刺五加黄芪片薄膜包衣的制备与质量控制

目的改进刺五加黄芪片包衣的质量和稳定性。方法采用羟丙甲基纤维素、丙烯酸树脂Ⅱ号为薄膜包衣主材对刺五加黄芪片进行薄膜包衣，并将其薄膜衣片与糖衣片进行质量和稳定性比较。结果薄膜包衣制备工艺可行，薄膜衣片外观、硬度、崩解时限、水分、稳定性、抗热性等均优于糖衣片。结论薄膜包衣可以改进刺五加黄芪片的质量。     

复方丹参片薄膜包衣工艺研究

目的将复方丹参片糖衣片改为薄膜衣片。方法以羟丙基甲基纤维素为主要成膜材料包衣,将生产的复方丹参薄膜衣片与糖衣片同时进行稳定性考察、比较。结果复方丹参薄膜衣片在抗湿性、硬度、稳定性、外观等方面均优于糖衣片。结论所用方法简单、工艺成熟。     

养血安神片薄膜包衣片的制备及稳定性考察

目的:研制养血安神薄膜包衣片,提高其稳定性.方法:以加速试验考察养血安神薄膜包衣片与糖衣片的稳定性.结果:与传统的糖衣片比较,养血安神薄膜包衣片可以明显缩短崩解时限,加速试验结果表明稳定性良好.结论:养血安神薄膜包衣片的稳定性良好.     

盘龙七片薄膜包衣工艺研究

目的研究盘龙七片的薄膜包衣技术,提高其稳定性。方法针对该品种的自身特点,通过正交实验摸索薄膜包衣工艺的最佳条件,并通过崩解度、耐温、耐湿稳定性实验,考察盘龙七片采用薄膜包衣与糖衣的稳定性。结果薄膜包衣可提高盘龙七片的储存期稳定性。结论盘龙七薄膜衣片质量优于其糖衣片。     

甲状腺片薄膜包衣片的制备及其稳定性的考察

目的研制甲状腺薄膜包衣片 ,提高稳定性。方法进行光照、高温、高湿及加速试验比较甲状腺薄膜包衣片与糖衣片的稳定性。结果甲状腺薄膜包衣片与传统的糖衣片比较具有较强的抗光照、高温及高湿的能力 ,加速试验结果稳定性良好。结论甲状腺薄膜包衣片的稳定性明显优于其糖衣片     

宣肺止咳薄膜衣片的制备及其稳定性研究

目的研究宣肺止咳薄膜衣片的制备及考察其稳定性。方法采用丙烯酸树脂制备薄膜衣片,应用加速试验进行稳定性研究,并与糖衣片进行比较。结果宣肺止咳薄膜衣片的包衣合格率、崩解时限、防潮性、微生物限度检查等指标均优于糖衣片,加速试验稳定性良好。结论制备宣肺止咳薄膜衣片的方法简单可行,质量稳定。     

秦息痛糖衣片改薄膜衣片的成型工艺研究

目的探索秦息痛糖衣片改为薄膜衣片的生产工艺。方法采用正交实验探索秦息痛薄膜衣片的最佳生产工艺参数,采用HPLC法,以片剂中青藤碱的含量为指标对正交实验结果进行验证。结果青藤碱质量浓度在1.032~10.88μg·mL-1范围内呈良好线性关系,平均回收率为99.49%,RSD值为2.79%(n=6)。秦息痛薄膜衣片最佳生产工艺:雾化气压0.4 MPa,包衣液喷速0.16~0.18kg·min-1,素片温度40℃,包衣液浓度10%。该工艺条件下生产的秦息痛薄膜衣片外观色泽均匀,表面平滑,崩解时限为29~31min,包衣合格率高于99.58%。HPLC法测得秦息痛薄膜衣片中青藤碱含量在10.48~10.55mg,符合标准要求。结论该制备工艺稳定,可为秦息痛薄膜衣片的工业化生产奠定基础。     

陈香露白露薄膜衣片的研制

目的:制备陈香露白露薄膜衣片,提高药物稳定性。方法:选用不同的粘合剂制备片芯,再选用不同的包衣材料进行包衣,比较陈香露白露薄膜衣片与糖衣片的稳定性。结果:采用10%聚乙烯吡咯烷酮乙醇液为粘合剂制备片芯,用隔离材料玉米阮将片芯保护,采用上海卡乐康公司的黄色或红棕色胃溶性包衣粉制备的陈香露白露薄膜衣片在外观质量上优于其它材料制备的成品,尤其是防渗油和防潮性方面优势明显;薄膜衣片稳定性优于糖衣片。结论:陈香露白露薄膜衣片质量稳定,制备工艺简单。     

关白附薄膜包衣片的处方和制备工艺研究

目的:研制关白附薄膜包衣片,为临床提供服用方便、疗效明显的抗房颤口服新药。方法:使用新型的直接压片辅料,筛选可压性和流动性良好的处方,运用全粉末直接压片技术制备关白附总碱盐片,并对其进行薄膜包衣。结果:优化后的处方流动性良好,片剂外观色泽均匀,硬度、片重差异、崩解时限等指标均符合《中华人民共和国药典》2010年版的要求,包衣后药物的引湿性有明显的改善。结论:采用全粉末压片技术制备关白附总碱盐片并用欧巴代进行包衣,有效地降低了药物的吸湿性,该工艺操作简单可行,适合工业化生产。     

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。     

Evaluation of Moisture Sorption by Tablet Cores Containing Superdisintegrants During the Aqueous Film Coating Process

A physical-chemical analysis of the extent of sorption of water by tablets containing superdisintegrants was carried out following the aqueous film coating of formulated tablets. Characterization of the uncoated and coated tablet properties was conducted using thermo-gravimetric analysis, differential scanning calorimetry, mercury intrusion porosimetry, and measurement of the tablet tensile strength. Tablet residual moisture content, pore system characteristics, tensile strength, and glass transition temperature of the amorphous polymer components of the tablet matrix were significantly affected after the coating operation. These findings were attributed to the penetration of water from the aqueous film coating solution into the tablet matrix.     

Quantitation of film coating on Zantac 75 mg tablets and Epivir HBV 100 mg tablets by ICP-AES

PURPOSE: To present a selective analytical Inductively Coupled Plasma-Atomic Emission Spectroscopy (ICP-AES) method developed and validated for the quantitation of tablet film coatings containing titanium. METHODS: Tablet samples were decomposed by either digestion or dry ashing. The amount of film tablet coating was calculated based on titanium content of the sample. RESULTS: The reported ICP-AES method was accurate, precise, sensitive and linear for determination of titanium concentrations from 2.9 to 8.6 ppm. CONCLUSION: This method provides an accurate determination of the amount of coating on a tablet and has general applicability for a variety of coating formulations containing different elements.     

Determination of SB 216469-S during tablet production using near-infrared reflectance spectroscopy

A near-infrared method was developed for analyzing SB 216469-S tablets at various stages of tablet processing, particularly after (i) high shear granulation, (ii) lubrication, (iii) core tablet compression, and (iv) aqueous film coating. Tablets with three different drug concentrations ranging from 1.5% (w/w) to 6.0% (w/w) were examined along with a placebo. Similarly, moisture levels during the granulation drying process were measured, along with the thickness of the tablet coating. Tablet identification inside blister packaging for clinical supplies was also demonstrated.     

新型水性胃溶薄膜包衣预混辅料的制备及防潮防裂性能研究

目的研究新型水性胃溶薄膜包衣预混辅料。方法制备一种新型水性胃溶薄膜包衣预混辅料，对其处方结构和制备工艺特点进行分析。将用该预混辅料配制的包衣液分别对复方丹参片、花红片、普乐安片和钙尔奇D片进行包衣，在温度（40±2）℃、相对湿度（75±5）％的条件下进行裸片加速试验7d，考察其防潮防裂性能；通过对该预混辅料中镁元素含量及100目筛余率的测定，考察其均匀度和粒度。结果该预混辅料粒度小于100目，混合均匀度不低于99．5％，并具有较强的防潮、防裂性能。结论制备得到了一种粒度细、均匀度高、防潮防裂性能强的水性胃溶薄膜包衣预混辅料。     

The Effect of Swelling Characteristics of Superdisintegrants on the Aqueous Coating Solution Penetration into the Tablet Matrix During the Film Coating Process

The mechanism and the extent of sorption of water molecules by tablets containing superdisintegrants and microcrystalline cellulose, following the aqueous film coating of formulated tablets, were investigated. The penetration of water from the coating solution into the tablet matrix resulted in significant changes in physical properties of the coated tablet cores, such as residual moisture content, tensile strength, and pore-size distribution. The swelling and the morphological characteristics of each individual disintegrant compound and microcrystalline cellulose were found to have important implications on the extent of penetration of water from the aqueous film coating solution. A hypothesis concerning the interaction between microcrystalline cellulose and the superdisintegrant particles present in the tablet matrix is proposed.     

格列吡嗪渗透泵片的水分散体包衣法研制及其体夕释药行为考察

目的制备格列吡嗪透泵片并考察其体外释药行为的影响因素。方法以丙烯酸树脂水分散体EudragitRS30D为包衣材料制备格列吡嗪渗透泵片,采用相似因子法考察包衣方面因素对体外释药行为的影响,并与同类进口片进行比较。结果衣膜中增塑荆种类、衣膜材料、释药介质对释药行为影响显著。结论采用水分散体包衣制备渗透泵控释片,同样达到了预期目的,为研究开发新型控释制剂奠定了基础。     

Combination of a hot-melt subcoating and an enteric coating for moisture protection of hygroscopic Sennae fructus tablets

The objective of this study was to investigate the efficiency of moisture protection of hot-melt coatings solely and in combination with an enteric coating on hygroscopic tablet cores containing a spray-dried Sennae fructus extract. Tablet cores were subcoated with different hot-melt coating materials: medium chain tryglycerides, stearic acid, Precirol^® ATO 5, and Compritol^® 888 ATO, at varying amounts and coated with Eudragit^® L 30D-55 for enteric resistance. Subcoating penetration, tablet disintegration, dissolution times, tablet hygroscopicity, and tablet properties such as weight, height, diameter, and hardness were analyzed. 3?mg/cm² of tablet surface seemed to be sufficient if sustained release is not required. Thereby, hot-melt coating did not adversely affect the tablet properties with regard to subsequent processing steps. Compared to the tablet cores it was possible to reduce the moisture uptake by 85% at 75% relative humidity with tablets coated with a combination of Precirol^® ATO 5 and Eudragit^® L 30D-55. This combination was more efficient than high amounts of Eudragit^® L 30D-55. Hot-melt coating proved to be a suitable technique for the application of subcoating material to tablet cores serving as a barrier against water permeation into hygroscopic tablet cores without exceeding the required disintegration times.     

Film coating as a method to enhance the preparation of tablets from dimenhydrinate crystals

Crystals of dimenhydrinate as a model drug were used for crystal coating, a method that can be applied to increase the flowability of a material and facilitate the tablet making. An increase in particle size was observed during the film coating. The change in shape of the coated particles was also examined. Some physicochemical parameters changed during coating, e.g. the surface free energy parameters and the wetting of the samples. The amount of coating material (and therefore the coating time) influenced several parameters (the shape of the particles, the flow properties and surface free energy parameters, compressibility and compactibility). Several parameters of prepared tablet (porosity, breaking hardness) were examined. Accordingly, coating of the crystals can be performed in order to enhance the handling of a material with insufficient properties for tablet making.     

Modeling the motion and orientation of various pharmaceutical tablet shapes in a film coating pan using DEM

Film coating uniformity is an important quality attribute of pharmaceutical tablets. Large variability in coating thickness can limit process efficiency or cause significant variation in the amount or delivery rate of the active pharmaceutical ingredient to the patient. In this work, the discrete element method (DEM) is used to computationally model the motion and orientation of several novel pharmaceutical tablet shapes in a film coating pan in order to predict coating uniformity. The model predictions are first confirmed with experimental data obtained from an equivalent film coating pan using a machine vision system. The model is then applied to predict coating uniformity for various tablet shapes, pan speeds, and pan loadings. The relative effects of these parameters on both inter- and intra-tablet film coating uniformity are assessed. The DEM results show intra-tablet coating uniformity is strongly influenced by tablet shape, and the extent of this can be predicted by a measure of the tablet shape. The tablet shape is shown to have little effect on the mixing of tablets, and thus, the inter-tablet coating uniformity. The pan rotation speed and pan loading are shown to have a small effect on intra-tablet coating uniformity but a more significant impact on inter-tablet uniformity. These results demonstrate the usefulness of modeling in guiding drug product development decisions such as selection of tablet shape and process operating conditions.