This PPT contain Monophasic Liquid Dosage Forms

1. MONOPHASIC DOSAGE FORMS
(For internal administration)
PREPARED BY:
Bhargavi Mistry
[Assistant Professor, School of
Pharmacy Rk University]

2. Prepared by: Bhargavi Mistry 2
LIST OF
CONTENT
1) Introduction 03
2) Classification 04
3) Simple mixture 05
4) Concentrates 08
5) Syrups 10
6) Elixirs 13
7) References 17
8) Questions 18

3. INTRODUCTION
Prepared by: Bhargavi Mistry 3
Ø “Monophasic” suggest that this system contains only one phase, no matter, whether the
components might be a minimum of two or more than two.
Ø Therefore, monophasic can be defined as a homogeneous one-phase system,
consisting of two or more components. Where one phase is solvent and the other is
solute.
Ø In general, the solvent is present in large quantities but there are a few exceptions like
simple syrup I.P, which contains 66.7% w/w of sucrose (solute) and 33.3% w/w water
(solvent).

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MONOPHASIC
FORMULATIONS
Liquids for internal
administration
Liquids for external
applications
1) Simple mixtures (monophasic)
and concentrates.
2) Syrups
3) Elixirs
1) Gargles
2) Mouthwashes
3) Throat paints
4) Douches
5) Enemas
6) Ear drops
7) Nasal drops & sprays
8) Liniments
9) Lotions
CLASSIFICATION

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Ø Simple monophasic mixtures can be called solutions which might be prepared by
combing solid or liquid in some other suitable vehicle.
ADVANTAGES
1) They can be given to children and adults, who have difficulty swallowing tablets &
capsules.
2) On set of action is rapid.
3) Clear solutions are able to detect any degradation of the drugs(s) in form of
precipitation, color change or bad odor of the drug.
4) They provide uniform dosage.
SIMPLE MIXTURE (Solution)

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DISADVANTAGES
1) They are less stable than solid dosage forms because of the fair chances of
decomposition of drugs in solution form.
2) Sometimes, find it difficult to mask the unpleasant taste of the drugs in solution form.
3) They are found difficult to carry because of their bulk and weight
4) There are chances of dose variation if given either by spoons or measuring cup.
5) Sudden breakage of glass bottle spoil whole of the product.
FORMULATION
Ø To formulate any monophasic mixture, a pharmacist requires mainly two components
i.e. soluble drug(s) & a suitable vehicle.
Ø Adjuncts are required to be added to the formulation if the drug(s) are poorly soluble, to
enhance the aesthetic property of the solution, or to improve the stability of the drug.

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METHODS FOR PREPARATION
SIMPLE SOLUTION
METHOD
CHEMICAL REACTION BY EXTRACTION
When a solute is dissolved in
a suitable solvent or vehicle.
E.g.
Compound sodium chloride
solution
When components of the
formulations are reacted
together in a suitable solvent
or vehicle.
E.g.
Hydrogen peroxide/solution
USP
When therapeutically active
ingredients from crude drugs,
whether of vegetable or
animal origin, are extracted
with water as a solvent or
with other solvents.
E.g.
Capsicum tinctures
01 02 03
EXAMPLES
1) Iodine tincture, I.P
2) Lugol’s solution, I.P
3) Cresol with soap solution

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Ø It is a concentrated monophasic preparation intended for oral administration in which
drug(s) is dissolved in a suitable vehicle.
FORMULATION
Ø To Formulating concentrated aromatic water, requires three components, Aromatic oil,
co-solvent & solvent/vehicle.
Ø VEHICLES:
Purified water is the only vehicle to prepare aromatic water. Sometimes, to enhance the
solubility, volatile oils and co-solvents like alcohols, glycerin, propylene glycols, etc.
Ø ADJUNCTS:
Distributing agents/ filter aid. E.g.: Talc.
CONCENTRATES

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METHODS FOR PREPARATION
DISTILLATION
METHOD
SOLUTION METHOD
ALTERNATIVE
SOLUTION METHOD
When distillation of the drug
is employed with purified
water.
2 ml volatile oil or 2 gm of
aromatic substances is shaken
with 1000 ml purified water
for 15 mins. Then, it is set
aside for 12 hrs for complete
saturation. And after that filter
the resultant solution.
In this method, 2 ml/ 2 gm of
volatile oil or substance, is
incorporated into talc with a
sufficient quantity of water.
Then mix with 1000 ml of
water and agitated for 10
mins. Then filter the resultant
slurry.
01 02 03
EXAMPLES
1) Concentrated anise water, B.P
2) Concentrated camphor water, B.P

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Ø It is a sweetened, viscous, concentrated solution of sucrose or other sugars in water or
any other suitable aqueous vehicles.
Ø Syrup can be divided into two types:
1) Simple flavoured syrup:
This syrup does not contain any medicament but contains some aromatic or
pleasantly flavoured substances.
2) Medicated syrups:
This syrup contains some medicinal substance(s) along with other additives.
SYRUPS

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ADVANTAGES
1) They provide pleasant means of administering a liquid form of a disagreeable-
tasting drug.
2) They are very much liked by youngsters and children.
3) They do not contain alcohol or if added, only in a very little volume.
4) They are suitable for any water-soluble stable drugs.
DISADVANTAGES
1) They are not suitable for diabetic patients.
2) Pleasant taste might have attracted the children to take more than the required dose.
3) If sucrose concentration is not proper i.e. 66.7% w/w, it is prone to microbial growth,
which requires the addition of preservatives.
4) Highly concentrated syrup may get crystallized if other substances like glycerin,
sorbitol, and other polyols are not added.

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METHODS FOR PREPARATION
SOLUTION BY USING
HEAT
SOLUTION WITH
AGITATION
PERCOLATION
METHOD
Sugar is added to the purified
water, and heat is applied
until a solution is affected.
The solution is allowed to
cool and the volume is
adjusted.
Sugar and other ingredients
are dissolved in purified
water and allowed to agitate
the mixture for a longer time
till all components get
dissolved.
Sucrose is percolated with
purified water(solvent). The
water is allowed to pass
through crystalline sucrose.
01 02 03
EXAMPLES
1) Simple syrup I.P
2) Ferrous sulphate syrup, U.S.P
FORMULATION
1) Sugar
2) Preservatives
3) Flavouring agents
4) Colouring agents
5) Stabilizers

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Ø Elixirs are clear, flavored, sweetened hydroalcoholic liquid preparations for oral
administration. The percentage of alcohol varies from 4 - 40%.
Ø Elixirs can be divided into two types:
1) Non-medicated elixir:
This type does not contain any medicament but contains some aromatic or pleasantly
flavored substances.
These elixirs are used as vehicles for other liquid preparations.
2) Medicated elixir:
This elixir contains some medicinal substance(s) along with other additives.
ELIXIRS

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ADVANTAGES
1) Hydroalcoholic environment maintains both water-soluble and alcohol-soluble
drugs in solution. Hence, elixirs are better than syrups in regard to stability.
2) Elixirs containing over 10 to 12% of alcohol are usually self-preservative and do
not require the addition of preservatives.
3) Elixirs are less viscous than syrups, and thus do not create difficulty in filtration
operation.
4) Elixirs are simple in manufacturing as prepared by simple solution method.
DISADVANTAGES
1) Elixir is less effective than syrups in masking the taste of medicinal substances.
2) Elixirs having a high percentage of alcohol require a sweetening agent other than
sucrose since sucrose is slightly soluble in alcohol.

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FORMULATION
Vehicle It should be hydroalcoholic, thus both purified water and
alcohol are needed to prepare a solvent system.
Sweetening agents Sucrose is used as the sweetening agent.
Saccharine is added only when the percentage of alcohol is
high.
Flavouring agents Volatile oils are the best selection for this purpose.
Colouring agents They are required to improve the appearance of elixirs.
Preservatives Do not require preservatives if it contains alcohol of more
than 10% & volatile oil as flavoring agents.

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EXAMPLES
1) Piperazine citrate elixir
2) Phenobarbital elixir USP
METHOD OF PREPARATION
Dissolve alcohol-soluble and water-soluble ingredients
separately in alcohol and water respectively.
The aqueous solution is added to the alcoholic solution.
When two solutions are completely mixed, make u the
volume with the vehicle.

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REFERENCES
1) Dr. A.K. Seth, A textbook of pharmaceutics, 2nd edition 2022, Pee Vee publication,
Page no. 273-285
2) Dr. G. K. Jani, Pharmaceutics 2, 6th edition, B. S. Shah Prakashan, Page no. 180-186

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QUESTIONS
1) Write a detailed note on the mixture and concentrates.
2) Write a brief account of syrup.
3) Write the advantages, disadvantages, and formulation aspects of syrup.
4) Define elixir. Discuss formulation aspects and give examples.
5) Enlist monophasic liquids for internal use and explain any one in detail.

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THANK YOU