| Formulation | Claim per tab | Function |
|---|
| Ingredient |
| Mixing: |
| Turbinafine | 283 mg | API |
| Empress 80 | 5 mg | Solubliser |
| Lactose | 17.0 mg | Diluent |
| Binding |
| I.P.A | QS | Vehicle |
| Hpmc e15 | 10 mg | Binder |
| Lubrication |
| Empress 80 | 5.0 mg | Solubliser |
| Mag. Stearate | 3.5 mg | Lubricant |
| Talc | 4.0 mg | Lubricant |
| Aerosil | 2 mg | Glident |
| Empress U | 10 mg | Dissolution improver |
| Cross povidone | 10 mg | DT improver |
Physical properties of tablets
| Avg. Weight | - | 350 mg |
| Hardness | - | 4-5kg/cm2 |
|
Procedure
- Slurry preparation:
- Pass accurately weighed Terbinafine ,Empress U, and Lactose through #60 in sifter.
- Mix them in a suitable blender for 15 minutes.( Ensure the uniform mixing is the crucial part in acquiring uniform dissolution)
- Binding and sizing:
- Take Iso-Propyl Alcohol &dissolve HPMC E15 bind above mixture properly.
- Pass the mass through # 10 sieve or 8mm Perforated screen.
- Dry the granules till LOD remains below 2 %.
- Again pass through 30# mesh.
- Lubrication:
- Sift the Magnesium Stearate, Empress U, Empress 80,Aerosil, Cross Povidone and Talc through 60# sieve separately.
- Mix above mixture in suitable blender.
- Compress the tablet having hardness 5-6 kg/cm2.
