欧巴代薄膜包衣预混剂在薄膜包衣中的应用

研究欧巴代薄膜包衣预混剂在薄膜包衣中的效果,以取得较为理想的包衣材料。方法：以强力脑清素片为例,通过普通薄膜包衣材料与欧巴代薄膜包衣预混剂两种衣配方,从外观、崩解度、耗时等方面作对比。结果：以欧巴代薄膜包衣预混剂包衣,薄膜衣片外观细腻、光洁,对崩解的影响小,操作简便,耗时短。结论：欧巴代薄膜包衣预混剂可替代普通薄膜包衣材料,进行薄膜包衣。     

新型薄膜包衣材料——欧巴代在片剂生产中的应用

薄膜包衣是片剂技术进步的一个标志,在使用了多种薄膜包衣物料后,我们选择了欧巴代,使产品质量有了显著的提高,从各方面衡量,欧巴代确定可以称得上是一种完善,可靠的品质辅料,值得大力推广和应用。     

具有杰出水汽阻隔性能的新型速释薄膜包衣系统——欧巴代(R)200新一代优化型薄膜包衣系统

上世纪90年代,卡乐康公司(www.colorcon.com.cn)在全球推出了以聚乙烯醇(PVA)为成膜材料的包衣系统.因具有黏度低、成膜性好、防潮性能强等优点,PVA被广泛用于各种片剂的薄膜包衣.从2007～2009年美国FDA批准的新药审批(NDA)数据来看,PVA已取代羟丙甲纤维素(HPMC),成为全配方包衣预混系统首选的成膜材料. 理想的速释薄膜包衣系统应具有包衣效率高、防潮性能好、对片芯的释放没有影响等特征.欧巴代(R)200 (Opadry(R) 200)是卡乐康最新优化的速释包衣系统,通过配方优化,保留了各种高分子材料用于速释薄膜包衣的优点.欧巴代(R) 200是适用于挑战性片芯的薄膜包衣系统,具有卓越的防潮性能和杰出的颜色稳定性,能够在更高的固含量条件下实现稳定的包衣.本文报道了欧巴代(R) 200的各种基础性能及在模型药物上的应用.     

中药提取物薄膜包衣工艺研究

目的:采用自制薄膜包衣液及市售薄膜包衣材料对中药提取物进行薄膜包衣.比较包衣材料的防潮性能,并对包衣增重进行筛选.结果:自制薄膜包衣液及市售薄膜包衣材料均可用于中药提取物的薄膜包衣.结论:从成本和质量上考虑,选择欧巴代AMB作为中药提取物片的包衣材料是最合适的.     

复方甘草薄膜衣片的制备及稳定性考察

目的：解决复方甘草片的吸潮及挥发问题。方法：选择新型薄膜衣包材欧巴代进行包衣，并考察其稳定性。结果：包衣后的抗潮湿、抗挥发性能明显增强，稳定性有较大提高。结论：利用欧巴代包衣材料进行薄膜包衣达到了预期目的。     

欧巴代在中药浸膏片薄膜包衣中的应用

目的:考察彩色包衣粉欧巴代OY-C及OY型号在中药浸膏片薄膜包衣中的应用工艺.方法:应用普通包衣锅,二种欧巴代与其他材料的包衣片进行对比实验.结果:二种欧巴代交替的混合包衣片,具有较佳的外观及防潮性能.     

欧巴代在中药浸膏片薄膜包衣中的应用

目的:考察彩色包衣粉欧巴代OY-C及OY型号在中药浸膏片薄膜包衣中的应用工艺.方法:应用普通包衣锅,二种欧巴代与其他材料的包衣片进行对比实验.结果:二种欧巴代交替的混合包衣片,具有较佳的外观及防潮性能.     

欧巴代在中药浸膏片薄膜包衣中的应用

目的：考察彩色包衣粉欧巴代ＯＹ－Ｃ及ＯＹ型号在中药浸膏片薄膜包衣中的应用工艺。方法：应用普通包衣锅,二种欧巴代与其他材料的包衣片进行对比实验。结果：二种欧巴代交替的混合包衣片,具有较佳的外观及防潮性能。     

薄膜包衣片替代糖衣片是大势所趋

传统的包衣口服片剂药物，十之八九会是糖衣片，但近年来，用薄膜包衣片替代糖衣片已成大势所趋。这是因为糖衣片的不足之处太多了。糖衣片的主要辅料成分是国外已淘汰的滑石粉。使用滑石粉的糖衣片往往使药片的片芯重量增大50％-100％，造成病患服用大量与药物成份不相干的辅料。薄膜包衣则是一种新型的包衣工艺，是直接在片芯外面包上一层薄薄的稳定性很好的膜。目前国际上使用最多、最名的薄膜包衣材料是来自美国的品牌“欧巴代”。     

肠溶型欧巴代在阿司匹林肠溶片薄膜包衣中的应用

欧巴代—新一代薄膜包衣材料 ,目前 ,该品已广泛应用于薄膜包衣 ,经过试验 ,我们选用肠溶型欧巴代进行阿司匹林片包衣 ,证明欧巴代用于肠溶衣片 ,具有操作简单、无需有机溶剂、生产效率高、质量稳定等优点 ,现简述如下 :1 阿司匹林片片芯处方及生产工艺处方　阿司匹林　　 2 5ｍｇ淀　　粉　　 30ｍｇ糊　　精　　 2 0ｍｇ生产工艺　按上述处方量称取原辅料 ,混匀 ,干法制粒 ,压片 ,每片含阿司匹林 2 5ｍｇ ,片重 75ｍｇ。2 肠溶包衣处方及包衣液制备　按 10 0ｋｇ片芯计 ,欧巴代 3ｋｇ ,乙醇溶液 (88% ) 4 0ｋｇ。包衣制备　按其处方称取…     

片剂薄膜包衣过程激光共聚焦成像及近红外光谱建模分析

目的 研究薄膜包衣的微观成膜过程，实现对包衣质量无损检测模型的构建。方法 采用聚乙烯吡咯烷酮为包衣材料对微晶纤维素片进行包衣，在包衣材料中加入罗丹明为示踪剂。测定包衣过程不同时间包衣增重和衣膜厚度，并通过激光共聚焦显微镜成像系统和近红外光谱技术分别测定包衣片衣膜的微观结构和宏观图谱，最后采用化学计量学的方法关联近红外图谱与衣膜质量，构建包衣过程的控制模型。结果 衣膜在片芯表面呈现非均匀分布，先分布于片芯两侧表面，后分布于片芯曲面，这种差异随包衣的进行逐渐降低，且在衣膜表面存有微小的孔隙结构。多元散色矫正预处理后的近红外光谱图形能够构建包衣质量的精确控制和预测模型。结论 激光共聚焦成像及近红外光谱技术能够分别从微观和宏观角度增进对薄膜包衣过程的理解和控制，有助于促进薄膜包衣技术的进一步开发利用。     

全水型薄膜包衣预混剂在复方丹参片生产中的应用研究

目的研究全水型薄膜包衣技术在复方丹参片生产中的应用,提高复方丹参片的质量稳定性。方法进行加速试验,比较复方丹参片全水型薄膜衣片与醇溶性薄膜衣片的综合质量和稳定性。结果全水型薄膜包衣片外观明显优于醇溶性薄膜衣片,在稳定性考察过程中含量测定和崩解时限均无明显变化。结论全水型薄膜包衣预混剂可用于复方丹参片的包衣生产。     

Detrimental Effect of the Film Coat Chemistry and Thickness on the Physical Stability of Amorphous Solid Dispersions in Tablet Formulations

Amorphous solid dispersions (ASDs) have been widely utilized to enhance the bioavailability of pharmaceutical drugs with poor aqueous solubility. The role of various excipients on the amorphous drug to crystalline form conversion in ASDs has been widely documented. However, there has been no published study to investigate the role of film coating material on the physical stability of an ASD based tablet formulation, to the best of our knowledge. Here we show that the film coating can potentially have a detrimental impact on the physical stability of spray dried intermediates (SDI) in tablet formulations. The impact of the film coating on the physical stability of SDI was found to be related to the film coat material composition, and an increase in the film coating thickness led to a reduction in the physical stability of SDI in tablets. Oral compressed tablets in which the film coat material was “mixed-in” with the formulation blend showed a similar or worse physical stability than film coated tablets, further underscoring the film coat material impact on physical stability, independent of the film coating process. This study demonstrates a need for careful consideration of the film coat material selection for ASD based pharmaceutical product development.     

Silk fibroin as a novel coating material for controlled release of theophylline

The aim of this study was to explore potential use of the silk fibroin (SF) as an aqueous coating material for theophylline tablets. We have examined the film forming and coating properties of heat-treated fibroin, SF solution having different amounts of polyethylene glycol (PEG) and 1-ethyl-3-(3-dimethyl aminopropyl)carbodiimide (EDC) cross-linked SF. Heat-treated SF material possessed a brittle structure, which resulted in poor film forming and coating properties. The optimum PEG amount in SF solution was determined as 17% (by weight) for an acceptable film forming and zero order release profile. EDC cross-linked SF has shown a very good film forming and coating property with a potential for sustaining the drug release from coated theophylline tablets. Dissolution data for coated theophylline tablets were analyzed using Ritger and Peppas equation to describe the mechanism of drug release. Drug release from the EDC coated tablets followed zero-order kinetics. Release rate constants were found to be 0.26, 0.19, 0.16% min⁻¹ for single-coated, double coated, and triple coated tablets, respectively. These results clearly demonstrated that silk fibroin has high utility as a novel aqueous coating material for controlled release products.     

盐酸二甲双胍缓释片处方筛选及工艺研究

对盐酸二甲双胍缓释片的处方及工艺进行筛选和研究。方法：根据释放度作为判断原则，对缓释骨架材料、填充剂、粘合剂、润滑剂及包衣材料的种类、规格、用量及工艺等进行了考察，并在此基础上采用正交试验1．9(3^4)方案对处方进行筛选。结果：以HPMC K100M及HPMC K15M作为盐酸二甲双胍缓释片的基本骨架材料，微晶纤维素作为填充剂，硬脂酸镁为润滑剂，4％HPMCE5的70％乙醇溶液适量作为粘合剂制成片芯，采用薄膜包衣法，以欧巴代的70％乙醇溶液作为薄膜包衣材料，制得盐酸二甲双胍缓释骨架片。结论：本制剂工艺简单，所用各种辅料均为国产化，成本低，制得盐酸二甲双胍缓释片释放度符合规定。     

青霉素V钾片包衣处方研究及稳定性考察

目的：通过研究不同包衣处方对青霉素V钾片进行包衣,并考察稳定性。方法：采用水溶性防潮包衣材料和醇溶性防潮包衣材料分别对青霉素V钾片进行包衣,并就其质量稳定性进行对比。结果：采用醇溶防潮包衣的青霉素V钾片,具有较佳的防潮性能和稳定性。结论：利用醇溶防潮包衣材料进行青霉素V钾片薄膜包衣,产品质量稳定,值得广泛应用。     

西嗪伪麻缓释片薄膜包衣工艺研究

目的:探讨西嗪伪麻缓释片的薄膜包衣的工艺.方法:采用正交实验确定薄膜包衣的工艺参数,选择最佳工艺.结果:确定了薄膜包衣的的最佳工艺条件:包衣的羟丙甲纤维素量为9%,喷速 14 mL·min-1,转速 12 r·min-1.结论:该片释放度符合标准规定,工艺稳定可行.     

薄膜包衣技术常见问题解决方法探索

目的讨论研究薄膜包衣中常见问题及解决方法.方法针对薄膜包衣过程中出现色差、粘片等技术问题,采用不同的方法进行解决.结果及结论通过调整片芯质量、调节包衣处方和操作可以保证薄膜包衣外观质量达到规定要求.     

丙戊酸钠薄膜衣片的制备及稳定性研究

目的研究丙戊酸钠薄膜衣片的制备方法。方法分别用全水型和醇溶型薄膜包衣预混剂对该素片进行包衣,与该品种同规格糖衣片同时进行稳定性考察比较。结果用全水型和醇溶型薄膜包衣预混剂对该产品素片进行包衣后,当增重达到（3．5±0．3）％时,本品6个月时的水分含量分别为6.3％、6．6％,糖衣片为8．9％,其他项目比糖衣片也显出一定的优势,且均符合规定。结论按该工艺生产的丙戊酸钠薄膜衣片符合质量标准要求,工艺稳定可靠,适合大生产需要。     

Evaluating the effect of coating equipment on tablet film quality using terahertz pulsed imaging

In this study, terahertz pulsed imaging (TPI) was employed to investigate the effect of the coating equipment (fluid bed and drum coater) on the structure of the applied film coating and subsequent dissolution behaviour. Six tablets from every batch coated with the same delayed release coating formulation under recommended process conditions (provided by the coating polymer supplier) were mapped individually to evaluate the effect of coating device on critical coating characteristics (coating thickness, surface morphology and density). Although the traditional coating quality parameter (weight gain) indicated no differences between both batches, TPI analysis revealed a lower mean coating thickness (CT) for tablets coated in the drum coater compared to fluid bed coated tablets (p < 0.05). Moreover, drum coated tablets showed a more pronounced CT variation between the two sides and the centre band of the biconvex tablets, with the CT around the centre band being 22.5% thinner than the top and bottom sides for the drum coated tablets and 12.5% thinner for fluid bed coated tablets. The TPI analysis suggested a denser coating for the drum coated tablets. Dissolution testing confirmed that the film coating density was the drug release governing factor, with faster drug release for tablets coated in the fluid bed coater (98 ± 4% after 6 h) compared to drum coated tablets (72 ± 6% after 6 h). Overall, TPI investigation revealed substantial differences in the applied film coating quality between tablets coated in the two coaters, which in turn correlated with the subsequent dissolution performance.