Disintegration Test is not Performed for Which Tablets

Disintegration test is an important in-process test of pharmaceutical products. It is not a true predicter of how well the dosage form will release its active ingredient in vivo.  If tablets are designed for chewable and extended release or sustained release are exempted from the disintegration test. As the tablet design for sustain release, the breakdown also controlled by proper matrix formation.

Disintegration test can be deleted from FP specifications with below justifications:

• Disintegration test is carried out as routine in-process control test.
• The dissolution test shows good release in short period of time (e.g. More than 80 % in 30 mins). If disintgration is inadequate, dissolution would not meet the requirements.

It is a well-known fact that complete disintegration does not necessarily imply complete dissolution, making dissolution testing necessary even when disintegration testing is successful.

For rapidly dissolving (dissolution >80% in 15 minutes at pH 1.2, 4.0 and 6.8) products containing drugs which are highly soluble throughout the physiological range (dose/solubility volume < 250 mL from pH 1.2 to 6.8), disintegration may be substituted for dissolution. Disintegration testing is most appropriate when a relationship to dissolution has been established or when disintegration is shown to be more discriminating than dissolution. In such cases dissolution testing may not be necessary. It is expected that development information will be provided to support the robustness of the formulation and manufacturing process with respect to the selection of dissolution vs. disintegration testing (see Decision Tree #7(1)).

For Bolus

In pharma industry, only do disintegration testing on bolus tablets due to its large size and that dissolution testing is very inaccurate; whereas dissolution everything.

When doing disso on a large bolus you may want to consider a large dissolution vessel (2L or 4L) with bolus baskets. You are likely to need the additional volume and basket size. Sometimes the paddle method would be difficult due to coning with the much larger tablet size.

Reference:

• ICH Topic Q 6 A