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    Diffusion-osmotic controlled drug-release pharmaceutical composition and process for preparing same
    1.
    发明授权
    Diffusion-osmotic controlled drug-release pharmaceutical composition and process for preparing same 失效
    扩散渗透控制药物释放药物组合物及其制备方法

    公开(公告)号：US5543155A

    公开(公告)日：1996-08-06

    申请号：US341209

    申请日：1994-12-05

    申请人： Pal Fekete ,  Maria Kiraly nee Ignacz ,  Gabor Sipos ,  Zsuzsanna Jambor nee Hoffmann ,  Gyorgy Ujfalussy ,  Magdolna Gora nee Hernyes ,  Imre Klebovich ,  Sandor Drabant ,  Attila Mandi ,  Gizella Kiss nee Szabo ,  Erzsebet Barczay ,  Maria Krisztian

    发明人： Pal Fekete ,  Maria Kiraly nee Ignacz ,  Gabor Sipos ,  Zsuzsanna Jambor nee Hoffmann ,  Gyorgy Ujfalussy ,  Magdolna Gora nee Hernyes ,  Imre Klebovich ,  Sandor Drabant ,  Attila Mandi ,  Gizella Kiss nee Szabo ,  Erzsebet Barczay ,  Maria Krisztian

    IPC分类号： A61K9/36 ,  A61J3/10 ,  A61K9/00 ,  A61K9/22 ,  A61K9/32 ,  A61K47/34 ,  A61K9/24

    CPC分类号： A61K9/0004 ,  Y10S514/96

    摘要： The invention relates to a novel diffusion-osmotic controlled drug-release pharmaceutical composition containing a one-layer tablet core including a polymeric film-coat, a therapeutically active agent and a hydrophilic polymer; if desired, a two-layer tablet core including active agent and hydrophilic polymer in the first layer thereof and a hydrophilic polymer in the second layer thereof; at least one bore on the part of film-coat in contact with the core or core layer containing the active agent; and, if desired, containing one or more bore(s) in the part thereof in contact with the second layer containing the hydrophilic polymer, which comprises an ammonium methacrylate copolymer as coating material and hydroxypropyl-methylcellulose as hydrophilic polymer. The composition according to the invention is useful for preparing controlled drug-release tablets containing as active agents e.g. .beta.-adrenergic inhibitors (e.g. propranolol) calcium-antagonists (e.g. nifedipine), angiotensin convertase enzyme (ACE) inhibitors (e.g. captopril); prazosin; or nitroglycerol, all used in heart and circulation diseases; vasodilatory active agents (e.g. pentoxyfylline), nonsteroidal antiinflammatory agents (e.g. naproxene), analgetic drugs (e.g. morphine) and drugs acting on the central nervous system (e.g. amitriptyline, buspiron). The invention furthermore relates to a process for the preparation of the above compositions.

    摘要翻译： 本发明涉及一种新颖的扩散渗透控制药物释放药物组合物，其含有包含聚合物膜包衣，治疗活性剂和亲水性聚合物的单层片芯; 如果需要，在其第一层中包含活性剂和亲水性聚合物的两层片芯和其第二层中的亲水性聚合物; 膜包衣部分的至少一个孔与含有活性剂的芯层或芯层接触; 并且如果需要，在其部分中含有与包含亲水性聚合物的第二层接触的一个或多个孔，其包含作为涂层材料的甲基丙烯酸铵共聚物和作为亲水性聚合物的羟丙基甲基纤维素。 根据本发明的组合物可用于制备包含作为活性剂的受控药物释放片剂，例如， β-肾上腺素能抑制剂（如普萘洛尔）钙拮抗剂（如硝苯地平），血管紧张素转化酶（ACE）抑制剂（如卡托普利）; 哌唑嗪 或硝酸甘油，均用于心脏和循环疾病; 血管舒张活性剂（例如戊氧基线），非甾体抗炎剂（例如萘普生），止痛药（例如吗啡）和作用于中枢神经系统的药物（例如阿米替林，buspiron）。 本发明还涉及制备上述组合物的方法。

    Process for the preparation of solid pharmaceutical compositions
    2.
    发明授权
    Process for the preparation of solid pharmaceutical compositions 失效
    制备固体药物组合物的方法

    公开(公告)号：US5240662A

    公开(公告)日：1993-08-31

    申请号：US827397

    申请日：1992-01-29

    申请人： Sandor Erdos ,  Denes Bezzegh ,  Janos Egri ,  Erzsebet Barczay ,  Olga Magyar ,  Katalin Sumeg

    发明人： Sandor Erdos ,  Denes Bezzegh ,  Janos Egri ,  Erzsebet Barczay ,  Olga Magyar ,  Katalin Sumeg

    IPC分类号： A61K9/22 ,  A61K9/20 ,  A61K9/28 ,  A61K31/19 ,  A61K31/195 ,  A61K31/198 ,  A61K47/20 ,  A61K47/38 ,  A61P25/14 ,  C07C229/36 ,  C07C243/18

    CPC分类号： A61K9/2077 ,  A61K31/195 ,  A61K9/2004

    摘要： The invention relates to a process for the preparation of solid pharmaceutical compositions. More specifically, the invention relates to a process for the preparation of tablets ensuring an increased active ingredient release, where said tablets comprise as active ingredient a mixture of L-3,4-dihydroxyphenylalanine and L-alpha-hydrazino-alpha-methyl-3,4-dihydroxyphenyl propionic acid in a (3-12):1 mass to mass ratio, which comprises admixing any of L-3,4-dihydroxyphenylalanine and L-alpha-hydrazino-alpha-methyl-3,4-dihydroxyphenyl propionic acid, or both of them, with a hydrophilic diluent, preferably lactose and/or microcrystalline cellulose, and optionally with a colouring agent, blending the mixture thus obtained with auxiliary agents conventionally used for the preparation of tablets and optionally with the other active ingredient, furthermore with a solution of stearin in an appropriate solvent, preferably an alkanol comprising 2 to 4 carbon atoms, drying and granulating the mixture thus obtained, optionally admixing further auxiliary agent(s) to the dry granulate, compressing it into tablets comprising 50 to 70% by mass of active ingredient and, if desired, applying a film-coating onto the surface of the tablets thus obtained. The process according to the invention provides tablets of appropriate quality with rapid active ingredient release.