CN108472262A - 具有奥美拉唑或泮托拉唑的口服配制品 - Google Patents
具有奥美拉唑或泮托拉唑的口服配制品 Download PDFInfo
- Publication number
- CN108472262A CN108472262A CN201580085732.8A CN201580085732A CN108472262A CN 108472262 A CN108472262 A CN 108472262A CN 201580085732 A CN201580085732 A CN 201580085732A CN 108472262 A CN108472262 A CN 108472262A
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- Prior art keywords
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- omeprazole
- pantoprazole
- drug
- eriodictyonone
- Prior art date
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- 229960000381 omeprazole Drugs 0.000 title claims abstract description 42
- IQPSEEYGBUAQFF-UHFFFAOYSA-N Pantoprazole Chemical compound COC1=CC=NC(CS(=O)C=2NC3=CC=C(OC(F)F)C=C3N=2)=C1OC IQPSEEYGBUAQFF-UHFFFAOYSA-N 0.000 title claims abstract description 30
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
- A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
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- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
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Abstract
提出一种配制品,所述配制品包含(a)奥美拉唑和/或泮托拉唑和(b)圣草酚和/或高圣草酚。
Description
技术领域
本发明涉及药物有效物质领域并且涉及具有以改良的盖仑制剂的奥美拉唑或泮托拉唑的成份口服配制品。
背景技术
奥美拉唑或泮托拉唑是出自质子泵抑制剂的药品,所述质子泵抑制剂用于治疗胃溃疡和十二指肠溃疡以及反流性食管炎。最重要的适应症是:
●治疗十二指肠溃疡(Ulcus duodeni);
●治疗胃溃疡(Ulcus ventriculi);
●治疗由于胃液反流引起的食管炎症(反流性食管炎);
●治疗由于胃酸反流到食管中引起的症状(胃食管反流病,胃灼热)
●治疗卓-艾氏综合症(胃泌素瘤)
●预防由于摄入特定的止痛剂或风湿病药剂(所谓的非甾体类消炎药)造成的食管炎症或胃溃疡和十二指肠溃疡的复发,以及
●幽门螺旋杆菌感染的组合疗法。
奥美拉唑和泮托拉唑的施用通常作为片剂或胶囊进行,少有也通过输液溶液施用。
缺点是:奥美拉唑和泮托拉唑具有浓厚的苦味,中和、掩盖或抑制所述苦味迄今是不可行的。口味的缺陷使口服不舒适,这导致患者经常放弃定期服用药物。
发明内容
因此,本发明的目的是在于,提供具有奥美拉唑或泮托拉唑的配制品,所述配制品不含所述缺点并且尤其特征在于中性的味道。另一子目的在于:通过改善的胃酸耐受性来改善奥美拉唑和泮托拉唑的生物利用度。
本发明的第一主题涉及一种配制品,所述配制品包含
(a)奥美拉唑和/或泮托拉唑和
(b)圣草酚和/或高圣草酚。
令人惊讶地发现:圣草酚和/或高圣草酚突出地适合用于遮盖或掩盖奥美拉唑或泮托拉唑的苦味。尤其共同使用将苦味减少了大约一半。还发现:组分(a)和组分(b)的混合物比单独的奥美拉唑或泮托拉唑具有更高的胃酸耐受性。于是,通过添加奥美拉唑或泮托拉唑与一种或两种添加剂也能够改善其生物利用度。
奥美拉唑
将合成词奥美拉唑应理解为物质(RS)-5-甲氧基-2-[(4-甲氧基-3,5-二甲基-2-吡啶基)甲基亚磺酰基]-1H-苯并咪唑(I)
奥美拉唑是第一种引入到治疗中的质子泵抑制剂并且90年代被批准作为耐受良好的胃药。自1998年以来,奥美拉唑也作为多装置丸剂系统(MUPS)出售。这些片剂是由小的、耐胃酸包衣的小丸构成的压缩片,所述压缩片在与液体接触时迅速分解。自2000年以来,奥美拉唑的(S)-对映异构体(埃索美拉唑,)已市售。埃索美拉唑经由CYP2A19增殖从而比消旋的奥美拉唑代谢更慢,那么与消旋体对比,产生减慢的血浆水平降低并且从而更好的生物利用度。最新的创新产品是美国Santarus公司的奥美拉唑碳酸氢钠制剂()。所述奥美拉唑碳酸氢钠制剂不需要耐胃酸包衣并且实现附加的施药形式,所述施药形式还应当尤其快速地释放有效物质。自2004年以来,美国市场上出售口服悬浮液,2006年批准了胶囊,预计很快就会批准咀嚼片剂。就本发明涉及的奥美拉唑而言,因此,包括全部上述异构体和盖仑制剂形式。
泮托拉唑((RS)-5-(二氟甲氧基)-2-[(3,4-二甲氧基-2-吡啶基)甲基亚磺酰基]苯并咪唑)(II)同样是质子泵抑制剂,并且是奥美拉唑的结构上密切相关的衍生物。泮托拉唑具有与奥美拉唑相同的适应症并且以非常相似或相同的施药形式给药。
因为奥美拉唑和泮托拉唑仅在碱性至中性的环境中稳定,所以有效物质经常使用在片剂或胶囊中,所述片剂或胶囊设有耐酸包衣,使得只有在小肠中才溶解而在结肠的酸性环境中不溶解。替选地,物质也能够应用于在口服摄入时碱性微环境中产生的碱性载体。
圣草酚和高圣草酚
在下列图片中示出的圣草酚2-(3,4-二羟基苯基)-5,7-二羟基-4-苯并二氢吡喃酮)和高圣草酚5-7-十二羟基-2-(4-羟基-3-甲氧基苯基)-4-苯并二氢吡喃-4-酮属于黄烷酮并且例如在圣草属亚种的北美圣草中作为有效物质发现(参见)。根据本发明,圣草酚和高圣草酚能够分别单独地或以混合物形式使用,其中黄烷酮能够用作0.1 2S:100 2R至0.12R:100 2R的对映异构体混合物,用作纯的对映异构体,或优选用作外35 2S:65 2R至652R:35 2S、尤其优选45 2S:55 2R至55 2R:45 2S的外消旋的(50:50)的或近似外消旋的混合物。在此,两种黄烷酮中的每种本身也能够完全或部分地呈盐,优选与钠、钾、钙、镁和铵的一价盐或二价盐形式存在。在此,尤其优选的是45 2S:55 2R至55 2R:45 2S的对映异构体比例的高圣草酚和/或45 2S:55 2R至55 2R:45 2S的对映异构体比例的高圣草酚-单钠盐和/或45 2S:55 2R至55 2R:45 2S的对映异构体比例的圣草酚。
口服配制品
根据本发明的口服配制品包含优选在大约4:1至400:1并且尤其大约8:1至200:1的重量比例的组分(a)和组分(b)。在此,组分(a)包含优选1000ppm至大约30000ppm,尤其大约2000ppm至20000ppm的量的奥美拉唑或泮托拉唑。还优选的是,口服配制品包含大约50ppm至大约500ppm并且尤其大约100ppm至大约200ppm的量的组分(b)圣草酚和/或高圣草酚。关于掩盖苦味方面,圣草酚和高圣草酚共同使用,更确切地说,尤其分别以大约25ppm至大约250ppm并且优选大约50ppm至大约150ppm的量使用被证明为尤其有利的。
如开始时所述的,奥美拉唑或泮托拉唑的口服施药形式能够以液体形式存在。然而,优选的盖仑制剂形式是口服施药形式,尤其口服固体或液体施药形式,并且例如能够包括呈溶液,悬浮液,乳液,吞咽粉末,咀嚼片剂,压缩片剂,胶囊,包衣片剂,吮吸糖果,耐嚼糖果,果胶或药用口香糖的形式。如果实施方式是固体的,那么如上所述,所述奥美拉唑或泮托拉唑优选具有耐酸包衣(在片剂的情况下)或外壳(在胶囊的情况下)。
片剂
根据本发明的口服配制品也能够是片剂。片剂能够包含用于该施药形式其他常用的组成部分,例如是:载体材料、分裂剂和/或着色剂和调味物质。制片本身是充分已知的产业规模的方法。示例性参见DE 10 2006 051529 A1(HENKEL),其中详细描述片剂的制造。
载体材料
合适的载体材料能够细分为填充剂和接合剂。填充剂负责片剂获得必需的尺寸/质量。使用淀粉(玉米淀粉,马铃薯淀粉和小麦淀粉)和乳糖。其他填充剂是:葡萄糖,甘露醇,山梨糖醇。由于其高的价格,果糖很少使用。蔗糖主要用于吮吸片剂。
相反,接合剂负责在颗粒或粉末中的粘着并且除压制压力之外负责片剂的强度。所述接合剂分为干接合剂,例如MCC(微晶纤维素)或淀粉,和湿接合剂/粘接剂以用于制粒,例如淀粉糨糊、纤维素醚、聚乙烯吡咯烷酮和明胶。
分裂剂
为了使预制的成型体的分解更容易,可行的是:将崩解助剂、所谓的片剂分裂剂添加到该药剂中,以便缩短分解时间。片剂分裂剂或分解加速剂应理解为负责片剂在水或其他介质中迅速分解并且有效物质顺利释放的助剂。
由于其作用也称作“分裂”剂的这些物质在水透过时其体积增大,其中一方面固有体积增大(膨胀),另一方面经由气体释放也能够产生压力,所述压力能够使片剂分解成更小的颗粒。众所周知的崩解助剂例如是碳酸盐/柠檬酸体系,其中也能够使用其他有机酸。膨胀的崩解助剂例如是合成的聚合物,如聚维酮(PVP),或天然的聚合物,或改性的天然材料,如纤维素和淀粉和其衍生物,藻酸盐或干酪素的衍生物。
基于纤维素的崩解剂用作优选的崩解剂。纯的纤维素具有化学式总组成(C6H10O5)n并且形式上看作是纤维二糖的β-1,4-聚乙酸盐,所述聚乙酸盐就其而言由两分子的葡萄糖构成。在此,适合的纤维素由大约500个至5000个葡萄糖单元构成,并且因此具有50000至500000的平均摩尔质量。在本发明的范围中,通过从纤维素中聚合物类似的反应获得的纤维素衍生物也能用作基于纤维素的崩解剂。在此,这种化学改性的纤维素例如包括酯化或醚化的产物,在所述酯化或醚化中羟基基团被氢原子取代。但如下纤维素也能够用作纤维素衍生物,在所述纤维素中羟基基团被不经由氧原子结合的官能团替代。例如,碱金属纤维素、羧甲基纤维素(CMC)、纤维素酯和纤维素醚以及氨基纤维素属于纤维素衍生物的组。所述纤维素衍生物优选不单独用作基于纤维素的崩解剂,而是以与纤维素的混合物形式使用。按基于纤维素的崩解剂计,所述混合物中的纤维素衍生物的含量优选在50重量%之下,尤其优选在20重量%之下。不含纤维素衍生物的纯的纤维素尤其优选用作基于纤维素的崩解剂。
用作崩解剂的纤维素优选不以细碎的形式使用,而是在添加到待压制的预混物之前转化成较粗糙的形式,例如制粒或压实。这样的崩解剂的粒径大多在200μm之上,优选至少90重量%在300μm和1600μm之间并且尤其至少90重量%在400μm和1200μm之间。
微晶纤维素能够用作基于纤维素的其他分解剂或该组分的组成部分。该微晶纤维素通过纤维素在如下条件下部分水解获得,所述条件仅侵蚀并且完全溶解纤维素的无定形区域(大约30%的总纤维素质量),但所述条件能够使结晶区域(大约70%)无损。通过水解产生的微细的纤维素的紧接着的解聚提供微晶纤维素,所述微晶纤维素具有大约5μm的一次粒径并且例如能压缩成具有200μm的中等粒径的颗粒。
此外,根据本发明,优选能够使用形成气体的泡腾体系。形成气体的泡腾体系能够由唯一的物质构成,所述物质在与水接触时释放气体。该化合物尤其能够指的是过氧化镁,所述过氧化镁在与水接触时释放氧气。然而,释放气体的泡腾体系就其而言通常由至少两种组成部分构成,所述组分彼此反应形成气体。在此能够考虑和实施大量例如释放氮气、氧气或氢气的体系,而根据经济和环境角度能够选择在洗涤剂和清洁剂中使用的泡腾体系。优选的泡腾体系由碱金属碳酸盐和/或碱金属碳酸氢盐以及酸化剂构成,所述酸化剂适合于从水溶液中的碱金属盐中释放二氧化碳。
着色剂
食用着色剂或简称着色剂是对适合于食用的配置品着色的食品添加剂。着色剂划分为天然的着色剂和合成的着色剂。天然等同的着色剂同样是合成的来源。天然等同的着色剂是自然界中存在的着色物质的合成的仿制品。适合在当前的组合物中使用的着色剂选自:姜黄素,E 100核黄素,乳黄素,乳黄素,维生素B2,E 101酒石黄,E 102喹啉黄,E 104日落黄S,日落黄RGL,E 110胭脂红,胭脂红酸,真胭脂红,E 120偶氮玉红,淡红,E 122苋菜红,E 123胭脂红A,丽春红4R,维多利亚猩红4R,E124赤藓红,E127诱惑红AC,E129专利蓝V,E131靛蓝,靛蓝胭脂红,E 132亮蓝FCF,专利蓝AE,酰胺蓝AE,E 133叶绿素,叶绿酸,E 140叶绿素的铜络合物,叶绿酸铜络合物,E 141亮酸绿,绿色S,E 142焦糖色,焦糖色,E 150a亚硫酸盐黑液-焦糖色(Sulfitlaugen-),E 150b氨法-焦糖色,E 150c亚硫酸铵法-焦糖色,E 150d亮黑FCF,亮黑PN,黑色PN,E 151植物炭,E 153棕色FK,E 154棕色HT,E155胡萝卜素,胡萝卜素,E 160a胭脂树红,胭脂树橙,降红木素,E 160b辣椒黄素,辣椒红素,E160c番茄红素,E 160dβ-阿朴-8’-胡萝卜醇,阿朴胡萝卜醇,β-胡萝卜醇,E 160eβ-阿朴-8’-胡萝卜酸乙酯(C30),阿朴胡萝卜酸酯,β-胡萝卜酸酯,E 160f叶黄素,叶黄质,E 161b角黄素,E161g甜菜碱,甜菜根,E 162花青素,E 163碳酸钙,E 170二氧化钛,E 171氧化铁,氢氧化铁,E 172铝,E 173银,E 174金,E 175立素玉红BK,红宝石着色剂BK,E 180。
调味物质
根据本发明的配制品能够包含一种或多种调味物质;调味物质通过例如欧洲或美国的司法限定,欧洲议会和理事会第(EC)2232/96号条例以及委员会实施条例(EU)872/2012号中定义的肯定列表。典型的实例包括:苯乙酮,烯丙基卡普伦,α-紫罗兰酮,β-紫罗兰酮,茴香醛,茴香基乙酸酯,茴香酰亚胺,苯甲醛,苯并噻唑,苄基乙酸酯,苄基醇,苄基安息香,β-紫罗兰酮,丁基丁酸,丁基卡普罗,丁苯酞,香芹酮,莰烯,石竹烯,桉树脑,肉桂乙酸乙酯,柠檬醛,香茅醇,香茅醛,乙酸香茅酯,乙酸环己酯,对聚伞花素,突厥酮,癸内酯,二氢苦参碱,二甲基蒽苯胺,二甲基蒽苯胺,十二内酯,乙氧基乙基乙酯,乙基丁酸,丁酸乙酯,辛酸乙酯,己酸乙酯,巴豆酸乙酯,乙基呋喃酮,乙基愈创木酚,异丁酸乙酯,异戊酸乙酯,乳酸乙酯,甲基丁酸乙酯,丙酸乙酯,桉叶脑,丁香酚,庚酸乙酯,4-(对羟基苯基)-2-丁酮,γ-癸内酯,香叶醇,乙酸香叶酯,乙酸香叶酯,葡萄柚醛,二氢茉莉酮酸甲酯(例如),胡椒醛,2-庚酮,3-庚酮,4-庚酮,反式-2-庚烯醛,顺式-4-庚烯醛,反式-2-己烯醛,顺式-3-己烯醇,反式-2-己烯酸,反式-3-己烯酸,顺式-2-乙酸叶醇酯,顺式-3-乙酸叶醇酯,顺式-3-辛酸己烯酯,反式-2-辛酸己烯酯,顺式-3-己烯醇甲酸酯,顺式-2-乙酸己酯,顺式-3-乙酸己酯,反式-2-乙酸己酯,顺式-3-甲酸己酯,对位-羟基苄基丙酮,异戊丁醇,异戊酸异戊酯,异丁基丁酸,异丁醛,异丁香甲醚,异丙基甲基噻唑,月桂酸,乙酰丙酸,芳樟醇,氧化芳樟醇,乙酸芳樟酯,薄荷脑,薄荷呋喃,邻氨基苯甲酸甲酯,甲基丁醇,甲基丁酸,2-甲基丁酸酯,己酸甲酯,肉桂酸甲酯,5-甲基糠醛,3,2,2-甲基环戊烯醇酮,6,5,2-甲基庚烯酮,二氢茉莉酮酸甲酯,茉莉酮酸甲酯,丁酸2-甲基丁酯,2-甲基-2-戊烯酸,硫代丁酸甲酯,3,1-甲基硫代己醇,3-(甲硫基)己醇乙酸酯,香橙醇,烯丙基乙酸酯,反式,反式-2,4-壬二烯醛,2,4-壬二烯醇,2,6-壬二烯醇,2,4-壬二烯醇,诺卡酮,δ-辛内酯,γ-辛内酯,2-辛醇,3-辛醇,1,3-辛烯醇,1-乙酸辛酯,3-乙酸辛酯,棕榈酸,三聚乙醛,水芹烯,戊二酮,乙酸苯乙酯,苯乙醇,苯乙醇,苯乙基异戊酸酯,胡椒醛,正丙醛,丁酸丙酯,胡薄荷酮,长叶薄荷醇,香橙醛,硫噻唑,萜品烯,萜品油烯,萜品醇,8,3-硫代薄荷酮,4,4,2-硫甲基戊聚糖,麝香草酚,δ-十一内酯,γ-十一内酯,缬草烯,缬草酸,香草醛,乙偶姻,乙基香草醛,异丁酸乙基香兰酯(=3-乙氧基-4-异丁甲氧基苯甲醛),2,5-二甲基-4-羟基-3(2H)-呋喃酮和其衍生物(在此优选环高呋喃酮(=2-乙基-4-羟基-5-甲基-3(2H)-呋喃酮),高呋喃酚(=2-乙基-5-甲基-4-羟基-3(2H)-呋喃酮和5-乙基-2-甲基-4-羟基-3(2H)-呋喃酮),麦芽酚和麦芽酚衍生物(在此优选乙基麦芽酚),香豆素和香豆素衍生物,γ-内酯(在此优选γ-十一内酯,γ-壬内酯,γ-癸内酯),δ-内酯(在此优选4-δ-甲基癸内酯,二氢戊基吡喃,δ-癸内酯,马铃薯内酯),山梨酸甲酯,双香草醛,4-羟基-2(或5)-乙基-5(或2)-甲基-3(2H)-呋喃酮,2-羟基-3-甲基-2-环戊烯酮,3-羟基-4,5-二甲基-2(5H)-呋喃酮,乙酸异戊酯,丁酸乙酯,丁酸丁酯,丁酸异戊酯,3-甲基-丁酸乙酯,正己酸乙酯,正己酸正丁酯,正辛酸乙酯,正辛酸异戊酯,乙基-3-甲基-3-苯基缩水甘油酯,乙基-2-反式-4-顺式-癸二烯酸酯,4-(对羟基苯基)-2-丁酮,1,1-二甲氧基-2,2,5-三甲基-4-己烷,2,6-二甲基-5-庚烯-1-醛和苯乙醛,2-甲基-3-(甲基硫代)呋喃,2-甲基-3-呋喃硫醇,双(2-甲基-3-呋喃基)二硫,糠基硫醇,甲硫基丙醛,2-乙酰基-2-噻唑啉,3-疏基-2-戊酮,2,5-二甲基-3-呋喃硫醇,2,4,5-三甲基噻唑,2-乙酰噻唑,2,4-二甲基-5-乙基噻唑,2-乙酰基-1-吡咯啉,2-甲基-3-乙基吡嗪,2-乙基-3,5-二甲基吡嗪,2-乙基-3,6-二甲基吡嗪,2,3-二乙基-5-甲基吡嗪,3-氯丙基-2-甲氧基吡嗪,3-异丁基-2-甲氧基吡嗪,2-乙酰吡嗪,2-戊基吡啶,(E,E)-2,4-癸二烯醛,(E,E)-2,4-壬二烯醛,(E)-2-辛烯醛,(E)-2-丙烯醛,2-十一碳烯醛,12-甲基十三醛,1-戊烯-3-酮,4-羟基-2,5-二甲基-3(2H)-呋喃酮,愈创木酚,3-羟基-4,5-二甲基-2(5H)-呋喃酮,3-羟基-4-甲基-5-乙基-2(5H)-呋喃酮,齐达罗醛,肉桂醇,水杨酸甲酯,异胡薄荷醇以及(在此未明确提及)这些物质的立体异构体,对映异构体,位置异构体,非对映异构体,顺式/反式-同分异构体或差向异构体。
调味物质也能够直接影响味道(味道调节剂)并且所述调味物质例如选自:谷氨酸钠,游离谷氨酸,核苷酸或其药学上可接受的盐,如JP 2007 110988 A中所述的斯插宾,茶皂素,如EP 1291342 B1中所述的吡啶-甜菜碱化合物,如WO 2002 087361 A1中所述的谷氨酸糖苷,如WO 2006 003107 A1中所述的苹果酸糖苷,如EP 0181421或WO 2007 042273 A1中所述的谷胱甘肽衍生物,烷基吡啶(优选如WO 2009 122318 A1和WO 2009 1223319 A1中所述的烷基吡啶),尤其2-己基吡啶,2-庚基吡啶和2-辛基吡啶,(2E,6Z)-N-环丙基-2,6-壬二烯酰胺,(2E,6Z)-N-乙基-2,6-壬二烯酰胺,N-[(2E)-3,7-二甲基-2,6-辛二烯基]环丙烷甲酰胺,N’-[(2-甲氧基-4-甲基苯基)甲基]-N-[2-(5-甲基-2-吡啶基)乙基]草酰胺,N'-[(2,4-二甲氧基苯基)甲基]-N-[2-(2-吡啶基)乙基]乙酰胺,N'-[(2-甲氧基-4-甲基-苯基)甲基]-N-[2-(2-吡啶基)乙基]草酰胺,N-(1-丙基丁基)-1,3-苯并二氧杂环戊烯-5-碳-草酰胺,1-(2-羟基-4-异丁氧基-苯基)-3-(2-吡啶基)丙-1-酮和1-(2-羟基-4-甲氧基-苯基)-3-(2-吡啶基)丙-1-酮,如EP 2,529,632-B1或WO 2013 000,673中所述的肉桂酸酰胺,降甜剂,根据EP 1909599 A1的橙皮素,根据EP 1972203 B1或EP 1998636 B1的根皮素,根据US 2010 292175 AA的羟基黄烷,根据EP 1972203 B1的4-羟基查耳酮,根据EP 2298084A2的、基于绣球花的提取物,或悬钩子亚种;乳清蛋白与卵磷脂的混合物,酵母提取物,植物水解产物,粉状蔬菜(例如洋葱粉,番茄粉),植物提取物(例如独活草或蘑菇例如香菇)的植物提取物,海藻和矿物盐混合物,尤其是根据US 2009 214728 AA的矿物盐混合物,根据EP2,529,632-B1的鲁米香胺或冬凌草甲素的混合物。
口香糖
根据本发明的口服配制品也能够是口香糖。该产品典型地包含不溶于水的组分和溶于水的组分。
也称作“胶基”的不溶于水的基底通常包括天然的弹性体或合成的弹性体,树脂,脂肪和油,增塑剂,填充材料,着色剂以及可能的蜡。基底占总组合物的份额通常共计5重量%至95重量%,优选10重量%至50重量%并且尤其20重量%至35重量%。在本发明的典型的设计方案中,基底由20重量%至60重量%的合成的弹性体,0重量%至30重量%的天然的弹性体,5重量%至55重量%的增塑剂,4重量%至35重量%的填充材料和次要量的添加剂,如着色剂,抗氧化剂等组成,附带条件是:所述添加剂至多少量溶于水。
例如,作为适合的合成的弹性体的例如是:具有(根据GPC)10000至100000并且优选50000至80000的平均分子量的聚异丁烯,异丁烯-异戊二烯共聚物(“丁基弹性体”),苯乙烯-丁二烯共聚物(苯乙烯:丁二烯比率例如为1:3至3:1),具有(根据GPC)2000至90000并且优选10000至65000的平均分子量的聚乙酸乙烯酯,聚异戊二烯,聚乙烯,乙酸乙烯酯-月桂酸乙烯酯共聚物和其混合物。适合的天然的弹性体的实例是橡胶,例如烟熏的或液体的乳胶或银菊胶以及天然橡胶物质,如节路顿胶,乐驰卡斯皮,佩里洛,香豆胶,巴拉塔树胶,巧克力铁线子,蔡克铁线子,Rosindinba,糖胶树胶,古塔胶以及其混合物。合成的弹性体和天然的弹性体以及其混合比例的选择基本上取决于:是否应借助口香糖产生气泡(“泡泡糖”)。优选使用如下弹性体混合物,所述弹性体混合物包含节路顿胶,糖胶树胶,香豆胶和巴拉塔树胶。
在多数情况下,弹性体在加工中被证实为太硬或可变形太小,使得证实为有利的是:共同使用专用的增塑剂,当然,所述增塑剂尤其也必须满足对于许可作为食品添加剂的全部要求。在这方面,首先考虑树脂酸的酯,例如低级脂肪醇或多元醇与完全或部分硬化的、单体的或低聚物的树脂酸的醇。尤其,将甲基酯,甘油酯,或季戊四醇酯以及其混合物用于该目的。替选地,也考虑萜烯树脂,所述萜烯树脂能够由α-蒎烯,β-蒎烯,δ-柠檬萜或其混合物派生。
碳酸镁或碳酸钙,研磨的浮石,硅酸盐,特别是硅酸镁或硅酸铝,粘土,氧化铝,滑石,二氧化钛,磷酸一钙,磷酸二钙和磷酸三钙,以及纤维素聚合物考虑作为填充材料或纹理剂。
合适的乳化剂是牛脂,硬化的牛脂,硬化的或部分硬化的植物油,可可脂,偏甘油酯,卵磷脂,甘油三乙酸酯和具有6个至22个并且优选12个至18个碳原子的饱和脂肪酸或不饱和脂肪酸以及其混合物。
例如许可用于食品着色的FD和C类型,植物提取物和水果提取物以及二氧化钛考虑作为着色剂和增白剂。
基底物质能够包含蜡或是不含蜡的;此外,在专利文献US 5,286,500中存在不含蜡的组合物的实例,其内容借此明确作为参引并入本文。除不溶于水的橡胶基底之外,口香糖配制品常常包含溶于水的部分,所述部分例如由增塑剂,甜味剂,填充材料,调味料,增味剂,乳化剂,着色剂,酸化剂,抗氧化剂等形成,在此附带条件是:组成部分具有至少足够的水溶性。根据特定代表的水溶性,因此,各个组成部份能够属于不溶于水的相和溶于水的相。然而,也可行的是:使用例如溶于水的乳化剂和不溶于水的乳化剂的组合,其中各个代表于是存在于不同的相中。通常不溶于水的份额共计配置品的5重量%至95重量%并且优选20重量%至80重量%。
溶于水的增塑剂添加给口香糖配置品,以便改善咀嚼性和咀嚼感,并且典型地以0.5重量%至15重量%的量添加到混合物中。典型的实例是甘油,卵磷脂以及山梨醇、硬化淀粉水解物或玉米糖浆的水溶液。
含糖的化合物和不含糖的化合物考虑作为甜味剂,所述化合物以按口香糖组合物计占5重量%至95重量%,优选20重量%至80重量%并且尤其30重量%至60重量%的量使用。典型的糖类甜味剂是蔗糖,右旋糖,麦芽糖,糊精,干燥的转化糖,果糖,左旋糖,半乳糖,玉米糖浆及其混合物。山梨醇,甘露糖醇,木糖醇,硬化淀粉水解产物,麦芽糖醇及其混合物考虑作为糖替代品。此外,也考虑所谓的HIAS(“高强度人造甜味剂”),例如三氯蔗糖,阿斯巴甜,乙酰磺胺酸盐,阿力甜,糖精和糖精盐,环拉酸及其盐,甘草甜素,二氢查尔酮,索马甜,莫尼糖蛋白等单独地或以混合物形式作为添加剂。尤其有效的是为国际专利申请WO2002 091849 A1(Wrigleys)的主题的疏水性HIAS和甜叶菊提取物及其活性的组成部分,特别是莱鲍迪苷A。这些物质的使用量主要与它们的性能相关并且典型地在0.02重量%至8重量%的范围中。
填充材料例如聚葡萄糖,果寡糖,Rafitilin,低聚果糖(NutraFlora),帕拉金糖寡糖,瓜尔胶水解物(Sun Fiber)以及糊精尤其适用于制造低卡路里口香糖。
其他调味料的选择实际上不受限并且对于本发明的本质不是关键性的。通常全部调味料的总份额按口香糖组合物计占0.1重量%至15重量%并且优选0.2重量%至5重量%。适合的其他调味料例如是精油,合成的香精等,例如欧茴香油,八角茴香油,香芹籽油,桉树油,茴香油,柠檬油,冬青油,丁香油等,如所述调味料也例如在口腔护理剂和牙齿护理剂中应用。
胶囊
胶囊应理解为球形的聚集体,所述聚集体包含至少一个固体的或液体的芯,所述芯被至少一个连续的外壳包围,所述胶囊能够包含根据本发明的配制品。有效物质能够被包衣材料包封并且在此作为具有大约0.5mm至大约15mm的直径的大胶囊或具有大约0.0001mm至大约0.5mm的直径的微胶囊存在。
包衣材料
在此,合适的包衣材料例如是淀粉,包括其降解产物以及以化学或物理方式产生的衍生物(尤其糊精和麦芽糊精),明胶,阿拉伯胶,琼脂,茄替胶,结冷胶,改性的纤维素和未改性的纤维素,支链淀粉,凝胶多糖,角叉菜胶,海藻酸,藻酸盐,果胶,菊粉,黄原胶和这些物质中的两种或多种的混合物。
固体的包封材料优选是明胶(尤其猪明胶,牛明胶,家禽明胶和/或鱼明胶),其中所述明胶优选具有大于或等于20,优选大于或等于24的阈值因子。在这些物质中,明胶是尤其优选的,因为所述明胶容易获得并且能够以不同的阈值因素获得所述明胶。
同样优选的是(尤其基于谷物,特别是玉米,小麦,木薯或马铃薯的)麦芽糊精,所述麦芽糊精优选具有在10至20的范围中的DE值。还优选的是纤维素(例如纤维素醚),藻酸盐(例如藻酸钠),角叉菜胶(例如β-角叉胶,ι-角叉胶,λ-角叉胶和/或κ-角叉菜胶),阿拉伯树胶,凝胶多糖和/或琼脂。
同样优选的是藻酸盐胶囊,如所述藻酸盐胶囊例如在下列文献中详细描述:EP0389700 A1,US 4,251,195,US 6,214,376,WO 2003 055587或WO 2004 050069 A1。
在另一优选的实施方式中,胶囊的外壳由凝聚产物构成,所述凝聚产物由阳离子单体或生物聚合物(例如壳聚糖)和阴离子单体,例如(甲基)丙烯酸酯或藻酸盐构成。
包封方法
胶囊一般是用成膜的聚合物包封精细分散的液相或固相,在其制造时,聚合物在乳化和凝聚或界面聚合之后沉积在待包封的材料上。根据另一方法,熔化的蜡被吸收到基体(“微海绵”)中,所述基体能够附加地用成膜的聚合物包封作为微颗粒。根据第三方法,颗粒用不同电荷的聚电解质交替覆层(“逐层”方法)。微小的胶囊能够如粉末那样干燥。除单核的微胶囊之外,多核的聚集体、也叫做微球也是已知的,所述微球包含分布在连续的外壳材料中的两个或多个核。单核微胶囊或多核微胶囊还能够被附加的第二、第三外壳等包围。外壳能够由天然的、半合成的或合成的材料构成。天然的外壳材料例如是阿拉伯树胶,琼脂,琼脂糖,麦芽糊精,海藻酸或其盐,例如藻酸钠或藻酸钙,脂肪和脂肪酸,鲸蜡醇,胶原蛋白,壳聚糖,卵磷脂,明胶,白蛋白,虫胶,多糖如淀粉或葡聚糖,多肽,蛋白质水解物,蔗糖和蜡。半合成的外壳材料还是化学改性的纤维素,尤其纤维素酯和纤维素醚,例如乙酸纤维素,乙基纤维素,羟丙基纤维素,羟丙基甲基纤维素和羧甲基纤维素,以及淀粉衍生物,尤其淀粉醚和淀粉酯。合成的外壳材料例如是聚合物,如聚丙烯酸酯,聚酰胺,聚乙烯醇或聚乙烯吡咯烷酮。
现有技术的微胶囊的实例是下列商品(在括号中分别说明外壳材料):HallcrestMicrocapsules(明胶,阿拉伯胶),Coletica Thalaspheres(海洋胶原),LipotecMillicapsules(海藻酸,琼脂琼脂),Induchem Unispheres(乳糖,微晶纤维素,羟丙基甲基纤维素);Unicerin C30(乳糖,微晶纤维素,羟丙基甲基纤维素),Kobo Glycospheres(改性淀粉,脂肪酸酯,磷脂),Softspheres(改性的琼脂)和Kuhs Probiol Nanospheres(磷脂)以及Primaspheres和Primasponges(壳聚糖,藻酸盐)和Primasys(磷脂)。
壳聚糖微胶囊和用于其制备的方法从现有技术中是充分已知的[WO 01/01926,WO01/01927,WO 01/01928,WO 01/01929]。具有在0.0001mm至5mm,优选0.001mm至0.5mm并且尤其0.005mm至0.1mm的范围中的平均直径、由外壳膜片和包含有效物质的基体构成的微胶囊例如能够通过如下方式获得
(a)从成胶剂、阳离子聚合物和有效物质配置基体,
(b)可能地,基体分散在油相中,
(c)分散的基体用阴离子聚合物的水溶液处理并且可能在此除去油相。
在此,只要使用阴离子聚合物替代步骤(a)中的阳离子聚合物,步骤(a)和步骤(c)就是可交换的,并且反之亦然。
通过用由不同电荷的聚电解质构成的层交替地包封有效物质的方式(逐层技术)也能够生产胶囊。就此而言,参见欧洲专利EP 1064088 B1(Max-Planck Gesellschaft)。
药品
本发明的另一主题是配制品,所述配制品包含
(a)奥美拉唑或泮托拉唑
(b)圣草酚和/或高圣草酚
作为药品,特别应用于用作治疗胃部和肠道的炎症以及反流性食管炎的药品。尤其,这些药剂确定用于口服摄入。这些药剂能够是片剂,胶囊,咀嚼片剂,溶液,乳液,悬浮液,直接摄取的粉末和颗粒剂,溶解于水中的粉末,耐嚼糖果,吮吸糖果,橡皮糖,口香糖,果胶等。
工业实用性
本发明的另外两个主题一方面涉及一种用于掩盖具有奥美拉唑成份的药物配制品的苦味的方法,所述方法包括下列步骤:
(i)提供用于制备药物配制品的载体物质;
(ii)出自步骤(i)的物质掺入有一定量的奥美拉唑或泮托拉唑;
(iii)出自步骤(ii)的物质掺入有一定量的圣草酚和/或高圣草酚;并且(iv)出自步骤(iii)的物质加工成药物最终产物
以及另一方面涉及圣草酚和/或高圣草酚的应用,该应用用于掩盖或抑制奥美拉唑或泮托拉唑的苦味。
药物最终产物例如能够是片剂,吮吸糖果或耐嚼糖果,口香糖,果胶或胶囊。
就上述优选实施方式而言提出物质混合物和量数据,这些也适用于要求保护的方法或要求保护的应用,使得避免重复。
具体实施方式
实例1至实例3,对比实例V1和对比实例V2
为了检测苦味掩盖效果,水溶液分别掺入有500ppm的奥美拉唑(V1)单独以及
(1)掺有100ppm的圣草酚(ED)或
(2)掺有100ppm的高圣草酚(HE)或
(3)掺有100ppm的圣草酚+100ppm的高圣草酚或
(V4)以及掺有100ppm的4’-氟-6-甲氧基黄烷酮作为不具有掩盖作用的对比物质,
并且品尝。溶液2至溶液5相对溶液1分别在双重对比试验中以随机的顺序被由20至30名测试者构成的有经验的调查对象品尝,并且对每个样本的苦味按0至100的分级进行评价。在表1中总结评价的平均值。
表1
奥美拉唑的苦味评价
如能够看出,ED和HE单独起奥美拉唑苦味的掩盖剂作用。令人惊讶地,减少45%的物质的组合与预期的减少37%的相加的掩盖作用明显更有效。实例V2中结构性应用的对比化合物不起作用,而相反甚至增强奥美拉唑的苦味。
应用实例
应用实例1
具有泮托拉唑和/或ED/HED的糖浆(按重量%表示量数据)
根据上述配方配置具有40mg的泮托拉唑/每剂的糖浆。将制剂充分混合至全部组分溶解。与对比配制品A对比,配制品B明显不那么苦。
应用实例2
具有奥美拉唑和ED/HED的粉末配制品(按重量%表示量数据)
根据上述配方配置具有20mg的泮托拉唑/每剂的粉末混合物(5g)。两种制剂干燥混合并且紧接着筛分。与对比配制品A对比,配制品B明显不那么苦。
应用实例3
具有奥美拉唑和ED/HED的咀嚼片剂(按重量%表示量数据)
根据上述配方配置具有10mg的泮托拉唑/每剂的咀嚼片剂(2g)。全部组分混合并且在1h至2h之后压制成片剂。与对比配制品A对比,配制品B明显不那么苦。
应用实例4
具有泮托拉唑和ED/HED的泡腾片(按重量%表示量数据)
根据上述配方配置具有40mg的泮托拉唑/每剂的泡腾片(2g)。全部组分充分混合,然后用由碳酸氢钠和柠檬酸(按1:1.36的重量比)构成的预备的混合物填充到100%。在1h至2h之后筛分并且压制成片剂。与对比配制品A对比,配制品B明显不那么苦。
应用实例5
具有泮托拉唑和ED/HED的果胶(按重量%表示量数据)
为了配置具有每剂20mg的泮托拉唑的果胶,将上述配方中列举的成份添加至干燥的糖浆混合物(89°Brix)。与对比配制品A对比,配制品B明显不那么苦。
Claims (16)
1.一种配制品,所述配制品包含
(a)奥美拉唑和/或泮托拉唑;和
(b)圣草酚和/或高圣草酚。
2.根据权利要求1所述的配制品,
其特征在于,
所述配制品包含大约4:1至400:1的重量比的组分(a)和组分(b)。
3.根据权利要求1和/或权利要求2所述的配制品,
其特征在于,
所述配制品包含大约2000ppm至大约20000ppm的量的奥美拉唑作为组分(a)。
4.根据权利要求1至3中至少一项所述的配制品,
其特征在于,
所述配制品包含大约50ppm至大约500ppm的量的圣草酚和/或高圣草酚作为组分(b)。
5.根据权利要求4所述的配制品,
其特征在于,
所述配制品分别包含大约25ppm至大约250ppm的圣草酚和高圣草酚作为组分(b)。
6.根据权利要求1至5中至少一项所述的配制品,
其特征在于,
所述配制品以固体形式存在。
7.根据权利要求6所述的配制品,
其特征在于,
所述配制品是片剂或口香糖。
8.根据权利要求7所述的配制品,
其特征在于,
所述配制品还包含载体材料,分裂剂和/或着色剂和调味物质。
9.根据权利要求7所述的配制品,
其特征在于,
所述配制品是胶囊。
10.根据权利要求6至9中至少一项所述的配制品,
其特征在于,
所述配制品具有耐酸的包衣或外壳。
11.根据权利要求1所述的配制品,其作为药品。
12.根据权利要求1所述的配制品,其用作为用于治疗胃部和肠道的炎症以及反流性食管炎的药品。
13.一种根据权利要求11或12的药品,
其特征在于,
所述药品确定用于口服摄入。
14.根据权利1至10中至少一项所述的配制品或根据权利要求11或12所述的药品,
其特征在于,
所述配制品或所述药品作为片剂,胶囊,咀嚼片剂,溶液,乳液,悬浮液,直接摄取的粉末,耐嚼糖果,吮吸糖果,橡皮糖,口香糖或果胶存在。
15.一种用于掩盖具有奥美拉唑或泮托拉唑的成份的药物配制品的苦味的方法,所述方法包括下列步骤:
(i)提供用于制备药物配制品的载体物质;
(ii)出自步骤(i)的物质掺入有一定量的奥美拉唑或泮托拉唑;
(iii)出自步骤(ii)的物质掺入有一定量的圣草酚和/或高圣草酚;并且
(iv)出自步骤(iii)的物质加工成药物最终产物。
16.一种圣草酚和/或高圣草酚的应用,该应用用于掩盖或抑制奥美拉唑或泮托拉唑的苦味。
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CN1551768A (zh) * | 2001-07-09 | 2004-12-01 | ����˹���ѧ���»� | 新型取代的苯并咪唑剂型及其应用方法 |
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CN1551768A (zh) * | 2001-07-09 | 2004-12-01 | ����˹���ѧ���»� | 新型取代的苯并咪唑剂型及其应用方法 |
WO2004066924A2 (en) * | 2003-01-24 | 2004-08-12 | Andrx Labs Llc | Novel pharmaceutical formulation containing a proton pump inhibitor and an antacid |
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