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The aim of this study was to investigate if the changes made in the specifications of the disintegration procedure impact the performance of the disintegration test described in USP chapters and . Different tablets and capsules were produced, and their disintegration times were determined. The following disintegration time parameters were analyzed: volume of the immersion fluid, type of apparatus (Apparatus A for method ; Apparatus B for method ), and attachment of a wire cloth to the basket assembly. By adjusting the compaction force and lubricant level, the disintegration time of the tablets was standardized to 15 min. The disintegration time change was statistically significant when varying the volume of the immersion fluid. The type of apparatus and the attachment of a wire cloth resulted in no significant difference in the disintegration time of capsules. The USP requirements for immersion medium volume should be strictly followed to obtain correct and reproducible test results. The disintegration test is a suitable performance test for certain pharmaceutical and dietary dosage forms.
Schmid et al. (Fri,) studied this question.
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