I making a subcutaneous formulation of conc. 20mg/ml in aqueous solution with cosolvent NMP. The pH of formulation is 6.55 and osmolality is 1352 mOsm that is the formulation is hypertonic. Is it important to make isotonic in case of SC injection and if then what i can do to decrease the osmolality?
And also do i need to add buffer to maintain the pH, i am worried if i do that it might increase the osmolality?
It is a single unit dose, do i need to add preservative?