Indexes to evaluate the propriety of one-dose package dispensing from the side of pharmaceutics include hardness and friability. However, the number of pharmaceuticals disclosing the details of these data is very restricted. Therefore we have investigated the propriety of one-dose package dispensing in levodopa/carbidopa preparations by measuring the change over time in hardness and friability of the pharmaceuticals for which it was thought that there were many opportunities to perform one-dose package dispensing. As a result, the propriety of one-dose package dispensing depends on brand and content in spite of the use of the same component pharmaceuticals, and the evaluation of two pharmaceuticals has shown that one-dose package dispensing was inappropriate. As a result of measuring the change over time in hygroscopicity, because hygroscopicity correlated extremely strongly with the ratio of decrease in hardness and the ratio of increase in friability, it was suggested that differences in the hygroscopicity of each drug influenced strongly the propriety of one-dose package dispensing. In addition, a possibility that the mass ratio of levodopa/carbidopa in a tablet and the initial mass of the tablet had also influenced the change was shown. Secondly, when we investigated the additives used, it was found that the inclusion of talc and the exclusion of microcrystalline cellulose caused inappropriate hardness in one of the drugs.
In order to perform a more detailed examination, it is necessary to have information about the amount of the additive, but this is not currently disclosed. Disclosure as soon as possible is desirable in order to achieve the proper use of pharmaceuticals.
The aim of this study was to introduce a concise method for evaluating the blending states of powdered medicines to the pharmacy. Digital image processing was used to identify precise parameters for the degree of blending. Digital photos of powdered medicine admixtures were taken with a microscope, and were analyzed to obtain RGB color element values. Then, RGB values were converted into lightness, Y, and color difference signal, Cr and Cb, of the YCrCb color space. In this study, we examined three kinds of admixture of Auzei® with lactose powder, Transamin®, or Asverin®. The Cr and Cb values of admixtures were found to be unaffected by the sample area size and linearly responsive to the blending ratio with less variation. However, the Y value was not sensitive to the blending ratio. Therefore, the degrees of blending were evaluated using Cr and Cb in both pestle/mortar and shaking cylinder vessel methods, which are familiar to pharmacies. The increase in the degree of blending calculated by Cr and Cb was observed as an increase in the number of blending in both methods. Thus, a sufficient state of dispersal could be detected easily. In conclusion, the degree of blending of powdered medicines to the final dispersal state was effectively monitored with this useful and concise method.