CN111096953A - 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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- 229960001233 pregabalin Drugs 0.000 title claims abstract description 50
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- A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
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Abstract
本申请提供了一种采用硅化微晶纤维素可粉末直接压片的普瑞巴林口崩片及其制备方法。将普瑞巴林与硅化微晶纤维素预混，其后将该预混物与其他辅料混合均匀，采用粉末直压工艺制成口崩片。该方法显著改善普瑞巴林的稳定性和可压性，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
普瑞巴林是新型的γ-氨基丁酸(GABA)受体激动剂，分子式为C8H17NO2 ，分子量为159.23，是一种白色结晶性粉末，易溶于水、碱性和酸性水溶液，本申请专利中普瑞巴林特指 S-普瑞巴林。普瑞巴林由辉瑞公司开发成功，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，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®）。但普瑞巴林制剂的制备过程中存在以下难度：（1）普瑞巴林分子内存在伯氨基和羧基，易发生分子内缩合而产生内酰胺，湿热作用及填充剂类辅料均会加速普瑞巴林发生分子内环化生成内酰胺杂质。另中国专利 CN02806750.9显示，乳糖与普瑞巴林之间会产生美拉德反应，生成多降解产物的乳糖络合物。（2）普瑞巴林原料是结晶状的粉末颗粒，可压性和流动性均较差，达不到常规的粉末直压或干法制粒要求。因此提高稳定性、可压性和流动性是制备普瑞巴林制剂的难点。乐瑞卡的服用方法为剂量为每次75或150mg每日两次；或者每次50mg或100mg每日三次。频繁服药常规胶囊剂对于老年患者以及同期服用多种药物的患者来说，服药顺应性是一个难点，基于此，开发出一种稳定性好、服用方便的普瑞巴林新剂型至关重要。
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。硅化微晶纤维素(silicified microcrystalline cellulose，SMCC)是由微晶纤维素和微粉硅胶以98：2(w/w) 比例，通过喷雾干燥得到的一种新型药用辅料。其具有良好的流动性和可压性、大比表面积带来的高负载能力和高崩解特性等独特性能，因而可用作直接压片的功能稀释剂，解决大剂量片剂体积大、小剂量片剂中活性成分分布不均等工艺难题。
因此，本申请提供了一种采用硅化微晶纤维素可粉末直接压片的普瑞巴林口崩片及其制备方法。将普瑞巴林与SMCC预混，其后将该预混物与其他辅料混合均匀，采用粉末直压工艺制成口崩片。该方法显著改善普瑞巴林的稳定性和可压性，并提高患者的服药顺应性。
发明内容
普瑞巴林分子内存在伯氨基和羧基，易发生分子内缩合而产生内酰胺，湿热作用及填充剂类辅料均会加速普瑞巴林发生分子内环化生成内酰胺杂质，因此常规湿法制粒可能会影响普瑞巴林制剂的稳定性；由于普瑞巴林的自身形态问题，其可压性和流动性均较差，通常达不到直接压片或干法制粒的要求。本申请将硅化微晶纤维素与原料药预混，充分改善原料药的可压性和流动性，使制备的口崩片稳定性和可压性优良，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：
普瑞巴林与硅化微晶纤维素预混，其后将该预混物与其他辅料混合均匀，采用粉末直压工艺制成口崩片。
进一步地，普瑞巴林口崩片，质量百分比组成为：普瑞巴林10-30%，填充剂10-80%、崩解剂5-20%、润滑剂0.5-2%、矫味剂1-3%。
进一步地，填充剂为硅化微晶纤维素、喷雾干燥甘露醇、预胶化淀粉、二水磷酸氢钙中的几种。
进一步地，填充剂为硅化微晶纤维素50、硅化微晶纤维素90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
| 组分 | 重量百分比（%） |
| 普瑞巴林 | 10.00 |
| 喷雾干燥甘露醇100SD | 50.00 |
| 硅化微晶纤维素50 | 30.00 |
| 羧甲基淀粉钠 | 8.00 |
| 阿斯巴甜 | 1.000 |
| 硬脂酸镁 | 1.000 |
制备工艺：
（1）将普瑞巴林与硅化微晶纤维素50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、羧甲基淀粉钠、阿斯巴甜过60目筛混合3次，混合均匀，作为预混物2备用；
（3）将预混物2与硬脂酸镁混合均匀，压制成片。
实施例2
| 组分 | 重量百分比（%） |
| 普瑞巴林 | 10.00 |
| 喷雾干燥甘露醇100SD | 54.00 |
| 硅化微晶纤维素90 | 30.00 |
| 交联羧甲基纤维素钠 | 4.00 |
| 阿斯巴甜 | 1.000 |
| 硬脂酸镁 | 1.000 |
制备工艺：
（1）将普瑞巴林与硅化微晶纤维素90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、交联羧甲基纤维素钠、阿斯巴甜过60目筛混合3次，混合均匀，作为预混物2备用；
（3）将预混物2与硬脂酸镁混合均匀，压制成片。
实施例3
| 组分 | 重量百分比（%） |
| 普瑞巴林 | 10.00 |
| 喷雾干燥甘露醇200SD | 50.00 |
| 硅化微晶纤维素90 | 15.00 |
| 硅化微晶纤维素50 | 15.00 |
| 羧甲基淀粉钠 | 8.00 |
| 阿斯巴甜 | 1.000 |
| 硬脂酸镁 | 1.000 |
制备工艺：
（1）将普瑞巴林与硅化微晶纤维素50采用等量递加方式过60目筛混合3次，作为预混物1备用；
（2）将预混物1与硅化微晶纤维素90过60目筛混合3次，作为预混物2备用；
（3）将预混物2与处方量的喷雾干燥甘露醇200SD、羧甲基淀粉钠、阿斯巴甜过60目筛混合3次，混合均匀，作为预混物3备用；
（4）将预混物3与硬脂酸镁混合均匀，压制成片。
实施例4
| 组分 | 重量百分比（%） |
| 普瑞巴林 | 10.00 |
| 喷雾干燥甘露醇100SD | 50.00 |
| 微晶纤维素PH102 | 30.00 |
| 羧甲基淀粉钠 | 8.000 |
| 阿斯巴甜 | 1.000 |
| 硬脂酸镁 | 1.000 |
制备工艺：
（1）将普瑞巴林与微晶纤维素PH102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、羧甲基淀粉钠、阿斯巴甜过60目筛混合3次，混合均匀，作为预混物2备用；
（3）将预混物2与硬脂酸镁混合均匀，压制成片。
实施例5
| 组分 | 重量百分比（%） |
| 普瑞巴林 | 10.00 |
| 喷雾干燥甘露醇100SD | 50.00 |
| 微晶纤维素PH102 | 30.00 |
| 羧甲基淀粉钠 | 8.000 |
| 阿斯巴甜 | 1.000 |
| 硬脂酸镁 | 1.000 |
制备工艺：
（1）将普瑞巴林与处方量的喷雾干燥甘露醇100SD、微晶纤维素PH102、羧甲基淀粉钠、阿斯巴甜过60目筛混合3次，混合均匀，作为预混物1备用；
（2）将预混物1与硬脂酸镁混合均匀，压制成片。
表1 普瑞巴林口崩片口感与崩解时间
表2 实施例4含量均匀度结果
| 序号 | 1 | 2 | 3 | 4 | 5 |
| 含量（%） | 93.24 | 92.36 | 114.33 | 105.63 | 91.59 |
| 序号 | 6 | 7 | 8 | 9 | 10 |
| 含量（%） | 95.36 | 104.25 | 90.06 | 97.12 | 113.38 |
A+2.20S=20.17＞15
表3 实施例5含量均匀度结果
| 序号 | 1 | 2 | 3 | 4 | 5 |
| 含量（%） | 102.09 | 93.2 | 100.54 | 105.66 | 93.98 |
| 序号 | 6 | 7 | 8 | 9 | 10 |
| 含量（%） | 95.46 | 100.18 | 102.04 | 92.48 | 108.68 |
A+2.20S=20.28＞15
实验结果及结论
本申请将普瑞巴林与硅化微晶纤维素预混，采用粉末直压工艺制备样品时，物料流动性和可压性优良，制备的口崩片口感较优，崩解时间、含量均匀度均合格。
Claims (5)
1.一种普瑞巴林口崩片，质量百分比组成为：普瑞巴林10-30%，填充剂10-80%、崩解剂5-20%、润滑剂0.5-2%、矫味剂1-3%。
2.如权利要求1所述的普瑞巴林口崩片，填充剂为硅化微晶纤维素、喷雾干燥甘露醇、预胶化淀粉、二水磷酸氢钙中的一种或几种。
3.如权利要求1所述的普瑞巴林口崩片，填充剂为硅化微晶纤维素50、硅化微晶纤维素90中的一种或几种。
4.如权利要求1所述的普瑞巴林口崩片，填充剂为喷雾干燥甘露醇100SD、喷雾干燥甘露醇200SD中的一种或几种。
5.一种普瑞巴林口崩片，其制备方法为普瑞巴林与硅化微晶纤维素预混，其后将该预混物与其他辅料混合均匀，采用粉末直压工艺制成口崩片。
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112715877A (zh) * | 2020-12-25 | 2021-04-30 | 武汉轻工大学 | 一种黄秋葵姜黄口崩片及其制备方法 |
| CN115581673A (zh) * | 2022-10-28 | 2023-01-10 | 浙江康恩贝制药股份有限公司 | 一种布洛芬颗粒及其制备方法 |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112715877A (zh) * | 2020-12-25 | 2021-04-30 | 武汉轻工大学 | 一种黄秋葵姜黄口崩片及其制备方法 |
| CN115581673A (zh) * | 2022-10-28 | 2023-01-10 | 浙江康恩贝制药股份有限公司 | 一种布洛芬颗粒及其制备方法 |
| CN115581673B (zh) * | 2022-10-28 | 2024-02-02 | 浙江康恩贝制药股份有限公司 | 一种布洛芬颗粒及其制备方法 |
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