I am developing a tablet of bcs class 2 molecule. I used here Magnesium stearate, microcrystalline cellulose, povidone K-30, sodium starch glycolate. Coating: Hypromellose, iron oxide black, PEG 400), polysorbate 80, titanium dioxide.
Dissolution media -50 mM Sodium Acetate buffer, pH 4.5, containing 0.75% SDS.
The problem is that when i conducted dissolution test the tablet crumble into large particle and rotated under the paddle. It seems a invisible boundary block them to release.
In chemistry review they mentioned- "during review it was seen that as tablet density becomes very low or porosity very high, dissolution performance deteriorate"
The API which you are using is amorphous or crystalline? (You can check in XRD)
If it is amorphous , then it may crystallize in the media , form a gel and the tablet will not break into tiny particles, instead it will crumble into large particles. What is the %w/w of SSG you are using in the formulation?
Dear Amit Kumar Acharzo
Has your pharmacotechnical development taken into account the properties of your active ingredient? and whether it is compatible with many aggregating and / or gliding excipients?
Beside what mentioned by my colleagues above, I would suggest stating the percentage of the different excipients you used in your formulation, and also how did your tablet behave in the disintegration test ? if it behave similarly, I will suspect the magnesium stearate, try to decrease its percentage and blending time with magnesium stearate as well.
May be due to high usage of polymer/binder concentration we can make changes in polymer concentrations and can check again
Hi Amit
It is so casual to form lumps or larger and irregular granules during the process of disintegration test. The size of disintegrated granules depend upon on the physical parameters like concentration of granulating mixture or binding agent, kneading time, mesh size before heating or before adding lubricants, mesh size for final sieving, force of punch on the granules, campdriver of the tabletting machine etc
Actually there is no problem if the tablet breaks in to larger fragments but if you are getting a bump in the release of the drug during dissolution you should be worried if it is a conventional release.
I can still help if you tell the concentration of binder and lubricant.
Thank you
Raja Rajeswari Kamisetti madam I used 3 per cent povidone K-30 as binder and 1 percent Mg-stearate.
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