Thursday , November 7 2024

Empagliflozin 25 mg Tablet | Formulation & Manufacturing Process

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:

SNCOMPOSITIONSPECIFICATIONQUANTITYFUNCTION
Active Ingredient(s):
1EmpagliflozinINN25.000 mgActive
Excipient(s):
2Microcrystalline Cellulose PH 102BP120.000 mgDiluent
3Lactose AnhydrousBP74.000 mgDiluent
4CrospovidoneBP10.000 mgDisintigrant
5Colloidal Silicon Dioxide-200BP1.000 mgGlidant
6Purified TalcBP2.000 mgGlidant
7Magnesium StearateBP3.000 mgLubricant
Coating Material(s):
8Hydroxypropyl Methylcellulose 15 cpsUSP6.160 mgFilm-forming agent
9Polyethylene Glycol – 6000USP0.308 mgPlasticizer
10Purified TalcBP0.320 mgAntiadherant
11Titanium DioxideBP0.500 mgOpacifying agent
12Apple Green Lake ColorPharma Grade0.030mgColoring agent
13* MethanolBP47.500 mgSolvent
14* Methylene ChlorideBP72.000 mgSolvent
* 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:

  1. Weigh active ingredients and excipients accurately.
  2. Pass Empagliflozin, and Lactose Anhydrous through # 20 mesh screen transfer to the Drum Blender and mix them for 5 minutes.   
  3. Add Microcrystalline Cellulose PH 102 to the Drum blender mix for 5 minutes.
  4. Add Crospovidone, Colloidal Silicon Dioxide-200 to Drum blender mix for 5 minutes
  5. Add Magnesium Stearate Drum blender mix for 2 minutes
  6. Inform the QA Executive to collect samples for QC analysis. After getting QC approval press the granule into tablets.
  7. After getting QC approval, blister packaging is done.   

N.B: Control tests are to be carried out before compression and blister packing.

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