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Metformin HCL 500mg

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:
Metformin500.0 mgActive Pharmaceutical Ingradient
Binder
WaterQS
PVP k3030 mgBinder
Lubrication
Empress SR120.0 mgSustained release polymer
Mag. Stearate7.0 mgLubricant
Talc7.0 mgLubricant
Mccp 102Qs to average weightFiller

Physical properties of tablets

Avg. Weight-Adjusted as per your punch size
Hardness-10-12kg/cm2

Procedure

    • Mixing:
      1. Pass accurately weighed Metformin , through #40 in sifter.
    • Binding and sizing:
      1. Take water& slowly add PVP K-30 in it and prepare paste & bind above mixture properly.further add water for kneading and allow the kneading to get uniform wet mass
      2. Pass the mass through # 10 sieve or 8mm Perforated screen.
      3. Dry the granules till LOD remains below 2 %.
      4. Again pass through 16 # 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 10-12kg/cm2.

Dissolution study

Apparatus : BASKET [Apparatus-2]

Medium : pH 6.8 Phosphate Buffer

Quantity : 900 ml

RPM : 100

Temp : 37±1oC

HOURS1st3rd10th
% Release37%66%92%
Limit25-50%45-75%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.