Recommended Starting Formulations
The following is suggested as a starting point using SuperTab® SD spray dried.
|
Component |
Typical %w/w |
Example mg / tab |
Example %w/w |
|
API |
<1 - 20 |
5.000 |
4.167 |
|
SuperTab® 11SD |
QS to 100% |
110.8 |
92.33 |
|
Primojel® |
3% |
3.600 |
3.000 |
|
Magnesium stearate |
0.5% |
0.600 |
0.500 |
|
Total |
100 |
120.0 |
100.0 |
Here is a suggested starting point using SuperTab® GR granulated.
|
Component |
Typical %w/w |
Example mg / tab |
Example %w/w |
|
API |
<1 - 20 |
1.000 |
1.000 |
|
SuperTab® 30GR |
QS to 100% |
95.50 |
95.50 |
|
Primojel® |
3% |
3.000 |
3.000 |
|
Magnesium stearate |
0.5% |
0.500 |
0.500 |
|
Total |
100 |
100.0 |
100.0 |
Here is a suggested starting point using SuperTab® AN anhydrous.
|
Component |
Typical %w/w |
Example mg / tab |
Example %w/w |
|
API |
<1 - 20 |
20.00 |
10.00 |
|
SuperTab® 21AN |
QS to 100% |
173.0 |
86.50 |
|
Primellose® |
3% |
6.000 |
3.000 |
|
Magnesium stearate |
0.5% |
1.000 |
0.500 |
|
Total |
100 |
200.0 |
100.0 |
Notes
- The above should be suitable for formulation of any low dose API without modification (up to about 10mg), and can be starting points for medium dose API's (up to about 50mg), provided that stability enhancing excipients are not needed.
- SuperTab® AN should be used if low total water content is required.
- Primellose® may be used instead of Primojel® in the SuperTab® SD and SuperTab® GR formulations.