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Enteric-Coated Tablet

Enteric preparation refers to the preparation made of enteric coating material, which is a kind of delayed release preparation. The purpose is to avoid the release of the drug in the gastric fluid, to ensure that the drug reaches the intestinal tract to be absorbed by the body after rapid release.

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Experimental parameters

Dissolution apparatus	RT3 Reciprocating Cylinder Apparatus
Temperature	37℃ ± 0.5℃
Medium Volume	200 mL
Reciprocating stroke	10 mm
Reciprocating rate	10 DPM
Medium	0-60 min (pH 1.2 HCl)/ 60-75 min (pH 6.5 PBS)/ 75-90min (pH 6.8 PBS/90-120min (pH 7.2PBS)/ 125-180 min (pH 7.5 PBS)

Experimental Result

①Reproducibility: We tested 6 pcs of this enteric-coated tablet and found that: the enteric-coated tablet showed almost no release during the first 2 hours of the dissolution phase. However, the release rate changed strongly within half an hour (120-150 min) into pH 7.5 PBS, and the average cumulative dissolution rate increased from 1.91% to 92.00% and gradually approached the dissolution endpoint. And the RSD% ranged from 0.91% to 7.83% over 120-150 min, which meets the requirement of method reproducibility.

CONCLUSION:The reciprocating cylinder method is capable of automatically changing multiple dissolution media during the experimental process, providing a dissolution environment more suitable for the gastrointestinal tract. The highly automated operation of the method can reduce the manual error and provide good reproducibility of the method.