Empress F
Technically Empress F is a Blend of Solublisers which supports solubility of Fexofenadine with lactose base, It has good effect on the tablets formulation where we have issues with its Dissolution
| Formulation | Claim per tab | Function |
|---|
| Ingredient |
| Mixing: |
| Fexofenadine | 120 mg | Active Pharmaceutical Ingradient |
| Empress F | 120mg | Solubliser |
| Tween 80 | 5 mg | surfactant |
| Empress U | 5 mg | solubliser |
| Binding |
| IPA | QS | Vehicle |
| Lubrication |
| Lactose | 50 mg |
| Mg. Stearate | 3.0 mg | Lubricant |
| Talc | 3.0 mg | Lubricant |
| Aerosil | 1 mg | Glident |
| Cross Povidone | 9 mg | Super Disintigerent |
| Empress U | 5 mg | Solubliser |
Physical properties of tablets
| Avg. Weight | - | 320 mg |
| Hardness | - | 7-8kg/cm2 |
|
Procedure
- Part I
- Slurry preparation:
- Dissolve Empress F and tween 80 in about as much ipa to make a free flowing slurry, now slowly add Fexofenadine and stir it continuous to prepare slurry and keep it aside for 4 hours ( minimum time recommended)
- Binding and sizing:
- Now add Lactose in it by passing through #40 mesh sieve
- Dry the lump in fbd or tray dryer with inlet temp of 400C till lod reaches 2% or less
- Size the granules with #30 mesh and break the retention with 1mm perforated screen in multimill
- Lubrication:
- Sift Talc, Magnesium Stearate, and Cross Povidone from #60 sieve and Aerosil from #40 mesh
- Mix above mixture with sized granules of step 6 in suitable blender.
- Compress the tablet having hardness 7-8 kg/cm2.
Note :
- This is the tentative formulation and the information is based on laboratory work with small scale equipment and does not indicate the product performance.
- Full scale testing and end product performance are the responsibility of the user.
- We suggest that you may be increase or decrease the quantity of polymer and types of Excipients according to your final formulation/requirements.
