CN112121020A - 一种普瑞巴林口崩片的制备方法 - Google Patents
一种普瑞巴林口崩片的制备方法 Download PDFInfo
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Abstract
本申请提供了一种采用与硅酸镁铝预混的普瑞巴林口崩片及其制备方法。将普瑞巴林与硅酸镁铝预混，其后将该预混物与其他辅料混合均匀，采用湿法制粒工艺制成口崩片。该方法显著改善普瑞巴林的口感及崩解，并提高患者的服药顺应性。
Description
技术领域
本申请属于医药技术领域，具体涉及含有普瑞巴林口崩片的制备方法。
背景技术
普瑞巴林是一种新型钙离子通道调节剂（非γ-氨基丁酸(GABA)受体激动剂或拮抗剂），能阻断电压依赖性钙通道，减少神经递质的释放，临床主要用于治疗外周神经痛以及辅助性治疗局限性部分癫痫发作。别名： C1-1008 ，异丁加巴。化学名称为：(S)-3-（氨甲基）-5-甲基己酸，分子式为：C8H17NO2，分子量为：159.23，物化性质： 白色结晶性粉末，熔点：184 - 186，该药是在开发的癫痫治疗药中最有希望的一个药物，疗效更好和给药更方便，也可以用于治疗疼痛和焦虑如带状疱疹后遗神经痛。
普瑞巴林目前已在多个国家和地区上市，上市剂型主要有胶囊剂、口服溶液和口崩片（商品名为“乐瑞卡”，LYRICA®）。口崩片是指不需用水或需用少量水，无需咀嚼，片剂置于舌面，遇唾液迅速溶解或崩解后，借吞咽动力，药物即可入胃起效的片剂。与普通片剂相比，口崩片具有起效快，生物利用度高，服用方便，首过效应低等优点，其更适用于老人、儿童、吞咽困难或饮水不便等特殊环境下的病人用药。硅酸镁铝，具有独特的三维空间链式结构及特殊的针、棒状晶体结构，因而有不同寻常的胶体和吸附性能。以其优异的增稠性、悬浮性、胶体摇融性能被广泛应用于油漆涂料行业。在水介质中形成"卡片宫"式的缔合网络结构。因而可利用硅酸镁铝优异的吸附性能改善普瑞巴林的苦涩感，进而改善普瑞巴林口崩片的口服顺应性问题。
因此，本申请提供了一种采用与硅酸镁铝预混的普瑞巴林口崩片及其制备方法。将普瑞巴林与硅酸镁铝预混，其后将该预混物与其他辅料混合均匀，采用湿法制粒工艺制成口崩片。该方法显著改善普瑞巴林的口感和崩解，并提高患者的服药顺应性。
发明内容
硅酸镁铝，具有独特的三维空间链式结构及特殊的针、棒状晶体结构，因而有不同寻常的胶体和吸附性能。以其优异的增稠性、悬浮性、胶体摇融性能被广泛应用于油漆涂料行业。在水介质中形成"卡片宫"式的缔合网络结构。因而可利用硅酸镁铝优异的吸附性能改善普瑞巴林的苦涩感，进而改善普瑞巴林口崩片的口服顺应性问题。
本申请将硅酸镁铝与原料药预混，充分改善原料药的苦涩感与普瑞巴林口崩片的崩解时间，使制备的口崩片口感和崩解时间较优，且口崩片能显著提高患者的服药顺应性。
本申请的目的是通过如下方案解决的：
普瑞巴林与硅酸镁铝预混，其后将该预混物与其他辅料混合均匀，采用湿法制粒工艺制成口崩片。
进一步地，普瑞巴林口崩片，质量百分比组成为：
普瑞巴林药物10-40%，
填充剂40-60%，
崩解剂5-20%，
润滑剂0.5-5%，
助流剂5-15%，
矫味剂3-10%。
进一步地，填充剂为微晶纤维素、喷雾干燥甘露醇、二水磷酸氢钙、硅酸镁铝中的一种或几种。
进一步地，硅酸镁铝型号为硅酸镁铝US2、硅酸镁铝UFL2、硅酸镁铝FH2中的一种或几种。
进一步地，矫味剂为硅酸镁铝、二氧化硅中的一种或几种。
进一步地，崩解剂为低取代羟丙基纤维素、羧甲基淀粉钠、交联羧甲基纤维素钠、硅酸镁铝和交联聚维酮中的一种或几种。
具体实施方式
为了更好的理解本发明，下面将通过本发明的实施例和实验数据对本发明及其优势和有益效果进行详细描述和说明，但这些实施例并不限制本发明。
实施例1
制备工艺：
（1）将普瑞巴林与硅酸镁铝US2过60目筛混合3次，作为预混物1备用；
（2）将预混物1与处方量的喷雾干燥甘露醇100SD、微晶纤维素、硅酸镁铝、PVPP、三氯蔗糖过60目筛混合3次，混合均匀；
（3）以纯化水为润湿剂制软材，30目筛制粒；
（4）在60℃下干燥至颗粒水分低于3%，30目筛整粒；
（5）将整粒后的颗粒折算收率，加入苦杏仁香精、硬脂酸镁混合均匀压制成片。
实施例2
制备工艺：
（1）将普瑞巴林与硅酸镁铝UFL2过60目筛混合3次，作为预混物1备用；
（2）将预混物1与处方量的喷雾干燥甘露醇100SD、微晶纤维素、硅酸镁铝、PVPP、三氯蔗糖过60目筛混合3次，混合均匀；
（3）以纯化水为润湿剂制软材，30目筛制粒；
（4）在60℃下干燥至颗粒水分低于3%，30目筛整粒；
（5）将整粒后的颗粒折算收率，加入苦杏仁香精、硬脂酸镁混合均匀压制成片。
实施例3
制备工艺：
（1）将普瑞巴林与硅酸镁铝FH2过60目筛混合3次，作为预混物1备用；
（2）将预混物1与处方量的喷雾干燥甘露醇100SD、微晶纤维素、硅酸镁铝、PVPP、三氯蔗糖过60目筛混合3次，混合均匀；
（3）以纯化水为润湿剂制软材，30目筛制粒；
（4）在60℃下干燥至颗粒水分低于3%，30目筛整粒；
（5）将整粒后的颗粒折算收率，加入苦杏仁香精、硬脂酸镁混合均匀压制成片。
实施例4
制备工艺：
（1）将普瑞巴林与二氧化硅过60目筛混合3次，作为预混物1备用；
（2）将预混物1与处方量的喷雾干燥甘露醇100SD、微晶纤维素、硅酸镁铝、PVPP、三氯蔗糖过60目筛混合3次，混合均匀；
（3）以纯化水为润湿剂制软材，30目筛制粒；
（4）在60℃下干燥至颗粒水分低于3%，30目筛整粒；
（5）将整粒后的颗粒折算收率，加入苦杏仁香精、硬脂酸镁混合均匀压制成片。
实施例5
制备工艺：
（1）将普瑞巴林与二氧化硅过60目筛混合3次，作为预混物1备用；
（2）将预混物1与处方量的喷雾干燥甘露醇100SD、微晶纤维素、硅酸镁铝、低取代羟丙基纤维素、三氯蔗糖过60目筛混合3次，混合均匀；
（3）以纯化水为润湿剂制软材，30目筛制粒；
（4）在60℃下干燥至颗粒水分低于3%，30目筛整粒；
（5）将整粒后的颗粒折算收率，加入苦杏仁香精、硬脂酸镁混合均匀压制成片。
质量评价方法
1.口感：入口是否有苦涩感；
2.崩解时限：检测片剂全部崩碎成小粒子并通过筛网的时间，若崩解时限小于60s，符合要求；
3.溶出检测：溶出条件为：桨法，0.1MHCL介质，900mL介质，37℃，50r/min，取10mL补10mL，取样时间为5min、10min、15min、30min、45min、60min。若15min时溶出度大于85%，即为快速溶出，符合要求。
表1 普瑞巴林口崩片崩解时间、口感及溶出度
实验结果及结论
本申请将普瑞巴林与硅酸镁铝预混，采用湿法制粒工艺制备样品时，制备的口崩片口感较优，崩解时间、溶出均合格。
Claims (6)
1.一种普瑞巴林口崩片，其特征在于处方中处方含量按重量计为：
普瑞巴林药物10-40%，
填充剂40-60%，
崩解剂5-20%，
润滑剂0.5-5%，
助流剂5-15%，
矫味剂3-10%。
2.如权利要求1所述的普瑞巴林口崩片，其特征在于所述的填充剂为微晶纤维素、喷雾干燥甘露醇、二水磷酸氢钙、硅酸镁铝中的一种或几种。
3.如权利要求1所述的普瑞巴林口崩片，其特征在于所述的硅酸镁铝型号为硅酸镁铝US2、硅酸镁铝UFL2、硅酸镁铝FH2中的一种或几种。
4.矫味剂为硅酸镁铝、二氧化硅中的一种或几种。
5.如权利要求1所述的普瑞巴林口崩片，其特征在于所述的崩解剂为低取代羟丙基纤维素、羧甲基淀粉钠、交联羧甲基纤维素钠、硅酸镁铝和交联聚维酮中的一种或几种。
6.一种普瑞巴林口崩片，其制备方法为普瑞巴林与硅酸镁铝预混，其后将该预混物与其他辅料混合均匀，采用湿法制粒工艺制成口崩片。
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