We have two batches of haloperidol 5 mg and haloperidol 1.5 mg … after a few days the tablet disintegration time has increased … it is an uncoated tablet … and starch binding is used …as lubricant magnesium stearate is used…and also maize starch and lactose is used as diluent…
Let me know with the followings,
- Amount of Binder concentration used.
- Hardness of the tablet - initial as well as the tab with increased disintegration.
- The time limit you have set as per your IHS .
- Whether this was the first batch with increased disintegration time or any else reported.
- Why don’t you use super-disintegrants in your formulation which will enhance the disintegration & % Dissolution.
- What was the moisture content for the granules, whether it was in limit or exceeds,
also check the moisture content for your tab with increased disintegration time.
- What was the primary packing material used, whether the tab was stored properly.
Hope you may get an idea by investigating with above said.
Thank you sir @R_D_SKN
You are always welcome @Mdkale…