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  • Title: Aging of tablets made with dibasic calcium phosphate dihydrate as matrix.
    Author: Lausier JM, Chiang CW, Zompa HA, Rhodes CT.
    Journal: J Pharm Sci; 1977 Nov; 66(11):1636-7. PubMed ID: 915749.
    Abstract:
    The aging of direct compression tablets made using dibasic calcium phosphate dihydrate as the tablet matrix was investigated over 16 weeks. The formula included 6% amaranth as a dye tracer. Two sets of stress storage conditions were used: 25 degrees and 50% relative humidity and 45 degrees and 75% relative humidity. Tablets were evaluated periodically by visual inspection; determination of the weight of 10 separate tablets, the size of 10 tablets measured by a micrometer screw gauge, and the hardness of 10 tablets as indicated by a Strong-Cobb hardness tester; the USP disintegration time test; and the USP dissolution test. Tablets stored at 25 degrees and 50% relative humidity showed an approximately linear increase in disintegration and dissolution time over 16 weeks with no other significant changes. Storage at 45 degrees and 75% relative himidity resulted in significant changes in most measured parameters; tablets showed blotching, substantial weight loss, and complex changes in disintegration and dissolution. The changes at elevated temperatures are related to loss of water of hydration; changes at 25 degrees must be due to other causes.
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