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Levocetirizine And Montelukast

FormulationClaim per tabFunction
Ingredient
Mixing:
Empress U10 mgDissolution enhancer
MCCP 10130 mgDiluent
Mannitol20.0 mgDiluent
LactoseQS to 160 mgDiluent
SSG2 mgDisintigerent
Aerosil 2001 mgGlident
Binder
I.P.Aq.sVehicle
PVP k304 mgBinder
Lubrication
Cross Povidone10 mgDisintigerant
Mag. Stearate2.0 mgLubricant
Talc2.0 mgLubricant
Aerosil 2001 mgGlident
SSG10 mgDisintigerent
Montelukast sodium#11 mgAPI
Levocetirizine5.25 mgActive Pharmaceutical Ingradient
Empress U5 mgDissolution Improver

Physical properties of tablets

Avg. Weight-150 mg
Hardness-3-4kg/cm2
Punch size-8mm Standard Concave

*Overage of levocetirizine is taken to maintain the result #montelikast sodium eq to montelukast


Procedure

    • Mixing:
      1. Mix Empress U , MCCP101, Mannitol , lactose and SSG thoroughly with sifting through #60
      2. Now Sift Aerosil 200 with # 40 and mix it with above said material in suitable blender for 30 minutes
    • Binding and sizing:
      1. Now dissolve PVPK30 in IPA and bind the premix of step 2
      2. Dry the wet mass the temperature of FBD or tray drier Strictly to be kept BELOW 40Oc
      3. Dry the granules till LOD remains below 2 %.
      4. Size the granules through 30 # mesh & retention through 1 mm perforated screen
    • Lubrication:
      1. Sift the Magnesium Stearate, Cross Povidone, SSG,Montelukast sod, EmpressU , Talc through 60# sieve separately, and Aerosil and Levocetirizine through 40# sieve.
      2. Mix above mixture in suitable blender.
      3. Compress the tablet having hardness 3-4kg/cm2.

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.