不同外形片剂对半分劈的准确度比较

目的：比较不同外形片剂对半分劈的准确性，为生产和选择适合于分劈的片形提供依据。方法：对4种不同外形的片剂双手对掰譬到4组分劈片，依照USP剂量单位一致性测定方法对各组分劈片进行测试，并对其重量差异进行方差齐性比较。结果：两条形片组通过了剂量单位一致性测定，而两圆形片组均未通过；方差齐性检查显示，无论有无刻线，条形片组与相应的圆形片组之间都有显著性差异（P〈0.05），条形片组分劈片重的分布较圆形片组集中。结论：条形片对半分劈准确性明显好于圆形片，可作为需经常分劈操作药片的主要片形。     

10种常用对半分劈片剂的准确度对比及其影响因素

目的:比较10种常用对半分劈片剂的准确度并分析影响因素.方法:按分劈片单剂量给药的用药频度排序,选取10种分劈片准确称重.依照《美国药典》(USP)剂量单位一致性测量方法进行数据处理.结果:5种无刻线分劈片,重量RSD范围9.8％ ～17.5％,均未通过USP剂量单位一致性测试;4种有刻线分劈片RSD范围2.4％ ～7.4％,可通过或接近剂量单位一致性测试,有无刻线对分劈片的重量差异有显著影响.此外,还存在质地疏松易掉屑,质地坚硬易导致分劈不对称等情况.结论:分劈片的片形、刻线、质地及分劈方法对其分劈准确度均有一定影响.     

地高辛分劈片在青岛地区的应用现状调查及片重差异测定

目的探讨地高辛分劈片在三甲医院住院患者中的应用现状及剂量差异。方法汇总各院医院信息系统（HIS）提供的2012年1月至3月用药数据以显示用药动态;采用称重法测定各院地高辛分劈片的片重差异,并计算剂量误差。结果地高辛分劈片与整片的用药频度比为（1.38∶1）,日均用量约为15～20个单剂量;3家医院分劈片平均片重之间差异无显著性（P〉0.05）,均未通过《美国药典》（USP）剂量单位一致性测定,且与2010年版《中国药典》片重差异不超出±7.5%的相关规定存有较大差距。结论地高辛是经常性的临床用药,但其分劈片难以达到准确的给药剂量,因此厂家应生产多一些剂量规格,以利临床合理用药。     

药师配发的分劈药片缺乏剂量一致性

目的:测定由药师配发的分劈药片的剂量一致性水平。方法:将16种常被分劈的药片进行分劈,并借用美国药典24(USP)中的剂量单位一致性测试法来评估所得半片是否有等同的剂量。结果:在所检测的16种分劈片中,有14种药片没有通过USP剂量单位一致性测试,且药片在分劈过程中都存在着剂量损耗。结论:药片分劈导致了较大的质量变异,为了节省开支或改善剂量而进行分劈药片的做法,有待商榷。     

不同厂家刻痕片及非刻痕片分剂量评价

目的:评价对不同厂家复方卡托普利片和复方对乙酰氨基酚片(Ⅱ)的刻痕片及非刻痕片采用3种方法的分剂量情况,促进合理用药。方法:以分剂量准确性、期望重量与实际重量差值(d)、重量损失百分比、等分片脆碎度为指标,采用手掰、剪刀、切药器3种方法对A厂(有刻痕)、B厂(无刻痕)的复方卡托普利片及C厂(无刻痕)、D厂(有刻痕)的复方对乙酰氨基酚片(Ⅱ)进行分剂量评价。结果:除D厂(3种方法)、C厂(切药器法)外,其余厂家或方法分剂量准确性均不符合《欧洲药典》第6版的规定。与手掰法比较,C厂剪刀法d值明显降低(P<0.05);与剪刀法比较,D厂切药器法d值明显降低(P<0.01)。3种方法间比较分剂量后重量损失百分比均具有统计学意义(P均<0.01),其中剪刀法>切药器法(除B厂外)>手掰法。等分片脆碎度结果表明,A厂切药器法不合格,B厂3种方法均不合格,其余厂家或方法均合格。结论:刻痕片较非刻痕片更适合分剂量,具体分剂量方法需根据药片物理参数情况进行选择。     

病区药房配发的分劈药片的重量变异性

目的探讨病区药房分劈并发出的药物半片重量的变异性.方法收集我院由病区药房发出的10种处方药片,每种10片,共计200个分劈半片.测定分劈片的重量(FW).采用<美国药典>第24版(USP24)剂量单位一致性测定方法,将每种处方药的FW均值与其理论重量(TW)均值进行比较,分析分劈药片的重量变异性.结果在200个分劈药片中,有21个(10.5%)重量偏离其FW均值的15%,涵盖了10种药片中的6种(60%);20个(10%)重量偏离其TW均值的15%,涵盖了10种药片中的5种(50%).10种分劈药片中有7种(70%)SD大于FW均值的6%.而TW的SD没有一个超出USP的6%限值.在总的10种处方药的分劈片中,只有3种(30%)符合USP标准,即FW不超过其FW均值的15%且SD不大于6%.结论药片分劈导致了难以接受的高比例重量变异.不宜将药片分劈作为一种普遍性做法.     

住院患者服用分劈药片的利弊

目的 :探讨住院患者服用分劈药片的利弊。方法 :收集我院由药师分劈、住院患者常用的13种处方药片 ,每种10片 ,共260个分劈片 ,采用《美国药典》剂量单位一致性测试方法分析分劈药片的重量变异性。结果 :药片分劈后均未通过剂量单位一致性测试。药片分劈效果与外形有关 ,带有刻线的相对好一些。在分劈过程中都存在一定的剂量损耗。结论 :药片分劈导致高比率的重量变异 ,故为节省开支而分劈药片的做法仅适合于那些低毒和剂量 -反应效应曲线相对平坦的药物 ,对于那些毒性较大和剂量 -反应效应曲线陡直的药物则不宜采用     

口服片剂分劈重量差异性的研究

目的 探讨口服片剂分劈后的重量差异性.方法 收集常分劈服用的12种处方药片,采用手工分劈和刀刻分劈,用<美国药典>(第24版)中适用于整片药片的剂量单位一致性测试,分析分劈药片的重量一致性.结果 手工分劈的片剂中有6种未通过一致性测试,刀刻分劈的有5种未通过一致性测试.带有刻痕的片剂较无刻痕的分劈效果好.结论 药片分劈导致了高比率的质量变异,仅适用于一些低毒和剂量-反应关系相对平坦的药物.     

住院药房片剂分劈使用情况分析

目的：了解心脏病专科医院住院患者普通片剂分劈使用的现状。方法：随机抽取我院住院药房2005年6月-2006年5月的电脑医嘱进行统计分析。结果：分劈使用率成人为9．28％、老年人为32．37％、儿童达73．79％，1／2片多见，分劈使用最多的药物是专科用药和利尿药；分劈使用率前3位的药品分别是地高辛片、阿司匹林泡腾片和酒石酸美托洛尔片，所占比例位居前3位的药品分别是酒石酸美托洛尔片、地高辛片和氢氯噻嗪片。结论：专科用药特点和儿童生理特征是分劈使用的主要原因；分劈使用率和所占比例较高药物建议生产企业生产小规格药物。门诊使用时药师应给患者必要的指导，以尽可能减小分劈使用的弊端。     

我院住院药房分劈药片使用状况调查及持续质量改进

目的了解调查住院药房分劈药片使用状况并对其进行持续质量改进。方法选取我院2016年10-12月住院患者电脑医嘱进行统计分析。结果分劈片总使用率为7.26%,分劈片剂使用率最高的科室为心内科,1/2片剂分劈最为多见,分劈使用率最高的药物前3位药品为地高辛片、多巴丝肼片和华法林片。结论由于专科用药及剂量调整需要,分劈药片不可避免,药品生产企业应改进规格或标注分劈刻痕,同时药师需对分劈片准确把关,以减少分劈片弊端,促进患者安全合理用药。     

Tablet splitting and weight uniformity of half-tablets of 4 medications in pharmacy practice

Background: Tablet splitting is a common practice for multiple reasons including cost savings; however, it does not necessarily result in weight-uniform half-tablets. Objectives: To determine weight uniformity of half-tablets resulting from splitting 4 products available in the Jordanian market and investigate the effect of tablet characteristics on weight uniformity of half-tablets. Methods: Ten random tablets each of warfarin 5?mg, digoxin 0.25 mg, phenobarbital 30 mg, and prednisolone 5 mg were weighed and split by 6 PharmD students using a knife. The resulting half-tablets were weighed and evaluated for weight uniformity. Other relevant physical characteristics of the 4 products were measured. Results: The average tablet hardness of the sampled tablets ranged from 40.3 N to 68.9 N. Digoxin, phenobarbital, and prednisolone half-tablets failed the weight uniformity test; however, warfarin half-tablets passed. Digoxin, warfarin, and phenobarbital tablets had a score line and warfarin tablets had the deepest score line of 0.81 mm. Conclusion: Splitting warfarin tablets produces weight-uniform half-tablets that may possibly be attributed to the hardness and the presence of a deep score line. Digoxin, phenobarbital, and prednisolone tablet splitting produces highly weight variable half-tablets. This can be of clinical significance in the case of the narrow therapeutic index medication digoxin.     

治疗窗窄药片5种分剂量准确性研究

目的了解5种治疗窗窄药片分剂量的准确性,为临床合理用药提供参考。方法应用药片切割器、剪刀、刀片对5种药片分剂量成2等份及4等份。结果 5种治疗窗窄药片中,硬度最大和最小的药片分别为氨茶碱、地高辛;直径最大和最小的药片分别为卡马西平、地高辛;厚度最大和最小的药片分别为卡马西平、地高辛。地高辛（切）、苯妥英钠（切）FW1/2和FW1/4与TW1/2和TW1/4比较差异有统计学意义（P〈0.05）;地高辛（剪）、氨茶碱（剪）、华法林钠（剪）、苯妥英钠（剪）FW1/4与TW1/4比较差异有统计学意义（P〈0.05和P〈0.01）;华法林钠（刀）FW1/2和FW1/4与TW1/2和TW1/4比较差异有统计学意义（P〈0.01）。5种药片用3种工具分剂量至少有5片超出质量差异15%,均不符合欧洲药典标准。分剂量成2等份时,应用剪刀超出平均质量15%的药片数均较其他2种方法多;分剂量成4等份时,3种方法超出平均质量15%的药片数均较分剂量成2等份时多。结论 5种治疗窗窄药片应用3种工具分剂量准确性较差,临床用药应引起足够的注意。需要调整给药剂量时,可考虑用液体制剂分剂量。     

小儿用药片不同分剂量方法的准确性研究

目的研究小儿用药片不同方法分剂量的准确性,为临床合理用药提供参考。方法分别采用刀片切割（A法）和磨粉分包（B法）对3种小儿用药片进行分剂量处理,每组各处理30片,精密称定,计算平均片重、重量损失百分比、重量差异及合格率,根据统计学结果分析比较A、B法分剂量的准确性。结果三种小儿用药片采用A、B法分剂量,两种方法的分剂量平均重量比较差异有统计学意义（P〈0.01）,A、B法重量损失百分比范围分别为1.00%-8.82%、9.13%-25.94%;两种方法的合格率比较差异有统计学意义（P〈0.05）,其合格率范围分别为35.71%-90.00%、16.00%-28.57%;A法分的剂量越多,重量损失及差异越大,合格率也越低。结论三种药片A、B法分剂量的准确性均不理想,临床用药应引起足够重视,需要使用分剂量药品时,应尽量避免用B法,A法也不宜分的剂量过小。     

Accuracy of tablet splitting: Comparison study between hand splitting and tablet cutter

Background

Tablet splitting is often used in pharmacy practice to adjust the administered doses. It is also used as a method of reducing medication costs.

Objective

To investigate the accuracy of tablet splitting by comparing hand splitting vs. a tablet cutter for a low dose drug tablet.

Methods

Salbutamol tablets (4 mg) were chosen as low dose tablets. A randomly selected equal number of tablets were split by hand and a tablet cutter, and the remaining tablets were kept whole. Weight variation and drug content were analysed for salbutamol in 0.1 N HCl using a validated spectrophotometric method. The percentages by which each whole tablet’s or half-tablet’s drug content and weight difference from sample mean values were compared with USP specification ranges for drug content. The %RSD was also calculated in order to determine whether the drugs met USP specification for %RSD. The tablets and half tablets were scanned using electron microscopy to show any visual differences arising from splitting.

Results

27.5% of samples differed from sample mean values by a percentage that fell outside of USP specification for weight, of which 15% from the tablet cutter and 25% from those split by hand fell outside the specifications. All whole tablets and half tablets met the USP specifications for drug content but the variation of content between the two halves reached 21.3% of total content in case of hand splitting, and 7.13% only for the tablet cutter. The %RSDs for drug content and weight met the USP specification for whole salbutamol tablets and the half tablets which were split by tablet cutter. The halves which were split by hand fell outside the specification for %RSD (drug content = 6.43%, weight = 8.33%). The differences were visually clear in the electron microscope scans.

Conclusion

Drug content variation in half-tablets appeared to be attributable to weight variation occurring during the splitting process. This could have serious clinical consequences for medications with a narrow therapeutic-toxic range. On the basis of our results, we recommend to avoid tablet splitting whenever possible or the use of an accurate tablet splitting device when splitting cannot be avoided.     

Comparison of tablet splitting techniques for dosing accuracy of nebivolol tablets: Hand splitting versus tablet cutter and knife

Tablet splitting is a common practice in clinical settings to lower doses, facilitate swallowing or save costs. Splitting devices can be used when hand splitting is difficult or painful. However, data on the accuracy of tablet splitting are limited and it presents a number of patient or formulation-related problems. Thirty nebivolol IR tablets on the Turkish market were split by hand, a tablet cutter (Rabır®) or a knife, and tested for weight variation, loss of mass, disintegration, and friability. The accuracy of split tablets was in the range of 75.4–121, 82.4–115, and 86.9–115% when split by hand, the cutter, and knife, respectively. No significant difference in accuracy was determined between the left and right sides split by the cutter (p = 0.222). The differences were significant for hand and knife splittings (p < 0.005). The precision was 9.02, 7.87, and 6.11% (CV%) for hand, tablet cutter, and knife, respectively. Only hand splitting failed to comply with the subdivision test of European Pharmacopoeia. The split portions met USP standards for friability (<1%). Splitting decreased the disintegration time (4.5 vs. 2.2 min). Overall, the accuracy of the tablet cutter was more favorable than hand splitting and knife. The study demonstrated that the splitting technique may result in inaccurate dosing and significant drug fluctuations for nebivolol tablets.     

Instability of digoxin in acid medium using a nonisotopic method.

A selective nonisotopic assay was used to investigate the digoxin hydrolysis rates at 37 +/- 0.1 degrees over the pH 1.1--2.2 range. The colorimetric method adopted is based on the use of a xanthydrol reagent after extraction with chloroform. The spectrofluorometric method specified in the dissolution test for digoxin tablets was nonspecific because of digoxigenin interference. Digoxin hydrolysis followed specific acid hydrolysis, and K values of the apparent first-order reaction varied from 0.0357 to 0.0027 min-1 over the pH range used. The effect of the dissolution medium on digoxin stability during the dissolution tests of the tablets also was studied. Water (the BP medium) and 0.6% HCl (the USP medium) were compared using the fluorometric method and the xanthydrol method. In the USP medium (pH 1.3), no hydrolysis was revealed by the fluorometric estimation whereas the xanthydrol method showed about 74% hydrolysis. In water, the two methods revealed no hydrolysis. The extent of hydrolysis after 1 hr in the USP medium was studied using three brands of digoxin tablets of differing dissolution characteristics. The fast dissolving brand showed relatively more hydrolysis than the slow dissolving tablets.     

Variability in tablet fragment weights when splitting unscored cyclobenzaprine 10 mg tablets.

OBJECTIVE: To determine the weight variation and calculated dosing variability of tablet fragments upon splitting unscored cyclobenzaprine hydrochloride 10 mg tablets using two common tablet splitting devices. DESIGN: Comparative pharmaceutics study. SETTING: Pharmacy school laboratory. PARTICIPANTS: Not applicable. INTERVENTIONS: Unscored cyclobenzaprine hydrochloride 10 mg tablets from one generic manufacturer were split with a tablet splitter or a kitchen knife by a licensed pharmacist and two doctor of pharmacy students (n = 15 tablets for each method per participant). MAIN OUTCOME MEASURES: Fragment weights (FWs) were compared with the theoretical weights (TWs), which were calculated as one half of the mean weight of the tablets used in each part of the experiment; means, relative standard deviations (RSDs), and percentages of TW were also calculated. RESULTS: The mean weight before splitting the 45 tablets with the tablet splitter was 136.6 +/- 2.1 mg (TW = 68.3 mg). The mean FW after splitting was 67.9 +/- 7.9 mg. The RSD of 11.6% corresponded to a range of 69.4% to 130.2% of the TW and an estimated drug content of the split fragments between 3.47 mg and 6.51 mg. The mean weight before splitting the 45 tablets cut with a kitchen knife was 136.6 +/- 2.0 mg (TW = 68.3 mg). The mean FW was 68.0 +/- 15.7 mg with a RSD of 23.2%, corresponding to a range of 49.9% to 149.5% of the TW and an estimated drug content of the split fragments between 2.49 mg and 7.48 CONCLUSION: Tablet fragments obtained after splitting this generic cyclobenzaprine 10 mg product varied considerably in weight and estimated drug content. Accordingly, splitting cyclobenzaprine 10 mg tablets to achieve 5 mg doses could result in unpredictable dosing and therapeutic response.     

Comparison of high-performance liquid chromatography and radioimmunoassay in the determination of content uniformity of digoxin tablets

Digoxin 0.25-mg tablets were dissolved and assayed by the standard high-performance liquid chromatography (HPLC) method specified in USP XX and by a radioimmunoassay (RIA) method modified for the assay of tablet solutions. For the RIA method, the filtrate was diluted to a theoretical concentration of 5 ng/ml. Aliquots of this dilution were then assayed for digoxin content using a commercial digoxin 125I RIA kit. Results from both methods were extrapolated to total tablet content and compared with the labeled amount for 20 individual tablets. All tablet assay results were within the USP standards for content uniformity of individual tablets. The individual tablet deviations from labeled amount by the RIA method were smaller when compared with the USP XX-specified HPLC method. Comparison of individual tablet assays show the RIA method to be both as precise and as accurate as the USP XX-specified HPLC method.