I want to know how to dissolve estradiol vaginal tabs for MLT method validation.
Tabs do not dissolve in buffered peptone water containing tween 80.
Kindly guide
Please check the solubility of raw materials.
@Gsg
Dear Girish,
estradiol tabs must undergo dissolution testing as well?, I don’t have any experience on this implant category of tablets, but to help you out i want to suggest the following, hope it will work. If yes do let us know.
The Composition of Estradiol (containing estradiol hemihydrate) contains HPMC ( Hypromellose or Hydroxypropyl Methylcellulose), Lactose Monohydrate, maize starch and Magnesium stearate. in all these composition all component are miscible in water except HPMC which form inert, hydrophilic matrix due to its natural origin.
The invitro analysis suggest the dissolution of Estradiol tabs in phosphate buffer with pH 4.75 ± 0.05.
Can you take phosphate buffer with higher pH equivalent to buffered peptone water and keep the tab submerged for longer period and check the dissolution of tab with or without shaking the solution.
if results are favorable, you can select that parameter and go ahead with validating the method.
Looking forward for your reply.