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Metformin HCL 850mg

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,

FormulationClaim per tabFunction
Ingredient
Mixing:
Metformin850.0 mgActive Pharmaceutical Ingradient
Binder
I.P.AQSVehicle
PVP k3035 mgBinder
Lubrication
Empress SR140.0 mgSustained release polymer
Mag. Stearate10 mgLubricant
Talc10 mgLubricant
LactoseQs to 1050 mg

Physical properties of tablets

Avg. Weight-1050 mg
Hardness-12-15kg/cm2

Procedure

    • Mixing:
      1. Pass accurately weighed Metformin, through #40 in sifter.
      2. Mix them in a suitable blender for 15 minutes.( Ensure the uniform mixing is the crucial part in acquiring uniform dissolution)
    • Binding and sizing:
      1. Take Iso-Propyl Alcohol & slowly add PVP K-30 in it and prepare paste & bind above mixture properly.
      2. Pass the mass through # 10 sieve or 8mm Perforated screen.
      3. Dry the granules till LOD remains below 2 %.
      4. Again pass through 20# mesh
    • Lubrication:
      1. Sift the Magnesium Stearate, Empress SR, MCCP102 and Talc through 60# sieve separately.
      2. Mix above mixture in suitable blender with sized granules from step-5.
      3. Compress the tablet having hardness 12-15kg/cm2.

Dissolution study

Apparatus : BASKET [Apparatus-2]

Medium : pH 6.8 Phosphate Buffer

Quantity : 900 ml

RPM : 100

Temp : 37±1oC

HOURS1st3rd10th
% Release32%61%92%
Limit25-50%45-70%NLT 80%

Note :

  1. This is the tentative formulation and the information is based on laboratory work with small scale equipment and does not indicate the product performance.
  2. Full scale testing and end product performance are the responsibility of the user.
  3. We suggest that you may be increase or decrease the quantity of polymer and types of Excipients according to your final formulation/requirements.