Disintegration test for Enteric coated tablets
The Enteric coated tablets are those tablets which bypass the
stomach and get metabolize in the intestine. So firstly the disintegration test
done with 0.1 M HCL for 2 hours, tablets should not dissolve in it till 2 hours
without disc . Then it must dissolve completely in phosphate buffer solution of
6.8 pH in 1 hour with or without disc.
Preparation of 0.1 M
HCL-
Add 8.5 ml of concentrated HCL (37.5%) in 100 ml of water in
a volumetric flask with continuously stirring and then make up the volume to
1000 ml with water and stir well.
Preparation of
Phosphate buffer solution 6.8pH-
1.
Mixed Phosphate Buffer pH 6.8 As Per IP :- 28.80
gm of disodium hydrogen phosphate and 11.45 gm of Potassium dihydrogen
phosphate in 1000 ml with water.
2.
Add 6.8 gm KH2PO4 and about 0.94 gm NaOH in
1000mL Water. Adjust the pH of solution by using dilute Orthophosphoric acid or NaOH.