Abstract
The methods for the preparation of hospital drugs (i.e., powder dilution, opening the capsule shells and tablet crushing) are not validated and vary among medical facilities. In order to explore a quick and effective preparation method for dantrolene sodium diluted powder from capsule formulation without any weight loss and to maintain acceptability in pediatric patients, the uniformity test, particle size distribution analysis, pass efficiency test (the feeding tubes patency) and sensory evaluation of the mouth feel were examined.
The diluted powder prepared by the capsule opening method has uniformity, although the recovery rate was slightly low compared to the crushing method. The crushing of whole capsules using the mill provided non-uniformity of content and variable particle size distribution. The contamination of capsule shell debris is probably part of the explanation for the non-uniformity of the contents. The powder sieved through a 100-micron screen following capsule crushing provided uniformity of contents without any loss. The results of passing tests, and administration via a feeding tube including gastrostomy were acceptable in both capsule opening and capsule crushed powder formulation. In the sensory test, the products that were screened using a 100-micron screen filter after capsule crushing had a less gritty mouth feel. These results suggest that capsule crushing and screening are validated as an alternative preparation method for dantrolene sodium diluted powder.
In this study, we succeeded in developing effective methods for dantrolene sodium diluted powder. Most hospital preparations were not validated for pediatric patients and further tests in practical use are required.
