CN1119998C - 去氧孕烯的压制干颗粒片 - Google Patents

去氧孕烯的压制干颗粒片 Download PDF

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CN1119998C
CN1119998C CN96194942A CN96194942A CN1119998C CN 1119998 C CN1119998 C CN 1119998C CN 96194942 A CN96194942 A CN 96194942A CN 96194942 A CN96194942 A CN 96194942A CN 1119998 C CN1119998 C CN 1119998C
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P·迪哈恩
C·P·希斯
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Abstract

本发明涉及通过滚筒压紧或通过压制得到的含有去氧孕烯的干颗粒压制片剂或颗粒剂，它能够用生产方法制备，其中方法的第一步是使用高压把去氧孕烯任选与其他活性化合物和/或赋型剂压紧，然后在第二步中粉碎成颗粒，此后在第三步中用本领域已知的方法把颗粒制成片剂或填入胶囊。

Description

去氧孕烯的压制干颗粒片
本发明涉及含有去氧孕烯的压制干颗粒片及其生产方法。
去氧孕烯是一种避孕的甾类，具有Desoge、Marvelon、Mercilon和Gracial各种商标的制剂被广泛使用。
人们发现去氧孕烯具有转化成片剂和颗粒的倾向。当片芯或颗粒含有非常低剂量的去氧孕烯时，这是特别有意义的。用去氧孕烯作活性成分的片剂一般含有25-150μg，且典型的是25，50，75，100或150μg的去氧孕烯。对去氧孕烯来说，已经用作避孕或HRT(激素替代疗法)药物中的活性成分，在它的安全性和可靠性方面，这是不能接受的。例如，在半衰期间损失10％的活性物质就会对该片剂中活性组分量产生巨大影响，并且片剂中活性成份的量少于发挥全部活性的量。
现在已经发现将含有去氧孕烯的干混物压缩能够用来防止从该片剂或颗粒向环境中转化去氧孕烯。除了去氧孕烯，该片剂或颗粒还能含有雌激素。
雌激素的例子包括炔雌醇、β-雌二醇、炔雌醇甲醚(17α-乙炔基雌二醇3-甲醚)、雌酮、雌二醇、戊酸雌二醇和具有雌激素活性的其他化合物。优选的雌激素是炔雌醇和β-雌二醇。
本文所用的“转化”包括去氧孕烯过早地留下剂量单位的任何过程。
术语“剂量单位”一般指适合作人或动物单一剂量的物理不连续单位，的每一剂量含有算出产生所需效果的预定量的活性物质。这种剂量单位的例子是片剂、颗粒剂、粉剂和丸剂。
制备各种剂量单位的方法和组分对本领域普通技术人员来说是熟知的。例如，在 Remingtons(第18版，A.R.Gennaro编辑的，MackPublishing Co.Easton，Pa，1990)第1633到1665页中已经描述了制备片剂和丸剂的方法和组分。
包括在压片混合物和最终剂量单位中的甾类的浓度当然取决于它的使用目的和该剂量单位的最终大小。用于剂量单位中的去氧孕烯的量对本领域普通技术人员也是熟知的。
本发明的片芯或颗粒一般含有稀释剂和任选的粘合剂。片芯或颗粒剂也将优选包括崩解剂。
稀释剂或“填料赋型剂”是加到单位剂量中来增加颗粒的和所得到的剂量单位的体积的并改善干躁-粘合特性的试剂。在这方面优选使用的稀释剂是乳糖。其他稀释剂包括甘露醇、山梨醇、(喷雾干燥的)乳糖、(微晶)纤维素、乙基纤维素、木糖醇、淀粉糖、淀粉、淀粉-衍生物、右旋糖、果糖、碳酸钙、磷酸钙，NaCaPO4，蔗糖及其混合物。该稀释剂一般占所得到的含甾类粒剂重量的70-95％。
粘合剂是用来把粘合性能赋予该颗粒和片剂并导致物理更稳定的剂量单位的试剂，它包括羟丙基纤维素、直链淀粉、淀粉、聚烯吡酮(聚乙烯吡咯烷酮)、羟丙基甲基纤维素、明胶、聚乙二醇、乙基纤维素、阿拉伯胶、明胶、甘油和淀粉为主的粘合剂。用于本发明的优选粘合剂是聚乙烯吡咯烷酮。粘合剂一般占所得到的含甾类片芯或颗粒重量的0.5-20％，并优选0.5到5％。
崩解的试剂或“崩解剂”是加到片剂中使它在给药后容易碎裂或崩解的物质或这种物质的混合物。一般这种试剂是改良的或未改良的淀粉、粘土、交联的PVP、改良或未改良的纤维素、树胶或藻酸。目前最优选的试剂是玉米淀粉、马铃薯淀粉、小麦淀粉和改良的淀粉。崩解剂一般占所得到的片剂混合物重量的5到50％，优选5到15％。
人们需要一种简单的生产方法，这种方法不需要用有机溶剂或水的湿粒制法并且不需要另外的干燥步骤。本发明涉及这种方法并提供含有去氧孕烯的压制的片剂或颗粒剂。更具体的是本发明涉及一种生产含有去氧孕烯的颗粒剂、胶囊或片剂的方法，所制备的产物中还任选有其他活性化合物和/或赋型剂，其中该方法的第一步是把去氧孕烯，任选与其他活性化合物和/或赋型剂混合，接着用高压压制，然后，在第二步将其粉碎成颗粒，之后第三步用本领域的已知方法把与润滑剂混合后的颗粒制成片剂或填入胶囊。
本方法比现有技术的方法较便宜，现有技术的方法包括分离的制粒步骤、有机溶剂或水或更昂贵的赋型剂以及干燥步骤。而且，本发明能够容易扩大。并且不使用有机溶剂，本发明方法提供了具有最小环境问题的工艺，而颗粒有改善的稳定性。
在多数情况中，不需要使用润滑剂，但为了防止在滚筒压缩期间去氧孕烯和/或雌激素粉末在滚筒上的粘着，可向该粉末中以2至0.01％w/w，并优选约0.25％w/w的量加入少量润滑剂，优选硬脂酸镁、硬脂酸、氢化蓖麻油、滑石或其混合物。
优选使用压制或滚筒压缩方法来压紧该粉末和任选的润滑剂(如硬脂酸镁或硬脂酸)。该方法的第一步是干法制粒步骤，其中没有使用溶剂并把含有去氧孕烯的粉末制成颗粒。在本发明方法中，压紧后得到去氧孕烯、雌激素和赋型剂的片或圆片，任选将这些片或圆片碎成不规则的细粒(颗粒)。作为一种附加的步骤，可把该颗粒筛分成所需的细粒或细粉，然后将细粉再循环到滚压料斗或压片机中。
在压紧过程中，所用的压力是一个重要的参数。用压力使滚筒间的温度增加。滚筒压力的增加造成压缩片的较高强度，从而造成低易碎性。而且，随着压力，产率增长。得到低易碎性和低降解以及高产率的适当压力是在约0.5和500MPa(兆帕斯卡)。优选的压力是约200-400MPa，这会得到最小的活性损失和最大产率。
压制机能够是任何压制机，例如凸型或凹型，具有直线或曲线形滚筒或粉末运送螺旋桨的不同外观的压制机。Alexander WP120滚筒压制机似乎是一种方便的压制机。
一般不得不把压制的粉末粉碎成较小的颗粒。这种破碎步骤对颗粒大小的分布很重要，颗粒的大小分布取决于所用的破碎方法。原则上，任何破碎机都能使用，例如锥形或滚筒型破碎机最好与Alexander Roller压制机的破碎筛、Comil锥形制粒机或Frewitt破碎筛一起使用。使用这类筛时，一般很容易得到大约50％的产率。筛出不能使用的细粉并将其再循环到压制步骤中。
优选的实施例是压制药片，用重功率的压片设备压制块或大片，然后研磨成所需颗粒特征。
颗粒可以压片或填入胶囊，例如填入硬胶囊如明胶胶囊。
按照上述方法，制备具有下列组分的去氧孕烯片：
    片Amg     片Bmg     片Cmg
  去氧孕烯炔雌醇淀粉葡糖酸钠硬脂酸甘露糖醇qasd硬脂酸镁PharmatoseDCL-11qsad     0.1500.0301.301.3065.0--     0.1500.0301.301.3065.0--     0.1500.0301.20--0.3060.0
本发明的片A是这样制得的：在Turbula混合机中用10％的甘露糖醇预混合去氧孕烯和EE并用250μm的筛筛分该混合物。把筛过的块与剩余的甘露糖醇和淀粉葡糖酸钠混合，接着在Lodiger 混合机中再与1.5％的硬脂酸(＜250μm)混合。以340MPa压制压缩物。破碎该块后，收集小于710μm的干颗粒并在Turbula混合机中与0.5％的硬脂酸混合。在KorschPH-106的压片机上把该混合物压成重为65mg的片。
本发明的片B(现有技术的片)是这样得到的：在Turbula混合机中用大约10％的甘露糖醇预混合去氧孕烯和EE并用250μm的筛筛分该混合物。把筛过的块与剩余的甘露糖醇和淀粉葡糖酸钠混合，接着在Lodiger混合机中再与1.5％的硬脂酸(＜250μm)混合。在Turbula混合机中与0.5％的硬脂酸进行混合。在Korsch PH-106的压片机上把该混合物压成重为65mg的片。
本发明的片C(现有技术的片)是这样得到的：在Gral高剪切混合机中用喷雾干燥的乳糖(Pharmatose DCL-11)预混合去氧孕烯和EE。之后，在混合物中也混合其他赋型剂并随后直接压成重为65mg的片。
把片A(本发明)的升华特性与现有技术的片B和片C的相比。在70℃15kPa压力下把样品存放72小时。在4℃的冷指状物上收集升华气体并定量分析升华的去氧孕烯的量：
    升华的去氧孕烯的量(％在起始片中的量)
    A             B             C9.0           12.3          15.2
本发明的片剂(A)显示了比现有技术中的片B和C改善的升华特性并由此预料有改善的半衰期。

Claims (4)

1.含有去氧烯的干颗粒压制片剂或颗粒剂，通过具有以下特征的滚筒压紧或通过压制法得到：第一步是使用0.5-500MPa压力把去氧孕烯和任选的其他活性化合物和/或赋型剂压紧，然后在第二步中粉碎成颗粒，此后在第三步中用本领域已知的方法把颗粒制成片剂或填入胶囊。
2.一种生产含有去氧孕烯的干颗粒压制片剂或颗粒的方法，其特征在于：方法的第一步是使用0.5-500MPa压力把去氧孕烯和任选的其他活性化合物和/或赋型剂压紧，然后在第二步中粉碎成颗粒，此后在第三步中用本领域已知的方法把颗粒制成片剂或填入胶囊。
3.根据权利要求2的方法，其中用滚筒压紧或压制压缩去氧孕烯和任选其他活性化合物和/或赋型剂。
4.根据权利要求2的方法，其中所用的压力在200-400MPa。
CN96194942A 1995-06-22 1996-06-18 去氧孕烯的压制干颗粒片 Expired - Fee Related CN1119998C (zh)

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EP0833642B1 (en) 2002-04-10
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ATE215825T1 (de) 2002-04-15
KR19990028214A (ko) 1999-04-15
BR9609208A (pt) 1999-05-11
CZ289133B6 (cs) 2001-11-14
HK1008923A1 (en) 1999-05-21
AU710710B2 (en) 1999-09-30
WO1997000682A1 (en) 1997-01-09
CN1188411A (zh) 1998-07-22
RU2159618C2 (ru) 2000-11-27
TR199701659T1 (xx) 1998-03-21
DE69620607D1 (de) 2002-05-16
CZ416597A3 (cs) 1998-06-17
JP4116672B2 (ja) 2008-07-09
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HU223943B1 (hu) 2005-03-29
DK0833642T3 (da) 2002-06-10
EP0833642A1 (en) 1998-04-08
PL184558B1 (pl) 2002-11-29
NO975986D0 (no) 1997-12-19
MX9710411A (es) 1998-07-31
CA2224269A1 (en) 1997-01-09
US6063403A (en) 2000-05-16
HUP9901350A2 (hu) 1999-08-30
PT833642E (pt) 2002-08-30
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AU6356696A (en) 1997-01-22
CA2224269C (en) 2008-06-17
PL324345A1 (en) 1998-05-25
KR100421526B1 (ko) 2004-05-20
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