Acebrophyline 200mg

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
Acebrophyline200.0 mgActive Pharmaceutical Ingradient
Mccp 10264 mgFiller
Empress SR25.0 mgSustained release polymer
Lactose60.0 mgDiluent
Empress SR6.0 mgSustained release polymer
Mg. Stearate4.0 mgLubricant
Mg. Stearate4.0 mgLubricant
Talc4.0 mgLubricant
Aerosil2 mgGlident

Physical properties of tablets

Avg. Weight-400 mg


  • Part I
    • Mixing:
      1. Pass accurately weighed Acebrophyline(100 mg) ,EmpressSR, Lactose and mccp101( 30 mg)through #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 & 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 24 # mesh.
  • Part II

    Prepare wet granules by adding Acebrophyline 100 mg and MCCP 102 (30 mg ) with IPA+MDC solution

    Mix the PARTI and PART II and proceed for lubrication

    • 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-2]

Medium : pH 6.8 Phosphate Buffer

Quantity : 900 ml

RPM : 50

Temp : 37±1oC

% Release16%27%52%89%
LimitNMT 25%25-40%40-75%NLT 70%

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.