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    Compound preparation for the treatment of hypogonadal men and men with hypophyseal diseases
    1.
    发明授权
    Compound preparation for the treatment of hypogonadal men and men with hypophyseal diseases 失效
    复方制剂治疗性腺功能减退的男性和男性患有垂体病

    公开(公告)号：US5855905A

    公开(公告)日：1999-01-05

    申请号：US841719

    申请日：1997-04-30

    申请人： Michael Oettel ,  Siegfried Golbs ,  Michael Dittgen ,  Carsten Timpe ,  Thomas Graser ,  Doris Hubler

    发明人： Michael Oettel ,  Siegfried Golbs ,  Michael Dittgen ,  Carsten Timpe ,  Thomas Graser ,  Doris Hubler

    IPC分类号： A61K31/565

    CPC分类号： A61K31/565

    摘要： A compound preparation for the treatment of hypogonadal men and men with hypophyseal diseases. This invention relates to compound preparations containing biogenous or synthetic androgens and biogenous or synthetic estrogens that are used for the treatment of imbalances of the testosterone metabolism in old age, of hypogonadal men, and of men with hypophyseal diseases. These compound preparations are present in various galenic formulations such as ointments, gels, sprays, TTS systems, tablets, lozenges, capsules, and suppositories. These preparations are used to treat the fluctuations of the testosterone metabolism occurring in old age and with certain diseases such as hypophyseal diseases (adenoma), hypogonadism and/or metabolic syndrome, to maintain the balance between androgens and estrogens found in young and healthy men in ill and/or elderly men as well. The preparations for treating these imbalances are suitable for oral, parenteral, percutaneous, sublingual or rectal administration depending on their galenic form. Thus, unphysiological changes in steroid-converting enzymes such as aromatases and reductases are avoided, which considerably improves the outcome of the therapy.

    摘要翻译： 用于治疗性腺功能减退的男性和男性的复方制剂。 本发明涉及包含生物或合成雄激素和生物或合成雌激素的化合物制剂，其用于治疗老年睾酮代谢失调，性腺机能不良男性和具有垂体浸润性疾病的男性的不平衡。 这些复合制剂存在于各种盖仑制剂如软膏，凝胶剂，喷雾剂，TTS系统，片剂，锭剂，胶囊和栓剂中。 这些制剂用于治疗老年发生的睾酮代谢的波动，以及诸如垂体疾病（腺瘤），性腺机能减退和/或代谢综合征等某些疾病，以维持年轻和健康男性发现的雄激素和雌激素之间的平衡 生病和/或老年男子。 用于治疗这些不平衡的制剂适用于口服，肠胃外，经皮，舌下或直肠给药，取决于其盖仑形式。 因此，避免类固醇转化酶如芳香酶和还原酶的非生理变化，这显着改善了治疗的结果。

    Bioadhesive tablet containing testosterone/testosterone ester mixtures and method for producing a predetermined testosterone time-release profile with same
    2.
    发明授权
    Bioadhesive tablet containing testosterone/testosterone ester mixtures and method for producing a predetermined testosterone time-release profile with same 失效
    含有睾酮/睾酮酯混合物的生物粘附片剂和用于产生具有相同的预定睾酮时间释放特性的方法

    公开(公告)号：US06977083B1

    公开(公告)日：2005-12-20

    申请号：US09806639

    申请日：1999-09-30

    申请人： Doris Huebler ,  Guenter Kaufmann ,  Michael Oettel ,  Holger Zimmermann ,  Michael Dittgen ,  Sabine Fricke ,  Manfred Boese ,  Ralf Ladwig ,  Sven Claussen ,  Carsten Timpe

    发明人： Doris Huebler ,  Guenter Kaufmann ,  Michael Oettel ,  Holger Zimmermann ,  Michael Dittgen ,  Sabine Fricke ,  Manfred Boese ,  Ralf Ladwig ,  Sven Claussen ,  Carsten Timpe

    IPC分类号： A61F13/00 ,  A61K9/00

    CPC分类号： A61K9/006

    摘要： The method of making a bioadhesive tablet for controlling testosterone blood level, especially in elderly men suffering from partial androgen deficiency, includes spray-drying an alcoholic solution or suspension of testosterone and at least one testosterone ester, preferably in a ratio of 1:10 to 1:1.5, separately or together, with an organic polymer and optionally one or more auxiliary ingredient to form an active ingredient premix. Then various other auxiliary ingredients are mixed, as needed, with the active ingredient premix to form the bioadhesive tablet with an active ingredient layer and an adhesive layer. The active ingredient layer contains an effective amount of the active ingredient premix. The adhesive layer includes auxiliary ingredients including the bioadhesive polymer. The bioadhesive tablet may be buccally administered to provide a predetermined timed release profile of testosterone, advantageously varying according to a circadian rhythm.

    摘要翻译： 制备用于控制睾酮血液水平的生物粘附片剂的方法，特别是在患有部分雄激素缺乏症的老年男性中，包括将睾酮和至少一种睾酮酯的醇溶液或悬浮液喷雾干燥，优选1:10至 1：1.5，分别或一起与有机聚合物和任选的一种或多种辅助成分形成活性成分预混物。 然后根据需要将各种其它辅助成分与活性成分预混合物混合以形成具有活性成分层和粘合剂层的生物粘附片剂。 活性成分层含有有效量的活性成分预混物。 粘合层包括辅助成分，包括生物粘附聚合物。 生物粘附片剂可以经口给药以提供睾酮的预定定时释放曲线，其有利地根据昼夜节律改变。

    Homogeneous preformulations containing high concentrations of steroids, for producing low-dose solid and semi-solid pharmaceutical preparations
    3.
    发明授权
    Homogeneous preformulations containing high concentrations of steroids, for producing low-dose solid and semi-solid pharmaceutical preparations 失效
    含有高浓度类固醇的均质预制品，用于生产低剂量固体和半固体药物制剂

    公开(公告)号：US06290931B1

    公开(公告)日：2001-09-18

    申请号：US09319802

    申请日：1999-06-10

    申请人： Detlef Grawe ,  Peter Hoesel ,  Peter Moellmann ,  Carsten Timpe ,  Michael Dittgen ,  Klaus Matthey

    发明人： Detlef Grawe ,  Peter Hoesel ,  Peter Moellmann ,  Carsten Timpe ,  Michael Dittgen ,  Klaus Matthey

    IPC分类号： A61K912

    CPC分类号： A61K31/569 ,  A61K9/1623 ,  A61K9/1676 ,  A61K31/567 ,  A61K31/575

    摘要： A homogeneous steroid-containing preformulation for production of solid and semi-solid pharmaceutical preparations containing a uniform constant dosage of at least one steroid in a range from 0.001 to 1 percent by weight is described. This steroid-containing preformulation contains of from 0.001 to 50 percent by weight of the at least one steroid. The homogeneous steroid-containing preformulation is made by a method including dissolving the at least one steroid in a solvent to form a dispersant; dispersing an adjuvant consisting of adjuvant particles in the dispersant in a mass ratio of the adjuvant to the at least one steroid of 1:1 to 1000:1 to form a suspension; and creating a spray-mist of the suspension so as to evaporate and remove the solvent from the suspension and thus to form a dried particulate which includes steroid-containing particles. The droplets in the spray mist have a droplet diameter greater than a mean diameter of the adjuvant particles. The maximum particle size of the dried particulate forming the steroid-containing preformulation is increased by less than 30 percent in comparison to an average particle size of the adjuvant particles.

    摘要翻译： 描述了用于生产固体和半固体药物制剂的均匀类固醇预制剂，其含有0.001至1重量％范围内的至少一种类固醇的均匀恒定剂量。 该含类固醇的预制剂含有0.001至50重量％的至少一种类固醇。 通过包括将至少一种类固醇溶解在溶剂中以形成分散剂的方法制备含均匀类固醇的预配制剂; 将助剂颗粒组成的佐剂以佐剂与至少一种类固醇的质量比为1:1至1000:1分散在分散剂中以形成悬浮液; 并产生悬浮液的喷雾，从而从悬浮液中蒸发除去溶剂，从而形成包含类固醇颗粒的干燥颗粒。 喷雾中的液滴的液滴直径大于辅助颗粒的平均直径。 与佐剂颗粒的平均粒径相比，形成含类固醇的预制剂的干燥颗粒的最大粒度增加小于30％。

    Method of making a perorally administered solid drug with controlled effective ingredient delivery
    4.
    发明授权
    Method of making a perorally administered solid drug with controlled effective ingredient delivery 失效
    制备具有受控有效成分递送的经口施用的固体药物的方法

    公开(公告)号：US6117450A

    公开(公告)日：2000-09-12

    申请号：US65863

    申请日：1998-04-24

    申请人： Michael Dittgen ,  Sabine Fricke ,  Carsten Timpe ,  Hagen Gerecke ,  Annette Eichardt

    发明人： Michael Dittgen ,  Sabine Fricke ,  Carsten Timpe ,  Hagen Gerecke ,  Annette Eichardt

    IPC分类号： A61K9/22 ,  A61K9/48 ,  A61K9/52 ,  A61P43/00 ,  A61K9/26 ,  A61K9/28

    CPC分类号： A61K9/4808

    摘要： The method of making a solid drug with controlled effective ingredient delivery for oral administration includes selecting a predetermined number of at least three of four compressed compositions containing an effective ingredient or effective ingredient combination defined by their release profile of effective ingredient and/or effective ingredient combination. The solid drug or medicinal preparation is formed according to known methods requiring only comparatively small apparatus expense and minimal time. Perorally administered solid drugs are made by this process which can provide widely varying pharmaceutically-required release profiles of effective ingredients or effective ingredient combinations, for example delayed release, uniformly maintained release or pulsatile release adjusted to fit a special rhythm.

    摘要翻译： 制备具有受控制的有效成分递送用于口服给药的固体药物的方法包括选择预定数量的四种压缩组合物中的至少三种，其包含由有效成分和/或有效成分组合的释放曲线限定的有效成分或有效成分组合 。 固体药物或药物制剂根据已知的方法形成，只需要较小的装置费用和最少的时间。 通过该方法制备经口施用的固体药物，其可以提供有效成分或有效成分组合的广泛变化的药学需要的释放曲线，例如延迟释放，均匀保持的释放或脉动释放，以适应特殊的节律。