述剂型在最大传播角的平均偏振光传播。
14.如权利要求1或2所述的剂型,其中,所述剂型在最大消光角具有约0-40个灰度单位的平均偏振光传播。
15.如权利要求1所述的剂型,其中,所述糖果组分中含有一种无定形冰糖成分,且所述剂型没有自由形成的表面。
16.如权利要求1或2所述的剂型,其中,所述活性成分是药物活性成分。
17.如权利要求1或2所述的剂型,其中,所述剂型包含含有活性成分的颗粒。
18.如权利要求17所述的剂型,其中,所述颗粒的平均粒度约为50-2000微米。
19.如权利要求17所述的剂型,其中,至少一部分颗粒是包衣颗粒。
20.如权利要求1或2所述的剂型,其中,所述剂型是一种完整的单体。
21.如权利要求1或2所述的剂型,其中,所述剂型在其表面不含任何接缝。
22.如权利要求1或2所述的剂型,其中,所述糖果组分含有一种无定形的冰糖成分。
23.如权利要求1或2所述的剂型,其中,所述剂型基本上不含直径为0.5-5.0微米的孔。
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US09/966,450 US6982094B2 (en) | 2001-09-28 | 2001-09-28 | Systems, methods and apparatuses for manufacturing dosage forms |
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CNB028234308A Expired - Fee Related CN100408029C (zh) | 2001-09-28 | 2002-09-28 | 有镶嵌部分的组合剂型 |
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- 2002-09-28 CN CNA028233549A patent/CN1592612A/zh active Pending
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- 2002-09-28 KR KR10-2004-7004659A patent/KR20040045032A/ko not_active Application Discontinuation
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2003
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- 2003-03-21 US US10/393,752 patent/US7635490B2/en not_active Expired - Fee Related
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- 2003-05-26 NO NO20032363A patent/NO20032363L/no not_active Application Discontinuation
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- 2003-05-26 NO NO20032364A patent/NO20032364L/no not_active Application Discontinuation
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2004
- 2004-04-20 NO NO20041613A patent/NO20041613L/no not_active Application Discontinuation
- 2004-04-28 CO CO04038884A patent/CO5570655A2/es unknown
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2005
- 2005-07-04 HK HK05105590A patent/HK1072902A1/xx not_active IP Right Cessation
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2008
- 2008-03-17 US US12/049,628 patent/US20080305150A1/en not_active Abandoned
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2009
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