Terpin Hydrate Linctus IP’66 is a traditional pharmaceutical preparation that relieves cough through its expectorant action. According to the Indian Pharmacopoeia 1966 standards, this linctus combines terpin hydrate with sugar syrup, alcohol, and citric acid to form a viscous, sweet-tasting oral liquid. In this pharmacy lab experiment, we’ll review the materials, principles, and steps required to accurately prepare 100 mL of Terpin Hydrate Linctus, ensuring quality, safety, and therapeutic efficacy.
Aim: Preparation of Terpin Hydrate Linctus IP’66
References
- Indian Pharmacopoeia (1966 Edition) – Monograph on Terpin Hydrate Linctus.
- Remington: The Science and Practice of Pharmacy – 22nd Edition.
- Research articles on “Cough Relief Mechanisms of Terpin Hydrate” from PubMed.
Objective
To prepare 100 mL of Terpin Hydrate Linctus IP’66 as per the Indian Pharmacopoeia (IP) 1966 standards.
Materials Required
Chemicals:
- Terpin Hydrate: 0.375 g
- Citric Acid: 0.05 g
- Codeine Phosphate (if prescribed): 0.01 g
- Sucrose: 65 g
- Alcohol (95% v/v): 10 mL
- Chloroform Spirit (Preservative): 0.25 mL
- Distilled Water: q.s. to 100 mL
Equipment:
- Analytical balance
- Beaker (100 mL, 250 mL)
- Stirring rod
- Measuring cylinder (10 mL, 100 mL)
- Water bath
- Funnel
- Amber-colored storage bottle
Principle
Linctus is a viscous oral liquid preparation intended to relieve a cough. Terpin hydrate acts as an expectorant to help clear mucus. The formula uses alcohol as a solvent to dissolve terpin hydrate and enhance its bioavailability, while sucrose provides viscosity and sweetness.
Procedure
1. Dissolution of Terpin Hydrate:
- Weigh 0.375 g of terpin hydrate and transfer it to a 100 mL beaker.
- Add 10 mL of alcohol and stir gently to dissolve the terpin hydrate completely.
2. Preparation of Sugar Syrup:
- Weigh 65 g of sucrose and dissolve it in 50 mL of distilled water by heating gently in a 250 mL beaker.
- Ensure complete dissolution of sucrose. Allow the solution to cool.
3. Incorporation of Preservative:
- Add 0.25 mL of chloroform spirit to the sugar syrup while stirring continuously.
4. Addition of Citric Acid:
- Weigh 0.05 g of citric acid and dissolve it in a small quantity of distilled water. Add it to the sugar syrup.
5. Combining Solutions:
- Slowly add the alcohol solution containing terpin hydrate to the sugar syrup with constant stirring.
6. Adjustment of Volume:
- Add distilled water q.s. to make up the total volume to 100 mL. Mix thoroughly.
7. Filtration and Packaging:
- Filter the linctus to remove any undissolved particles.
- Transfer the linctus to an amber-colored storage bottle and label it appropriately.
Label
- Product Name: Terpin Hydrate Linctus IP’66
- Dosage: As directed by the physician (typically 5-10 mL every 6-8 hours).
- Storage: Store at room temperature, away from light and heat.
- Shake well before use.
- Keep out of reach of children.
Precautions
- Ensure accurate weighing of terpin hydrate to avoid overdose.
- Do not overheat the solution to prevent degradation of active ingredients.
- Maintain proper hygiene during preparation to prevent contamination.
- Ensure the final product is free of undissolved particles.
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Frequently Asked Questions (FAQs)
1. What is Terpin Hydrate Linctus used for?
Answer: Terpin Hydrate Linctus is primarily used as an expectorant to help loosen mucus in the airways, making it easier to cough up and relieve chest congestion.
2. Why is alcohol used in the preparation of Terpin Hydrate Linctus?
Answer: Alcohol acts as a solvent to dissolve terpin hydrate effectively and also helps in preserving the formulation.
3. Can Terpin Hydrate Linctus be prepared without chloroform spirit?
Answer: Chloroform spirit is used as a preservative. While optional, excluding it could reduce the shelf life and stability of the formulation.
4. What are the key precautions during preparation?
Answer: Avoid overheating the sugar solution and ensure accurate weighing of all ingredients to maintain pharmacopoeial standards.
5. Is Terpin Hydrate Linctus safe for children?
Answer: It should only be administered to children under medical supervision. Codeine-containing formulations may have age restrictions.