Itopride HCL SR 50mg
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: | ||
| Itopride | 150.0 mg | Active Pharmaceutical Ingradient |
| Lactose | Qs to 400 mg | Filler |
| Empress SR | 100.0 mg | Sustained Release Polymer |
| Binding | ||
| I.P.A | q.s | Vehicle |
| PVP k30 | 40 mg | Binder |
| Lubrication | ||
| Empress SR | 20.0 mg | Sustained release polymer |
| Mg. Stearate | 4.0 mg | Lubricant |
| Talc | 4.0 mg | Lubricant |
Physical properties of tablets
| Avg. Weight | - | 400 mg |
| Hardness | - | 8-9kg/cm2 |
Procedure
- Part I
- Mixing:
- Pass accurately weighed Diclofenac , , Lactose and mccp101through #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 & 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 2 %.
- Again pass through 20# mesh.
- Lubrication:
- Sift the Magnesium Stearate, Empress SR, and Talc through 60# sieve separately.
- Mix above mixture in suitable blender.
- Compress the tablet having hardness 5-6 kg/cm2.
- Mixing:
Dissolution study
Apparatus : Paddle [Apparatus-1]
Medium : 0.1N HCl for first 2 hour & pH 6.8 Phosphate Buffer for rest
Quantity : 900 ml
RPM : 50
Temp : 37±1oC
| HOURS | 2nd | 4th | 6th | 12th |
|---|---|---|---|---|
| % Release | 14.25% | 36.5% | 62% | 93% |
| Limit | NMT 20% | 20-50% | 50-75% | NLT 75% |
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.