ABSTRACT
OBJECTIVE: To discuss the technical requirements of scored tablets combining with the current situation of clinical use of scored tablets and the domestic and national technical requirements. METHODS: The FDA guidance on tablet scoring was introduced in detail, on this basis, the general considerations on the technical requirements of generic scored tablets were put forward. RESULTS: AND CONCLUSION: It was suggested that the evaluation criteria should be established on the basis of taking a full consideration on product characteristics in the process of research and development, scored tablets should be developed in accordance with clinical needs, and specification description should be standardized for clarifying the clinical use of the scored tablets.
ABSTRACT
OBJECTIVE:To investigate the utilization of the most used splitting drugs in the inpatients of our hospital,and to promote rational use of splitting drugs. METHODS:The medical orders of oral tablets in the inpatients of our hospital in Jan. 2016 were analyzed statistically in respects of consumption quantity,classification dosage,department dosage and the proportion of scored tablets. RESULTS & CONCLUSIONS:There were 217389 medical orders of tablets in the inpatients of our hospital in Jan. 2016. There were 12792 medical orders of splitting drugs,with utilization rate of 5.88%. The most used splitting tablet were car-diovascular drugs and drug for nervous system,accounting for 53.31% and 20.72% of total. The splitting tablets were mostly used in respiratory and critical care medicine department. Top 10 departments in the list of the number of splitting drug medical orders prescribed 8993 splitting drug medical orders,accounted for 70.30% of total. Top 20 drugs in the list of the number of splitting drugs were involved in 8971 medical orders,accounting for 70.13%of total;there were 14 kinds of scored drugs and 7506 medi-cal orders of splitting scored drugs,accounting for 83.67% of top 20 medical orders of splitting drugs. Among splitting drugs,49 types had scored-line,which were prescribed in 9265 medical orders of splitting drug,accounting for 72.43% of all medical or-ders of splitting drug. Lacking of information in most package inserts about the tablet can or can not split,it is suggested to note this information in package inserts by pharmaceutical enterprises. For commonly used splitting drugs without scored-line,it is pro-posed to produce small-size drugs or add scored-line.
ABSTRACT
OBJECTIVE: To evaluate the accuracy of splitting tablets and provide references for safe medication of children orally taking divided tablets. METHODS: Eight kinds of tablets with different sizes were split into half-tablet by hand, scissors, blade, and tablet-splitter, among which seven kinds of tablets were divided into quarter. The splitting results were tested according to the half-dose evaluation standards of the European Pharmacopoeia. RESULTS: Among the eight kinds of drugs split into half-tablets, six divided by tablet-splitter passed the test; meanwhile, all of the seven kinds of tablets divided into quarter by the four methods failed the test. CONCLUSION: Not all tablets, especially unscored tablets, are fit for splitting. Tablet-splitter may improve the accuracy of tablet-splitting when dividing into half-tablet. The weight variabilities of the four approaches to split tablets are obvious, and the splitting accuracy is low, which may cause a drug safety risk we should pay attention to. Furthermore, tablet-splitter is recommended to divide tablets with diameters greater than 6 mm when splitting cannot be avoided.