We are facing problem with our formulation development. Our API is in oleoresin form which is granulated with carrier to form granules, than mixed with extrgranular excipients in order to compress.
Compressed tablets appears good but after keeping them in accelerated stability conditions tablets thickness got increased.
Open for suggestions!
in order to answer, pls write what is the hardness, lubricant added and what is the concn of binder, range of the siz of the granules prepared, compression force used.
please see all these parameters because they effect the tableting prop.
Thanks Rajeswari...
Its an ODT
Hardness: 25-30 N
Lubricant: Sodium steryl Fumarate
Binder (PGS): approx. 2%
If I understand your question, then the increase you are experiencing is already a sign of instability. It may be due to one or more of the excipient swelling due to moisture sorption. What we do not know now is wether and how the hardness is affected during stability testing. But clearly speaking if you increase tablet size during formulation, it does not affect stability but if it increases on its own during testing then something is wrong somewhere
I suggest you carry out moisture sorption test for all the excipients used. Also carry out dsc for thermal analysis. God bless!
Hi! Shuaib,
The problem you are facing in accelerated stability is due to the absorption of moisture. By absorbing moisture your tablets thickness have increased. Please check the weight of your tablets as well. I'm sure that the weight must also have increased.
What type of packing have you used for your tablets? I would suggest you to use PVDC blister of 40 gsm or greater than that so that your tablets can withstand during stability. You can also go for Alu-Alu packing. I would also recommend to use 1% Aerosil in your formulation during lubrication stage. Check the final moisture content of your lubricated granules and try to keep it as minimum as possible (less than 2%).
I hope this will help you. All the best.
Regards,
Abhishek
Dear G Pursoken,
Thanks for your valuable suggestion. Can you please elaborate what is ambient condition? If any supporting literature you have that will be great. Even I will make a search.
Thanks
ODTs have relatively high porosity and rapid liquid penetrability. It may be due to absorption of moisture and subsequent swelling possibly by binder or disintegrant. Increase compressibility of tablet and check moisture before and after subjecting to high relative humidity.
Improve compressibility and check for moisture content before and after subjecting to high relative humidity (60% for 24 hr) in standard packing. Check moisture content of granules keep it low. Avoid high quantity of avecil
Thickness increase due to moisture absorption:-
1. Select appropriate packing material, alu-alu packing or PVDC more then 40 gsm
2. Add Aerosil in your formualion for moisture absorption
3. Protect tablets with seal (moisture barrier) coating
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