Empagliflozin is an antidiabetic medication used to improve glucose control in people with type 2 diabetes. It is not recommended for type 1 diabetes. It is taken by mouth. Empagliflozin is an inhibitor of the sodium glucose co-transporter-2 (SGLT-2), and works by increasing sugar loss in urine.
Empagliflozin was approved for medical use in the United States and in the European Union in 2014. It is on the World Health Organization’s List of Essential Medicines. In 2020, it was the 102nd most commonly prescribed medication in the United States, with more than 6 million prescriptions. It has received approval as a generic medication from the US Food and Drug Administration (FDA).
There are several dosage forms and strengths available with Empagliflozin. The most common of which is Empagliflozin 25 mg Tablet.
Each film-coated tablet contains Empagliflozin INN 25 mg. The formulation & manufacturing process of Empagliflozin 25 mg Tablet is as below:
Formulation:
Each tablet contains:
SN | COMPOSITION | SPECIFICATION | QUANTITY | FUNCTION |
Active Ingredient(s): | ||||
1 | Empagliflozin | INN | 25.000 mg | Active |
Excipient(s): | ||||
2 | Microcrystalline Cellulose PH 102 | BP | 120.000 mg | Diluent |
3 | Lactose Anhydrous | BP | 74.000 mg | Diluent |
4 | Crospovidone | BP | 10.000 mg | Disintigrant |
5 | Colloidal Silicon Dioxide-200 | BP | 1.000 mg | Glidant |
6 | Purified Talc | BP | 2.000 mg | Glidant |
7 | Magnesium Stearate | BP | 3.000 mg | Lubricant |
Coating Material(s): | ||||
8 | Hydroxypropyl Methylcellulose 15 cps | USP | 6.160 mg | Film-forming agent |
9 | Polyethylene Glycol – 6000 | USP | 0.308 mg | Plasticizer |
10 | Purified Talc | BP | 0.320 mg | Antiadherant |
11 | Titanium Dioxide | BP | 0.500 mg | Opacifying agent |
12 | Apple Green Lake Color | Pharma Grade | 0.030mg | Coloring agent |
13 | * Methanol | BP | 47.500 mg | Solvent |
14 | * Methylene Chloride | BP | 72.000 mg | Solvent |
* 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:
- Weigh active ingredients and excipients accurately.
- Pass Empagliflozin, and Lactose Anhydrous through # 20 mesh screen transfer to the Drum Blender and mix them for 5 minutes.
- Add Microcrystalline Cellulose PH 102 to the Drum blender mix for 5 minutes.
- Add Crospovidone, Colloidal Silicon Dioxide-200 to Drum blender mix for 5 minutes
- Add Magnesium Stearate Drum blender mix for 2 minutes
- Inform the QA Executive to collect samples for QC analysis. After getting QC approval press the granule into tablets.
- After getting QC approval, blister packaging is done.
N.B: Control tests are to be carried out before compression and blister packing.