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CN1596100A - 可食用组合物及含可食用外壳的制剂 - Google Patents

可食用组合物及含可食用外壳的制剂 Download PDF

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Publication number
CN1596100A
CN1596100A CNA028236386A CN02823638A CN1596100A CN 1596100 A CN1596100 A CN 1596100A CN A028236386 A CNA028236386 A CN A028236386A CN 02823638 A CN02823638 A CN 02823638A CN 1596100 A CN1596100 A CN 1596100A
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China
Prior art keywords
formulation
product
crystallizable
shell
substrate
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Pending
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CNA028236386A
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English (en)
Inventor
F·J·布尼克
G·B·拉贝拉
H·S·索登
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Kenvue Brands LLC
Original Assignee
McNeil PPC Inc
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Publication date
Priority claimed from US09/966,509 external-priority patent/US6767200B2/en
Priority claimed from US09/966,497 external-priority patent/US7122143B2/en
Priority claimed from US09/966,450 external-priority patent/US6982094B2/en
Priority claimed from US09/966,939 external-priority patent/US6837696B2/en
Priority claimed from US09/967,414 external-priority patent/US6742646B2/en
Application filed by McNeil PPC Inc filed Critical McNeil PPC Inc
Publication of CN1596100A publication Critical patent/CN1596100A/zh
Pending legal-status Critical Current

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Abstract

本发明涉及一种至少含有占产品总重量约50％的可结晶碳水化合物的可食用产品，其中至少约90％的可结晶碳水化合物是平均粒度约100微米或以下的晶体，此产品在干燥后水分含量失重不超过约5％，此产品的横截面区域至少约30％无横纹，此产物的横截面面积范围约在1－900平方毫米。本发明还涉及一种制剂，该制剂至少含有一种活性组分和所述可食用产品，或者至少含有一种活性组分和所述可食用产品的外壳及底物如核仁。外壳、核仁或二者都含有活性组分如药用活性组分。

Description

可食用组合物及含可食用外壳的制剂
发明背景
发明领域
本发明涉及一种可食用产品，该产品本身可用于制备制剂或作为制剂外壳的组成成分，如组成外壳的药用组合物。本发明的制剂包含至少一种活性组分和该可食用产品本身，或者包括含有该可食用产品的外壳和至少部分被外壳包裹在内的底物或核仁。
背景信息
糖衣在糖果业中是众所周知的，通常用作包裹含果冻、巧克力、软糖等糖果核仁。
制备糖衣的常规方法包括硬淘洗和软淘洗技术，详细描述见Lachman，L.，Lieberman，H.A.，和Kanig，J.L.的《工业制药的原理与实践》(TheTheory and Practice of Industrial Pharmacy)第二版，Lea &Febiger，Philadelphia，1976，12章359-368页，W.P.P.Edwards的《糖果业科学》(The Science of Sugar Confectionery)第一版，The Royal Society ofChemistry，London，2000，8章95-100页，以及B.W.Minifie的《巧克力、可可与糖果业：科学与技术》(Chocolate，Cocoa，and Confectionery：Science andTechnology)，AVI Publishing Company，Inc.1980年1月，19章608-613页。通过硬淘洗方法制备的外壳其晶体颗粒相对较小，约2-20微米，并且其颗粒直径分布范围相对较窄。硬淘洗制备的糖衣用光学显微镜作为横截面观察通数层。
软淘洗技术制备的外壳其晶体颗粒直径分布范围较宽，其中至少有一部分晶体的直径超过100微米。糖衣包裹的药片是大家所熟悉的，其典型组成及制备方法见Ceschel，G.C.等人的《片剂的糖衣包被》(Sugar Coating of Tablets)，Bollettino Chimico Farmaceutico，119卷127-134页，1980，Schneider，H.；Speiser，P.的“Contibution to Sugar Coating Tablets”Pharmaceutica ActaHelvettae，43卷394-410页，以及Porter，S.C.的《片剂的包被：第一部分》(TabletCoating.Part 1)，Drug Cosmet.Ind.，128卷，1981年5月，46-53及86-93页。这些制剂具有光滑的硬壳，该硬壳有保护作用，可以增加其物理和化学稳定性，改善其外观，还可以增加甜味。常规的糖衣制备方法较费时，故加工成本高。
因此，本发明的目的之一在于提供一种制备制剂的可食用外壳的方法，该方法省时、加工成本低。
本发明的另外一个目的是提供一种含这种可食用外壳制剂的制备方法。
本发明的另外一个目的在于提供一种可施加于底物如核仁的可食用产品。
本发明的另外一个目的在于提供一种含有本发明可食用外壳的制剂。
本发明的另外一个目的在于提供一种含有本发明可食用产品的制剂。
本领域技术人员通过本文对本发明的详细描述可以了解本发明的其他目的、特征及优点。
发明概述
本发明的可食用产品至少含有占产品总重量约50％的可结晶碳水化合物，其中至少约90％的可结晶碳水化合物是平均粒度约100微米或以下的晶体，该产品在干燥后水份含量失重不超过5％，该产物的横截面区域至少约30％无横纹，该产物的横截面面积约在1-900平方毫米范围内。
在另一个实施方式中，该产品含有约60％的可结晶碳水化合物。
在另一个实施方式中，该产品含有约75％的可结晶碳水化合物。
在另一个实施方式中，所述晶体的平均粒度小于约50微米。
在另一个实施方式中，该产品干燥后水份含量失重不超过约3％。
在另一个实施方式中，该产品干燥后水份含量失重不超过约1％。
在另一个实施方式中，该产品的横截面区域至少约50％无横纹。
在另一个实施方式中，该产品的横截面区域至少约80％无横纹。
在另一个实施方式中，该产品至少含有一种活性成分。
在一个实施方式中，本发明的可食用产品可以通过如下方法制备：(a)将流动性可结晶碳水化合物注射到模具腔中；(b)使该流动性可结晶碳水化合物在模具腔中硬化形成可食用产品；以及(c)将可食用产品从模具腔中取出。
本发明的制剂至少含有一种活性组分和可食用外壳，该外壳位于所述底物的至少一部分上，该外壳至少含有占外壳总重量约50％的可结晶碳水化合物，并且至少约90％的可结晶碳水化合物是平均粒度约100微米或以下的晶体，此外壳在干燥后水份不超过5％，此外壳的横截面区域至少约30％无横纹，此制剂的横截面面积约在1-900平方毫米范围内。
在另外一个实施方式中，此外壳的第一部分和第二部分在界面处相连接。
在另外一个实施方式中，此外壳的第一部分和第二部分外观不同。
在另外一个实施方式中，所述底物含有活性组分。
在另外一个实施方式中，所述底物是一种核仁，可食用外壳将此核仁包裹在其中。
在另外一个实施方式中，此外壳含有活性组分。
在另外一个实施方式中，所述核仁含有活性组分。
在另外一个实施方式中，此外壳和核仁各含有活性组分。
在另外一个实施方式中，所述活性组分在该制剂与液体介质接触时可溶解，所述活性组分的溶解符合USP规程，可使片剂所含活性组分立即释放。
在一个实施方式中，本发明的制剂可通过下列方法制备：(a)提供一种底物；(b)用可食用外壳包裹该底物的至少一部分，其中所述外壳至少含有占外壳总重量约50％的可结晶碳水化合物，并且至少约90％的可结晶碳水化合物是平均粒度约100微米或以下的晶体，外壳干燥后水份含量失重不超过约5％，外壳的横截面区域至少约30％无横纹，该制剂的横截面面积约在1-900平方毫米范围内。(c)所述底物或外壳或两者含有至少一种活性组分。
在一个实施方式中，本发明的制剂可通过下列方法制备：(a)将加热的流动性可结晶碳水化合物注入含有底物的模具腔中，使该流动性可结晶碳水化合物包裹模具腔内该底物的第一部分；(c)改变模具腔内的温度诱导包裹该底物的第一部分的流动性可结晶碳水化合物热激结晶；(d)打开模具腔并转动含底物的模具部分使与底物的第二部分接触；(e)关闭模具腔；(f)将加热的流动性可结晶碳水化合物注入模具腔中，使流动性可结晶碳水化合物包裹模具腔内该底物的第二部分；(g)迅速改变模具腔内的温度诱导包裹该底物的第二部分的流动性可结晶碳水化合物热激结晶；以及(h)将底物从模具腔中取出。
在另外一个实施方式中，本发明的制剂含有至少一种活性组分和至少占总重量约50％的可结晶碳水化合物，其中至少约90％的可结晶碳水化合物是平均粒度约100微米或以下的晶体，干燥后水份含量失重不超过约5％，此制剂的横截面区域至少约30％无横纹，此制剂的横截面面积约在1-900平方毫米范围内。
在另外一个实施方式中，此制剂含有约60％的可结晶碳水化合物。
在另一个实施方式中，此制剂含有约75％的可结晶碳水化合物。
在另一个实施方式中，所述晶体的平均粒度小于约50微米。
在另一个实施方式中，此制剂干燥后水份含量失重不超过约3％。
在另一个实施方式中，此制剂干燥后水份含量失重不超过约1％。
在另一个实施方式中，此制剂的横截面区域至少约50％无横纹。
在另一个实施方式中，此制剂的横截面区域至少约80％无横纹。
附图简要说明
图1A和1B描述用以前淘洗工艺制备的糖衣外壳横截面的显微照片。
图2A和2B分别描述实施例1所述制剂的横截面图和侧视图。
发明详述
本文所用的术语“制剂”适用于任何固体、半固体或液体组合物，该组合物含有特定的预先设定剂量的某种组分，如下面所描述的活性组分。适宜的制剂可以是药物转运系统，包括口服给药、颊部给药；或者输送矿物质、维生素或其他营养物质的组合物，口腔护理药物，食用香料等。本发明的优选制剂是固体，但是可以含有液体或半固体成分。在一个最佳实施方式中，此制剂是一种口服给药系统负责将药用活性组分运送到人的胃肠道中。
可用于本发明的适宜的活性组分包括药物、矿物质、维生素以及其他营养物质、口腔护理药物、食用香料及它们的混合物。适宜的药物包括镇痛药、抗炎药、治疗关节炎的药物、麻醉药、抗组胺药、镇咳药、抗生素、抗感染药、抗病毒药、抗凝剂、抗抑郁药、治疗糖尿病药物、止吐药、排气药、抗真菌药、抗惊厥药、食欲抑制剂、支气管扩张剂、心血管药物、中枢神经系统药物、中枢神经系统激动剂、减充血剂、利尿剂、祛痰药、胃肠药、治疗偏头疼药、运动疾病药物、黏液溶解剂、肌肉松弛剂、骨质疏松治疗药、多聚二甲硅氧烷、呼吸系统药物、催眠药、泌尿道药物及上述药物的混合物。
适宜的口腔护理剂包括呼吸清凉剂、洁齿剂、抗微生物药物、牙齿矿物质剂、牙齿腐蚀抑制剂、局麻药物、mucoprotectants等。
适宜的食用香料包括薄荷脑、薄荷、白苏香料、水果香料、巧克力、香草、泡泡糖香味剂、咖啡香料、甜酒香料及上述物质的组合等。
适宜的胃肠道药物例子包括抑酸剂如碳酸钙、氢氧化镁、氧化镁、碳酸镁、氢氧化铝、碳酸氢钠、二氢化铝碳酸钠；刺激性泻剂如比沙可啶、波希鼠李皮、丹蒽醌、番泻叶、酚酞、芦荟、海狸油、蓖麻油酸、脱氢胆酸及其上述物质混合物；H2受体拮抗剂如法莫替丁、雷尼替丁、西咪替丁、尼扎替丁；质子泵抑制剂如奥美拉唑或兰索拉唑；胃肠道细胞保护剂如sucraflate和米索前列醇；胃肠道动力药如prucalopride；抗幽门杆菌抗生素如克拉霉素、阿莫西林、四环素及甲硝唑；止泻药如苯乙哌啶和洛哌丁胺；溴环扁吡酯；止吐药如奥丹西隆；止痛药如氨基水杨酸。
在本发明的一个实施方式中，所述活性药物可选自比沙可啶、法莫替丁、雷尼替丁、西咪替丁、prucalopride、苯乙哌啶、洛哌丁胺、乳糖酶、氨基水杨酸、铋、抑酸剂、以及药学上可接受的盐、酯、异构体或上述物质的混合物。
在本发明的另外一个实施方式中，所述活性药物可选自对乙酰氨基酚、乙酰水杨酸、布洛芬、甲氧奈普酸、酮洛芬、氟布洛芬、二氯芬酸、环苯扎林、美洛昔康、rofecoxib、CELECOXIB、以及药用盐、酯、异构体或上述物质的混合物。
在本发明的另外一个实施方式中，所述活性药物可选自伪麻黄碱、苯丙醇胺、扑尔敏、右美沙芬、苯海拉明、阿司咪唑、特非那定、fexofenadine、氯雷他定、desloratadine、西替立嗪、上述物质的混合物、以及药学上可接受的盐、酯、异构体或其混合物。
适宜的聚二甲硅氧烷包括而不限于二甲聚硅氧烷和二甲硅油，这些在美国专利4,906,478、5,275,822和6,103,260中有描述，其内容都清楚地被纳入本文作为参考。本文所用的术语“二甲硅油”指一类较宽范围的多聚二甲硅氧烷，包括而不限于二甲硅油和二甲聚硅氧烷。
这些活性组分以有效治疗量包含在本制剂中，治疗有效量是在口服后可产生所需治疗效果的量，这不难由本领域技术人员确定。在确定此剂量时，如本领域所熟知的那样应考虑服用的具体活性组分、该活性组分的生物利用度、剂量方案、病人的年龄和体重以及其他需考虑的因素。在一个实施方式中，此制剂的核心至少含有约85％的该活性组分。
如果该活性组分有不良味道并且该制剂打算通过咀嚼或在咽下前能在口腔内崩解，那么如本领域所熟知的那样可在活性组分外包被上一层掩盖异味的包衣。合适的异味掩盖包衣的例子见美国专利4,851,226,5,075,114和5,489,436中描述。一些商品化的掩盖异味活性组分也可以采用，例如用乙基纤维素或其他聚合物包裹的对乙酰氨基酚粒子也可用于本发明中。团聚包裹的(Coaccervation-encapsulated)的对乙酰氨基酚可从Eurand America，Inc.(Vandalia，Ohio)或Circa Inc.(Dayton，Ohio)购买。
在一个实施方式中所述制剂含有一个压缩的核心，适用于压缩的赋形剂包括填料、粘合剂、崩解质、润滑剂、glidants等。
适宜的填料包括水溶性可压缩碳水化合物，如糖类，包括葡萄糖、蔗糖、麦芽糖和乳糖，糖-醇，包括D-甘露醇、山梨醇、maltitol、木糖醇，淀粉水解物，包括糊精、糊精麦芽糖复合剂等，水不溶性可塑性矫形材料如微晶纤维素或其他纤维素衍生物，水不溶性易碎折材料如磷酸氢钙、磷酸钙或其混合物。
适宜的粘合剂包括干粘合剂如聚乙烯吡咯烷酮、羟丙基甲基纤维素等；湿润粘合剂如水溶性聚合物，包括水状胶质如藻酸盐、琼脂、树胶、洋槐豆、角叉菜胶、焦油、阿拉伯树胶、黄蓍胶、果胶、苍耳烷、gellan、糊精-麦芽糖复合剂、半乳甘露聚糖、PUSSTULAN、昆布多糖、scleroglucan、阿拉伯树胶、菊糖、果胶、whelan、rhamsan、zooglan、甲醇化物、几丁质、环糊精、壳聚糖、聚乙烯吡咯烷酮、纤维素、淀粉等；以及上述物质的衍生物及混合物。
适宜的崩解剂包括淀粉羟乙酸钠、交联聚乙烯吡咯烷酮、交联羧甲纤维素、淀粉、微晶纤维素等。
适宜的润滑剂包括长链脂肪酸及其盐，如硬脂酸镁、硬脂酸、滑石及石蜡。
适宜的glidants包括胶体二氧化硅等类似物质。
本发明的制剂还可以含有药用佐剂，其中包括防腐剂、高强度甜料如天冬酰苯丙氨酸甲酯、乙酰舒泛钾、羟糖铝及糖精；香料、抗氧化剂、表面活性剂及着色剂。
所述活性组分或成分优选在接触液体如水、胃酸、肠液等时能溶解。在一个优选实施方式中，活性组分的溶解特征符合USP规程，可使片剂所含活性组分立即释放。在一个需要使活性组分能被吸收进入动物循环系统的实施方式中，此活性组分或成分优选在接触液体如水、胃酸、肠液等时能溶解。在一个实施方式中，此活性组分的溶解特征符合USP规程，可使片剂所含活性组分立即释放。例如，USP24规定对乙酰氨基酚片剂在pH5.8的磷酸缓冲液中，用USP装置2(桨板)50rpm搅拌，30分钟，至少要有80％的对乙酰氨基酚从该制剂中释放出来，对于布洛芬片剂，USP24规定在pH7.2的磷酸缓冲液中，用USP装置2(桨板)50rpm搅拌，60分钟内，至少要有80％的对乙酰氨基酚从该制剂中释放出来。见USP24，2000版，19-20及856页(1999)。在另一实施方式中，该活性组分的溶解特征经过修饰：即可控释、缓释、延长、滞后、长期、延迟释放等。
此制剂中活性组分或成分可以任何形式存在。例如，此活性组分可以在分子水平上分散开来，即溶化或溶解在制剂中，或者以颗粒的形式存在，因而可以是包衣的，也可以是不包衣的。如果活性组分以颗粒形式存在，典型颗粒(包衣或未包衣)的平均粒度约为1-2000微米。在一优选实施方式中此颗粒是平均粒度约1-300微米的晶体。在另外一个优选实施方式中，这些颗粒是平均粒度为约50-2000微米的粒子或小球，较好约50-1000微米，最好100-800微米。
本发明的可食用产品至少含有重量百分比约50％的可结晶碳水化合物，较好至少约60％，最好至少约75％。适宜的可结晶碳水化合物包括单糖和寡糖。己醛糖如阿洛糖的D和L异构体、阿蜀糖、葡萄糖、甘露糖、古洛糖、艾杜糖、半乳糖、太洛糖，己酮糖如果糖的D和L异构体，山梨糖及其羟化物如山梨糖醇和D-甘露醇都是本发明所包括的单糖。1，2-二糖如蔗糖和海藻糖，1，4-二糖如麦芽糖、乳糖和纤维二糖，1，6-二糖如龙胆二糖和蜜二糖，三糖如蜜三糖以及蔗糖的异构体如isomaltulose和羟化类似物都是本发明所包括的寡糖。降解二糖(如麦芽糖和乳糖)的其他氢化形式如麦芽醇和乳糖醇也是优选的。另外，优选戊醛糖的氢化形式如D核糖和L核糖、阿拉伯糖、木糖和来苏糖以及丁醛糖的氢化形式和赤藓糖和苏糖，例子分别为木糖醇和赤藓醇。
在一个实施方式中，可结晶碳水化合物可选自蔗糖、山梨糖醇、D-甘露醇、木糖醇、赤藓醇、麦芽醇、乳糖醇及其上述物质的衍生物和混合物。在一个实施方式中，可结晶碳水化合物是一种软糖，而在另一实施方式中，可结晶碳水化合物是糖玻璃，例如加热的糖和玉蜀黍糖浆混合物冷却后得到的产物。
可结晶碳水化合物应具有适宜的颗粒大小，优选的颗粒大小范围在约2-1000微米之间。在一个实施方式中，可结晶碳水化合物是软糖，其颗粒大小优选约2-35微米的。在另外的实施方式中，可结晶碳水化合物被加热至熔化状态，其颗粒大小为约2-1000微米或约1000-5000微米。
优选的可结晶碳水化合物其结晶形式至少约为总重量的90％，平均粒度约为100微米或更小，通常约为50微米或更小。
本发明的可食用产品水分含量通常应为干燥时失重小于约5％，较好的是小于3％，最好的是小于1％。干燥失重(L.O.D.)可通过如下方法测定：取一份可食用产品样品(一般约1-10克)分成约1-2平方毫米大小的小份或磨成粗粉。将已知量的制备样品放入一已配衡的铝制船形器皿中，放入装有无水硫酸钙或其他适宜干燥剂的干燥器中，直到重量恒定。原样品与干燥后样品重量的差异以水分含量百分数表示。另外也可以用USP的方法<731>测定干燥失重。
制备成本高时间长的淘洗技术现有方法所生产的糖包衣片剂和药物制剂特征是具有横纹模式，这类制剂或其糖衣壳的横截面可见此种横纹(见实施例图1A和1B)。这些特征性横纹是由以下多次重复步骤组成的淘洗过程的指征：a)施加糖浆，然后b)热空气干燥旋转包衣盘(如许多层精细结晶糖组成的盘)中的制剂翻滚床，每次干燥后加一次糖结晶形成一层。各层的厚度通常在约0.01-0.013毫米范围内。
另外，本发明的可食用产品可以很方便地通过熔铸过程直接施加到所述物用作糖外壳，在5分钟或更短时间内，如60秒或更短、30秒或更短、10秒或更短、在某些特定实施方式中1秒或更短的时间内，生成一层完整的匀质层。因此，本发明的可食用产品至少约30％的横截面面积是无横纹，较好至少约50％，最好至少约80％无横纹。本文所述的“无横纹”指当在放大及灯光条件下观看时，其外观和糖基质的内部结构均匀一致。例如，用光学显微镜放大50-400倍观察时此产品的横截面无横纹并且折光特性均一。
本发明的可食用产品或可食用外壳所具有的横截面面积约在约1-900平方毫米范围内，较好约25-400平方毫米，最好约50-100平方毫米范围内。
图1A和1B显示用以前的淘洗技术制备的包衣组合物，具有横纹，与本发明所制备的产物不同。图1A显示用以前的DRIXORAL技术12小时制备出的片剂(从Schering Plough Inc.购买到)的横截面的显微照片。图1B显示用以前的ADVIL技术制备出的片剂(从Wyeth Inc.购买到)的横截面显微照片。这两种以前技术的产品用50-400倍光学显微镜观察时都可以清楚地看到横纹。
本发明的可食用产品可用下列方法制备：(a)将流动性可结晶碳水化合物注入模具腔中；(b)使该流动性可结晶碳水化合物在模具的腔中硬化成为可食用产品；(c)将该可食用产品从模具腔中取出。(d)任选将该可食用产品干燥；以及(e)任选将该可食用产品的表面抛光或磨光。在一个实施方式中，该方法还包括诱导模具腔内的流动性结晶碳水化合物热激结晶，使其在模具腔内硬化。
另外一个实施方式中的方法，包括使该流动性可结晶碳水化合物冷却至其玻璃化转化温度以下，使其在模具腔内形成含有不定形糖玻璃的非流动性结块。
本文所述的“流动性可结晶碳水化合物”指含有可结晶碳水化合物的可流动块，例如分散在饱和碳水化合物溶液中的碳水化合物结晶，即不定形玻璃形式的软碳水化合物或熔化的碳水化合物。本文所述的“硬化”指使块状物体不流动。
本发明制备具有外壳包裹所述核仁或底物至少一部分的可食用产品的一种优选方法包括：(a)将加热的流动性可结晶碳水化合物注入含有所述物质的模具腔中，使该流动性可结晶碳水化合物包裹模具腔内底物的第一部分；(b)迅速改变模具腔内的温度诱导包裹底物第一部分的流动性可结晶碳水化合物热激结晶；(c)打开模具腔并转动含底物的模具部分暴露该底物的第二部分；(d)关闭模具腔；(e)将加热的流动性可结晶碳水化合物注入模具腔中，从而使流动性可结晶碳水化合物包裹模具腔内该底物的第二部分；(f)迅速改变模具腔内的温度诱导包裹底物第二部分的流动性可结晶碳水化合物热激结晶；以及(g)将已包衣的底物从模具腔中取出。流动性可结晶碳水化合物可在加热进料罐中加热。
在一个具体实施方式中，所述外壳包括毗邻的两部分，因而形成一层完全包裹底物或核心的外壳。任选地可干燥此外壳，和任选地将外壳放在旋转盘中完成抛光或磨光。
一种适合制备流动性可结晶碳水化合物的方法是将可结晶碳水化合物与足量的水混合，任选地在非结晶碳水化合物中混合，和任选地将碳水化合物与水的化合物加热，以得到所需要的固体成分。在某些实施方式中，可将可结晶碳水化合物以晶体形式加入加热的碳水化合物和水的混合物中。加热可结晶碳水化合物的适宜温度约100-165℃。在某些实施方式中，可将可结晶碳水化合物加热至其熔点温度之上，例如约145-165℃。在这些实施方式中，流动性可结晶碳水化合物是玻璃形式。在另外一些特定实施方式中，可将可结晶碳水化合物加热至其熔点温度之下，例如约100-130℃。在这些实施方式中，此流动性可结晶碳水化合物是软糖形式。
在某些实施方式中，将可结晶碳水化合物与非结晶碳水化合物混合在一起加热，二者比例约为50∶50-90∶10。在某些流动性可结晶碳水化合物是玻璃形式的实施方式中，可结晶碳水化合物与非结晶碳水化合物混合的优选比例约50∶50-69∶41。在某些流动性可结晶碳水化合物是以软糖形式的实施方式中，可结晶碳水化合物与非结晶碳水化合物混合的优选比例是约70∶30-90∶10。在这些实施方式中，此流动性可结晶碳水化合物最好在冷却过程中加以搅拌。
在一个具体实施方式中，此流动性可结晶碳水化合物是亚稳定性玻璃形式，不搅拌冷却约1-60分钟后发生结晶。在这个实施方式中，可结晶碳水化合物与非结晶碳水化合物混合的比例约65∶35-75∶25之间。为了诱导可结晶碳水化合物结晶，可以另外将约占可结晶碳水化合物重量1％的结晶形式的可结晶碳水化合物加到已加热的碳水化合物和水的混合物中。
合适的保持加热的流动性可结晶碳水化合物的温度为约80-98℃，通过从此较高温度快速改变铸模腔温度，进行铸模腔温度的快速改变至适当的“冷循环”温度，以激发该可结晶碳水化合物结晶。适合的冷循环温度范围约为-10℃至60℃，优选-10℃至25℃。将该动性可结晶碳水化合物冷却至其玻璃转化温度以下，以形成含不定形糖-玻璃的合适铸模温度范围为约0-80℃。
在一个实施方式中，本发明的制剂是一种含有至少一种活性组分和本发明的可食用产品的固体制剂。
在另外一个实施方式中，本发明的制剂至少含有一种活性组分、一种用本发明可食用产品制成的可食用外壳和作为核仁的底物，可食用外壳位于底物上或至少包裹该底物的一部分。本文所述的术语“底物”指一种表面或一种位于下面的支持物，其上有其他材料存在，术语“核仁”指一种材料，如被另外某些材料如外壳所包围或包裹的物质。外壳、核仁、底物或它们的组合物可以含有活性组分，如药用活性组分。
在一个实施方式中，可食用外壳至少包裹该底物的一部分。该底物可以是任何可食用材料，优选固体形态的如胶囊、片剂、小丸、菱形、小球、颗粒、粉末、太妃糖、奶油杏仁糖、焦糖、巧克力等；半固体形态的如凝胶、胶冻、乳酪、软糖等；以及液体形态的如悬液、溶液、糖浆、乳剂等。
在另一实施方式中，所述底物是一种被压制或铸造的核仁。此核仁可任选地部分被压制的、铸造的或喷雾形成的亚包衣层所覆盖。在本发明的一个优选实施方式中，此核仁获自压制粉末。该粉末优选含有一种活性组分，还任选地含各种赋形剂，如粘合剂、崩解剂、润滑剂、填料、glidants等，这些物质是常规的或是有药用特性或无药用特性的其它颗粒材料，如片剂的无活性安慰剂混合物，糖果混合物等。在一个实施方式中，此核仁含有活性组分、粉末状腊(如虫胶腊、微晶体腊、聚乙二醇等)，和任选的崩解剂和润滑剂，在待批美国专利申请09/966,493的4-11页有其详细描述，本文已纳入作为参考。
此核仁可以是不同形状，例如在一个实施方式中此核仁可以是截短锥体形状。在另一些实施方式中，此核仁可以是多角体，如立方体、锥体、棱形等；或可以是具有某些非平面的几何立体形状，如锥体、圆柱体、球形、隆突形等。可用于本发明的示范性核形状包括由压制工具形状的形成的片剂形状，见“TheElizabeth Companies Tablet Design Training Manual”(Elizabeth Carbide DieCo.，Inc.，P7(Mckeesport，PA.)，本文已纳入作为参考。)的描述，其具体形状如下(片剂的形状与压制工具的形状正好相反)：
1.浅凹形
2.标准凹形
3.深凹形
4.极深凹形
5.修饰的球面凹形
6.标准对开凹形
7.标准双对开凹形
8.标准欧洲对开凹形
9.标准部分对开凹形
10.双面幅射形
11.斜角凹形
12.平面形
13.平面斜角边缘形(F.F.B.E.).
14.F.F.B.E.Bisect.
15.F.F.B.E.Double Bisect.
16.环形
17.浅凹形
18.椭圆形
19.卵形
20.胶囊
21.长方形
22.正方形
23.三角形
24.六边形
25.五角形
26.八角形
27.钻石形
28.箭头形
29.弹头形
30.桶形
31.半月形
32.盾牌形
33.心形
34.杏仁形
35.碟形House/Home Plate.
36.平行四边形
37.小多角形
38.8形/杠铃形
39.蝴蝶结形
40.不规则三角形
在本发明的另外一个实施方式中，本发明的制剂含有粉末状混合物制成的核心，其平均粒度约50-500微米，例如约100-500微米。
在本发明的另外一个实施方式中，此核由基本上不含水溶性多聚粘合剂及水合聚合物的粉末直接压制成片剂。该组合物的优点是保持了快速释放溶解的特点、处理过程简化、材料成本降低、并且使制剂保持了最佳的物理和化学稳定性。
在一个优选实施方式中，此核仁通过压制方法制备，压制设备见美国待批专利申请09/966,509第16-27页的详细描述，本文已纳入作为参考。具体地说该核仁用一种旋转压制模块制成，该模块包括填充区、插入区、压缩区、排出区和清洗区，该模块位于如美国专利申请09/966,509中图6所示的双排铸模结构的机器上。压制模块的铸模优选用真空泵帮助填充，在每个铸模上或附近装有一个过滤器。压制模块的清洗区包括一个任选的粉末回收系统以从过滤器回收剩余粉末，并将粉末送回铸模中。
此核仁或者可以用热设定成型方法和设备制备，见美国专利申请09/966,450第57-63页的详细描述，本文已纳入作为参考。在这个实施方式中，此核仁通过将可流动形式的起始材料注入铸模槽中形成。起始材料优选含有活性组分的，热设定材料的温度优选在其熔点温度之上但在该活性组分的降解温度之下。起始材料在铸模室中被冷却固化成为成型的核(即具有铸模形状的核)。
根据本方法，起始材料必须是可流动形式的。例如可以含有悬浮于熔化基质如聚合物基质中的固体颗粒。起始材料可以是完全熔化的或是浆糊形式。起始材料可以含有溶解于熔化材料中的活性组分。另外，起始材料可以通过将固体溶于溶剂中制备，然后在铸模后将溶剂从起始材料中蒸发掉。
此核仁也可以用热循环铸模方法和设备制备，见美国专利申请09/966,497第27-51页的详细描述，本文已纳入作为参考。在美国专利申请09/966,497描述的热循环铸模方法和设备中，采用了具有图3所示通用结构的热循环铸模模具。此热循环铸模模具200包含一个转头202，在其周围有一组铸模单元204。此热循环铸模模具包括一个储存槽206(见图4)，用于盛装可流动材料以制备此核仁。另外，此热循环铸模模具还装有一种温度控制系统用于快速加热和冷却铸模单元。图55和图56描述了这样一种温度控制系统600。
在本发明的另外一个实施方式中，所述核仁含有一个或多个植入物，该植入物可以制成任何形状或尺寸。例如可以是不规则形状的植入物，具有一个以上对称轴形状。该植入物也可以是圆柱形。在一个优选实施方式中，该植入物用待批美国专利申请09/966,450第57-63页所描述的方法和设备通过本文所述的热设定铸模过程制备。制备植入物的起始材料可以含有任何需要的掺入到成形产物中的可食用材料，包括活性组分如前述与核仁有关的那些活性组分、营养物质、维生素、矿物质、香料、甜料等。
起始材料优选包含一种活性组分和一种热设定材料。此热设定材料可以是任何可食用材料，在约37-120℃之间可流动，在约0-35℃之间是固体。优选的热设定材料包括水溶性聚合物如聚烷基甘油、氧化聚乙烯及其衍生物、蔗糖酯；脂肪类物质如可可脂、氢化植物油如棕榈仁油、棉花子油、向日葵油和大豆油；甘油酯、甘油二酯及甘油三酯、磷酸酯、蜡类如carnuba wax、鲸蜡、蜂蜡、candelillawax、虫胶、微晶体蜡及石蜡；含脂混合物如巧克力；无定型玻璃状的糖如用于制作硬糖果的糖、过饱和糖溶液如用于制作软糖的糖溶液；低水分聚合物溶液如水分含量达到约30％的明胶和其他水状胶体的混合物，例如用于制作gummi甜食的那些物质。在一个特别优选的实施方式中，此热设定材料是一种水溶性聚合物如聚乙烯甘油。
在本发明的一个实施方式中，植入物的平均直径约为100-1000微米。在本发明的另外一个实施方式中，植入物的平均直径或厚度约为此核仁直径或厚度的10％-90％。本发明的另外一个实施方式中此核仁含有多个植入物。
本发明的外壳可以通过注射使可食用产品成型而制备，优点可以最大程度地降低或消除直接压制填料-粘合剂的需要，如微晶体纤维素、喷雾干燥的乳糖、矿物质盐如磷酸钙、结晶糖如蔗糖、右旋糖等。这些材料的缺点是可破坏外壳的透明度和稳定性。本发明的外壳优选含有直接压制的填料-粘合剂含量少于约10％、少于1％或少于0.1％。因此本发明的外壳是一种压制包衣壳改进型，如WO 00/18447描述的那样，其直接压制的填料-粘合剂含量至少约占30％。
在本发明的一个优选实施方式中，可采用待批美国专利申请09/966,497第27-51页所描述的热循环方法和设备制备，将加热的可流动化可结晶碳水化合物形式的外壳施加到核仁上。在这个实施方式中，用热循环铸模模具制备的加热的可流动可结晶碳水化合物具有本文附图3所示的通用结构。热循环铸模模具200包含一个转头202，在其周围有一组铸模单元204。此热循环铸模模具包括一个储存槽206(见图4)，用于盛装加热的可流动可结晶碳水化合物。另外，此热循环铸模模具还装有一温度控制系统用于快速加热和冷却铸模单元。图55和图56描述了这样一种温度控制系统600。
优选此热循环铸模模具具有如待批美国专利申请09/966,497中图28A所示的类型，含有一系列的铸模单元204。如图28C所示，铸模单元204包括上位铸模组件214、可旋转的中间铸模组件212和下位铸模组件210。将核仁被不断地输送到铸模组件中，铸模组件随后闭合包裹核仁。可结晶碳水化合物在储存槽206中被加热成可流动的状态，然后注入到闭合铸模组件组成的铸模腔中。降低该流动性可结晶碳水化合物的温度使其硬化。打开铸模组件吐出已包衣的核仁。包衣分两步进行，核的两半通过中间铸模组件的旋转分别包衣，如待批美国专利申请09/966,497图28B中的流程图所示。
在本发明的一个实施方式中，只有所述底物或核仁含有一种或多种活性组分。在本发明的另外一个实施方式中，只有所述外壳含有一种或多种活性组分。而在本发明的其他实施方式中，只有所述植入物含有一种或多种活性组分。本发明还有一些实施方式中仁核和外壳都含有一种或多种活性组分。在本发明的另外一些实施方式中，一个或多个核仁、外壳或植入物都含有一种或多种活性组分。
在另外一个实施方式中，本发明的制剂还可以含有一种底物或核仁，其含有的组合物与外壳的不同。在另外一个实施方式中，外壳材料也可具有与该制剂的底物或外壳的功能。另外一个实施方式中，此制剂还可含有一种位于外壳表面的糖衣。
在另外一个实施方式中，此外壳分含有第一部分和第二部分，二者在界面处相连。
在另外一个实施方式中，此外壳的第一部分和第二部分外观彼此不同。例如第一部分和第二部分的大小、形状、局部结构或其他几何特征、色彩、色调、透明度及光泽不同。
在另外一个实施方式中，本发明的制剂通过如下方法制备，该方法包括提供一种底物以及该底物的至少一部分用可食用外壳包裹。此外壳至少含有占外壳总重量约50％的可结晶碳水化合物。可结晶碳水化合物中至少约90％的是晶体，其平均粒度小于约100微米，外壳的水分含量干燥失重时不超过5％，较好不超过3％，最好不超过1％。外壳的横截面区域至少约30％无横纹，较好至少约50％，最好的是至少约80％无横纹，此制剂的横截面面积约约1-900平方毫米，优选约25-400平方毫米。
本发明将用以下面的实施例进一步说明，但这些实施例不意味着对本发明的任何限定。
实施例1
根据本发明按照下述方式制备一批铸模对乙酰氨基酚片剂：
A.软糖的制备(90％固体)：将软糖(Amerfond，购自Domino Foods)置于具有恒温控制的行星状混合盘中，室温下，混合盘配置有一浆叶，边缓慢混合边加入表1所设定浓度的水。混合持续进行直到软糖变得光滑均一。
                         表1
    组分     ％     mg/片     gms/批
    Amerfond     90.00     353.09     202.84
    纯水USP     10.00     39.23     22.54
    总计     100.00     392.32     225.38
B.Bob糖浆的制备：取一个两夸脱的不粘果酱盘和一个软膏刀，将蔗糖、玉蜀黍糖浆和水按照表2所示的浓度加到盘中，记录毛重。将混合物在火上烘煮成87％的固体(约115℃)。
                               表2
    组分     ％     mg/片     gms/批
    蔗糖     81.00     989.85     568.64
    玉蜀黍糖浆42D.E.(80％)     7.50     91.65     52.65
    纯水     11.50     140.54     80.73
    总计     100.00     1222.04     702.02
C.终产品：将转化糖、水和香料以表3所示浓度加到放置软糖(A)的行星状混合盘中，缓慢混合直到均一。混合盘用锡箔覆盖加热到90℃。然后加入煮好的″bob″糖浆(B)，充分混合。加入对乙酰氨基酚再混合直到光滑均一。加入少量水以维持自由流动状态。
                            表3
    组分     ％     mg/片     gms/批
    软糖(90％固体)     17.77     392.32     225.38
  “bob″(87％固体)     55.4     1222.04     702.02
    对乙酰氨基酚     22.64     500.00     287.24
    纯水     3.69     81.50     46.82
    转化糖     0.11     2.39     1.373
    Sucralose     0.07     1.49     0.856
    香料     0.38     8.50     4.883
    总计     100.00     2208.24     1268.57
最终的混合物在室温下置于双片橡胶或硅模具中。模具加满后立刻使混合物充分硬化从模具中取出。完全干燥产品并使其进一步硬化。
将铸成的核心转移到包衣锅中用绿色外壳包被观察效果。图2A和图2B显示铸成的制剂横截面面及侧视图，该制剂具有一个铸成的核仁20和绿色的外壳22。实施例1的制剂不含有任何条纹。
实施例2
按照本发明所制备的一批糖衣固体制剂。下表4显示本发明的软糖混合物用作制剂的外壳：
                          表4
    组分   商品名     供应商   mg/片   理论Kg/批
   软糖(90％固体) Amerfond  Domino Sugar   196     83.40
   Bob糖浆(87％固体)   611     260.00
    纯水   42     17.87
  转化糖溶液(72％固体)   1     0.43
    总计   850     361.7
将干的软糖置于行星状混合盘中，用一浆叶缓慢混合，加入占总重量10％的纯水，直到软糖变得光滑均一。然后将转化糖溶液和纯水与软糖混合完全。将烧煮颗粒状蔗糖、42DE玉蜀黍糖浆和水(75∶7∶18％w/w)的混合物成为87％固体或115℃得到的Bob糖浆加入到软糖/转化糖混合物中混合直至均一(约2分钟)。
将软糖混合物转移到加热的储存槽中。此储存槽见待批美国专利申请09/966,497第27-51页所描述，在其附图4中标记为206。储存槽内的软糖混合物温度维持在90-95℃，用一机动混合浆叶(未在图中标出)缓慢混合。将储存槽盖好，加压至约150psi或至足够的压力使温热的软糖混合物流到热循环铸模模具中，如待批美国专利申请09/966,497所述。
通过待批美国专利申请09/966,509第16-27页所述的压制方法和设备制备核仁，本文已纳入作为参考。具体说，用一种旋转压制模块制备核仁，该模块包括填充区、插入区、压制区、排出区和清洗区，该模块位于带有美国专利申请09/966,509图6所示的双排铸模结构的装置上。此压制模块的铸模优选在真空泵的帮助下填充，在每个铸模中或附近有一个过滤器。该压制模块的清洗区包括一任选的粉末回收系统以从过滤器回收剩余粉末，并将粉末送回铸模中。核仁被一个转移装置接收，该装置的结构见美国专利申请09/966,414中图3所述，标示为300，本文已纳入作为参考。该转移装置包含一组转移单元304，304以悬臂方式固定在带子312上，如美国专利申请09/966,414中图68和图69所示。此转移装置与连接的压制模具和热循环铸模模具同步旋转和操作。转移单元304包括定位器330以在这些核仁绕转移装置转动时抓住核仁。
该转移装置将核仁转移到热循环铸模模具，铸模模具将软糖混合物施加到核上。该热循环铸模模具类型见待批美国专利申请09/966,497中图28A所示。热循环铸模模具的铸模单元204含有如图28C所示的上位铸模组件214、可旋转的中间铸模组件212和下位铸模组件210。核仁被不断地输送到铸模组件中，随后闭关铸模组件包住核仁。匀速冷却铸模组件到约10℃。然后将加热的流动性软糖混合物填入铸模组件中。软糖混合物是一种过饱和糖溶液，受激发生结晶化成为硬固体物包裹压制核仁。打开铸模组件排出已包衣的核仁。包衣分两步进行，核仁的两半通过中间铸模组件的旋转分别包衣，见美国专利申请09/966,497图28B中的流程图所示。
一旦软糖混合物作为外壳充分包裹核仁后(约1-60秒)，打开铸模组件，使处于加工中的制剂排出热循环铸模模具，运送到干燥器中使外壳完全硬化，并去除残余水分，得到制剂终产品。
干燥后，已包衣的核可任选地在包衣盘上添加色彩、香料、光泽或使其光滑完成加工。
实施例3
按照本发明采用下表5所示的剂量制备的一批固体制剂：
                         表5
    组分   商品名     供应商  mg/片  理论Kg/批
    软糖(90％固体) Amerfond  Domino Sugar    196     83.40
 Bob糖浆(87％固体)    611     260.00
    对乙酰氨基酚  Malincrodt    325     138.30
    纯水    42     17.87
转化糖溶液(72％固体)    1     0.43
    总计    1175     500.0
将干的软糖置于行星状混合盘中，用一浆叶缓慢混合，加入占总重量10％的纯水，直到软糖变得光滑均一。然后将转化糖溶液和纯水与软糖合并完全混合。将颗粒状蔗糖、42DE玉蜀黍糖浆和水(75∶7∶18％w/w)的混合物烧煮成为87％固体或115℃而得到的Bob糖浆加入到软糖/转化糖混合物中混匀至均一(约2分钟)。将此混合物的温度保持在90-95℃，加入对乙酰氨基酚，混合均匀。
将对乙酰氨基酚软糖混合物转移到加热的储存槽中。此储存槽见待批美国专利申请09/966,497第27-51页所述，在附图4中标记为206。将储存槽内的对乙酰氨基酚软糖混合物维持在90-95℃，用一机动混合浆叶(未在图中标出)缓慢搅拌。将储存槽206盖好，加压至约150psi或至足够的压力使对乙酰氨基酚/软糖混合物流到热循环铸模模具中，此模具的具体结构见待批美国专利申请09/966,497的图26A所述。该热循环铸模模具包括中心铸模组件212和上位铸模组件214，如图26C所描述，二者相配共同形成铸模腔。转子202旋转时，相对的中心铸模组件及上位铸模组件关闭。将铸模组件匀速地冷却至约10℃。将对乙酰氨基酚/软糖混合物注入到模具腔中。附着对乙酰氨基酚/软糖混合物进入模具腔，过饱和糖溶液受激而结晶成为包含有悬浮对乙酰氨基酚晶体的硬固体物。一旦此固体物形成(约1-60秒)，打开铸模组件，使已制成的制剂排出热循环铸模模具，运送到干燥器中完全硬化。
干燥后，任选地将该制剂在包被盘上添加色彩、香料、光泽或使其光滑完成加工。
尽管本发明已参考具体实施方式进行了说明，但本领域技术人员懂得，可进行各种改动或修改但它们均属于本发明的范围之内。

Claims (30)

1.一种可食用产品，其特征在于，该产品含有至少占产品总重量约50％的可结晶碳水化合物，其中至少约90％的可结晶碳水化合物是平均粒度约100微米或以下的晶体，该产品干燥后水份含量失重不超过5％，该产品的横截面区域至少约30％无横纹，该产品的横截面面积约在1-900平方毫米范围内。
2.如权利要求1所述的产品，其特征在于，该产品中含有约60％的可结晶碳水化合物。
3.如权利要求2所述的产品，其特征在于，该产品中含有约75％的可结晶碳水化合物。
4.如权利要求1所述的产品，其特征在于，该产品中的晶体平均粒度小于约50微米。
5.如权利要求1所述的产品，其特征在于，该产品干燥后水份含量丢失不超过约3％。
6.如权利要求5所述的产品，其特征在于，该产品干燥后水份含量丢失不超过约1％。
7.如权利要求1所述的产品，其特征在于，其中该产品的横截面面积至少约50％无横纹。
8.如权利要求1所述的产品，其特征在于，其中该产品的横截面面积至少约80％无横纹。
9.如权利要求1所述的产品，其特征在于，该产品至少含有一种活性组分。
10.一种制备可食用产品的方法，其特征在于，该方法包括：(a)流动性可结晶碳水化合物注射到模具腔中；(b)使流动性可结晶碳水化合物在模具腔中硬化成为可食用产品；以及(c)将可食用产品从模具腔中取出。
11.一种可食用产品，由包括下列步骤的方法制备：a)将流动性可结晶碳水化合物注入铸模腔中；b)使铸模腔中的流动性可结晶碳水化合物硬化成为可食用产品；和c)从铸模膜中取出该可食用产品。
12.一种制剂，包含至少一种活性组分和位于底物至少一部分上的可食用外壳，其中该外壳至少含有占其重量约50％的可结晶碳水化合物，并且重量至少约90％的可结晶碳水化合物是平均粒度约100微米或以下的晶体，该外壳干燥后水份含量失重不超过5％，该外壳的横截面区域至少约30％无横纹，该制剂的横截面面积约在1-900平方毫米范围。
13.如权利要求12所述的制剂，其特征在于，外壳的第一部分和第二部分在界面处相连接。
14.如权利要求13所述的制剂，其特征在于，外壳的第一部分和第二部分外观可不同。
15.如权利要求12所述的制剂，其特征在于，所述底物含有活性组分。
16.如权利要求12所述的制剂，其特征在于，所述底物是一个核心，可食用外壳将该核心包裹其中。
17.如权利要求12所述的制剂，其特征在于，所述外壳含有活性组分。
18.如权利要求16所述的制剂，其特征在于，所述核心含有活性组分。
19.如权利要求16所述的制剂，其特征在于，外壳和核各含有一种活性组分。
20.如权利要求17-19中任一项所述的制剂，其特征在于，所述活性组分在该制剂接触液体介质时可溶解，活性组分的溶解符合USP规程，可使片剂所含活性组分立即释放。
21.一种制剂，由包括下列步骤的方法制备：
(a)提供底物；
(b)用可食用外壳包裹该底物的至少一部分，其中所述外壳至少含有占外壳总重量约50％的可结晶碳水化合物，并且重量至少约90％的可结晶碳水化合物是平均粒度约100微米或以下的晶体，所述外壳干燥后水份含量失重不超过5％，外壳的横截面区域至少约30％无横纹，所述制剂的横截面面积约在1-900平方毫米范围内；以及
(c)所述底物或外壳或两者都含有至少一种活性组分。
22.一种制备制剂的方法，该方法包括：(a)将加热的流动性可结晶碳水化合物注入含有底物模具腔中，使该流动性可结晶碳水化合物包裹模具腔内该底物的的第一部分；(c)改变模具腔内的温度诱导包裹该底物第一部分的流动性可结晶碳水化合物热激结晶；(d)打开模具腔并转动含该底物的模具部分使底物的第二部分暴露；(e)关闭模具腔；(f)将加热的流动性可结晶碳水化合物注入模具腔中，使该流动性可结晶碳水化合物包裹模具腔内该底物的第二部分；(g)迅速改变模具腔内的温度诱导包裹该底物第二部分的流动性可结晶碳水化合物热激结晶；以及(h)将所述底物从模具腔中取出。
23.一种制剂，包含至少一种活性组分和至少占总重量约50％的可结晶碳水化合物，其中至少约90％的可结晶碳水化合物是平均粒度约100微米或以下的晶体，该制剂干燥后水份含量失重不超过5％，该制剂横截面区域至少约30％无横纹，该制剂的横截面面积约约在1-900平方毫米范围内。
24.如权利要求23所述的制剂，其特征在于，该制剂中含有约60％的可结晶碳水化合物。
25.如权利要求24所述的制剂，其特征在于，该制剂中含有约75％的可结晶碳水化合物。
26.如权利要求23所述的制剂，其特征在于，该制剂中晶体的平均粒度小于约50微米。
27.如权利要求23所述的制剂，其特征在于，该制剂干燥后水份含量失重不超过约3％。
28.如权利要求26所述的制剂，其特征在于，该制剂干燥后水份含量失重不超过约1％。
29.如权利要求23所述的制剂，其特征在于，该制剂的横截面区域至少约50％无横纹。
30.如权利要求23所述的制剂，其特征在于，该制剂的横截面区域至少约80％无横纹。
CNA028236386A 2001-09-28 2002-09-28 可食用组合物及含可食用外壳的制剂 Pending CN1596100A (zh)

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US09/967,414 2001-09-28
US09/966,509 US6767200B2 (en) 2001-09-28 2001-09-28 Systems, methods and apparatuses for manufacturing dosage forms
US09/966,450 2001-09-28
US09/966,497 US7122143B2 (en) 2001-09-28 2001-09-28 Methods for manufacturing dosage forms
US09/966,939 2001-09-28
US09/966,450 US6982094B2 (en) 2001-09-28 2001-09-28 Systems, methods and apparatuses for manufacturing dosage forms
US09/966,497 2001-09-28
US09/966,509 2001-09-28
US09/966,939 US6837696B2 (en) 2001-09-28 2001-09-28 Apparatus for manufacturing dosage forms
US09/967,414 US6742646B2 (en) 2001-09-28 2001-09-28 Systems, methods and apparatuses for manufacturing dosage forms

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CNA028236416A Pending CN1596104A (zh) 2001-09-28 2002-09-28 改进的释放剂型
CNA028236505A Pending CN1596101A (zh) 2001-09-28 2002-09-28 含有糖果组分的剂型
CNA028236386A Pending CN1596100A (zh) 2001-09-28 2002-09-28 可食用组合物及含可食用外壳的制剂
CNA028235401A Pending CN1596102A (zh) 2001-09-28 2002-09-28 调节释放剂型
CNA028233441A Pending CN1592611A (zh) 2001-09-28 2002-09-28 改良释放的剂型
CNB028234308A Expired - Fee Related CN100408029C (zh) 2001-09-28 2002-09-28 有镶嵌部分的组合剂型
CNA028233476A Pending CN1592610A (zh) 2001-09-28 2002-09-28 改良的释放剂型
CNA028233611A Pending CN1638740A (zh) 2001-09-28 2002-09-28 释出得到修饰的剂型
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