Effect of Preservative Environment on Alfacalcidol Content in Preparations

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  • アルファカルシドール製剤成分含量に及ぼす保存環境の影響

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Abstract

In the present study, we examined the effects of light, temperature and humidity on the residual rate of alfacalcidol in four commercially available preparations of alfacalcidol (Alfarol^<[O!R]>) capsules, Alfarol^<[O!R]>powder. Warkmin^<[O!R]> capsules and Onealfa^<[O!R]>) tablets). The tests were performed for up to 10 weeks with PTP seals, or without PTP seals. The changes in residual rate of alfacalcidol in Alfarol^<[O!R]>powder packaged with cellophane-laminate paper, and Onealfa^<[O!R]> tablets packaged with celiophane-laminate paper after crushing were also examined, The residual rate of alfacalcidol decreased in Alfarol^<[O!R]> capsules packaged with PTP seals under fluorescent lighting (1000 lux) and in Alfarol^<[O!R]>powder without an aluminum seal under ail conditions. There were no changes in the contents of alfacalcidol in Alfarol^<[O!R]> capsules with PTP seals and Alfarol^<[O!R]> powder packaged by aluminum seal. A slight decrease in the residual rate of alfacalcidol in Warkmin^<[O!R]> capsules was found under fluorescent lighting. The residual rate of alfacalcidol decreased in Onealfa^<[O!R]> tablets under high temperature and/or high humidity. Alfarol^<[O!R]> powder packaged with cellophane-Iaminate paper and Onealfa^<[O!R]> tablets packaged with cellophane-laminete paper after crushing were found to be unstable, indicating that long-term storage should be avoided when these formulations are prepared.

Journal

  • 病院薬学

    病院薬学 23 (5), 437-444, 1997-10-10

    日本病院薬剤師会

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