ABSTRACT
Objective: The measurement of compounded topical medications’ uniformity is an important component of quality assessment. This study was aimed to evaluate appropriate mixing time for external preparations using a planetary centrifugal mixer.Methods: In order to evaluate the product uniformity of mixtures of five different steroid cream (Antebate®, Myser®, Methaderm®, Lidomex®, and Locoid®) with three different heparinoid oil-based cream (Hirudoid®, “Nichi-Iko” cream and “Nipro” cream), steroid cream and heparinoid oil-based cream (5 g each) were added into a 13 mL container and mixed using the mixer (NanKo Rentaro NRE-120®, THINKY) at rotation speed of 800 rpm and revolution speed of 2,000 rpm. We sampled 0.1 g of the mixture from three spots (top, middle, and bottom portions) of the container then, measured the steroid content by HPLC method. The yield value points of each cream and heparinoid oil-based cream were also measured by spread meter.Results: Our results showed that when the coefficient of variation (CV) is less than 15.2 %, a mixing time of at least 120 s was required to achieve proper mixing to obtain the permissible limit of steroid cream and heparinoid oil-based cream. Also the greater difference of the yield value between steroid cream and heparinoid oil-based cream tended to be mixed easier.Conclusions: These results suggest that the spread ability of steroid cream and heparinoid oil-based cream affects the mixing efficiency of a planetary centrifugal mixer.
ABSTRACT
[<b>summery</b>]<br> Our hospital appointed a pharmacist to be safety control manager of drugs. With the aim of promoting an appropriate use of drugs, the safety control manager of drugs ensures the appropriate storage, the expiration, and the use record with control drugs following the business procedure every month. These requirements were confirmed at all divisions of hospital, and then the nonconformity was recorded following the procedure.<br> The largest number of nonconformity were entry on drugs unseal date and an exceeded the cutoff point of inventory. We couldn’t gain sufficient improvement about an appropriate use of drugs. The causes of this nonconformity were dispersion of drugs at each division and insufficient inventory control of drugs. We attempted to gather and to keep drugs into one group. As a result, the number of nonconformity greatly decreased at all divisions. The amount of money of stock in hospital was decreased by about 20%.<br> These results suggested that the confirmation of requirements with business procedure by the safety control manager’s rounds of hospital was extremely helpful method with an appropriate use of drugs.