Metformin HCL 1000mg
Empress SR
Technically Empress SR is a Carbomer. This grade of carbomer is Benzene Free grade used in oral preparations, in suspensions, tablets, or sustained release preparation. In tablet formulations,
| Formulation | Claim per tab | Function |
|---|---|---|
| Ingredient | ||
| Mixing: | ||
| Metformin | 1000.0 mg | Active Pharmaceutical Ingradient |
| Binder | ||
| Water | QS | Vehicle |
| PVP k30 | 40 mg | Binder |
| Lubrication | ||
| Empress SR | 150.0 mg | Sustained release polymer |
| Mag. Stearate | 15.0 mg | Lubricant |
| Talc | 15.0 mg | Lubricant |
| Aerosil | 7 mg | Glident |
| Lactose | Qs as per average weight | |
Physical properties of tablets
| Avg. Weight | - | As per punch |
| Hardness | - | 12-15kg/cm2 |
Procedure
- Mixing:
- Pass accurately weighed Metformin, through #40 in sifter.
- Binding and sizing:
- Take water & slowly add PVP K-30 in it and prepare paste & bind above mixture properly.
- Pass the mass through # 10 sieve or 8mm Perforated screen.
- Dry the granules till LOD remains below 3-4%.
- Again pass through 16# mesh
- Lubrication:
- Sift the Magnesium Stearate and Talc through 60# and Empress SR and aerosil through #40 separately.
- Mix above mixture in suitable blender with sized granules from step-5.
- Compress the tablet having hardness 12-15kg/cm2.
- Mixing:
Dissolution study
Apparatus : BASKET [Apparatus-2]
Medium : pH 6.8 Phosphate Buffer
Quantity : 900 ml
RPM : 100
Temp : 37±1oC
| HOURS | 1st | 3rd | 10th |
|---|---|---|---|
| % Release | 34% | 65% | 90% |
| Limit | 25-50% | 45-70% | NLT 80% |
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.