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: |
TAMSULOSIN | 0.4 mg | Active Pharmaceutical Ingradient |
MCCP 102 | 63 mg | Filler |
LACTOSE | 99.5 mg | Filler |
Binding |
IPA | Qs | Vehicle |
PVPk30 | 10 mg | Binder |
Lubrication |
Talc | 3 mg | Lubricant |
Magnesium stearate | 3 mg | Lubricant |
Empress SR | 20 mg | Sustained release polymer |
Aerosil | 1.5 mg | Glident |
Physical properties of tablets
Avg. Weight | - | 200mg |
Hardness | - | 5-6kg/cm2 |
|
Procedure
- Mixing:
- Pass Tamsulosin ,MCCPH102 and Lactose through 60 # in sifter( with geometrical mixing to get uniformity) 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
Dissolution study
Apparatus : Paddle [Apparatus-2]
Medium : pH 7.2 Phosphate Buffer
Quantity : 900 ml
RPM : 50
Temp : 37±1oC
COMMULATIVE PERCENTAGE OF RELEASE TO BE CALCULATED
HOURS | 1st | 4th | 8th | 12th |
---|
% Release | 14.28% | 30.26% | 46.78% | 85.26% |
Limit | NMT 25% | 20-40% | 40-65% | 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.