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Significance of drug content and of drug proportion to the content uniformity of solid dosage forms



Significance of drug content and of drug proportion to the content uniformity of solid dosage forms



Acta Pharmaceutica Jugoslavica 38(4): 279-286



With directly compressed tablets, the drug content (0.2 mg to 5 mg per tablet) and the drug proportion (0.1% to 5%) were varied in the ratio of 1:50, using milled K-dichromate as drug model. By applying diluents of different segregation tendency (Avicel PH 101, Elcema G 250), tablets of random mixtures and of incomplete mixtures were produced. In accordance with the theory of random mixtures, the content uniformity of the tablets was found to be only dependent on the drug content but not on the drug proportion. With both series of experiments, the drug content variation of the tablets significantly increased as the drug content decreased. If the drug content was kept constant, the content variations were found to be constant, independent of the mixing ratio drug/diluent and independent of the tablet weight (20 mg to 1000 mg).

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