PRACTICAL 1

TITLE: PREPARATION OF MONOPHASIC LIQUID DOSAGE FORMS

OBJECTIVE:

1. Preparation of potassium permanganate solution BPC

2. Preparation of Syrup BP.
INTRODUCTION
Liquid dosage forms are available in the form of monophasic liquid dosage form and biphasic
liquid dosage form. Monophasic liquid dosage forms can be defined as liquid preparation
containing two or more components as a single phase system. It is also defined as true
solution which means a clear homogenous mixture that is prepared by dissolving solute in a
suitable solvent which is known as vehicle. Monophasic liquid dosage forms are also further
can be classified according to administration route. Examples of monophasic liquid dosage
form meant for internal route administration are syrups, mixtures, elixirs and linctus. Liquids
meant for external route of administration are further classified according to site of
application. Examples of liquid preparations applied on skin are lotions, liniments, collodions
and paint. Liqiud preparations that are used in mouth cavities are mouthwash, gargles and
throat paint. Monophasic liquid preparations instilled into body cavities are douches, ear
drops, nasal drops, eye drops and enema. The main concern in preparing monophasic liquid
preparations is solubility of the solute.It is very important to make sure that the active drug
ingredient and excipients are completely dissolved and free from foreign particles.In order to
increase the solubility of the active drug ingredient appropriate solvent must be used.Besides
that,suitable excipients such as surfactants can be used to increase the solubility of the
drug.The choice of excipient used must be inert and compatible with the drug and other
excipients so the stability of the monophasic liquid dosage preparation can be
maintained.Inappropriate selection of excipients results in negative influence on stability and
toxicity of dosage form.In addition to that, solubility of the solute also can be increased in
mechanical term such as increasing the temperature, increase stirring time and speed and
many more.The optimum solubility usually can be achieved by combination of both usage of
excipients and mechanical method.This will reduce the usage of unnecessary excipients and
ease the preparation of monophasic liquid dosage form.
PRINCIPLE:

Solution: Pharmaceutical solutions are clear and monophasic liquid preparations with one or
combination of vehicles. To prepare solutions all ingredients must be dissolved in selected
vehicle including active pharmaceutical ingredients.

Syrup: Pharmaceutical syrups consists of sugar dissolved in water. These are highly
concentrated, obviously viscous preparations. And they may or may not contain therapeutic
agent.

MATERIALS & METHOD:

Follow the manual

CALCULATIONS

a) Preparation of Syrup BP

1. The amount of sucrose needed

667g in 1000gm of water

X gm in 150gm of water

X = (150 x 667) / 1000

= 100.05gm of sucrose

2. The amount of preservative needed

0.15% of preservative in 1000gm of syrup

X gm of preservative in 150gm of syrup

X = (0.15/100) x 150

= 0.225gm of preservative

3. The amount of purified water required

= 150gm – (100.05gm of sucrose + 0.225gm of preservative)

 = 49.725gm of purified water needed

b) Preparation of Potassium Permanganate Solution BPC

1. The amount of Potassium Permanganate needed

2.0gm of potassium permanganate in 1000ml of purified water

X gm of potassium permanganate in 100ml of purified water

X = (2.0 x 100) / 1000

= 0.2gm of potassium permanganate

RESULTS:

DISCUSSION:

1. The syrup was produced by the method with the aid of heat. Mostly syrups are prepared
by this method. By this method the syrups are produced quickly as possible or when
the syrup’s components are not damaged or volatilized by heat. When using heat,
temperature must be carefully controlled to avoid decomposing and darkening the syrup
(caramelization). The use of boiled and purified water in the preparation of a syrup can
enhance its permanency. The addition of antimicrobial agents will increase the shelf
life of a syrup. As the syrup contains 66.7%w/w sucrose it is viscous enough and able to
 resist the growth of antimicrobials. The amount of preservatives used in syrups are
varies according to the proportion of water available of microbial growth and capability
of preservative itself. The commonly used preservatives in syrups are Benzoic acid (0.1%
to 0.2%), Sodium benzoate (0.1% to 0.2%), Methyl-, Propyl- and butyl parabens (0.1%).
The stability of syrups can be preserved by storing at low temperature, adding
preservatives in the formulation and by maintenance of a high concentration of sucrose
as part of formulation. In many cases, very concentrated syrups, sucrose tends to
crystallize form solution in low temperatures. This can be overcome by adding slightly
excess of water which will permits the syrups to maintain physical stability in varying
temperatures. Syrups retards oxidation because it is partly hydrolysed into reducing
sugars, such as dextrose.

2. The preparation of potassium permanganate solution does not require any antimicrobial
agents as potassium permanganate itself has antiseptic properties. Potassium
permanganate are less stable in liquid form than solid state. The potassium
permanganate solution must be stored in amber coloured bottle as potassium
permanganate is very light sensitive. When exposed to light, potassium permanganate
will photo decompose to form potassium manganate and manganese dioxide.
Potassium permanganate also should be stored in low temperature because increase in
temperature to extreme level will cause burning. Potassium permanganate should be
stored in closed bottles, away from any acidic vapours or volatile organic compounds.
KMnO4 solutions should be covered as they will slowly break down in open air, due to
dust or other chemical vapours. The solubility of potassium permanganate can be
increased by stirring it.

3. Packaging and storage also plays an important role in improving the stability of
monophasic liquid dosage forms. Potassium permanganate should be stored in amber
coloured bottles as they are light sensitive. It must be made sure that the bottles are
clean and free from any foreign particles prior to filling of solutions and syrups.

CONCLUSION:

Syrups and solutions are examples of monophasic liquid dosage forms. The solubility of
the active pharmaceutical ingredient is the main concern in formulation of monophasic
liquid dosage forms. The solubility can be achieved by addition of excipients and
 mechanical methods or combination of both. The packaging of dosage also plays an
important role in improving stability of monophasic liquid dosage forms.

REFERENCE:

1. Rees T. The stability of potassium permanganate solutions. Journal of Chemical

Education. 1987;64(12):1058.

2. Potassium permanganate [Internet]. Sciencemadness Wiki. 2018 [cited 11 November

2018]. Available from:
http://sciencemadness.wikia.com/wiki/Potassium_permanganate

3. Jones D. “Pharmaceutics-Dosage Form and Designs, London Pharmaceutical Press;

2008,pg 1-24

4. Florence A, Attwood D. Physicochemical principles of pharmacy. 4th ed. London:

Pharmaceutical Press; 2006, pg 113-123.

Questions:

1. Note down storage requirements for potassium permanganate solution and syrup.

Potassium permanganate should be stored in amber coloured bottles as they are light
sensitive. Potassium permanganate also should be stored in low temperature because
increase in temperature to extreme level will cause burning. The syrup must be stored at
low temperature and avoid from direct sunlight.

2. Note down label requirements for potassium permanganate solution and syrup

For labelling of potassium permanganate, it must clearly state that it is intended for for
external use only in red like “FOR EXERTERNAL USE ONLY” and the cap of the
bottle should be in red. The indication for potassium permanganate also must be stated
such as anti-septic, for disinfectant or for soaking purpose. If dilution is required, the
proper instruction must be written clearly and in simple manner. The storage details of
 potassium permanganate also must be stated like “Keep in cool and dry place, Avoid
from direct sunlight”. For labelling of Syrup BP, it must be clearly state that it is for
internal use only like “FOR INTERNAL USE ONLY” and the cap of the bottle should
be in black..The indication of syrup must state like “used as a vehicle”.The storage details
of syrup also must be stated such as “Keep in cool and dry place” and :Avoid from direct
sunlight”. For both the preparations, manufacturing date and expiry date must be stated.
Besides that warning like “KEEP AWAY FROM CHILDREN” must be stated for
safety purposes.

3. State applications of potassium permanganate solution

The uses of potassium permanganate solution are:

a) Infected eczema. A dilution of 1 part in 10,000is used. Add it to a basin or bath tub
and soak the affected part of the body.

b) Superficial wounds. Apply a dilution of 1 part in 10,000 to a bandage and apply it

over the wound. Change the bandage two to three times a day.

c) Athlete’s foot. For severe infections, soak the foot in a 1 part in 10,000 dilution of
potassium permanganate every eight hours.

d) Impetigo. Gently rub a dilution of 1 part in 10,000 on the affected skin to removed
loose bits of skin.

4. State advantages of syrup as vehicle

a) Used to mask the bitter taste of drug
b) Also can be used as viscosity enhancers.The higher concentration of sucrose
makes it more viscous
c) Preservative action of syrup.As the syrup contains concentration of sucrose
66.7% w/w , the syrup is resistant to microbial growth due to unavailability of
water required for the growth of microorganisms.
d) Thick character of syrup has soothing effect on irritated tissues of throat