Manufacturing of Calcium Gluconate Injection USP and BP ...

 

Uses of Calcium Gluconate Injection:

Calcium gluconate injection is a medication used to treat conditions associated with low calcium levels in the body, a condition known as hypocalcemia. Hypocalcemia can occur due to various reasons, such as vitamin D deficiency, chronic kidney disease, hypoparathyroidism, and certain medications. Calcium gluconate helps raise calcium levels in the blood, which is essential for proper functioning of muscles, nerves, and bones.

To prepare ampoules each containing 10 ml of Calcium Gluconate injection.

FORMULA:

Ingredients Official Formula.

Calcium Gluconate 9.65 g

Calcium D-saccharate 0.35 g

Water for injection qs 100 ml

Requirements

APPARATUS:

• Ampoules
• 10ml Beakers
• 100ml, 250ml Measuring cylinder
• 10ml Syringe with needle
• Whatmann filter paper
• Autoclave

CHEMICALS:

• Calcium gluconate
• Calcium D-saccharate
•  Water for injection

Procedure:

• Calculate working formula based upon the number of injections to be prepared. The manufacturing
• operations are done in clean rooms.
• Cleaning of Ampoules:
• Cleaning of Type-I glass ampoules is carried out by washing with de-ionized water and autoclaving.

Preparation of Calcium Gluconate Solution:

1. The desired amount of calcium gluconate and calcium D-saccharate are accurately weighed.

2. On the account of solubility calcium gluconate is first dissolved in water for injection in beaker

3. Then calcium D-saccharate is dissolved in the above solution. The solution is then allowed to cool.

4. After cooling the drug solution is filtered through Whatmann filter paper to remove any foreign particles.

Formulation: 

The sterilized calcium gluconate solution is then formulated to create the final injectable product. This may involve adjusting the concentration, pH, and other parameters to ensure the solution is safe and effective for injection.

Ampoule Filling:

Ampoule filling is done by following the usual method.

Sealing of Ampoules:

The ampoules are sealed by using pull sealing technique.

Sterilization:

Calcium gluconate injection is subjected to terminal sterilization by autoclaving at 121◦C at 15 psi for 30 minutes.

Labelling and Packing:

Ampoules are labeled and packed in a suitable ampoule box.

Brand Names:

Calcium gluconate injection is available under various brand names, depending on the manufacturer and region. Some common brand names include:

Calcio-Gry®

Calcite®

Glucocal™

Calglucon®

Calciglucon®

It's important to note that brand names may vary in different countries, and there might be other brand names available as well. Always consult a healthcare professional for accurate information about medication options and their availability.