Light Stability of Cyclosporin Fine Granules after Packaging
10.11256/jjdi.14.35
- VernacularTitle:シクロスポリン細粒の分包調剤後の光安定性に関する検討
- Author:
Shingo Yamazaki
;
Hiroyoshi Nakamura
;
Shin-ichi Yamagata
;
Hiromitsu Nakasa
;
Noritaka Ariyoshi
;
Mitsukazu Kitada
- Publication Type:Journal Article
- Keywords:
cyclosporin;
fine granules;
light stability;
residual rate
- From:Japanese Journal of Drug Informatics
2012;14(1):35-39
- CountryJapan
- Language:English
-
Abstract:
Objective: The objective of this study was to clarify the light stability of cyclosporin fine granules 17%?? Mylan ??(CsA-FG) after packaging by a dividing and packing machine.
Methods: CsA-FG packaged within cellophane-laminate paper was stored under three different covering conditions: (stored uncovered, in a medicine bag, or in a light shielding bag). In these covering conditions, we examined changes in the residual rate and elution pattern of CsA for up to 12 weeks in the differently covered samples stored at room temperature under fluorescent lighting.
Results: Under the light exposure condition, the residual rate decreased with time and fell below 95 percent at 12th week. Although a slight decline in the residual rate was observed in samples stored in the medicine bag at 12th week, the rate was less than 5%. On the other hand, no change in the residual rate was observed for samples stored in the light shielding bag storage for up to 12 weeks. There was no change in the elution pattern of CsA in any group, except the decline in the elution rate caused as the resulting from the decline in the residual rate.
Conclusion: In this study, we have clarified that the packaged CsA-FG covered by stored in a medicine bag or light shielding bag is stable for up to 12 weeks under normal storage conditions. However, CsA-FG should be stored in a light shielding bag or undergo the split dispensation, if it’s stored in a more severe lighting condition and/or if it is to be stored for more than three months.
