| Formulation | Claim per tab | Function |
|---|
| Ingredient |
| Mixing: |
| Empress U | 10 mg | Dissolution enhancer |
| MCCP 101 | 30 mg | Diluent |
| Mannitol | 20.0 mg | Diluent |
| Lactose | QS to 160 mg | Diluent |
| SSG | 2 mg | Disintigerent |
| Aerosil 200 | 1 mg | Glident |
| Binder |
| I.P.A | q.s | Vehicle |
| PVP k30 | 4 mg | Binder |
| Lubrication |
| Cross Povidone | 10 mg | Disintigerant |
| Mag. Stearate | 2.0 mg | Lubricant |
| Talc | 2.0 mg | Lubricant |
| Aerosil 200 | 1 mg | Glident |
| SSG | 10 mg | Disintigerent |
| Montelukast sodium# | 11 mg | API |
| Levocetirizine | 5.25 mg | Active Pharmaceutical Ingradient |
| Empress U | 5 mg | Dissolution Improver |
Physical properties of tablets
| Avg. Weight | - | 150 mg |
| Hardness | - | 3-4kg/cm2 |
| Punch size | - | 8mm Standard Concave |
|
*Overage of levocetirizine is taken to maintain the result #montelikast sodium eq to montelukast
Procedure
- Mixing:
- Mix Empress U , MCCP101, Mannitol , lactose and SSG thoroughly with sifting through #60
- Now Sift Aerosil 200 with # 40 and mix it with above said material in suitable blender for 30 minutes
- Binding and sizing:
- Now dissolve PVPK30 in IPA and bind the premix of step 2
- Dry the wet mass the temperature of FBD or tray drier Strictly to be kept BELOW 40Oc
- Dry the granules till LOD remains below 2 %.
- Size the granules through 30 # mesh & retention through 1 mm perforated screen
- Lubrication:
- Sift the Magnesium Stearate, Cross Povidone, SSG,Montelukast sod, EmpressU , Talc through 60# sieve separately, and Aerosil and Levocetirizine through 40# sieve.
- Mix above mixture in suitable blender.
- Compress the tablet having hardness 3-4kg/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.