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:

Formulation:

Each tablet contains:

Sl.	Name of the Ingredients	Specification	Overage	Quantity	Function
Active Ingredient
1	Cefuroxime Axetil	USP	–	675.68 mg (Equivalent to Cefuroxime 500 mg)	Active
Excipients
2	Maize Starch	BP	–	175.00 mg
3	Crospovidone	BP	–	20.00 mg
4	Sodium Starch Glycolate	BP	–	75.00 mg
5	Purified Talc	BP	–	6.00 mg
6	Magnesium Stearate	BP	–	4.00 mg
7	Purified Water	BP	–	878.00 mg
Coating Materials
8	Hydroxypropyl Methylcellulose (15 cps)	BP	–	9.56 mg
9	Polyethylene Glycol – 6000	BP	–	2.39 mg
10	Propylene Glycol	BP	–	1.60 mg
11	Purified Talc	BP	–	2.39 mg
12	Titanium Dioxide	BP	–	2.39 mg
13	Lemon Yellow Color	Pharma Grade	–	0.125 mg
14	*Purified Water	BP	–	153.23 mg
15	*Carnauba Wax	BP	–	1.00 mg
16	*Chloroform	BP	–	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.