Accelerated stability of few of our products have shown a huge increase in the hardness from 75N to 190N, what can be the reason? we have used the excipients like MCC, aerosil can they be the reason?
Every API or Formulation have its own tendency to release and gain(Uptake) moisture within other qualitative & quantitative formula. As you mention the excipient, its seem a IR formulation. If dissolution shows consistence results over this hardness fluctuation I don’t think so any stability impact upon time to time.
I think it may be due to the lolymers like Aerosil (Colloidal silicon dioxide) at increased temperature it may be hard .