CN101346147B - 协同粘合剂组合物、其制备方法及活性物质和所述粘合剂的具有有益的硬度和脆碎度的片剂 - Google Patents
协同粘合剂组合物、其制备方法及活性物质和所述粘合剂的具有有益的硬度和脆碎度的片剂 Download PDFInfo
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- CN101346147B CN101346147B CN200680044892.9A CN200680044892A CN101346147B CN 101346147 B CN101346147 B CN 101346147B CN 200680044892 A CN200680044892 A CN 200680044892A CN 101346147 B CN101346147 B CN 101346147B
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Abstract
使用共处理的(a)乙烯基吡咯烷酮(VP)和乙酸乙烯(VA)的共聚物与(b)微晶纤维素(MCC)的协同粘合剂组合物,以1-30∶99-70的(a)∶(b)的重量比,经喷雾干燥得到对于活性物质而言易于压缩的赋形剂粘合剂粉末,通过直接压缩制得药用的、营养的或维生素活性的化合物或组合物(例如不易压缩的药物)的片剂。在可接受的压缩力下,本文得到的片剂具有有益的硬度和脆碎度。
Description
发明背景
1.发明领域
本发明涉及药用的、营养的或维生素活性的化合物或组合物(例如不易压缩的药物)的压片,且更具体地,涉及一种新的和改进的协同粘合剂组合物及其制备方法,以及涉及通过在适当的压缩力下直接压缩而将这样的活性物质和粘合剂加工成具有有益的硬度和脆碎度的片剂。
2.现有技术描述
许多商品化的填充材料(如微晶纤维素和硅化微晶纤维素)可用于制备药用的、营养的和维生素活性的化合物与组合物的片剂。Tobyn,M.J.在Int.J of Pharmceutics,169,183-194(1998)中描述了这样的材料。然而,活性物质例如难以压缩的药物需要压片机在高压缩力下操作以提供合适的硬度和低脆碎度的片剂。而且,为获得这些结果,可能需要大量填充剂,这样不利地增加了片剂的尺寸。
A.Moroni等人在美国专利6,524,617中描述了用于在低压缩力下制备硬度适当和低脆碎度的药用片剂的协同粘合剂组合物,其排除了在进一步加工时对片剂的损害,且无需片剂尺寸的显著增加。该Moroni组合物包含VP-VA共聚物和微晶纤维素。
因此,本发明的一个目的是提供改进的协同粘合剂组合物及其制备方法,其用于通过在低压缩力下直接压缩形成药用的、营养的或维生素化合物或组合物(例如不易压缩的药物)的片剂,该方法使片剂具有有益的硬度和低脆碎度。
发明概述
药用的、营养的或维生素活性的化合物或组合物的片剂(例如不易压缩的药物)通过使用共处理的(a)30-90∶70-10的适当重量比的乙烯基吡咯烷酮(VP)和乙酸乙烯(VA)的共聚物及微晶纤维素(MCC)的粘合剂组合物直接压缩制得,其中(a)∶(b)的重量比为1-30∶99-70。本发明的组合物为水分散体形式,在预定温度和喷雾速率下经喷雾干燥以提供对于这样的活性物质具有期望粒径的赋形剂粘合剂粉末。本文得到的片剂具有有益的硬度和脆碎度,且是在可接受的压缩力下加工的。
在本发明的粘合剂组合物中优选的共聚物是约60重量%的VP和约40重量%的VA的重量比的VP和VA。
最优选的粘合剂组合物是约10∶90的重量比的VP-VA和MCC。
在本发明的制备粘合剂组合物的方法中,共聚物VP-VA(S-630,International Specialty Products,Inc.)的水分散体和微晶纤维素在预定温度和喷雾速率下经喷雾干燥,以制备特别适于直接压缩这样的活性物质(包括不易压缩的药物活性物质)的粘合剂粉末。优选地,在入口温度为约200-300℃和出口温度为约75-95℃,以约12000-24000rpm的旋转喷雾速率进行喷雾干燥。
本发明制得的药用片剂通常包含可为不易压缩的药物的1-85重量%的活性物质和99-15%的本发明共处理的粘合剂粉末。适宜地,这样的药片具有至少6kP的硬度和小于2%的脆碎度。
通过直接压缩粘合剂粉末和活性物质以及任选的其他通常在这样的制剂中存在的赋形剂制得片剂。在约2000至7000lbs下直接压缩制剂,提供了具有约6-20kP的硬度和约1-2%的脆碎度的片剂。
发明详述
本发明可使用的活性物质没有特别限制。
适宜的药用的、营养的和维生素活性物质包括,但不限于:硫酸阿巴卡韦、醋丁洛尔、对乙酰氨基酚、乙酰半胱氨酸、阿司匹林、阿昔洛韦、阿普唑仑、白蛋白、阿法骨化醇、尿囊素、别嘌醇、氨溴索、阿米卡星、阿米洛利、氨基乙酸、胺碘酮、阿米替林、氨氯地平、阿莫西林、氨苄西林、氨普那韦、抗坏血酸、阿司帕坦、阿司咪唑、阿扎那韦、阿替洛尔、阿西美辛、阿奇霉素、二氢化阿奇霉素(azithromycin dihydride)、倍氯米松、苄丝肼、氢氧化苄烷铵、苯佐卡因、苯甲酸、倍他米松(betametasone)、苯扎贝特、生物素、比哌立登、比索洛尔、溴西泮、溴己新、溴隐亭、布地奈德、丁苯羟酸、丁咯地尔、丁螺环酮、咖啡因、樟脑、卡托普利、卡马西平、卡比多巴、卡铂、氯氨苄青霉素(cefachlor)、头孢氨苄、头孢羟氨苄、头孢唑林、头孢克肟、头孢噻肟、头孢噻甲羧肟、头孢曲松、头孢呋辛、氯霉素、氯己定、氯苯那敏、氯噻酮、胆碱、西司他丁、西咪替丁、环丙沙星、西沙必利、顺铂、克拉霉素、克拉维酸、氯米帕明、氯硝西泮、可乐定、克霉唑、氯氮平、可待因、考来烯胺、辅酶Q10、色甘酸、氰钴胺、环孢菌素、环丙孕酮、地拉韦啶甲磺酸盐、地昔帕明、去氧孕烯、地塞米松、右泛醇、右美沙芬、右丙氧芬(dextropropoxiphene)、地西泮、双氯芬酸、地高辛、双氢可待因、双氢麦角胺、地尔硫、苯海拉明、双嘧达莫、安乃近、双异丙吡胺、多潘立酮、多巴胺、多西环素、盐酸多柔比星、屈大麻酚、依法韦仑、恩曲他滨、依那普利、恩氟沙星、麻黄碱、肾上腺素、麦角骨化醇、麦角胺、红霉素、雌二醇、炔雌醇、依托泊苷、依泽替米贝、法莫替丁、非洛地平、非诺贝特、非诺特罗、芬太尼、盐酸非索非那定、黄素单核苷酸、氟康唑、氟桂利嗪、氟尿嘧啶、氟西汀、氟比洛芬、氟他胺、呋山那韦、呋山那韦钙、呋塞米、丙氧鸟苷、吉非贝齐、庆大霉素、银杏(ginkgo biloba)、格列本脲、格列甲嗪、甘草、愈创甘油醚、胍那苄、氟哌啶醇、肝素、透明质酸、氢氯噻嗪、氢可酮、氢化可的松、氢吗啡酮、羟四霉素、氢氧化异丙托铵、布洛芬、亚胺培南、硫酸茚地那韦、吲哚美辛、碘海醇、碘帕醇、硝酸异山梨酯、单硝酸异山梨酯、异维甲酸、伊曲康唑、酮替芬、酮康唑、酮洛芬、酮咯酸、拉贝洛尔、乳果糖、拉米夫定、卵磷脂、左卡尼汀、左旋多巴、左谷酰胺、左炔诺孕酮、左甲状腺素、利多卡因、脂肪酶、赖诺普利、洛哌丁胺、洛匹那韦、氯雷他定、劳拉西泮、洛伐他汀、甲羟孕酮、薄荷脑、氨甲蝶呤、甲基多巴、甲泼尼龙、甲氧氯普胺、美托洛尔、咪康唑、咪达唑仑、米诺环素、米诺地尔、米索前列醇、吗啡、多种维生素和矿物质、制霉菌素、N-甲基麻黄碱、纳多洛尔、萘呋胺、萘普生、甲磺酸奈非那韦、新霉素、奈韦拉平、尼卡地平、尼麦角林、烟酰胺、尼古丁、烟酸、硝苯地平、尼莫地平、尼群地平、尼扎替丁、炔诺酮、诺氟沙星、炔诺孕酮、去甲替林、氧氟沙星、奥美拉唑、奥坦西隆、胰液素、泛醇、泮托拉唑、泛酸、对乙酰氨基酚、青霉素G、青霉素V、苯巴比妥、苯福林、苯丙醇胺、苯妥英、盐酸吡格列酮、吡罗昔康、多粘菌素B、聚维酮碘、普伐他汀、普拉西泮、哌唑嗪、泼尼松龙、泼尼松、丙谷美辛、普罗帕酮、普萘洛尔、伪麻黄碱、吡哆醇、奎尼丁、雷米普利、雷尼替丁、利血平、视黄醇、病毒唑、核黄素、利托那韦、利福平、芦丁、糖精、沙丁胺醇、降钙素、水杨酸、沙奎那韦、辛伐他汀、生长激素、索他洛尔、螺内酯、司他夫定、硫糖铝、舒巴坦、磺胺甲噁唑、柳氮磺胺吡啶、舒必利、他莫昔芬、替加氟、富马酸替诺福韦酯(tenofovir disoproxilfumarate)、替诺昔康、替普瑞酮、特拉唑嗪、盐酸特比萘芬、特布他林、特非那定、茶碱、硫胺、噻洛芬酸、噻氯匹定、噻吗洛尔、氨甲环酸、维甲酸、曲安奈德、氨苯蝶啶、甲氧苄啶、曲克芦丁、尿嘧啶、盐酸缬更昔洛韦(valgancyclovir hydrochloride)、丙戊酸、万古霉素、维拉帕米、维生素E、扎西他滨、齐多夫定、佐替平。
下面将用实施例的方式对本发明进行详细说明。
实施例1
VP-VA共聚物(重量比60∶40)和MCC以重量比1-30∶99∶70的粘合剂组合物的水分散体,和约15-30%的固体含量,在入口温度200-300℃和出口温度75-95℃,在实验室规模的圆盘或喷嘴喷雾干燥器中以12000-24000rpm的喷雾速率喷雾干燥。收集自由流动的粘合剂组合物粉末。该粉末具有约20-120μ的平均粒径。
实施例2
实施例1得到的自由流动的粘合剂粉末与不易压缩的药物(对乙酰氨基酚)以药物:粘合剂为50∶20的重量比混合,制剂的其余组分包含填充剂(27%)、崩解剂(2%)、助流剂(0.5%)和润滑剂(0.5%)。下文表1给出了准备用于直接压缩成片剂的喷雾干燥的粘合剂组合物与药物的制剂。按不同重量比使用VP-VA(S-630)和MCC的喷雾干燥的粉末制得针对这样的制剂的试验1-3,而试验4-5(对照品)仅利用这些物质的物理混合制得。表2的结果显示,与对照品试验4-5相比,本发明的试验1-3具有显著增加的片剂硬度和降低的脆碎度。
表1
本发明的药物制剂和对照品
表2
表1的制剂的药物片剂的物理性质
3000lbs.C.F. | 1 | 2 | 3 | 4 | 5 |
压缩力(lbs) | 3057.42 | 2945.01 | 3034.94 | 2967.49 | 2989.97 |
片剂重量(mg) | 351.21 | 354.17 | 349.86 | 356.69 | 357.56 |
片剂硬度(kP) | 8.90 | 10.95 | 10.22 | 7.65 | 8.18 |
崩解(分钟:秒) | 0’13” | 0’13” | 0’13” | --- | --- |
脆碎度(%损失) | 0.78 | 0.55 | 0.50 | 1.49 | 1.29 |
5000lbs.C.F. | 1 | 2 | 3 | 4 | 5 |
压缩力(lbs) | 5013.26 | 5013.26 | 4945.82 | 4990.78 | 4923.34 |
片剂重量(mg) | 359.85 | 355.14 | 352.89 | 364.59 | 357.65 |
片剂硬度(kP) | 11.82 | 13.10 | 12.82 | 8.53 | 10.93 |
崩解(分钟:秒) | 0’15” | 0’15” | 0’15” | --- | --- |
脆碎度(%损失) | 0.68 | 0.60 | 0.51 | 1.18 | 1.14 |
7000lbs.C.F. | 1 | 2 | 3 | 4 | 5 |
压缩力(lbs) | 7036.55 | 6991.59 | 6991.59 | 6991.59 | 7014.07 |
片剂重量(mg) | 351.33 | 356.83 | 352.10 | 359.03 | 358.78 |
片剂硬度(kP) | 13.17 | 13.78 | 14.17 | 8.98 | 9.27 |
崩解(分钟:秒) | 0’20” | 0’28” | 0’33” | --- | --- |
脆碎度(%损失) | 0.50 | 0.49 | 0.41 | 1.09 | 0.82 |
尽管已根据本发明的某些具体实施方案描述了本发明,但要理解,在本领域的技术内可以进行改变和修饰。相应地,本发明意在仅通过所附权利要求进行限定。
Claims (9)
1.通过直接压缩制得药用的、营养的或维生素活性的化合物或组合物的片剂的方法,其包括:提供(a)乙烯基吡咯烷酮和乙酸乙烯的共聚物与(b)微晶纤维素的水分散体,其中(a)与(b)的重量比为1-30:99-70;将所述水分散体在200-300℃的入口温度和75-95℃的出口温度,以12000-24000rpm的喷雾速率进行喷雾干燥以形成其粉末;将所述粉末与活性物质混合,并通过在2000-7000lbs下直接压缩形成其具有8-30kP的硬度和1-2%的脆碎度的片剂,其中(a)具有30-90乙烯基吡咯烷酮与70-10乙酸乙烯的重量比。
2.如权利要求1所述的方法,其中所述共聚物包含60重量%乙烯基吡咯烷酮和40%乙酸乙烯。
3.如权利要求1所述的方法,其中所述粘合剂粉末具有20-120μ的平均粒径。
4.如权利要求1所述的方法,其中所述活性物质在所述片剂中以1-85重量%的量存在且所述粘合剂组合物以99-15重量%的量存在。
5.如权利要求4所述的方法,其中所述活性物质在所述粘合剂组合物和药物的混合物中以50-70重量%的量存在。
6.如权利要求1所述的方法,其中所述片剂还包含其他赋形剂。
7.如权利要求1所述的方法,其中所述活性物质为不易压缩的药物。
8.通过在200-300℃的入口温度和75-95℃的出口温度,以12000-24000rpm的喷雾速率喷雾干燥(a)乙烯基吡咯烷酮和乙酸乙烯的共聚物与(b)微晶纤维素的水分散体得到的自由流动的共处理的粉末粘合剂组合物,其中(a):(b)的重量比为1-30:99-70,并且(a)包含30-90%乙烯基吡咯烷酮和10-70%乙酸乙烯。
9.如权利要求8所述的自由流动的共处理的粉末粘合剂组合物,其具有20-120μ的平均粒径。
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US11/290,715 | 2005-11-30 | ||
PCT/US2006/038194 WO2007064397A2 (en) | 2005-11-30 | 2006-09-28 | Synergistic binder composition, method for making same, and tablets of an active and said binder having advantageous hardness and friability |
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CN101708336B (zh) * | 2009-10-23 | 2011-09-14 | 湖南湘药制药有限公司 | 一种药用预混辅料 |
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US6066334A (en) * | 1997-03-10 | 2000-05-23 | Basf Aktiengesellschaft | Use of redispersible polymer powders or polymer granules as binders for producing solid pharmaceutical presentations |
US6524617B1 (en) * | 2001-07-25 | 2003-02-25 | Isp Investments Inc. | Synergistic filler composition |
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TW506836B (en) * | 1996-06-14 | 2002-10-21 | Janssen Pharmaceutica Nv | Fast-dissolving galanthamine hydrobromide tablet |
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US6066334A (en) * | 1997-03-10 | 2000-05-23 | Basf Aktiengesellschaft | Use of redispersible polymer powders or polymer granules as binders for producing solid pharmaceutical presentations |
US6524617B1 (en) * | 2001-07-25 | 2003-02-25 | Isp Investments Inc. | Synergistic filler composition |
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Title |
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A novel copovidone binder for dry granulation and direct-compression tableting.;Antonio Moroni;Pharmaceutical Technology drug delivery;20011231;24;权利要求29-31,第8页右栏第1段,图5(e)、(f) * |
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US8168219B2 (en) | 2012-05-01 |
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GB2448430A8 (en) | 2008-10-29 |
US20070122472A1 (en) | 2007-05-31 |
WO2007064397A3 (en) | 2007-07-19 |
GB0810227D0 (en) | 2008-07-09 |
CN101346147A (zh) | 2009-01-14 |
GB2448430A (en) | 2008-10-15 |
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