Pharma Jogot
Cefuroxime is a second-generation cephalosporin antibiotic used to treat and prevent several bacterial infections. These include pneumonia, meningitis, otitis media, sepsis, urinary tract infections, and Lyme disease. It is used by mouth or by injection into a vein or muscle.
Cefuroxime was patented in 1971 and approved for medical use in 1977. It is on the World Health Organization’s List of Essential Medicines. In 2020, it was the 325th most commonly prescribed medication in the United States, with more than 800 thousand prescriptions.
There are several dosage forms and strengths available with Cefuroxime. One of the most common of which is Cefuroxime 125 mg/5 ml Powder For Suspension.
Each 5 ml reconstituted suspension contains Cefuroxime 125 mg as Cefuroxime Axetil USP. The formulation & manufacturing process of Cefuroxime 125 mg/5 ml Powder For Suspension is as follows:
Formulation:
Each 5 ml reconstituted suspension contains:
| SL | COMPOSITION | SPECIFICATION | QUANTITY | FUNCTION |
| Active Ingredient(s) | ||||
| 1 | Cefuroxime Axetil (As Taste Masked Powder) | USP | 125.00 mg | |
| Excipient(s) | ||||
| 2 | Sucrose | BP | 600.00 mg | |
| 3 | Aspartame | BP | 3.50 mg | |
| 4 | Methyl Hydroxybenzoate | BP | 1.00 mg | |
| 5 | Propyl Hydroxybenzoate | BP | 0.20 mg | |
| 6 | Microcrystalline Cellulose & Carmellose Sodium – C91 | BP | 5.00 mg | |
| 7 | Carmellose Sodium | BP | 1.50 mg | |
| 8 | Colloidal Anhydrous Silica – 200 | BP | 10.00 mg | |
| 9 | Saccharin Sodium | BP | 2.50 mg | |
| 10 | Banana Flavor Powder | Pharma Grade | 25.00 mg | |
| * The formulation varies from Man to Man, Machine to Machine, Method to Method, and Materials to Materials. | ||||
Manufacturing Process:
- Active ingredients and excipients are weighed accurately.
- Cefuroxime Axetil, Sodium Saccharin, Microcrystalline Cellulose & Carmellose Sodium – C91, and Aspartame are passed through a # 30 mesh screen and are to be mixed for 5 minutes.
- Add Colloidal Anhydrous Silica – 200, Carmellose Sodium mix for 5 minutes.
- Then add Methyl Hydroxybenzoate, Propyl Hydroxybenzoate, and Sucrose mix for 10 minutes. Then add Banana flavor. Finally, mix for 10 minutes.
- After getting approval from the QC department, bottle filling & sealing will be is done.