CN101453996B - 药物递送组合物 - Google Patents
药物递送组合物 Download PDFInfo
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- CN101453996B CN101453996B CN200780019665.5A CN200780019665A CN101453996B CN 101453996 B CN101453996 B CN 101453996B CN 200780019665 A CN200780019665 A CN 200780019665A CN 101453996 B CN101453996 B CN 101453996B
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Abstract
一种包含挤出球状体的药物递送组合物。所述球状体包含至少一种活性医药成分;至少一种挤出-滚圆助剂;至少一种超崩解剂;和至少一种助流剂、至少一种润滑剂、和/或至少一种油。所述球状体也可经涂覆。另一方面,药物递送组合物包含经涂覆球状体,所述经涂覆球状体具有惰性球状体和至少一个用于所述球状体的涂层。所述涂层包含至少一种活性医药成分和至少一种超崩解剂。
Description
技术领域
本发明涉及药物递送组合物。本发明还涉及其用途和其制造方法。
背景技术
有许多技术已经用于提供受控和持续释放医药剂型以维持医药的治疗血清水平并最小化因缺少患者依从性而造成的错过药物剂量后果和满足通过控制其血液浓度降低药物副作用的需要。
例如,业内有半透膜环绕渗透活性药物核的延长释放片剂。半透膜用以界定存储室。这些片剂通过以下起作用:其允许流体(例如胃或肠液)透过涂覆膜并溶解活性成份以便活性成份可穿过涂覆膜中的通道通过渗透张力释放,或如果活性成分不溶于透过流体,则通过膨胀剂(例如水凝胶)使其挤过所述通道。这些渗透片剂的一些代表性实例可发现于美国专利第3,845,770号、第3,916,899号、第4,034,758号、第4,077,407号和第4,783,337号。这些装置的问题是其繁琐且难以制造。由于已知其在胃肠道中运输期间过早破裂或留有一些药物内容物(其可导致由所述装置释放和递送的药物较少),故其效率和精度也值得怀疑。因此,常见所述装置包含超出至少10%的药物来解决剂量递送中的所述低效率。此实践并不经济且存在危险,尤其若使用强效药物,因为已知这些装置在运输中破裂且因此释放过量剂量。
用于活性医药成分的控制或延迟释放的有效医药组合物的发展相当大地受以下事实的制约:目前最好的实践大部分取决于聚合物基质片剂系统;例如,持续释放装置,例如涂覆有释放控制涂层的片剂、含水溶性聚合物化合物的基质片剂、含蜡的基质片剂、含水不溶化合物的基质片剂和诸如此类。例如,美国专利第3,629,393号(纳可默托(Nakamoto))利用三组份系统来提供缓释片剂,其中将活性成分与疏水性脂肪酸盐和聚合物的颗粒与水胶体和载剂的颗粒及载剂和活性剂或缓冲剂的颗粒组合,然后将其直接压制成片剂。美国专利第3,728,445号(巴德尼(Bardani))揭示缓释片剂,其通过将活性成分与固体糖赋形剂混合、通过用乙酸邻苯二甲酸纤维素溶液润湿将其粒化、蒸发溶剂、回收颗粒并在高压下压制来形成。美国专利第6,645,528号教示多孔药物基质和其制造方法。所述系统由于其经由单一单元进行药物递送而具有缺点。由于单一单元在胃肠道中运输期间可能丧失能力或其完整性受到损害而导致剂量倾卸,故此为药物递送提供高风险途径。而且,单一单元片剂可能完好无损的被排泄出而不释放药物。
因此,需要比单一聚合物基质片剂更具有可重现上胃肠通过模式的药物递送系统。
发明内容
一方面,提供包含挤出球状体的药物递送组合物,所述球状体包含:至少一种活性医药成分;至少一种挤出-滚圆助剂;至少一种超崩解剂;和至少一种助流剂、至少一种润滑剂、和/或至少一种油。
另一方面,提供包含经涂覆球状体的药物递送组合物,所述经涂覆球状体包含惰性球状体和至少一种用于所述球状体的涂层,所述涂层包含至少一种活性医药成分和至少一种超崩解剂。
另一方面,提供用于将药物递送组合物投与给哺乳动物以提供所述至少一种活性医药成分的定时、脉冲、时间治疗、延长或受控释放的方法。
另一方面,提供药物递送组合物在医药中的用途,所述医药对哺乳动物提供所述至少一种活性医药成分的定时、脉冲、时间治疗、延长或受控释放。
另一方面,提供药物递送组合物的用途,其用于对哺乳动物提供所述至少一种活性医药成分的定时、脉冲、时间治疗、延长或受控释放。
另一方面,提供制造所述药物递送组合物的方法,所述方法包含:
将所述组合物的干物质组合以提供均匀掺合物;
将所述颗粒与所述至少一种助流剂、至少一种润滑剂、和/或至少一种油组合以提供适用于挤出-滚圆的湿团块;和
挤出所述湿团块以形成所述球状体。
另一方面,所述湿团块具有可塑性。另一方面,所述湿团块包含约1:0.7到约1:2的挤出助剂与所述至少一种助流剂、至少一种润滑剂、和/或至少一种油。
当实验本发明以下详细阐述后,本发明的新颖特征对所属领域的技术人员将显而易见。然而,应了解,本发明的详细说明和所呈现的特定实例尽管表示本发明的某些实施例,但仅出于阐述目的而提供,这是因为根据本发明的详细阐述和以下权利要求书在本发明精神和范围内的各种改变和修改对于所属领域的技术人员将显而易见。
附图说明
现在将参照附图更全面的说明本发明的某些实施例。
图1是实例3的胶囊的溶解曲线;且
图2是实例3的片剂的溶解曲线。
具体实施方式
本发明是关于药物递送组合物和其使用和制造方法以控制活性医药成分在哺乳动物中的递送速率和程度。
在一个实施例中,所述药物递送组合物包含球状体。所述球状体包含至少一种活性医药成分;至少一种挤出-滚圆助剂;至少一种超崩解剂;和至少一种助流剂、至少一种润滑剂、和/或至少一种油。
所述球状体可进一步包含至少一种卡波姆(carbomer)、至少一种缓冲剂、至少一种电解质、玉米醇溶蛋白(zein)、和/或水。所述组合物的球状体可通过挤出、通常挤出-滚圆工艺制得。
所述球状体可包含约0.1wt%到约80wt%的至少一种活性医药成分、约10wt%到约90wt%的至少一种挤出-滚圆助剂、约0.1wt%到约70wt%的至少一种超崩解剂、约0.1wt%到约70wt%的至少一种助流剂、约0.1wt%到约70wt%的至少一种润滑剂、和约0.1wt%到约50wt%的至少一种油。
视需要,所述球状体可进一步包含约0wt%到约50wt%的至少一种卡波姆、约0wt%到约25wt%的至少一种缓冲剂、约0wt%到约55wt%的至少一种电解质、约0wt%到约25wt%的玉米醇溶蛋白、和/或约0wt%到约10wt%的水。这些wt%是基于所述球状体的总重量。
所述球状体的其它实施例包括:
所述活性医药成分的存在量也可为约5wt%到约70wt%;约10wt%到约70wt%;约20wt%到约60wt%;约30wt%到约60wt%;或约40wt%到约60wt%。
所述挤出-滚圆助剂的存在量也可为约10wt%到约70wt%;约20wt%到约70wt%;约30wt%到约70wt%;约40wt%到约70wt%;约50wt%到约70wt%;或约55wt%到约70wt%。
所述超崩解剂的存在量也可为约2wt%到约70wt%;约20wt%到约70wt%;约30wt%到约70wt%;约40wt%到约70wt%;约50wt%到约70wt%;或约55wt%到约70wt%。
所述助流剂的存在量也可为约1wt%到约20wt%;约1wt%到约15wt%;约2wt%到约15wt%;约5wt%到约15wt%;或约5wt%到约10wt%。
所述润滑剂的存在量也可为约0.5wt%到约5wt%;约0.5wt%到约4wt%;约0.5wt%到约3wt%;约0.5wt%到约2wt%;或约1wt%到约2wt%。
所述油的存在量也可为约0.5wt%到约5wt%;约0.5wt%到约4wt%;约0.5wt%到约3wt%;约0.5wt%到约2wt%;或约1wt%到约2wt%。
例如,在比较进食与空腹状态下的投药时,药物递送组合物的球状体比单一聚合物基质片剂往往具有更可重现的上部GI运输模式。由于GI通过时间是药物递送期间与血浆浓度变化性有关的重要参数,故此使得使用多微粒药物递送组合物(例如球状体)比单一聚合物基质系统更合意。由于多微粒药物递送组合物可包含多个含药物的球状体,所以使用多微粒药物递送组合物代替单一聚合物基质片剂更有利。因此,与先前技术的单一聚合物基质片剂相比,少许球状体完整性的损失不再具有统计学显著性。因此,当经制备可作为多微粒药物递送组合物使用时,许多治疗剂的递送将最有效。
上述药物递送组合物的球状体也可经(例如)至少一层聚合物膜涂层;至少一层肠溶衣;至少一层非肠溶衣;和/或至少一层半透膜涂层涂覆。通常,所述涂层以所述球状体和涂层的总重量计占约0.5wt%到约50wt%。更通常,所述涂层占约1wt%到约20wt%、约1wt%到约10wt%、约1wt%到约7wt%、约3.5wt%到约7wt%、约3.5wt%到约6wt%、或约4wt%到约5wt%。而且,可有一层以上的涂层,例如,两层或三层涂层。
本文所述涂层中组份的重量百分数是以涂层的重量计。
任何适宜涂层皆可用于本发明球状体。例如,所述涂层可包括:
肠溶衣,其可包含至少一种肠溶材料和至少一种超崩解剂。视需要,所述涂层进一步包含至少一种虹吸剂(wickingagent)、角叉菜胶和至少一种增塑剂。通常,所述涂层包含约10wt%到约90wt%的肠溶材料,例如纤维素酯或聚甲基丙烯酸酯;约0.5wt%到约60wt%的超崩解剂;约0wt%到约60wt%的虹吸剂,例如微晶纤维素;约0wt%到约60wt%的角叉菜胶和约0wt%到约25wt%的增塑剂(例如聚乙二醇)。
非肠溶衣,其可包含至少一种非肠溶材料和至少一种超崩解剂。视需要,所述涂层进一步包含至少一种虹吸剂、角叉菜胶和至少一种增塑剂。通常,所述涂层包含约10wt%到约90wt%的非肠溶材料,例如乙基纤维素和/或聚乙酸乙烯基酯;约0.5wt%到约60wt%的超崩解剂;约0wt%到约60wt%的虹吸剂,例如微晶纤维素;约0wt%到约60wt%的角叉菜胶和约0wt%到约25wt%的增塑剂(例如聚乙二醇)。
半透膜涂层,其可包含至少一种半透膜材料和至少一种超崩解剂。视需要,所述涂层进一步包含至少一种虹吸剂、角叉菜胶和至少一种增塑剂。通常,所述涂层包含约10wt%到约90wt%的半透膜材料,例如乙酸邻苯二甲酸纤维素;约0.5wt%到约60wt%的超崩解剂;约0wt%到约60wt%的虹吸剂,例如微晶纤维素;约0wt%到约60wt%的角叉菜胶和约0wt%到约25wt%的增塑剂(例如聚乙二醇)。
涂层组合物的其它实施例包括:
肠溶材料也可以约5wt%到约90wt%;约10wt%到约80wt%;约20wt%到约80wt%;约30wt%到约70wt%;或约40wt%到约70wt%存在于涂层中。
非肠溶材料也可约5wt%到约90wt%;约10wt%到约80wt%;约20wt%到约80wt%;约30wt%到约70wt%;或约40wt%到约70wt%以存在于涂层中。
半透膜材料也可以约5wt%到约90wt%;约10wt%到约80wt%;约20wt%到约80wt%;约30wt%到约70wt%;或约40wt%到约70wt%存在于涂层中。
超崩解剂也可以约0.5wt%到约55wt%;约0.5wt%到约40wt%;约0.5wt%到约30wt%;约1wt%到约20wt%;或约10wt%到约20wt%存在于涂层中。
虹吸剂也可以约0.5wt%到约55wt%;约0.5wt%到约50wt%;约0.5wt%到约40wt%;约5wt%到约40wt%;或约20wt%到约40wt%存在于涂层中。
角叉菜胶也可以约0.5wt%到约55wt%;约0.5wt%到约50wt%;约0.5wt%到约40wt%;约5wt%到约40wt%;或约20wt%到约40wt%存在于涂层中。
增塑剂也可以约0.5wt%到约25wt%;约1wt%到约20wt%;约5wt%到约20wt%;约5wt%到约15wt%;或约1wt%到约5wt%存在于涂层中。
在特定实施例中,所述经涂覆球状体的涂层包含约10wt%到约90wt%的肠溶材料,例如纤维素酯和/或聚甲基丙烯酸酯;约0.5wt%到约60wt%的超崩解剂;约0.5wt%到约60wt%的虹吸剂,例如微晶纤维素;约0wt%到约60wt%的角叉菜胶和约0wt%到约25wt%的增塑剂(例如聚乙二醇)。
在另一实施例中,所述经涂覆球状体的涂层包含约10wt%到约90wt%的非肠溶材料,例如乙基纤维素和/或聚乙酸乙烯基酯;约0.5wt%到约60wt%的超崩解剂;约0.5wt%到约60wt%的虹吸剂,例如微晶纤维素;约0wt%到约60wt%的角叉菜胶和约0wt%到约25wt%的增塑剂(例如聚乙二醇)。在再一实施例中,所述经涂覆球状体的涂层包含约10wt%到约90wt%的半透膜材料,例如乙酸邻苯二甲酸纤维素;约0.5wt%到约60wt%的超崩解剂;约0.5wt%到约60wt%的虹吸剂,例如微晶纤维素;约0wt%到约60wt%的角叉菜胶和约0wt%到约25wt%的增塑剂(例如聚乙二醇)。
在另一实施例中,所述经涂覆球状体的涂层包含约10wt%到约90wt%的聚乙酸乙烯基酯和/或乙基纤维素;约0.5wt%到约60wt%的超崩解剂;约0.5wt%到约60wt%的虹吸剂,例如微晶纤维素;约0wt%到约60wt%的角叉菜胶和约0wt%到约25wt%的增塑剂(例如聚乙二醇)。
所述组合物的球状体(例如,有或没有涂层)可做成胶囊(例如放于胶囊中)和/或压制成(例如)片剂和/或囊片和/或组合到药囊中。例如,将至少一个涂覆有至少一层聚合物膜涂层的球状体群体做成胶囊或压制成至少一种片剂。在又一实例中,将至少一个涂覆有至少一层肠溶衣的球状体群体做成胶囊或压制成至少一种片剂。在再一实例中,将至少一个涂覆有至少一层非肠溶衣的球状体群体做成胶囊或压制成至少一种片剂。在又一实例中,将至少一个涂覆有至少一层半透膜涂层的球状体群体做成胶囊或压制成至少一种片剂。
所述药物递送组合物也可包含经涂覆惰性球状体。惰性球状体的任何适宜涂层是包含至少一种活性医药成分的涂层组合物。
在实施例中,涂层可包括至少一种活性医药成分和至少一种超崩解剂。通常,所述涂层包含约0.1wt%到约80wt%的至少一种活性医药成分和约0.5wt%到约60wt%的超崩解剂。视需要,所述涂层可进一步包含至少一种虹吸剂、角叉菜胶、至少一种增塑剂、至少一种电解质、至少一种油、至少一种水溶性可胶凝聚合物、至少一种水不溶有机可溶聚合物、至少一种助流剂、至少一种缓冲剂和水。通常,约0wt%到约60wt%的虹吸剂;约0wt%到约60wt%的角叉菜胶;约0wt%到约25wt%的增塑剂,例如聚乙二醇;约0wt%到约55wt%的至少一种电解质、约0wt%到约55wt%的至少一种油、约0wt%到约50wt%的至少一种水溶性可胶凝聚合物、约0wt%到约50wt%的至少一种水不溶有机可溶聚合物、约0wt%到约25wt%的至少一种助流剂、约0wt%到约25wt%的至少一种缓冲剂、和/或约0wt%到约10wt%的水。
用于惰性球状体的涂层组合物的其它实施例包括:
活性医药成分也可以约0.5wt%到约90wt%;约10wt%到约80wt%;约20wt%到约80wt%;约30wt%到约70wt%;或约40wt%到约70wt%存在于涂层中。
超崩解剂也可以约0.5wt%到约55wt%;约0.5wt%到约40wt%;约0.5wt%到约30wt%;约1wt%到约20wt%;或约10wt%到约20wt%存在于涂层中。
虹吸剂也可以约0.5wt%到约90wt%;约0.5wt%到约80wt%;约0.5wt%到约70wt%;约5wt%到约60wt%;或约20wt%到约60wt%存在于涂层中。
角叉菜胶也可以约0.5wt%到约90wt%;约0.5wt%到约80wt%;约0.5wt%到约70wt%;约5wt%到约60wt%;或约20wt%到约60wt%存在于涂层中。
增塑剂也可以约0.5wt%到约25wt%;约1wt%到约20wt%;约5wt%到约20wt%;约5wt%到约15wt%;或约1wt%到约5wt%存在于涂层中。
在特定实施例中,所述涂层组合物包含约0.1wt%到约80wt%的至少一种活性医药成分;约0.5wt%到约60wt%的超崩解剂;约0.5wt%到约60wt%的虹吸剂,例如微晶纤维素和/或果胶;约0wt%到约60wt%的角叉菜胶和约0wt%到约25wt%的增塑剂(例如聚乙二醇)。所述涂层组合物可进一步包含约0wt%到约55wt%的至少一种电解质、约0wt%到约55wt%的至少一种油、约0wt%到约90wt%的至少一种增塑剂、约0wt%到约50wt%至少一种水溶性可胶凝聚合物、约0wt%到约50wt%至少一种水不溶有机可溶聚合物、约0wt%到约25wt%的至少一种助流剂、约0wt%到约25wt%的至少一种缓冲剂、和/或约0wt%到约10wt%的水。
在某些实施例中,有约10wt%到约90wt%的惰性球状体和约0.5wt%到约50wt%的涂层组合物。所述涂层组合物包含约0.1wt%到约80wt%的至少一种活性医药成分、约0.1wt%到约50wt%的至少一种超崩解剂、约0.5wt%到约90wt%的虹吸剂、和约0.5wt%到约90wt%的角叉菜胶。通常,所述涂层组合物包含约0.1wt%到约80wt%的至少一种活性医药成分、约0.1wt%到约50wt%的至少一种超崩解剂、约0.5wt%到约90wt%的微晶纤维素、和约0.5wt%到约90wt%的角叉菜胶。视需要,所述涂层组合物可进一步包含约0wt%到约55wt%的至少一种电解质、约0wt%到约55wt%的至少一种油、约0wt%到约90wt%的聚乙二醇、约0wt%到约50wt%的羟丙基甲基纤维素、约0wt%到约50wt%的聚乙酸乙烯酯、约0wt%到约25wt%的至少一种助流剂、约0wt%到约25wt%的至少一种缓冲剂、和/或约0wt%到约10wt%的水。
可使用的惰性球状体的实例是任何医药上可接受的惰性球状体,例如且不限于糖球状体、淀粉球状体和/或纤维素球状体。
本发明的球状体和/或经涂覆球状体可为任何适用于药物递送的尺寸。球状体可具有小于约6mm;约0.01mm到约5.0mm;或约0.15mm到约5mm的直径。
通常将涂层涂覆到球状体上以获得约0.1mg/cm2到约20mg/cm2的表面积。
本发明的药物递送组合物实施例可用于对哺乳动物提供至少一种活性医药成分的定时、脉冲、时间治疗、延长或受控释放。本发明的药物递送组合物可为提供球状体释放的任何适宜形式。例如,所述组合物可呈片剂或胶囊形式,例如将至少一个球状体群体做成胶囊(例如,放于胶囊中)或压制成片剂。片剂或胶囊自身也可经(例如)聚合物膜(例如聚甲基丙烯酸酯共聚物)涂覆以提供至少一种活性医药成分的定时、脉冲、时间治疗、延长或受控释放。
在实施例中,提供用于治疗其中药物递送组合物中的至少一种活性医药成分有效的疾病的方法。所述方法包含向需要所述治疗的哺乳动物投与本发明的定时、脉冲、时间治疗、控制或延迟释放的药物递送组合物。
本发明的药物递送组合物可用于治疗高血压、咽痛、糖尿病、HIVAIDS、疼痛、抑郁症、精神病、微生物感染、胃食管反流病、阳痿、癌症、心血管疾病、胃(gastric/stomach)溃疡、血液病症、恶心、癫痫、帕金森氏病(Parkinson′sdisease)、肥胖病、疟疾、痛风、哮喘、勃起功能障碍、阳痿、尿失禁、肠易激综合征、溃疡性结肠炎、吸烟、关节炎、鼻炎、阿尔茨海默病(Alzheimer′sdisease)、注意力缺乏症、囊性纤维化、焦虑症、失眠、头痛、真菌感染、疱疹、高血糖、高脂血、低血压、高胆固醇、甲状腺功能减退、感染、炎症、躁狂症、绝经、多发性硬化、骨质疏松症、移植排斥、精神分裂症、神经病症。
药物递送组合物可在嘴中快速、瞬间溶解或融化,释放球状体。在特定实施例中,所述药物递送组合物具有其中在最初1小时释放约0%至50%的活性医药成分且在大约24小时内释放大于约70%的溶解曲线。
对于各种释放速率,可使用各种球状体群体。例如,为获得脉冲释放,则经涂覆球状体群体可与未涂覆球状体群体组合并放到胶囊中或压制成片剂。或者,可将具有不同释放速率的经涂覆球状体组合在一起并放到胶囊中或压制成片剂。
制造药物递送组合物的方法
所述球状体可通过挤出-滚圆来制备。此外,药物粉末或药物溶液层化可用于涂覆球状体。在此一实施例中,球状体自身可为惰性且涂层自身包含活性医药成分。
当制备球状体(包括涂覆球状体)时,液体倾向于迁移至球状体表面且诱发表面可塑性。在极低含量下,表面湿度有助于润滑且增强球状体移动。在高含量下,且尤其在降低的挤出-滚圆助剂的比例下,液体可使得球状体彼此和滚圆机壁粘在一起。其亦导致未受控制的颗粒生长和粒径的宽分布,且因此批料可受到破坏。此着重说明用于润滑的液体的量与无结块的球状体的生产之间存在的关系。本发明的药物递送组合物引入高调配物容许范围,从而使球状体的刚性与可塑性之间达成平衡。使用本文所述的方法,可方便且一致的制造具有窄尺寸分布范围的球状体。此方法降低了生产过程后由于在所需尺寸范围内产量低而将材料丢弃或重新加工的可能性。
从本文所述的球状体组合物可获得好的挤出物和球状体,例如,包含以下的组合物:约0.1wt%到约80wt%的至少一种活性医药成分、约10wt%到约90wt%的至少一种挤出-滚圆助剂、约0.1wt%到约70wt%的至少一种超崩解剂、约0.1wt%到约70wt%的至少一种助流剂、约0.1wt%到约70wt%的至少一种润滑剂、和约0.1wt%到约50wt%的至少一种油。视需要,所述球状体可进一步包含约0wt%到约50wt%的至少一种卡波姆、约0wt%到约25wt%的至少一种缓冲剂、约0wt%到约55wt%的至少一种电解质、约0wt%到约25wt%的玉米醇溶蛋白、和/或约0wt%到约10wt%的水。
在一个实施例中,为使用挤出-滚圆制造球状体,挤出物是首先将所述组合物的干物质在行星式混合机中掺和适当时间以提供均相掺合物来制备;通常,约5分钟。将所述均相掺合物使用至少一种助流剂、至少一种润滑剂、和/或至少一种油(例如,水、油、和有时增塑剂的水溶液)粒化约5分钟。造粒时间、终点和造粒液体的量由挤出-滚圆作业期间所得湿团块的行为(例如,应具有可塑性)来决定。通常,使用约1:0.7到约1:2的挤出助剂比至少一种助流剂、至少一种润滑剂、和/或至少一种油来形成所得湿团块。例如,使用约100wt%:70wt%到约100wt%:200wt%的挤出助剂比至少一种助流剂、至少一种润滑剂和/或至少一种油来形成所得湿团块。使所述湿团块通过挤出机以形成棒。将挤出物装填于滚圆机旋转板上并以预定rpm旋转约30秒到约5分钟或持续适当时间以提供球状体。收获所述球状体并干燥。在一个实施例中,将球状体干燥以提供水含量小于约10wt%的球状体。在特定实施例中,将所述球状体在约40℃下在盘式干燥烘箱中干燥约16小时以提供小于约10wt%的水含量。造粒溶液作为粘结剂,且与以上所列示的润滑剂、油和助流剂一起帮助挤出-滚圆工艺。
为涂覆球状体,将涂层组合物(例如但不限于涂层组合物的溶液、分散液或悬浮液)涂覆到所述球状体上。所述球状体在用涂层组合物涂覆之前可不含涂层或已具有至少一个涂层。所述涂层组合物可使用医药工业中所用的大体上维持大部分球状体完整性的任何适宜涂覆方法来涂覆。例如,可使用流化床、粉末层化和/或离心工艺。可重复涂覆方法以提供一个以上的涂层。
所述涂层组合物可包含聚合物膜、肠溶材料;非肠溶材料;和/或半透膜材料。通常,所得涂层以所述球状体和涂层的总重量计占约0.5wt%到约50wt%。
在特定实施例中,所述涂层组合物包含约10wt%到约90wt%的肠溶材料,例如纤维素酯和/或聚甲基丙烯酸酯;约0.5wt%到约60wt%的超崩解剂;约0.5wt%到约60wt%的虹吸剂,例如微晶纤维素;约0wt%到约60wt%的角叉菜胶和约0wt%到约25wt%的增塑剂(例如聚乙二醇)。
在又一实施例中,所述涂层组合物包含约10wt%到约90wt%的非肠溶材料,例如乙基纤维素和/或聚乙酸乙烯基酯;约0.5wt%到约60wt%的超崩解剂;约0.5wt%到约60wt%的虹吸剂,例如微晶纤维素;约0wt%到约60wt%的角叉菜胶和约0wt%到约25wt%的增塑剂(例如聚乙二醇)。在再一实施例中,所述涂层组合物包含约10wt%到约90wt%的半透膜材料,例如乙酸邻苯二甲酸纤维素;约0.5wt%到约60wt%的超崩解剂;约0.5wt%到约60wt%的虹吸剂,例如微晶纤维素;约0wt%到约60wt%的角叉菜胶和约0wt%到约25wt%的增塑剂(例如聚乙二醇)。
在另一实施例中,所述涂层组合物包含约10wt%到约90wt%的聚乙酸乙烯基酯和/或乙基纤维素;约0.5wt%到约60wt%的超崩解剂;约0.5wt%到约60wt%的虹吸剂,例如微晶纤维素;约0wt%到约60wt%的角叉菜胶和约0wt%到约25wt%的增塑剂(例如聚乙二醇)。
为涂覆惰性球状体,可使用与上文所述类似的方法。所述涂层组合物包含约0.1wt%到约80wt%的至少一种活性医药成分和约0.5wt%到约60wt%的超崩解剂。视需要,所述涂层可进一步包含至少一种虹吸剂、角叉菜胶、至少一种增塑剂、至少一种电解质、至少一种油、至少一种水溶性可胶凝聚合物、至少一种水不溶有机可溶聚合物、至少一种助流剂、至少一种缓冲剂、和水。例如,将涂层组合物的溶液、分散液或悬浮液涂覆到惰性球状体上。所述球状体在用涂层组合物涂覆之前可不含涂层或已具有至少一个涂层。所述涂层组合物可使用医药工业中所用的大体上维持大部分球状体完整性的任何适宜涂覆方法来涂覆。例如,可使用流化床、粉末层化和/或离心工艺。所述惰性球状体可为例如糖、淀粉和/或纤维素球状体。
在另一实施例中,所述涂层组合物可使用粉末层化在涂覆盘中涂覆。将涂层组合物添加到惰性球状体同时旋转所述涂覆盘。将溶液蒸发,留下环绕球状体的活性医药成分层。
一旦如本文所述形成经涂覆球状体,所述球状体可进一步经涂覆。所述经涂覆球状体也可进一步用一或多层聚合物膜涂覆。
药物递送组合物的组份的实例
就活性医药成分而言,活性医药成分是指在活体内提供治疗、诊断、或预防效果的化学或生物分子。预期用于本文所述组合物中的活性医药成分包括药物的以下种类和实例和这些药物的替代形式(例如替代盐形式、游离酸形式、游离碱形式、和水合物):镇痛药/解热药(例如,阿司匹林(aspirin)、醋氨酚(acetaminophen)、布洛芬(ibuprofen)、萘普生钠(naproxensodium)、丁丙诺啡(buprenorphine)、盐酸丙氧吩(propoxyphenehydrochloride)、萘磺酸丙氧吩(propoxyphenenapsylate)、盐酸哌替啶(meperidinehydrochloride)、盐酸二氢吗啡酮(hydromorphonehydrochloride)、吗啡(morphine)、羟可酮(oxycodone)、可待因(codeine)、重酒石酸二氢可待因(dihydrocodeinebitartrate)、喷他佐辛(pentazocine)、重酒石酸二氢可待因酮(hydrocodonebitartrate)、左啡诺(levorphanol)、二氟尼柳(diflunisal)、水杨酸三乙醇胺(trolaminesalicylate)、盐酸纳布啡(nalbuphinehydrochloride)、甲芬那酸(mefenamicacid)、布托啡诺(butorphanol)、水杨酸胆碱(cholinesalicylate)、布他比妥(butalbital)、柠檬酸苯托沙敏(phenyltoloxaminecitrate)、柠檬酸苯海拉明(diphenhydraminecitrate)、左美丙嗪(methotrimeprazine)、盐酸桂美君(cinnamedrinehydrochloride)、和甲丙氨酯(meprobamate));平喘药(例如,酮替芬(ketotifen)和曲呫诺(traxanox));抗生素(例如,新霉素(neomycin)、链霉素(streptomycin)、氯霉素(chloramphenicol)、头孢菌素(cephalosporin)、氨苄西林(ampicillin)、青霉素(penicillin)、四环素(tetracycline)、和环丙沙星(ciprofloxacin));抗抑郁药(例如,奈福泮(nefopam)、奥昔哌汀(oxypertine)、多塞平(doxepin)、阿莫沙平(amoxapine)、曲唑酮(trazodone)、阿米替林(amitriptyline)、马普替林(maprotiline)、苯乙肼(phenelzine)、地昔帕明(desipramine)、去甲替林(nortriptyline)、反苯环丙胺(tranylcypromine)、氟西汀(fluoxetine)、多塞平、丙咪嗪(imipramine)、双羟萘酸丙咪嗪(imipraminepamoate)、异卡波肼(isocarboxazid)、曲米帕明(trimipramine)、文拉法辛(venlafaxine)、帕罗西汀(paroxetine)、和普罗替林(protriptyline));抗糖尿病药(例如,磺酰脲衍生物);抗真菌剂(例如,灰黄霉素(griseofulvin)、两性霉素B(amphotericinB)、制菌霉素(nystatin)、和克念菌素(candicidin));抗高血压药(例如,心得安(propanolol)、普罗帕酮(propafenone)、氧烯洛尔(oxyprenolol)、利血平(reserpine)、曲美芬(trimethaphan)、酚苄明(phenoxybenzamine)、盐酸帕吉林(pargylinehydrochloride)、地舍平(deserpidine)、二氮嗪(diazoxide)、一硫酸胍乙啶(guanethidinemonosulfate)、米诺地尔(minoxidil)、瑞西那明(rescinnamine)、硝普钠(sodiumnitroprusside)、蛇根萝芙木(rauwolfiaserpentina)、阿舍西隆(alseroxylon)、和酚妥拉明(phentolamine));消炎药(例如,(非类固醇类的)吲哚美辛(indomethacin)、氟比洛芬(flurbiprofen)、萘普生(naproxen)、布洛芬、雷米那酮(ramifenazone)、吡罗昔康(piroxicam)、(甾族的)可的松(cortisone)、地塞米松(dexamethasone)、氟扎可特(fluazacort)、塞来考昔(celecoxib)、罗非昔布(rofecoxib)、氢化可的松(hydrocortisone)、泼尼松龙(prednisolone)、和泼尼松(prednisone));抗肿瘤药(例如,环磷酰胺(cyclophosphamide)、放线菌素(actinomycin)、博来霉素(bleomycin)、柔红霉素(daunorubicin)、多柔比星(doxorubicin)、表柔比星(epirubicin)、丝裂霉素(mitomycin)、甲氨蝶呤(methotrexate)、氟尿嘧啶(fluorouracil)、卡铂(carboplatin)、卡莫司汀(carmustine)(BCNU)、赛氮芥(methyl-CCNU)、顺铂(cisplatin)、依托泊苷(etoposide)、喜树碱(camptothecin)和其衍生物、苯芥胆甾醇(phenesterine)、紫杉醇(paclitaxel)和其衍生物、多西他赛(docetaxel)和其衍生物、长春碱(vinblastine)、长春新碱(vincristine)、长春新碱(tamoxifen)、和哌泊舒凡(piposulfan));抗焦虑剂(例如,劳拉西泮(lorazepam)、普拉西泮(prazepam)、氯氮卓(chlordiazepoxide)、奥沙西泮(oxazepam)、二钾氯氮卓(clorazepatedipotassium)、地西泮(diazepam)、双羟萘酸羟嗪(hydroxyzinepamoate)、盐酸羟嗪(hydroxyzinehydrochloride)、阿普唑仑(alprazolam)、氟哌利多(droperidol)、哈拉西泮(halazepam)、氯美扎酮(chlormezanone)、和丹曲林(dantrolene));免疫抑制剂(例如,环孢菌素(cyclosporine)、硫唑嘌呤(azathioprine)、咪唑立宾(mizoribine)、和FK506(他罗利姆(tacrolimus)));抗偏头痛药(例如,麦角胺(ergotamine)、双丙戊酸钠(divalproex)、半乳糖二酸甲异辛烯胺(isometheptenemucate)、和氯醛比林(dichloralphenazone));镇静药/安眠药(例如,巴比妥类(barbiturates),例如戊巴比妥(pentobarbital)、戊巴比妥、和司可巴比妥(secobarbital));和苯并二氮呼,例如盐酸氟西泮、三唑仑(triazolam)、和咪达唑仑(midazolam);抗心绞痛剂(例如,β-肾上腺素能阻断剂;钙通道阻断剂,例如尼索地平(nisoldipine));和硝酸盐,例如硝酸甘油(nitroglycerin)、硝酸异山梨酯、戊四硝酯(pentaerythritoltetranitrate)、和丁四硝酯(erythrityltetranitrate));抗精神病剂(例如,氟哌啶醇(haloperidol)、丁二酸洛沙平(loxapinesuccinate)、盐酸洛沙平(loxapinehydrochloride)、硫利达嗪(thioridazine)、盐酸硫利达嗪、替沃噻吨(thiothixene)、氟奋乃静(fluphenazine)、癸氟奋乃静(fluphenazinedecanoate)、氟奋乃静庚酸酯(fluphenazineenanthate)、三氟拉嗪(trifluoperazine)、氯丙嗪(chlorpromazine)、奋乃静(perphenazine)、柠檬酸锂、利培酮(risperidone)、和丙氯拉嗪(prochlorperazine));抗躁狂药(例如,碳酸锂);抗心律不齐药(例如,溴苄铵托西酸盐(bretyliumtosylate)、艾司洛尔(esmolol)、胺碘酮(amiodarone)、恩卡尼(encainide)、地高辛(digoxin)、洋地黄毒苷(digitoxin)、美西律(mexiletine)、磷酸丙吡胺(disopyramidephosphate)、普鲁卡因胺(procainamide)、硫酸奎尼丁(quinidinesulfate)、葡糖酸奎尼丁(quinidinegluconate)、奎尼丁聚半乳糖醛酸盐(quinidinepolygalacturonate)、氟卡尼(flecainideacetate)、妥卡尼(tocainide)、和利多卡因(lidocaine));抗关节炎剂(例如,保泰松(phenylbutazone)、舒林酸(sulindac)、青霉胺(penicillamine)、双水杨酯(salsalate)、吡罗昔康(piroxicam)、硫唑嘌呤(azathioprine)、吲哚美辛、甲氯灭酸的结合碱(meclofenamate)、硫代苹果酸金钠(goldsodiumthiomalate)、金诺芬(auranofin)、金硫葡糖(aurothioglucose)、和托美丁钠(tolmetinsodium));抗痛风剂(例如,秋水仙碱(colchicine)、和别嘌呤醇(allopurinol));抗凝血药(例如,肝素、肝素钠、和华法林钠(warfarinsodium));血栓溶解剂(例如,尿激酶、链激酶、和阿替普酶(alteplase));抗纤溶剂(例如,氨基己酸);活血药(例如,己酮可可碱(pentoxifylline));抗血小板剂(例如,阿司匹林);抗惊厥药(例如,丙戊酸(valproicacid)、双丙戊酸钠(divalproexsodium)、苯妥英(phenytoin)、苯妥英钠、氯硝西泮(clonazepam)、扑米酮(primidone)、苯巴比妥(phenobarbital)、异戊巴比妥钠(amobarbitalsodium)、甲琥胺(methsuximide)、美沙比妥(metharbital)、甲苯比妥(mephobarbital)、美芬妥英(mephenytoin)、苯琥胺(phensuximide)、甲乙双酮(paramethadione)、乙苯妥英(ethotoin)、(phenacemide)、司可巴比妥钠、二钾氯氮卓(clorazepatedipotassium)、和三甲双酮(trimethadione));抗帕金森病药(antiparkinsonagent)(例如,乙琥胺(ethosuximide));抗组胺药/止痒药(例如,羟嗪、苯海拉明(diphenhydramine)、氯苯那敏(chlorpheniramine)、马来酸溴苯那敏(brompheniraminemaleate)、盐酸赛庚啶(cyproheptadinehydrochloride)、特非那定(terfenadine)、富马酸氯马斯汀(clemastinefumarate)、曲普利啶(triprolidine)、卡比沙明(carbinoxamine)、二苯拉林(diphenylpyraline)、苯茚胺(phenindamine)、阿扎他定(azatadine)、曲吡那敏(tripelennamine)、富马酸右旋氯苯吡胺(dexchlorpheniraminemaleate)、甲地嗪(methdilazine)、氯雷他定(loratadine)和);用于钙调节的药剂(例如,降钙素(calcitonin)、和甲状旁腺素(parathyroidhormone));抗细菌剂(例如,硫酸阿米卡星(amikacinsulfate)、氨曲南(aztreonam)、氯霉素、棕榈氯霉素、环丙沙星、克林霉素(clindamycin)、克林霉素棕榈酸酯、克林霉素磷酸酯、甲硝唑(metronidazole)、甲硝唑盐酸盐、硫酸庆大霉素(gentamicinsulfate)、盐酸林可霉素(lincomycinhydrochloride)、硫酸妥布霉素(tobramycinsulfate)、盐酸万古霉素(vancomycinhydrochloride)、硫酸多粘菌素B(polymyxinBsulfate)、多粘菌素e甲磺酸钠(colistimethatesodium)、和硫酸多粘菌素e(colistinsulfate));抗病毒剂(例如,干扰素α、β或γ、齐多夫定(zidovudine)、盐酸金刚烷胺(amantadinehydrochloride)、利巴韦林(ribavirin)、和阿昔洛韦(acyclovir));抗微生物药(例如,头孢菌素类,例如头孢唑林钠(cefazolinsodium)、头孢拉定(cephradine)、头孢克洛(cefaclor)、头孢匹林钠(cephapirinsodium)、头孢唑肟钠(ceftizoximesodium)、头孢哌酮钠(cefoperazonesodium)、头孢替坦二钠(cefotetandisodium)、头孢呋辛钠(cefuroximesodium)、头孢噻肟钠(cefotaximesodium)、头孢羟氨苄一水合物(cefadroxilmonohydrate)、头孢氨苄(cephalexin)、头孢噻吩钠(cephalothinsodium)、头孢氨苄盐酸盐一水合物、头孢孟多酯钠(cefamandolenafate)、头孢孟多酯钠(cefoxitinsodium)、头孢尼西钠(cefonicidsodium)、头孢雷特(ceforanide)、头孢曲松钠(ceftriaxonesodium)、头孢他啶(ceftazidime)、头孢羟氨苄(cefadroxil)、头孢拉定、和头孢呋辛钠);青霉素类(例如氨苄西林、阿莫西林(amoxicillin)、苄星青霉素G(penicillinGbenzathine)、环己西林(cyclacillin)、氨苄西林钠、青霉素G钾(penicillinGpotassium)、青霉素V钾(penicillinVpotassium)、哌拉西林钠(piperacillinsodium)、苯唑西林钠(oxacillinsodium)、盐酸巴氨西林(bacampicillinhydrochloride)、氯唑西林钠(cloxacillinsodium)、替卡西林钠(ticarcillindisodium)、阿洛西林钠(aziocillinsodium)、卡茚西林钠(carbenicillinindanylsodium)、普鲁卡因青霉素g(penicillinGprocaine)、甲氧苯青霉素钠(methicillinsodium)、和萘夫西林钠(nafcillinsodium));红霉素类,例如琥乙红霉素(erythromycinethylsuccinate)、红霉素、依托红霉素(erythromycinestolate)、乳糖酸红霉素(erythromycinlactobionate)、硬脂酸红霉素、和琥乙红霉素;和四环素类,例如盐酸四环素、盐酸多西环素(doxycyclinehyclate)、和盐酸多西环素(minocyclinehydrochloride)、阿奇霉素(azithromycin)、克拉霉素(clarithromycin);抗感染药(例如,GM-CSF);支气管扩张剂(例如,拟效感神经药,例如盐酸肾上腺素、硫酸间羟异丙肾上腺素(metaproterenolsulfate)、硫酸特布他林(terbutalinesulfate)、异他林(isoetharine)、甲磺酸乙基异丙肾上腺素(isoetharinemesylate)、异他林盐酸盐、硫酸沙丁胺醇(albuterolsulfate)、沙丁胺醇、双甲苯喘定甲磺酸盐(bitolterolmesylate)、盐酸异丙肾上腺素、硫酸特布他林(terbutalinesulfate)、重酒石酸肾上腺素(epinephrinebitartrate)、硫酸间羟异丙肾上腺素、肾上腺素、和重酒石酸肾上腺素);抗胆碱能药,例如异丙托溴铵(ipratropiumbromide);黄嘌呤类,例如氨茶碱(aminophylline)、二羟丙茶碱(dyphylline)、硫酸间羟异丙肾上腺素、和氨茶碱;肥大细胞稳定剂,例如色甘酸钠;吸入皮质类固醇,例如丙酸倍氯米松(beclomethasonedipropionate)(BDP)、和丙酸倍氯米松一水合物;舒喘灵(Salbutamol);异丙托溴铵;布地奈德(budesonide);酮替芬(ketotifen);沙美特罗(salmeterol);昔萘酸盐(xinafoate);硫酸特布他林(terbutalinesulfate);曲安西龙(triamcinolone);茶碱(theophylline);奈多罗米钠(nedocromilsodium);硫酸间羟异丙肾上腺素;沙丁胺醇;氟尼缩松(flunisolide);丙酸氟替卡松(fluticasoneproprionate)、甾族化合物和激素(例如,雄激素类例如达那唑(danazol)、环戊丙酸睾酮(testosteronecypionate)、氟甲睾酮(fluoxymesterone)、乙睾酮(ethyltestosterone)、庚酸睾酮(testosteroneenathate)、甲睾酮(methyltestosterone)、氟甲睾酮、和环戊丙酸睾酮);雌激素类,例如雌二醇、硫酸雌酮哌嗪(estropipate)、和共轭雌激素;孕激素类,例如乙酸甲氧基孕酮、和乙酸炔诺酮;皮质类固醇类,例如曲安西龙、倍他米松(betamethasone)、倍他米松磷酸钠、地塞米松、地塞米松磷酸钠、乙酸地塞米松泼尼松、乙酸甲泼尼龙(methylprednisoloneacetate)悬浮液、曲安奈德(triamcinoloneacetonide)、甲泼尼龙、泼尼松龙磷酸钠(prednisolonesodiumphosphate)、琥珀酸钠甲泼尼龙、氢化可的松琥珀酸钠(hydrocortisonesodiumsuccinate)、己曲安奈德(triamcinolonehexacetonide)、氢化可的松、氢化可的松环戊丙酸酯、泼尼松龙、乙酸氟氢可的松(fludrocortisoneacetate)、乙酸对氟米松(paramethasoneacetate)、泼尼松龙叔丁乙酯(prednisolonetebutate)、乙酸泼尼松龙、泼尼松龙磷酸钠、和氢化可的松琥珀酸钠;和甲状腺激素类,例如左甲状腺素钠;降糖药(例如,人胰岛素、纯化牛胰岛素、纯化猪胰岛素、格列本脲(glyburide)、氯磺丙脲(chlorpropamide)、甲苯磺丁脲(tolbutamide)、和妥拉磺脲(tolazamide));降血脂药(例如,氯贝丁酯(clofibrate)、右甲状腺素钠、普罗布可(probucol)、辛伐他汀(simvastatin)、普伐他汀(pravastatin)、阿托伐他汀(atorvastatin)、洛伐他汀(lovastatin)、和烟酸(niacin));蛋白质(例如,DNase、藻酸酶、超氧化物歧化酶、和脂肪酶);核酸(例如,编码任何治疗有用蛋白质(包括本文所述的任何蛋白质)的有义或反义核酸);用于红细胞生成刺激的药剂(例如,红细胞生成素);抗溃疡药/抗反流药(例如,法莫替丁(famotidine)、西咪替丁(cimetidine)、和盐酸雷尼替丁(ranitidinehydrochloride));止恶心药/止吐药(例如,美克洛嗪盐酸盐(meclizinehydrochloride)、大麻隆(nabilone)、丙氯拉嗪(prochlorperazine)、茶苯海明(dimenhydrinate)、盐酸异丙嗪(promethazinehydrochloride)、硫乙拉嗪(thiethylperazine)、和东莨菪碱(scopolamine));油溶性维生素(例如,维生素A、D、E、K、和诸如此类;以及其它药物,例如米托坦(mitotane)、卤代亚硝基脲、蒽环类化合物、和艾力替新(ellipticine)。
这些和其它有用类型药物的说明和每一类型中物质的列表可发现于马丁戴尔(Martindale)的额外药典(TheExtraPharmacopoeia),第30版(英国医药出版社(ThePharmaceuticalPress),伦敦1993)。
用于本文所述组合物和方法中的其它药物的实例包括头孢曲松(ceftriaxone)、头孢他啶(ceftazidime)、奥沙普秦(oxaprozin)、沙丁胺醇、伐昔洛韦(valacyclovir)、尿促卵泡素(urofollitropin)、泛昔洛韦(famciclovir)、氟他胺(flutamide)、依那普利(enalapril)、福辛普利(fosinopril)、阿卡波糖(acarbose)、劳拉西泮、促滤泡素(follitropin)、氟西汀、赖诺普利(lisinopril)、曲马朵(tramadol)、左氧氟沙星(levofloxacin)、扎鲁司特(zafirlukast)、干扰素、生长激素、白介素、促红细胞生成素、粒细胞刺激因子、尼扎替丁(nizatidine)、培哚普利(perindopril)、特丁胺(erbumine)、腺苷、阿屈膦酸盐(alendronate)、前列地尔(alprostadil)、贝那普利(benazepril)、倍他洛尔(betaxolol)、硫酸博来霉素、右芬氟拉明(dexfenfluramine)、芬太尼(fentanyl)、弗莱尼德(flecainid)、吉西他滨(gemcitabine)、乙酸格拉默(glatirameracetate)、格拉司琼(granisetron)、拉米夫定(lamivudine)、哌甲酯(methylphenidate)、锰福地吡三钠(mangafodipirtrisodium)、美沙拉秦(mesalamine)、富马酸美托洛尔(metoprololfumarate)、甲硝唑(metronidazole)、米格列醇(miglitol)、莫昔普利(moexipril)、孟鲁司特(montelukast)、乙酸奥曲肽(octreotideacetate)、奥洛他定(olopatadine)、帕立骨化醇(paricalcitol)、生长激素、琥珀酸舒马普坦(sumatriptansuccinate)、他克林(tacrine)、萘丁美酮(nabumetone)、曲伐沙星(trovafloxacin)、多拉司琼(dolasetron)、齐多夫定、非那雄胺(finasteride)、妥布霉素(tobramycin)、伊拉地平(isradipine)、托卡朋(tolcapone)、依诺肝素(enoxaparin)、氟康唑(fluconazole)、特比萘芬(terbinafine)、帕玛二磷酸(pamidronate)、去羟肌苷(didanosine)、西沙必利(cisapride)、文拉法辛(venlafaxine)、曲格列酮(troglitazone)、氟伐他汀(fluvastatin)、氯沙坦(losartan)、伊米苷酶(imiglucerase)、多奈哌齐(donepezil)、奥氮平(olanzapine)、缬沙坦(valsartan)、非索非那定(fexofenadine)、降钙素、和异丙托溴铵。这些药物通常认为是水溶性的。
其它药物包括沙丁胺醇、阿达帕林(adapalene)、甲磺酸多沙唑嗪(doxazosinmesylate)、糠酸莫米松(mometasonefuroate)、熊去氧胆酸(ursodiol)、两性霉素、马来酸依那普利(enalaprilmaleate)、非洛地平(felodipine)、盐酸奈法唑酮(nefazodonehydrochloride)、戊柔比星(valrubicin)、阿苯达唑(albendazole)、共轭雌激素类、乙酸甲羟孕酮、盐酸尼卡地平(nicardipinehydrochloride)、酒石酸唑吡坦(Zolpidemtartrate)、苯磺酸氨氯地平(amlodipinebesylate)、炔雌醇、卢比替康(rubitecan)、苯磺酸氨氯地平/盐酸贝那普利(benazeprilhydrochloride)、盐酸帕罗西汀(paroxetinehydrochloride)、紫杉醇、阿托伐醌(atovaquone)、非洛地平(felodipine)、普达非洛(podofilox)、帕立骨化醇、二丙酸倍他米松、(fentanyl)、盐酸普拉克索(pramipexoledihydrochloride)、维生素D3和有关类似物、非那雄胺(finasteride)、富马酸喹硫平(quetiapinefumarate)、前列地尔(alprostadil)、坎地沙坦(candesartan)、环庚塞(cilexetil)、左旋多巴(fluconazole)、利托那韦(ritonavir)、白消安(busulfan)、卡马西平(carbamazepine)、氟马西尼(flumazenil)、利培酮(risperidone)、卡比多巴(carbidopa)、卡比多巴(levodopa)、更昔洛韦(ganciclovir)、沙奎那韦(saquinavir)、氨普那韦(amprenavir)、卡铂、格列本脲、盐酸舍曲林(sertralinehydrochloride)、罗非昔布卡维地洛(rofecoxibcarvedilol)、卤倍他索丙酸酯(halobetasolproprionate)、柠檬酸西地那非(sildenafilcitrate)、塞来考昔、氯噻酮(chlorthalidone)、咪喹莫特(imiquimod)、辛伐他汀、西酞普兰(citalopram)、环丙沙星、盐酸依立替康(irinotecanhydrochloride)、司帕沙星(sparfloxacin)、依法韦伦(efavirenz)、西沙必利一水合物、兰索拉唑(lansoprazole)、盐酸坦洛新(tamsulosinhydrochloride)、莫达非尼(modafinil)、克拉霉素、来曲唑(letrozole)、盐酸特比萘芬(terbinafinehydrochloride)、马来酸罗格列酮(rosiglitazonemaleate)、盐酸洛美沙星(lomefloxacinhydrochloride)、盐酸替罗非班(tirofibanhydrochloride)、替米沙坦(telmisartan)、地西泮、氯雷他定、柠檬酸托瑞米芬(toremifenecitrate)、沙利度胺(thalidomide)、地诺前列酮(dinoprostone)、盐酸甲氟喹(mefloquinehydrochloride)、氯喹(chloroquine)、群多普利(trandolapril)、多西他赛、盐酸米托蒽醌(mitoxantronehydrochloride)、维a酸(tretinoin)、依托度酸(etodolac)、乙酸曲安西龙、雌二醇、熊去氧胆酸、甲磺奈非那韦(nelfinavirmesylate)、茚地那韦(indinavir)、丙酸倍氯米松、奥沙普秦、氟他胺、法莫替丁、泼尼松、头孢呋辛、劳拉西泮、地高辛、洛伐他汀、灰黄霉素、萘普生、布洛芬、异维a酸(isotretinoin)、柠檬酸他莫西芬(tamoxifencitrate)、尼莫地平(nimodipine)、胺碘酮(amiodarone)、和阿普唑仑。
就挤出-滚圆助剂而言,可使用任何适宜挤出-滚圆助剂,例如微晶纤维素、果胶和乙基纤维素。
就超崩解剂而言,任何可改良和调节活性医药成分释放的超崩解剂皆适宜。例如且不限于,羟基乙酸淀粉钠(sodiumstarchglycolate)、交联羧甲纤维素钠、交联N-乙烯基-2-吡咯烷酮的均聚物、和海藻酸、交联纤维素、交联聚合物、交联淀粉、离子交换树脂、交联聚维酮和其组合。
就助流剂而言,可使用任何适宜助流剂,例如滑石粉、二氧化硅、淀粉、硅酸钙、卡波斯(Cabosil)、丝劳德(Syloid)、和二氧化硅气凝胶。通常,使用二氧化硅。
就润滑剂而言,任何适宜润滑剂是水、碱金属硬脂酸盐(例如硬脂酸镁、硬脂酸钙、硬脂酸锌)、聚乙二醇、己二酸、氢化植物油、氯化钠、思迪渃泰斯(sterotex)、单硬脂酸甘油酯、滑石粉、聚乙二醇、苯甲酸钠、月桂基硫酸钠、月桂基硫酸镁、硬脂酰基富马酸钠、轻质矿物油和诸如此类可使用。可使用蜡质脂肪酸酯,例如以“抗普瑞特()”产品出售的山嵛酸甘油酯。其它有用市售润滑剂包括“Stear-O-Wet”和“莫维特斯(Myvatex)TL”。通常,硬脂酸镁、滑石粉和/或单硬脂酸甘油酯。
就油而言,可使用任何适宜油,例如,一或多种选自以下的油:扁桃仁油、杏仁油、鳄梨油、黑醋栗油(BlackCurrantOil)、14%GLA、琉璃苣油、20%GLA、介花油、胡萝卜油、蓖麻油、丁香叶油、椰子油、玉米油、棉籽油、月见草油、9%GLA、亚麻籽油、55%ALA、葡萄籽油、榛子油、大麻籽油、ALA/GLA、氢化油、荷荷芭油(JojobaOil)、金黄荷荷芭油(GoldenJojobaOil)、无色透明的夏威夷核油(water-whiteKukuiNutOil)、澳洲坚果核油(MacadamiaNutOil)、燕麦油、橄榄油、特级初榨橄榄油渣(ExtraVirginOliveOilPomace)/“B”级、橄榄油、纯/NF的棕榈油、欧芹籽油、桃仁油、花生油、美洲山核桃油(PecanOil)、阿月浑子油(PistachioOil)、南瓜籽油、米糠油、玫瑰果油、迷迭香油、红花油、亚油酸红花油(Linoleic′SafflowerOil)、高油酸油(High-Oleic)、NF级的芝麻油、香油、大豆油、葵花籽油、高油酸色拉葵花籽油(SaladSunflowerOilHigh-Oleic)、茶树油、植物油、甘油USP、胡桃油、小麦胚芽油、冷榨油(Cold-pressed)和矿物油或其它类似的油。
就虹吸剂而言,虹吸剂产生通道或孔。实例包括微晶纤维素、果胶、胶体二氧化硅、高岭土、二氧化钛、氧化铝、月桂基硫酸钠、低分子量聚乙烯基吡咯烷酮、聚酯和聚乙烯。
就电解质而言,可使用任何适宜电解质,例如一或多种能够提供钠(Na+)、钾(K+)、氯(Cl-)、钙(Ca2+)、镁(Mg2+)、碳酸氢根(HCO3 -)、磷酸根(PO4 2-)、和硫酸根(SO4 2-)离子的盐。
聚合物膜的实例包括聚甲基丙烯酸酯共聚物和肠溶材料。
就肠溶材料而言,用于本发明的肠溶聚合物包括纤维素的酯和其衍生物(乙酸邻苯二甲酸纤维素、羟丙基甲基纤维素邻苯二甲酸酯、乙酸羟丙基甲基纤维素琥珀酸酯)、聚甲基丙烯酸酯、聚乙酸乙烯邻苯二甲酸酯、甲基丙烯酸-甲基丙烯酸酯共聚物和虫胶。可使用的一些市售材料是由偌曼医药(RhomPharma)制造的以商品名因卓吉特(Eudragit)(L100、S100、L30D55)出售的甲基丙烯酸共聚物、来自伊士曼化学公司(EastmanChemicalCo.)的纤维醋法酯(Cellacefate)(乙酸邻苯二甲酸纤维素)、来自FMC公司的安奎特克(Aquateric)(乙酸邻苯二甲酸纤维素水分散液)和来自ShinEtsuK.K的乙酸羟丙基甲基纤维素琥珀酸酯水分散液。
非肠溶材料的实例包括纤维素醚和乙基纤维素。
半透膜材料的实例包括乙酸邻苯二甲酸纤维素和乙酸纤维素。
增塑剂的实例包括聚乙二醇、癸二酸二丁酯、柠檬酸三乙酯、蓖麻油、单硬脂酸甘油酯、邻苯二甲酸二乙酯和三庚酸甘油酯。
术语“定时释放”、“脉冲释放”、“时间治疗释放”、“延长释放”和“受控释放”出于本发明目的定义为药物自剂型以当所述药物的剂量以定时释放、脉冲释放、时间治疗释放、延长释放或受控释放形式投与时药物的血液(例如,血浆)浓度(含量)在选定时期内维持在治疗范围内但低于毒性含量的速率释放。
当介绍本文所揭示要素时,除非上下文明确说明,否则冠词“一种(a、an)”、“所述(the和said)”欲指有一或多种要素。例如,术语“一种化合物”和“至少一种化合物”可包括多个化合物,包括其混合物。术语“包含”、“具有”、“包括”欲为开放式的且意指除所列举要素外尚有其它要素。
以上揭示内容概括的阐述了本发明。参考以下特定实例可获得更全面理解。所述实例仅用于阐释本发明而非意欲限定本发明的范围。在条件允许或有利的情况下涵盖形式变化和等效内容的替代。尽管本文使用特定术语,但所述术语意欲具有叙述性意义且并非用于限制目的。
实例
实例1:受控释放哌甲酯HCI球状体
这是一个两步工艺,其中立即释放球状体是通过挤出-滚圆工艺、随后将受控释放涂层涂覆到所述球状体上以形成受控释放球状体来制造。
(1)无涂层的球状体的制造
组份 | 调配物I(wt%) | 调配物II(wt%) | 调配物III(wt%) |
哌甲酯HCl | 25 | 25 | 20 |
卡波姆 | 0.5 | - | - |
果胶 | 5 | - | - |
微晶纤维素 | 60 | 60 | 60至67 |
乙基纤维素* | - | - | 3至10 |
交联聚维酮 | 4.5 | 5 | 5 |
滑石粉 | 5 | 10 | 5 |
水 | QS | QS | QS |
*用作造粒水溶液(安奎考特(Aquacoat)TM)
QS通常为约100wt%到约200wt%
就各调配物而言,将材料装载到行星式混合机中并掺和约5分钟。对于调配物I和调配物II而言,将所得均相掺合物利用足量水粒化约3分钟,而对于调配物III使用乙基纤维素的水溶液(商业品牌安奎考特(Aquacoat)TM)。使用25型考雷沃(Caleva)挤出机将湿团块挤出。将挤出物以约500克的量在240型考雷沃(Caleva)滚圆机中滚圆。将湿球状体在约40℃下在盘式干燥烘箱中干燥到LOD(干燥损失)小于约2wt%。
(2)球状体的涂覆
将约1000g来自调配物I的球状体用水性分散液涂覆,所述分散液由约500g安奎考特(Aquacoat)TM(例如,乙基纤维素分散液)、约40g透明路斯特(LustreClear)TM(例如,角叉菜胶和微晶纤维素)、约35.5g癸二酸二丁酯、和约114g水组成。将球状体涂覆到重量增加为球状体重量的约6%。
将约1000g来自调配物II的球状体用水性分散液涂覆,所述分散液由约500g安奎考特(Aquacoat)TM(例如,乙基纤维素分散液)、约40g透明路斯特(LustreClear)TM(例如,角叉菜胶和微晶纤维素)、约36g癸二酸二丁酯、和约114g水组成。将球状体涂覆到重量增加为球状体重量的约6%。
将约1250g来自调配物III的球状体用水性分散液涂覆,所述分散液由约350g安奎考特(Aquacoat)TM(例如,乙基纤维素分散液)、约36g癸二酸二丁酯、20g颜料和约72g水组成。将球状体涂覆到重量增加为球状体重量的约12%。
在UniGlatt流化床涂布器中使用顶部喷射组合件实施涂覆。将经涂覆球状体在盘式干燥烘箱中在约60℃下干燥约2小时。
实例2:脉冲释放文拉法辛HCl胶囊或片剂
这是一个三步工艺,其中立即释放球状体是通过挤出-滚圆工艺随后将受控释放涂层涂覆到一些球状体上来制造。为获得脉冲释放,将经涂覆球状体群体与未涂覆球状体群体组合并放到胶囊中或压制成片剂。或者,将具有不同释放速率的经涂覆球状体组合在一起并放到胶囊中或压制成片剂。
(1)立即释放球状体的制造
组份调配物IV(wt%)调配物V(wt%)
文法拉辛HCl3940
果胶5-
微晶纤维素4545
氯化钠-2
椰子油1-
交联聚维酮53
滑石粉510
水QSQS
QS通常为约100wt%到约200wt%
就各调配物而言,将材料装载到行星式混合机中并掺和约5分钟。将所得均相掺合物利用足量水粒化约3分钟。使用25型考雷沃(Caleva)挤出机将湿团块挤出。将挤出物以约500克的量在240型考雷沃(Caleva)滚圆机中滚圆。将湿球状体在约40℃下在盘式干燥烘箱中干燥到LOD(干燥损失)小于约2wt%。
(2)立即释放球状体的涂覆
将约1000g来自调配物IV的球状体用水性分散液涂覆,所述分散液由约500gof安奎考特(Aquacoat)TM(例如,乙基纤维素分散液)、约40g透明路斯特(LustreClear)TM(例如,角叉菜胶和微晶纤维素)、约36g癸二酸二丁酯、和约114g水组成。将球状体涂覆到重量增加为球状体重量的约6%以产生调配物IVa,同时使用类似水性分散液将调配物V涂覆到重量增加为球状体重量的15%以产生调配物Va。
在UniGlatt流化床涂布器中使用顶部喷射组合件实施涂覆。将经涂覆球状体在盘式干燥烘箱中在约60℃下干燥约2小时。
(3)脉冲释放文法拉辛HCl的组合
1型
1型是由10wt%调配物IV、45wt%调配物IVa和45wt%调配物Va构成。
2型
2型是由30wt%调配物IV和70wt%调配物Va构成。
3型
3型是由40wt%调配物IVa和60wt%调配物Va构成。
将这些组合(1型、2型或3型)做成胶囊或压制成片剂。
实例3:时间治疗或定时释放卡维地洛胶囊或片剂
这是一个三步工艺,其中立即释放球状体是通过溶液层化工艺制造,其中流化床涂布器随后将受控释放涂层涂覆到球状体上。为获得时间治疗释放,将经受控释放涂覆群体的球状体用甲基丙烯酸共聚物和/或纤维素酯涂覆并放到胶囊中。或者,将经受控释放涂覆群体的球状体压制成片剂并将所述片剂用甲基丙烯酸酯共聚物和/或纤维素酯涂覆。
(1)立即释放球状体的制造
组份 | 调配物VI(wt%) | 调配物VII(wt%) | 调配物VIII(wt%) |
卡维地洛 | 5 | 5 | 5 |
挤出糖球 | 88 | 88 | 88 |
*透明路斯特IM | 5 | - | 2 |
**欧巴代IM | - | 5 | 3 |
交联聚维酮 | 2 | 2 | 2 |
水 | QS | QS | QS |
*含角叉菜胶和微晶纤维素
**含羟丙基甲基纤维素
QS通常为约100wt%到约200wt%
就各调配物而言,将卡维地洛和交联聚维酮缓慢添加到透明路斯特(LustreClear)TM和/或欧巴代(Opadry)TM的水溶液中并充分混合。将糖球(18-20网目)用药物分散液在UniGlatt流化床涂布器中涂覆。将所述球状体涂覆到重量增加为球状体重量的约10%。将所述球状体干燥到LOD(干燥损失)小于约2wt%。
(2)受控释放球状体的制造
将约1000g来自调配物VI的球状体用水性分散液涂覆,所述分散液由约500g安奎考特(Aquacoat)TM(例如,乙基纤维素分散液)、约40g透明路斯特(LustreClear)TM(例如,角叉菜胶和微晶纤维素)、约35.5g癸二酸二丁酯、和约114g水组成。将所述球状体涂覆到重量增加为球状体重量的约6%。
将约1000g来自调配物VII的球状体用水性分散液涂覆,所述分散液由约500g安奎考特(Aquacoat)TM(例如,乙基纤维素分散液)、约40g透明路斯特(LustreClear)TM(例如,角叉菜胶和微晶纤维素)、约36g癸二酸二丁酯、和约114g水组成。将所述球状体涂覆到重量增加为球状体重量的约6%。
将约1000g来自调配物VIII的球状体用水性分散液涂覆,所述分散液由约500g安奎考特(Aquacoat)TM(例如,乙基纤维素分散液)、约40g透明路斯特(LustreClear)TM(例如,角叉菜胶和微晶纤维素)、约36g癸二酸二丁酯、和约114g水组成。将所述球状体涂覆到重量增加为球状体重量的约6%。
将约1000g来自调配物VI的球状体用由约400g因卓吉特(Eudragit)NE30DTM和约60g滑石粉组成的水性分散液涂覆到重量增加为球状体重量的约6%。
将约1000g来自调配物VII的球状体用由约400g因卓吉特(Eudragit)NE30DTM和约60g滑石粉组成的水性分散液涂覆到重量增加为球状体重量的约6%。
将约1000g来自调配物VIII的球状体用由约400g因卓吉特(Eudragit)NE30DTM和约60g滑石粉组成的水性分散液涂覆到重量增加为球状体重量的约6%。
在UniGlatt流化床涂布器中使用顶部喷射组合件实施涂覆。将经涂覆球状体在盘式干燥烘箱中在约60℃下干燥约2小时。
(3)时间治疗或定时释放卡维地洛的制造
(I)胶囊
将受控释放球状体用由约1142g因卓吉特(Eudragit)L30D55TM(例如,甲基丙烯酸共聚物)、约137g单硬脂酸甘油酯、约41g柠檬酸三乙酰基酯和约679g水组成的水性分散液涂覆和/或由约1142g纤维素酯、约137g单硬脂酸甘油酯、约41g柠檬酸三乙酰基酯、和约679g水组成的水性分散液涂覆到重量增加足以获得所期望的约1小时到约12小时的延迟时间。然后将其放到胶囊中。图1展示这些胶囊的溶解曲线。
(II)片剂
将受控释放涂覆群体的球状体和/或惰性球状体压制成片剂并将所述片剂用由约1142g因卓吉特(Eudragit)L30D55TM(例如,甲基丙烯酸共聚物)、约137g单硬脂酸甘油酯、约41g柠檬酸三乙酰基酯、和约679g水组成的水性分散液和/或由约1142g纤维素酯、约137g单硬脂酸甘油酯、约41g柠檬酸三乙酰基酯、和约679g水组成的水性分散液涂覆到重量增加足以获得所期望的约1小时到约12小时的延迟时间为止。图1展示这些片剂的溶解曲线。
Claims (120)
1.一种包含两种或更多种挤出球状体的药物递送组合物,所述两种或更多种挤出球状体中的每个包含:
占0.1wt%到80wt%的至少一种活性医药成分;
占10wt%到70wt%的至少一种挤出-滚圆助剂,所述挤出-滚圆助剂选自如下构成的群组:微晶纤维素、果胶和/或乙基纤维素;
占2wt%到70wt%的至少一种超崩解剂,所述超崩解剂选自:羟基乙酸淀粉钠(sodiumstarchglycolate)、交联羧甲纤维素钠、海藻酸、交联纤维素、交联聚合物、交联淀粉、和离子交换树脂;和
占1wt%到20wt%的至少一种助流剂、占0.5wt%到5wt%的至少一种润滑剂、和/或占0.5wt%到5wt%的至少一种油,
其中所述至少一种助流剂包含二氧化硅、淀粉、硅酸钙、滑石粉、卡波斯、丝劳德、和二氧化硅气凝胶;
其中所述至少一种润滑剂包含碱金属硬脂酸盐、聚乙二醇、己二酸、氢化植物油、氯化钠、思迪渃泰斯、单硬脂酸甘油酯、滑石粉、苯甲酸钠、月桂基硫酸钠、月桂基硫酸镁、硬脂酰基富马酸钠、轻质矿物油、和/或蜡状脂肪酸酯;
其中所述至少一种油包含一或多种选自以下的油:植物油、甘油、USP、冷榨油和矿物油;
其中所述两种或更多种挤出球状体中的每个涂覆有至少如下不同配比的乙基纤维素分散液、角叉菜胶、微晶纤维素和癸二酸二丁酯;
其中所述涂覆的涂层以所述挤出球状体和所述涂层的总重量计占0.5wt%到50wt%。
2.如权利要求1所述的药物递送组合物,其中所述植物油选自:
杏仁油、鳄梨油、黑醋栗油、14%GLA、琉璃苣油、20%GLA、介花油、胡萝卜油、蓖麻油、丁香叶油、椰子油、玉米油、棉籽油、月见草油、9%GLA、亚麻籽油、55%ALA、葡萄籽油、榛子油、大麻籽油、ALA/GLA、氢化油、荷荷芭油、无色透明的夏威夷核油、澳洲坚果核油、燕麦油、橄榄油、特级初榨橄榄油渣/“B”级、纯/NF的棕榈油、欧芹籽油、花生油、美洲山核桃油、阿月浑子油、南瓜籽油、米糠油、玫瑰果油、迷迭香油、高油酸油、香油、大豆油、葵花籽油、茶树油、胡桃油或小麦胚芽油。
3.如权利要求1所述的药物递送组合物,其中所述交联聚合物是交联N-乙烯基-2-吡咯烷酮的均聚物。
4.如权利要求1所述的药物递送组合物,其中所述交联聚合物是交联聚维酮。
5.如权利要求2所述的药物递送组合物,其中所述桃仁油是扁桃仁油。
6.如权利要求2所述的药物递送组合物,其中所述荷荷芭油是金黄荷荷芭油。
7.如权利要求2所述的药物递送组合物,其中所述红花油是亚油酸红花油。
8.如权利要求2所述的药物递送组合物,其中所述香油是NF级的芝麻油。
9.如权利要求2所述的药物递送组合物,其中所述葵花籽油是高油酸色拉葵花籽油。
10.如权利要求1所述的药物递送组合物,其中所述至少一种活性医药成分占5wt%到70wt%。
11.如权利要求1所述的药物递送组合物,其中所述至少一种活性医药成分占10wt%到70wt%。
12.如权利要求1所述的药物递送组合物,其中所述至少一种活性医药成分占20wt%到60wt%。
13.如权利要求1所述的药物递送组合物,其中所述至少一种活性医药成分占30wt%到60wt%。
14.如权利要求1所述的药物递送组合物,其中所述至少一种活性医药成分占40wt%到60wt%。
15.如权利要求1所述的药物递送组合物,其中所述至少一种挤出-滚圆助剂占20wt%到70wt%。
16.如权利要求1所述的药物递送组合物,其中所述至少一种挤出-滚圆助剂占30wt%到70wt%。
17.如权利要求1所述的药物递送组合物,其中所述至少一种挤出-滚圆助剂占40wt%到70wt%。
18.如权利要求1所述的药物递送组合物,其中所述至少一种挤出-滚圆助剂占50wt%到70wt%。
19.如权利要求1所述的药物递送组合物,其中所述至少一种挤出-滚圆助剂占55wt%到70wt%。
20.如权利要求1所述的药物递送组合物,其中所述至少一种超崩解剂占20wt%到70wt%。
21.如权利要求1所述的药物递送组合物,其中所述至少一种超崩解剂占30wt%到70wt%。
22.如权利要求1所述的药物递送组合物,其中所述至少一种超崩解剂占40wt%到70wt%。
23.如权利要求1所述的药物递送组合物,其中所述至少一种超崩解剂占50wt%到70wt%。
24.如权利要求1所述的药物递送组合物,其中所述至少一种超崩解剂占55wt%到70wt%。
25.如权利要求1所述的药物递送组合物,其中所述至少一种助流剂占1wt%到15wt%。
26.如权利要求1所述的药物递送组合物,其中所述至少一种助流剂占2wt%到15wt%。
27.如权利要求1所述的药物递送组合物,其中所述至少一种助流剂占5wt%到15wt%。
28.如权利要求1所述的药物递送组合物,其中所述至少一种助流剂占5wt%到10wt%。
29.如权利要求1所述的药物递送组合物,其中所述至少一种润滑剂占0.5wt%到4wt%。
30.如权利要求1所述的药物递送组合物,其中所述至少一种润滑剂占0.5wt%到3wt%.
31.如权利要求1所述的药物递送组合物,其中所述至少一种润滑剂占0.5wt%到2wt%。
32.如权利要求1所述的药物递送组合物,其中所述至少一种润滑剂占1wt%到2wt%。
33.如权利要求1所述的药物递送组合物,其中所述至少一种油占0.5wt%到4wt%。
34.如权利要求1所述的药物递送组合物,其中所述至少一种油占0.5wt%到3wt%。
35.如权利要求1所述的药物递送组合物,其中所述至少一种油占0.5wt%到2wt%。
36.如权利要求1所述的药物递送组合物,其中所述至少一种油占1wt%到2wt%。
37.如权利要求1所述的药物递送组合物,其进一步包含至少一种卡波姆、至少一种缓冲剂、至少一种电解质、玉米醇溶蛋白、和/或水。
38.如权利要求1所述的药物递送组合物,其中所述至少一种超崩解剂占0.5wt%到55wt%。
39.如权利要求1所述的药物递送组合物,其中所述至少一种超崩解剂占0.5wt%到40wt%。
40.如权利要求1所述的药物递送组合物,其中所述至少一种超崩解剂占0.5wt%到30wt%。
41.如权利要求1所述的药物递送组合物,其中所述至少一种超崩解剂占1wt%到20wt%。
42.如权利要求1所述的药物递送组合物,其中所述至少一种超崩解剂占10wt%到20wt%。
43.如权利要求1和38中任一权利要求所述的药物递送组合物,其中所述微晶纤维素占0.5wt%到55wt%。
44.如权利要求1和38中任一权利要求所述的药物递送组合物,其中所述微晶纤维素占0.5wt%到50wt%。
45.如权利要求1和38中任一权利要求所述的药物递送组合物,其中所述微晶纤维素占0.5wt%到40wt%。
46.如权利要求1和38中任一权利要求所述的药物递送组合物,其中所述微晶纤维素占5wt%到40wt%。
47.如权利要求1和38中任一权利要求所述的药物递送组合物,其中所述微晶纤维素占20wt%到40wt%。
48.如权利要求1和38中任一权利要求所述的药物递送组合物,其中角叉菜胶占0.5wt%到50wt%。
49.如权利要求1和38中任一权利要求所述的药物递送组合物,其中角叉菜胶占0.5wt%到40wt%.
50.如权利要求1和38中任一权利要求所述的药物递送组合物,其中角叉菜胶占5wt%到40wt%。
51.如权利要求1和38中任一权利要求所述的药物递送组合物,其中角叉菜胶占20wt%到40wt%。
52.如权利要求1和38中任一权利要求所述的药物递送组合物,其中所述癸二酸二丁酯占0.5wt%到25wt%;。
53.如权利要求1和38中任一权利要求所述的药物递送组合物,其中所述癸二酸二丁酯占1wt%到20wt%。
54.如权利要求1和38中任一权利要求所述的药物递送组合物,其中所述癸二酸二丁酯占5wt%到20wt%。
55.如权利要求1和38中任一权利要求所述的药物递送组合物,其中所述癸二酸二丁酯占5wt%到15wt%。
56.如权利要求1和38中任一权利要求所述的药物递送组合物,其中所述癸二酸二丁酯占1wt%到5wt%。
57.如权利要求1所述的药物递送组合物,其中所述涂层占1wt%到20wt%。
58.如权利要求1所述的药物递送组合物,其中所述涂层占1wt%到10wt%。
59.如权利要求1所述的药物递送组合物,其中所述涂层占1wt%到7wt%。
60.如权利要求1所述的药物递送组合物,其中所述涂层占3.5wt%到7wt%。
61.如权利要求1所述的药物递送组合物,其中所述涂层占3.5wt%到6wt%。
62.如权利要求1所述的药物递送组合物,其中所述涂层占4wt%到5wt%。
63.如权利要求1所述的药物递送组合物,其中将所述涂层涂覆到所述挤出球状体上以获得0.1mg/cm2到20mg/cm2的表面积。
64.如权利要求1、38、57和63中任一权利要求所述的药物递送组合物,其中将所述药物递送组合物做成胶囊或压制成片剂。
65.如权利要求1、38、57和63中任一权利要求所述的药物递送组合物,其中将所述药物递送组合物压制成囊片。
66.如权利要求1、38、57和63中任一权利要求所述的药物递送组合物,其中所述挤出球状体为胶囊和/或药囊形式。
67.如权利要求1、38、57和63中任一权利要求所述的药物递送组合物,其中所述至少一种活性医药成分包含在活体内提供治疗、诊断、或预防效果的化学或生物分子。
68.一种药物递送组合物,其包含具有惰性球状体和至少一个用于所述惰性球状体的涂层的两种或更多种经涂覆球状体,所述涂层包含占0.1wt%到90wt%的至少一种活性医药成分;其中所述两种或更多种经涂覆球状体中的每个进一步涂覆有至少如下不同配比的乙基纤维素分散液、角叉菜胶、微晶纤维素和癸二酸二丁酯;
其中包含乙基纤维素分散液、角叉菜胶、微晶纤维素和癸二酸二丁酯的所述涂层以所述经涂覆球状体和涂层的总重量计占0.5wt%到50wt%;
所述组合物进一步包含在所述涂层中占0.1wt%到80wt%的至少一种超崩解剂,所述超崩解剂选自羟基乙酸淀粉钠、交联羧甲纤维素钠、海藻酸、交联纤维素、交联聚合物、交联淀粉、和离子交换树脂。
69.如权利要求68所述的药物递送组合物,其中所述至少一种活性医药成分占0.1wt%到80wt%。
70.如权利要求68所述的药物递送组合物,其中所述至少一种活性医药成分占10wt%到80wt%。
71.如权利要求68所述的药物递送组合物,其中所述至少一种活性医药成分占20wt%到80wt%。
72.如权利要求68所述的药物递送组合物,其中所述至少一种活性医药成分占30wt%到70wt%。
73.如权利要求68所述的药物递送组合物,其中所述至少一种活性医药成分占40wt%到70wt%。
74.如权利要求68所述的药物递送组合物,其中至少一种超崩解剂在所述涂层中占0.5wt%到55wt%。
75.如权利要求68所述的药物递送组合物,其中至少一种超崩解剂在所述涂层中占0.5wt%到40wt%。
76.如权利要求68所述的药物递送组合物,其中至少一种超崩解剂在所述涂层中占0.5wt%到30wt%。
77.如权利要求68所述的药物递送组合物,其中至少一种超崩解剂在所述涂层中占1wt%到20wt%。
78.如权利要求68所述的药物递送组合物,其中至少一种超崩解剂在所述涂层中占10wt%到20wt%。
79.如权利要求68所述的药物递送组合物,其中所述微晶纤维素占0.5wt%到80wt%。
80.如权利要求68所述的药物递送组合物,其中所述微晶纤维素占0.5wt%到70wt%。
81.如权利要求68所述的药物递送组合物,其中所述微晶纤维素占5wt%到60wt%。
82.如权利要求68所述的药物递送组合物,其中所述微晶纤维素占20wt%到60wt%。
83.如权利要求68所述的药物递送组合物,其中所述角叉菜胶占0.5wt%到90wt%。
84.如权利要求68所述的药物递送组合物,其中所述角叉菜胶占0.5wt%到80wt%。
85.如权利要求68所述的药物递送组合物,其中所述角叉菜胶占0.5wt%到70wt%。
86.如权利要求68所述的药物递送组合物,其中所述角叉菜胶占5wt%到60wt%。
87.如权利要求68所述的药物递送组合物,其中所述角叉菜胶占20wt%到60wt%。
88.如权利要求68所述的药物递送组合物,其中所述癸二酸二丁酯占0.5wt%到25wt%。
89.如权利要求68所述的药物递送组合物,其中所述癸二酸二丁酯占1wt%到20wt%.
90.如权利要求68所述的药物递送组合物,其中所述癸二酸二丁酯占5wt%到20wt%。
91.如权利要求68所述的药物递送组合物,其中所述癸二酸二丁酯占5wt%到15wt%。
92.如权利要求68所述的药物递送组合物,其中所述癸二酸二丁酯占1wt%到5wt%。
93.如权利要求68所述的药物递送组合物,其中所述至少一个涂层包含0.1wt%到80wt%的所述至少一种活性医药成分、0.5wt%到90wt%的所述微晶纤维素、和0.5wt%到90wt%的角叉菜胶。
94.如权利要求68所述的药物递送组合物,其中所述至少一种活性医药成分包含在活体内提供治疗、诊断、或预防效果的化学或生物分子。
95.如权利要求68所述的药物递送组合物,其中所述涂层占1wt%到20wt%。
96.如权利要求68所述的药物递送组合物,其中所述涂层占1wt%到10wt%。
97.如权利要求68所述的药物递送组合物,其中所述涂层占1wt%到7wt%。
98.如权利要求68所述的药物递送组合物,其中所述涂层占3.5wt%到7wt%。
99.如权利要求68所述的药物递送组合物,其中所述涂层占3.5wt%到6wt%。
100.如权利要求68所述的药物递送组合物,其中所述涂层占4wt%到5wt%。
101.如权利要求68所述的药物递送组合物,其中将所述涂层涂覆到所述球状体上以获得0.1mg/cm2到20mg/cm2的表面积。
102.如权利要求68所述的药物递送组合物,其中将所述药物递送组合物做成胶囊或压制成片剂。
103.如权利要求68所述的药物递送组合物,其中将所述药物递送组合物压制成囊片。
104.如权利要求68所述的药物递送组合物,其中所述球状体为胶囊和/或药囊形式。
105.如权利要求68所述的药物递送组合物,其中所述惰性球状体包含糖球状体、淀粉球状体和/或纤维素球状体。
106.如权利要求68所述的药物递送组合物,其中所述活性医药成分如下构成的群组:哌甲酯、文拉法辛和卡维地洛。
107.如权利要求68所述的药物递送组合物,其中所述交联聚合物是交联N-乙烯基-2-吡咯烷酮的均聚物。
108.如权利要求68所述的药物递送组合物,其中所述交联聚合物是交联聚维酮。
109.一种如权利要求1至108中任一权利要求所述的药物递送组合物的用途,其用于制备对哺乳动物提供所述至少一种活性医药成分的定时、脉冲、时间治疗、延长或受控释放的药物。
110.如权利要求109所述的用途,所述药物用于治疗所述药物递送组合物中的所述至少一种活性医药成分会有效的疾病。
111.一种用于制造如权利要求1至67中任一权利要求所述的药物递送组合物的方法,所述方法包含:
将所述组合物的干物质组合以提供均匀掺合物;
将颗粒与所述至少一种助流剂、至少一种润滑剂、和/或至少一种油组合以提供适用于挤出-滚圆的湿团块;
将所述湿团块挤出以形成所述球状体;和
进一步涂覆所述球状体。
112.如权利要求111所述的方法,其中所述湿团块具有可塑性。
113.如权利要求111或112所述的方法,其中所述湿团块包含1:0.7到1:2的挤出助剂比所述至少一种助流剂、至少一种润滑剂、和/或至少一种油。
114.如权利要求111或112所述的方法,其中进一步将所述颗粒与至少一种增塑剂组合。
115.如权利要求111或112所述的方法,其中在挤出所述湿团块之后,将所述挤出物装载到滚圆机旋转板上并旋转以提供所述球状体。
116.如权利要求111或112所述的方法,其中将所述球状体干燥以提供水含量小于10wt%的球状体。
117.如权利要求111或112所述的方法,其中使用涂层的溶液、分散液或悬浮液来涂覆所述球状体。
118.如权利要求111或112所述的方法,其进一步包含将所述球状体做成胶囊。
119.如权利要求111或112所述的方法,其进一步包含将所述球状体组合到片剂、囊片和/或药囊中。
120.如权利要求111或112所述的方法,其进一步将所述球状体组合到胶囊中。
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- 2007-04-03 WO PCT/CA2007/000548 patent/WO2007112579A1/en active Application Filing
- 2007-04-03 EP EP07719478A patent/EP2010162A4/en not_active Ceased
- 2007-04-03 JP JP2009503378A patent/JP5349290B2/ja not_active Expired - Fee Related
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Also Published As
Publication number | Publication date |
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WO2007112579A1 (en) | 2007-10-11 |
US20090304787A1 (en) | 2009-12-10 |
JP2013256518A (ja) | 2013-12-26 |
CA2648278A1 (en) | 2007-10-11 |
EP2010162A1 (en) | 2009-01-07 |
JP5349290B2 (ja) | 2013-11-20 |
CA2648278C (en) | 2019-05-28 |
EP2010162A4 (en) | 2013-01-09 |
JP2009532388A (ja) | 2009-09-10 |
CN101453996A (zh) | 2009-06-10 |
US20190083399A9 (en) | 2019-03-21 |
JP5592547B2 (ja) | 2014-09-17 |
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