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,

FormulationClaim per tabFunction
Ingredient
Mixing:
Itopride150.0 mgActive Pharmaceutical Ingradient
LactoseQs to 400 mgFiller
Empress SR100.0 mgSustained Release Polymer
Binding
I.P.Aq.sVehicle
PVP k3040 mgBinder
Lubrication
Empress SR20.0 mgSustained release polymer
Mg. Stearate4.0 mgLubricant
Talc4.0 mgLubricant

Physical properties of tablets

Avg. Weight-400 mg
Hardness-8-9kg/cm2

Procedure

  • Part I
    • Mixing:
      1. Pass accurately weighed Diclofenac , , Lactose and mccp101through #60 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, and Talc through 60# sieve separately.
      2. Mix above mixture in suitable blender.
      3. Compress the tablet having hardness 5-6 kg/cm2.

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

HOURS2nd4th6th12th
% Release14.25%36.5%62%93%
LimitNMT 20%20-50%50-75%NLT 75%

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.