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11. 发明授权

US07906141B2 Sustained-release, oral pharmaceutical forms of formulation 失效
标题翻译：持续释放，口服药物形式的配方
公开(公告)号：US07906141B2
公开(公告)日：2011-03-15
申请号：US10084676
申请日：2002-02-28
申请人： Iris Ziegler , Johannes Bartholomaeus
发明人： Iris Ziegler , Johannes Bartholomaeus
IPC分类号： A61K9/22 , A61K9/52 , A61K31/135
CPC分类号： A61K31/19 , A61K9/1617 , A61K9/1623 , A61K9/1652 , A61K9/2081 , A61K9/2846 , A61K9/5015 , A61K9/5026 , A61K9/5047 , A61K31/135 , A61K31/137 , A61K31/195 , A61K31/196 , A61K31/428 , A61K31/60 , A61K2300/00
摘要： A sustained-release, oral pharmaceutical formulation of tramadol comprising a compound formed in situ of tramadol or its salt and a pharmaceutically acceptable acidic substance. The compound formed in situ has a desired water solubility. Also provided are methods of treatment using the pharmaceutical formulations. Method for preparing such formulations are also provided. The preparation method comprises repeatedly mixing tramadol or its salt with the acidic substance, and moistening the mixture and formulating the mixture under an energy input, such as heat or pressure. Optionally, drying, repeated granulating, extrudation and pelleting may also be included.
摘要翻译：曲马多的缓释口服药物制剂，其包含由曲马多或其盐原位形成的化合物和药学上可接受的酸性物质。原位形成的化合物具有所需的水溶性。还提供了使用药物制剂的治疗方法。还提供了制备这些制剂的方法。制备方法包括将曲马多或其盐与酸性物质重复混合，并在能量输入如热或压力下润湿混合物并配制该混合物。任选地，还可以包括干燥，重复造粒，挤出和造粒。

12. 发明授权

US06558701B2 Multilayer tablet for administering a fixed combination of tramadol and diclofenac 失效
公开(公告)号：US06558701B2
公开(公告)日：2003-05-06
申请号：US10016121
申请日：2001-12-17
申请人： Johannes Bartholomaeus , Iris Ziegler
发明人： Johannes Bartholomaeus , Iris Ziegler
IPC分类号： A61K922
CPC分类号： A61K31/195 , A61K9/209 , A61K31/135 , A61K2300/00
摘要： A multilayer tablet for oral administration containing at least one Tramadol layer including Tramadol or a physiologically acceptable salt thereof; at least one diclofenac layer including diclofenac or a physiologically acceptable salt thereof, and at least one separating layer which separates the tramadol layer(s) and the diclofenac layer(s) from each other.

13. 发明授权

US07897173B2 Sustained-release, oral pharmaceutical formulations and methods of making and using same 失效
标题翻译：持续释放，口服药物制剂及其制备和使用方法
公开(公告)号：US07897173B2
公开(公告)日：2011-03-01
申请号：US10837755
申请日：2004-05-04
申请人： Iris Ziegler , Johannes Bartholomaeus
发明人： Iris Ziegler , Johannes Bartholomaeus
IPC分类号： A61K9/00 , A61K31/137
CPC分类号： A61K31/19 , A61K9/1617 , A61K9/1623 , A61K9/1652 , A61K9/2081 , A61K9/2846 , A61K9/5015 , A61K9/5026 , A61K9/5047 , A61K31/135 , A61K31/137 , A61K31/195 , A61K31/196 , A61K31/428 , A61K31/60 , A61K2300/00
摘要： A sustained-release, oral pharmaceutical formulation of tramadol comprising a compound formed in situ of tramadol or a tramadol salt and a pharmaceutically acceptable acidic substance. The compound formed in situ has a desired water solubility. Also provided are methods of treatment using the pharmaceutical formulations. Method for preparing such formulations are also provided. The preparation method comprises repeatedly mixing tramadol or its salt with the acidic substance, and moistening the mixture and formulating the mixture under an energy input, such as heat or pressure. Optionally, drying, repeated granulating, extrudation and pelleting may also be included.
摘要翻译：曲马多的缓释口服药物制剂，其包含由曲马多或曲马多盐和药学上可接受的酸性物质原位形成的化合物。原位形成的化合物具有所需的水溶性。还提供了使用药物制剂的治疗方法。还提供了制备这些制剂的方法。制备方法包括将曲马多或其盐与酸性物质重复混合，并在能量输入如热或压力下润湿混合物并配制该混合物。任选地，还可以包括干燥，重复造粒，挤出和造粒。

14. 发明授权

US07666860B2 Melt-formulated, multi-particulate oral dosage form 有权
标题翻译：融合配方，多粒度口服剂型
公开(公告)号：US07666860B2
公开(公告)日：2010-02-23
申请号：US11366583
申请日：2006-03-03
申请人： Iris Ziegler , Johannes Bartholomaeus , Dieter Schateikis
发明人： Iris Ziegler , Johannes Bartholomaeus , Dieter Schateikis
IPC分类号： A01N43/10 , A61K31/43 , A61K9/14 , A61K9/127
CPC分类号： A61K9/1652 , A61K9/0095 , A61K9/1623 , A61K31/424 , A61K2300/00
摘要： A melt-formulated, multiparticulate, oral dosage form containing clavulanic acid and/or at least one physiologically acceptable salt thereof and at least one sucrose fatty acid ester and optionally further physiologically acceptable auxiliary substances; a process for producing such a dosage form, combination dosage forms with β-lactam antibiotics, and the pharmaceutical use thereof, e.g., for treating bacterial infections.
摘要翻译：含有克拉维酸和/或其至少一种生理学上可接受的盐和至少一种蔗糖脂肪酸酯和任选的其它生理上可接受的辅助物质的熔融配制的多颗粒口服剂型; 用于制备这种剂型的方法，与β-内酰胺抗生素的组合剂型及其药物用途，例如用于治疗细菌感染。

15. 发明授权

US07410965B2 Delayed release pharmaceutical composition containing 1-dimethyl-amino-3-(3-methoxyphenyl)-2-methyl-pentan-3-ol 失效
标题翻译：含有1-二甲基 - 氨基-3-（3-甲氧基苯基）-2-甲基 - 戊-3-醇的延迟释放药物组合物
公开(公告)号：US07410965B2
公开(公告)日：2008-08-12
申请号：US10998159
申请日：2004-11-29
申请人： Johannes Bartholomaeus , Iris Ziegler
发明人： Johannes Bartholomaeus , Iris Ziegler
IPC分类号： A61K31/535 , C07C69/96 , C07C229/00 , C07C261/00 , C07F9/02
CPC分类号： A61K31/13 , A61K9/2054
摘要： A delayed release pharmaceutical formulation containing 1-dimethylamino-3-(3-methoxyphenyl)-2-methylpentan-3-ol or a pharmaceutically acceptable salt thereof in a matrix; said matrix containing from 1 to 80 wt. % of at least one pharmaceutically acceptable, matrix-forming, hydrophilic or hydrophobic polymer and having the following in vitro dissolution rate relative to 100 wt. % of the 1-dimethylamino-3-(3-methoxyphenyl)-2-methylpentan-3-ol contained in the formulation: 3-35 wt. % released after 0.5 hour, 5-50 wt. % released after 1 hour, 10-75 wt. % released after 2 hours, 15-82 wt. % released after 3 hours, 30-97 wt. % released after 6 hours, more than 50 wt. % released after 12 hours, more than 70 wt. % released after 18 hours, and more than 80 wt. % released after 24 hours.
摘要翻译：含有1-二甲基氨基-3-（3-甲氧基苯基）-2-甲基戊-3-醇或其药学上可接受的盐的基质中的延迟释放药物制剂; 所述基质含有1至80wt。至少一种药学上可接受的，基质形成的，亲水的或疏水的聚合物的％，并且相对于100重量％具有以下体外溶出速率。制剂中所含的1-二甲基氨基-3-（3-甲氧基苯基）-2-甲基戊-3-醇的％：3-35重量％ 0.5小时后释放％，5-50重量％ 1小时后释放％，10-75重量％ 2小时后释放％，15-82wt。 3小时后释放％，30-97重量％ 6小时后释放％，超过50重量％ 12小时后释放％，超过70wt。 18小时后释放％，超过80重量％。 24小时后释放％。

16. 发明授权

US06576260B2 Sustained-release form of administration containing tramadol saccharinate 失效
公开(公告)号：US06576260B2
公开(公告)日：2003-06-10
申请号：US10084248
申请日：2002-02-28
申请人： Johannes Bartholomaeus , Heinrich Kugelmann , Iris Ziegler
发明人： Johannes Bartholomaeus , Heinrich Kugelmann , Iris Ziegler
IPC分类号： A61K926
CPC分类号： C07D275/06 , A61K9/0056 , A61K9/0058 , A61K9/0095 , A61K9/1652 , A61K9/2054 , A61K9/2081 , A61K9/2846 , A61K9/5015 , A61K9/5026 , A61K9/5047 , A61K31/135 , A61K31/137 , A61K31/19 , A61K31/195 , A61K31/205 , A61K31/428 , A61K31/54 , A61K31/60 , C07C217/74 , C07C307/02 , C07C2601/14 , C07D291/06 , A61K2300/00
摘要： Disclosed herein is sustained-release formulations of tramadol comprising tramadol saccharinate coated with at least one sustained-release coating. The sustained release formulations may also contain tramadol in non-sustained release form, and other pharmaceutically acceptable excipients. Also disclosed are methods of preparation of and methods of treatment using the inventive formulations.

17. 发明授权

US08383152B2 Pharmaceutical dosage form 有权
标题翻译：药物剂型
公开(公告)号：US08383152B2
公开(公告)日：2013-02-26
申请号：US12358415
申请日：2009-01-23
申请人： Eugeen Marie Jozef Jans , Filip René Irena Kiekens , Jody Firmin Marceline Voorspoels , Anne Faure , Elisabeth Arkenau-Maric , Lutz Barnscheid , Johannes Bartholomäus , Marc Frevel , Eric Galia , Iris Ziegler , Andrea Schüssele
发明人： Eugeen Marie Jozef Jans , Filip René Irena Kiekens , Jody Firmin Marceline Voorspoels , Anne Faure , Elisabeth Arkenau-Maric , Lutz Barnscheid , Johannes Bartholomäus , Marc Frevel , Eric Galia , Iris Ziegler , Andrea Schüssele
IPC分类号： A61K9/22 , A61K9/20 , A61K9/28 , A61K31/135
CPC分类号： A61K9/2072 , A61K9/2018 , A61K9/2031 , A61K9/2054 , A61K9/2059 , A61K31/135 , A61K31/137 , Y10T428/24479
摘要： The invention relates to a pharmaceutical dosage form, preferably with controlled release of a pharmacologically active compound (A) contained therein, the pharmaceutical dosage form very preferably being tamper-resistant and most preferably having a breaking strength B1 of at least 500 N in direction of extension E1 and having a breaking strength B2 of less than 500 N in direction of extension E2.
摘要翻译：本发明涉及药物剂型，优选具有其中所含的药理活性化合物（A）的受控释放，所述药物剂型非常优选是防篡改的，最优选地具有至少500N的断裂强度B1，方向为并且在延伸方向E2具有小于500N的断裂强度B2。

18. 发明申请

US20080300569A1 Storage-Stable Oral Dosage Form of Amoxicillin and Clavulanic Acid 审中-公开
标题翻译：阿莫西林和克拉维酸的储存稳定口服剂型
公开(公告)号：US20080300569A1
公开(公告)日：2008-12-04
申请号：US12192784
申请日：2008-08-15
申请人： Dieter SCHATEIKIS , Elke Sternberger , Iris Ziegler
发明人： Dieter SCHATEIKIS , Elke Sternberger , Iris Ziegler
IPC分类号： A61B19/00
CPC分类号： A47G21/183 , A61J7/0038 , A61K9/0095 , A61K9/1611 , A61K9/1623 , A61K9/5026 , A61K9/5084 , A61K31/00 , A61K31/424 , A61K31/43 , A61K45/06 , A61K2300/00
摘要： An airtight-packaged system including: (1) a combination of two independently prepared pharmaceutical drug forms composed of a first drug form in aqueous formulation containing amoxicillin trihydrate as active pharmaceutical ingredient and a second drug form prepared separately from the first and containing potassium clavulanate as active pharmaceutical ingredient, in which the active ingredients in the combination of the first and second drug forms are present in a nominal weight ratio of amoxicillin to clavulanic acid of from 20:1 to 1:1, and (2) a preparation containing at least one desiccant in amounts such that when the packaged system is stored under stress conditions at 40° C. and 75% relative humidity for up to 3 months, the dimerization of amoxicillin trihydrate does not exceed 1.5% by weight, and the degradation of clavulanic acid does not exceed 10% by weight.
摘要翻译：一种气密包装系统，包括：（1）由含有阿莫西林三水合物作为活性药物成分的水性制剂中的第一种药物形式和由第一种和第一种并以克拉维酸钾分开制备的第二种药物形式组合的两种独立制备的药物形式的组合，活性药物成分，其中第一和第二药物形式的组合中的活性成分以20:1至1:1的标称重量比的阿莫西林与克拉维酸存在，和（2）至少含有至少一种干燥剂的量使得当包装系统在40℃和75％相对湿度的压力条件下储存长达3个月时，阿莫西林三水合物的二聚化不超过1.5重量％，并且克拉维酸的降解不超过10重量％。

19. 发明授权

US08147874B2 Coated pellets 有权
标题翻译：涂层颗粒
公开(公告)号：US08147874B2
公开(公告)日：2012-04-03
申请号：US12483646
申请日：2009-06-12
申请人： Iris Ziegler , Irwin Jacobs
发明人： Iris Ziegler , Irwin Jacobs
IPC分类号： A61K9/14 , A61K9/28 , A61K9/34 , A61K9/42
CPC分类号： A61K9/5015 , A61K9/0095 , A61K9/5026 , A61K9/5036 , A61K9/5047 , Y02A50/473 , Y02A50/475 , Y02A50/481
摘要： Coated pellets which comprise an active pharmaceutical ingredient that is poorly soluble in water, release at least 80% of the active ingredient under in vitro conditions in phosphate buffer at pH 5.0 after 30 minutes and are bioequivalent to a liquid formulation of the active ingredient under in vitro fed status test conditions and/or are coated with a composition, which includes a lipophilic component (A) and a hydrogel former (B), wherein the pure lipophilic component (A) has (i) an HLB value of ≦5, and/or (ii) a melting range of ≧60° C., and/or (iii) a solidification range Δ of less than 35° C., and/or (iv) a density of ≧0.80 g cm−3.
摘要翻译：包含难溶于水的活性药物成分的包被的丸粒在体外条件下在30分钟后在pH 5.0的磷酸盐缓冲液中释放至少80％的活性成分，并且与活性成分的液体制剂在生物等效于在体外饲养状态测试条件和/或涂覆有包含亲脂性组分（A）和水凝胶形成剂（B）的组合物，其中纯亲脂性组分（A）具有（i）HLB值为＆lt; 和/或（ii）熔点范围≥60℃，和/或（iii）凝固范围＆Dgr; 小于35℃，和/或（iv）≧0.80g cm -3的密度。

20. 发明授权

US06558704B1 Process for preparing pellets containing up to 90 wt.% of a pharmaceutical active ingredient 失效
标题翻译：制备含有至多90重量％药物活性成分的丸粒的方法
公开(公告)号：US06558704B1
公开(公告)日：2003-05-06
申请号：US09484015
申请日：2000-01-18
申请人： Johannes Heinrich Bartholomaeus , Iris Ziegler
发明人： Johannes Heinrich Bartholomaeus , Iris Ziegler
IPC分类号： A61K914
CPC分类号： A61K9/1694 , A61K9/1652
摘要： A process for the preparation of pellets containing ≧50 wt. % of a pharmaceutical active ingredient having a solubility in water of ≧0.5 g/ml, by aqueous granulation of the mixture containing the active ingredient, extrusion, rounding and drying of the moist granules, using a mixture consisting of A) at least 50 wt. % of at least one active ingredient having a solubility in water of ≧0.5 g/ml, and B) at most 50 wt. % of the combination of a) a microcrystalline cellulose having an average particle size of 15 to 20 &mgr;m and b) a low-substituted hydropropyl cellulose having an average particle size in the range of 10 to 25 &mgr;m, the weight ratio of a):b) being in the range of 4:6 to 6:4.
摘要翻译：制备含有> = 50wt。通过含有活性成分的混合物的水性造粒，湿润颗粒的挤出，倒圆和干燥，使用由以下组成的混合物组成的混合物：％）至少50重量％。％的至少一种在水中的溶解度> = 0.5g / ml的活性成分，和B）至多50wt。 a）平均粒径为15〜20μm的微晶纤维素和b）平均粒径为10〜25μm的低取代的羟丙基纤维素的组合的a）a）的重量比：b）在4：6到6：4的范围内。

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