Metoprolol 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: | ||
| Metoprolol Succinate | 47.5 mg | Active Pharmaceutical Ingradient |
| MCCp 102 | 121.5 mg | Filler |
| Empress SR | 50 mg | Sustained release polymer |
| Aerosil | 5 mg | Glident |
| PVPk30 | 35 mg | Binder |
| IPA | Qs | Vehicle |
| Talc | 6 mg | Lubricant |
| Magnesium stearate | 3 mg | Lubricant |
| Empress SR | 20 mg | SR material |
| Aerosil | 2 mg | Glident |
Physical properties of tablets
| Avg. Weight | - | 290mg |
| Hardness | - | 8-10kg/cm2 |
Procedure
- Mixing:
- Pass Metoprolol Succinate and MCCPH102, Empress SR through 60 # in sifter and aerosil in #40 sifter
- mix it insuitable blender for 15 mins.
- Binder Preparation and Binding:
- Dissolve PVPK30 in IPA and prepare clear solution
- Now bind the Premix using binder prepared in Step 1 and if necessary add additional IPA to get a wet mass ,
- Pass the weight mass through #12 sieve to get uniform wet granules and dry it at inlet temp of 40o c
- Now size the granules using #30 to get dry granules
- Lubrication:
- Collect the dried granules in blender
- Sift the material Talc, EmpressSR, Mg Stearate and Aerosil with #60 sieve.
- Mix the lubricants in Dried granules and compress the tablet with following parameter
- Mixing:
Dissolution study
Apparatus : Paddle [Apparatus-2]
Medium : pH 6.8 Phosphate Buffer
Quantity : 500 ml
RPM : 50
Temp : 37±1oC
| HOURS | 1st | 4th | 8th | 20th |
|---|---|---|---|---|
| % Release | 18.38% | 34.64% | 51.24% | 86.45% |
| Limit | NMT 25% | 20-40% | 40-60% | 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.