Paracetamol Pediatric Elixir is a sweetened, flavored liquid formulation specially designed for children, offering effective relief from fever and pain. This lab experiment walks you through the accurate preparation of 100 mL of paracetamol elixir using pharmaceutical-grade ingredients and standard procedures. With the right balance of preservatives, cosolvents, and pH adjustment, this formulation ensures stability, safety, and palatability. Whether you’re a pharmacy student or an educator, this guide is an essential reference for mastering oral pediatric formulations in compliance with British Pharmacopoeia standards.

Aim: Preparation of Paracetamol Pediatric Elixir

References

1. Pharmaceutical Formulation Design and Preparation – Aulton, M.E.
2. British Pharmacopoeia (2023) – Monograph on Oral Liquid Preparations.
3. Articles from PubMed on “Paracetamol Elixir Stability.”

Objective

To prepare 100 mL of paracetamol pediatric elixir, ensuring accurate formulation and compliance with pharmaceutical standards.

Materials Required

Chemicals:

• Paracetamol (Active Ingredient): 2.4 g
• Sucrose (Sweetening Agent): 40 g
• Glycerin (Cosolvent): 10 mL
• Sorbitol Solution (70% w/v, Sweetening Agent): 5 mL
• Methyl Paraben (Preservative): 0.1 g
• Propyl Paraben (Preservative): 0.02 g
• Propylene Glycol (Cosolvent): 10 mL
• Citric Acid (pH Adjuster): q.s.
• Sodium Benzoate (Preservative): 0.1 g
• Flavor (e.g., Raspberry, Orange): q.s.
• Distilled Water: q.s. to 100 mL

Equipment:

• Analytical balance
• Beakers (100 mL, 250 mL)
• Stirring rod
• Measuring cylinders (10 mL, 100 mL)
• Water bath
• pH meter or pH indicator paper
• Funnel
• Storage bottles (Amber-colored)

Principle

Paracetamol pediatric elixir is a liquid oral formulation designed for children. It combines the therapeutic effects of paracetamol with a sweetened, palatable base. Cosolvents enhance the solubility of paracetamol, while preservatives ensure microbial stability. The pH is adjusted to maintain drug stability.

Procedure

1. Dissolution of Paracetamol:

• Weigh 2.4 g of paracetamol and transfer it to a 100 mL beaker.
• Add 10 mL of propylene glycol and stir until the paracetamol dissolves completely.

2. Preparation of the Base:

• In another 250 mL beaker, dissolve 40 g of sucrose in 30 mL of distilled water by gentle heating.
• Add 10 mL of glycerin and 5 mL of sorbitol solution to the sucrose solution. Stir to mix well.

3. Incorporation of Preservatives:

• Dissolve 0.1 g of methyl paraben and 0.02 g of propyl paraben in 10 mL of propylene glycol using gentle heating. Add this mixture to the sucrose base with continuous stirring.

4. pH Adjustment:

• Measure the pH of the solution. Add citric acid solution dropwise to adjust the pH to 4.5-6.0, suitable for paracetamol stability and pediatric use.

5. Addition of Flavor:

• Add the desired amount of flavor to mask the bitter taste of paracetamol. Mix thoroughly.

6. Combining Solutions:

• Gradually add the paracetamol solution to the prepared base while stirring continuously.

7. Final Dilution:

• Add distilled water q.s. to make up the volume to 100 mL. Stir the mixture until homogeneous.

8. Filtration and Packaging:

• Filter the final elixir through a fine filter or muslin cloth to remove any undissolved particles.
• Transfer the elixir into amber-colored bottles to protect it from light. Label the bottles appropriately.

Label

• Product Name: Paracetamol Pediatric Elixir
• Dosage: Each 5 mL contains 120 mg of paracetamol.
• Storage: Store at room temperature, away from direct sunlight.
• Shake well before use.
• Keep out of reach of children.

Precautions

1. Ensure all equipment is clean and sterilized.
2. Avoid overheating to prevent degradation of the active ingredient and other excipients.
3. Maintain proper pH to ensure stability and palatability.
4. Perform quality checks for uniformity and clarity.

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Frequently Asked Questions (FAQs)

1. What is Paracetamol Pediatric Elixir used for?
Answer: It is used to treat fever and mild to moderate pain in children. The liquid form makes it easier for pediatric administration.

2. Why are cosolvents like glycerin and propylene glycol used in the elixir?
Answer: They help improve the solubility of paracetamol and ensure a uniform, stable solution.

3. What is the ideal pH range for paracetamol elixir?
Answer: The pH should be adjusted to between 4.5 and 6.0 to ensure stability and taste compatibility for children.

4. How should the paracetamol elixir be stored after preparation?
Answer: Store the elixir in an amber-colored bottle at room temperature, away from direct light and heat.

5. What is the dose of paracetamol in this elixir formulation?
Answer: Each 5 mL of the elixir contains 120 mg of paracetamol, following standard pediatric dosing guidelines.