CN1642531A - 美味咀嚼片剂 - Google Patents

美味咀嚼片剂 Download PDF

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CN1642531A
CN1642531A CNA038070448A CN03807044A CN1642531A CN 1642531 A CN1642531 A CN 1642531A CN A038070448 A CNA038070448 A CN A038070448A CN 03807044 A CN03807044 A CN 03807044A CN 1642531 A CN1642531 A CN 1642531A
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cetirizine
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卡斯拉·卡斯雷安
坦亚·哈夫利尔
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Abstract

本文公开了一种经口给药的西替利嗪二氢氯酸的美味咀嚼片剂。通过添加葡萄和香草香味剂,提高其美味。

Description

美味咀嚼片剂
技术领域
本发明涉及口腔咀嚼片剂,特别涉及一种可以提供以美味掩盖药剂中的苦味的可咀嚼片剂。
背景技术
西替利嗪(Cetirizine)是2-[2-[4-[(4-氯苯基)苯甲基]-1-哌嗪基]乙氧基]乙酸的普通名,通常为二氢氯酸盐。西替利嗪是具有口服活性的选择性H1受体拮抗剂,目前应用于2岁或2岁以上患者的季节性过敏治疗。目前应用于儿科的商业产品(ZyrtecTM)一种为白色、膜包衣、瞬间释放(immediate release)浓度为5和10mgA的口服片剂,另一种为含有浓度为1mg/ml的西替利嗪氢氯酸盐的甜味糖浆。在欧洲专利号为058,146、294,993和357,369,和WO92/02212中描述了在片剂和胶囊中控制或持续释放西替利嗪的西替利嗪制剂。止咳糖浆型口服制剂公开于WO 94/08551。
对于吞咽传统片剂或胶囊有困难的患者,例如儿童,在药品工业中广泛应用咀嚼片剂。另外,咀嚼片剂可以避免,由液体产生的例如溢出和玷污等意外情况。
可是,口服系统的一个缺点是,特别对于儿童,有时药物很苦,味道不好,有气味或服药方式令人不愉快。为了掩盖这些化合物的味道,过去进行了许多努力,或者通过精心制作的香味剂和/或者甜料传递系统、药物在其他物质中吸附或用聚合物、脂类、碳水化合物或其他相似物胶束化的方法。这些味道掩盖的方法,基本上通过在口服中防止其与味蕾接触,在胃中崩解和释放活性的方法防止苦味。
例如,美国专利No.4650663揭示一种口服药物传递系统的制备,将一种有令人不快味道的止咳药,例如那可丁、咳必清或氯化联苯二醇氢氯酸盐吸附到硅酸镁薄片上,合并成为咀嚼片剂或锭剂。声称吸附剂(absorbate)掩盖苦味到可以忽略的程度,以达到更好的患者顺从。
美国专利6027746揭示了一种含有分散在口服悬浮液中的药物的软咀嚼明胶胶囊,其包含有一种可以掩盖苦味或不良气味药物活性成分的药剂吸附剂(medicament adsorbate)(例如抗组胺剂,解充血药及其相似物)。
美国专利6270790揭示一种软、凸起形状、被压缩咀嚼片剂。药物活性剂的苦或不良气味,通过用90∶10到50∶50的醋酸纤维素或乙酸丁酸纤维素与聚乙烯吡咯烷酮或羟丙基纤维素共混聚合物对药物包衣而得到掩盖。可是,包衣需要额外制造步骤,从而增加了片剂的制造成本。
美国专利3558600描述了一种对隶属于取代的1-(对-氯-二苯甲基)-哌嗪族的抗组胺剂,其苦味进行掩盖的方法。此方法包括将活性物质从自由碱转化成长链烃的硫酸盐,例如硬脂基硫酸盐(stearyl sulfate)。
另一种已知的掩盖活性成分气味的方法包括生成活性成分和环糊精的包合复合物(inclusion complex)。在这种情况下,可以通过捕获活性成分掩盖气味,并且其不能在口中释放。在WO99/01133中描述了西替利嗪与β-环糊精的应用。
特别是为了提高儿童的顺从性,仍存在西替利嗪美味形式制剂的需要。
发明内容
本发明提供一种美味咀嚼片剂,包含西替利嗪或制药学上可以接受的盐(优选,二氢氯酸盐)、甜味剂(例如,丁磺氨钠)、葡萄香味剂和香草香味剂以4∶1到2∶1比例的混合物(优选比例从3∶1到2∶1)、环糊精(优选β-环糊精),以及一种或多种赋形剂(例如,硬脂酸镁、胶质二氧化硅、无水乳糖、微晶纤维素、以瓜耳胶改性的微晶纤维素、交联羧甲纤维素钠、甘露醇、蔗糖和糊精化蔗糖)。
在优选实施方案中,提供一种美味咀嚼双层片剂,其包含,(a)第一层和(b)第二层,第一层包含西替利嗪或制药学上可以接受的盐(优选西替利嗪二氢氯酸盐)、葡萄香味剂和香草香味剂以4∶1到2∶1比例的混合物、β-环糊精、着色剂,一种或多种赋形剂(例如,硬脂酸镁、胶质二氧化硅、无水乳糖、微晶纤维素、以瓜耳胶改性的微晶纤维素、交联羧甲纤维素钠);第二层包含甘露醇或糊精化蔗糖、葡萄香味剂和香草香味剂以4∶1到2∶1比例的混合物、着色剂。一种或多种赋形剂(例如,硬脂酸镁)。
具体实施方式
本发明涉及一种为儿童设计的更加美味的西替利嗪片剂,在医生推荐下可以提高治疗顺从性。西替利嗪是一种非常苦的药物,因此,诱使儿童服用很是困难。经市场调查研究表明,5-12岁的儿童偏爱葡萄味道。可是,申请人发现,向葡萄香味剂中添加香草香味剂,可以提高葡萄香味剂的味道,因此,可以使片剂更加美味,特别是对于儿童。
合适的葡萄香味剂包含天然和人工香味剂,通常可以通过许多世界常见生产厂商得到,例如Givaudan(Vernier,瑞士)、Ungerer & Company(LincolnPark,新泽西州)和International Flavors & Fragrances(New York,纽约)等。本领域普通技术人员将会认识到有很多种商业资源可用,包括常规混合者(custom blender)。优选的葡萄香味剂系统是由Givaudan生产的人工葡萄香味剂486939(Artificial Grape Flavor 486939)。合适的香草香味剂包含天然和合成香味剂,并且可以通过许多世界常见生产厂商得到,例如,CHR Hansen,Inc.(Milwaukee,WI)、Givaudan(Vernier,瑞士)、Ungerer & Company(LincolnPark,新泽西州)和International Flavors & Fragrances(New York,纽约)等。本领域普通技术人员将会认识到有很多种商业资源可用,包括常规混合者(custom blender)。优选香草香味剂是来自CHR Hansen,Inc.的药用粉状香草香味剂(PharmaSweet Powder Vanilla Flavor Enhancer)。葡萄香味剂与香草香味剂的重量比,通常在约4∶1到2∶1的范围,优选约3∶1到2∶1。片剂中的香味剂通常占重量的约0.2%到1.0%,优选为约0.3%到0.4%。本领域普通技术人员会懂得,香味剂的准确用量将依据所用特定香味剂的强度而变化,也知道如何调整浓度,达到合适的味觉程度。所用的特定香味剂的量,也会受到管理机构(即,美国食品药品管理委员会)所批准的应用于药物产品中时浓度的限制。葡萄和香草香味剂可以,在加入药物组合物之前混和,或单独添加。
西替利嗪属于取代的二苯甲基哌嗪族,例如,2-[2-[4-[(4-氯苯基)苯甲基]-1-哌嗪基]乙氧基]乙醇(羟嗪),2-[2-[4-双[(4-氟苯基)甲基]-1-哌嗪基]乙氧基]醋酸(乙氟利嗪),1-[(4-氯苯基)苯甲基]-4-[(3-甲苯基)-甲基]哌嗪(氯苯甲嗪),或1-[(4-叔丁苯基)甲基]-4-[(4-氯苯基)苯甲基]哌嗪(布克力嗪),它们旋光异构体,以及其药物可接受盐。相应地,本领域普通技术人员会懂得,本发明可用于上面提及的西替利嗪族,以及西替利嗪与其药物可接受盐。片剂中的西替利嗪的量,依据特定剂量需要而发生变化。通常,对于5mgA或10mgA的片剂,西替利嗪占片剂重量的比率约为2.0%到2.5%。
本领域普通技术人员会懂得,本发明可用于其他苦味药物活性成分,特别是那些为本领域普通技术人员熟知的抗组胺剂和解充血药。
组合物中还可以包含着色剂,以提高片剂外观,尤其是,着色剂赋予的吸引人的着色可以提高患者的合作程度。在本发明中,应用蓝色颜料和红色颜料可以代表性地得到紫色,以与葡萄的香味相匹配。蓝色与红色着色剂的相对数量可以发生变化,这取决于各着色剂特定的色泽,以及需要紫色的颜色深浅。一般来说,被管理机构认可的,可以应用在药学领域的任何红、蓝或紫色着色剂(天然或合成)均可应用。
任何标准的、药用的赋形剂均可应用于咀嚼片剂制造中,它们可以提供足够的压缩,例如稀释剂(如,甘露醇、山梨醇、乳糖、蔗糖、压缩糖,例如可以从Austin Products Inc.,Holmdel,NJ得到的DiPacTM(糊精化蔗糖)),崩解剂或溶胀剂(例如,聚乙烯聚吡咯烷酮,交联羧甲纤维素钠(例如可以从FMC BioPolymer,Philadelphia,PA得到的Ac-Di-SolTM),淀粉及衍生物,纤维素及衍生物,微晶纤维素,例如均从FMC BioPolymer,Philadelphia,PA得到的AvicelTMPH 101或AvicelTM CE-15(瓜耳胶改性的微晶纤维素),润滑剂(例如硬脂酸镁),以及流动剂(例如,胶质二氧化硅,如可以从CabotCorporation,Kokomo,IN得到的Cab-O-Sil M5)。
甜味剂经常应用于给予组合物愉悦的香味。本发明中应用的甜味剂包含天然甜味剂,例如蔗糖、葡萄糖、果糖、转化糖、甘露醇、三片梨醇及其相似物,和合成甜味剂,例如糖精、阿司帕坦、乙酰舒泛钾,环己氨磺酸盐以及为本领域普通技术人员熟悉的其他商业人工甜味剂。一种优选甜味剂是乙酰舒泛钾(可以从Nutrinova,Frankfort,德国,得到的SunettTM)。加入一定数量此甜味剂以得到期望的甜度。典型的,甜味剂加入量约为1.0%到5.0%。对于本领域普通技术人员会懂得,甜味剂的量,随着特定甜味剂的强度和管性机构批准的应用于药物产品中的浓度而改变。
应用于本发明中合适的环糊精包含α,β,或γ环糊精,或烷基化或者羟烷基化衍生物,例如七(2,6-二-o-甲基)-β-环糊精(DIMEB),随机甲基化β环糊精(RAMEB),以及羟丙基β-环糊精(HPβCD)。优选环糊精是β-环糊精(可以从Cerestar USA,Inc.,Hammond,Indiaha或以商品名KleptoseTM从RoquetteAmerica,Inc.,Keokuk.IA得到)。如若需要,可以事先制备活性物质与环糊精的复合物,例如,在水存在下揉搓活性物质和环糊精,或者准备一种包含有希望摩尔比的活性物质和环糊精的水溶液。选择性地,活性物质和环糊精可以与赋形剂和佐剂简单的混和。优选的活性物质与环糊精的摩尔比为约1.0到4.0。
制造单层或双层片的典型的制作工艺,通常包括混和所需成分,使西替利嗪、着色剂和香味剂均匀分布。如若需要,掺合成混合物之前,可以在水存在下在行星式搅拌机中揉搓西替利嗪和环糊精20分钟生成西替利嗪和环糊精(例如β-环糊精)包合复合物。混合物在干燥箱里干燥。干燥后,使复合物与着色剂/香味剂混和物混合。然后,用为本领域普通人员熟知的标准方法,将混合物压制成单层或双层片(例如,KilianT-100压片机或Courtoy 292/43旋转双层压片机)。优选地,含有羟基基团的赋形剂(例如甘露醇),因其羟基可以与西替利嗪形成酯类,所以需要与西替利嗪分开,以避免形成酯类。因此,优选剂型是双层结构,使西替利嗪与糖类如甘露醇处在不同片层上。为形成片剂的统一包装规格,可以向两层中加入着色剂和香味剂。
片剂可以保存在玻璃或高密度聚乙烯(HDPE)瓶中,可含有或不含有热诱导封口瓶。瓶中可以含有干燥剂。选择性地,片剂还可以用本领域普通技术人员熟知的标准方法包裹成泡包装(blister packs)。
为了更好地披露和揭示本发明的实施方案,以及本发明中可咀嚼片剂的制作方法,提供了以下实施例。本领域普通技术人员应当理解,这些实施例仅仅作为阐明目的所用,在不脱离由所附权利要求书所限定的本发明的精神和范围的情况下,可以对这些公式进行细小的修改。
实施例
西替利嗪双层可咀嚼片剂:
使用下列两种配方制备双层可咀嚼片剂。先分别制备各配方,然后在双层压片机上压缩。
                       配方1:活性层
成分     %片剂重量
西替利嗪2HCl     2.22
β环糊精,KleptoseTM 20OF     18.33
乙酰舒泛钾     0.78
胶质二氧化硅     0.24
微晶纤维素     9.75
人工葡萄香味剂486939(Givaudan Roure)     0.13
药用甜味剂FL PWD Nat(K)     0.04
乳糖一水合物     12.22
染料:胭脂红#09349*     0.05
染料:FD&C蓝#2铝淀*     0.05
硬脂酸镁     0.61
                   配方2:安慰剂层
成分     %片剂重量
甘露醇     53.60
乙酰舒泛钾     1.04
人工葡萄香味剂486939(Givaudan Route)     0.17
药用甜味剂FL PWD Nat(K)     0.06
染料:胭脂红#09349*     0.07
染料:FD&C蓝#2铝淀*     0.07
硬脂酸镁     0.56
*可以从Warner-Jenkinson,South Plainfields,新泽西州,得到。

Claims (12)

1、一种美味可咀嚼片剂,包含
(a)西替利嗪或药学可接受盐,
(b)甜味剂,
(c)葡萄香味剂与香草香味剂的比率约为4∶1到2∶1的混合物,
(d)环糊精,和
(e)一种或多种其他赋形剂。
2、权利要求1所述的片剂,其药学可接受盐为西替利嗪二氢氯酸盐。
3、权利要求1所述的片剂,还包含有红色、蓝色或紫色着色剂。
4、权利要求1所述的片剂,其环糊精为β-环糊精。
5、权利要求2所述的片剂,其环糊精为β-环糊精。
6、权利要求1所述的片剂,其中所述的一种或多种其他赋形剂选自:硬脂酸镁、胶质二氧化硅、无水乳糖、微晶纤维素、以瓜耳胶改性的微晶纤维素、交联羧甲纤维素钠、甘露醇、蔗糖和糊精化蔗糖。
7、权利要求1,2,3,4,5或6所述的片剂,其中所述的甜味剂为乙酰舒泛钾。
8、一种美味双层可咀嚼片剂,包括
(a)第一层,其包含
(i)西替利嗪或药学可接受盐,
(ii)葡萄香味剂与香草香味剂的比率约为4∶1到2∶1的混合物,
(iii)β-环糊精,
(iv)着色剂,和
(v)一种或多种其他赋形剂;以及
(b)第二层,其包含
(i)甘露醇或糊精化蔗糖,
(ii)葡萄香味剂与香草香味剂的比率约为4∶1到2∶1的混合物,
(iii)着色剂,和
(iv)一种或多种赋形剂。
9、权利要求8所述的片剂,其中所述的药学可接受盐为西替利嗪二氢氯酸盐。
10、权利要求8或9所述的片剂,其中所述的一种或多种其他赋形剂选自:硬脂酸镁、胶质二氧化硅、无水乳糖、微晶纤维素、以瓜耳胶改性的微晶纤维素、交联羧甲纤维素钠、甘露醇、蔗糖和糊精化蔗糖。
11、权利要求8或9所述的片剂,其中第二层中的一种或多种其他赋形剂为硬脂酸镁。
12、权利要求10所述的片剂,其中第二层中的一种或多种其他赋形剂为硬脂酸镁。
CNB038070448A 2002-04-04 2003-03-26 美味咀嚼片剂 Expired - Fee Related CN100335041C (zh)

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