I am having an issue regarding sitagliptin 50mg and Metformin 1000 mg formulation (Janumet formula)… Tablets are very weak and Friability 0.6% hardness NMT 25 Kp… Which causes splitting, capping and broken edges during coating process.
Is there any chance to solve this issue??
Please check your formula design , specially concentration of binder and please check your excipients is directly compressible or not? When it is directly compressible , show's good results, but if it is granulating type then change your method of preparation for good results.
Dear shubham,
Its wet granulation using povidone k25 as binder. The granulation process is done by using Metformin and povidone k25 only. Then for the final blend the remaining materials added: sitagliptin + smcc90+ SLS and for lubrication sodium stearyl fumarate.
And the LOD of powder in between 1 to 1.4 % friability will be 0.6% which during coating process it will damaged. And when the LOD of powder is 1.5 - 2 % sticking appears and Friability will be 0.09 % which will not show a problem during coating but the problem will be the sticking.
I tried to increase the lubricant % upto 2. But didn't help.
Try to check the solubility of your drug in coating polymer. Secondly, try with any other binder like corn starch.
This is because of metformin low compressibility & compactability.
1.Wet granulate Metformin with PVP k-30 in high shear granulation method. Keep LOD 1.5%.
2. Use SSF, SLS with MCC PH 112 in Lubrication.
3. Maintain granules and fines ratio (60/40)
4. Maintain temperature in compression area.
5. Use SSF and SLS in 1.5% each in lubrication.
Dear Seeddeeg, Metformin formulations usually have this issue, because the compactability properties are very poor, so you have to correctly design your granulation process and select excipients with excellent plastic properties. Please consider the following recommendations:
1. Employ Kollidon VA 64 Fine (Copovidone with high superficial area). Use moist aqueous granulation (MAG). Moist granulation: 1.5-2.0 %
2. Add a little aerosil 200 or Syloid (0.5-1.5 %), this will reduce the sticking problem and does not impact in the tablet hardness
2. Add Avicel PH105 or PEG 8000 as extragranular for capping issue and conferring better plastic properties to the powder
3. For the coating process employ PVA-PEG co-polymer due to the rapid film formation (Opadry Qx or Kollicoat IR) High solid aqueous dispersion give you a rapid application thus reducing the broken edges.
- Badges
- Science topic
- Similar topics
- Engineering
- Materials Engineering
- Powders