CN109310637A - 剂型的生产方法 - Google Patents
剂型的生产方法 Download PDFInfo
- Publication number
- CN109310637A CN109310637A CN201780038246.XA CN201780038246A CN109310637A CN 109310637 A CN109310637 A CN 109310637A CN 201780038246 A CN201780038246 A CN 201780038246A CN 109310637 A CN109310637 A CN 109310637A
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- China
- Prior art keywords
- pellet
- calcium carbonate
- agent
- acid
- alcohol
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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- 239000002552 dosage form Substances 0.000 title claims abstract description 50
- 238000004519 manufacturing process Methods 0.000 title claims abstract description 17
- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical compound [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 claims abstract description 321
- 239000008188 pellet Substances 0.000 claims abstract description 198
- 229910000019 calcium carbonate Inorganic materials 0.000 claims abstract description 154
- 238000000034 method Methods 0.000 claims abstract description 109
- 238000006557 surface reaction Methods 0.000 claims abstract description 86
- 239000003814 drug Substances 0.000 claims abstract description 66
- 229940079593 drug Drugs 0.000 claims abstract description 52
- 239000002775 capsule Substances 0.000 claims abstract description 34
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- 238000004806 packaging method and process Methods 0.000 claims abstract description 7
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- CURLTUGMZLYLDI-UHFFFAOYSA-N Carbon dioxide Chemical compound O=C=O CURLTUGMZLYLDI-UHFFFAOYSA-N 0.000 claims description 122
- 239000002243 precursor Substances 0.000 claims description 109
- 235000019441 ethanol Nutrition 0.000 claims description 92
- 239000003795 chemical substances by application Substances 0.000 claims description 88
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- -1 macromolecular Substances 0.000 claims description 86
- 239000000470 constituent Substances 0.000 claims description 79
- 150000002500 ions Chemical class 0.000 claims description 72
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- 239000001569 carbon dioxide Substances 0.000 claims description 60
- 238000009472 formulation Methods 0.000 claims description 58
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 39
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- 239000013543 active substance Substances 0.000 claims description 36
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- 238000012545 processing Methods 0.000 claims description 26
- 238000011065 in-situ storage Methods 0.000 claims description 24
- QSHDDOUJBYECFT-UHFFFAOYSA-N mercury Chemical compound [Hg] QSHDDOUJBYECFT-UHFFFAOYSA-N 0.000 claims description 23
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- IAZDPXIOMUYVGZ-UHFFFAOYSA-N Dimethylsulphoxide Chemical compound CS(C)=O IAZDPXIOMUYVGZ-UHFFFAOYSA-N 0.000 claims description 6
- KFZMGEQAYNKOFK-UHFFFAOYSA-N Isopropanol Chemical compound CC(C)O KFZMGEQAYNKOFK-UHFFFAOYSA-N 0.000 claims description 6
- WYURNTSHIVDZCO-UHFFFAOYSA-N Tetrahydrofuran Chemical compound C1CCOC1 WYURNTSHIVDZCO-UHFFFAOYSA-N 0.000 claims description 6
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- NWUYHJFMYQTDRP-UHFFFAOYSA-N 1,2-bis(ethenyl)benzene;1-ethenyl-2-ethylbenzene;styrene Chemical compound C=CC1=CC=CC=C1.CCC1=CC=CC=C1C=C.C=CC1=CC=CC=C1C=C NWUYHJFMYQTDRP-UHFFFAOYSA-N 0.000 claims description 4
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- 239000008185 minitablet Substances 0.000 claims description 4
- BDERNNFJNOPAEC-UHFFFAOYSA-N propan-1-ol Chemical compound CCCO BDERNNFJNOPAEC-UHFFFAOYSA-N 0.000 claims description 4
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- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims description 3
- 229920001800 Shellac Polymers 0.000 claims description 3
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims description 3
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Abstract
本发明涉及一种剂型的生产方法;通过该方法获得的由经表面反应的碳酸钙构成的粒料、以及片剂和/或胶囊;经表面反应的碳酸钙在这种方法中的用途;包含该粒料的剂型;该粒料或者该片剂和/或胶囊或者该剂型在药物、营养物、农业、化妆品、家用、食品、包装和个人护理产品中的用途;以及包含该粒料或者该片剂和/或胶囊或者该剂型的药物、营养物、农业、化妆品、家用、食品、包装和个人护理产品。
Description
技术领域
本发明涉及一种剂型的生产方法;通过该方法获得的由经表面反应的碳酸钙构成的粒料、以及片剂和/或胶囊;经表面反应的碳酸钙在这种方法中的用途;包含该粒料的剂型;该粒料或者该片剂和/或胶囊或者该剂型在药物、营养物、农业、化妆品、家用、食品、包装和个人护理产品中的用途;以及包含该粒料或者该片剂和/或胶囊或者该剂型的药物、营养物、农业、化妆品、家用、食品、包装和个人护理产品。
背景技术
经表面反应的碳酸钙粉末可在各种各样的应用中作为载体使用,这归因于它的高孔隙率以及加载活性/非活性试剂的能力。因而,经表面反应的碳酸钙在剂型的生产中变得越来越重要。取决于最终用途,这种剂型的载体材料或基质需要首先与所需活性成分或非活性前体材料混合,并且需要发现相容的配制助剂以便能够生产该剂型。这种剂型主要由粉末制造。然而,针对这种粉末经常出现的问题是它们不能自由流动、具有低的堆密度、并且产生过多粉尘。因而,已开发出用于生产呈包含经表面反应的碳酸钙的压实材料形式的剂型并且避免了前述缺点的方法。
例如,未公开的欧洲专利申请EP 15 160 194.5涉及用于生产可分散剂型的方法,包括以下步骤:a)提供官能化的含碳酸钙材料,其是天然研磨或沉淀碳酸钙与二氧化碳和一种或多种酸在水性介质中的反应产物,其中该二氧化碳通过酸处理原位形成和/或从外部来源供应;b)提供至少一种崩解剂;c)任选地,提供至少一种其他配制助剂;d)使步骤a)的官能化的含碳酸钙材料、步骤b)的该至少一种崩解剂和步骤c)的该任选的至少一种其他配制助剂混合;以及e)借助辊式压实机(roller compactor)在2-20巴范围内的压实压力下将步骤d)中获得的混合物压实成带;以及f)将步骤e)的带磨碎成粒料,g)通过至少一种筛目尺寸筛分步骤f)的粒料。
未公开的欧洲专利申请EP 14 199 037.4涉及用于生产药物递送系统的方法,包括以下步骤:a)提供经表面反应的碳酸钙,其是天然研磨或沉淀碳酸钙与二氧化碳和一种或多种酸在水性介质中的反应产物,其中该二氧化碳通过酸处理原位形成和/或从外部来源供应;b)提供至少一种药物活性剂或其药物非活性前体;c)提供至少一种配制助剂;d)使步骤a)的经表面反应的碳酸钙、步骤b)的该至少一种药物活性剂或其药物非活性前体和步骤c)的该至少一种配制助剂混合;以及e)借助辊式压实机在4-20巴范围内的压实压力下压实步骤d)中获得的混合物;以及f)压实在步骤e)中获得的辊式压实的混合物以获得药物递送系统。
未公开的欧洲专利申请EP 15 197 395.5涉及用于生产包含经表面反应的碳酸钙的粒料的方法,其特征在于以下步骤:a)提供经表面反应的碳酸钙,其中该经表面反应的碳酸钙是天然研磨或沉淀碳酸钙与二氧化碳和一种或多种H3O+离子供体在水性介质中的反应产物,其中该二氧化碳通过H3O+离子供体处理原位形成和/或从外部来源供应;b)提供呈液体形式的一种或多种活性成分,c)用该呈液体形式的一种或多种活性成分使经表面反应的碳酸钙饱和,d)提供一种或多种粘结剂,以及e)将步骤c)中获得的饱和的经表面反应的碳酸钙与步骤d)的一种或多种粘结剂在搅拌下于搅拌装置中合并。
然而,在前述文献中描述的方法还需要在压实期间使用例如一种或多种粘结剂和/或一种或多种崩解剂的一种或多种配制助剂,其需要与所使用的经表面反应的碳酸钙粉末以及活性剂相容,且进一步必须适合于期望的最终用途,例如必须被批准用于人类和/或动物消耗的用途。
因而,对于以下这样的剂型及其生产方法存在持续的需求:其提供与现有剂型相同或甚至更好的性能并且尤其允许在例如一种或多种粘结剂和/或一种或多种崩解剂的一种或多种配制助剂不存在的情况下生产压实的剂型。此外,期望该方法允许生产相对于用于制备其的粉末而言具有改善的流动性、松散堆密度和振实堆密度以及显著更少的撒粉或几乎不撒粉并且因而可容易地用在进一步处理中的剂型。除此之外,期望提供一种剂型生产方法,其是有效的且允许剂型充分压实。
发明内容
因而,本发明的一个目的在于提供一种剂型生产方法。另一目的也可见于提供一种用于生产剂型的高效压实方法。进一步的目的可见于提供一种用于在例如一种或多种粘结剂和/或一种或多种崩解剂的一种或多种配制助剂不存在的情况下生产压实的剂型的方法。另一目的可见于提供一种用于生产剂型的方法,相对于用于制成该剂型的粉末而言,该剂型具有改善的流动性、松散堆密度和振实堆密度并且显著更少的撒粉或几乎不撒粉且因而可容易地用在进一步处理中。
一种或多种前述及其他问题通过如在本文中的独立权利要求所定义的主题来解决。本发明有利的实施方案在相应从属权利要求中定义。
本发明的第一方面涉及一种用于生产剂型的方法。该方法包括以下步骤:
a)提供经表面反应的碳酸钙,其中该经表面反应的碳酸钙是天然研磨或沉淀碳酸钙与二氧化碳和一种或多种H3O+离子供体在水性介质中的反应产物,其中该二氧化碳通过H3O+离子供体处理原位形成和/或从外部来源供应;
b)借助于辊式压实机在1-30kN/cm范围内的压实压力下将步骤a)的经表面反应的碳酸钙压实成压实形式
c)将步骤b)的该压实形式磨碎成粒料;
其中步骤b)中获得的压实形式由步骤a)的该经表面反应的碳酸钙构成。
根据本发明的另一方面,提供由如在本文中所定义的经表面反应的碳酸钙构成并且任选地与如在本文中所定义的至少一种配制助剂混合和/或加载有如在本文中所定义的至少一种活性成分和/或其非活性前体的粒料。根据本发明进一步的方面,提供通过如在本文中所定义的方法而获得的片剂和/或胶囊。
根据本发明的再进一步的方面,提供包含如在本文中所定义的粒料的剂型,优选片剂、迷你片剂或胶囊。
根据本发明的再另一方面,提供如在本文中所定义的粒料或者如在本文中所定义的片剂和/或胶囊或者如在本文中所定义的剂型在药物、营养物、农业、化妆品、家用、食品、包装和个人护理产品中的用途。
根据本发明的进一步的方面,提供包含如在本文中所定义的粒料或者如在本文中所定义的片剂和/或胶囊或者如在本文中所定义的剂型的药物、营养物、农业、化妆品、家用、食品、包装和个人护理产品。
根据本发明的另一方面,提供经表面反应的碳酸钙在如在本文中所定义的方法中的用途。
根据本发明方法的一种实施方案,该天然研磨碳酸钙选自含碳酸钙的矿物,该矿物选自大理石、白垩、白云石、石灰石及其混合物;或者该沉淀碳酸钙选自具有文石、球霰石或方解石型矿物学晶型的沉淀碳酸钙及其混合物。
根据本发明方法的另一实施方案,该经表面反应的碳酸钙a)具有根据ISO 9277使用氮气和BET方法测量的20m2/g-450m2/g、优选20m2/g-250m2/g、更优选30m2/g-160m2/g、最优选40m2/g-150m2/g、进一步更优选40m2/g-140m2/g的BET比表面积;和/或b)包含具有1μm-50μm、优选1-45μm、更优选2-30μm、甚至更优选3-15μm、并且最优选4-12μm的体积中值颗粒直径d50的粒子;和/或c)具有由汞侵入孔隙率测定法测量结果计算的在0.15-1.35cm3/g、优选0.30-1.30cm3/g、并且最优选0.40-1.25cm3/g范围内的粒子内侵入式比孔容。
根据本发明方法的再另一种实施方案,辊式压实步骤b)在1-28kN/cm的范围内、更优选在1-20kN/cm的范围内并且最优选在2-10kN/cm的范围内的辊式压实压力下进行。
根据本发明方法的一种实施方案,该方法进一步包括步骤d):通过至少一种筛目尺寸筛分步骤c)的粒料。
根据本发明的另一种实施方案,筛分步骤d)通过在两种或更多种不同的筛目尺寸上筛分来进行,优选利用90μm、180μm、250μm、355μm、500μm和710μm的筛目尺寸来进行。
根据本发明方法的另一实施方案,该方法进一步包括步骤e1):使在步骤b)中获得的该压实形式或者在步骤c)和/或如果存在的步骤d)中获得的粒料与该至少一种配制助剂混合。
根据本发明方法的一种实施方案,该至少一种配制助剂选自崩解剂,优选选自改性纤维素胶,不溶性交联聚乙烯吡咯烷酮,乙醇酸淀粉(starch glycolates),微晶纤维素,预胶凝化淀粉,羧甲基淀粉钠,低取代羟丙基纤维素,N-乙烯基-2-吡咯烷酮的均聚物,烷基纤维素酯,羟烷基纤维素酯,羧基烷基纤维素酯,藻酸盐,微晶纤维素及其多晶型,离子交换树脂,树胶,甲壳素,壳聚糖,粘土,结冷胶,交联泼拉克林(polacrillin)共聚物,琼脂,明胶,糊精,丙烯酸聚合物,羧甲基纤维素钠/钙,邻苯二甲酸羟丙基甲基纤维素,虫胶或其混合物,润滑剂,尤其是相内润滑剂和/或相外润滑剂,抗冲改性剂,增塑剂,蜡,稳定剂,颜料,着色剂,香味剂,味觉掩蔽剂,调味剂,甜味剂,口感改良剂,稀释剂,成膜剂,粘合剂,缓冲剂,吸附剂,气味掩蔽剂及其混合物。
根据本发明方法的另一种实施方案,该方法进一步包括步骤e2):利用至少一种活性成分和/或其非活性前体加载在步骤b)中获得的该压实形式或者在步骤c)和/或如果存在的步骤d)中获得的该粒料。
根据本发明方法的再另一实施方案,该至少一种活性成分和/或其非活性前体选自日用化妆香精(fragrances),食用香精(flavours),草本提取物,水果提取物,营养剂,痕量矿物,防护剂,食品,化妆品,阻燃剂,酶,大分子,杀虫剂,肥料,防腐剂,抗氧化剂,反应性化学品,合成来源、半合成来源、天然来源的药物活性剂或者其药物非活性前体,及其混合物。
根据本发明方法的一种实施方案,该至少一种活性成分和/或其非活性前体呈液体形式,优选该至少一种活性成分和/或其非活性前体提供于溶剂中,优选该溶剂选自水、甲醇、乙醇、正丁醇、异丙醇、正丙醇、正辛醇、丙酮、二甲基亚砜、二甲基甲酰胺、四氢呋喃、植物油及其衍生物、动物油及其衍生物、熔融脂肪和蜡,及其混合物,并且更优选该溶剂为水、乙醇和/或丙酮。
根据本发明方法的另一实施方案,加载步骤e2)通过将该至少一种活性成分和/或其非活性前体喷涂或滴加到在步骤b)中获得的该压实形式或者在步骤c)和/或如果存在的步骤d)中获得的该粒料上并且将其在选自流化床干燥机/造粒机、犁铧式混合器(ploughshare mixer)、立式或卧式混合器、高或低剪切混合器以及高速掺合机的装置中混合来进行。
根据本发明方法的再另一种实施方案,该方法进一步包括最终步骤f):将步骤e2)中获得的该经加载的粒料制片或者将步骤e2)中获得该经加载的粒料填充至胶囊中。
应当理解,出于本发明的目的,以下术语具有以下含义。
出于本发明的目的,“酸”被定义为布朗斯台德-洛瑞酸(-Lowryacid),即其为H3O+离子提供者。“酸式盐”被定义为H3O+离子提供者,例如被正电性元素部分中和的含氢盐。“盐”被定义为由阴离子和阳离子形成的电中性离子化合物。“部分结晶盐”被定义为在XRD分析时呈现基本上离散的衍射图样的盐。
根据本发明,pKa是表示与在给定酸中的给定可电离氢相关的酸解离常数的符号,且表明此氢在给定温度下在水中的平衡下由这种酸的自然解离程度。这种pKa值可见于以下的参考教材中,例如:Harris,D.C.“Quantitative Chemical Analysis:第3版”,1991年,W.H.Freeman&Co.(USA),ISBN 0-7167-2170-8。
“经表面反应的碳酸钙”是这样的材料:其包含碳酸钙和优选自该碳酸钙的至少一部分的表面延伸的水不溶性的至少部分结晶的非碳酸钙盐。形成所述至少部分结晶的非碳酸钙盐的钙离子主要源自也用以形成经表面反应的碳酸钙核的起始碳酸钙材料。这种盐可包括OH-阴离子和/或结晶水。
在本发明的含义中,“水不溶性”材料被定义为这样的材料:当其与去离子水混合且在20℃下在具有0.2μm孔尺寸的过滤器上过滤以回收液体滤液时,100g所述液体滤液在95-100℃下蒸发之后提供小于或等于0.1g的回收的固体材料。“水溶性”材料被定义为这样的材料:100g所述液体滤液在95-100℃下蒸发之后导致回收大于0.1g的回收的固体材料。
在本发明的含义中,碳酸钙的“比表面积(SSA)”被定义为碳酸钙的表面积除以其质量。如在本文中所使用的,使用BET等温线通过氮气吸附(ISO 9277:2010)测量比表面积且以m2/g规定。
应当理解,术语“至少一种活性成分和/或其非活性前体”与配制助剂不同,即该至少一种活性成分和/或其非活性前体不包括以下各项(其本身也不是以下各项):粘结剂、崩解剂、润滑剂、抗冲改性剂、增塑剂、蜡、稳定剂、颜料、着色剂、香味剂、味觉掩蔽剂、调味剂、口感改良剂、稀释剂、成膜剂、粘合剂、缓冲剂、吸附剂、气味掩蔽剂及其混合物。
在本发明的含义中,术语“压实(compacting)”是指在压力下获得的粒料硬度的提高以及体积和/或密度的降低。
当术语“包括或包含(comprising)”在本说明书和权利要求书中使用时,其并不排除其他要素。出于本发明的目的,术语“由……构成(consisting of)”被认为是术语“包括或包含(comprising of)”的优选实施方案。如果在下文中定义一个组集(group)包括至少一定数目的实施方案,则这也被理解为公开了一个组集,其优选仅由这些实施方案构成。
在谈论单数名词时使用不定冠词或定冠词如“a”、“an”、或“the”的情况下,这包括了该名词的复数,除非一些情况下另外具体指出。
诸如“可获得(obtainable)”或“可定义(definable)”以及“获得(的)(obtained)”或“定义(的)(defined)”的术语可互换使用。这例如意味着,除非上下文另外明确指出,否则术语“获得(的)”并不意味着指示例如一种实施方案必须通过例如术语“获得(的)”之后的步骤序列来获得,虽然术语“获得(的)”或“定义(的)”总是包括此类限制性理解作为优选实施方案。
根据本发明,已经发现可通过在例如粘结剂和/或崩解剂的配制助剂不存在的情况下压实经表面反应的碳酸钙来制备剂型。经压实的经表面反应的碳酸钙然后用至少一种活性成分和/或其非活性前体加载。此外,所生产的剂型相对于用于制备它的粉末而言具有改善的流动性、松散堆密度和振实堆密度,并且显著更少的撒粉或几乎不撒粉并且因而可容易地用于进一步处理。除此之外,该方法提供了有效压实该剂型的可能性。
在下文中提及本发明的进一步细节并且尤其是用于生产剂型的方法的前述步骤。
方法步骤a)
在本发明方法的步骤a)中,提供经表面反应的碳酸钙。
经表面反应的碳酸钙是天然研磨碳酸钙或沉淀碳酸钙与二氧化碳和一种或多种H3O+离子供体的反应产物,其中该二氧化碳通过H3O+离子供体处理原位形成和/或从外部来源供应。
在本发明的上下文中,H3O+离子供体为布朗斯台德酸和/或酸式盐。
“酸式盐”被定义为H3O+离子提供者,例如通过正电性元素部分中和的含氢盐。“盐”被定义为由阴离子和阳离子形成的电中性离子化合物。“部分结晶盐”被定义为在XRD分析时呈现基本上离散的衍射图样的盐。
在本发明的一种优选的实施方案中,该经表面反应的碳酸钙通过包括以下步骤的方法获得:(a)提供天然或沉淀碳酸钙的悬浮液,(b)向步骤a)的该悬浮液中添加至少一种在20℃下具有0或更小的pKa值或者在20℃下具有0-2.5的pKa值的酸,以及(c)在步骤(b)之前、期间或之后用二氧化碳处理步骤(a)的该悬浮液。根据另一实施方案,该经表面反应的碳酸钙通过包括以下步骤的方法获得:(A)提供天然或沉淀碳酸钙,(B)提供至少一种水溶性酸,(C)提供气态CO2,(D)使步骤(A)的所述天然或沉淀碳酸钙与步骤(B)的该至少一种酸以及步骤(C)的CO2接触,其特征在于:(i)步骤B)的该至少一种酸在20℃下具有大于2.5且小于或等于7的pKa,所述pKa与其第一可用氢的电离相关,且在此第一可用氢失去时形成能够形成水溶性钙盐的相应阴离子,且(ii)在使该至少一种酸与天然或沉淀碳酸钙接触之后,另外提供至少一种水溶性盐,其在含氢盐情形下在20℃下具有大于7的pKa(所述pKa与该第一可用氢的电离相关),且其盐阴离子能够形成水不溶性钙盐。
“天然研磨碳酸钙(GCC)”(或“天然碳酸钙”)优选选自含碳酸钙的矿物,所述含碳酸钙的矿物选自大理石、白垩、白云石、石灰石及其混合物。天然研磨碳酸钙可进一步包含天然存在的组分例如碳酸镁、铝硅酸盐等。
通常,天然研磨碳酸钙的研磨可以是干或湿研磨步骤并且可例如在使得粉碎主要由使用辅助体冲击产生的条件下,用任何传统研磨装置进行,也即在以下的一种或多种中进行:球磨机、棒磨机、振动研磨机、轧碎机、离心冲击研磨机、立式珠磨机、磨碎机、销棒粉碎机、锤磨机、粉磨机、撕碎机、去块机、切割机(knife cutter)或本领域技术人员已知的其它此类设备。在含碳酸钙矿物材料包含湿研磨的含碳酸钙矿物材料的情况下,研磨步骤可在使得发生自体研磨的条件下和/或通过水平球磨和/或本领域技术人员已知的其它此类方法来进行。由此获得的经湿加工的天然研磨的含碳酸钙矿物材料可通过众所周知的方法,例如通过絮凝、过滤或强制蒸发(在干燥之前)来洗涤并脱水。后续干燥步骤(必要时)可在单一步骤(例如喷雾干燥)中进行,或者在至少两个步骤中进行。还常见地,这种矿物材料进行选矿步骤(例如浮选、漂白或磁性分离步骤)以去除杂质。
在本发明含义中的“沉淀碳酸钙”(PCC)为合成的物质,通常通过在水性环境中在二氧化碳与氢氧化钙反应之后沉淀或通过将钙离子和碳酸根离子(例如,CaCl2及Na2CO3)从溶液中沉淀出来而获得。生产PCC的其它可能方式为石灰纯碱法,或者Solvay法,其中PCC为氨生产的副产物。沉淀碳酸钙以三种初级晶形存在:方解石、文石和球霰石,且对于这些晶形中的每一晶形而言存在许多不同的多晶型物(晶体惯态)。方解石具有三角结构,该三角结构具有典型的晶体惯态如偏三角面体的(S-PCC)、斜方六面体的(R-PCC)、六角形棱柱的、轴面的、胶体的(C-PCC)、立方的及棱柱的(P-PCC)。文石为正斜方晶结构,该正斜方晶结构具有成对六角形棱晶的典型晶体惯态,以及细长棱柱的、弯曲叶片状的、陡锥状、凿尖晶体、分叉树及珊瑚或蠕虫状的形式的多种分类。球霰石属于六方晶系。所获得的PCC浆料可机械脱水和干燥。
根据本发明的一种实施方案,该沉淀碳酸钙为优选包含文石、球霰石或方解石矿物晶形或其混合物的沉淀碳酸钙。
沉淀碳酸钙可以在用二氧化碳和至少一种H3O+离子供体处理之前通过与用于研磨如上所述的天然碳酸钙的相同方式进行研磨。
根据本发明的一种实施方案,天然研磨或沉淀碳酸钙为粒子的形式,所述粒子具有重量中值粒子尺寸d50为0.05-10.0μm,优选0.2-5.0μm,更优选0.4-3.0μm,最优选0.6-1.2μm,尤其是0.7μm。根据本发明的另一种实施方案,天然研磨或沉淀碳酸钙为粒子的形式,所述粒子具有顶切粒子尺寸d98为0.15-55μm,优选1-40μm,更优选2-25μm,最优选3-15μm,尤其是4μm。
该天然研磨和/或沉淀碳酸钙可以干燥使用或悬浮在水中。优选地,相应的浆料具有范围为1%重量-90%重量、更优选3%重量-60%重量、甚至更优选5%重量-40%重量并且最优选10%重量-25%重量的天然研磨或沉淀碳酸钙的含量,基于浆料的重量计。
用于制备经表面反应的碳酸钙的该一种或多种H3O+离子供体可为在制备条件下产生H3O+离子的任何强酸、中强酸或弱酸或其混合物。根据本发明,该至少一种H3O+离子供体也可以是在制备条件下产生H3O+离子的酸式盐。
根据一种实施方案,该至少一种H3O+离子供体为具有在20℃下为0或更小的pKa值的强酸。
根据另一种实施方案,该至少一种H3O+离子供体为具有在20℃下为0-2.5的pKa值的中强酸。如果在20℃下的pKa为0或更小,则该酸优选选自硫酸,盐酸或者其混合物。如果在20℃下的pKa为0-2.5,则该H3O+离子供体优选选自H2SO3,H3PO4,草酸,或其混合物。该至少一种H3O+离子供体也可以是酸式盐,例如HSO4 -或H2PO4 -,其为通过相应阳离子如Li+、Na+或K+至少部分中和的,或者HPO4 2-,其为通过相应阳离子如Li+、Na+、K+、Mg2+或Ca2+至少部分中和的。该至少一种H3O+离子供体也可以是一种或多种酸和一种或多种酸式盐的混合物。
根据又另一种实施方案,该至少一种H3O+离子供体为弱酸,其具有在20℃下测量时为大于2.5且小于或等于7的pKa值(与第一可用氢的电离相关),并且具有能够形成水溶性钙盐的相应阴离子。之后,额外添加至少一种水溶性盐,其在含氢盐的情况下具有在20℃下测量时为大于7的pKa(与第一可用氢的电离相关)并且其盐阴离子能够形成水不溶性钙盐。根据一种优选实施方案,该弱酸具有在20℃下为2.5-5的pKa值,并且更优选地,该弱酸选自醋酸,甲酸,丙酸,以及其混合物。所述水溶性盐的示例性阳离子选自钾、钠、锂及其混合物。在一种更优选的实施方案中,所述阳离子为钠或钾。所述水溶性盐的示例性阴离子选自磷酸根、磷酸二氢根、磷酸单氢根、草酸根、硅酸根、其混合物及其水合物。在一种更优选的实施方案中,所述阴离子选自磷酸根、磷酸二氢根、磷酸单氢根、其混合物及其水合物。在一种最优选的实施方案中,所述阴离子选自磷酸二氢根、磷酸单氢根、其混合物及其水合物。可逐滴进行或在一个步骤中进行水溶性盐的添加。在逐滴添加的情况下,此添加优选在10分钟的时间周期内发生。更优选地在一个步骤中添加所述盐。
根据本发明的一种实施方案,该至少一种H3O+离子供体选自盐酸、硫酸、亚硫酸、磷酸、柠檬酸、草酸、醋酸、甲酸及其混合物。优选地,该至少一种H3O+离子供体选自盐酸、硫酸、亚硫酸、磷酸、草酸、H2PO4 -(其为通过相应阳离子如Li+、Na+或K+至少部分中和的),HPO4 2-(其为通过相应阳离子如Li+、Na+、K+、Mg2+或Ca2+至少部分中和的),及其混合物,更优选地,该至少一种酸选自盐酸、硫酸、亚硫酸、磷酸、草酸或其混合物,且最优选地,该至少一种H3O+离子供体为磷酸。
该一种或多种H3O+离子供体可作为浓缩溶液或更稀释的溶液被添加至该悬浮液中。优选地,该H3O+离子供体与该天然或沉淀碳酸钙的摩尔比为0.01至4,更优选0.02至2,甚至更优选0.05至1并且最优选0.1至0.58。
作为另外可选方案,也可在悬浮该天然研磨或沉淀碳酸钙之前将该H3O+离子供体添加至水中。
在下一个步骤中,利用二氧化碳处理天然研磨或沉淀碳酸钙。如果诸如硫酸或盐酸的强酸被用于天然研磨或沉淀碳酸钙的H3O+离子供体处理,则二氧化碳自动形成。另外可选地或者额外地,二氧化碳可由外部来源供应。
H3O+离子供体处理和利用二氧化碳的处理可同时进行,当使用强酸或中强酸时情况就是如此。也可首先进行H3O+离子供体处理,例如利用在20℃下具有0至2.5范围内的pKa的中强酸来进行,其中二氧化碳原位形成,并且因此,二氧化碳处理将自动地与H3O+离子供体处理同时进行,接着进行利用由外部来源供应的二氧化碳的额外处理。
优选地,悬浮液中气态二氧化碳的浓度就体积而言使得比率(悬浮液体积):(气态CO2的体积)为1:0.05至1:20,甚至更优选为1:0.05至1:5。
在一种优选实施方案中,H3O+离子供体处理步骤和/或二氧化碳处理步骤重复至少一次,更优选多次。根据一种实施方案,在至少约5分钟、优选至少约10分钟、典型地约10至约20分钟、更优选约30分钟、甚至更优选约45分钟并且有时约1小时或更长的时间周期内添加该至少一种H3O+离子供体。
在H3O+离子供体处理及二氧化碳处理之后,在20℃下测量的水性悬浮液的pH值自然地达到大于6.0、优选大于6.5、更优选大于7.0、甚至更优选大于7.5的值,由此将表面反应的天然或沉淀碳酸钙制备为具有大于6.0、优选大于6.5、更优选大于7.0、甚至更优选大于7.5的pH值的水性悬浮液。
关于经表面反应的天然研磨碳酸钙的制备的进一步细节被公开在以下文献中:WO00/39222A1,WO 2004/083316A1,WO 2005/121257A2,WO 2009/074492 A1,EP 2 264 108A1,EP 2 264 109 A1和US 2004/0020410 A1,这些参考文献的内容在此被包括在本申请中。
类似地,获得经表面反应的沉淀碳酸钙。正如可从WO 2009/074492 A1详细获取的,经表面反应的沉淀碳酸钙通过如下方式获得:使沉淀碳酸钙与H3O+离子并且与溶解于水性介质中且能够形成水不溶性钙盐的阴离子在水性介质中接触,以形成经表面反应的沉淀碳酸钙的浆料,其中所述经表面反应的沉淀碳酸钙包含在沉淀碳酸钙的至少一部分的表面上形成的所述阴离子的不溶性的至少部分结晶的钙盐。
所述溶解的钙离子对应于相对于沉淀碳酸钙被H3O+离子溶解而天然生成的溶解钙离子来说过量的溶解的钙离子,其中所述H3O+离子仅以该阴离子的抗衡离子的形式提供,也即经由添加酸或非钙酸式盐的形式的阴离子,并且不存在任何另外的钙离子或钙离子生成来源。
所述过量的溶解的钙离子优选通过添加可溶中性或酸式钙盐而提供,或通过添加原位产生可溶中性或酸式钙盐的酸或中性或酸式非钙盐而提供。
所述H3O+离子可通过添加酸或所述阴离子的酸式盐而提供,或通过添加同时用于提供所有或部分的所述过量的溶解的钙离子的酸或酸式盐而提供。
在制备经表面反应的天然研磨或沉淀碳酸钙的一种优选实施方案中,使天然研磨或沉淀碳酸钙在至少一种选自以下的化合物的存在下与酸和/或二氧化碳反应:硅酸盐、二氧化硅、氢氧化铝、碱土铝酸盐如铝酸钠或铝酸钾、氧化镁或其混合物。优选地,该至少一种硅酸盐选自硅酸铝、硅酸钙或碱土金属硅酸盐。这些组分可在添加酸和/或二氧化碳之前添加至包含天然或沉淀碳酸钙的水性悬浮液中。
另外可选地,硅酸盐和/或二氧化硅和/或氢氧化铝和/或碱土铝酸盐和/或氧化镁组分可在天然研磨或沉淀碳酸钙与酸及二氧化碳已经开始反应时添加至天然研磨或沉淀碳酸钙的水性悬浮液中。关于在至少一种硅酸盐和/或二氧化硅和/或氢氧化铝和/或碱土铝酸盐组分存在下制备经表面反应的天然研磨或沉淀碳酸钙的其它细节揭示于WO 2004/083316 A1中,此参考文献的内容在此被包含在本申请中。
可使经表面反应的碳酸钙保持悬浮液状态,任选地通过分散剂使其进一步稳定化。可使用本领域技术人员已知的传统分散剂。优选的分散剂包括聚丙烯酸和/或羧甲基纤维素。
另外可选地,可干燥上述水性悬浮液,由此获得呈粒料或粉末形式的固体(也即干燥或含有不呈流体形式的很少的水)经表面反应的天然或沉淀碳酸钙。
经表面反应的碳酸钙可具有不同的粒子形状,例如玫瑰、高尔夫球和/或大脑的形状。
在一种优选的实施方案中,该经表面反应的碳酸钙具有根据ISO 9277使用氮气和BET方法测量的20m2/g-450m2/g、优选20m2/g-250m2/g、更优选30m2/g-160m2/g、最优选40m2/g-150m2/g、进一步更优选40m2/g-140m2/g的比表面积。在本发明的含义中,BET比表面积被定义为粒子的表面积除以粒子的质量。如在本文中使用的,比表面积使用BET等温线通过吸附(ISO 9277:2010)来测量且以m2/g规定。
根据一种实施方案,该经表面反应的碳酸钙包含具有1-50μm、优选1-45μm、更优选2-30μm、甚至更优选3-15μm、且最优选4-12μm的体积中值颗粒直径d50(体积)的粒子。
此外可优选该经表面反应的碳酸钙包含具有小于或等于40.0μm、优选小于或等于30.0μm、更优选小于或等于25.0μm、进一步更优选小于或等于20.0μm、更优选小于或等于19.0μm的颗粒直径d98(体积)的粒子。优选该经表面反应的碳酸钙包含具有在5.0-40μm、优选6-30μm、更优选7.0-25.0μm、进一步更优选10.0-20.0μm、更优选11.0-19.0μm的范围内的颗粒直径d98(体积)的粒子。
值dx表示下述这样的直径:相对于该直径,x%的粒子具有小于dx的直径。这意味着d98值是指下述这样的粒子尺寸:其中所有粒子的98%小于该粒子尺寸。d98值也被称作“顶切(top cut)”。dx值可以用体积或重量百分数给出。d50(重量)值因而是重量中值粒子尺寸,也即所有颗粒的50%重量小于该粒子尺寸并且d50(体积)值是体积中值粒子尺寸,也即所有颗粒的50%体积小于该粒子尺寸。
使用Malvern Mastersizer 2000激光衍射系统评价体积中值颗粒尺寸d50。使用Malvern Mastersizer 2000激光衍射系统测量的d50或d98值指示出的直径值为:分别50%或98%体积的粒子具有小于这个值的直径。通过测量获得的原始数据使用米氏理论、以粒子折射率1.57以及吸收指数0.005进行分析。
重量中值颗粒尺寸通过沉降法测量,所述沉降法是在重力场中的沉降行为的分析。使用Micromeritics Instrument Corporation的SedigraphTM 5100或5120进行测量。方法及仪器为本领域技术人员所知且通常用于确定填料和颜料的颗粒尺寸。在0.1%重量Na4P2O7的水溶液中进行测量。使用高速搅拌器及超声分散样品。
方法及仪器为本领域技术人员所知且通常用于确定填料和颜料的颗粒尺寸。
使用Micromeritics Autopore V 9620汞孔率计,使用汞侵入孔隙率测定法(mercury intrusion porosimetry)测量结果测量比孔容,所述汞孔率计具有最大施加汞压为414MPa(60 000psi),等效于0.004μm(~nm)的拉普拉斯喉径。在每个压力步骤使用的平衡时间是20秒。将样品材料密封在5cm3室的粉末透度计中用于分析。使用软件Pore-Comp(Gane,P.A.C.,Kettle,J.P.,Matthews,G.P.和Ridgway,C.J.,“Void Space Structure ofCompressible Polymer Spheres and Consolidated Calcium Carbonate Paper-CoatingFormulations”,Industrial and Engineering Chemistry Research,35(5),1996年,第1753-1764页),针对汞压缩、透度计膨胀和样品材料压缩来校正数据。
在累积侵入数据中见到的总孔体积可被分成两个区域,其中从214μm降至约1-4μm的侵入数据显示具有强烈贡献的任何附聚结构之间的样品的粗填充。在这些直径之下的是粒子自身的精细粒子间填充。如果它们也具有粒子内孔,则此区域显现双峰,并且通过获取由汞侵入比峰转折点更细(即比双峰拐点更细)的孔的比孔容,因而定义比粒子内孔体积。这三个区域的总和给出了粉末的总全部孔体积,但强烈地取决于原始样品压实/在分布的粗孔末端处的粉末的沉降。
通过获取累积侵入曲线的第一导数,揭示了基于等效拉普拉斯直径的孔尺寸分布,其必然包括孔屏蔽。微分曲线清楚地显示了粗附聚孔结构区域、粒子间孔区域和粒子内孔区域(如果存在的话)。已知粒子内孔直径范围,则可以从总孔体积中减去剩余粒子间和附聚体间孔体积,以给出在每单位质量孔体积(比孔容)方面的单独的内部孔的希望的孔体积。当然,相同的减法原理也适用于分离任何感兴趣的其它孔尺寸区域。
优选地,该经表面反应的碳酸钙具有由汞侵入孔隙率测定法测量结果计算的在0.15-1.35cm3/g、优选0.30-1.30cm3/g、且最优选0.40-1.25cm3/g范围内的粒子内侵入式比孔容。
通过汞孔隙率测定法测量结果确定的经表面反应的碳酸钙的孔直径优选在4-500nm的范围内、更优选20-80nm、尤其30-70nm、例如50nm。
通过汞孔隙率测定法测量结果确定的经表面反应的碳酸钙的粒子内孔尺寸优选在0.004-1.6μm范围内、更优选在0.005-1.3μm的范围内、尤其优选0.006-1.15μm、且最优选0.007-1.0μm,例如0.004-0.51μm。
根据一种优选的实施方案,步骤a)中提供的该经表面反应的碳酸钙的粒子内和/或粒子间孔为中空的,因此步骤a)的该经表面反应的碳酸钙是未加载的。
该经表面反应的碳酸钙可呈粉尘或粉末形式且优选呈粉末形式。
方法步骤b)
根据本发明方法的步骤b),步骤a)的经表面反应的碳酸钙借助于辊式压实机在1-30kN/cm范围内的压实压力下压实成压实形式。
术语“辊式压实(roller compacting)”是指这样的过程:在该过程中细粉末在两个反向旋转的辊之间受压迫并且被压制成压实形式例如带、针状物和/或薄片。
出于本发明的目的,辊式压实可由本领域技术人员已知的任何适合的辊式压实机进行。例如用美国Fitzpatrick公司的Chilsonator CCS220辊式压实机来进行。
本发明方法的一个要求在于:方法步骤b)在1-30kN/cm范围内的压实压力下进行。优选地,辊式压实步骤b)在1-28kN/cm范围内、更优选在1-20kN/cm范围内、且最优选在2-10kN/cm范围内的辊式压实压力下进行。
额外地或另外可选地,调节辊式压实步骤期间的进料速度和辊速,使得针对压实形式获得0.2-6mm、优选0.3-3mm、且更优选0.4-1mm的厚度。例如,调节辊式压实步骤d)期间的进料速度和辊速,使得针对压实形式获得0.2-6mm、优选0.3-3mm、且最优选0.4-1mm的厚度。另外可选地,调节辊式压实步骤d)期间的进料速度和辊速,使得针对压实形式获得0.2-6mm、优选0.3-3mm、且最优选0.4-1mm的厚度。
本发明方法的优点之一在于该经表面反应的碳酸钙的压实可在例如一种或多种粘合剂和/或一种或多种崩解剂的一种或多种配制助剂不存在的情况下进行。
因此,本发明的一个特定要求是:步骤b)中获得的该经表面反应的碳酸钙的压实形式由步骤a)的该经表面反应的碳酸钙构成。
方法步骤c)
根据本发明方法的步骤c),将步骤b)中获得的压实形式磨碎成粒料。
用本领域技术人员已知的任何传统磨机进行磨碎。例如,用来自美国Fitzpatrick公司的进行磨碎。
在一种实施方案中,步骤c)的获得的粒料具有10-4500μm、优选50-2500μm、且更优选100-1200μm、并且更优选180-710μm的中值颗粒尺寸。
额外地或者另外可选地,步骤c)的获得的粒料具有根据ISO 9277使用氮气和BET方法测量的20m2/g-450m2/g、优选20m2/g-250m2/g、更优选30m2/g-160m2/g、最优选40m2/g-150m2/g、再更优选40m2/g-140m2/g的BET比表面积。
额外地或者另外可选地,步骤c)的获得的粒料具有0.1-0.9g/mL、优选0.2-0.8g/mL、更优选0.3-0.7g/mL、最优选0.4-0.6g/mL的堆密度(bulk density)。
额外地或者另外可选地,步骤c)的获得的粒料具有0.1-0.9g/mL、优选0.2-0.9g/mL、更优选0.3-0.8g/mL、最优选0.4-0.7g/mL、再更优选0.5-0.7g/mL的振实密度。
额外地或者另外可选地,步骤c)的获得的粒料具有10-40、优选12-35、更优选14-32、最优选14-30、再更优选15-28的压缩指数。
额外地或者另外可选地,步骤c)的获得的粒料具有10-80°、优选15-75°、更优选20-70°、最优选30-65°、再更优选35-60°的静止角。
优选地,步骤c)的获得的粒料具有
i)10-4500μm、优选50-2500μm、且更优选100-1200μm、且再更优选180-710μm的中值颗粒尺寸;以及
ii)根据ISO 9277使用氮气和BET方法测量的20m2/g-450m2/g、优选20m2/g-250m2/g、更优选30m2/g-160m2/g、最优选40m2/g-150m2/g、再更优选40m2/g-140m2/g的BET比表面积;以及
iii)0.1-0.9g/mL、优选0.2-0.8g/mL、更优选0.3-0.7g/mL、最优选0.4-0.6g/mL的堆密度;以及
iv)0.1-0.9g/mL、优选0.2-0.9g/mL、更优选0.3-0.8g/mL、最优选0.4-0.7g/mL、再更优选0.5-0.7g/mL的振实密度;以及
v)10-40、优选12-35、更优选14-32、最优选14-30、再更优选15-28的压缩指数;以及
vi)10-80°、优选15-75°、更优选20-70°、最优选30-65°、再更优选35-60°的静止角。
任选的方法步骤
根据本发明的任选的方法步骤d),步骤c)中获得的粒料进行至少一个通过至少一种筛目尺寸的筛分步骤d)。
这种筛分可用本领域技术人员已知的任何传统的筛分手段进行。可使用一种或多种筛目尺寸进行筛分。适合的筛目尺寸为(但不限于)约90μm、180μm、250μm、355μm、500μm和710μm的筛目尺寸。
经筛分的粒料因而具有通过在不同筛目尺寸上筛分,优选通过用约90μm、180μm、250μm、355μm、500μm和710μm的筛目尺寸筛分而获得的180-710μm的中值颗粒尺寸。更优选地,通过用约90μm、180μm、250μm、355μm、500μm和710μm的筛目尺寸筛分并且将经筛分的粒料合并从而排除掉具有小于90μm和大于710μm的中值颗粒尺寸的粒料。例如,用瑞士VibroRetsch的振动筛分塔进行筛分。
在一种实施方案中,使用约180μm、250μm、355μm、500μm和710μm的筛目尺寸进行筛分。
经筛分的粒料因而具有通过在不同的筛目尺寸上筛分,优选通过用约180μm、250μm、355μm、500μm和710μm的筛目尺寸上筛分而获得的180-710μm的中值颗粒尺寸。更优选地,通过用约180μm、250μm、355μm、500μm和710μm的筛目尺寸筛分并且将经筛分的粒料合并从而排除掉具有小于180μm和大于710μm的颗粒尺寸的粒料。例如,用瑞士Vibro Retsch的振动筛分塔进行筛分。
在另外可选的技术方案中,使用约250μm、355μm、500μm和710μm的筛目尺寸进行筛分。
经筛分的粒料因而具有通过在不同的筛目尺寸上筛分,优选通过用约250μm、355μm、500μm和710μm的筛目尺寸上筛分而获得的250-710μm的中值颗粒尺寸。更优选地,通过用约250μm、355μm、500μm和710μm的筛目尺寸筛分并且将经筛分的粒料合并从而排除掉具有小于250μm和大于710μm的颗粒尺寸的粒料。例如,用瑞士Vibro Retsch的振动筛分塔进行筛分。
在本发明的理解中,其他筛目尺寸以及其他筛目尺寸的组合落入本发明的精神内。
在这种实施方案中,用于生产剂型的方法包括以下步骤,优选由以下步骤构成:
a)提供经表面反应的碳酸钙,其中该经表面反应的碳酸钙是天然研磨或沉淀碳酸钙与二氧化碳和一种或多种H3O+离子供体在水性介质中的反应产物,其中该二氧化碳通过H3O+离子供体处理原位形成和/或从外部来源供应;
b)借助于辊式压实机在1-30kN/cm范围内的压实压力下将步骤a)的经表面反应的碳酸钙压实成压实形式;
c)将步骤b)的该压实形式磨碎成粒料;以及
d)通过至少一种筛目尺寸筛分步骤c)的该粒料;
其中步骤b)中获得的压实形式由步骤a)的该经表面反应的碳酸钙构成。
如上文已经阐述的,在例如一种或多种粘结剂和/或一种或多种崩解剂的一种或多种配制助剂不存在的情况下制备步骤c)中获得的该经表面反应的碳酸钙的压实形式。
然而,步骤b)中获得的该经表面反应的碳酸钙的压实形式可与至少一种配制助剂混合。
因而,在一种实施方案中,该方法进一步包括步骤e1):使在步骤c)和/或如果存在的步骤d)中获得的该粒料与至少一种配制助剂混合。优选地,在步骤d)中获得的该粒料在混合步骤e1)中与该至少一种配制助剂混合。
混合步骤e1)可通过以任何顺序使在步骤c)和/或如果存在的步骤d)中获得的该粒料与该至少一种配制助剂混合以形成混合物来进行。
出于本发明的目的,在本领域中已知的任何适合的混合手段可用于进行混合步骤e1)。然而,混合步骤e1)优选在混合器和/或掺合机、优选例如转鼓混合器的混合器中进行。
表述“至少一种”配制助剂是指该配制助剂包含一种或多种配制助剂。
根据本发明的一种实施方案,该配制助剂仅包含一种配制助剂。根据本发明的另一实施方案,该配制助剂包含两种或更多种配制助剂的混合物。例如,该配制助剂包含两种或三种配制助剂的混合物。
在一种实施方案中,该至少一种配制助剂仅包含一种配制助剂。
例如,该至少一种配制助剂选自崩解剂,润滑剂,抗冲改性剂,增塑剂,蜡,稳定剂,颜料,着色剂,香味剂,味觉掩蔽剂,调味剂,甜味剂,口感改良剂,稀释剂,成膜剂,粘合剂,缓冲剂,吸附剂,气味掩蔽剂及其混合物。在一种实施方案中,该至少一种配制助剂也可为粘结剂。
在本领域技术人员的理解范围内,所提及的配制助剂仅具有说明性特性且并不旨在具有限制性特性。
优选地,该至少一种配制助剂是崩解剂,选自改性纤维素胶、不溶性交联聚乙烯吡咯烷酮、乙醇酸淀粉,微晶纤维素,预胶凝化淀粉,羧甲基淀粉钠,低取代羟丙基纤维素,N-乙烯基-2-吡咯烷酮的均聚物,烷基纤维素酯,羟烷基纤维素酯,羧基烷基纤维素酯,藻酸盐,微晶纤维素及其多晶型,离子交换树脂,树胶,甲壳素,壳聚糖,粘土,结冷胶,交联泼拉克林共聚物,琼脂,明胶,糊精,丙烯酸聚合物,羧甲基纤维素钠/钙,邻苯二甲酸羟丙基甲基纤维素,虫胶或其混合物。
适合的崩解剂的实例为美国FMC的其为改性纤维素胶;德国BASF的CL,其为不溶性交联聚乙烯吡咯烷酮;德国JRS的其为乙醇酸淀粉钠;瑞士Pharmatrans Sanaq AG的MCC多晶型物II(MCC SANAQ ),其为微晶纤维素的稳定晶体的II型多晶型物,作为标准微晶纤维素(MCC)的MCC SANAQ 102。
在一种实施方案中,该至少一种配制助剂为润滑剂,尤其是相内润滑剂和/或相外润滑剂,优选至少一种相外润滑剂。另外可选地,该至少一种配制助剂为至少一种相内润滑剂和相外润滑剂。
所述至少一种相内润滑剂可选自脂肪酸的脱水山梨糖醇酯和聚氧乙基化氢化蓖麻油(例如以商标名出售的产品)、环氧乙烷和环氧丙烷的嵌段共聚物(例如以商标名和POLOXAMER出售的产品)、聚氧乙烯脂肪醇醚、聚氧乙烯脱水山梨糖醇脂肪酸酯、脂肪酸的脱水山梨糖醇酯和聚氧乙烯硬脂酸酯、硬脂醇、二山萮酸甘油酯、硬脂酰富马酸钠、丙三醇二硬脂酸酯及其组合。优选地,该至少一种相内润滑剂为硬脂酰富马酸钠。
所述至少一种相外润滑剂可选自卵磷脂、聚氧乙烯硬脂酸酯、聚氧乙烯脱水山梨糖醇脂肪酸酯、脂肪酸盐、可食脂肪酸的单甘油酯和二甘油酯的单乙酰基和二乙酰基酒石酸酯、可食脂肪酸的单甘油酯和二甘油酯的柠檬酸酯、脂肪酸的蔗糖酯、脂肪酸的聚甘油酯、酯交换型蓖麻油酸的聚甘油酯(E476)、硬脂酰乳酸钠、硬脂酰富马酸钠、硬脂酸镁和/或硬脂酸钙、氢化植物油、硬脂酸、月桂基硫酸钠、月桂基硫酸镁、胶体二氧化硅、滑石及其组合。优选地,所述至少一种相外润滑剂为硬脂酸镁和/或硬脂酸钙,更优选硬脂酸镁。
在一种实施方案中,该至少一种配制助剂为增塑剂。例如,该增塑剂可以是基于柠檬酸酯的增塑剂,选自柠檬酸三乙酯(TEC)、柠檬酸三丁酯(TBC)、柠檬酸乙酰基三丁酯(ATBC)、柠檬酸乙酰基三乙酯(ATEC)和柠檬酸乙酰基三2-乙基-己酯(ATEHC)。
根据进一步的实施方案,该至少一种配制助剂可进一步选自稀释剂、成膜剂、粘合剂、缓冲剂、吸附剂、天然或合成香味剂、天然或合成调味剂、天然或合成着色剂、天然或合成甜味剂、天然或合成气味掩蔽剂、天然或合成味道或味觉掩蔽剂、天然和/或合成口感改良剂及其混合物。
适合的天然或合成香味剂包括人类或其他动物通常在极低浓度下通过嗅觉感知的一种或多种挥发性化合物。
适合的天然或合成调味剂包括但不限于薄荷如胡椒薄荷,薄荷醇,香草,肉桂,各种水果调味剂(单独或混合的),精油如麝香草酚,桉树脑,薄荷醇和水杨酸甲酯,烯丙基吡嗪,甲氧基吡嗪,2-异丁基-3-甲氧基吡嗪,乙酰基-L-吡嗪,2-乙酰氧基吡嗪,醛,醇,酯,酮,吡嗪,酚醛树脂,萜类及其混合物。
该调味剂通常以将根据个人口味而改变的量利用,且可例如以最终剂型的重量的约0.5%-约4%的范围内利用。
适合的天然或合成着色剂包括但不限于二氧化钛、黄酮染料、异喹啉染料、多烯着色剂、吡喃着色剂、萘醌染料、醌和蒽醌染料、苯并吡喃染料、苯并吡喃酮染料以及靛类染料和吲哚着色剂。其实例为焦糖着色、胭脂树红、叶绿酸、胭脂虫红、甜菜苷、姜黄、番红花、红辣椒、番茄红素、露兜树和蝶豆花。
适合的天然或合成甜味剂包括但不限于木糖、核糖、葡萄糖、甘露糖、半乳糖、果糖、右旋糖、蔗糖、糖、麦芽糖、部分水解淀粉或玉米糖浆固体,以及糖醇如山梨糖醇、木糖醇、甘露糖醇及其混合物;水溶性人造甜味剂如可溶性糖精盐(即糖精钠或钙盐)、环己基氨基磺酸盐、丁磺胺-K等,以及游离酸形式的糖精和基于阿斯巴甜的甜味剂如L-天冬氨酸-苯丙氨酸甲酯、或
一般而言,甜味剂的量将随针对特定剂型组成而选择的甜味剂的期望量而变化。
适合的天然和/或合成口感改良剂包括但不限于大阪Sumitomo Seika提供的聚环氧乙烷(PEO-1NF),Lot.L20141017A,日本Shin–Etsu的羟丙基纤维素(L-HPC LH-11),Lot.505200,德国Gummi arabicum Pheur,Roth的羟基丙基乙基纤维素(Methocel E15 LVPremium EP),Lot.LD250012N23,Lot.024208213,或Instant胶AA(法国Nexira),或其组合。
在一种实施方案中,该至少一种配制助剂以基于步骤a)的该经表面反应的碳酸钙的总重量计为约0.1%重量-约99.0%重量、优选约0.3%重量-约5.0%重量、甚至更优选约0.3%重量-约10.0%重量,再更优选约0.3%重量-约5.0%重量且最优选约0.5%重量-约2.5%重量的总量提供。
如果该方法包括提供至少一种配制助剂,则该用于生产剂型的方法包括以下步骤,优选由以下步骤构成:
a)提供经表面反应的碳酸钙,其中该经表面反应的碳酸钙是天然研磨或沉淀碳酸钙与二氧化碳和一种或多种H3O+离子供体在水性介质中的反应产物,其中该二氧化碳通过H3O+离子供体处理原位形成和/或从外部来源供应;
b)借助于辊式压实机在1-30kN/cm范围内的压实压力下将步骤a)的经表面反应的碳酸钙压实成压实形式;
c)将步骤b)的该压实形式磨碎成粒料;以及
e1)使步骤c)中获得的该粒料与至少一种配制助剂混合;
其中步骤b)中获得的压实形式由步骤a)的该经表面反应的碳酸钙构成。
如果该方法进一步包括筛分,则该用于生产剂型的方法包括以下步骤,优选由以下步骤构成:
a)提供经表面反应的碳酸钙,其中该经表面反应的碳酸钙是天然研磨或沉淀碳酸钙与二氧化碳和一种或多种H3O+离子供体在水性介质中的反应产物,其中该二氧化碳通过H3O+离子供体处理原位形成和/或从外部来源供应;
b)借助于辊式压实机在1-30kN/cm范围内的压实压力下将步骤a)的经表面反应的碳酸钙压实成压实形式;
c)将步骤b)的该压实形式磨碎成粒料;
d)通过至少一种筛目尺寸筛分步骤c)的该粒料;以及
e1)使步骤d)中获得的该粒料与至少一种配制助剂混合;
其中步骤b)中获得的压实形式由步骤a)的该经表面反应的碳酸钙构成。
额外地或者另外可选地,步骤b)中获得的该经表面反应的碳酸钙的压实形式或者步骤c)或如果存在的步骤d)中获得的该粒料可用至少一种活性成分和/或其非活性前体加载。
因而,在一种实施方案中,该方法进一步包括步骤e2):利用该至少一种活性成分和/或其非活性前体加载步骤b)中获得的该压实形式或者步骤c)或如果存在的步骤d)中获得的该粒料。优选地,在加载步骤e2)中利用该至少一种活性成分和/或其非活性前体加载步骤d)中获得的该粒料。
在本发明的一种实施方案中,该至少一种活性成分和/或其非活性前体包含以下物质、优选由以下物质构成:一种活性成分或其非活性前体。另外可选地,该至少一种活性成分和/或其非活性前体包含以下物质、优选由以下物质构成:两种或更多种活性成分和/或其非活性前体。例如,该至少一种活性成分和/或其非活性前体包含以下物质、优选由以下物质构成:两种或三种活性成分和/或其非活性前体。
优选的,该至少一种活性成分和/或其非活性前体包含以下物质、优选由以下物质构成:一种活性成分或其非活性前体。
在本发明的含义中,术语“活性成分”是指在有机体中具有特定效果且在人类、动物、微生物和/或植物中引起特定反应的物质。
应当理解,该至少一种活性成分和/或其非活性前体可为手性化合物。因而,该至少一种活性成分和/或其非活性前体涵盖(R)-对映异构体、(S)-对映异构体及其混合物,例如外消旋混合物。
额外地或另外可选地,该至少一种活性成分和/或其非活性前体可为异构化合物。因而,该至少一种活性成分和/或其非活性前体涵盖(Z)-异构体、(E)-异构体及其混合物。
例如,该至少一种活性成分和/或其非活性前体选自日用化妆香精,食用香精,草本提取物,水果提取物,营养剂,痕量矿物,防护剂,食品,化妆品,阻燃剂,酶,大分子,杀虫剂,肥料,防腐剂,抗氧化剂,反应性化学品,合成来源、半合成来源、天然来源的药物活性剂或者其药物非活性前体,及其混合物。
日用化妆香精优选为具有至少约100g/mol分子量的醇、醛和/或酮,且其单独或与其他日用化妆香精组合用于散发气味、芳香味、香精味或香味。例如,该日用化妆香精可选自2,4-二甲基-3-环己烯-1-甲醇(花香醇(floralol))、2,4-二甲基环己烷甲醇(二氢花香醇)、5,6-二甲基-1-甲基乙烯基双环[2.2.1]庚-5-烯-2-甲醇(亚波醇(arbozol))、α,α,-4-三甲基-3-环己烯-1-甲醇(α-松油醇)、2,4,6-三甲基-3-环己烯-1-甲醇(异环香叶醇)、4-(1-甲基乙基)环己烷甲醇(五月铃兰醇(mayol))、α-3,3-三甲基-2-降冰片烷甲醇、1,1-二甲基-1-(4-甲基环己-3-烯基)甲醇、2-苯乙醇、2-环己基乙醇、2-(邻甲基苯基)-乙醇、2-(间甲基苯基)乙醇、2-(对甲基苯基)乙醇、6,6-二甲基双环-[3.1.1]庚-2-烯-2-乙醇(诺卜醇(nopol))、2-(4-甲基苯氧基)-乙醇、3,3-二甲基-Δ2-β-降冰片烷乙醇(派奇明托(patchomint))、2-甲基-2-环己基乙醇、1-(4-异丙基环己基)-乙醇、1-苯乙醇、1,1-二甲基-2-苯乙醇、1,1-二甲基-2-(4-甲基-苯基)乙醇、1-苯基丙醇、3-苯基丙醇、2-苯基丙醇(向水性醇)、2-(环十二烷基)丙-1-醇(羟基龙涎呋喃(Hydroxy-ambran))、2,2-二甲基-3-(3-甲基苯基)-丙-1-醇(美研醇(Majantol))、2-甲基-3-苯基丙醇、3-苯基-2-丙烯-1-醇(肉桂醇)、2-甲基-3-苯基-2-丙烯-1-醇(甲基肉桂醇)、α-正戊基-3-苯基-2-丙烯-1-醇(α-戊基-肉桂醇)、乙基-3-羟基-3-苯基丙酸酯、2-(4-甲基苯基)-2-丙醇、3-(4-甲基环己-3-烯)丁醇、2-甲基-4-(2,2,3-三甲基-3-环戊烯-1-基)丁醇、2-乙基-4-(2,2,3-三甲基-环戊-3-烯基)-2-丁烯-1-醇、3-甲基-2-丁烯-1-醇(异戊烯醇)、2-甲基-4-(2,2,3-三甲基-3-环戊烯-1-基)-2-丁烯-1-醇、3-羟基丁酸乙酯、4-苯基-3-丁烯-2-醇、2-甲基-4-苯基丁-2-醇、4-(4-羟基苯基)丁-2-酮、4-(4-羟基-3-甲氧基苯基)-丁-2-酮、3-甲基-戊醇、3-甲基-3-戊烯-1-醇、1-(2-丙烯基)环戊-1-醇(鸢醇(plinol))、2-甲基-4-苯基戊醇(圆柚芳晶(Pamplefleur))、3-甲基-5-苯基戊醇(吩醇(Phenoxanol))、2-甲基-5-苯基戊醇、2-甲基-5-(2,3-二甲基三环[2.2.1.0.sup.(2,6)]庚-3-基)-2-戊烯-1-醇(檀香醇(santalol))、4-甲基-1-苯基-2-戊醇、5-(2,2,3-三甲基-3-环戊烯基)-3-甲基戊-2-醇(人造檀香(sandalore))、(1-甲基-双环[2.1.1]庚烯-2-基)-2-甲基戊-1-烯-3-醇、3-甲基-1-苯基戊-3-醇、1,2-二甲基-3-(1-甲基乙烯基)环戊-1-醇、2-异丙基-5-甲基-2-己烯醇、顺式-3-己烯-1-醇、反式-2-己烯-1-醇、2-异丙烯基-4-甲基-4-己烯-1-醇(熏衣草醇(Lavandulol))、2-乙基-2-异戊烯基-3-己烯醇、1-羟甲基-4-异丙烯基-1-环己烯(二氢对异丙苄基醇)、1-甲基-4-异丙烯基环己-6-烯-2-醇(香芹烯醇(carvenol))、6-甲基-3-异丙烯基环己-1-醇(二氢香芹烯醇)、1-甲基-4-异丙烯基环己-3-醇、4-异丙基-1-甲基环己-3-醇、4-叔丁基环己醇、2-叔丁基环己醇、2-叔丁基-4-甲基环己醇(香根醇(rootanol))、4-异丙基-环己醇、4-甲基-1-(1-甲基乙基)-3-环己烯-1-醇、2-(5,6,6-三甲基-2-降冰片基)环己醇、异冰片基环己醇、3,3,5-三甲基环己醇、1-甲基-4-异丙基环己-3-醇、1-甲基-4-异丙基环己烷-8-醇(二氢松油醇)、1,2-二甲基-3-(1-甲基乙基)环己-1-醇、庚醇、2,4-二甲基庚-1-醇、6-庚基-5-庚烯-2-醇(异沉香醇)、2,4-二甲基-2,6-庚烷二烯醇、6,6-二甲基-2-氧甲基-双环[3.1.1]庚-2-烯(桃金娘烯醇(myrtenol))、4-甲基-2,4-庚二烯-1-醇、3,4,5,6,6-五甲基-2-庚醇、3,6-二甲基-3-乙烯基-5-庚烯-2-醇、6,6-二甲基-3-羟基-2-亚甲基双环[3.1.1]庚烷、1,7,7-三甲基双环[2.2.1]庚-2-醇、2,6-二甲基庚-2-醇(二米吐尔(dimetol))、2,6,6-三甲基双环[1.3.3]庚-2-醇、辛醇、2-辛烯醇、2-甲基辛-2-醇、2-甲基-6-亚甲基-7-辛烯-2-醇(香叶烯醇(myrcenol))、7-甲基辛-1-醇、3,7-二甲基-6-辛烯醇、3,7-二甲基-7-辛烯醇、3,7-二甲基-6-辛烯-1-醇(香茅醇)、3,7-二甲基-2,6-辛二烯-1-醇(香叶醇)、3,7-二甲基-2,6-辛二烯-1-醇(橙花醇)、3,7-二甲基-7-甲氧基辛-2-醇(沙针醇(osyrol))、3,7-二甲基-1,6-辛二烯-3-醇(沉香醇)、3,7-二甲基辛-1-醇(香叶醇(pelargol))、3,7-二甲基辛-3-醇(四氢芳樟醇)、2,4-辛二烯-1-醇、3,7-二甲基-6-辛烯-3-醇(二氢沉香醇)、2,6-二甲基-7-辛烯-2-醇(二氢月桂烯醇)、2,6-二甲基-5,7-辛二烯-2-醇、4,7-二甲基-4-乙烯基-6-辛烯-3-醇、3-甲基辛-3-醇、2,6-二甲基辛-2-醇、2,6-二甲基辛-3-醇、3,6-二甲基辛-3-醇、2,6-二甲基-7-辛烯-2-醇、2,6-二甲基-3,5-辛二烯-2-醇(蘑菇醇(muguol))、3-甲基-1-辛烯-3-醇、7-羟基-3,7-二甲基辛醛、3-壬醇、2,6-壬二烯-1-醇、顺式-6-壬烯-1-醇、6,8-二甲基壬-2-醇、3-(羟甲基)-2-壬酮、2-壬烯-1-醇、2,4-壬二烯-1-醇、3,7-二甲基-1,6-壬二烯-3-醇、癸醇、9-癸烯醇、2-苄基-M-二氧杂-5-醇、2-癸烯-1-醇、2,4-癸二烯-1-醇、4-甲基-3-癸烯-5-醇、3,7,9-三甲基-1,6-癸二烯-3-醇(异丁基沉香醇)、十一烷醇、2-十一碳烯-1-醇、10-十一碳烯-1-醇、2-十二碳烯-1-醇、2,4-十二碳二烯-1-醇、2,7,11-三甲基-2,6,10-十二碳三烯-1-醇(法呢醇(farnesol))、3,7,11-三甲基-1,6,10,-十二碳三烯-3-醇(橙花叔醇(nerolidol))、3,7,11,15-四甲基十六碳-2-烯-1-醇(植醇(phytol))、3,7,11,15-四甲基十六碳-1-烯-3-醇(异植醇(isophytol))、苯甲醇、对甲氧基苯甲醇(茴香基醇(anisyl))、对伞花(cymen)-7-醇(对异丙苄基醇)、4-甲基苯甲醇、3,4-亚甲二氧基苯甲醇、水杨酸甲酯、水杨酸苄酯、顺式水杨酸-3-己烯酯、水杨酸正戊酯、2-苯乙基水杨酸酯、水杨酸正己酯、2-甲基-5-异丙基苯酚、4-乙基-2-甲氧基苯酚、4-烯丙基-2-甲氧基苯酚(丁香酚)、2-甲氧基-4-(1-丙烯基)苯酚(异丁香酚)、4-烯丙基-2,6-二甲氧基-苯酚、4-叔丁基苯酚、2-乙氧基-4-甲基苯酚、2-甲基-4-乙烯基苯酚、2-异丙基-5-甲基苯酚(麝香草酚)、邻羟基苯甲酸异戊酯、2-羟基-苯甲酸乙酯、2,4-二羟基-3,6-二甲基苯甲酸甲酯、3-羟基-5-甲氧基-1-甲苯、2-叔丁基-4-甲基-1-羟基苯、1-乙氧基-2-羟基-4-丙烯基苯、4-羟基甲苯、4-羟基-3-甲氧基苯甲醛、2-乙氧基-4-羟基苯甲醛、十氢-2-萘酚、2,5,5-三甲基-八氢-2-萘酚、1,3,3-三甲基-2-降冰片烷醇(葑醇(fenchol))、3a,4,5,6,7,7a-六氢-2,4-二甲基-4,7-亚甲基-1H-茚-5-醇、3a,4,5,6,7,7a-六氢-3,4-二甲基-4,7-亚甲基-1H-茚-5-醇、2-甲基-2-乙烯基-5-(1-羟基-1-甲基乙基)四氢呋喃、β-石竹烯醇、香草醛、乙基香草醛、肉桂醛、苯甲醛、苯乙醛、庚醛、辛醛、癸醛、十一烷醛、十一烯醛、十二烷醛、十三烷醛、甲基壬醛、二癸醛、茴香醛、香茅醛、香茅基氧基醛、仙客来醛、α-己基肉桂醛、羟基香茅醛、α-甲基肉桂醛、甲基壬基乙醛、丙基苯基醛、柠檬醛、紫苏醛、甲苯醛、甲苯乙醛、对异丙基苯甲醛、水杨醛、α-戊基肉桂醛和胡椒醛及其混合物。
也可使用各种精油、草本提取物和/或水果提取物,优选具有各种药用或者膳食补充性能的那些。精油、草本提取物和/或水果提取物通常是可以药用或用于调味的提取物或芳香植物、植物部分、水果或水果部分。适合的草本提取物和/或水果提取物可单独或在各种混合物中使用。常用精油、草本提取物和/或水果提取物包括紫锥花(Echinacea)、白毛茛(Goldenseal)、金盏草(Calendula)、迷迭香(Rosemary)、百里香(Thyme)、卡瓦椒(KavaKava)、芦荟(Aloe)、血根草(Blood Root)、葡萄柚籽提取物(Grapefruit Seed Extract)、黑升麻(Black Cohosh)、人参(Ginseng)、瓜拉那(Guarana)、蔓越橘(Cranberry)、银杏叶(Ginko Biloba)、圣约翰草(St.John's Wort)、月见草油(Evening Primrose Oil)、育亨宾树皮(Yohimbe Bark)、绿茶(Green Tea)、麻黄(Ma Huang)、玛咖(Maca)、覆盆子(Bilberry)、叶黄素(Lutein)、姜(Ginger)、含有丁香酚的油及其组合。
可使用各种营养剂,几乎包括任何维生素、矿物和/或植物化学成分。例如,可使用维生素A、维生素B1、维生素B6、维生素B12、维生素B2、维生素B6、维生素D、维生素E(即生育酚)、维生素K、硫胺素、核黄素、生物素、叶酸、烟酸、泛酸、Q10、α硫辛酸、二氢硫辛酸、姜黄素、叶黄素、β-隐黄质、番茄红素、叶黄素、玉米黄素、虾青素、β-胡萝卜素、胡萝卜素、混合类胡萝卜素、多酚、类黄酮、钠、钾、钙、镁、硫、氯、胆碱;和/或植物化学成分,例如类胡萝卜素、叶绿素、叶绿酸、纤维、类黄酮、花青素、矢车菊色素(cyaniding)、花翠素、锦葵色素、天竺葵色素、芍药色素、矮牵牛花素、黄烷醇、儿茶素、表儿茶素、表没食子儿茶素、表没食子儿茶素没食子酸酯、茶黄素、茶红素、原花青素、黄酮醇、槲皮素、堪非醇、杨梅素、异鼠李素、黄碱醇橙皮素(flavononeshesperetin)、柚皮素、圣草酚、桔皮素、黄酮类、芹黄素、木犀草素、木脂素、植物雌激素、白藜芦醇、异黄酮、大豆黄素、染料木黄酮、黄豆黄素、大豆异黄酮及其组合。可用作活性成分的营养剂的实例阐述于美国专利申请公开第2003/0157213 Al号、第2003/0206993号和第2003/0099741 Al号中,出于所有目的,通过引用将其全文并入本文中。
在一种实施方案中,可使用痕量矿物,例如锰、锌、铜、氟、钼、碘、钴、铬、硒、磷及其组合。
酶可包括但不限于辅酶Q10、胃蛋白酶、植酸酶、胰蛋白酶、脂肪酶、蛋白酶、纤维素酶、乳糖酶及其组合。大分子优选为已知的蛋白质、抗体、受体、载体、多肽、肽、益生菌或脂质。
杀虫剂(pesticides)优选为本领域技术人员已知的任何已知的除草剂、杀昆虫剂(insecticide)、昆虫生长调节剂、杀线虫剂、杀白蚁剂、杀软体动物剂、杀鱼剂、杀鸟剂、杀鼠剂、食肉动物毒杀剂(predacide)、杀菌剂、驱虫剂、动物趋避剂、抗微生物剂、杀真菌剂、消毒剂(disinfectant)(抗微生物剂)和消毒杀菌剂(sanitizer)。
应注意,防腐剂可为本领域技术人员已知的任何此类化合物。例如,防腐剂可包括但不限于苯氧基乙醇,乙基己基甘油,对羟基苯甲酸酯如对羟基苯甲酸甲酯,对羟基苯甲酸乙酯,对羟基苯甲酸丙酯,对羟基苯甲酸丁酯及其混合物,苯扎氯铵,氯丁醇,苯甲醇,氯化十六烷基吡啶酒石酸,乳酸,苹果酸,乙酸,苯甲酸,苯甲酸钠,山梨酸,山梨酸钾及其混合物。
抗氧化剂优选选自丁基羟基茴香醚(BHA),丁基羟基甲苯(BHT),没食子酸酯,类胡萝卜素,多酚如白藜芦醇,类黄酮及其混合物,多酚衍生物,生育酚及其盐,β胡萝卜素,泛醌(ubichinon),生育三烯酚,二氢槲皮素,天然来源的抗氧化剂及其混合物。如果抗氧化剂为天然来源的,则该抗氧化剂可为例如针叶树提取物,海岸松树皮提取物如来自瑞士Horphag的和/或余甘子果提取物如来从德国Sabinsa公司的
该药物活性剂或其药物非活性前体优选选自合成来源、半合成来源、天然来源及其组合的药物活性剂或药物非活性前体。
因而,药物活性剂涉及合成来源、半合成来源、天然来源及其组合的药物活性剂。另外,该药物活性剂的药物非活性前体涉及合成来源、半合成来源、天然来源及其组合的药物非活性前体并且将在随后阶段中被活化成相应的药物活性剂。
这种药物活性或非活性前药的转化或活化是本领域技术人员已知的并且常见地用在例如胃和/或胃肠途径中的转化和活化,例如通过pH介导或酶介导的活化。
在本领域技术人员的理解范围内,所提及的活化方法仅具有说明性特性,且不旨在具有限制性特性。
应注意,该药物活性剂或其药物非活性前体可为本领域技术人员已知的任何此类化合物。
当施用于人和/或动物时,药物活性剂因而包括提供预防和/或治疗性能的任何化合物。实例包括但不限于药物活性剂、治疗活性剂、兽用活性剂、营养物和生长调节剂及其相应的活性或非活性前体。
例如,该药物活性剂或其药物非活性前体可为抗炎剂。这种试剂可包括但不限于非类固醇抗炎剂或NSAID,例如丙酸衍生物;乙酸衍生物;芬那酸衍生物;联苯羧酸衍生物;和昔康(oxicams)。所有这些NSAID被充分描述于Sunshine等人的美国专利第4,985,459号中,关于这些NSAID的描述,其全文通过引用并入本文中。可用的NSAID的实例包括乙酰水杨酸、布洛芬(ibuprofen)、萘普生(naproxen)、苯洛芬(benoxaprofen)、氟比洛芬(flurbiprofen)、非诺洛芬(fenoprofen)、芬布芬(fenbufen)、酮洛芬(ketoprofen)、吲哚洛芬(indoprofen)、吡洛芬(pirprofen)、卡洛芬(carprofen)、奥沙普嗪(oxaprozin)、普拉洛芬(pranoprofen)、微洛芬(microprofen)、硫洛芬(tioxaprofen)、舒洛芬(suprofen)、阿明洛芬(alminoprofen)、噻洛芬酸(tiaprofenic acid)、氟洛芬(fluprofen)、布氯酸(bucloxic acid)及其混合物。
同样可用的是类固醇抗炎药如氢化可的松等,以及COX-2抑制剂如美洛昔康(meloxicam)、塞来昔布(celecoxib)、罗非考昔(rofecoxib)、伐地考昔(valdecoxib)、艾托考昔(etoricoxib)或其混合物。可使用任何上述抗炎剂的混合物。
可用作药物活性剂或其药物非活性前体的其他材料包括常见已知的口腔和咽喉产品。这些产品包括但不限于上呼吸道试剂如苯肾上腺素、苯海拉明、右美沙芬(dextromethorphan)、溴己新和氯苯吡胺(chiorpheniramine);胃肠试剂如法莫替丁(famotidine)、洛哌丁胺(loperamide)和聚二甲基硅油;抗真菌剂如硝酸咪康唑(miconazolenitrate);抗生素和镇痛剂如酮洛芬和氟比洛芬(fluribuprofen)。
该至少一种药物活性剂或其药物非活性前体可为抗牙垢剂。适用于本文的抗牙垢剂包括磷酸盐。磷酸盐包括焦磷酸盐、多磷酸盐、多膦酸盐及其混合物。焦磷酸盐是用于牙科护理产品的最著名的磷酸盐之一。递送到牙齿的焦磷酸根离子来自焦磷酸盐。适用于本发明药物递送系统的焦磷酸盐包括焦磷酸二碱金属盐、焦磷酸四碱金属盐及其混合物。优选非水合以及水合形式的焦磷酸二氢二钠(Na2H2P2O7)、焦磷酸四钠(Na4P2O7)和焦磷酸四钾(K4P2O7)。抗牙结石磷酸盐包括焦磷酸钾和焦磷酸钠;三聚磷酸钠;二膦酸盐,例如乙烷-l-羟基-1,1-二磷酸盐;1-氮杂环庚烷-1,1-二膦酸盐;和线性烷基二膦酸盐;线性羧酸和柠檬酸钠和锌。
该药物活性剂或其药物非活性前体也可选自焦亚硫酸钠、丁基羟基甲苯、丁基化羟基苯甲醚。
该药物活性剂或其药物非活性前体也可选自麻黄碱(ephedrine)、镁加铝(magaldrate)、假麻黄碱(pseudoephedrine)、西地那非(sildenafil)、利多卡因(xylocaine)、苯扎氯铵(benzalconium chloride)、咖啡因(caffeine)、去养肾上腺素(phenylephrine)、安非拉酮(amfepramone)、奥利司他(orlistat)、西布曲明(sibutramine)、对乙酰氨基酚(acetaminophen)、阿司匹林(aspirin)、格列酮(glitazones)、二甲双胍(metformin)、氯丙嗪(chlorpromazine)、乘晕宁(dimenhydrinat)、多潘立酮(domperidone)、美克洛嗪(meclozine)、甲氧氯普胺(metoclopramide)、奥丹西隆(odansetron)、泼尼松龙(prednisolone)、普鲁米近(promethazine)、阿伐斯汀(acrivastine)、西替利嗪(cetirizine)、桂利嗪(cinnarizine)、氯马斯汀(clemastine)、赛克利嗪(cyclizine)、地氯雷他定(desloratadine)、右氯苯那敏(dexchlorpheniramine)、茶苯海明(dimenhydrinate)、依巴司汀(ebastine)、非索非那定(fexofenadine)、布洛芬(ibuprofen)、左沃普洛辛(levolevoproricin)、氯雷他定(loratadine)、美克洛嗪(meclozine)、咪唑斯汀(mizolastine)、普鲁米近(promethazine)、咪康唑(miconazole)、二乙酸氯己定(chlorhexidine diacetate)、氟化物、十肽KSL(decapeptide KSL)、氟化铝、氨基螯合钙(aminochelated calcium)、氟化铵、氟硅酸铵、单氟磷酸铵、氟化钙、葡萄糖酸钙、甘油磷酸钙、乳酸钙、单氟磷酸钙、碳酸钙、尿素、氯化十六烷基吡啶氯己定、二葡萄糖酸氯己定(chlorhexidine digluconate)、氯化氯己定(chlorhexidine chloride)、氯己定二乙酸酯(chlorhexidine diacetate)、CPP酪蛋白磷酸肽(CPP caseine phospho peptide)、赫克特丁(hexetedine)、十八碳烯基氟化铵(octadecentyl ammonium fluoride)、氟硅酸钾、氯化钾、单氟磷酸钾、碳酸氢钠、碳酸钠、氟化钠、氟硅酸钠、单氟磷酸钠、三聚磷酸钠、氟化亚锡、硬脂酰三羟乙基丙二胺二氢氟化物、氯化锶、焦磷酸四钾、焦磷酸四钠、正磷酸三钾、正磷酸三钠、藻酸、氢氧化铝、碳酸氢钠、西地那非(sildenafil)、他达拉非(tadalafil)、伐地那非(vardenafil)、育亨宾(yohimbine)、西咪替丁(cimetidine)、尼沙替丁(nizatidine)、雷尼替丁(ranitidine)、乙酰水杨酸、氯吡格雷(clopidogrel)、乙酰半胱氨酸、溴己新(bromhexine)、可待因(codeine)、右美沙芬(dextromethorphan)、苯海拉明(diphenhydramine)、诺斯卡品(noscapine)、苯丙醇胺(phenylpropanolamine)、维生素D、辛伐他汀(simvastatin)、吡沙可啶(bisacodyl)、乳糖醇(lactitol)、乳果糖(lactulose)、氧化镁、匹克硫酸钠、番泻叶苷(senna glycosides)、苯佐卡因(benzocaine)、利多卡因(lidocaine)、四卡因(tetracaine)、阿莫曲坦(almotriptan)、依来曲坦(eletriptan)、那拉曲坦(naratriptan)、利扎曲坦(rizatriptan)、舒马曲坦(sumatriptan)、佐米曲坦(zolmitriptan)、钙、铬、铜、碘、镁、锰、钼、磷、硒、锌、氯胺、氢过氧化物、甲硝唑、曲安奈德(triamcinolonacetonide)、苯索氯铵(benzethonium chl.)、十六基吡啶氯(cetylpyrid.chl.)、氯己定、氟化物、利多卡因、双性霉素(amphotericin)、咪康唑(miconazole)、制霉菌素(nystatin)、鱼油、银杏(ginkgo biloba)、人参、姜、紫松果菊(purpleconeflower)、锯棕榈(saw palmetto)、西替利嗪(cetirizine)、左旋西替利嗪(levocetirizine)、氯雷他定(loratadine)、双氯芬酸(diclofenac)、氟比洛芬(flurbiprofen)、阿伐斯丁假麻黄碱(acrivastine pseudoephedrine)、氯雷他定假麻黄碱(loratadine pseudoephedrine)、葡糖胺、透明质酸、十肽KSL-W、十肽KSL、白藜芦醇(resveratrol)、迷索前列醇(misoprostol)、安非他酮(bupropion)、盐酸恩丹西酮(ondansetron HCl)、埃索美拉唑(esomeprazole)、兰索拉唑(lansoprazole)、奥美拉唑(omeprazole)、泮托拉唑(pantoprazole)、雷贝拉唑(rabeprazole)、细菌等、洛哌丁胺(loperamide)、聚二甲基础硅油(simethicone)、乙酰水杨酸等、硫糖铝(sucralfate)、克霉唑(clotrimazole)、氟康唑(fluconazole)、伊曲康唑(itraconazole)、酮康唑(ketoconazole)、特比萘芬(terbinafine)、别嘌呤醇(allopurinol)、丙磺舒(probenecid)、阿托伐他汀(atorvastatin)、氟伐他汀(fluvastatin)、洛伐他汀(lovastatin)、烟酸(nicotinic acid)、普伐他汀(pravastatin)、罗素他汀(rosuvastatin)、辛伐他汀(simvastatin)、匹鲁卡品(pilocarpine)、萘普生(naproxen)、阿仑膦酸盐(alendronate)、依替膦酸盐(etidronate)、雷诺昔酚(raloxifene)、利塞膦酸盐(risedronate)、苯并二氮卓类(benzodiazepines)、戒酒硫(disulphiram)、纳曲酮(naltrexone)、丁丙诺啡(buprenorphine)、可待因(codeine)、右旋丙氧吩(dextropropoxyphene)、芬太尼(fentanyl)、氢吗啡酮(hydromorphone)、凯托米酮(ketobemidone)、酮洛芬(ketoprofen)、美沙酮(methadone)、吗啡(morphine)、萘普生(naproxen)、尼可吗啡(nicomorphine)、羟考酮(oxycodone)、哌替啶(pethidine)、曲马多(tramadol)、阿莫西林(amoxicillin)、氨苄青霉素(ampicillin)、阿奇霉素(azithromycin)、环丙沙星(ciprofloxacin)、克拉霉素(clarithromycin)、强力霉素(doxycyclin)、红霉素(erythromycin)、夫西地酸(fusidic acid)、赖甲环素(lymecycline)、甲硝唑(metronidazole)、莫西沙星(moxifloxacin)、氧氟沙星(ofloxacin)、土霉素(oxytetracycline)、苯氧基甲基青霉素(phenoxymethylpenicillin)、利福霉素(rifamycins)、罗红霉素(roxithromycin)、磺胺噻唑(sulphamethizole)、四环素(tetracycline)、甲氧苄啶(trimethoprim)、万古霉素(vancomycin)、阿卡波糖(acarbose)、格列本脲(glibenclamide)、格列齐特(gliclazide)、格列美脲(glimepiride)、格列吡嗪(glipizide)、胰岛素(insulin)、瑞格列奈(repaglinide)、甲苯磺丁脲(tolbutamide)、奥司他韦(oseltamivir)、阿昔洛韦(aciclovir)、泛昔洛韦(famciclovir)、喷昔洛韦(penciclovir)、缬更昔洛韦(valganciclovir)、氨氯地平(amlopidine)、地尔硫卓(diltiazem)、非洛地平(felodipine)、硝苯地平(nifedipine)、维拉帕米(verapamil)、非那雄胺(finasteride)、米诺地尔(minoxidil)、可卡因(cocaine)、丁丙诺啡(buphrenorphin)、氯压定(clonidine)、美沙酮(methadone)、纳曲酮(naltrexone)、钙拮抗剂(calciumantagonists)、氯压定(clonidine)、麦角胺(ergotamine)、β-阻断剂(β-blockers)、醋氯芬酸(aceclofenac)、塞内昔布(celecoxib)、右布洛芬(dexiprofen)、依托度酸(etodolac)、吲哚美辛(indometacin)、酮洛芬(ketoprofen)、酮咯酸(ketorolac)、氯诺昔康(lornoxicam)、美洛昔康(meloxicam)、萘丁美酮(nabumetone)、厄罗昔康(oiroxicam)、帕瑞考昔(parecoxib)、保泰松(phenylbutazone)、吡罗昔康(piroxicam)、噻洛芬酸(tiaprofenic acid)、托芬那酸(tolfenamic acid)、阿立哌唑(aripiprazole)、氯丙嗪(chlorpromazine)、氯丙硫葸(chlorprothixene)、氯氮平(clozapine)、氟哌噻吨(flupentixol)、氟非那嗪(fluphenazine)、氟哌啶醇(haloperidol)、碳酸锂、柠檬酸锂、美哌隆(melperone)、五氟利多(penfluridol)、哌氰嗪(periciazine)、奋乃静(perphenazine)、哌迷清(pimozide)、匹泮哌隆(pipamperone)、丙氯拉嗪(prochlorperazine)、利培酮(risperidone)、硫醚嗪(thioridizin)、氟康唑(fluconazole)、伊曲康唑(itraconazole)、酮康唑(ketoconazole)、伏立康唑(voriconazole)、鸦片(opium)、苯二氮卓(benzodiazepines)、氢新(hydroxine)、甲丙胺酯(meprobamate)、啡噻嗪(phenothiazine)、氨基乙酸铝(aluminiumaminoacetate)、艾美拉唑(esomeprazole)、法莫替丁(famotidine)、氧化镁、尼扎替丁(nizatide)、奥美拉唑(omeprazole)、泮托拉唑(pantoprazole)、氟康唑(fluconazole)、伊曲康唑(itraconazole)、酮康唑(ketoconazole)、甲硝唑(metronidazole)、苯丙胺(amphetamine)、阿替洛尔(atenolol)、富马酸比索洛尔(bisoprolol fumarate)、美托洛尔(metoprolol)、美托洛尔(metropolol)、吲哚洛尔(pindolol)、普萘洛尔(propranolol)、金诺芬(auranofin)和苄达酸(bendazac)。
可用的药物活性剂或其药物非活性前体的其他实例可包括选自以下治疗剂的活性成分:镇痛剂、麻醉剂、退热剂、抗过敏药、抗心律失常剂、食欲抑制剂、抗真菌剂、抗炎剂、支气管扩张剂、心血管药物、冠状动脉扩张剂、脑扩张剂、外周血管扩张剂、抗感染剂、精神药物、抗躁狂剂、兴奋剂、抗组胺药、轻泻剂、减充血剂、胃肠镇静剂、性功能障碍剂、消毒剂、抗腹泻剂、抗心绞痛剂、血管扩张剂、抗高血压剂、血管收缩剂、偏头痛治疗剂、抗生素、镇静剂、抗精神病剂、抗肿瘤药物、抗凝血剂、抗血栓剂、催眠剂、镇静剂、止吐剂、抗恶心剂、抗惊厥剂、神经肌肉剂、高血糖剂和低血糖剂、甲状腺剂和抗甲状腺剂、利尿剂、抗痉挛剂、子宫松弛剂、抗肥胖剂、厌食剂、解痉剂、合成代谢剂、促红细胞生成剂、抗哮喘剂、祛痰剂、咳嗽抑制剂、黏液溶解剂、抗尿毒症剂、牙科赋形剂、口气清新剂、抗酸剂、抗利尿剂、抗胀气剂、β阻断剂、牙齿增白剂、酶、辅酶、蛋白质、能量增强剂、纤维、益生菌、益生元、NSAID、止咳剂、碱充血剂、抗组胺药、祛痰剂、止泻剂、氢拮抗剂、质子泵抑制剂、通用非选择性CNS抑制剂、通用非选择性CNS兴奋剂、选择性CNS功能改良药物、抗帕金森病药、麻醉镇痛药、镇痛剂、精神药理学药和性功能障碍剂。
可用的药物活性剂或其药物非活性前体的实例也可包括:酪蛋白糖基巨肽(CGMP)、三氯生(Triclosan)、氯化十六烷基吡啶溴化度米芬(Domiphen bromide)、季铵盐、锌组分、血根碱、氟化物、阿来西定(Alexidine)、欧克尼定(Octonidine)、EDTA、阿司匹林、对乙酰氨基酚、布洛芬、酮洛芬、二氟尼柳(diflunisal)、非诺洛芬钙、萘普生、托美丁钠、吲哚美辛、苯佐那酯(Benzonatate)、乙二磺酸卡拉美芬(Caramiphen edisylate)、薄荷醇、氢溴酸右美沙芬、盐酸可可碱、盐酸氯苯达诺(Chlophendianol Hydrochloride)、盐酸假麻黄碱、苯肾上腺素(Phenylephrine)、苯丙醇胺、硫酸假麻黄碱、马来酸溴苯那敏(Brompheniramine maleate)、马来酸氯苯那敏(Chlorpheniramine maleate)、马来酸卡比沙明(Carbinoxamine maleate)、富马酸氯马斯汀(Clemastine fumarate)、马来酸地氯苯那敏(Dexchlorpheniramine maleate)、盐酸苯海拉明(Dephenhydraminehydrochloride)、盐酸二苯胺、马来酸哌吡庚啶(Azatadine maleate)、柠檬酸苯海拉明(Diphenhydramine citrate)、琥珀酸多西拉敏(Doxylamine succinate)、盐酸异丙嗪(Promethazine hydrochloride)、马来酸吡拉明(Pyrilamine maleate)、柠檬酸三苯胺(Tripellenamine citrate)、盐酸曲普利啶(Triprolidine hydrochloride)、阿昔伐他汀(Acrivastine)、氯雷他定(Loratadine)、溴苯那敏(Brompheniramine)、德溴非明(Dexbrompheniamine)、愈创甘油醚(Guaifenesin)、吐根(Ipecac)、碘化钾、水合萜品(Terpin hydrate)、洛哌丁胺(Loperamide)、法莫替丁(Famotidine)、雷尼替丁(Ranitidine)、奥美拉唑(Omeprazole)、兰索拉唑(Lansoprazole)、脂族醇、巴比妥酸盐(Barbiturate)、咖啡因(caffeine)、马钱子碱(strychnine)、木防己苦毒素(Picrotoxin)、戊四氮、苯基乙内酰脲、苯巴比妥(Phenobarbital)、普里米酮(Primidone)、卡马西平(Carbamazapine)、乙琥胺、甲琥胺、苯琥胺(Phensuximide)、三甲双酮(Trimethadione)、地西泮(Diazepam)、苯并二氮卓(Benzodiazepine)、苯乙酰脲、苯丁酰脲、乙酰唑胺、苏太明(Sulthiame)、溴化物、左旋多巴(Levodopa)、金刚胺(Amantadine)、吗啡碱(Morphine)、海洛因(Heroin)、氢吗啡酮(Hydromorphone)、美托酮(Metopon)、羟吗啡酮(Oxymorphone)、左吗喃(Levophanol)、可待因(Codeine)、氢可酮(Hydrocodone)、羟考酮(Xycodone)、纳洛芬(Nalorphine)、纳洛酮(Naloxone)、纳曲酮(Naltrexone)、水杨酸盐、苯基丁氮酮(Phenylbutazone)、吲哚美辛(Indomethacin)、非那西汀(Phenacetin)、氯丙嗪(Chlorpromazine)、左美丙嗪(Methotrimeprazine)、氟哌啶醇(Haloperidol)、氯氮平(Clozapine)、利血平(Reserpine)、丙咪嗪(Imipramine)、反苯环丙胺(Tranylcypromine)、苯乙肼(Phenelzine)、锂、柠檬酸西地那非(Sildenafil citrate)、他达拉非(Tadalafil)和伐地那非CL(Vardenafil CL)。例如,丁香酚可被用作麻醉剂。
可用的药物活性剂或其药物非活性前体的实例可包括选自以下的活性成分:ACE抑制剂、抗心绞痛药、抗心律失常剂、抗哮喘剂、抗胆固醇血剂、镇痛剂、麻醉剂、抗惊厥剂、抗抑郁剂、抗糖尿病剂、抗腹泻制剂、解毒剂、抗组胺药、抗高血压药、抗炎剂、抗脂质剂、抗躁剂、止恶心药、抗中风剂、抗甲状腺制剂、抗肿瘤药物、抗病毒剂、痤疮药物、生物碱、氨基酸制剂、止咳剂、抗尿毒症剂、抗病毒药物、合成代谢制剂、全身和非全身抗感染剂、抗肿瘤药、抗帕金森病剂、抗风湿病剂、食欲刺激剂、生物学反应调节剂、血液改良剂、骨骼代谢调节剂、心血管剂、中枢神经系统刺激剂、胆碱酯酶抑制剂、避孕药、碱充血剂、膳食补充剂、多巴胺受体促效剂、子宫内膜异位处理剂、酶、勃起功能障碍疗法(例如目前以ViagraTM出售的柠檬酸西地那非(sildenafil citrate)、生育剂、胃肠道药、顺势疗法治疗物、激素、高钙血症处理剂和低钙血症处理剂、免疫调节剂、免疫抑制剂、偏头痛制剂、动晕症治疗剂、肌肉松弛剂、肥胖管理剂、骨质疏松症制剂、催产剂、副交感神经阻断药、副交感神经药、前列腺素、精神治疗剂、呼吸道剂、镇静剂、戒烟助剂(例如溴麦角环肽)、交感神经剂、震颤制剂、泌尿道药、血管扩张剂、轻泻剂、抗酸剂、离子交换树脂、退烧药、食欲抑制剂、祛痰剂、抗焦虑剂、抗溃疡剂、抗炎物质、冠状动脉扩张剂、脑扩张剂、外周血管扩张剂、精神药物、兴奋剂、抗高血压药物、血管收缩剂、偏头痛治疗剂、抗生素、安神剂、抗精神病药、抗肿瘤药物、抗凝血剂、抗血栓药物、安眠药、止吐药、抗恶心药、抗惊厥剂、神经肌肉药、高血糖剂和低血糖剂、甲状腺和抗甲状腺制剂、利尿剂、抗痉挛药、子宫松弛剂、抗肥胖药物、促红血球生成药、抗哮喘剂、止咳剂、黏液溶解剂、DNA和遗传修饰药以及其组合。
预期可用的药物活性剂或其药物非活性前体的实例也可包括抗酸剂、H2-拮抗剂和镇痛剂。例如,可单独使用碳酸钙成分或与氢氧化镁和/或氢氧化铝组合来制备抗酸剂。此外,抗酸剂可与H2-拮抗剂组合使用。
镇痛剂包括鸦片制剂以及鸦片制剂衍生物,例如OxycontinTM、布洛芬、阿司匹林、对乙酰氨基酚及其可任选地包括咖啡因的组合。
其他可用的药物活性剂或其药物非活性前体可包括止泻剂,例如ImmodiumTMAD、抗组胺药、止咳剂、碱充血剂、维生素和口气清新剂。也预期在本文中使用的是抗焦虑剂,例如XanaxTM;抗精神病药,例如ClozarilTM和HaldolTM;非类固醇抗炎剂(NSAID),例如布洛芬、萘普生钠、VoltarenTM和LodineTM;抗组胺药,例如ClaritinTM、HismanalTM、RelafenTM和TavistTM;止吐药,例如KytrilTM和CesametTM;支气管扩张剂,例如BentolinTM、ProventilTM;抗抑郁药,例如ProzacTM、ZoloftTM和PaxilTM;抗偏头痛剂,例如ImigraTM;ACE抑制剂,例如VasotecTM、CapotenTM和ZestrilTM;抗阿尔茨海默病药,例如NicergolineTM;以及CaH拮抗剂,例如ProcardiaTM、AdalatTM和CalanTM。
预期用于本发明中的普遍的H2-拮抗剂包括西咪替丁、盐酸雷尼替丁、法莫替丁、尼沙替丁(nizatidine)、乙溴替丁(ebrotidine)、咪芬替丁(mifentidine)、罗沙替丁(roxatidine)、匹沙替丁(pisatidine)和乙酸罗沙替丁(aceroxatidine)。
活性抗酸成分可包括但不限于以下物质:氢氧化铝、氨基乙酸二羟基铝、氨基乙酸、磷酸铝、碳酸二羟铝钠、碳酸氢盐、铝酸铋、碳酸铋、碱式碳酸铋、碱式没食子酸铋、次硝酸铋、次水杨酸铋(bismuth subsilysilate)、磷酸钙、柠檬酸根离子(酸或盐)、氨基乙酸、水合硫酸镁铝、镁加铝、硅酸镁铝、碳酸镁、甘氨酸镁、氢氧化镁、氧化镁、三硅酸镁、乳固体、磷酸氢二或二氢铝钙、磷酸三钙、碳酸氢钾、酒石酸钠、碳酸氢钠、硅酸镁铝、酒石酸和盐。
在一些实施方案中,该药物活性剂或其药物非活性前体可选自镇痛剂/麻醉剂,例如薄荷醇、苯酚、己基间苯二酚、苯佐卡因、盐酸达克罗宁、苯甲醇、水杨醇及其组合。在一些实施方案中,该药物活性剂或其药物非活性前体可选自缓和剂,例如滑榆树皮(slipperyelm bark)、果胶、明胶及其组合。在一些实施方案中,该药物活性剂或其药物非活性前体可选自防腐败剂(antiseptic)成分,例如氯化十六烷基吡啶溴化杜米芬(domiphenbromide)、地喹氯铵(dequalinium chloride)、丁香酚及其组合。
在一些实施方案中,该药物活性剂或其药物非活性前体可选自止咳成分,例如盐酸氯苯达诺、可待因、磷酸可待因、硫酸可待因、右美沙芬、氢溴酸右美沙芬、柠檬酸苯海拉明和盐酸苯海拉明及其组合。
在一些实施方案中,该药物活性剂或其药物非活性前体可选自咽喉舒缓剂,例如蜂蜜、蜂胶、芦荟(aloe vera)、丙三醇、薄荷醇及其组合。在其他实施方案中,该药物活性剂或其药物非活性前体可选自咳嗽抑制剂。这种咳嗽抑制剂可分成两组:改变痰的质地或产量的那些,例如黏液溶解剂和祛痰药;以及抑制咳嗽反射的那些,例如可待因(麻醉性咳嗽抑制剂)、抗组胺、右美沙芬和异丙肾上腺素(非麻醉性咳嗽抑制剂)。
在其他实施方案中,该药物活性剂或其药物非活性前体可选自以下的止咳剂:可待因、右美沙芬、右羟吗喃、苯海拉明、氢可酮、诺斯卡品、羟考酮、喷托维林及其组合。在一些实施方案中,该药物活性剂或其药物非活性前体可选自抗组胺药,例如阿伐斯汀、阿扎他定、溴苯那敏、氯非尼拉敏、氯马斯汀、赛庚啶、右溴苯那敏、茶苯海明、苯海拉明、苯吡拉明、安泰乐、美克利嗪、苯茚胺、苯托沙敏、普鲁米近、比拉明、曲吡那明、曲普利定及其组合。在一些实施方案中,该药物活性剂或其药物非活性前体可选自非镇静抗组胺药,例如阿司咪唑、西替利嗪、依巴斯汀、非索非那定、氯雷他定、特非那定及其组合。
例如,所述至少一种活性成分和/或其非活性前体选自日用化妆香精,食用香精,精油,杀虫剂,杀真菌剂,药物活性剂或其药物非活性前体如防腐败剂和/或麻醉剂及其混合物。最优选地,所述至少一种活性成分和/或其非活性前体为药物活性剂或其药物非活性前体,例如防腐败剂和/或麻醉剂或其混合物。
优选该至少一种活性成分和/或其非活性前体呈液体形式。
在本发明的含义中,术语“液体”是指非气态流体组合物,其包含该至少一种活性成分和/或其非活性前体或由该至少一种活性成分和/或其非活性前体构成,该组合物在使用的压力条件和温度(即进行该方法、优选该方法的步骤e2)时所处的温度)下易于流动。
应当理解,该至少一种活性成分和/或其非活性前体可被原样使用,只要其呈液体形式或在溶剂中。如果该至少一种活性成分和/或其非活性前体在室温下为固体,则该至少一种活性成分和/或其非活性前体优选提供于(水性或有机)溶剂中以便形成溶液、分散体如纳米分散体、乳液如纳米乳液或悬浮液如纳米悬浮液。
如果该至少一种活性成分和/或其非活性前体提供于溶剂中,则该溶剂优选选自水、甲醇、乙醇、正丁醇、异丙醇、正丙醇、正辛醇、丙酮、二甲基亚砜、二甲基甲酰胺、四氢呋喃、植物油及其衍生物、动物油及其衍生物、熔融脂肪和蜡及其混合物,并且更优选该溶剂为水、乙醇和/或丙酮。更优选该溶剂为乙醇和/或丙酮。
如果该至少一种活性成分和/或其非活性前体在室温下为固体,则该至少一种活性成分和/或其非活性前体也能够以熔融的状态提供,即如果熔融温度低于180℃、优选20-100℃,则该至少一种活性成分和/或其非活性前体优选以熔融的状态提供。
如果该至少一种活性成分和/或其非活性前体本身是液体,则该至少一种活性成分和/或其非活性前体在高于0℃、例如在3-180℃、优选10-100℃并且最优选10-40℃的温度范围内优选为液体。例如,该至少一种活性成分和/或其非活性前体在高于0℃、例如在3-180℃、优选10-100℃且最优选10-40℃的温度范围内在环境压力条件下(即在大气压下)为液体。
在一种实施方案中,将该至少一种活性成分和/或其非活性前体溶解于溶剂中。也即,该至少一种活性成分和/或其非活性前体和溶剂形成体系,在该体系中未在溶剂中观测到离散固体粒子并且因而形成“溶液”。
术语“悬浮液”是指以下这样的体系:其包含基本上不溶性的固体和溶剂以及任选的其他添加剂并且通常含有大量固体且因而与用于形成其的溶剂相比更为粘性且通常具有更高的密度。然而,术语“基本上不溶性(essentially insoluble)”不排除固体材料的至少一部分在某些条件下如在提高的温度下溶解于水中。
如果该至少一种活性成分和/或其非活性前体在溶剂中提供,则该溶剂优选在方法步骤e2)之后直接移除,例如通过蒸发来进行。术语“之后直接”是指在加载步骤e2)和所定义的溶剂移除之间不实施其他的步骤。然而,应当理解,溶剂的移除可及时地与方法步骤e2)分离。
在本发明方法的步骤e2)中,用该至少一种活性成分和/或其非活性前体加载在步骤b)中获得的该经表面反应的碳酸钙的压实形式或者在步骤c)或如果存在的步骤d)中获得的该粒料。例如,用该至少一种活性成分和/或其非活性前体加载在步骤d)中获得的该粒料。
优选地,通过将该至少一种活性成分和/或其非活性前体喷涂或滴加至在步骤b)中获得的该经表面反应的碳酸钙的压实形式或者在步骤c)或如果存在的步骤d)中获得的该粒料上并且在适合于将该至少一种活性成分和/或其非活性前体均匀分布到该经表面反应的碳酸钙的压实形式或者该粒料上的装置中将它们混合来进行加载步骤e2)。
出于本发明的目的,可使用在本领域中已知的任何适合的手段。然而,加载步骤e2)优选在选自以下的装置中发生:流化床干燥机/造粒机、犁铧式混合器、立式或卧式混合器、高或低剪切混合器和高速掺合机。
应当理解,加载步骤e2)可在宽温度和/或压力范围内进行。例如,加载步骤e2)在高于0℃、例如在3-180℃的范围内、优选10-100℃且最优选10-40℃的温度范围内,在环境压力条件下(即在大气压下)进行。另外可选地,加载步骤e2)在高于0℃,例如在3-180℃的范围内、优选10-100℃且最优选10-40℃的温度范围内在真空下进行。
在一种实施方案中,加载步骤e2)在环境温度和压力条件下进行,例如在室温如约5-35℃、优选10-30℃且最优选15-25℃下并且在大气压下进行。另外可选地,加载步骤e2)在环境温度下如在室温如约5-35℃、优选10-30℃且最优选15-25℃下且在真空下进行。
如果该方法包括提供至少一种活性成分和/或其非活性前体,则该用于生产剂型的方法包括以下步骤,优选由以下步骤构成:
a)提供经表面反应的碳酸钙,其中该经表面反应的碳酸钙是天然研磨或沉淀碳酸钙与二氧化碳和一种或多种H3O+离子供体在水性介质中的反应产物,其中该二氧化碳通过H3O+离子供体处理原位形成和/或从外部来源供应;
b)借助于辊式压实机在1-30kN/cm范围内的压实压力下将步骤a)的经表面反应的碳酸钙压实成压实形式;
c)将步骤b)的该压实形式磨碎成粒料;以及
e2)用至少一种活性成分和/或其非活性前体加载在步骤b)中获得的该压实形式或者在步骤c)中获得的该粒料、优选在步骤c)中获得的该粒料以获得经加载的粒料;
其中步骤b)中获得的压实形式由步骤a)的该经表面反应的碳酸钙构成。
在一种实施方案中,该方法包括筛分在步骤c)中获得的该粒料从而获得具有特定颗粒尺寸的粒料的步骤。
如果该方法进一步包括筛分,则该用于生产剂型的方法包括以下步骤,优选由以下步骤构成:
a)提供经表面反应的碳酸钙,其中该经表面反应的碳酸钙是天然研磨或沉淀碳酸钙与二氧化碳和一种或多种H3O+离子供体在水性介质中的反应产物,其中该二氧化碳通过H3O+离子供体处理原位形成和/或从外部来源供应;
b)借助于辊式压实机在1-30kN/cm范围内的压实压力下将步骤a)的经表面反应的碳酸钙压实成压实形式;
c)将步骤b)的该压实形式磨碎成粒料;以及
e2)用至少一种活性成分和/或其非活性前体加载在步骤b)中获得的该压实形式或者在步骤c)中获得的该粒料、优选在步骤c)中获得的该粒料以用于获得经加载的粒料;
d)通过至少一种筛目尺寸筛分步骤c)或者e2)的该粒料。
其中步骤b)中获得的压实形式由步骤a)的该经表面反应的碳酸钙构成。
优选加载步骤e2)在筛分步骤d)之后进行。因而该用于生产剂型的方法包括以下步骤,优选由以下步骤构成:
a)提供经表面反应的碳酸钙,其中该经表面反应的碳酸钙是天然研磨或沉淀碳酸钙与二氧化碳和一种或多种H3O+离子供体在水性介质中的反应产物,其中该二氧化碳通过H3O+离子供体处理原位形成和/或从外部来源供应;
b)借助于辊式压实机在1-30kN/cm范围内的压实压力下将步骤a)的经表面反应的碳酸钙压实成压实形式;
c)将步骤b)的该压实形式磨碎成粒料;
d)通过至少一种筛目尺寸筛分步骤c)的该粒料;以及
e2)用至少一种活性成分和/或其非活性前体加载在步骤d)中获得的该粒料以用于获得经加载的粒料;
其中步骤b)中获得的压实形式由步骤a)的该经表面反应的碳酸钙构成。
在一种实施方案中,该方法包括提供至少一种活性成分和/或其非活性前体以及提供至少一种配制助剂。因而,该用于生产剂型的方法包括以下步骤,优选由以下步骤构成:
a)提供经表面反应的碳酸钙,其中该经表面反应的碳酸钙是天然研磨或沉淀碳酸钙与二氧化碳和一种或多种H3O+离子供体在水性介质中的反应产物,其中该二氧化碳通过H3O+离子供体处理原位形成和/或从外部来源供应;
b)借助于辊式压实机在1-30kN/cm范围内的压实压力下将步骤a)的经表面反应的碳酸钙压实成压实形式;
c)将步骤b)的该压实形式磨碎成粒料;
e1)使步骤c)中获得的该粒料与至少一种配制助剂混合;以及
e2)用至少一种活性成分和/或其非活性前体加载在步骤b)中获得的该压实形式或者在步骤c)中获得的该粒料、优选在步骤c)中获得的该粒料以用于获得经加载的粒料;
其中步骤b)中获得的压实形式由步骤a)的该经表面反应的碳酸钙构成。
如果该方法进一步包括筛分,该用于生产剂型的方法包括以下步骤,优选由以下步骤构成:
a)提供经表面反应的碳酸钙,其中该经表面反应的碳酸钙是天然研磨或沉淀碳酸钙与二氧化碳和一种或多种H3O+离子供体在水性介质中的反应产物,其中该二氧化碳通过H3O+离子供体处理原位形成和/或从外部来源供应;
b)借助于辊式压实机在1-30kN/cm范围内的压实压力下将步骤a)的经表面反应的碳酸钙压实成压实形式;
c)将步骤b)的该压实形式磨碎成粒料;
d)通过至少一种筛目尺寸筛分步骤c)或者e2)的该粒料;
e1)使步骤d)中获得的该粒料与至少一种配制助剂混合;以及
e2)用至少一种活性成分和/或其非活性前体加载在步骤b)中获得的该压实形式或者在步骤c)或者步骤d)中获得的该粒料、优选在步骤d)中获得的该粒料以用于获得经加载的粒料;
其中步骤b)中获得的压实形式由步骤a)的该经表面反应的碳酸钙构成。
优选地,加载步骤e2)在筛分步骤d)之后进行。在这种实施方案中,该用于生产剂型的方法包括以下步骤,优选由以下步骤构成:
a)提供经表面反应的碳酸钙,其中该经表面反应的碳酸钙是天然研磨或沉淀碳酸钙与二氧化碳和一种或多种H3O+离子供体在水性介质中的反应产物,其中该二氧化碳通过H3O+离子供体处理原位形成和/或从外部来源供应;
b)借助于辊式压实机在1-30kN/cm范围内的压实压力下将步骤a)的经表面反应的碳酸钙压实成压实形式;
c)将步骤b)的该压实形式磨碎成粒料;
d)通过至少一种筛目尺寸筛分步骤c)的该粒料;
e1)使步骤d)中获得的该粒料与至少一种配制助剂混合;以及
e2)用至少一种活性成分和/或其非活性前体加载在步骤d)中获得的该粒料以用于获得经加载的粒料;
其中步骤b)中获得的压实形式由步骤a)的该经表面反应的碳酸钙构成。
如果该方法包括方法步骤e1)和步骤e2),这些步骤能够以任何顺序同时或者分别进行。
在一种实施方案中,方法步骤e1)和步骤e2)是同时进行的。例如,方法步骤e1)和步骤e2)是同时进行的,其中在掺合机中提供该至少一种配制助剂和该至少一种活性成分和/或其非活性前体。也即,所述至少一种配制助剂以及该至少一种活性成分和/或其非活性前体可在进行方法步骤e1)和步骤e2)之前预混合。
在一种实施方案中,方法步骤e1)和步骤e2)彼此独立地进行,即以任何顺序分别进行。例如,方法步骤e2)在步骤e1)之前进行。
应当理解,步骤e2)中获得的该粒料可进行涂覆步骤e3),即在进行任选的制片步骤f)之前。这种涂覆是本领域中公知的并且可用本领域技术人员已知的任何传统涂覆手段制备。优选地,该涂覆步骤用针对混合步骤e1)定义的该至少一种配制助剂进行。
在另外的任选实施方案中,该方法进一步包括最终步骤f):将步骤e2)或者步骤e1)或者步骤d)中获得的该粒料制片,条件是步骤d)在步骤e2)或者步骤e1)之后进行,或者将步骤e2)或者步骤e1)或者步骤d)中获得的该粒料填充至胶囊中,条件是步骤d)在步骤e2)或者步骤e1)之后进行。
在本发明的含义中,术语“制片(tableting)”是指将材料压实或模制成片剂形状的过程。片剂可呈本领域中已知的任何形状和尺寸。“胶囊”可以是本领域中已知的任何种类的胶囊。例如,胶囊可为明胶胶囊或HPMC胶囊。
步骤f)在0.5-100kN范围内的压缩力下进行。应当注意,步骤f)中使用的压缩力取决于步骤e2)中提供的特定的至少一种活性成分和/或其非活性前体。本领域技术人员因而将相应地调适该压缩力。优选地,步骤f)在1.0-100kN的范围内、且最优选在1.5-80kN的范围内的压缩力下进行。例如,步骤f)在2.0-60kN的范围内、且最优选在2.5-50kN或者2.5-20kN的范围内的压缩力下进行。
制片可用本领域技术人员已知的任何传统的压实机进行。例如,用例如来自德国Fette Compacting公司的Fette 1200i压片机的压片机进行制片。
应当理解,制片步骤f)中获得的该片剂可经历最终的涂覆步骤。这种涂覆步骤是本领域公知的并且可用本领域技术人员已知的任何传统的涂覆手段制备。
在这种实施方案中,该用于生产剂型的方法包括以下步骤,优选由以下步骤构成:
a)提供经表面反应的碳酸钙,其中该经表面反应的碳酸钙是天然研磨或沉淀碳酸钙与二氧化碳和一种或多种H3O+离子供体在水性介质中的反应产物,其中该二氧化碳通过H3O+离子供体处理原位形成和/或从外部来源供应;
b)借助于辊式压实机在1-30kN/cm范围内的压实压力下将步骤a)的经表面反应的碳酸钙压实成压实形式;
c)将步骤b)的该压实形式磨碎成粒料;
e1)任选地,使步骤e2)中获得的该粒料与至少一种配制助剂混合;
e2)用至少一种活性成分和/或其非活性前体加载在步骤b)中获得的该压实形式或者在步骤c)中获得的该粒料、优选在步骤c)中获得的该粒料以用于获得经加载的粒料;以及
f)将步骤e1)中获得的该粒料制片或者将步骤e1)中获得的该粒料填充至胶囊中;
其中步骤b)中获得的压实形式由步骤a)的该经表面反应的碳酸钙构成。
如果该方法进一步包括筛分,则该用于生产剂型的方法包括以下步骤,优选由以下步骤构成:
a)提供经表面反应的碳酸钙,其中该经表面反应的碳酸钙是天然研磨或沉淀碳酸钙与二氧化碳和一种或多种H3O+离子供体在水性介质中的反应产物,其中该二氧化碳通过H3O+离子供体处理原位形成和/或从外部来源供应;
b)借助于辊式压实机在1-30kN/cm范围内的压实压力下将步骤a)的经表面反应的碳酸钙压实成压实形式;
c)将步骤b)的该压实形式磨碎成粒料;
d)通过至少一种筛目尺寸筛分步骤e2)或如果存在的步骤e1)的该粒料;
e1)任选地,使步骤e2)中获得的该粒料与至少一种配制助剂混合;
e2)用至少一种活性成分和/或其非活性前体加载在步骤b)中获得的该压实形式或者在步骤c)中获得的该粒料、优选在步骤c)中获得的该粒料以用于获得经加载的粒料;
f)将步骤d)中获得的该粒料制片或者将步骤d)中获得的该粒料填充至胶囊中;
其中步骤b)中获得的压实形式由步骤a)的该经表面反应的碳酸钙构成。
优选地,加载步骤e2)在筛分步骤d)之后进行。在这种实施方案中,该用于生产剂型的方法包括以下步骤,优选由以下步骤构成:
a)提供经表面反应的碳酸钙,其中该经表面反应的碳酸钙是天然研磨或沉淀碳酸钙与二氧化碳和一种或多种H3O+离子供体在水性介质中的反应产物,其中该二氧化碳通过H3O+离子供体处理原位形成和/或从外部来源供应;
b)借助于辊式压实机在1-30kN/cm范围内的压实压力下将步骤a)的经表面反应的碳酸钙压实成压实形式;
c)将步骤b)的该压实形式磨碎成粒料;
d)通过至少一种筛目尺寸筛分步骤c)的该粒料;
e1)任选地,使步骤e2)中获得的该粒料与至少一种配制助剂混合;
e2)用至少一种活性成分和/或其非活性前体加载在步骤d)中获得的该粒料;以及
f)将步骤e2)或者如果存在的步骤e1)中获得的该粒料制片或者将步骤e2)或者如果存在的步骤e1)中获得的该粒料填充至胶囊中;
其中步骤b)中获得的压实形式由步骤a)的该经表面反应的碳酸钙构成。
优选地,该用于生产剂型的方法包括以下步骤,优选由以下步骤构成:
a)提供经表面反应的碳酸钙,其中该经表面反应的碳酸钙是天然研磨或沉淀碳酸钙与二氧化碳和一种或多种H3O+离子供体在水性介质中的反应产物,其中该二氧化碳通过H3O+离子供体处理原位形成和/或从外部来源供应;
b)借助于辊式压实机在1-30kN/cm范围内的压实压力下将步骤a)的经表面反应的碳酸钙压实成压实形式;
c)将步骤b)的该压实形式磨碎成粒料;
d)通过至少一种筛目尺寸筛分步骤c)的该粒料;
e1)使步骤e2)中获得的该粒料与至少一种配制助剂混合;
e2)用至少一种活性成分和/或其非活性前体加载在步骤d)中获得的该粒料以用于获得经加载的粒料;以及
f)将步骤e1)中获得的该粒料制片或者将步骤e1)中获得的该粒料填充至胶囊中;
其中步骤b)中获得的压实形式由步骤a)的该经表面反应的碳酸钙构成。
另外可选地,该用于生产剂型的方法包括以下步骤,优选由以下步骤构成:
a)提供经表面反应的碳酸钙,其中该经表面反应的碳酸钙是天然研磨或沉淀碳酸钙与二氧化碳和一种或多种H3O+离子供体在水性介质中的反应产物,其中该二氧化碳通过H3O+离子供体处理原位形成和/或从外部来源供应;
b)借助于辊式压实机在1-30kN/cm范围内的压实压力下将步骤a)的经表面反应的碳酸钙压实成压实形式;
c)将步骤b)的该压实形式磨碎成粒料;
d)通过至少一种筛目尺寸筛分步骤c)的该粒料;
e1)使步骤d)中获得的该粒料与至少一种配制助剂混合;
e2)用至少一种活性成分和/或其非活性前体加载在步骤e1)中获得的该粒料以用于获得经加载的粒料;以及
f)将步骤e2)中获得的该粒料制片或者将步骤e2)中获得的该粒料填充至胶囊中;
其中步骤b)中获得的压实形式由步骤a)的该经表面反应的碳酸钙构成。
在一种实施方案中,该用于生产剂型的方法包括以下步骤,优选由以下步骤构成:
a)提供经表面反应的碳酸钙,其中该经表面反应的碳酸钙是天然研磨或沉淀碳酸钙与二氧化碳和一种或多种H3O+离子供体在水性介质中的反应产物,其中该二氧化碳通过H3O+离子供体处理原位形成和/或从外部来源供应;
b)借助于辊式压实机在1-30kN/cm范围内的压实压力下将步骤a)的经表面反应的碳酸钙压实成压实形式;
c)将步骤b)的该压实形式磨碎成粒料;
d)通过至少一种筛目尺寸筛分步骤c)的该粒料;
e1)使步骤d)中获得的该粒料与至少一种配制助剂混合;
e2)用至少一种活性成分和/或其非活性前体加载在步骤e1)中获得的该粒料以用于获得经加载的粒料;
e3)用至少一种配制助剂涂覆步骤e2)中获得的该粒料;
f)将步骤e3)中获得的该粒料制片或者将步骤e3)中获得的该粒料填充至胶囊中;并且
其中步骤b)中获得的压实形式由步骤a)的该经表面反应的碳酸钙构成。
另外可选地,该用于生产剂型的方法包括以下步骤,优选由以下步骤构成:
a)提供经表面反应的碳酸钙,其中该经表面反应的碳酸钙是天然研磨或沉淀碳酸钙与二氧化碳和一种或多种H3O+离子供体在水性介质中的反应产物,其中该二氧化碳通过H3O+离子供体处理原位形成和/或从外部来源供应;
b)借助于辊式压实机在1-30kN/cm范围内的压实压力下将步骤a)的经表面反应的碳酸钙压实成压实形式;
c)将步骤b)的该压实形式磨碎成粒料;
d)通过至少一种筛目尺寸筛分步骤c)的该粒料;
e1)使步骤e2)中获得的该粒料与至少一种配制助剂混合;
e2)用至少一种活性成分和/或其非活性前体加载在步骤d)中获得的该粒料以用于获得经加载的粒料;
e3)用至少一种配制助剂涂覆步骤e1)中获得的该粒料;
f)将步骤e3)中获得的该粒料制片或者将步骤e3)中获得的该粒料填充至胶囊中;
其中步骤b)中获得的压实形式由步骤a)的该经表面反应的碳酸钙构成。
通过该方法获得的剂型可以是粒料、片剂、迷你片剂或者胶囊。
因而,在一个方面中,本发明进一步涉及由如在本文中所定义的经表面反应的碳酸钙构成并且任选地与如在本文中所定义的至少一种配制助剂混合和/或加载有如在本文中所定义的至少一种活性成分和/或其非活性前体的粒料。例如,该粒料由如在本文中所定义的经表面反应的碳酸钙构成并且混合和/或涂覆有如在本文中所定义的至少一种配制助剂和/或加载有如在本文中所定义的至少一种活性成分和/或其非活性前体。优选地,该粒料由如在本文中所定义的经表面反应的碳酸钙构成并且与如在本文中所定义的至少一种配制助剂混合或者加载有如在本文中所定义的至少一种活性成分和/或其非活性前体,优选加载有如在本文中所定义的至少一种活性成分和/或其非活性前体。另外可选地,该粒料由如在本文中所定义的经表面反应的碳酸钙构成并且与如在本文中所定义的至少一种配制助剂混合并且加载有如在本文中所定义的至少一种活性成分和/或其非活性前体。优选地,该粒料通过如在本文中所定义的方法获得。
在另一个方面中,本发明进一步涉及通过如在本文中所定义的方法而获得的片剂和/或胶囊。
因而,可在宽尺寸范围内制备剂型,其中不同尺寸级分可通过传统手段如筛分来分离。
通常,该剂型可具有0.1-20.0mm、优选0.2-15.0mm、且更优选0.3-10.0mm的重量中值粒子尺寸。
鉴于获得的良好结果,本发明在另一个方面中涉及通过该方法获得的剂型,优选片剂、迷你片剂或胶囊。
另一方面涉及如在本文中所定义的粒料或者如在本文中所定义的片剂和/或胶囊或者如在本文中所定义的剂型在药物、营养物、农业、化妆品、家用、包装食品和个人护理产品中的用途。
根据再一方面,提供包含如在本文中所定义的粒料或者如在本文中所定义的片剂和/或胶囊或者如在本文中所定义的剂型的药物、营养物、农业、化妆品、家用、食品、包装和个人护理产品。
再一方面涉及经表面反应的碳酸钙在如在本文中所定义的方法中的用途。
关于该方法、该剂型、该经表面反应的碳酸钙、该至少一种活性成分和/或其非活性前体、该至少一种配制助剂及其优选的实施方案的定义,参考上文在讨论本发明方法的技术细节时提供的说明。
附图说明
图1显示构成粒料的FCC的SEM图片。
图2显示构成加载有10%丁香酚的粒料的FCC的SEM图片。
图3显示构成加载有25%丁香酚的粒料的FCC的SEM图片。
图4显示构成加载有40%丁香酚的粒料的FCC的SEM图片。
图5显示构成加载有10%布洛芬的粒料的FCC的SEM图片。
图6显示构成加载有40%布洛芬的粒料的FCC的SEM图片。
具体实施方式
以下的实施例和测试将说明本发明,但并非意味着以任何方式限制本发明。
实施例
材料和方法
1.测量方法
使用以下的测量方法评价在实施例和权利要求中给出的参数。
材料的BET比表面积(SSA)
经由根据ISO 9277的BET法,使用氮气,在通过在250℃下加热30分钟的周期调理样品之后测量BET比表面积。在这种测量之前,样品进行过滤、冲洗并且在110℃下在烘箱中干燥至少12小时。
微粒材料的粒子尺寸分布(直径<X的粒子的体积%)、d50值(体积中值颗粒直径)和d98值:
使用Malvern Mastersizer 2000激光衍射系统评价体积中值颗粒直径d50。使用Malvern Mastersizer 2000激光衍射系统测量的d50或者d98值表示的直径值使得以体积计分别为50%或者98%的粒子具有小于该值的直径。使用米氏(Mie)理论分析通过测量结果获得的原始数据,其中粒子折射率为1.57并且吸收系数为0.005。
通过在重力场中沉降行为分析的沉降方法测定重量中值颗粒直径。用Micromeritics Instrument公司的SedigraphTM 5100进行测量。方法及仪器是本领域技术人员已知的并且常见地用于测定填料及颜料的颗粒尺寸。在0.1%重量的Na4P2O7的水溶液中进行测量。使用高速搅拌器及超声分散样品。
使用振动筛分塔分析粒料的粒子尺寸分布。将120g粒料的等分试样放置在具有90μm、180μm、250μm、355μm、500μm、710μm和1mm筛目尺寸的钢丝筛网(Retsch,德国)上。筛分塔在1mm的摇动位移下以10秒的时间间隔摇动3分钟。
方法和仪器是本领域技术人员已知的并且常见地用于测定填料和颜料的颗粒尺寸。
经表面反应的碳酸钙的粒子内侵入式比孔容(以cm3/g计)
使用Micromeritics Autopore V 9620汞孔率计,使用汞侵入孔隙率测定法测量结果测量比孔容,所述汞孔率计具有最大施加汞压为414MPa(60 000psi),等效于0.004μm(~nm)的拉普拉斯喉径。在每个压力步骤使用的平衡时间是20秒。将样品材料密封在5cm3室的粉末透度计中用于分析。使用软件Pore-Comp(Gane,P.A.C.,Kettle,J.P.,Matthews,G.P.和Ridgway,C.J.,“Void Space Structure of Compressible Polymer Spheres andConsolidated Calcium Carbonate Paper-Coating Formulations”,Industrial andEngineering Chemistry Research,35(5),1996年,第1753-1764页),针对汞压缩、透度计膨胀和样品材料压缩来校正数据。
在累积侵入数据中见到的总孔体积可被分成两个区域,其中从214μm降至约1-4μm的侵入数据显示具有强烈贡献的任何附聚结构之间的样品的粗填充。在这些直径之下的是粒子自身的精细粒子间填充。如果它们也具有粒子内孔,则此区域显现双峰,并且通过获取由汞侵入比峰转折点更细(即比双峰拐点更细)的孔的比孔容,因而定义比粒子内孔体积。这三个区域的总和给出了粉末的总全部孔体积,但强烈地取决于原始样品压实/在分布的粗孔末端处的粉末的沉降。
通过获取累积侵入曲线的第一导数,揭示了基于等效拉普拉斯直径的孔尺寸分布,其必然包括孔屏蔽。微分曲线清楚地显示了粗附聚孔结构区域、粒子间孔区域和粒子内孔区域(如果存在的话)。已知粒子内孔直径范围,则可以从总孔体积中减去剩余粒子间和附聚体间孔体积,以给出在每单位质量孔体积(比孔容)方面的单独的内部孔的希望的孔体积。当然,相同的减法原理也适用于分离任何感兴趣的其它孔尺寸区域。
加载有活性剂的经表面反应的碳酸钙粒料的粒子内侵入式比孔容(以cm3/g计)
使用Micromeritics Autopore V 9620汞孔率计,使用汞侵入孔隙率测定法测量结果测量比孔容,所述汞孔率计具有最大施加汞压为414MPa(60 000psi),等效于0.004μm(~nm)的拉普拉斯喉径。在每个压力步骤使用的平衡时间是20秒。将样品材料密封在3cm3室的粉末透度计中用于分析。使用软件Pore-Comp(Gane,P.A.C.,Kettle,J.P.,Matthews,G.P.和Ridgway,C.J.,“Void Space Structure of Compressible Polymer Spheres andConsolidated Calcium Carbonate Paper-Coating Formulations”,Industrial andEngineering Chemistry Research,35(5),1996年,第1753-1764页),针对汞压缩、透度计膨胀和样品材料压缩来校正数据。
累积侵入曲线的第一导数显示粒子内和粒子间孔体积区域在所有情况下均不是独立的和可分离的。因而,为了显示相对于空粒料的加载的样品的孔体积差异,每个样品的孔体积通过获取代表来自经造粒材料的粒子内和粒子间孔体积的总和的侵入体积的针对低于5μm的孔直径的累积侵入曲线来获得。
松散堆密度
120g所选颗粒级分(180μm-710μm)的粒料经由0.5mm筛网借助刷子进行筛分。经由粉末漏斗,将100±0.5g该样品小心地填充至250mL量筒中且以最接近的1mL读取体积。根据下式计算松散堆密度:
松散堆密度[g/mL]=堆体积[mL]/经称重的样品[g]
并且以最接近的0.01g/mL记录结果。
振实密度
120g所选颗粒级分(180μm-710μm)的粒料经由0.5mm筛网借助刷子进行筛分。经由粉末漏斗,将100±0.5g该样品小心地填充至250mL量筒中。该带刻度的筒连接至配备有能够产生振实的沉降设备的支撑物上。该筒固定于该支撑物中并且在1250次振实之后读取体积。随后进行由1250次振实构成的第二振实步骤并且读取体积值。当该第二振实体积值与该第一振实体积值相差不超过2mL时,就是振实体积。当该值相差超过2mL时,重复1250次振实的振实步骤直到在随后的步骤中观测到不超过2mL的差值为止。
静止角
在流动性测试仪中测量静止角。装备有10mm喷嘴的料斗填充有大约150ml粒料。在排空料斗之后,借助激光束测量粒料斜面并且计算静止角。静止角β为图7中所示计算的斜面侧边相对于水平线的角度。
压缩指数
如下计算压缩指数:
压缩指数=(振实密度-堆密度)/振实密度×100
热重分析(TGA)
TGA基本上用于测定矿物样品和填充的有机材料的烧失量。用于测量TGA的设备为Mettler-Toledo TGA/DSC1(TGA 1STARe系统)并且所使用的坩埚为900μl氧化铝。该方法由两个加热步骤构成,第一步骤以20℃/分钟的加热速率在30-130℃之间持续10分钟,并且第二步骤以20℃/分钟的加热速率在130-570℃之间持续20分钟。
2.材料
将经表面反应的碳酸钙(FCC)(来自Omya International AG,瑞士)与微晶纤维素(PH 102,FMC BioPolymer,爱尔兰)进行比较。经表面反应的碳酸钙进一步的细节总结于下表1中:
表1:
选择丁香酚(≥98%,FCC,FG,Sigma Aldrich,W246700,CAS编号97-53-0、EC编号202-589-1)和布洛芬(Shashun Pharmaceuticals有限公司,BP/Ph.Eur.,Cas编号15687-27-1)作为活性成分。
3.造粒实验
通过辊式压实使FCC造粒
使用Fitzpatrick CCS220执行造粒。棒磨机和锉削的1mm筛网用于造粒。参数设定为:
使用具有90、180、250、355、500、710和1000μm的Retsch塔式筛分振动器AS300生产在250-710μm之间的粒料级分。
粒子尺寸分布以及其他参数概述于表2、3和4中。
表2:所制造的空粒料的粒子尺寸分布
用FCC制造的平均PSD粒料(质量级分%) | 粒料尺寸范围(μm) |
0.01 | 0-90 |
3.32 | 90-180 |
18.37 | 180-250 |
17.90 | 250-355 |
18.34 | 355-500 |
36.18 | 500-710 |
5.85 | 710-1 000 |
0.01 | <1 000 |
表3:在250-710μm范围内测量的参数
参数 | 空粒料 |
比表面积(m<sup>2</sup>/g) | 52 |
粒子中值直径(筛分)(d<sub>50</sub>,μm) | 500 |
堆密度(g/mL) | 0.48 |
振实密度(g/mL) | 0.61 |
压缩指数 | 21.31 |
静止角(°) | 47 |
表4:孔体积
参数 | 空粒料 |
截断体积cm<sup>3</sup>/g-直径范围0.004-4.9μm | 0.897 |
利用从加载有丁香酚的FCC粒料获得的粒料制片
从加载丁香酚的FCC获得的粒料进一步在Turbula混合器(Willy A.Bachofen,Turbula T10B)中与0.5%重量的润滑剂(硬脂酸镁,Ligamed MF-2-V,Cas编号557-04-0,Peter Greven)混合5分钟。混合物进一步用于在使用EU1”工具、10mm填充凸轮、8个标准凸圆形10mm冲头以及15000片/小时的制片速度的Fette 1200i中来制备片剂。调节填充深度以获得2、4和6kN的压缩力并且片剂重量固定在175mg。制片参数概述于表5中。
表5.制片参数
构成粒料的FCC的SEM图片显示于图1中。
使用丁香酚加载FCC粒料
将150g FCC粒料(250-710μm)放置在3L塑料烧杯中。使粒料加载16.7g(10%重量)、50g(25%重量)和100g丁香酚(40%重量)的丁香酚(Sigma Aldrich W246700)。丁香酚通过借助于具有两个1.52mm宽的止动管的蠕动泵Ismatec IPC 8以1-2滴/秒的速率进行滴加来加载。在加载时,使用开放式叶片式混合器以80-120rpm的速度范围用顶置式搅拌器IKA RW20持久地混合粒料。在全部液体量被加载至FCC粒料上之后,将经加载的粒料静置以再混合10分钟。
从加载丁香酚的FCC粒料获得的结果概述于表6、7和8中。
表6:所制造的粒料的粒子尺寸分布
表7:在250-710μm范围内测量的参数
表8:孔体积
利用从加载有丁香酚的FCC粒料获得的粒料进行制片
从加载有丁香酚的FCC获得的粒料进一步在Turbula混合器(Willy A.Bachofen,Turbula T10B)中与0.5%重量的润滑剂(硬脂酸镁,Ligamed MF-2-V,Cas编号557-04-0,Peter Greven)混合5分钟。混合物进一步用于在使用EU1”工具、10mm填充凸轮、8个标准凸圆形10mm冲头以及15000片/小时的制片速度的Fette 1200i中来制备片剂。调节填充深度以获得2、4和6kN的压缩力并且片剂重量固定在175mg。制片参数概述于表9中。
表9.制片参数
加载有10%或25%或40%丁香酚的粒料的SEM图片显示于图2、3和4中。
利用布洛芬加载FCC粒料
将150g FCC粒料(250-710μm)放置在3L塑料烧杯中。将粉末用16.7g(10%重量)和100g(40%重量/重量)的布洛芬(BASF)加载。布洛芬首先溶解于分别对应10%重量和40%重量加载量的75g和150g丙酮中。布洛芬丙酮溶液通过在每15秒5次击打的速率下借助喷涂瓶喷涂而加载。在加载时,使用开放式叶片式混合器以80-120rpm的速度用顶置式搅拌器IKA RW20持久地混合粒料。在全部溶液量被加载至FCC粒料上之后,将经加载的粒料静置以再混合10分钟。经加载的粉末在真空烘箱ThermoScientific VT 6130下干燥直到不能再收集到溶剂为止。
从加载布洛芬的FCC粒料获得的结果概述于表10、11和12中。
表10:所制造的粒料的粒子尺寸分布
表11:在250-710μm范围内测量的参数
表12:孔体积
利用获自加载有布洛芬的FCC粒料的粒料进行制片
从加载有丁香酚的FCC获得的粒料进一步在Turbula混合器(Willy A.Bachofen,Turbula T10B)中与0.5%重量的润滑剂(硬脂酸镁,Ligamed MF-2-V,Cas编号557-04-0,Peter Greven)混合5分钟。混合物进一步用于在使用EU1”工具、10mm填充凸轮、8个标准凸圆形10mm冲头以及15000片/小时的制片速度的Fette 1200i中来制备片剂。调节填充深度以获得2、4和6kN的压缩力并且片剂重量固定在175mg。制片参数概述于表13中。
表13.制片参数
加载有10%或40%布洛芬的粒料的SEM图片显示于图5和6中。
Claims (19)
1.生产包含经表面反应的碳酸钙的粒料的方法,包括以下步骤:
a)提供经表面反应的碳酸钙,其中该经表面反应的碳酸钙是天然研磨或沉淀碳酸钙与二氧化碳和一种或多种H3O+离子供体在水性介质中的反应产物,其中该二氧化碳由H3O+离子供体处理原位形成和/或从外部来源供应;
b)借助辊式压实机在1-30kN/cm范围内的压实压力下将步骤a)的该经表面反应的碳酸钙压实成压实形式;
c)将步骤b)的该压实形式磨碎成粒料;
其中步骤b)中获得的该压实形式由步骤a)的该经表面反应的碳酸钙构成。
2.权利要求1的方法,其中该天然研磨碳酸钙选自含碳酸钙的矿物,该矿物选自大理石、白垩、白云石、石灰石及其混合物;或该沉淀碳酸钙选自具有文石、球霰石或方解石矿物学晶型的沉淀碳酸钙及其混合物。
3.根据权利要求1或2中任一项的方法,其中该经表面反应的碳酸钙
a)具有根据ISO 9277使用氮气和BET方法测量的20m2/g-450m2/g、优选20m2/g-250m2/g、更优选30m2/g-160m2/g、最优选40m2/g-150m2/g、进一步更优选40m2/g-140m2/g的BET比表面积;和/或
b)包含具有1μm-50μm、优选1-45μm、更优选2-30μm、甚至更优选3-15μm、且最优选4-12μm的体积中值颗粒直径d50的粒子;和/或
c)具有由汞侵入孔隙率测定法测量结果计算的在0.15-1.35cm3/g、优选0.30-1.30cm3/g、且最优选0.40-1.25cm3/g范围内的粒子内侵入式比孔容。
4.根据权利要求1-3中任一项的方法,其中辊式压实步骤b)在1-28kN/cm范围内、更优选在1-20kN/cm范围内并且最优选在2-10kN/cm范围内的辊式压实压力下进行。
5.根据权利要求1-4中任一项的方法,进一步包括通过至少一种筛目尺寸筛分步骤c)的该粒料的步骤d)。
6.根据权利要求5的方法,其中筛分步骤d)通过在两种或更多种不同的筛目尺寸上筛分来进行,优选利用90μm、180μm、250μm、355μm、500μm和710μm的筛目尺寸来进行。
7.根据权利要求1-6中任一项的方法,进一步包括步骤e1):使在步骤c)和/或如果存在的步骤d)中获得的该粒料与至少一种配制助剂混合。
8.根据权利要求7的方法,其中该至少一种配制助剂选自崩解剂,优选选自改性纤维素胶,不溶性交联聚乙烯吡咯烷酮,乙醇酸淀粉,微晶纤维素,预胶凝化淀粉,羧甲基淀粉钠,低取代羟丙基纤维素,N-乙烯基-2-吡咯烷酮的均聚物,烷基纤维素酯,羟烷基纤维素酯,羧基烷基纤维素酯,藻酸盐,微晶纤维素及其多晶型,离子交换树脂,树胶,甲壳素,壳聚糖,粘土,结冷胶,交联泼拉克林共聚物,琼脂,明胶,糊精,丙烯酸聚合物,羧甲基纤维素钠/钙,邻苯二甲酸羟丙基甲基纤维素,虫胶或其混合物,润滑剂,尤其是相内润滑剂和/或相外润滑剂,抗冲改性剂,增塑剂,蜡,稳定剂,颜料,着色剂,香味剂,味觉掩蔽剂,调味剂,甜味剂,口感改良剂,稀释剂,成膜剂,粘合剂,缓冲剂,吸附剂,气味掩蔽剂及其混合物。
9.根据权利要求1-8中任一项的方法,进一步包括步骤e2):利用至少一种活性成分和/或其非活性前体加载在步骤b)中获得的该压实形式或者在步骤c)或者如果存在的步骤d)中获得的该粒料以用于获得经加载的粒料。
10.根据权利要求9的方法,其中该至少一种活性成分和/或其非活性前体选自日用化妆香精,食用香精,草本提取物,水果提取物,营养剂,痕量矿物,防护剂,食品,化妆品,阻燃剂,酶,大分子,杀虫剂,肥料,防腐剂,抗氧化剂,反应性化学品,合成来源、半合成来源、天然来源的药物活性剂或者其药物非活性前体,及其混合物。
11.根据权利要求9或10的方法,其中该至少一种活性成分和/或其非活性前体呈液体形式,优选该至少一种活性成分和/或其非活性前体在溶剂中提供,优选该溶剂选自水、甲醇、乙醇、正丁醇、异丙醇、正丙醇、正辛醇、丙酮、二甲基亚砜、二甲基甲酰胺、四氢呋喃、植物油及其衍生物、动物油及其衍生物、熔融脂肪和蜡,及其混合物,并且更优选该溶剂为水、乙醇和/或丙酮。
12.根据权利要求9-11中任一项的方法,其中加载步骤e2)通过将该至少一种活性成分和/或其非活性前体喷涂或滴加到在步骤b)中获得的该压实形式或者在步骤c)或如果存在的步骤d)中获得的该粒料上并且在选自流化床干燥机/造粒机、犁铧式混合器、立式或卧式混合器、高或低剪切混合器以及高速掺合机的装置中混合来进行。
13.根据权利要求9-12中任一项的方法,进一步包括最终步骤f):将步骤e2)中获得的该经加载的粒料制片或者将步骤e2)中获得的该经加载的粒料填充至胶囊中。
14.粒料,其由根据在权利要求1-3中任一项所定义的经表面反应的碳酸钙构成并且任选地与根据在权利要求8中所定义的至少一种配制助剂混合和/或加载有根据在权利要求10中所定义的至少一种活性成分和/或其非活性前体。
15.通过根据权利要求13的方法获得的片剂和/或胶囊。
16.包含权利要求14的粒料的剂型,优选片剂、迷你片剂或胶囊。
17.权利要求14的粒料或者权利要求15的片剂和/或胶囊或者权利要求16的剂型在药物、营养物、农业、化妆品、家用、食品、包装和个人护理产品中的用途。
18.药物、营养物、农业、化妆品、家用、食品、包装和个人护理产品,其包含权利要求14的粒料或者权利要求15的片剂和/或胶囊或者权利要求16的剂型。
19.在权利要求1-3中任一项所定义的经表面反应的碳酸钙在根据权利要求1-13中任一项的方法中的用途。
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JP2019201629A (ja) * | 2018-05-17 | 2019-11-28 | 大正製薬株式会社 | 固形物 |
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EP4171515A1 (en) * | 2020-06-25 | 2023-05-03 | Omya International AG | Co-ground active(s) comprising product comprising surface-reacted calcium carbonate |
KR102553710B1 (ko) * | 2022-11-18 | 2023-07-11 | 고덕상 | 미네랄 촉매제를 이용한 가축사료 제조방법 |
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EP3471704B1 (en) | 2022-09-07 |
US20190183801A1 (en) | 2019-06-20 |
RU2019100989A3 (zh) | 2020-09-10 |
TW201803553A (zh) | 2018-02-01 |
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US11369571B2 (en) | 2022-06-28 |
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