Pharma Jogot
Metformin is the main first-line medication for the treatment of type 2 diabetes, particularly in people who are overweight. It is also used in the treatment of polycystic ovary syndrome. It is sometimes used as an off-label adjunct to lessen the risk of metabolic syndrome in people who take antipsychotics. Metformin is not associated with weight gain and is taken by mouth.
Metformin was first described in scientific literature in 1922 by Emil Werner and James Bell. French physician Jean Sterne began the study in humans in the 1950s. It was introduced as a medication in France in 1957 and the United States in 1995. Metformin is on the World Health Organization’s List of Essential Medicines, and is the most widely used medication for diabetes taken by mouth. It is available as a generic medication. In 2020, it was the third most commonly prescribed medication in the United States, with more than 92 million prescriptions.
There are several dosage forms and strengths available with Metformin Hydrochloride. The most common of which is Metformin Hydrochloride 850 mg Tablet.
Each film-coated tablet contains Metformin Hydrochloride BP 850 mg. The formulation & manufacturing process of Metformin Hydrochloride 850 mg is as below:
Formulation:
Each tablet contains:
| SN | COMPOSITION | SPECIFICATION | QUANTITY | FUNCTION |
| Active Ingredient | ||||
| 1 | Metformin Hydrochloride | BP | 850.000 mg | |
| Excipients | ||||
| 2 | Polyvinylpyrrolidone K – 30 | BP | 50.000 mg | |
| 3 | Maize Starch | BP | 80.000 mg | |
| 4 | Microcrystalline Cellulose – 101 | BP | 70.000 mg | |
| 5 | Sodium Starch Glycolate | BP | 15.000 mg | |
| 6 | Purified Talc | BP | 7.000 mg | |
| 7 | Magnesium Stearate | BP | 4.000 mg | |
| 8 | Isopropyl Alcohol | BP | Quantity Sufficient | |
| Coating Material(s) | ||||
| 7 | Hydroxypropyl Methylcellulose | BP | 26.667 mg | |
| 8 | Polyethylene Glycol 6000 | BP | 5.000 mg | |
| 9 | Polyethylene Glycol 400 | BP | 2.000 mg | |
| 10 | Propylene Glycol | BP | 4.333 mg | |
| 11 | Purified Talc | BP | 4.167 mg | |
| 12 | Titanium Dioxide | BP | 5.000 mg | |
| 13 | * Purified Water | BP | 333.333 mg | |
| 14 | * Carnauba Wax | BP | 0.050 mg | |
| 15 | * Chloroform | BP | 8.330 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. Tablets 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.