Call 9719900777

Levocetirizine and montelukast

Formulation Claim per tab Function
Ingredient
Mixing:
Levocetirizine* 5.25 mg Active Pharmaceutical Ingradient
Sodium bicarb 10 mg Dissolution enhancer
MCCP 101 30 mg Diluent
Mannitol 20.0 mg Diluent
Lactose QS to 160 mg Diluent
SSG 2 mg Disintigerent
Aerosil 200 1 mg Glident
Binder
PVPK30 4 mg Binder
Sodium lauryl sulphate 1.5 mg Surfactant
IPA Qs Vehicle
Lubrication
Talc 2 mg Lubricant
Mag. Stearate 2 mg Lubricant
Cross Povidone 10 mg Disintigerant
Aerosil 200 1 mg Glident
SSG 10 mg Disintigerent
Montelukast sodium# 11 mg API
Sodium carbonate 5 mg Dissolution 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.