NORFLOXACIN + METRONIDAZOLE SUSPENSION

NORFLOXACIN + METRONIDAZOLE SUSPENSION:
Batch Size    :     400 Lts.
Claims     :    Each 5 ml. provides Norfloxacin 100 mg and Metronidazole as
Metronidazole Benzoate 100 mgs.


Sr. 
Ingredients 
Quantity 
Metronidazole Benzoate 
14.1 Kgs. 
Norfloxacin + Resin Complex
16.0 Kgs. 
Methyl Paraben Sodium 
400.0 Gms. 
Propyl Paraben Sodium 
90.0 Gms 
Guar Gum 
2.0 Kgs 
Sorbitol Liquid 
40.0 Kgs. 
Polysorbate 80 
400.0 Gms. 
Colour Tartrazine 
16.0 Gms. 
Essence Mixed Fruit Conc. 
800.0 Gms. 
Essence Peppermint 
400.0 Gms.
Sucrose 
200.0 Kgs. 
Purified water  
400 .0 Kgs. 
Please Note
To mask the bitter taste of Norfloxacin it is combined with Indian 204 Resin.
PROCEDURE
  1. Manufacturing process for Norfloxacin Resinate
    1. In a suitable SS charge the followings:
    2. Purified water 800 Lts.
    3. Charge 8.00 Kgs of Norfloxacin slowly under stirring to form 1 % fine suspension. Norfloxacin will partly dissolve and party will remain in suspension.
    4. Now charge 8.00 Kgs. of Indion 204 resia slowly under stirring.
    5. When all the addition is complete stir for additional 2 hours. During this period all the Norfloxacin will combine with the resin to form Norfloxacin Resinate.
    6. Filter the resultant resinate over buchner funnel.
    7. Wash the resinate on the filter with purified water to remove any unabsorbed Norfloxacin.
    8. Suck dry as far as possible.
    9. Dry the resinate at room temperature to constant weight.
    10. Use the dried resinate for the batch.
    Please Note
    The absorption is almost quantitative. The absorbed Norfloxacin does not get desorbed when resuspended in water.
    The Norfloxacin resinate will weigh about 16.00 Kgs. (on dry anhydrous basis )
II    Manufacturing process for suspension
A    Prepare the primary syrup as per follows
  1. Take 100 Lts. of purified water. Heat it to boiling.
  2. Add to it 200 Kgs of sugar under stirring. Stir until dissolved completely.
  3. Filter hot.
B    Mix methyl Paraban Sodium, Propyl Paraben sodium and guar gum together and
charge to the filtered syrup and stir to dissolve completely.
C    Keep it overnight.
On the next day add sorbitol liquid and tween 80 under stirring.
D    Now add one by one the followings in small quantities under stirring.
Metronidazole Benzoate     14.1 Kgs.
Norfloxacin Resinate    16.0 Kgs.
E    Mix further for 60 minutes.
F    Pass through colloid mill. Makeup the volume to 400 Lts.
Keep overnight for maturation.
G    Next day dissolve colour in the water and mix with the bulk suspension. Finally
add the flavour and make up the volume to 400 Lts.
H    Stir for one hour and send for filling.
Please Note :
    The pH adjustment is not required. It is self-achieved to a value around 7.0.
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