Preparation of Calcium Gluconate injection
BP506P Industrial Pharmacy I Practical
Aim: To prepare and submit 3 ampoules each containing 10 ml calcium gluconate injection.
Theory:
Calcium is the most abundant cation and the fifth most common inorganic element in the human body. Calcium is essential for the maintenance of the nervous, muscular, and skeletal systems, and for cell membrane and capillary permeability. Its role in bone structure and muscle contraction is well known, but calcium is also important for blood coagulation, nerve conduction, and electrical conduction in the myocardium. Calcium gluconate is calcium salt of gluconic acid, an oxidation product of glucose) an element or mineral necessary for normal nerve, muscle, and cardiac function4alcium as the gluconate salt helps to maintain calcium balance and prevent bone loss when taken orally)this agent may also be chemopreventive for colon and other cancers. Calcium gluconate injection is a sterile, preservative-free, nonpyrogenic, solution of calcium gluconate, a form of calcium, for intravenous administration of calcium gluconate increases serum ionized calcium level. calcium gluconate into ionized calcium in plasma. Ionized calcium and gluconate are normal constituents of body fluids.
Synonym: d-gluconic acid, calcium salt structure:
Standard IP: calcium gluconate injection contains a quantity of calcium equivalent to not less than 8.5% and not more than 9.4 % of a stated amount of calcium gluconate.
Formulation of calcium gluconate injection
| Ingredients | Quantity given/ampoule | Quantity taken (no. of ampoule x quantity given) |
| Calcium gluconate | 1 g | |
| Calcium D saccharate | 350 mg | |
| Water for injection (q.s) | 10 ml |
Apparatus:
Beaker, measuring cylinder, syringe, needle, ampoules,whatman filter paper/membrane filter, autoclave
Procedure:
Type I glass ampoules are selected and clean. The formulation is carried out in clean area.
Weigh accurately calcium gluconate and calcium d saccharate.
Dissolve calcium gluconate in water for injection in a beaker with application of heat then add calcium d saccharate to it.
Adjust the pH in between 6-8 with 10% sodium hydroxide solution.
Keep the solution for cooling.
After cooling, filter the solution through whatman filter paper/ 0.45 pmmembrane filter to remove any particulate matter.
Fill the prepared injection in ampoules (type i) with the help of syringe.
Seal the ampoules by pull seal technique.
Sterilize the ampoules by autoclaving at 121°C for 30 minutes.
Packing: In a suitable ampoule box the ampoules are packed and labeled.
Storage: store below 40°C, preferably between 15°C and 30°C, unless otherwise specified by manufacturer. No preservative added. Store in a well closed container and use only if solution is clear and seal intact.
Dosage: adults: 500 mg – 2 grams (5-20 inn children. 200-500 mg (2-5 ml) infants: not more than 200 mg (not more than 2 ml)
Dosage strengths:
Injectable solution: 100mg/m1 tablet: 50, 500, 650mg Capsule: 500mg
Route of administration:
Calcium gluconate injection is for intravenous use only, it is not to be administered intramuscularly, intramyocardially, subcutaneously, or permitted to extravasate into any body tissue; may cause severe tissue necrosis and/or sloughing, and abscess formation
Method of administration:
The intravenous administration rate should not exceed 2 ml (0.45 mmol of calcium) per minute.
The patient should be in the lying position and should be closely observed during injection- monitoring should include heart rate or ecg.
Category: this medication is used to prevent or treat low blood calcium levels in people who do not get enough calcium from their diets. It may be used to treat conditions caused by low calcium levels such as bone loss (osteoporosis).
Side effects: constipation and upset stomach, dry mouth, increased thirst, and increased urination. Allege reaction such as rash, itching, dizziness, trouble breathing.
Precaution: if you have any of the following health problems, consult your doctor or pharmacist beta° using this product high calcium levels (hypercalcomial, kidney disease, kidney stones link.
Calcium gluconate preparation reaction:
Calcium gluconate is a medication used to treat conditions caused by calcium deficiencies. It’s also used in certain medical procedures, like treating high blood potassium levels. The preparation of calcium gluconate involves a chemical reaction between calcium carbonate (or calcium hydroxide) and gluconic acid. Here’s the simplified reaction:
Calcium Carbonate + Gluconic Acid → Calcium Gluconate + Carbon Dioxide + Water
The chemical equation for this reaction is more detailed:
CaCO3 + 2C6H12O7 → Ca(C6H11O7)2 + CO2 + H2O
In this reaction:
- Calcium carbonate (CaCO3) or calcium hydroxide (Ca(OH)2) serves as the source of calcium ions (Ca²⁺).
- Gluconic acid (C6H12O7) is an organic acid that provides the gluconate ions (C6H11O7⁻).
- The reaction between them produces calcium gluconate (Ca(C6H11O7)2), carbon dioxide (CO2), and water (H2O).
The resulting calcium gluconate is typically used in pharmaceuticals and medical settings to provide a controlled and easily absorbable form of calcium for various treatments. It’s available in different formulations for oral, intravenous, and topical use.
Industrial Pharmacy I Practical
- Preformulation studies on paracetamol/aspirin/or any other drug
- Preparation and evaluation of Paracetamol tablets
- Preparation and evaluation of Aspirin tablets
- Coating of tablets- film coating of tables/granules
- Preparation and evaluation of Tetracycline capsules
- Preparation of Calcium Gluconate injection
- Preparation of Ascorbic Acid injection
- Quality control test of (as per IP) marketed tablets and capsules
- Preparation of Eye drops/ and Eye ointments
- Preparation of Creams (cold / vanishing cream)
- Evaluation of Glass containers (as per IP)
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