公开(公告)号：US08900637B2

公开(公告)日：2014-12-02

申请号：US12095767

申请日：2005-12-02

申请人： Sachin Pundlik Kolhe ,  Subrata Kundu ,  Sanjay Chhagan Wagh ,  Makarand Krishnakumar Avachat ,  Himadri Sen

发明人： Sachin Pundlik Kolhe ,  Subrata Kundu ,  Sanjay Chhagan Wagh ,  Makarand Krishnakumar Avachat ,  Himadri Sen

IPC分类号： A61K9/16 ,  A61K31/00 ,  A61K9/28

CPC分类号： A61K31/00 ,  A61K9/1635 ,  A61K9/2886

摘要： A stable taste masked, pharmaceutical composition comprising a plurality of coated, non-disintegrating discrete dosage units, said units comprising of a core comprising one or more cephalosporins such as cefuroxime axetil and cefpodoxime proxetil and one or more coating layers. Cefuroxime axetil is in α-crystalline and amorphous forms, where at least 30% of the Cefuroxime axetil is in the α-crystalline form, wherein the particle size distribution of the α-crystalline form being such that 100% of the particles have a particle size below 250μ. The ratio of the crystalline fraction to the amorphous fraction ranges from 0.3:0.7 to 0.99:0.01. The particle size of cefpodoxime proxetil is such that 90% of the particles are below 15μ. The process of preparation of coated, non-disintegrating pellets comprising the steps of reducing the particle size of the one or more cephalosporins, blending with the other excipients, wet granulation, extrusion, spheronization, drying and screening to obtain pellets, said pellets being further coated with one or more layers of film coating to achieve taste masking.

摘要翻译： 稳定的掩味的药物组合物，其包含多个涂覆的，不分散的离散剂量单位，所述单元由包含一种或多种头孢菌素如头孢呋辛酯和头孢泊肟酯的核心和一个或多个涂层组成。 头孢呋辛酯是α-晶型和无定形形式，其中至少30％的头孢呋辛酯为α-结晶形式，其中α-晶型的粒度分布使得100％的颗粒具有颗粒 尺寸低于250μ。 结晶部分与无定形部分的比例为0.3:0.7至0.99:0.01。 头孢泊肟酯的粒径使得90％的颗粒小于15μ。 包衣，非崩解丸剂的制备方法包括以下步骤：减少一种或多种头孢菌素的粒度，与其它赋形剂混合，湿法制粒，挤出，滚圆，干燥和筛选以获得丸粒，所述丸粒进一步 涂覆一层或多层薄膜包衣以达到掩味。

公开(公告)号：US20090022809A1

公开(公告)日：2009-01-22

申请号：US12095767

申请日：2005-12-02

申请人： Sachin Pundlik Kolhe ,  Subrata Kundu ,  Sanjay Chhagan Wagh ,  Makarand Krishnakumar Avachat ,  Himadri Sen

发明人： Sachin Pundlik Kolhe ,  Subrata Kundu ,  Sanjay Chhagan Wagh ,  Makarand Krishnakumar Avachat ,  Himadri Sen

IPC分类号： A61K9/16

CPC分类号： A61K31/00 ,  A61K9/1635 ,  A61K9/2886

摘要： A stable taste masked, pharmaceutical composition comprising a plurality of coated, non-disintegrating discrete dosage units, said units comprising of a core comprising one or more cephalosporins such as cefuroxime axetil and cefpodoxime proxetil and one or more coating layers. Cefuroxime axetil is in α-crystalline and amorphous forms, where at least 30% of the Cefuroxime axetil is in the α-crystalline form, wherein the particle size distribution of the α-crystalline form being such that 100% of the particles have a particle size below 250μ. The ratio of the crystalline fraction to the amorphous fraction ranges from 0.3:0.7 to 0.99:0.01. The particle size of cefpodoxime proxetil is such that 90% of the particles are below 15μ. The process of preparation of coated, non-disintegrating pellets comprising the steps of reducing the particle size of the one or more cephalosporins, blending with the other excipients, wet granulation, extrusion, spheronization, drying and screening to obtain pellets, said pellets being further coated with one or more layers of film coating to achieve taste masking.

摘要翻译： 稳定的掩味的药物组合物，其包含多个涂覆的，不分散的离散剂量单位，所述单元由包含一种或多种头孢菌素如头孢呋辛酯和头孢泊肟酯的核心和一个或多个涂层组成。 头孢呋辛酯是α-晶型和无定形形式，其中至少30％的头孢呋辛酯为α-晶型，其中α-晶形的粒度分布使得100％的颗粒具有颗粒 尺寸在250mu以下。 结晶部分与无定形部分的比例为0.3:0.7至0.99:0.01。 头孢泊肟酯的粒径使得90％的颗粒小于15mu。 包衣，非崩解丸剂的制备方法包括以下步骤：减少一种或多种头孢菌素的粒度，与其它赋形剂混合，湿法制粒，挤出，滚圆，干燥和筛选以获得丸粒，所述丸粒进一步 涂覆一层或多层薄膜包衣以达到掩味。