Pharma Jogot
Rosuvastatin is a statin medication, used to prevent cardiovascular disease in those at high risk and treat abnormal lipids. It is recommended to be used together with dietary changes, exercise, and weight loss. It is taken orally (by mouth).
Rosuvastatin was patented in 1991, and approved for medical use in the United States in 2003. It is available as a generic medication. In 2020, it was the seventeenth most commonly prescribed medication in the United States, with more than 29 million prescriptions.
There are several dosage forms and strengths available with Rosuvastatin. One of the most common of which is Rosuvastatin 10 mg Tablet.
Each film-coated tablet contains Rosuvastatin 10 mg as Rosuvastatin Calcium BP. The formulation & manufacturing process of Rosuvastatin 10 mg Tablet is as below:
Formulation:
Each tablet contains:
| SN | NAME OF INGREDIENTS | SPECIFICATION | QUANTITY | FUNCTION |
| Active Ingredient | ||||
| 1 | Rosuvastatin Calcium | BP | 10.388 mg (equivalent to Rosuvastatin 10 mg) | |
| Excipients | ||||
| 2 | Microcrystalline Cellulose 101 | BP | 83.865 mg | |
| 3 | Sodium Starch Glycolate | BP | 7.000 mg | |
| 4 | Colloidal Anhydrous Silica | BP | 3.000 mg | |
| 5 | Magnesium Stearate | BP | 2.004 mg | |
| 6 | Lactose Monohydrate | BP | 63.770 mg | |
| 7 | Polyvinylpyrrolidone K-30 | BP | 2.394 mg | |
| Coating Materials | ||||
| 8 | Hydroxypropyl Methylcellulose | BP | 3.498 mg | |
| 9 | Polyethylene Glycol 6000 | BP | 0.756 mg | |
| 10 | Propylene Glycol | BP | 1.002 mg | |
| 11 | Purified Talc | BP | 0.7380 mg | |
| 12 | Titanium Dioxide | BP | 0.7560 mg | |
| 13 | * Carnauba Wax | BP | 0.102 mg | |
| 14 | * Chloroform | BP | 1.338 mg | |
| 15 | * Purified Water | BP | 46.670 mg | |
| * Will not appear in the final product | ||||
| ** The formulation varies from Man to Man, Machine to Machine, Method to Method, and Materials to Materials. | ||||
Manufacturing Process:
The process consists of sieving the active ingredient & excipients through the Vibration Shifter and granules preparation by rapid mixture/granulator & blending that is followed by a Drum Blender. Tablet will be compressed by the tablet compression machine and coating will be carried out by Auto coater. Tablets will be blistered by the Blister machine.