Dissolution of clomiphene citrate Tablet

Production
1

What r the solubility & permeability enhancer for active clomiphene citrate?

Or what might be the changes required to achieve dissolution 80 Limit%?

Last Result achieved upto 65%

Avg wt is 200mg

Formula as follow

API
LACTOSE
STARCH
BETA CYCLODEXTRIN
SLS

IPA+PVPK30 BINDING

30# Sieve Grains after Drying

Lubrication

Mg stearte
Talc
Aerosil
Cross povidone
CCS
SLS

2

Try to use polysorbate in binder solution

1 Like
3

Sir I already used Tween 80

1 Like
4

try with 3% cross carmelose sodium intragranular n 3% in final blend

1 Like
5

For drying FBD is used or tray dryer?

1 Like
6

Tray dryer

7

it may also be the reason.bcz tray dryer produce hard granules.

8

check by using no 40 sieve after drying.

9

if flow remain good dissolution will be improved

10

Dear @Rakesh132600290011
What was the conc of SLS, that you have added to your formulation, (in USFDA inactive ingredient database - it limited upto 6mg ) - upon adding above this, it will definitely affects the disso.
You can also try using Tween 80 + Kolliphor RH 40 in binder step which will enhance the wettability of the drug. Assure that the mixing of binder soln was uniformly mixed & granulated.
Better you omit cyclodextrin , because physical mixture doesn’t provide favourable result if & only if it was formulated as melt extrusion technique.
use Kyron t314 instead of crospovidone in lubrication step upto 2-2.5%, which will also enhance the dissolution of drug.