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1.
摘要:口服制剂中部分化学药物以及多种中药成分都具有苦味,极大限制了该类药物的应用。因此,减少药物苦味,提高患者依从性十分重要。近年来,高分子材料在掩盖药物不良味道中取得了一定成果。一些常用的高分子掩味材料如壳聚糖、环糊精和泊洛沙姆等可通过形成物理屏障、包合苦味分子或静电作用等加载苦味药物,减少药物与苦味受体的接触,以达到掩味的目的。本文将对目前常用的掩味高分子材料及其掩味机制进行综述。  相似文献   

2.
口服固体制剂掩味技术的研究进展   总被引:2,自引:0,他引:2  
陈曼  操锋  平其能 《药学进展》2009,33(5):212-217
综述各种新兴口服固体制剂掩味技术的原理、特点及制备过程,并简述口服掩味技术评价方法的最新进展。口服固体制剂中许多药物由于受到不良口味的影响,致使病人的用药顺应性差、临床应用受限。近年来在使用矫味剂、麻痹剂等掩味手段的基础上产生了许多新兴的掩味技术,如喷动床包衣、粉末包衣和盐析包衣等。  相似文献   

3.
目的:研究黄连提取物掩味技术。方法:在考察黄连提取物的具体方法及溶剂时将盐酸小檗碱含量当作主要指标,选择提取方法,在掩味处理提取物时主要应用包衣法。结果:提取时应用50%乙醇回流,黄连提取物颗粒包衣液制备材料用PEG6000与丙烯酸树脂Ⅱ号,70:15:15为包衣材料、增塑剂以及抗静电剂比例,经掩味后有较好口感。结论:采用上述技术掩味黄连提取物简单且便于操作,实用性高。  相似文献   

4.
口服药物掩味方法的研究进展   总被引:1,自引:1,他引:1  
胡连栋  贾慧卿 《中国药房》2007,18(7):552-554
口服制剂中的许多药物常因有异味而使其应用受限。为此,需要采取技术掩盖药物的异味。药物掩味原理主要有:(1)将味蕾与药物隔开或对味蕾进行暂时可逆性麻痹;(2)加入矫味剂或将药物的结构进行改造,制备成无苦味的前体药物。常用的掩味方法有:添加矫味剂;聚合物包衣;离子交换树脂吸附;包合;微囊化;固体分散;改变流变性质;添加表面活性剂;制成前药;喷雾冷凝法;添加苦味抑制剂等。近年来,药物掩味研究取得了长足进步,笔者在查阅大量文献的基础上,就相关研究进展简要综述如下。  相似文献   

5.
《中南药学》2017,(2):197-202
大多数药物在口服给药时有苦味,因此在口服制剂中掩盖其不适的口感十分必要,但也面临着巨大的挑战。双螺杆挤出,是目前在医药领域被广泛发展的一种新技术,其在掩味制剂中的应用也成为一种新的研究趋势。双螺杆挤出技术实现苦味药物的掩味,其选择合适的载体材料和制备工艺尤为重要,本文就这两方面及其掩味原理进行了综述,为掩味技术提供新的研究方向。  相似文献   

6.
药用丙烯酸树脂在制剂中的应用进展   总被引:1,自引:0,他引:1  
白靖  李骞  王静  曹德英 《中国药房》2011,(17):1613-1616
目的:介绍药用丙烯酸树脂在药物制剂中应用的最新进展。方法:根据文献,以药用丙烯酸树脂中的德国商品尤特奇为代表,综述了该类辅料的理化性质及在制剂领域中的应用。结果:丙烯酸树脂根据溶解特性分为pH依赖型与pH非依赖型2种;主要用作缓控释制剂、口服定位释药系统、微球与微囊等制剂中的包衣材料及载体,可达到缓、控释或定位释放的目的,还可起到掩味、提高药物稳定性等作用。结论:丙烯酸树脂因具有多种功能和特殊性质而成为多种制剂的重要辅料,在制剂领域中具有广阔的前景。  相似文献   

7.
目的 本文以盐酸小檗碱为模型药物,研究精制后聚丙烯酸树脂IV号作为包衣材料的掩味能力。方法 建立了盐酸小襞碱紫外分光光度法含量测定方法学,并以蔗糖微丸为丸心,采用流化床沸腾上药制备了盐酸小襞碱微丸。分别采用精制前的聚丙烯酸树脂IV号、精制后的聚丙烯酸树脂IV号,以及市售尤特奇? EPO作为包衣材料,制备了不同包衣增重的盐酸小襞碱掩味微丸,并对其口感和水中释放度进行测定。结果 成功建立盐酸小襞碱紫外分光光度法含量测定方法学;制备了盐酸小襞碱普通微丸,含量均一度和上药量符合要求。不同包衣材料制备了不同包衣增重的盐酸小襞碱掩味微丸,经聚丙烯酸树脂IV号包衣后,微丸的苦味被显著掩盖,同时对微丸在水中溶出度的测定结果显示,随着包衣增重的不断变大,微丸的溶出量显著下降;对于精制后的聚丙烯酸树脂Ⅳ,包衣增重达到4.0%时才能充分起到掩盖苦味的作用;而对于尤特奇?EPO,3.0%的包衣增重即可达到相同要求。结论 在相同的包衣增重下,尤特奇?EPO的掩味能力明显优于精制前后的聚丙烯酸树脂Ⅳ,而精制后的聚丙烯酸树脂Ⅳ的掩味能力较精制前有所提高。  相似文献   

8.
何朝星  何函星  王静  曹德英 《中国药房》2011,(45):4297-4300
目的:为掩味口腔崩解片的研究提供参考。方法:根据文献,对口腔崩解片中采用的掩味技术进行综述。结果与结论:主要的掩味技术包括:添加矫味剂;对颗粒、粉末进行包衣;制备包合物、固体分散体、离子交换树脂复合物、微丸、微囊、微球;采用挤出沉淀法制备药物-载体复合物,喷雾干燥法制备掩味粒子等。上述掩味技术的广泛应用,在改善口腔崩解片的口感和提高患者依从性方面取得了一定进展,在很大程度上促进了口腔崩解片的发展。  相似文献   

9.
苦味药物口服制剂的掩味问题是制剂学面临的一个重大挑战。传统的掩味方法主要是添加矫味剂等辅料,但其在应用中存在很大局限。本文综述目前固体分散、包衣、包合、微囊化/微球、离子交换等技术应用到药物掩味技术研究之中的进展,这些技术克服了传统掩味方法的局限和不足,必将促使药物更为广泛地应用。但是这些新出现的掩味技术在标准化、产业化以及效果评价等方面存在一些问题。此外,国内口服制剂掩味技术的研究与应用明显落后于国外,要加快研发步伐。  相似文献   

10.
目的:综述各种可用于口服液体制剂的掩味技术及目前中药口服液体制剂掩味技术的研究现状。方法:查阅近十几年来的中外文献期刊和各国专利,对各种口服液体制剂的掩味技术进行了分类总结。结果:以适当的方法对中药口服液体制剂进行了初步的掩味研究,使该种剂型掩味技术取得了一定的进展。结论:人们对药物的掩味要求越来越高,我们应该开发更为有效的掩味方法。  相似文献   

11.
A HPLC assay for coating integrity of topiramate sprinkle formulation   总被引:2,自引:0,他引:2  
A HPLC method has been developed for the determination of coating integrity of topiramate sprinkle formulation. This method determines the completeness of the sprinkle coating and, indirectly, the completeness of taste masking of the product. This method utilizes a sample preparation where the sprinkles are placed in a specially designed stainless steel basket equipped with a screen, 25-mesh size, at the bottom. Water is used to solubilize any incompletely coated drug. The aqueous solution is analyzed for topiramate using a phenyl column in the reversed-phase mode, isocratic elution, and refractive index detection. This analytical method, for recovered topiramate, provides an indirect measure of drug taste-masking in the sprinkle formulation. It was also used in formulation selection by screening sprinkles beads that contained different amounts of coating to see which formula can best mask the taste with an acceptable level of exposed topiramate drug substance. This method has been validated to meet FDA validation guidelines.  相似文献   

12.
ABSTRACT

Introduction: Although many techniques, such as complexation and microencapsulation, are used to mask the unpleasant taste of drugs, the success of all masking processes is evaluated in the same way. To evaluate the success of a masking process, a masked formulation must pass two tests: a structural test and an in vitro in vivo test.

Areas covered: This review article highlights structural evaluation and in vitro in vivo evaluation of a taste-masking process. The structural evaluation has two criteria: the absence of any chemical interaction between the drug and the masking agent and the molecular distribution of drug in the network of masking agent. The in vitro in vivo section can be verified by electronic tongues, dissolution test, and volunteers and it should confirm that the final product, after applying the masking process, will have a lower rank in terms of taste.

Expert opinion: This critical review helps researchers and industrial partners to evaluate a taste-masking process in a systematic way, leading to better understanding of taste-masking process and consequently improving the efficiency of masked dosage forms while hindering the unpleasant taste of drugs. This will ultimately improve the quality of life of many patients.  相似文献   

13.
The spray drying technique was used to obtain the roxithromycin containing microcapsules with high taste masking efficiency. Eudragit L30D-55 was chosen as a barrier coating. The taste was evaluated by an electronic tongue, and taste-masking effect in water lasted at least several dozen hours.  相似文献   

14.
Drugs exhibiting satisfactory absorption from the oral mucosa or intended for immediate pharmacological action can be advantageously formulated as orally fast-disintegrating tablets (FDTs or ODTs). Therefore, taste masking of active ingredients becomes essential in these systems because the drug is entirely released in the mouth. Despite advances in the FDT technologies, formulation of drugs with a bitter taste is still a challenge, especially when the amount of drug is high. In this study, a new solution is being developed to incorporate higher doses of a model bitter taste drug; ketoprofen, without affecting the fast-disintegrating properties of the formulation. The unpleasant taste of the active drug usually masked by adding flavoring ingredients and sweeteners to improve taste and palatability but in this study a novel approach of using a polymer; Eudragit EPO and a granulation procedure of this polymer with the active drug was applied to mask the bitter taste of ketoprofen. In order to produce ketoprofen FDT formulations, a two-stepped procedure was followed; granulation process with the taste-masking agent (Eudragit EPO) and then direct compression (F3 and F4). In F1 and F2 formulations, granulation process was not implemented in order to observe the effect of application method of Eudragit EPO. As well as observing the effect of taste-masking agent, crospovidone and sodium starch glycolate were used in different concentrations (2, 4 and 8wt%) to examine the influence of superdisintegrants on FDT properties. All the FDTs containing 30?mg ketoprofen (F1, F2, F3 and F4) were evaluated by means of in vitro quality control tests.  相似文献   

15.

儿童偏好甜味,药物的苦味常常导致患儿服药顺应性降低,苦味药物的掩味是儿童口服制剂研发过程中面临的一大难题。简介苦味产生机制,传统和新型掩味方法和技术,各制药公司提出的掩味专利以及掩味效果的评价方法等,为掩味制剂的进一步开发提供参考。

  相似文献   

16.
INTRODUCTION: In the last decade the development of orally disintegrating tablets (ODTs) and thin-film platforms has grown enormously in the field of pharmaceutical industry. A wide variety of new masking technologies combined with the aforementioned platforms have been developed in order to mask the taste of bitter active substances and achieve patient compliance. The commercial success and viability of such products requires the development of robust formulations with excellent palatability, disintegration times, physicochemical stability and pharmacokinetic profiles. AREAS COVERED: In this review, emerging taste-masking technologies applied to solid dosage form manufacturing are summarized. The unique features and principles of taste-masking approaches used with ODT platforms are discussed, including the advantages and limitations of each technology. A brief discussion is also included on the taste masking of thin-film technologies, owing to their similar applications and requirements. EXPERT OPINION: This review elucidates the unique features of current commercially available or highly promising ODT and thin-film technologies, along with taste-masking approaches used in the manufacturing of oral solid dosage forms. A better understanding of these drug delivery approaches will help researchers to select the appropriate platform, or to develop innovative products with improved safety, compliance and clinical value.  相似文献   

17.
Drugs having bitter tastes cause low patient compliance. Many taste-masking techniques such as physical barrier coatings, chemical modification and sensory masking have been developed. Among chemical modification, the inclusion complexation of drugs with cyclodextrins (CyDs) can provide the effective bitter taste-masking effects without complicated formulation and/or delayed dissolution of drugs. Herein, we describe some quantitative methods to evaluate the taste-masking effects of CyD complexes with drugs in solution and the solid state. In addition, we introduce the recent applications of CyDs to excipients for taste masking against various bitter-taste drugs, as well as discuss the possible mechanisms for the taste-masking effect of CyD complexation.  相似文献   

18.
Introduction: In the last decade the development of orally disintegrating tablets (ODTs) and thin-film platforms has grown enormously in the field of pharmaceutical industry. A wide variety of new masking technologies combined with the aforementioned platforms have been developed in order to mask the taste of bitter active substances and achieve patient compliance. The commercial success and viability of such products requires the development of robust formulations with excellent palatability, disintegration times, physicochemical stability and pharmacokinetic profiles.

Areas covered: In this review, emerging taste-masking technologies applied to solid dosage form manufacturing are summarized. The unique features and principles of taste-masking approaches used with ODT platforms are discussed, including the advantages and limitations of each technology. A brief discussion is also included on the taste masking of thin-film technologies, owing to their similar applications and requirements.

Expert opinion: This review elucidates the unique features of current commercially available or highly promising ODT and thin-film technologies, along with taste-masking approaches used in the manufacturing of oral solid dosage forms. A better understanding of these drug delivery approaches will help researchers to select the appropriate platform, or to develop innovative products with improved safety, compliance and clinical value.  相似文献   

19.
Conventional taste-masking strategies are used to overcome the bitter taste perception of pharmaceuticals by coating the drug particles and/or adding flavoring agents. However, for certain product categories such as rapid dissolve sublingual tablets, taste-masking is challenging. Programs exploring such formulation strategies in the LO-CS phase or post CS phase possess very little toxicological information available in order to conduct human taste panel studies. The potential of a bitter taste perception can present a significant business risk. The objective of the study was to validate a rat behavioral avoidance model that identifies bitter-tasting compounds. Most classic bitter substances elicit a response in the micromolar concentration range while most drugs elicit a response in the millimolar range, hence a validation exercise was conducted to examine if the existing biological model was sensitive enough to identify known bitter tasting drugs as such. Five compounds: ergotamine tartrate, fluoxetine, sucrose, sumatriptan and povidone were chosen to represent a spectrum of compounds. The bitter tasting compounds were identified as such in the model. Based on these results, the assay may serve as a useful surrogate test to identify compounds that may have bitter taste issues.  相似文献   

20.
The purpose of this study is to assess the feasibility for taste masking and comparison of taste intensity during formulation development using a multichannel taste sensor system (e-Tongue). Seven taste sensors used in the e-Tongue were cross-selective for five basic tastes while having different sensitivity or responsibility for different tastes. Each of the individual sensors concurrently contributes to the detection of most substances in a complicated sample through the different electronic output. Taste-masking efficiency was evaluated using quinine as a bitter model compound and a sweetener, acesulfame K, as a bitterness inhibitor. In a 0.2 mM quinine solution, the group distance obtained from e-Tongue analysis was reduced with increasing concentration of acesulfame K. This result suggests that the sensors could detect the inhibition of bitterness by a sweetener and could be used for optimization of the sweetener level in a liquid formulation. In addition, the bitterness inhibition of quinine by using other known taste-masking excipients including sodium acetate, NaCl, Prosweet® flavor, and Debittering® powder or soft drinks could be detected by the e-Tongue. These results further suggest that the e-Tongue should be useful in a taste-masking evaluation study on selecting appropriate taste-masking excipients for a solution formulation or a reconstitution vehicle for a drug-in-bottle formulation. In another study, the intensity of the taste for several drug substances known to be bitter was compared using the e-Tongue. It was found that the group distance was 695 for prednisolone and 686 for quinine, which is much higher than that of caffeine (102). These results indicate that the taste of prednisolone and quinine is stronger or more bitter than that of caffeine as expected. Based on the group distance, the relative intensity of bitterness for these compounds could be ranked in the following order: ranitidine HCl > prednisolone Na > quinine HClphenylthiourea > paracetamol  sucrose octaacetate > caffeine. In conclusion, the multichannel taste sensor or e-Tongue may be a useful tool to evaluate taste-masking efficiency for solution formulations and to compare bitterness intensity of formulations and drug substances during pharmaceutical product development.  相似文献   

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