Piperazine Citrate Elixir is a sweetened, flavored liquid formulation widely used as an anthelmintic, especially for treating roundworm and pinworm infections. In pharmacy labs, its preparation helps students understand hydro-alcoholic solution design, solubility enhancement, and quality control testing. This elixir improves patient compliance due to its palatable form and effective API delivery. The process involves accurate weighing, dissolution in co-solvents, flavoring, and filtration. This guide provides a detailed step-by-step procedure for preparing 1000 mL of piperazine citrate elixir, following pharmaceutical formulation standards. Learn the materials, principles, and quality checks required for successful formulation in an academic or industrial pharmacy setting.

Aim: Preparation of Piperazine Citrate Elixir

References

1. British Pharmacopoeia Codex 1968.
2. Ansel, H. C., Allen, L. V., & Popovich, N. G. Pharmaceutical Dosage Forms and Drug Delivery Systems.
3. Lachman, L., Lieberman, H. A., & Kanig, J. L. The Theory and Practice of Industrial Pharmacy.

Objective

To prepare piperazine citrate elixir, a pharmaceutical liquid formulation, and understand the procedure, properties, and quality control tests associated with its preparation.

Principle

The formulation involves the dissolution of piperazine citrate in a hydro-alcoholic base containing a sweetener and flavoring agents to ensure solubility, stability, and patient compliance.

Materials Required

Chemicals Required:

• Piperazine Citrate: 12 g
• Ethanol (95%): 50 mL
• Sucrose: 60 g
• Purified Water: Quantity Sufficient (QS) to 1000 mL
• Glycerin: 10 mL
• Flavoring agent (e.g., Lemon essence): 5 mL

Apparatus Required:

• Beaker (1000 mL)
• Measuring cylinder
• Glass rod
• Funnel
• Filtration assembly

Procedure

1. Dissolution of Piperazine Citrate:

• Dissolve 12 g of piperazine citrate in approximately 800 mL of purified water. Stir until completely dissolved.

2. Preparation of Sweetening Solution:

• Dissolve 60 g of sucrose in the above solution with continuous stirring.

3. Addition of Co-solvents:

• Add 10 mL of glycerin to the solution.
• Gradually add 50 mL of ethanol (95%) while stirring.

4. Flavoring:

• Incorporate 5 mL of the chosen flavoring agent (e.g., lemon essence) into the solution.

5. Adjusting Volume:

• Make up the final volume to 1000 mL with purified water. Mix thoroughly.

6. Filtration:

• Filter the solution using a filtration assembly to ensure clarity.

7. Packaging and Storage:

• Transfer the prepared elixir into clean, amber-colored bottles with airtight caps.
• Store in a cool, dry place away from direct sunlight.

8. Observation and Results

• Appearance: Clear, colorless liquid.
• Taste: Sweet with a hint of flavor (e.g., lemon).
• Odor: Pleasant, depending on the flavoring agent used.

9. Quality Control Tests

• Clarity Test: The elixir should appear clear and free from particulate matter.
• pH Test: Measure the pH of the elixir. It should be within the range of 5 to 7.
• Assay of Piperazine Citrate: Perform an assay to determine the concentration of Piperazine Citrate using titrimetric or spectrophotometric methods.
• Specific Gravity: Measure using a hydrometer. It should meet the pharmacopoeial standards.
• Alcohol Content: Verify the ethanol content using distillation or gas chromatography.

Discussion

• Role of Ethanol and Glycerin: Ethanol acts as a solvent for the active ingredient, while glycerin improves sweetness and viscosity.
• Importance of Filtration: Filtration ensures the elixir is clear, enhancing its aesthetic appeal and patient compliance.
• Flavoring Agents: Adding flavoring agents masks any unpleasant taste of piperazine citrate, making it suitable for pediatric use.

Applications

• Used in the treatment of roundworm (ascariasis) and pinworm (enterobiasis) infections.
• Suitable for administration in children and adults due to its palatability.

Precautions

1. Ensure accurate weighing of all ingredients to maintain therapeutic efficacy.
2. Store the elixir properly to prevent degradation or microbial growth.
3. Use purified water to avoid impurities that may affect clarity.

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Viva-voce questions

1. What is Piperazine Citrate Elixir used for?

Answer: Piperazine Citrate Elixir is commonly used as an anthelmintic to treat parasitic worm infections such as ascariasis and enterobiasis.

2. Why is ethanol used in piperazine citrate elixir preparation?

Answer: Ethanol acts as a co-solvent that enhances the solubility of piperazine citrate and stabilizes the formulation.

3. What is the role of glycerin in the elixir formulation?

Answer: Glycerin acts as a viscosity enhancer and sweetening agent, improving taste and mouthfeel.

4. How is the quality of piperazine citrate elixir tested?

Answer: Quality tests include pH measurement, clarity check, alcohol content analysis, assay of piperazine citrate, and specific gravity evaluation.

5. What precautions should be taken during elixir preparation?

Answer: Ensure accurate ingredient weighing, use purified water, and store in amber bottles away from light to maintain stability and safety.