I have come up with the problem of crystal formation of Prednisolone sodium phosphate after drying. Prednisolone sodium phosphate is an amorphous solid and freely soluble in water. In my case, I'm preparing a film combining polymers and drug. Although both the polymer and drug are soluble completely in water, there was crystal formation after allowing the mixture to dry. I would be really grateful for your answers. Thank you.
I had an experience with a polymer and a drug and after formulation and drying using freeze dryer I got amorphous nature of the drug. So, here is the question, how you do the drying process ?
@ Ahmad Mohamad Zaiter Yeah, exactly. I had the same problem. In fact, I was drying my polymeric solution containing a drug in an oven at 40°C. While mixing the Prednisolone sodium phosphate and PVA (polymers) were homogeneously distributed. But, after drying my prepared film contained crystal and it was too brittle... What did you do in your case? I would appreciate your input. Thank you
Agree that freeze drying is not an optimal solution -- the drug is then likely to only be metastable as an amorphous solid mixture in the film; any small amount of water (other than allowing only single molecules of water to visit any prednisolone molecule at any time!) may initiate the drug crystallization. You may want to choose your surfactant not only for its micelle-forming ability and non-toxicity but also for its plasticization of the PVA film? (depending on intended use)
Dear Sandeep,
please check the saturation solubility of the drug...
use crystallization inhibitors (like HPMC, PVP, HPMCAS ...) and optimize the concentration of crystallization inhibitors.
Regards,
Jagadish K.R
I think you should try different crystallization inhibitors. PVP and HPMCAS are good options. Check this.
http://www.tandfonline.com/doi/full/10.3109/10837450.2014.1003655
Since both drug and polymer water soluble complete solubility cause smaller particle formation very easily. As time progress these particle aggregate and forms Crystal. Addition of polymeric stabilizer or surfactant with low hlb may help. If you freeze dry can add cryoprotectant. Otherwise choose polymer which soluble in organic solvent.
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