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Empagliflozin 5 mg + Metformin Hydrochloride 500 mg Tablet | Formulation & Manufacturing Process

Empagliflozin is an inhibitor of Sodium-Glucose Co-Transporter 2 (SGLT2). SGLT2 is the predominant transporter, responsible for the re-absorption of glucose from the kidney back into circulation. By inhibiting SGLT2, Empagliflozin reduces renal re-absorption of filtered glucose and lowers the renal threshold for glucose thereby increasing urinary glucose excretion.

Metformin hydrochloride is a biguanide-type oral anti-hyperglycemic drug, used in the management of type 2 diabetes. It lowers both basal and postprandial plasma glucose. It does not produce hypoglycemia. Metformin hydrochloride decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by an increase in peripheral glucose uptake and utilization.

This medication is a combination of 2 drugs: empagliflozin and metformin hydrochloride. It is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems.

There are several dosage forms and strengths available with Empagliflozin + Metformin Hydrochloride. The most common of which is Empagliflozin 5 mg + Metformin Hydrochloride 500 mg Tablet.

Each film-coated tablet contains Empagliflozin INN 5 mg and Metformin Hydrochloride USP 500 mg. The formulation & manufacturing process of Empagliflozin 5 mg + Metformin Hydrochloride 500 mg Tablet is as below:

Formulation:

Each tablet contains:

SNCOMPOSITIONSPECIFICATIONQUANTITYFUNCTION
Active Ingredient(s):
1EmpagliflozinINN5.000 mgActive
2Metformin HydrochlorideUSP500.000 mgActive
Excipient(s):
3Microcrystalline Cellulose PH 101BP91.000 mgDiluent
4Maize StarchBP23.000 mgDiluent
5Povidone K-30BP15.000 mgBinder
6CrospovidoneBP7.000 mgDisintegrant
7Sodium Starch GlycolateBP35.000 mgDisintegrant
8Colloidal Silicon Dioxide – 200BP7.000 mgGlidant
9Magnesium StearateBP3.000 mgLubricant
Coating Material(s):
10Hydroxypropyl Methylcellulose 15 cpsUSP9.200 mgFilm forming agent
11Polyethylene Glycol – 6000USP3.380 mgPlasticizer
12Purified TalcBP0.320 mgAntiadherant
13Titanium DioxideBP3.710 mgOpacifying agent
14Apple Green Lake ColorPharma Grade0.050 mgColoring agent
15* MethanolBP135.000 mgSolvent
16* Methylene ChlorideBP88.000 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, Metformin Hydrochloride, and Microcrystalline Cellulose PH 101 through the # 30 mesh screen transfer to the SS vat, and mix them for 5 minutes.   
  3. Add the described amount in BMR Maize starch, and sodium starch glycolate to step-2 mix for 5 minutes.
  4. Prepare Crospovidone solution and paste it with the described amount of maize starch.
  5. Prepare granules with Rapid Mixing Granulator.
  6. Add Crospovidone, and Colloidal Silicon Dioxide-200 to the Drum blender mix for 5 minutes.
  7. Add Magnessium Stearate Drum blender mix for 2 minutes.
  8. Inform the QA Executive to collect samples for QC analysis. After getting QC approval press the granule into tablets.
  9. 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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