The document describes the preparation of a 30 ml Piperazine citrate elixir BP. It provides the ingredients, quantities, and step-by-step procedure to make the elixir. Piperazine citrate is dissolved in water and then other ingredients like chloroform spirit, orange oil, and glycerin are added. Finally, simple syrup and water are added to adjust the final volume to 30 ml. The completed elixir is submitted for inspection in an amber bottle with storage instructions on the label.

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Experiment No.2
Aim:
To prepare and submit Piperazine citrate elixir BP (30 ml)
Requirements:
Piperazine citrate, chloroform spirit, orange oil, syrup, Glycerin, beaker,
stirrer, spatula, measuring cylinder, and purified water.
Principle:
Elixirs are clear, flavored, sweetened hydroalcoholic liquid preparations for
oral administration. The Percentage of alcohol varies from 4 to 40 %. In this
elixirs Propylene glycol, ethanol, and glycerol these are all acts a vehicle and
co-solvent to increase the solubility of poorly soluble ingredients.
Chloroform spirit acts as a preservative. Invert syrup acts as a sweetening
agent.
Formulation Table:
Ingredients
Quantity Prescribed
(100 ml)
Quantity taken
(30 ml)
Piperazine Citrate 18 gm 5.4 gm
Chloroform spirit 0.5 ml 0.15 ml
Glycerin 10 ml 3 ml
Orange oil 0.25 ml 0.075 ml
Syrup 50 ml 15 ml
Purified water up to 100 ml 30 ml
Note: All calculation will be done by student itself & the quantities of
ingredients are tentative and depends on the experiment performer.
Theory:
Elixir is monophasic liquid dosage form.
Elixirs are clear, flavoured, sweetened hydro-alcoholic liquid preparations
intended for oral administration. The percentage of alcohol varies from 4 to

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40 %. As compared to syrups, elixirs are easy to prepare, stable, less viscous
and less sweet.
In elixirs, propylene glycol, ethanol, and glycerol act as a vehicle and co-
solvent to increase the solubility of poorly soluble ingredients.
Glycerine act as co-solvent and increase the viscosity of solution.
Chloroform spirit acts as a preservative.
Simple syrup used as sweeter and used to mask unpleasant acid taste of
piperazine citrate.
Orange oil acts as flavouring agent.
Piperazine citrate: Acts as anthelmintic.
Anthelmentics are the antiparasitic drugs that expels parasitic worms
(round and tape worms) from the body.
Piperazine is an organic compound which consists of a six-membered ring
containing two opposing nitrogen atoms. Upon entry into the systemic
circulation, the drug is partly oxidized and partly eliminated as an
unchanged compound. Piperazine was first introduced as an anthelmintic in
1953. It is effective against the intestinal nematodes roundworm (Ascaris
lumbricoides), pinworm and threadworm (Enterobius vermicularis).
Piperazine produces a neuromuscular block led to muscle paralysis of the
worms which are consequently dislodged and expelled in the faeces.
Procedure:
1. Calculate approximate amount of purified water required for the
preparation: Approximately 6ml
How?
30 ml – (5.4 +0.15+ 3+ 0.075+15) = 30-23.625 = 6.375 ml
2. Dissolve 5.4 gm of piperazine citrate (5.4g) in purified water (2/3rd
) amount
of water i. e. 6.375 *2/3= 4.25 ml in mortal and pestle.
3. Add orange oil 0.075 ml. Add chloroform spirit 0.15 ml and glycerin 3ml
in the piperazine citrate solution with continuous stirring.
4. Now add simple syrup 15ml to above prepared solution with uniform
mixing clock wise in mortal and pestle.

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5. Then at last, adjust the final volume 30 ml with purified water q.s.
quantity sufficient) i.e 2.125 required.
6. Transfer the elixir to the narrow mouth dispensing bottle and label it and
dispense.
Uses: Anthelmintic
Dose: For round worms: single dose (up to 30ml)
For thread worm: 4-15ml daily in divided doses.
Direction: Shake well before use. Do not dilute with water.
Storage: Store in a cool place away from light.
OR
Stored in a well closed container at a temperature not exceeding 25 0C.
Sample format of Label:
Result: 30ml Piperazine citrate elixir BP is submitted in amour coloured
narrow mouth bottle for inspection with special instruction on label as store
in cool place away from light, temperature not exceeding 25°C.
MULTIPLE CHOICE QUESTIONS
Q. 1. What is the use of Glycerin in elixir?
Preservative
Vehicle
Colouring agent

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Flavouring agent
Q. 2. Chloroform spirit is used in elixir as ______.
Preservative
Vehicle
Colouring agent
Flavouring agent
Q. 3. Elixirs are hydroalcoholic preparations.
(b) False
(a) True
Q.4. Elixirs are protected from direct light.
(a) True
(b) False
Q. 5. Stabilizers are used in elixirs ______.
(a) as colouring agent
(b) as preservatives
(c) for stability
(d) for solubility
VIVA VOCE QUESTIONS
Q. 1. What is elixir?
Q.2. What are main components of elixir?
Q. 3. What is the difference between elixir and syrup?

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DIFFERENCES BETWEEN SYRUPS AND ELIXIRS
Sr.
No.
Syrup Elixir
1. Syrup is concentrated, viscous,
aqueous solution of sugar or a
sugar substitute with or
without flavor and medical
substance.
Elixirs are clear, pleasantly
flavored, sweetened hydro
alcoholic liquids intended
for oral use.
2. Syrups are thicker than elixirs. Elixirs are thinner than syrups.
3. Primary solvents is sugar and
water.
Primary solvents are alcohol
and water.
4. Syrups are more viscous than
elixirs.
Elixirs are less viscous than
syrups.
5. Syrup may or may not use an
alcohol for solubility purpose.
An elixirs must use alcohol for
solubility purpose.
Q.4. What is thread worm and round worm?
Threadworms, also known as pinworms, are tiny parasitic worms that infect the
large intestine of humans. Threadworms are a common type of worm infection,
particularly in children under the age of 10. The worms are white and look like
small pieces of thread. Intestinal parasitic worms which infect at least 20% of
children at any one time. Enterobius vermicularis is a small, white worm about 1
cm long with a blunt head and a fine, hair-like, pointed tail. Eggs are laid on the
skin around the child's anus and itching causes scratching and reinfection via the
mouth. Threadworms can be removed with drugs such as mebendazole or
piperazine, but all the members of the family must be treated. Also known as
pinworms.
Roundworm: A type of parasitic worm that hatches in the intestines and lives
there. The eggs of the roundworm usually enter the body through contaminated
water or food or on fingers placed in the mouth after the hands have touched a
contaminated object. Symptoms of roundworm infections include fatigue, weight
loss, irritability, poor appetite, abdominal pain, and diarrhea. Treatment with
medication results in a cure in about a week. Without treatment, anemia and
malnutrition can develop. An example of a roundworm is Trichuris trichiura, also
known as the human whipworm. This worm is found worldwide, but infections
are most frequent in areas with tropical weather and poor sanitation practices, and
among children.

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Q.5. Why a single dose therapy is used for round worm infection?
Albendazole is used to treat round worm infection as drug has terminal
elimination half-life ranges from 8 to 12 hours (single dose, 400mg). Hence
single dose therapy is used for round worm infection.
Q.6. How elixirs are prepared?
Elixir
(a) Definition:
The USP XVII defines elixirs as a clear, sweetened hydro-alcoholic liquid
intended for oral use containing flavouring substances or active medicinal
agents.
The primary solvents in elixirs used are:
Alcohol and water, with glycerin, sorbitol and syrup as an additional solvent
and/or sweetening agents.
Method of preparation:
1. Dissolve the water-soluble ingredients in part of the water, add and
dissolve the sucrose in it.
2. Dissolve the other ingredients in the alcohol. (Concentration of alcohol
should be 5- 40% to make clear solution).
3. The aqueous solution is then added to the alcoholic solution with constant
stirring and makes up the volume with the solvent or vehicle specified in the
formulation.
4. Sucrose increases viscosity but decreases the solubility properties of water
and so must be added after the primary solution has been carried out.
5. The high alcoholic content is maintained during preparation by adding an
aqueous phase to the alcoholic solution.
6. Elixirs should be brilliantly clear and therefore strained or filtered, if
necessary, subjected to clarifying action of purified talc or siliceous earth.
Use:

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They are used either as vehicles or for the therapeutic effect of the medicinal
substances that they contain.
(b) Classification:
1. Flavoured elixirs: These are used for flavouring purpose and as vehicles
in other liquid preparations for oral use.
2. Non-medicated elixirs:
1. Simple, no therapeutic agents.
2. May only contain alcohol, sweetening agents, colouring agents.
3. Self-preservative.
Uses:
1. They are used purely as diluting agents.
2. Solvents for drugs [containing approximately 25 percent alcohol, e.g.,
simple elixir, Iso-alcoholic elixir or low alcohol elixir (containing 8-10%
alcohol), High alcoholic elixir (containing 75-78% alcohol)].
Example:
Aromatic Elixir U.S.P.
Isoalcoholic Elixir etc.
3. Medicated elixirs:
Examples:
Dexamethasone Elixir U.S.P. (to treat conditions such as arthritis,
blood/hormone disorders, allergic reactions, skin diseases, eye problems,
breathing problems, bowel disorders, cancer, and immune system disorders. It is
also used as a test for an adrenal gland disorder) (Cushing's syndrome).,

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Phenobarbital Elixir U.S.P. etc. (in the treatment and prophylaxis of febrile
seizures.)
4. Dry elixirs:
1. Dry elixirs containing a non-steroidal anti-inflammatory drug and ethanol
were encapsulated in dextrin.

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2. The dissolution rate constant of the drug from the microcapsules usually
increased considerably compared to the drug alone, possibly due to the
cosolvent ethanol.
Examples:
Dexibuprofen Dry Elixir (to treat painful conditions such as arthritis, sprains
and strains, period (menstrual) pain, and dental pain.),
Nifedipine Dry Elixir, etc. (to treat high blood pressure)
Formulation of Elixirs
Generally, elixirs contain the following ingredients:
1. Vehicles:
About 10-20% of alcohol is used for keeping oils, vegetable extracts, tannins,
etc. in solution form. (Tannins: A yellowish or brownish bitter-tasting organic
substance present in some galls, barks, and other plant tissues, consisting of
derivatives of gallic acid.)
Glycerol and propylene glycol are used as a solvent.
2. Stabilizers:
In neomycin elixir, citric acid is used to adjust pH 4.0 to 5.0 to minimize the
darkening that occurs on storage.
Disodium edetate should be used to isolate heavy metals that catalyse the
decomposition of antibiotics.
3. Flavouring agents:
Sweetening agents and fruit flavors are used in medicinal preparation.
e. g. (i) Black currant syrup in chloral Elixir,
(ii) Compound orange spirits with glycerol in phenobarbital elixir.
4. Preservatives:
In elixir, fermentation and mold growth are inhibited when it contains more
than 20% of alcohol, propylene glycol, or glycerol.
The commonly used preservatives are double strength chloroform, spirit,
and benzoic acid, and methyl ester of p- hydroxybenzoic acid.
(c) Advantages of Elixirs:

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1. Elixirs maintain both water-soluble and alcohol-soluble components in
solution.
2. They are more stable because of self-preservation property.
3. They are easily prepared by simple solution method.
4. They are used as vehicle and for dilution of medicated elixirs
5. They are good at masking taste of bitter drugs and excipients.
6. Elixirs have low viscosity and thus flow more freely.
7. These are flexible and easy to administer to patients having swallowing
problems.
(d) Disadvantages of Elixirs
1. Less effective than syrups in masking taste of medicated substances.
2. Contains alcohol that accentuates saline taste of bromides as well as they
can nasty/ unpleasant to children and adults who avoid alcohol.
3. As syrups contain volatile components, they need to be stored in airtight
containers to prevent losses.
4. They should not be stored in the vicinity of heat source.
(e) Formulation of Elixir: Aromatic Elixir USP
Ingredients Quantity Use
Compound Orange Spirit 12 mL Flavour
Syrup 375 mL Sweetener
Talc 30 g Adsorbent
Alcohol and Purified water q s.to make 1000 mL Vehicle
Method of Preparation:
1. Add sufficient quantity of alcohol to the compound orange spirit to make
250 mL.
2. Add to this the syrup in several portions, agitating vigorously after each
addition and then add the same manner, the required quantity of purified
water.

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3. Mix the talc with the liquid and filter through a filter wetted with diluted
alcohol, returning the filtrate until a clear liquid obtained.
4. Compound Orange Spirit in this formulation is used to ensure a uniform
proportion of the several oils (i.e., orange, lemon, coriander, and anise), in
every lot of the elixir.
5. The alcoholic solution also preserves the delicate flavours of orange and
lemon for a considerable time.
Use: Pleasantly flavoured vehicle in the preparation of many medicated
elixirs.
(f) Storage of Elixirs:
1. Similar to syrups, elixirs are also preserved in tightly closed, light-resistant
containers avoiding exposure to excessive heat, light and moisture until it is
opened, and in some case,
2. It must be stored in a refrigerator till its consumption.
3. Elixir preparation under use must be properly closed after withdrawal of
dose and,
4. Stored at places that prevent environmental effects, away from children.
(g) Quality Control Tests:
(1) Sucrose concentration:
There is no specific method for the determination of sucrose in syrup, but
one can use HPLC and UV-spectroscopy for this purpose.
(2) Alcohol content:
The quantitative determination of alcohol is performed using distillation
method unless otherwise specified in the individual monograph. The amount
of alcohol in preparation headspace in a container is determined by gas
chromatography.
(3) Refractive index:
The refractive index of elixirs is determined by using Abbe's refractometer.
It should be in the range of 1.4608 to 1.4630.
(4) Other quality control tests:

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Used include visual inspection, consistence, identification, pourability,
viscosity, relative density, pH, clarity or opalescence, cap locking,
sterilization and precipitation, light transmittance, microbial limit and
physical stability similar to the solution and syrup preparations.