Die wall sticking problem in Amoxicillin Dispersible tablets

Production
1

in compression die wall sticking problem

2

Name of lubricant used?
check the amount of lubricant.
Saome time addition of aerosil also help out to prevent die wall sticking

3

magnesium stearate concentration 0.30%, when increasing magnesium concentration capping problem observed

4

u can chek by conducting a trial by addition of 0.2 percent colliodal silon dioxide or adjust concentration acc to req.
we faced similar problem with divalporex sodium where mg stearate was not working to eliminate die wall sticking.by increasing the amount of mg stearate sticking was incresed due to effect of heat production on mg sterate during compression melting effect.mg stearte qty was reduced n balanced by colloidal silicon dioxide.Die wall sticking was eliminated.

1 Like
5

colloidal sicon dioxide/aerosil also act as humactant mean take moisture from product.
it should be used afrer sieving

1 Like
6

we are not used Areosil in formulation because Innovator not used aerosil in formulation, product for Eurpope markets and customer need same formulation or Excipients which was used in Innovator.

7

ok.
u r facing this problem from day first of mfg or later on?

8

after one day

9

can u share formulation?to chek check the nature of excepients

10

Amoxicillin trihydrate
Aspartame
Flavour wild cheery
Crospovidone XL
Magnesium stearate

11

formulation is very simple.
one trick is to lubricate punches n dies with mg stearate.for this simply add 10,20 gm of mg stearate in machine feedr and run the machine for a while mg st will b taken by dies n punches then add product powder n start compression.
2ndly Increase hardness some time increasing hardness also prevent sticking.

12

same trials we are performed but problem not resolved. when hardness increase faced capping problem

13

then try to conduct a trial by slugging 2,3 kg tabs.

14

by slugging DT more then 03 Minutes limit (nmt 02)

15

in trial for sluging ad half crospovidon in sluging n remainins after seiving the slug.hop so DT n particle size will remain within limits

16

Just do one thing dry Amoxicillin trihydrate raw material for 10 - 15 minutes. And then do the rest process…

1 Like
17

use tray dryer or oven for drying bcz in FBD loss will occur due to fine particles

18

Compression of Amoxicillin DT Tablets try to perform in controlled area i.e, Temperature and RH should be less than 15% before equipment and Punch & Die Cleaning with Standard Cleaning agent mostly used in Pharmaceutical Manufacturing Industry.
Regards
Rahul Kumar
KAPL Dharwad

19

Dry all the excipient which is used during lubrication stage ( Disintegrant, Glidant, and Lubricant)
Try to Use IR Dryer for these aforesaid materials drying ( Moisture Content NMT 1%)

20

I think there is no requirement of Low RH for Amoxicillin trihydrate tabs.
and yes Excipients drying is required .