Cefuroxime 500 mg Tablet | Formulation & Manufacturing Process

Cefuroxime is a second-generation oral cephalosporin antibiotic that is resistant to hydrolysis by β-lactamases produced by Gram-negative bacteria. It is indicated for Upper respiratory tract infections, Lower respiratory tract infections, Urinary tract infections, Skin & soft tissue infections, Gonorrhoea, Early Lyme disease, etc.

It was patented in 1976 and approved for medical use in 1987.

There are several dosage forms and strengths available with Cefuroxime. The most common of which is Cefuroxime 500 mg Tablet.

Each film-coated tablet contains Cefuroxime USP 500 mg as Cefuroxime Axetil USP. The formulation and manufacturing process of Cefuroxime 500 mg Tablet is as below:


Each tablet contains:

Sl.Name of the IngredientsSpecificationOverageQuantityFunction
Active Ingredient
1Cefuroxime AxetilUSP     675.68 mg
(Equivalent to
Cefuroxime 500 mg)
2Maize StarchBP     175.00 mg 
3CrospovidoneBP     20.00 mg 
4Sodium Starch GlycolateBP       75.00 mg 
5Purified TalcBP         6.00 mg 
6Magnesium StearateBP         4.00 mg 
7Purified WaterBP     878.00 mg 
Coating Materials
8Hydroxypropyl Methylcellulose (15 cps)BP      9.56 mg 
9Polyethylene Glycol – 6000BP      2.39 mg 
10Propylene GlycolBP      1.60 mg 
11Purified TalcBP      2.39 mg 
12Titanium DioxideBP      2.39 mg 
13Lemon Yellow ColorPharma Grade    0.125 mg 
14*Purified WaterBP  153.23 mg 
15*Carnauba WaxBP      1.00 mg 
16*ChloroformBP      5.00 mg 

* Does not appear in the final product.

Manufacturing Process:

Step-1: Dispensing and checking
Dispense and check the raw materials and their weights as per weighing order and bring them to the processing room. Check that the processing machinery, equipment, and manufacturing area are clean. Take QA approval before going for processing.  
Step-2: Sieving
Pass Cefuroxime Axetil & Maize Starch through a 20-mesh sieve.  
Step-3: Dry mixing
Mix Cefuroxime Axetil & Maize Starch in a Planetary/Pass Mixer for 20 minutes.  
Step-4: Wet mixing
Add 35.0 Kg of Purified Water in 4 (Four) consecutive steps with 5 minutes intervals of each addition and then mix for 20 minutes.  
Step-5: Primary drying
Dry this wet mass in a Fluidized Bed Dryer for 3.0 hours at a temperature of 60oC.  
Step-6: Grinding
Grind this semi-dried mass by the Multimill using a 3.0 mm Screen.  
Step-7: Final drying
Dry this ground mass in a Fluidized Bed Dryer for 1.50 hours at a temperature of 60oC to achieve a L.O.D. of 2.50 – 3.50% at 80oC.  
Step-8: Sieving
Pass Sodium Starch Glycolate, Crospovidone, Purified Talc & Magnesium Stearate through a 40-mesh sieve.  
Step-9: Blending
Blend this dried mass with Sodium Starch Glycolate and then lubricate with Purified Talc & Magnesium Stearate.  
Step-10: Blending
Now blend this slugged mass with Crospovidone.
Step-11: Sampling of blended granules by the Quality Control Department for test & analysis
Inform the Quality Control Department to collect the sample for necessary testing & analysis.  
Step-12: Compression of blended granules after getting test & analysis reports from Quality Control Department
Compress to form a tablet according to the specification by using 18.2 X 9.2 mm oblong, standard concave punches.  
Step-13: Film coating
Coat the tablets of step-12 using a film coating solution by maintaining the required parameters.  
Step-14: Blistering, printing & packaging
Blister the film-coated tablets. Package the blister strips in printed cartons having batch no. manufacturing & expiry dates & MRP.  

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