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1.发明授权公开(公告)号：US08846088B2
公开(公告)日：2014-09-30
申请号：US11883532
申请日：2006-02-02
CPC分类号： A61K9/1623 , A61K9/1694 , A61K9/2018
摘要： A novel method for the preparation of a tablet comprising a calcium-containing compound, the method involves a melt granulation process by which a sugar alcohol is melted and embeds the calcium-containing compound so that a sufficient taste masking of the chalkiness is substantially achieved and an unpleasant mouth feel of the calcium-containing compound is substantially avoided, while at the same time obtaining a low tablet volume. The method of the invention is especially suitable for the manufacturing of tablets having a high load of a calcium-containing compound.
摘要翻译： 一种用于制备包含含钙化合物的片剂的新方法，所述方法包括熔融制粒方法，通过该方法将糖醇熔融并包埋含钙化合物，使得基本上实现了足够的垩白味道掩蔽， 基本上避免了含钙化合物的令人不愉快的口感，同时获得低的片剂体积。 本发明的方法特别适用于制造具有高负荷的含钙化合物的片剂。
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公开(公告)号：US09101565B2
公开(公告)日：2015-08-11
申请号：US13129664
申请日：2009-11-17
CPC分类号： A61K33/10 , A61J3/10 , A61K9/2018 , A61K9/2072 , A61K9/2095 , A61K9/282 , A61K33/06
摘要： The present invention relates to a method for the preparation of a tablet comprising at least 50% w/w of calcium carbonate, the method comprising i) providing a particulate composition comprising a) calcium carbonate, b) a binding sugar alcohol selected from sorbitol or isomalt, or combinations thereof, c) a non-binding sugar alcohol selected from mannitol, maltitol or xylitol, or combinations thereof, and ii) compressing said composition using a tabletting machine equipped with at least one pair of punches and dies, wherein the pair of punches and die before filling the die with said particulate composition is sprayed with a composition comprising a lubricant selected from magnesium stearate, calcium stearate or stearic acid or combinations thereof.
摘要翻译： 本发明涉及一种制备包含至少50％w / w碳酸钙的片剂的方法，所述方法包括i）提供包含a）碳酸钙的颗粒组合物，b）选自山梨醇或 异麦芽酮糖醇或其组合，c）选自甘露醇，麦芽糖醇或木糖醇的非结合性糖醇或其组合，以及ii）使用配备有至少一对冲头和模具的压片机压缩所述组合物，其中所述对 用含有选自硬脂酸镁，硬脂酸钙或硬脂酸的润滑剂或其组合的润滑剂的组合物喷涂用所述颗粒组合物填充模头之前的冲头和模具。
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公开(公告)号：US10258576B2
公开(公告)日：2019-04-16
申请号：US11597454
申请日：2005-05-24
摘要： The present invention relates to a particulate material and a solid dosage form notably tablets comprising a regularly shaped calcium-containing compound such as a calcium salt as a therapeutically and/or prophylactically active substance and a pharmaceutically acceptable sugar alcohol such as, e.g., sorbitol and/or isomalt that has a micro structure as evidenced by SEM. The invention also relates to a process for the preparation of the particulate material and solid dosage form. The process involves agglomeration of the calcium-containing compound and the pharmaceutically acceptable sugar alcohol by means of roller compaction. The particulate material obtained by roller compaction is suitable for use in the further processing of the particulate material into e.g. tablets such as chewing tablets.
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公开(公告)号：US08906411B2
公开(公告)日：2014-12-09
申请号：US12085697
申请日：2006-12-07
CPC分类号： A61K9/1611 , A23L29/37 , A23L33/16 , A23P10/20 , A23V2002/00 , A61K9/1623 , A61K9/1694 , A61K9/2009 , A61K9/2018 , A61K9/2095 , A61K31/7004 , A61K33/06 , A61K33/42 , A61K2300/00 , A23V2250/64 , A23V2250/1578
摘要： A pre-compacted materiel comprising one or more calcium-containing compounds and one or more sugar alcohols, wherein the calcium-containing compound having a polycrystallic porous structure. The pre-compacted material is preferably obtained by roller compaction and is suitable for use in the further processing of the pre-compacted material into composition like e.g. tablets.
摘要翻译： 一种预先压实的物质，其包含一种或多种含钙化合物和一种或多种糖醇，其中所述含钙化合物具有多金属多孔结构。 预压实的材料优选通过辊压而获得，并且适用于将预压实材料进一步加工成组合物，例如， 片剂
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5.发明授权公开(公告)号：US08808735B2
公开(公告)日：2014-08-19
申请号：US11883536
申请日：2006-02-02
CPC分类号： A61K9/1623 , A61K9/1694 , A61K9/2018
摘要： The present invention relates to a novel process for the preparation of a granulate comprising a calcium-containing compound as an active substance. The method comprises a method for the preparation of a granulate comprising a calcium-containing compound as an active substance, the method comprising, i) feeding a granulation chamber with a composition comprising the calcium-containing compound, ii) wet-massing the composition with a granulation liquid optionally comprising a pharmaceutically acceptable binder for a time period of at the most 30 sec to obtain a wet granulate, iii) drying the thus obtained wet granulate. A granulate obtained by the present method is especially suitable in the preparation of solid dosage forms, in particular in the preparation of tablets.
摘要翻译： 本发明涉及一种制备包含含钙化合物作为活性物质的颗粒的新方法。 该方法包括用于制备包含含钙化合物作为活性物质的颗粒的方法，所述方法包括：i）向含有含钙化合物的组合物喂养造粒室，ii）将组合物湿化， 任选地包含药学上可接受的粘合剂的造粒液，时间为最多30秒以获得湿颗粒，iii）干燥由此获得的湿颗粒。 通过本方法获得的颗粒特别适用于制备固体剂型，特别是制备片剂。
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公开(公告)号：US20110287098A1
公开(公告)日：2011-11-24
申请号：US13129664
申请日：2009-11-17
CPC分类号： A61K33/10 , A61J3/10 , A61K9/2018 , A61K9/2072 , A61K9/2095 , A61K9/282 , A61K33/06
摘要： The present invention relates to a method for the preparation of a tablet comprising at least 50% w/w of calcium carbonate, the method comprising i) providing a particulate composition comprising a) calcium carbonate, b) a binding sugar alcohol selected from sorbitol or isomalt, or combinations thereof, c) a non-binding sugar alcohol selected from mannitol, maltitol or xylitol, or combinations thereof, and ii) compressing said composition using a tabletting machine equipped with at least one pair of punches and dies, wherein the pair of punches and die before filling the die with said particulate composition is sprayed with a composition comprising a lubricant selected from magnesium stearate, calcium stearate or stearic acid or combinations thereof.
摘要翻译： 本发明涉及一种制备包含至少50％w / w碳酸钙的片剂的方法，所述方法包括i）提供包含a）碳酸钙的颗粒组合物，b）选自山梨醇或 异麦芽酮糖醇或其组合，c）选自甘露醇，麦芽糖醇或木糖醇的非结合性糖醇或其组合，以及ii）使用配备有至少一对冲头和模具的压片机压缩所述组合物，其中所述对 用含有选自硬脂酸镁，硬脂酸钙或硬脂酸的润滑剂或其组合的润滑剂的组合物喷涂用所述颗粒组合物填充模头之前的冲头和模具。
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公开(公告)号：US20090275540A1
公开(公告)日：2009-11-05
申请号：US12085697
申请日：2006-12-07
CPC分类号： A61K9/1611 , A23L29/37 , A23L33/16 , A23P10/20 , A23V2002/00 , A61K9/1623 , A61K9/1694 , A61K9/2009 , A61K9/2018 , A61K9/2095 , A61K31/7004 , A61K33/06 , A61K33/42 , A61K2300/00 , A23V2250/64 , A23V2250/1578
摘要： A pre-compacted materiel comprising one or more calcium-containing compounds and one or more sugar alcohols, wherein the calcium-containing compound having a polycrystallic porous structure. The pre-compacted material is preferably obtained by roller compaction and is suitable for use in the further processing of the pre-compacted material into composition like e.g. tablets.
摘要翻译： 一种预先压实的物质，其包含一种或多种含钙化合物和一种或多种糖醇，其中所述含钙化合物具有多金属多孔结构。 预压实的材料优选通过辊压而获得，并且适用于将预压实材料进一步加工成组合物，例如， 片剂
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公开(公告)号：US08231899B2
公开(公告)日：2012-07-31
申请号：US10758233
申请日：2004-01-13
CPC分类号： A61K9/1617 , A61K9/1611 , A61K9/1652
摘要： The present invention relates to an oral modified release pharmaceutical composition for the administration of a therapeutically and/or prophylactically effective amount of an active substance (a drug substance) to obtain a relatively fast or quick onset of the therapeutic and/or prophylactic effect. The drug substances contained in a modified release pharmaceutical composition according to the invention are suitably a drug substance which has a very low solubitity under acidic conditions, i.e. under conditions similar to those present in the stomach and/or drug substances which have a pKa value below about 5.5 such as in a range of from about 4 to about 5. The composition is based on a powder comprising a therapeutically and/or prophylactically active substance and has such a particle size that: when the powder is subjected to a sieve analysis, then at least about 90% w/w of the particles passes through sieves 180 μm and the powder is contacted with an aqueous medium to form a particulate composition, which has such a particle size that when the particulate composition is subjected to a sieve analysis, then at least about 50% w/w of the particles passes through sieve 180 μm. Furthermore, the composition, when tested in accordance with the dissolution method (I) defined herein employing 0.07 N hydrochloric acid as dissolution medium, releases at least about 50% w/w of the active substance within the first 20 min of the test.
摘要翻译： 本发明涉及用于给予治疗和/或预防有效量的活性物质（药物物质）以获得治疗和/或预防效果相对快速或快速发作的口服释放药物组合物。 包含在根据本发明的调释释放药物组合物中的药物物质合适地是在酸性条件下具有非常低的溶解度的药物物质，即在与pKa值低于pKa值的胃和/或药物物质中存在的条件相似的条件下 约5.5，例如在约4至约5的范围内。该组合物基于包含治疗和/或预防活性物质的粉末，并且具有如下的粒径：当粉末进行筛分分析时，则 至少约90％w / w的颗粒通过180μm的筛子，并且粉末与水性介质接触以形成颗粒组合物，其具有这样的颗粒尺寸，即当颗粒组合物进行筛分分析时， 颗粒的至少约50％w / w通过筛180μm。 此外，当根据本文定义的溶解方法（I）使用0.07N盐酸作为溶解介质测试时，组合物在试验的最初20分钟内释放至少约50％w / w的活性物质。
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