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1. 发明申请

WO9906046A9 COMBINATIONS OF HMG-COA REDUCTASE INHIBITORS AND NICOTINIC ACID AND METHODS FOR TREATING HYPERLIPIDEMIA 审中-公开
标题翻译： HMG-COA还原酶抑制剂与烟碱酸的组合以及治疗高脂血症的方法
公开(公告)号：WO9906046A9
公开(公告)日：1999-04-29
申请号：PCT/US9815989
申请日：1998-07-31
申请人： KOS PHARMA INC
发明人： BOVA DAVID J , DUNNE JOSEPHINE
IPC分类号： A61K9/22 , A61K9/24 , A61K31/44 , A61K31/455 , A61K31/465 , A61K31/60 , A61K9/20
CPC分类号： A61K31/465 , A61K9/209 , A61K31/44 , A61K31/455 , A61K31/60
摘要： The present invention relates to solid pharmaceutical combinations for oral administration comprising nicotinic acid or a nicotinic acid compound or mixtures thereof in an extended release form and an HMG-CoA reductase inhibitor, which are useful for altering lipid levels in subjects suffering from, for example, hyperlipidemia and atherosclerosis, without causing drug-induced hepatotoxicity, myopathy or rhabdomyolysis. The present invention also relates to methods of altering serum lipids in subjects to treat, for example, hyperlipidemia in hyperlipidemics, lipidemia in normolipidemics diagnosed with or predisposed to cardiovascular disease, and atherosclerosis, by administering such oral solid pharmaceutical combinations once per day as a single dose during the evening hours, without causing drug-induced hepatotoxicity, myopathy or rhabdomyolysis, or without causing in at least an appreciable number of individuals drug-induced hepatotoxicity, myopathy or rhabdomyolysis to such a level that discontinuation of such therapy would be required. More particularly, the present invention concerns oral solid pharmaceutical combinations comprised of, for example, (1) an HMG-CoA reductase inhibitor for immediate or extended release, (2) nicotinic acid, a nicotinic acid compound or mixtures thereof, and (3) a swelling agent to form a sustained release composition for extended release of the nicotinic acid or nicotinic acid compound or mixtures thereof for nocturnal or evening dosing for reducing serum lipids and increasing HDL-cholesterol. In accordance with the present invention, and by way of example, a composition for oral administration during the evening hours to alter serum lipids comprised of nicotinic acid and hydroxypropyl methylcellulose in the form of an extended or sustained release tablet or caplet coated with a coating comprising an HMG-CoA reductase inhibitor in immediate release form is disclosed. Also in accordance with the present invention, the pharmaceutical combinations may include a nonsteroidal anti-inflammatory agent for reducing the capacity of nicotinic acid or nicotinic acid compounds to provoke flushing reactions in individuals.
摘要翻译：本发明涉及用于口服给药的固体药物组合，其包含呈延长释放形式的烟酸或烟酸化合物或其混合物和HMG-CoA还原酶抑制剂，其可用于改变患有（例如）高脂血症和动脉粥样硬化，而不引起药物诱导的肝毒性，肌病或横纹肌溶解症。本发明还涉及改变受试者的血脂以治疗例如高脂血症中的高脂血症，诊断患有心血管疾病或易患心血管疾病或易患心血管疾病的血脂正常的血脂异常和动脉粥样硬化的方法，其通过每天一次给予这种口服固体药物组合在不引起药物引起的肝毒性，肌病或横纹肌溶解的情况下，或者至少在可察觉数量的个体中没有导致药物诱导的肝毒性，肌病或横纹肌溶解至需要停止这种治疗的水平。更特别地，本发明涉及口服固体药物组合，其包含例如（1）用于立即或延长释放的HMG-CoA还原酶抑制剂，（2）烟酸，烟酸化合物或其混合物，和（3）溶胀剂以形成延迟释放烟酸或烟酸化合物或其混合物的持续释放组合物用于夜间或夜间给药以减少血脂和增加HDL-胆固醇。根据本发明，并且举例来说，用于在傍晚时间口服给药的组合物，以改变包含烟酸和羟丙基甲基纤维素的血清脂质，所述血清脂质为延伸或缓释片剂或囊片，其形式为涂覆有包衣公开了立即释放形式的HMG-CoA还原酶抑制剂。还根据本发明，药物组合可以包括用于降低烟酸或烟酸化合物在个体中引起潮红反应的能力的非甾体抗炎剂。

2. 发明申请

WO9906035A3 COMBINATIONS OF HMG-CoA REDUCTASE INHIBITORS AND NICOTINIC ACID COMPOUNDS AND METHODS FOR TREATING HYPERLIPIDEMIA ONCE A DAY AT NIGHT 审中-公开
标题翻译： HMG-CoA还原酶抑制剂与烟碱酸化合物的组合以及在晚上一天治疗高脂血症的方法
公开(公告)号：WO9906035A3
公开(公告)日：1999-04-22
申请号：PCT/US9815990
申请日：1998-07-31
申请人： KOS PHARMA INC
发明人： BOVA DAVID J , DUNNE JOSEPHINE
IPC分类号： A61K9/16 , A61K9/20 , A61K9/24 , A61K9/48 , A61K31/455 , A61K45/06 , A61P3/06 , A61P9/10 , A61K31/785
CPC分类号： A61K45/06 , A61K9/2054 , A61K9/209 , A61K31/455 , A61K31/44 , A61K31/40 , A61K31/365 , A61K31/22 , A61K2300/00
摘要： The present invention relates to solid pharmaceutical combinations for oral administration comprising nicotinic acid or a nicotinic acid compound or mixtures thereof in an extended release form and an HMG-CoA reductase inhibitor, which are useful for altering lipid levels in subjects suffering from, for example, hyperlipidemia and atherosclerosis, without causing drug-induced hepatotoxicity, myopathy or rhabdomyolysis. The present invention also relates to methods of altering serum lipids in subjects to treat, for example, hyperlipidemia in hyperlipidemics, lipidemia in normolipidemics diagnosed with or predisposed to cardiovascular disease, and atherosclerosis, by administering such oral solid pharmaceutical combinations once per day as a single dose during the evening hours, without causing drug-induced hepatotoxicity, myopathy or rhabdomyolysis, or without causing in at least an appreciable number of individuals drug-induced hepatotoxicity, myopathy or rhabdomyolysis to such a level that discontinuation of such therapy would be required. More particularly, the present invention concerns oral solid pharmaceutical combinations comprised of, for example, (1) an HMG-CoA reductase inhibitor for immediate or extended release, (2) nicotinic acid, a nicotinic acid compound or mixtures thereof, and (3) a swelling agent to form a sustained release composition for extended release of the nicotinic acid or nicotinic acid compound or mixtures thereof for nocturnal or evening dosing for reducing serum lipids and increasing HDL-cholesterol. In accordance with the present invention, and by way of example, a composition for oral administration during the evening hours to alter serum lipids comprised of nicotinic acid and hydroxypropyl methylcellulose in the form of an extended or sustained release tablet or caplet coated with a coating comprising an HMG-CoA reductase inhibitor in immediate release form is disclosed. Also in accordance with the present invention, the pharmaceutical combinations may include a nonsteroidal anti-inflammatory agent for reducing the capacity of nicotinic acid or nicotinic acid compounds to provoke flushing reactions in individuals.
摘要翻译：本发明涉及用于口服给药的固体药物组合，其包含呈延长释放形式的烟酸或烟酸化合物或其混合物和HMG-CoA还原酶抑制剂，其可用于改变患有（例如）高脂血症和动脉粥样硬化，而不引起药物诱导的肝毒性，肌病或横纹肌溶解症。本发明还涉及改变受试者的血脂以治疗例如高脂血症中的高脂血症，诊断患有心血管疾病或易患心血管疾病或易患心血管疾病的血脂正常的血脂异常和动脉粥样硬化的方法，其通过每天一次给予这种口服固体药物组合在不引起药物引起的肝毒性，肌病或横纹肌溶解的情况下，或者至少在可察觉数量的个体中没有导致药物诱导的肝毒性，肌病或横纹肌溶解至需要停止这种治疗的水平。更特别地，本发明涉及口服固体药物组合，其包含例如（1）用于立即或延长释放的HMG-CoA还原酶抑制剂，（2）烟酸，烟酸化合物或其混合物，和（3）溶胀剂以形成延迟释放烟酸或烟酸化合物或其混合物的持续释放组合物用于夜间或夜间给药以减少血脂和增加HDL-胆固醇。根据本发明，并且举例来说，用于在傍晚时间口服给药的组合物，以改变包含烟酸和羟丙基甲基纤维素的血清脂质，所述血清脂质为延伸或缓释片剂或囊片，其形式为涂覆有包衣公开了立即释放形式的HMG-CoA还原酶抑制剂。还根据本发明，药物组合可以包括用于降低烟酸或烟酸化合物在个体中引起潮红反应的能力的非甾体抗炎剂。

3. 发明专利

CA2283159C NICOTINIC ACID COMPOSITIONS FOR TREATING HYPERLIPIDEMIA AND RELATED METHODS THEREFOR 未知
公开(公告)号：CA2283159C
公开(公告)日：2007-06-19
申请号：CA2283159
申请日：1998-03-06
申请人： KOS PHARMA INC
发明人： BOVA DAVID J
IPC分类号： A61K31/455 , A61K9/20 , A61K9/22 , A61K31/44 , A61P3/06
摘要： An orally administered antihyperlipidemia composition according to the prese nt invention includes from about 250 to about 3000 parts by weight of nicotinic acid, and from about 5 to about 50 parts by weight of hydroxypropyl methylcellulose. Also, a method of treating hyperlipidemia in a hyperlipidemic having a substantially periodic physiological loss of consciousness includes the steps of forming a composition having an effective antihyperlipidemic amount of nicotinic aci d and a time release sustaining amount of a swelling agent. The method also includes the step of orally administering the composition to the hyperlipidemic once per day "nocturnally", that is in the evening or at night.

4. 发明专利

CA2298549A1 COMBINATIONS OF HMG-COA REDUCTASE INHIBITORS AND NICOTINIC ACID COMPOUNDS AND METHODS FOR TREATING HYPERLIPIDEMIA ONCE A DAY AT NIGHT 未知
公开(公告)号：CA2298549A1
公开(公告)日：1999-02-11
申请号：CA2298549
申请日：1998-07-31
申请人： KOS PHARMA INC
发明人： DUNNE JOSEPHINE , BOVA DAVID J
IPC分类号： A61K9/16 , A61K9/20 , A61K9/24 , A61K9/48 , A61K31/455 , A61K45/06 , A61P3/06 , A61P9/10 , A61K31/00
摘要： The present invention relates to solid pharmaceutical combinations for oral administration comprising nicotinic acid or a nicotinic acid compound or mixtures thereof in an extended release form and an HMG-CoA reductase inhibitor, which are useful for altering lipid levels in subjects suffering from, for example, hyperlipidemia and atherosclerosis, without causing druginduced hepatotoxicity, myopathy or rhabdomyolysis. The present invention also relates to methods of altering serum lipids in subjects to treat, for example, hyperlipidemia in hyperlipidemics, lipidemia in normolipidemics diagnosed with or predisposed to cardiovascular disease, and atherosclerosis, by administering such oral solid pharmaceutical combinations once per day as a single dose during the evening hours, without causing drug-induced hepatotoxicity, myopathy or rhabdomyolysis, or without causing in at least an appreciable number of individuals drug-induced hepatotoxicity, myopathy or rhabdomyolysis to such a level that discontinuation of such therapy would be required. More particularly, the present invention concerns oral solid pharmaceutical combinations comprised of, for example, (1) an HMG-CoA reductase inhibitor for immediate or extended release, (2) nicotinic acid, a nicotinic acid compound or mixtures thereof, and (3) a swelling agent to form a sustained release composition for extended release of the nicotinic acid or nicotinic acid compound or mixtures thereof for nocturnal or evening dosing for reducing serum lipids and increasing HDL-cholesterol. In accordance with the present invention, and by way of example, a composition for oral administration during the evening hours to alter serum lipids comprised of nicotinic acid and hydroxypropyl methylcellulose in the form of an extended or sustained release tablet or caplet coated with a coating comprising an HMG-CoA reductase inhibitor in immediate release form is disclosed. Also in accordance with the present invention, the pharmaceutical combinations may include a nonsteroidal anti-inflammatory agent for reducing the capacity of nicotinic acid or nicotinic acid compounds to provoke flushing reactions in individuals.

5. 发明专利

CA2297764A1 COMBINATIONS OF HMG-COA REDUCTASE INHIBITORS AND NICOTINIC ACID AND METHODS FOR TREATING HYPERLIPIDEMIA 未知
公开(公告)号：CA2297764A1
公开(公告)日：1999-02-11
申请号：CA2297764
申请日：1998-07-31
申请人： KOS PHARMA INC
发明人： BOVA DAVID J , DUNNE JOSEPHINE
IPC分类号： A61K9/22 , A61K9/24 , A61K31/44 , A61K31/455 , A61K31/465 , A61K31/60 , A61K9/20
摘要： The present invention relates to solid pharmaceutical combinations for oral administration comprising nicotinic acid or a nicotinic acid compound or mixtures thereof in an extended release form and an HMG-CoA reductase inhibitor, which are useful for altering lipid levels in subjects suffering from, for example, hyperlipidemia and atherosclerosis, without causing druginduced hepatotoxicity, myopathy or rhabdomyolysis. The present invention also relates to methods of altering serum lipids in subjects to treat, for example, hyperlipidemia in hyperlipidemics, lipidemia in normolipidemics diagnosed with or predisposed to cardiovascular disease, and atherosclerosis, by administering such oral solid pharmaceutical combinations once per day as a single dose during the evening hours, without causing drug-induced hepatotoxicity, myopathy or rhabdomyolysis, or without causing in at least an appreciable number of individuals drug-induced hepatotoxicity, myopathy or rhabdomyolysis to such a level that discontinuation of such therapy would be required. More particularly, the present invention concerns oral solid pharmaceutical combinations comprised of, for example, (1) an HMG-CoA reductase inhibitor for immediate or extended release, (2) nicotinic acid, a nicotinic acid compound or mixtures thereof, and (3) a swelling agent to form a sustained release composition for extended release of the nicotinic acid or nicotinic acid compound or mixtures thereof for nocturnal or evening dosing for reducing serum lipids and increasing HDL-cholesterol. In accordance with the present invention, and by way of example, a composition for oral administration during the evening hours to alter serum lipids comprised of nicotinic acid and hydroxypropyl methylcellulose in the form of an extended or sustained release tablet or caplet coated with a coating comprising an HMG-CoA reductase inhibitor in immediate release form is disclosed. Also in accordance with the present invention, the pharmaceutical combinations may include a nonsteroidal anti-inflammatory agent for reducing the capacity of nicotinic acid or nicotinic acid compounds to provoke flushing reactions in individuals.

6. 发明专利

CA2298549C COMBINATIONS OF HMG-COA REDUCTASE INHIBITORS AND NICOTINIC ACID COMPOUNDS AND METHODS FOR TREATING HYPERLIPIDEMIA ONCE A DAY AT NIGHT 未知
公开(公告)号：CA2298549C
公开(公告)日：2006-01-10
申请号：CA2298549
申请日：1998-07-31
申请人： KOS PHARMA INC
发明人： BOVA DAVID J , DUNNE JOSEPHINE
IPC分类号： A61K9/16 , A61K31/00 , A61K9/20 , A61K9/24 , A61K9/48 , A61K31/455 , A61K45/06 , A61P3/06 , A61P9/10
摘要： The present invention relates to solid pharmaceutical combinations for oral administration comprising nicotinic acid or a nicotinic acid compound or mixtures thereof in an extended release form and an HMG-CoA reductase inhibitor, which are useful for altering lipid levels in subjects suffering from, for example, hyperlipidemia and athetosclerosis, without causing drug-induced hepatotoxicity, myopathy or rhabdomyolysis. The present invention also relates to methods of altering serum lipids in subjects to treat, for example, hyperlipidemia in hyperlipidemics, lipidemia in normolipidemics diagnosed with or predisposed to cardiovascular disease, and atherosclerosis, by administering such oral solid pharmaceutical combinations once per day as a single dose during the evening hours, without causing drug-induced hepatotoxicity, myopathy or rhabdomyolysis, or without causing in at least a n appreciable number of individuals drug-induced hepatotoxicity, myopathy or rhabdomyolysis to such a level that discontinuation of such therapy would be required. More particularly, the present invention concerns oral solid pharmaceutical combinations comprised of, for example, ( 1) an HMG-CoA reductase inhibitor for immediate or extended release, (2) nicotinic acid, a nicotinic acid compound or mixtures thereof, and (3) a swelling agent to form a sustained release composition for extended release of the nicotinic acid or nicotinic acid compound or mixtures thereof for nocturnal or evening dosing for reducing serum lipids and increasing HDL-cholesterol. In accordance with the present invention, and by way of example, a composition for oral administration during the evening hours to alter serum lipids comprised of nicotinic acid and hydroxypropyl methylcellulose in the form of an extended or sustained release tablet or caplet coated with a coating comprising an HMG-CoA reductase inhibitor in immediate release form is disclosed. Also in accordance with the present invention, the pharmaceutical combinations may include a nonsteroidal anti-inflammatory agent for reducing the capacity of nicotinic acid or nicotinic acid compound s to provoke flushing reactions in individuals.

7. 发明专利

BR9815549A 未知
公开(公告)号：BR9815549A
公开(公告)日：2004-06-22
申请号：BR9815549
申请日：1998-07-31
申请人： KOS PHARMA INC
发明人： BOVA DAVID J , DUNNE JOSEPHINE
IPC分类号： A61K9/22 , A61K9/24 , A61K31/44 , A61K31/455 , A61K31/465 , A61K31/60 , A61K9/20
摘要： A pharmaceutical composition for once per day administration to alter lipids in an individual without causing drug-induced hepatotoxicity, myopathy or rhabdomyolysis, said pharmaceutical composition comprising an effective lipid altering amount of nicotinic acid in an extended release form and an effective lipid altering amount of an HMG-CoA reductase inhibitor.

8. 发明专利

NO20000407D0 未知
公开(公告)号：NO20000407D0
公开(公告)日：2000-01-27
申请号：NO20000407
申请日：2000-01-27
申请人： KOS PHARMA INC
发明人： BOVA DAVID J , DUNNE JOSEPHINE
IPC分类号： A61K9/22 , A61K9/24 , A61K31/44 , A61K31/455 , A61K31/465 , A61K31/60 , A61K
摘要： A pharmaceutical composition for once per day administration to alter lipids in an individual without causing drug-induced hepatotoxicity, myopathy or rhabdomyolysis, said pharmaceutical composition comprising an effective lipid altering amount of nicotinic acid in an extended release form and an effective lipid altering amount of an HMG-CoA reductase inhibitor.

9. 发明专利

NO20000407L 未知
公开(公告)号：NO20000407L
公开(公告)日：2000-03-16
申请号：NO20000407
申请日：2000-01-27
申请人： KOS PHARMA INC
发明人： BOVA DAVID J , DUNNE JOSEPHINE
IPC分类号： A61K9/22 , A61K9/24 , A61K31/44 , A61K31/455 , A61K31/465 , A61K31/60 , A61K9/20 , A61P3/06
摘要： A pharmaceutical composition for once per day administration to alter lipids in an individual without causing drug-induced hepatotoxicity, myopathy or rhabdomyolysis, said pharmaceutical composition comprising an effective lipid altering amount of nicotinic acid in an extended release form and an effective lipid altering amount of an HMG-CoA reductase inhibitor.

10. 发明专利

NO20000439D0 未知
公开(公告)号：NO20000439D0
公开(公告)日：2000-01-27
申请号：NO20000439
申请日：2000-01-27
申请人： KOS PHARMA INC
发明人： BOVA DAVID J , DUNNE JOSEPHINE
IPC分类号： A61K9/16 , A61K9/20 , A61K9/24 , A61K9/48 , A61K31/455 , A61K45/06 , A61P3/06 , A61P9/10 , A61K

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