Melt granulation of a composition containing a calcium-containing compound
    1.
    发明授权
    Melt granulation of a composition containing a calcium-containing compound 有权
    含有钙化合物的组合物的熔融造粒

    公开(公告)号:US08846088B2

    公开(公告)日:2014-09-30

    申请号:US11883532

    申请日:2006-02-02

    IPC分类号: A61K9/36 B29B9/00

    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。

    Dissolution stability of calcium carbonate tablets
    2.
    发明授权
    Dissolution stability of calcium carbonate tablets 有权
    碳酸钙片的溶解稳定性

    公开(公告)号:US09101565B2

    公开(公告)日:2015-08-11

    申请号:US13129664

    申请日:2009-11-17

    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。

    Fast wet-massing method for the preparation of calcium-containing compositions
    5.
    发明授权
    Fast wet-massing method for the preparation of calcium-containing compositions 有权
    用于制备含钙组合物的快速湿法组合法

    公开(公告)号:US08808735B2

    公开(公告)日:2014-08-19

    申请号:US11883536

    申请日:2006-02-02

    IPC分类号: A61K9/48 A61K33/10 A61K9/20

    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。

    DISSOLUTION STABILITY OF CALCIUM CARBONATE TABLETS
    6.
    发明申请
    DISSOLUTION STABILITY OF CALCIUM CARBONATE TABLETS 有权
    碳酸钙片的溶解稳定性

    公开(公告)号:US20110287098A1

    公开(公告)日:2011-11-24

    申请号:US13129664

    申请日:2009-11-17

    IPC分类号: A61K9/20 A61K9/42 A61K33/10

    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。

    Controlled release pharmaceutical composition for oral use containing midodrine and/or active metabolite, desglymidodrine

    公开(公告)号:US07070803B2

    公开(公告)日:2006-07-04

    申请号:US09823202

    申请日:2001-03-29

    IPC分类号: A61K9/16 A61K9/22 A61K9/52

    摘要: Novel controlled release pharmaceutical compositions for oral use containing midodrine and/or its active metabolite desglymidodrine. The novel compositions are designed to release midodrine and/or desglymidodrine after oral intake in a manner which enables absorption to take place in the gastrointestinal tract so that a relatively fast peak plasma concentration of the active metabolite desglymidodrine is obtained followed by a prolonged and relatively constant plasma concentration of desglymidodrine.The novel compositions may be designed for administration once or twice daily, i.e. a therapeutically effective concentration of desglymidodrine is maintained for a period of at least 10-16 hours followed by a wash out period of about 8-12 hours in order to avoid the well-known midodrine related side effect with respect to supine hypertension. The therapeutically effective concentration of desglymidodrine is regarded as a plasma concentration of desglymidodrine of at least about 3 ng/ml. A composition is designed to release midodrine and/or desglymidodrine in at least the following consecutive steps: i) an initial relatively fast release of midodrine and/or desglymidodrine (in order to obtain a relatively fast onset of action), ii) a steady release or a slower release than in step 1 of midodrine and/or desglymidodrine (in order to maintain a plasma concentration of desglymidodrine which is prolonged and relatively constant), iii) a second rise in release of midodrine and/or desglymidodrine (in order to take advantage of absorption from the colon, i.e. such a second rise release is designed to take place when the composition (or the disintegrated parts of the composition) reaches the colon; normally this is regarded to take about 8 hours after oral intake, and iv) a decline in release rate corresponding to that essentially all midodrine and/or desglymidodrine have been released from the composition.Also disclosed is a method for treating orthostatic hypotension and/or urinary incontinence, the method comprising administration to a patient in need thereof of an effective amount of midodrine and/or desglymidodrine in a composition according to the invention.

    Pharmaceutical kit comprising midodrine as active drug substance
    10.
    发明授权
    Pharmaceutical kit comprising midodrine as active drug substance 失效
    药物试剂盒包含米多君作为活性药物

    公开(公告)号:US06761904B2

    公开(公告)日:2004-07-13

    申请号:US09823093

    申请日:2001-03-29

    IPC分类号: A61K920

    摘要: The invention provides a novel pharmaceutical kit comprising a controlled release pharmaceutical compositions for oral use containing midodrine and/or its active metabolite desglymidodrine. The controlled release composition is designed to release midodrine and/or desglymidodrine after oral intake in a manner which enables absorption to take place in the gastrointestinal tract so that a relatively fast peak plasma concentration of the active metabolite desglymidodrine is obtained, followed by a prolonged and relatively constant plasma concentration of desglymidodrine. The invention also provides a method for treating orthostatic hypotension and/or urinary incontinence, the method comprising administration to a patient in need thereof of an effective amount of midodrine and/or desglymidodrine in a kit.

    摘要翻译: 本发明提供了一种新颖的药物试剂盒,其包含含有米多君和/或其活性代谢物去糖质胞苷的用于口服的控释药物组合物。 控制释放组合物被设计为在口服摄入后以能够在胃肠道中进行吸收的方式释放midodrine和/或desglymidodrine,从而获得活性代谢物desglymidodrine的相对快速的峰值血浆浓度,随后延长和 相对恒定的血浆浓度的desglymidodrine。 本发明还提供了一种治疗体位性低血压和/或尿失禁的方法,所述方法包括向有需要的患者施用试剂盒中有效量的米多君和/或去糖质鼠。