CN117462509A - 肠溶性软明胶胶囊 - Google Patents
肠溶性软明胶胶囊 Download PDFInfo
- Publication number
- CN117462509A CN117462509A CN202311185911.1A CN202311185911A CN117462509A CN 117462509 A CN117462509 A CN 117462509A CN 202311185911 A CN202311185911 A CN 202311185911A CN 117462509 A CN117462509 A CN 117462509A
- Authority
- CN
- China
- Prior art keywords
- oil
- enteric
- shell composition
- gelatin
- carrageenan
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
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- 239000000203 mixture Substances 0.000 claims abstract description 104
- 239000000463 material Substances 0.000 claims abstract description 36
- 108010010803 Gelatin Proteins 0.000 claims description 71
- 239000008273 gelatin Substances 0.000 claims description 71
- 229920000159 gelatin Polymers 0.000 claims description 71
- 235000019322 gelatine Nutrition 0.000 claims description 71
- 235000011852 gelatine desserts Nutrition 0.000 claims description 71
- 238000000034 method Methods 0.000 claims description 64
- 239000000679 carrageenan Substances 0.000 claims description 39
- 229920001525 carrageenan Polymers 0.000 claims description 39
- 229940113118 carrageenan Drugs 0.000 claims description 39
- -1 ivacaiton Chemical compound 0.000 claims description 36
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 34
- 235000010418 carrageenan Nutrition 0.000 claims description 30
- UHVMMEOXYDMDKI-JKYCWFKZSA-L zinc;1-(5-cyanopyridin-2-yl)-3-[(1s,2s)-2-(6-fluoro-2-hydroxy-3-propanoylphenyl)cyclopropyl]urea;diacetate Chemical compound [Zn+2].CC([O-])=O.CC([O-])=O.CCC(=O)C1=CC=C(F)C([C@H]2[C@H](C2)NC(=O)NC=2N=CC(=CC=2)C#N)=C1O UHVMMEOXYDMDKI-JKYCWFKZSA-L 0.000 claims description 30
- 239000004014 plasticizer Substances 0.000 claims description 29
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- 241000251468 Actinopterygii Species 0.000 claims description 4
- PVNIIMVLHYAWGP-UHFFFAOYSA-N Niacin Chemical compound OC(=O)C1=CC=CN=C1 PVNIIMVLHYAWGP-UHFFFAOYSA-N 0.000 claims description 4
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- RZEKVGVHFLEQIL-UHFFFAOYSA-N celecoxib Chemical compound C1=CC(C)=CC=C1C1=CC(C(F)(F)F)=NN1C1=CC=C(S(N)(=O)=O)C=C1 RZEKVGVHFLEQIL-UHFFFAOYSA-N 0.000 claims description 3
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Abstract
本发明提供了肠溶性软明胶胶囊,其包括填充材料和肠溶性壳组合物,其特征在于所述胶囊的肠溶性质无需肠溶衣或外加的常规肠溶聚合物就可以获得。
Description
本申请是基于申请日为2019年3月15日,申请号为201980019429.6(PCT/US2019/022477),发明名称为:“肠溶性软明胶胶囊”的专利申请的分案申请。
技术领域
本发明涉及肠溶性软明胶胶囊,其中明胶基的壳组合物无需使用肠溶衣或添加肠溶聚合物就具有肠溶性质。
发明背景
由于胶囊易于吞咽,且无需为掩盖活性药物的不良味道进行调味,因此软明胶胶囊(特别是软明胶胶囊/或软明胶胶囊)提供了一种更易被患者接受的剂型。药品的软明胶胶囊化为进一步提高药物成分的生物利用度提供了潜景。例如,明胶壳破裂时,活性成分会迅速以液体形式释放。
为创造出肠溶性剂型,本领域人员做出了努力。设计肠溶性剂型是为了保护剂型成分免受胃部环境的影响。例如,可以通过在生产的剂型(例如片剂或胶囊)表面添加肠溶衣来制备肠溶性剂型。此类包衣可通过喷雾所述剂型,而后干燥所述剂型(通常在升高的温度下)的方式来实现。这种使用肠溶衣包衣胶囊的方法可以导致其在性能和外观方面的损害。例如,胶囊可能有粗糙感,包衣可能涂布不均,和/或肠溶衣易于从剂型上破裂或剥落。此外,涂布肠溶包衣过程的效率很低。
其他的肠溶性剂型也已开发,这种剂型在其胶囊壳中加入了常规的肠溶聚合物(例如,酸不溶性聚合物)。但是,这种常规肠溶聚合物的添加会导致胶囊由于不充分密封而易于泄漏。
因此,目前需要一种不需要使用肠溶衣或不需要在壳中添加常规肠溶聚合物的肠溶性软明胶胶囊。
出人意料地发现,本发明的明胶基壳组合物,无需使用肠溶衣或掺入常规的肠溶性聚合物,就具有令人满意的肠溶性。
发明内容
本发明涉及一种肠溶性软明胶胶囊。所述肠溶性软明胶胶囊包含(a)填充材料和(2)肠溶性壳组合物。本发明肠溶性软明胶胶囊不包含肠溶衣或添加的常规肠溶聚合物。因此,所述肠溶性壳组合物消除了对添加肠溶衣的需求,同时最小化了包衣过程中损坏胶囊的风险。本发明还涉及肠溶性软明胶胶囊的制备方法。
在一些实施方案中,所述肠溶性壳组合物包括:(a)明胶,(b)卡拉胶,(c)增塑剂和(d)溶剂。在另一个实施方案中,所述肠溶性壳组合物包括:(a)明胶,(b)卡拉胶,(c)增塑剂,(d)溶剂以及(e)缓冲剂和/或碱化剂。本发明还涉及制备肠溶性软明胶胶囊的方法。
方案详述
本发明通过开发肠溶口服剂型来推进现有技术,特别是肠溶性软明胶胶囊,其无需施用肠溶衣或在胶囊壳中添加常规的肠溶聚合物,即可获得常规的肠溶剂型优势。本发明的肠溶性软明胶胶囊不会在胃的环境中溶解,而是在肠中溶解。这种机制有利于递送可能引起胃刺激或对胃的酸性环境敏感的活性成分。本发明的肠溶软明胶胶囊在胃的环境中不溶解,而是在肠中溶解。这种机制有利于递送可能引起胃刺激或对胃的酸性环境敏感的活性成分。
如本发明所用,术语“肠溶”是指物质的抗溶解或抗崩解性质,使得满足在胃环境中不会溶解或崩解的条件。例如,本发明描述的实施方案包括肠溶性壳组合物,其溶于生物、人造或模拟的肠液而不是生物、人造或模拟的胃液。如本发明所用,术语“药物活性成分”是指可以用于诊断、治愈、缓解、治疗或预防病症的药物或化合物。术语“症状”是指可以通过向受试者给药有效量的活性成分来治疗或预防的那些医学症状。可从肠溶性软明胶胶囊中获益的非限制性实例性的症状包括但不限于含有乳酸菌的胶囊、鱼油胶囊、质子泵抑制剂、阿司匹林和类似产品。
如本发明所用,术语“活性成分”是指任何旨在产生治疗、预防或其他可预期效果的物质,无论其是否已为此目的获得政府机构的批准。该术语就具体成分而言,其包括药物活性成分,和所有药学上可接受的盐、溶剂合物及其晶型,其中所述盐、溶剂合物和晶型是具有药物活性的。
任何药物活性成分可以用于本发明的目的,其包括水溶性的和难溶于水的那些。适合的药物活性成分包括但不局限于:止痛药和抗炎药、抗酸药、驱虫药、抗心律不齐药、抗菌药、抗凝剂、抗抑郁药、抗糖尿病药、抗腹泻药、抗癫痫药、抗真菌药、抗痛风药、抗高血压药、抗疟疾药、抗偏头痛药、抗毒蕈碱药、抗肿瘤药和免疫抑制剂、抗原生动物药、抗风湿药、抗甲状腺药、抗病毒药、抗焦虑药、镇静药、安眠和抗精神病药、β受体阻滞剂、心脏正性肌力药、皮质类固醇、止咳药、细胞毒素、减充血药、利尿剂、酶、抗帕金森氏病药物、胃肠道药物、组胺受体拮抗剂、脂质调节剂、局部麻醉药、神经肌肉药、硝酸盐和抗心绞痛药、营养剂、阿片类镇痛药、口服疫苗、蛋白质、肽和重组药物、性激素和避孕药、杀精子剂、兴奋剂及它们的组合。
在一些实施方案中,有效药物成分可以选自但不限于:达比加群、决奈达隆、替卡格雷、伊洛立酮、依伐卡托、米哚妥林、阿西马朵林、倍氯米松、阿普利司特、沙巴他滨、林西替尼、阿比特龙、维生素D类似物(例如,骨化二醇、骨化三醇、帕立骨化醇、度骨化醇)、COX-2抑制剂(例如,塞来昔布、伐地考昔、罗非考昔)、他克莫司、睾酮、鲁比前列酮,其药学上可接受的盐,及以它们的组合。
在一些实施方案中,剂型中的脂质可选自但不限于:杏仁油、摩洛哥坚果油、鳄梨油、琉璃苣种子油、芥花油(canola oil)、腰果油、蓖麻油、氢化蓖麻油、可可脂、椰子油、菜籽油、玉米油、棉籽油、葡萄籽油、榛子油、大麻油、羟基化卵磷脂、卵磷脂、亚麻籽油、夏威夷果油、芒果奶油、马尼拉油、蒙刚果坚果油、橄榄油、棕榈仁油、棕榈油、花生油、山核桃油、紫苏籽油、松子油、开心果油、罂粟籽油、南瓜籽油、米糠油、红花油、芝麻油、乳木果油、大豆油、向日葵油、氢化植物油、核桃油和西瓜子油。其他油和脂肪可包括但不限于鱼油(omega-3)、磷虾油、动物和植物脂肪(例如其氢化形式)、游离脂肪酸以及甘油单酯、甘油二酯和甘油三酯(其具有C8、C10、C12、C14、C16、C18、C20和C22脂肪酸),及它们的组合。
根据某些实施方案,活性成分可以包括降脂剂,所述降脂剂包括但不限于他汀类药物(例如洛伐他汀、辛伐他汀、普伐他汀、氟伐他汀、阿托伐他汀、罗苏伐他汀和匹伐他汀)、贝特类药物(例如氯贝特、环丙贝特、苯扎贝特、非诺贝特和吉非贝齐)、烟酸、胆汁酸螯合剂、依泽替米贝、洛米他肽、植物甾醇及其药学上可接受的盐、水合物、溶剂合物和前药,及它们的任意的混合物等。
合适的营养保健活性成分可包括但不限于:5-羟基色氨酸、乙酰基L-肉碱、α硫辛酸、α-酮戊二酸酯、蜂产品、甜菜碱盐酸盐、牛软骨、咖啡因、鲸蜡基肉豆蔻酸酯、炭、壳聚糖、胆碱、硫酸软骨素、辅酶Q10、胶原、初乳、肌酸、氰钴胺(维生素812)、二甲基氨基乙醇、富马酸、锗倍半氧化物、腺体产品、葡萄糖胺盐酸盐、硫酸葡萄糖胺、丁酸羟甲酯、免疫球蛋白、乳酸、左旋肉碱、肝产品、苹果酸、无水麦芽糖、甘露糖(d-甘露糖)、甲基磺酰甲烷、植物甾醇、吡啶甲酸、丙酮酸盐、红曲酵母提取物、S-腺苷甲硫氨酸、硒酵母、鲨鱼软骨、可可碱、硫酸氧钒和酵母。
合适的营养补剂活性成分可以包括:维生素、矿物质、纤维、脂肪酸、氨基酸、草药补剂,及以上的组合。
合适的维生素活性成分可以包括但不限于:抗坏血酸(维生素C)、B族维生素、生物素、脂溶性维生素、叶酸、羟柠檬酸、肌醇、矿物质抗坏血酸盐、混合生育酚、烟酸(维生素B3)、乳清酸、对氨基苯甲酸、泛酸盐、泛酸(维生素B5)、盐酸吡哆辛(维生素B6)、核黄素(维生素B2)、合成维生素、硫胺素(维生素B1)、生育三烯酚、维生素A、维生素D、维生素E、维生素F、维生素K、维生素油和油溶性维生素。
合适的草药补充活性剂可以包括但不限于以下物质:山金车、越桔、黑升麻、猫爪草、洋甘菊、松果菊、月见草油、胡芦巴、亚麻籽、小白菊、大蒜、姜根、银杏叶、人参、菊科植物、山楂、醉椒、甘草、水飞蓟、车前子、萝芙木、番泻叶、大豆、圣约翰草、锯棕榈、姜黄、缬草。
矿物质活性剂可以包括但不限于以下物质:硼、钙、螯合的矿物质、氯化物、铬、涂覆的矿物质、钴、铜、石灰岩、碘、铁、镁、锰、矿物质预混合物、矿物产品、钼、磷、钾、硒、钠、钒、苹果酸、丙酮酸、锌和其他矿物质。
其他可能的活性剂的例子包括但不限于:抗组胺药(例如,雷尼替丁、茶苯海明、苯海拉明、氯苯那敏和马来酸氯苯那敏)、非甾体类抗炎药(例如,阿司匹林、塞来昔布、Cox-2抑制剂、双氯芬酸、贝诺沙普洛芬、氟比洛芬、非诺洛芬、氟布芬、吲哚洛芬、吡罗洛芬、卡洛芬、奥沙普嗪、普洛洛芬、莫洛洛芬、三氧阿布洛芬、舒普洛芬、氨基布洛芬、氟洛芬、布氯酸、吲哚美辛、舒林酸、佐美酸、噻虫啉、齐多美霉素、阿西美辛、芬替扎克、克林达那克、奥沙平、美洛芬那酸、氟灭酸、氮氟灭酸、托芬那酸、二氟尼柳、氟苯柳、吡罗昔康、舒多昔康、异昔康、醋氯芬酸、阿洛昔芬、阿扎哌唑、苯甲酸酯、溴芬酸、卡洛芬、胆碱水杨酸镁、双氟尼沙、依托度酸、依托考昔、法沙明、芬布芬、非诺洛芬、氟比洛芬、布洛芬、吲哚美辛、酮洛芬、酮咯酸、氯诺昔康、洛索洛芬、美洛昔康、甲芬那酸、安乃近、甲基水杨酸、水杨酸镁、萘丁美酮、萘普生、尼美舒利、羟基保泰松、帕瑞昔布、保泰松、水杨酸水杨酸酯、舒林酸、亚砜吡嗪、替诺昔康、噻洛芬酸、托美汀(其药学上可接受的盐及其混合物)和对乙酰氨基酚、止吐药(例如,甲氧氯普胺、甲基纳曲酮)、抗癫痫药(例如,苯妥英、眠尔通和硝基安定)、血管扩张剂(例如,硝苯地平、罂粟碱、地尔硫卓和尼卡地平)、止咳药和祛痰药(例如磷酸可待因)、抗哮喘药(例如茶碱)、抗酸药、抗痉挛药(例如阿托品、莨菪胺)、抗糖尿病药(例如胰岛素)、利尿药(例如利尿酸、苄氟噻嗪(bendrofluthiazide))、升压药(例如,普萘洛尔、可乐定)、降压药(例如,可乐定、甲基多巴)、支气管扩张剂(例如,舒喘宁)、类固醇(例如,皮质醇、曲安西龙、泼尼松)、抗生素(例如,四环素)、治痔药、催眠药、精神药物、止泻药、化痰药、镇静剂、减充血剂(例如,伪麻黄碱)、通便剂、维生素、兴奋剂(包括,如苯丙醇胺等食欲抑制剂)和大麻素,及其药学上可接受的盐、水合物、溶剂合物和前药。
活性剂也可以是苯并二氮卓类药物、巴比妥类药物、兴奋剂,或其混合物。术语“苯并二氮卓类药物”是指苯并二氮卓及苯并二氮卓的衍生物,所述药物可以抑制中枢神经系统;苯并二氮卓包括但不限于:阿普唑仑、溴马西泮、氯地西泮、二钾氯氮、地西泮、艾司唑仑、氟拉泽泮、哈拉泽泮、酮唑仑、劳拉西泮、硝西泮、奥沙西泮、普拉西泮、夸西泮、替马西泮、三唑仑、利他林,及其药学上可接受的盐、水合物、溶剂合物、前药和混合物。可用作活性成分的苯并二氮卓拮抗剂包括但不限于,氟马西尼及其药学上可接受的盐、水合物、溶剂合物及混合物。
术语“巴比妥类药物”是指衍生自巴比妥酸(2,4,6-三氧六氢嘧啶)的镇静催眠药。巴比妥类药物包括但不限于,阿密妥、阿普比妥、仲丁比妥、布他比妥、美索比妥、普罗米那、美沙比妥、戊巴比妥、苯巴比妥、司可巴比妥,和其药学上可接受的盐、水合物、溶剂合物、前药及其混合物。可用作活性剂的巴比妥拮抗剂包括但不限于安非他明及其药学上可接受的盐、水合物、溶剂合物及混合物。
术语“兴奋剂”包括但不限于安非他命(例如,右旋安非他命树脂复合物、右旋安非他命树、甲基苯丙胺、利他林)以及其药学上可接受的盐、水合物和溶剂合物,及其混合物。可以用作活性剂的兴奋剂拮抗剂包括但不限于苯并二氮卓类药物及其药学上可接受的盐、水合物、溶剂合物及混合物。
本发明剂型包含多种活性剂和它们的药学上可接受的盐。药学上可接受的盐包括但不限于:无机酸盐(例如,盐酸盐、氢溴酸盐、硫酸盐、磷酸盐等);有机酸盐(例如,甲酸盐、乙酸盐、三氟乙酸盐、马来酸盐、酒石酸盐等);磺酸盐(例如,甲磺酸盐、苯磺酸盐、对甲苯磺酸盐等);氨基酸盐(例如,精氨酸盐、天冬氨酸盐、谷氨酸盐等)和金属盐(例如,钠盐、钾盐、铯盐等);碱土金属盐(例如,钙盐、镁盐等);有机胺盐(例如,三乙胺盐、吡啶盐、甲基吡啶盐、乙醇胺盐、三乙醇胺盐、二环己基胺盐、N,N'-二苄基乙二胺盐等)。
如本发明所用,术语“治疗有效”和“有效量”是指产生期望的治疗结果需要的活性剂的量或给药速率。
如本发明所用,“壳”或“壳组合物”是指软明胶胶囊的壳,其将填充材料包囊于胶囊中。
如本发明所用,“常规的肠溶性聚合物”是指(但不限于)丙烯酸和甲基丙烯酸聚合物,其以商标和其他常规的酸不溶聚合物(例如,丙烯酸甲酯-甲基丙烯酸共聚物)购得。其他常规酸不溶聚合物包括但不限于:醋酸琥珀酸纤维素、邻苯二甲酸醋酸纤维素、乙酸丁酸纤维素、羟丙基甲基纤维素邻苯二甲酸酯、羟丙基甲基醋酸乙酸琥珀酸酯(羟丙甲纤维素乙酸琥珀酸酯)、邻苯二甲酸聚乙酸乙烯酯(PVAP)、藻酸盐(例如,藻酸钠和藻酸钾)、硬脂酸、和虫胶。在一些实施方案中,本发明的肠溶性壳组合物不包括酸不溶聚合物。换句话说,所述肠溶性壳组合物和肠溶性软明胶胶囊“不含或基本不含常规的肠溶聚合物”。
如本发明所使用,“不含或基本不含”是指所述组合物包含的所述成分约低于1%w/w、约低于0.5%w/w、约低于0.25%w/w、约低于0.1%w/w、约低于0.05%w/w、约低于0.01%w/w、或0%w/w。
如本发明所使用,“填充材料”或“填充物”是指一种被肠溶性胶囊壳包裹的组合物,且其包含至少一种药物活性成分。
如本发明所使用,“肠溶性胶囊”或“肠溶性软明胶胶囊”是指一种具有肠溶性的胶囊,一旦将填充材料包囊在壳中便将该胶囊干燥。无需进一步的处理步骤。
如本发明所使用,与实测量有关的“约”是指本领域技术人员在进行测量和行使与测量目的和测量设备精度相称的专注水平时,所期望的该实测量的正常变化。在某些实施方案中,术语“约”包括引用数值±10%,例如“约10”会包括从9至11。
术语与实测量有关“至少约”是指本领域技术人员在进行测量和行使与测量目的和测量设备精度相称的专注水平时,所期望的该实测量的正常变化,以及任意大于实测量的量。在某些实施方案中,术语“至少约”包括引用数值减去10%,和任意大于实测量的量(比如,“至少约10”将包括9,和大于9的任意值);该术语也可表述为“约10或更大”。类似的,术语“约小于”通常包括引用数值加10%,和任意小于实测量的量(比如,“约小于10”将包括11,和小于11的任意值);该术语也可表述为“约10或更小”。
如本发明所使用,除另有说明,“一”和“一个”和“所述”是指一个或多个。因此,例如提及“赋形剂”包括单一赋形剂以及两种或更多种不同赋形剂的混合物等。
除本发明另外指出,否则本文中对数值范围的记载仅旨在用作单独提及落入该范围内的每个单独值的简写方法,并且每个单独的值并入本说明书中,如同其在本文中单独记载一样。除非本文另有说明或与上下文明显相矛盾,否则本文所述的所有方法均可以任何合适的顺序进行。
除非另外指出,否则本文提供的任何和所有实例或示例性语言(例如,“诸如”)的使用仅旨在更好地说明某些材料和方法,而不对范围构成限制。说明书中的任何语言都不应被解释为表明任何未声明的要素对所公开的材料和方法而言是必要的。
根据第一个实施方案,肠溶性软明胶胶囊包含:(a)填充材料和(b)肠溶性壳组合物,其中所述填充材料包含至少一种药物活性成分,其中所述肠溶性壳组合物包含明胶、卡拉胶、增塑剂和溶剂,其中所述肠溶性壳组合物不含常规的肠溶性聚合物。
根据第二个实施方案,肠溶性软明胶胶囊包含:(a)填充材料和(b)肠溶性壳组合物,其中所述填充材料包含至少一种药物活性成分,其中所述肠溶性壳包含明胶、卡拉胶、增塑剂和溶剂,以及任选地,缓冲剂和/或碱化剂,其中所述肠溶性壳组合物不含常规的肠溶性聚合物。
合适的填充材料包含至少一种药物活性成分,该成分可依据已知方法制造。除包括至少一种所述药物活性成分之外,合适的填充材料可包括其他填充组分,例如调味剂、甜味剂、着色剂和填充剂或其他药学上可接受的赋形剂或添加剂(例如合成染料和无机氧化物)。本领域普通技术人员可以容易地确定药物活性成分和药学上可接受的赋形剂的合适的量。值得注意的是,已经发现包含本发明所述的肠溶性软明胶胶囊和填充组合物的剂型表现出合适的稳定性,所述填充组合物具有约2.5至约6.5、或约3.0至约6.0、或约3.5至约5.5的pH值。根据实施方案,所述填充物组合物可以是碱性填充物,例如埃索美拉唑。
在一个实施方案中,所述肠溶性壳组合物中的明胶可以包括但不限于单独或组合使用,A型明胶、B型明胶、皮明胶、鱼明胶、猪明胶和/或骨明胶。在一个实施方案中,所述明胶是高冻力A型明胶。在一个实施方案中,所述明胶是高冻力B型明胶。在一个实施方案中,所述明胶是250冻力明胶。在另一个实施方案中,仅有一种类型的明胶。在另一个实施方案中,所述明胶是至少两种类型的明胶的组合。在一个实施方案中,所述肠溶性壳组合物的明胶量为约10%w/w到约30%w/w,更优选地,约15%w/w到约30%w/w,最优选地,约25%w/w到约30%w/w。
在一个实施方案中,所述肠溶性壳组合物中的卡拉胶可以是κ-卡拉胶、ι-卡拉胶、λ-卡拉胶,及其混合物。根据一个实施方案,所述卡拉胶是κ-卡拉胶。根据另一个实施方案,所述卡拉胶是ι-卡拉胶。在一个实施方案中,肠溶性壳组合物中卡拉胶的量为约2%w/w至约10%w/w,更优选为约2%w/w至约8%w/w,最优选为约2%w/w至约5%w/w。
在一些实施方案中,所述肠溶性壳组合物中的增塑剂可以包括甘油、丙三醇、山梨糖醇及其组合。其他合适的增塑剂可以包括但不限于糖醇增塑剂(例如,异麦芽酮糖醇、麦芽糖醇、木糖醇、赤藓糖醇、阿多尼醇、半乳糖醇、季戊四醇或甘露醇);或多元醇增塑剂(例如,双甘油、乙二醇、二乙二醇、三乙二醇、四乙二醇、二丙二醇、高达10,000MW的聚乙二醇、新戊二醇、丙二醇、1,3-丙二醇、2-甲基-1,3-丙二醇,三羟甲基丙烷、聚醚多元醇、乙醇胺,及其混合物)。其他示例性增塑剂还可包括但不限于,低分子量聚合物、寡聚物、共聚物、油类、小分子有机物、具有脂肪族羟基的低分子量多元醇、酯型增塑剂、乙二醇醚、聚丙二醇、多嵌段聚合物、单嵌段聚合物、柠檬酸酯类增塑剂和三醋精。诸如此类的增塑剂可以包括1,2-丁二醇、2,3-丁二醇、苯乙烯二醇、单丙二醇单异丙醚、丙二醇单乙醚、乙二醇单乙醚、二甘醇单乙醚、山梨醇乳酸、乳酸乙酯、乳酸丁酯、乙醇酸乙酯、癸二酸二丁酯、柠檬酸乙酰基三丁酯、柠檬酸三乙酯、单硬脂酸甘油酯、聚山梨酸酯-80、柠檬酸乙酰基三乙酯、柠檬酸三丁酯和乙醇酸烯丙酯,及其混合物。在一个实施方案中,所述肠溶性壳组合物中的塑增剂的量为约10%w/w至约35%w/w,更优选为约10%w/w至约30%w/w,最优选为约15%w/w至约28%w/w。
在一些实施方案中,所述肠溶性壳组合物和肠溶性软明胶胶囊可以不含或基本不含常规的肠溶性聚合物。
在一些实施方案中,所述肠溶性壳组合物和肠溶性软明胶胶囊可以不含或基本不含二价阳离子,如Ca2+(例如CaCl2)或Mg2+(例如MgCl2)。
在一个实施方案中,所述肠溶性壳组合物的溶剂可能或包括水。在一个实施方案中,所述胶囊壳中溶剂的量为约20%w/w至约50%w/w,更优选为约30%w/w至约50%w/w,最优选为约35%w/w至约50%w/w。
在一个实施方案中,所述肠溶性壳组合物也包括缓冲剂和/或碱化剂。合适的缓冲剂和/或碱化剂包括但不限于,氢氧化铵、氢氧化钠、碳酸钠、柠檬酸钠、磷酸三钠和/或磷酸氢二钠。在一个实施方案中,所述缓冲剂是磷酸氢二钠。在一个实施方案中,所述肠溶性壳组合物中缓冲剂的量为约0.1%w/w至约3%w/w,更优选为约0.5%w/w至约1%w/w,最优选为约0.5%w/w至约0.9%w/w。
在一些实施方案中,所述肠溶性壳组合物可以任选地包含添加剂,例如着色剂、调味剂、甜味剂、填充剂、抗氧化剂、稀释剂或其他药学上可接受的赋形剂或添加剂(例如,合成染料和无机氧化物)。
示例性的合适的着色剂可以包括但不限于诸如白色、黑色、黄色、蓝色、绿色、粉色、红色、橙色、紫色、靛蓝和棕色等颜色。在特定实施方案中,剂型的颜色可以指示其中所含的成分(例如一种或多种活性成分)。
示例性的合适的调味剂可包括但不限于“香料提取物”,其通过提取原料(例如,动物或植物材料)的一部分获得,其通常通过使用溶剂(例如,乙醇或水)获得;天然香精,其通过从花朵、果实、根等或整个植物中提取精油获得。
剂型中的其他示例性调味剂可以包括但不限于口气清新化合物(如薄荷醇、留兰香和肉桂)、咖啡豆、其他调味剂或香料(例如水果调味剂——樱桃、橙子、葡萄等),尤其是用于口腔卫生的调味剂,和用于牙齿和口腔清洁的活性物质(例如季铵盐碱)。可以使用口味增强剂(如酒石酸、柠檬酸、香草醛等)来增强口味效果。
示例性的甜味剂可包括但不限于一种或多种人造甜味剂、一种或多种天然甜味剂或其组合。人造甜味剂包括,例如乙酰磺胺酸及其各种盐(例如其钾盐,以购得)、阿力甜、阿斯巴甜(以/>和/>购得)、阿斯巴甜-乙酰磺胺盐(以购得)、新橙皮苷二氢查尔酮、柚皮素二氢查耳酮、二氢查耳酮化合物、纽甜、甜蜜素、糖精及其各种盐(例如钠盐,以/>购得)、甜菊糖、蔗糖的氯代衍生物(例如三氯蔗糖,以/>和/>购得)和罗汉果甙。天然甜味剂包括例如葡萄糖、右旋糖、转化糖、果糖、蔗糖、甘草酸、甘草酸一铵(以/>购得)、甜叶菊甜叶菊(Steviaside)、天然强力甜味剂(如罗汉果)、多元醇(如山梨糖醇、甘露醇、木糖醇、赤藓糖醇等)。
根据一个实施方案的肠溶性软明胶胶囊可以在酸性介质下在约1小时、约2小时、约3小时、约4小时、约5小时,或比约1-5小时更长的时间内保持完整,并且可以在肠液中在约120分钟或更少、或约100分钟或更少、或约80分钟或更少、或约60分钟或更少、或约45分钟或更少、或约30分钟或更少、或约10分钟或更少、或约5分钟或更少的时间内崩解。使用英国药典/美国药典记载方法可以测定崩解。例如,使用美国药典<701>崩解试验,软明胶胶囊可以在吊篮-支架组件中崩解。吊篮-支架组件可包括6根开口的透明管,每根透明管长77.5±2.5毫米,内径20.7至23毫米,壁厚1.0至2.8毫米;该管由两块六孔板固定在垂直位置,其板径为88至92mm,其板厚为5至8.5mm,其孔径为22至26mm,其孔与板的中心等距,且彼此间等距间隔。连接到下板下表面的是编织不锈钢编织物,其孔径为1.8到2.2毫米,其线径为0.57到0.66毫米。该设备的部件通过穿过两块板的三个螺栓组装并牢固地固定。提供了一种将吊篮-支架组件通过轴上的点悬挂于升降装置上的合适的方法。只有在专著中规定或允许的情况下,才允许使用圆盘。另外,具有上述编织和直径规格的可移动金属丝织物会被附接到吊篮-支架组件的上板的表面。
在吊篮的六根管中各放置一个(1)剂量单位,如果必要可添加圆片,所述吊篮是吊篮-支架组件的吊篮。每一肠溶性软明胶胶囊可以浸没在温度维持为37℃±2℃的0.1N HCl中。在120分钟、或100分钟、或80分钟、或60分钟、或45分钟、或30分钟、或10分钟、或5分钟后,将吊篮提出液体,并观察肠溶性软明胶胶囊以检查其是否已经全部完全崩解。如果1个或2个肠溶性软明胶胶囊未完全崩解,则对另外的12个肠溶性软明胶胶囊重复试验。如果试验总计18个肠溶性软明胶胶囊中不少于16个胶囊崩解,那么即可满足要求。
填充材料的包囊可以使用任意常规方法完成。作为一个例子,可以使用旋转模具进行包囊。在实施方案中,由于肠溶性软明胶胶囊中的明胶的熔点相对较高,因此包囊过程可以使用用于素食胶囊的设备和方法。
根据一个实施方案,通过以下方法制备肠溶性软明胶胶囊,所述方法包括以下步骤:(a)制备填充材料,所述填充材料包含至少一种药物活性成分;和(b)在所述肠溶性壳组合物中包囊步骤(a)的填充材料。根据步骤(b)的包囊方法,可以进一步包括制备肠溶性壳组合物的子步骤,例如,在温度为约50℃至约65℃下煮明胶,以产生无气泡的凝胶;升温明胶至约70℃至约90℃,优选地约80℃至约90℃,接着在搅拌下将卡拉胶和丙三醇(甘油)的预混合物分散在该明胶中,得到透明的明胶溶液。
在一个实施方案中,所述肠溶性壳组合物包括(a)卡拉胶、(b)明胶、(c)增塑剂、(d)溶剂,和任选地(e)缓冲剂和/或碱化剂。
在一个实施方案中,所述肠溶性壳组合物基本由(a)卡拉胶、(b)明胶、(c)增塑剂、(d)溶剂,和任选地(e)缓冲剂和/或碱化剂组成。
在一个实施方案中,所述肠溶性壳组合物由(a)卡拉胶、(b)明胶、(c)增塑剂、(d)溶剂,和任选地(e)缓冲剂和/或碱化剂组成。
在一个实施方案中,所述肠溶性壳组合物包括:(a)卡拉胶,其约1%w/w到约20%w/w,约1.5%w/w到约15%w/w,或约2%w/w到约10%w/w,(b)明胶,其约1%w/w到约50%w/w,约5%w/w到约40%w/w,或约10%w/w到约30%w/w,(c)增塑剂,其约1%w/w到约55%w/w,约5%w/w到约45%w/w,或约10%w/w到约35%w/w,(d)溶剂,其约5%w/w到约60%w/w,约10%w/w到约55%w/w,或约20%w/w到约50%w/w,(e)缓冲剂和/或碱化剂,其约0.01%w/w到约10%w/w,约0.05%w/w到约5%w/w,或约0.1%w/w到约3%w/w。
在一个实施方案中,所述肠溶性壳组合物基本由下列物质组成:(a)卡拉胶,其约1%w/w到约20%w/w,约1.5%w/w到约15%w/w,或约2%w/w到约10%w/w,(b)明胶,其约1%w/w到约50%w/w,约5%w/w到约40%w/w,或约10%w/w到约30%w/w,(c)增塑剂,其约1%w/w到约55%w/w,约5%w/w到约45%w/w,或约10%w/w到约35%w/w,(d)溶剂,其约5%w/w到约60%w/w,约10%w/w到约55%w/w,或约20%w/w到约50%w/w,(e)缓冲剂和/或碱化剂,其约0.01%w/w到约10%w/w,约0.05%w/w到约5%w/w,或约0.1%w/w到约3%w/w。
在一个实施方案中,所述肠溶性壳组合物由下列物质组成:(a)卡拉胶,其约1%w/w到约20%w/w,约1.5%w/w到约15%w/w,或约2%w/w到约10%w/w,(b)明胶,其约1%w/w到约50%w/w,约5%w/w到约40%w/w,或约10%w/w到约30%w/w,(c)增塑剂,其约1%w/w到约55%w/w,约5%w/w到约45%w/w,或约10%w/w到约35%w/w,(d)溶剂,其约5%w/w到约60%w/w,约10%w/w到约55%w/w,或约20%w/w到约50%w/w,(e)缓冲剂和/或碱化剂,其约0.01%w/w到约10%w/w,约0.05%w/w到约5%w/w,或约0.1%w/w到约3%w/w。
实施例
本发明特有的实施方案现在将通过引用以下的实施例来描述。应理解这些实施例的单独公开仅是范例性的,并不以任何方式限制本发明的范围。
实施例1
制备具有下表1所列组分的肠溶性软明胶胶囊。在凝胶熔化器中,加入水、甘油和明胶。搅拌混合物并在真空下加热到70℃至80℃(标准凝胶工艺),然后混合并加热到82℃至85℃。接下来,在室温下加入卡拉胶和甘油的预混合物。再次将混合物在真空下加热到82℃至85℃以除去空气。从熔化器中取出混合物,并向其混入着色剂和调味剂。最后包封所述混合物。
表1.
(250冻力皮/骨)明胶 | 26.28%w/w |
卡拉胶(Iota) | 2.89%w/w |
甘油 | 24.48%w/w |
水,纯化的 | 45.88%w/w |
其他添加剂,包括着色剂和调味剂 | 0.47%w/w |
总计 | 100% |
在胶囊干燥后,立即将该样品置于0.1N HCl中进行肠崩解测试。所述胶囊通过了溶解时间测试。所述胶囊同时存储在HDPE瓶中,并在25℃/60%RH和30℃/75%RH条件下测试其稳定性。在0、2、3和6个月,胶囊在所有温度下的所有0.1N HCl和磷酸盐缓冲液中均通过了崩解试验,并符合美国药典/英国药典/欧洲药典的要求。(例如,见上文所述的美国药典崩解测试)。
表2.
比较例
通过上述方法制备具有表2所示组分的肠溶性软明胶胶囊。
表3.
比较例B和比较例D无法提供可以成功包囊的组合物。比较例A和比较例C能够被包囊。在胶囊干燥后,立即将样品置放于0.1N HCl中进行肠崩解测试(参见例如上述美国药典崩解方法)。两组胶囊均未通过崩解时间测试。将一些胶囊置于35℃的烘箱中退火4天。退火后所有胶囊均通过了崩解试验。结果表明,胶囊密封层(热熔接点)需要一段进一步的热平衡时间才能形成粘合强度。
肠溶软明胶技术的关键因素是制造方法。耐酸性依赖于牢固的胶囊密封性,这通常被认为是软明胶胶囊的最弱部分。强力的密封性只能通过结合强力的凝胶、熟练的模具设计以及在包衣过程中控制工艺参数来实现。通过使用高冻力明胶和优化凝胶配方,可以获得更强的凝胶。在实施例1中,肠溶性软明胶胶囊的包囊使用旋转模具包囊方法。但是,采用与Vegicap凝胶类似方法产生凝胶带,即与明胶方法不同的按需熔化。
本发明涉及:
1.一种肠溶性软明胶胶囊,其包含:
(a)填充材料;和
(b)肠溶性胶囊壳组合物,
其中所述填充材料包含至少一种药物活性成分,和
其中所述肠溶性壳组合物包含约2%w/w到10%w/w的卡拉胶,约10%w/w到30%w/w的明胶,约10%w/w到35%w/w的增塑剂,约20%w/w到50%w/w的溶剂,和
其中所述肠溶性软明胶胶囊不含常规的肠溶性聚合物。
2.一种肠溶性软明胶胶囊,其包含:
(a)填充材料;和
(b)肠溶性胶囊壳组合物,
其中所述填充材料包含至少一种药物活性成分,和
其中所述肠溶性壳组合物包含约2%w/w到10%w/w的卡拉胶,约10%w/w到30%w/w的明胶,约10%w/w到35%w/w的增塑剂,约20%w/w到50%w/w的溶剂,以及约0.1%w/w到3%w/w的缓冲剂和/或碱化剂,和
其中所述肠肠溶性软明胶胶囊不含常规的肠溶性聚合物。
3.实施方案1或2的肠溶性软明胶胶囊,其中所述卡拉胶包括以下中的至少一种:ι-卡拉胶、κ-卡拉胶和其混合物。
4.实施方案3的肠溶性软明胶胶囊,其中所述卡拉胶是ι-卡拉胶。
5.实施方案1或2的肠溶性软明胶胶囊,其中所述明胶包括以下中的至少一种:A型明胶、B型明胶和其混合物。
6.实施方案1或2的肠溶性软明胶胶囊,其中所述明胶包括以下中的至少一种:鱼明胶、皮明胶、骨明胶和其混合物。
7.实施方案5的肠溶性软明胶胶囊,其中所述明胶是B型高冻力明胶。
8.实施方案5的肠溶性软明胶胶囊,其中所述明胶是A型高冻力明胶。
9.实施方案1或2的肠溶性软明胶胶囊,其中所述增塑剂包括以下中的至少一种:丙三醇、甘油、山梨糖醇和其混合物。
10.实施方案9的肠溶性软明胶胶囊,其中所述增塑剂是丙三醇。
11.实施方案1或2的肠溶性软明胶胶囊,其中所述溶剂是水。
12.实施方案2的肠溶性软明胶胶囊,其中所述缓冲液是磷酸氢二钠。
13.实施方案1的肠溶性软明胶胶囊,进一步包括缓冲液。
14.实施方案1-13任一项的肠溶性软明胶胶囊,其中所述胶囊在酸性介质中在约1小时、约2小时、约3小时、约4小时、或约5小时的时间内崩解。
15.实施方案1-14任一项的肠溶性软明胶胶囊,其中所述填充材料具有约2.5至约6.5,约3.0至约6.0,约3.5至约5.5的pH值。
16.制备实施方案1或2的肠溶性软明胶胶囊的方法,其包括以下步骤:
(a)制备填充材料;和
(b)使用肠溶性壳组合物包囊所述填充材料。
17.实施方案16的方法,其还包括制备所述肠溶性壳组合物,其通过添加溶剂、甘油和明胶至熔化器中形成混合物。
18.实施方案17的方法,其包括在真空中约70℃至约80℃的温度将所述混合物混合。
19.实施方案18的方法,其还包括将所述混合物加热至约82℃至约85℃的温度。
20.实施方案17-19任一项的方法,其还包括将所述混合物和预混合物混合,所述预混合物是卡拉胶和增塑剂的预混合物。
Claims (39)
1.一种制备肠溶性软明胶胶囊的方法,包括:
向凝胶熔化器中加入溶剂、增塑剂和明胶以形成混合物;
在真空下搅拌加热该混合物至第一温度,然后搅拌加热该混合物至第二温度;
在室温下向该混合物中加入卡拉胶以形成肠溶壳组合物;
在搅拌的同时,在真空下将肠溶壳组合物加热至第二温度;
从凝胶熔化器中取出肠溶壳组合物;和
由肠溶壳组合物形成所述肠溶性软明胶胶囊。
2.根据权利要求1的方法,还包括:在形成所述肠溶性软明胶胶囊之前,将从凝胶熔化器取出的肠溶壳组合物与着色剂和调味剂或两者结合。
3.根据权利要求1的方法,还包括向该混合物中加入缓冲剂。
4.根据权利要求3的方法,其中所述缓冲剂包括磷酸二钠氢氧化铵、氢氧化钠、碳酸钠、柠檬酸钠、磷酸三钠、磷酸二钠或其组合。
5.根据权利要求3或4所述的方法,其中所述肠溶壳组合物包含约0.1%w/w至约3%w/w的量的缓冲剂。
6.权利要求1的方法,其中所述第一温度为约70℃至约80℃,和所述第二温度为约82℃至约85℃。
7.根据权利要求1的方法,其中所述溶剂包括水。
8.根据权利要求1或7的方法,其中所述肠溶壳组合物包含约20%w/w至约50%w/w的量的溶剂。
9.根据权利要求1的方法,其中所述增塑剂包括丙三醇、甘油、山梨醇或其组合。
10.根据权利要求1或9的方法,其中所述肠溶壳组合物包含约10%w/w至约35%w/w的量的增塑剂。
11.根据权利要求1的方法,其中所述明胶包括A型明胶、B型明胶、鱼明胶、皮明胶、骨明胶或其组合。
12.根据权利要求1或11的方法,其中所述肠溶壳组合物包含约10%w/w至约30%w/w的量的明胶。
13.根据权利要求1的方法,其中所述卡拉胶是ι-卡拉胶、κ-卡拉胶、λ-卡拉胶或其组合。
14.根据权利要求1或13的方法,其中所述肠溶壳组合物包含约2.75%w/w至约10%w/w的卡拉胶。
15.权利要求1的方法,其中添加所述卡拉胶包括添加所述卡拉胶和甘油的预混合物。
16.根据权利要求1的方法,其中在搅拌的同时在真空下将所述肠溶壳组合物加热至所述第二温度包括将所述肠溶壳组合物除去空气。
17.根据权利要求1的方法,其中所述肠溶性软明胶胶囊在酸性介质中在不超过约1小时、约2小时、约3小时、约4小时或约5小时的时间内崩解。
18.根据权利要求1的方法,其中形成所述肠溶性软明胶胶囊包括包封填充材料。
19.根据权利要求18的方法,其中所述填充材料具有约2.5至约6.5、或约3.0至约6.0、或约3.5至约5.5的pH值。
20.一种用肠溶性软明胶胶囊包封填充材料的方法,包括:
提供所述填充材料;和
使用肠溶壳组合物包封所述填充材料以形成肠溶性软明胶胶囊,其中所述肠溶壳组合物包含:
卡拉胶;
增塑剂;
明胶;和
溶剂。
21.根据权利要求20的方法,其中所述肠溶壳组合物还包含:缓冲剂。
22.根据权利要求21的方法,其中所述缓冲剂包括磷酸二钠氢氧化铵、氢氧化钠、碳酸钠、柠檬酸钠、磷酸三钠、磷酸二钠或其组合。
23.根据权利要求21或22的方法,其中所述肠溶壳组合物包含约0.1%w/w至约3%w/w的量的缓冲剂。
24.根据权利要求20的方法,其中所述溶剂包括水。
25.根据权利要求20或24的方法,其中所述肠溶壳组合物包含约20%w/w至约50%w/w的量的溶剂。
26.根据权利要求20的方法,其中所述增塑剂包括丙三醇、甘油、山梨醇或其组合。
27.根据权利要求20或26的方法,其中所述肠溶壳组合物包含约10%w/w至约35%w/w的量的增塑剂。
28.根据权利要求20的方法,其中所述明胶包括A型明胶、B型明胶、鱼明胶、皮明胶、骨明胶或其组合。
29.根据权利要求20或28的方法,其中所述肠溶壳组合物包含约10%w/w至约30%w/w的量的明胶。
30.根据权利要求20的方法,其中所述卡拉胶是ι-卡拉胶、κ-卡拉胶、λ-卡拉胶或其组合。
31.根据权利要求20或30的方法,其中所述肠溶壳组合物包含约2.75%w/w至约10%w/w的卡拉胶。
32.根据权利要求20的方法,其中所述肠溶性软明胶胶囊在酸性介质中在不超过约1小时、约2小时、约3小时、约4小时或约5小时的时间内崩解。
33.根据权利要求20的方法,其中所述填充材料具有约2.5至约6.5、或约3.0至约6.0、或约3.5至约5.5的pH值。
34.根据权利要求20述的方法,其中所述填充材料包含有效量的活性成分或其药学上可接受的盐、溶剂化物或晶型。
35.根据权利要求20的方法,其中所述填充材料包括达比加群、决奈达隆、替卡格雷、伊洛立酮、依伐卡托、米哚妥林、阿西马朵林、倍氯米松、阿普利司特、沙巴他滨、林西替尼、阿比特龙、骨化二醇、骨化三醇、帕立骨化醇、度骨化醇、COX-2抑制剂、他克莫司、睾酮、鲁比前列酮,其药学上可接受的盐、其水合物、其溶剂化物、其前药或其组合。
36.根据权利要求20的方法,其中所述填充材料包括洛伐他汀、辛伐他汀、普伐他汀、氟伐他汀、阿托伐他汀、罗苏伐他汀、匹伐他汀、氯贝特、环丙贝特、苯扎贝特、非诺贝特、吉非贝齐、烟酸、胆汁酸螯合剂、依泽替米贝、洛米他肽、植物甾醇,其药学上可接受的盐、其水合物、其溶剂化物、其前药或其组合。
37.根据权利要求20的方法,其中所述填充材料包含杏仁油、摩洛哥坚果油、鳄梨油、琉璃苣种子油、芥花油、腰果油、蓖麻油、氢化蓖麻油、可可脂、椰子油、菜籽油、玉米油、棉籽油、葡萄籽油、榛子油、大麻油、羟基化卵磷脂、卵磷脂、亚麻籽油、夏威夷果油、芒果奶油、马尼拉油、蒙刚果坚果油、橄榄油、棕榈仁油、棕榈油、花生油、山核桃油、紫苏籽油、松子油、开心果油、罂粟籽油、南瓜籽油、米糠油、红花油、芝麻油、乳木果油、大豆油、向日葵油、氢化植物油、核桃油、西瓜籽油、鱼油、磷虾油、动物脂肪、植物脂肪、游离脂肪酸甘油单酯、甘油二酯或甘油三酯,或它们的组合。
38.根据权利要求20的方法,其中所述填充材料包括维生素、矿物质、纤维、脂肪酸、氨基酸或其组合。
39.根据权利要求20的方法,其中所述填充材料包括抗组胺药、阿司匹林、塞来昔布、双氯芬酸、贝诺沙普洛芬、氟比洛芬、非诺洛芬、氟布芬、吲哚洛芬、吡罗洛芬、卡洛芬、奥沙普嗪、普洛洛芬、莫洛洛芬、三氧阿布洛芬、舒普洛芬、氨基布洛芬、氟洛芬、布氯酸、吲哚美辛、舒林酸、佐美酸、噻虫啉、齐多美霉素、阿西美辛、芬替扎克、克林达那克、奥沙平、美洛芬那酸、氟灭酸、氮氟灭酸、托芬那酸、二氟尼柳、氟苯柳、吡罗昔康、舒多昔康、异昔康、醋氯芬酸、阿洛昔芬、阿扎哌唑、苯甲酸酯、溴芬酸、卡洛芬、胆碱水杨酸镁、双氟尼沙、依托度酸、依托考昔、法沙明、芬布芬、非诺洛芬、氟比洛芬、布洛芬、吲哚美辛、酮洛芬、酮咯酸、氯诺昔康、洛索洛芬、美洛昔康、甲芬那酸、安乃近、甲基水杨酸、水杨酸镁、萘丁美酮、萘普生、尼美舒利、羟基保泰松、帕瑞昔布、保泰松、水杨酸水杨酸酯、舒林酸、亚砜吡嗪、替诺昔康、噻洛芬酸、托美汀、对乙酰氨基酚、止吐药、抗癫痫药、血管扩张剂、止咳药、祛痰药、抗哮喘药、抗酸药、抗痉挛药、抗糖尿病药、利尿药、升压药、降压药、支气管扩张剂、类固醇、抗生素、治痔药、催眠药、精神药物、止泻药、化痰药、镇静剂、减充血剂、通便剂、兴奋剂、大麻素,其药学上可接受的盐、其水合物、其溶剂化物、其前药或其组合。
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JP2024059780A (ja) | 2024-05-01 |
CN112105334A (zh) | 2020-12-18 |
CA3092145A1 (en) | 2019-09-19 |
IL276943A (en) | 2020-10-29 |
BR112020018255A2 (pt) | 2020-12-29 |
EP3764973A4 (en) | 2022-01-05 |
MX2020009206A (es) | 2020-11-09 |
CO2020011451A2 (es) | 2021-01-29 |
SG11202008208VA (en) | 2020-09-29 |
PH12020500641A1 (en) | 2021-06-07 |
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