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Technology-1 PHR212.2
Technology-1 PHR212.2
June 7, 2020
DEPARTMENT OF PHARMACEUTICAL SCIENCES
[Company address]
1. What is meant by the physical stability of a pharmaceutical suspension? Discuss
the factors affecting the physical stability of a suspension. (8)
Ans: Suspension is a pharmaceutical preparation in which solid particle (drug) is uniformly
distribute into a liquid disperse system. It is a heterogeneous system. The solid particle does not
dissolve in liquid phase, so it is very necessary to maintain the drug stability. There are two
stability to maintain which are chemical stability and physical stability. Physical stability for
suspension means uniform distribution of drug particle in disperse medium. Uniform distribution
of drug particle is dependent on particle size, wetting of the particle, sedimentation etc. Example:
the standard size of the particle is 1-50 micro meters. If the particle size is more than this it may
cause sedimentation and if the size is less that this it may form a compact cake setting at bottom
of the containers. Both of the suspension will lose its physical stability. So the uniform
distribution of particle size can maintain the physical stability of suspension. [1]
F a c t o r s e ff e c ti n g p h y s ic a l
There are some factor which should be considered as they can be responsible for hampering the
stability of a pharmaceutical suspension. Those are ;
wetting agent
sedimentation
Deflocculation and
flocculation
Solid
particles Hydrophilic can be
dispersed easily
Suspending
media
B-Particle size:
Particle size of any suspension is critical and must be reduced within the range.
If the particle size is too big it will not disperse in the suspension rather it will settle in
the bottom of the jar or due to Brownian movement the particle will aggregate and form a
hard cake which can be irreversible.
If the particle size is too small, particles will easily form hard cake at the bottom of the
container.
Particles size greater than 5μm may cause irritation when it will be injected to the eye.
Particles size greater than 25 μm may block a needle.
C-Sedimentation:
d2 (p1-p2) g
v =
18
Where:
v = velocity of sedimentation
g = acceleration of gravity
According to the Stoke's equation, by decreasing the particle size, the velocity of
sedimentation of particles and the difference between the densities of the particles and the
vehicle can be reduce.
The viscosity of the vehicle also affects the velocity of sedimentation. Velocity of
sedimentation decreases as the viscosity of the vehicle increases. The viscosity and
density of any vehicle are inversely proportional.
The following table illustrates the relative properties of flocculated and Non-
flocculated suspension:
It should be noted that the deflocculated suspensions should be avoided
because of the formation of irreversible solid hard cake. Although
flocculated suspensions sediment faster and form a clear supernatant, these
are easy to re-disperse
These are the factors that affects the physical stability of a suspension.
Antacids are basic substances which on ingestion react with gastric acid and lower the acidity of
gastric content, chiefly used in the treatment of hyperchlorhydria peptic ulcer, heartburn,
indigestion or gastroesophageal reflux disease. It is recently widely used to reduce hyperacidity
of stomach. Antacids are available over the counter and are taken orally to quickly relieve the
abovementioned complications temporarily. The hydroxide is the base most commonly
employed in antacids, but carbonate, bicarbonate and trisilicate ions are also used. The
therapeutic efficacy and adverse effects depend on the metallic ion with which the base is
combined and this is usually aluminum, magnesium or sodium. Antacid is available in various
dosages form. Example tablet, syrup, suspension etc.
There are lots of preparation method for antacid suspension. For large scale production many
machineries are used. the small scale (50ml) lab rotary production of antacid is described below:
Materials:
Apparatus:
Glycerin 5ml
Color q.s.
Flavor q.s.
The mechanism action of an emulsifying agent according to the theories are described below:
When a glass of water is added in a glass of oil, it does not dissolve with each other. Both of
these immiscible liquid create two layers. One phase is water and another phase is oil.
There is a layer where these two immiscible liquid has met, this layer is called an interface. The
surfactant works int this interface .the surfactant has two ends. One is hydrophobic, it works with
oils and another is hydrophilic it works with water.
Because of the two distinct nature of the two liquid, it repels with each other. When the
surfactant is added it works in the interface layer by minimizing the interfacial tension of the two
liquids.it reduces the repletion between the two immiscible. Also, it reduces the attraction
between own molecule by breaking the molecule in small. By this, the molecule loses its
tendency to attract the same molecule. Thus, it can dissolve with another liquid system.
3.The plastic or interfacial film theory of emulsification: This is also known as absorption
theory. the surfactant is finely divided into the particle, the works at interfacial layer. When the
surfactant added in the liquid they surround the oil molecule in the water-oil emulsion. This
surfactant is absorbed by the oil globules and it makes the globule smaller.so this small molecule
dissolves in the water phase and makes the emulsion stable.
7. Classify emulsifying agents and write about the properties of each class. (8)
Ans: The substance which are added to a emulsion in order to prevent the coalescence of the
globules in the liquid immiscible phase are called emulsifying agent.
They are also known as emulsifiers. They act by reducing the interfacial tension between the two
immiscible liquid phases and help to form a stable emulsion. For formulating a stable emulsion,
choosing the right emulsifying agent is important. Sometimes a single emulsifying agent can not
provide all the desirable properties for stabilizing the emulsion. For those cases, mixture of
emulsifying agent is used.
There are major types of emulsifying agent:
Emulsifying agent
1. Natural emulsifying agents: These emulsifying agents are collected from natural source.they
are non-toxic and mostly used for the oral and parental dosage form. Example: tragacanth,
acacia, agar, pectin and starch. These are collected from a natural vegetable source. Gelatin, Egg
yolk and Wool fat (anhydrous lanolin) are emulsifiers which are collected from animal sources.
Properties;
Found from the natural source. Example: Vegetable and animal source
Non-toxic
Carbohydrates act a good medium for the growth of microorganism, therefore emulsions
prepared using these emulsifying agents have to be suitably preserved to prevent
microbial contamination.
Agar, tragacanth which is thicking agent is used in the emulsion to reduce the creaming
effect
Type A gelatin (Cationic) is generally used for preparing o/w emulsion while type B
gelatin is used for o/w emulsions of pH 8 and above.
2.Synthetic emulsifier: Synthetic emulsifying agent is the most used emulsifying agent. This
emulsifier is used for large scale industrial preparation. Synthetic emulsifying agents are;
sodium carboxymethylcellulose, hydroxypropyl cellulose and methylcellulose. They are used
for formulating o/w type of emulsions.
not change the pH of the emulsion because of the presence of electrolytes. Example
Polyoxyethylene sorbitan monooleate (Tween80) and Polyoxyethylene sorbitan
monolaurate
Anionic synthetic agent: anion of the molecule act as an emulsifying agent. Example
sulfonates.
3. Surface active agent / Surfactants: Surfactant are an emulsifying agent which reduce the
surface tension by absorbing in oil phase . it has two ends one is hydrophilic which act on water
surface and another is hydrophobic which act on oil surface of a oil-water emulsion
Properties:
Surfactants can be divided into 3 types. Non-ionic, anionic and cationic.
In anionic agent lipophilic portion id negatively charge and in cationic portion lipophilic
portion is positively charged .both positive and negative charge interact with each-other
and neutralized each other.
It can be bactericidal.
pH is 3-10
Example: organic soaps such as triethanolamine oleate.
8. What are the signs of a deteriorated emulsion? Discuss briefly the reasons for
deterioration of emulsion. How to correct those? (8)
Ans: Emulsion is a pharmaceutical liquid preparation where two-phase are immiscible and one
phase is dispersed as globule in the other liquid phase which is stabilized by an emulsifying
agent. Like other liquid preparation, the emulsion is not very stable and many precautions are
taken to make it stabilized. The emulsion is considered unstable when;
o The disperse phase form aggregates of globule
o The aggregation of globule rise to the top or bottom of the emulsion
o If the two-phase separate and form a distinct layer.
There are certain factors which are responsible for the deterioration of emulsion. Those are
discussed below ;
Flocculation :
• Flocculation is a weak reversible process between emulsion droplets which are separated by the
dispersion phase . However, a gentle agitation can re-dispreads the aggerates . It is considered as
a precursor to the irreversible coalescence.
• It differs from coalescence mainly in that interfacial film and individual droplets remain intact.
•The reversibility of flocculation depends upon the strength of the interaction between particles
as its depends on the charges on the surface of the emulsified globules.
It is the strategy during which droplets join with each other and form large globule. this globule
cannot be recovered by simple agitation. When two droplets get contact i.e. as a floccule, thin
liquid films composed of the continual phase and adsorbed emulsifier are formed between them.
Coalescence takes place in two distinct steps. It begins with the drainage of these films because
the droplets approach one another and ends with film rupture. Hence, the key factor which
prevents coalescence is that the mechanical strength of an electrical barrier. that's why natural
gums and proteins are so useful as auxiliary emulsifiers when used at a low level, but can even
be used as primary emulsifiers at high concentration. Unlike creaming it's an process. .
the
decomposition
of emulsifying
agents
produce
rancidity in
contaminate
the oil and
the aqueous
destroy oil
phase
soluble
vitamins
Phase inversion
In phase inversion o/w type emulsion changes into w/o type and vice versa. It is a physical
instability. It may be brought about -
By the addition of an electrolyte
by changing the phase volume ratio
by temperature changes.
Phase inversion can be minimized by:
1- use of proper emulsifier
2- keeping the concentration of dispersed phase between 30 to 60 %
3-storing the emulsion in a cool place.
These are the classification of emulsifying agents and the properties of each class has been
discussed above.
This method is not suitable for viscous oil. This method is useful for the preparation of emulsion
of extremely sensitive oils like volatile oil which have low viscosity.[2]
11. What is the general principle of ointment preparation? Describe various methods of
ointment preparation. (8)
Ans: Ointments are semi-solid preparations intended for external use, this is easily spread and
their plastic viscosity may be controlled by modification of the formulation. Ointments are
typically used as Emollients (that make the skin more pliable), Protective barriers (which prevent
harmful substances from coming in contact with the skin), Vehicles (in which to incorporate
medication).[3]
The general method of ointment preparation. There are 2 types of the general method of ointment
preparation.
general
mathod
incorporation fusion
method method
In the incorporation method, it involves the blending of the ingredient into the vehicle. for small
volumes, a glass slab and a pair of spatulas are used and for larger volumes, mortar and pestle is
used.
Fusion method:[4]
This method is used when the base contains solids that have higher melting points such as waxes,
cetyl alcohol and glyceryl monostearate. This method is also useful for solid medicaments that
are readily soluble in melted bases.
The method is given below:
From the discussions above, we can learn that ointment can be prepared in these methods.
12. Describe the important properties of any ten (10) gelling agents. (8)
Ans: a gel is a semisolid liquid preparation. Gels are semisolid systems consisting of dispersions
of small or large molecules in an aqueous liquid vehicle rendered jelly-like by the addition of a
gelling agent It can use mediation purpose and non-mediate purpose.in pharmaceutical industry
the use of gel as a vehicle is increasing day by day. Gelling agents are the gel-forming mediators,
which thicken and stabilize the formulation.
Tragacanth:
Acacia:
Gelatin:
Sodium alginate:
Polyvinyl alcohol:
For the get preparation, 2.5% of polyvinyl alcohol is used.
It is a water-soluble synthetic agent
It becomes dry when it applies to the skin
Polyvinyl alcohol first dissolve in cold water the hot water is added to it
Methylcellulose:
Plastibase:
It is a mixture of polyethene (5%) and mineral oil (95%)
It is liquid at 900C
Below the 900C it became a gel-like substance
Agar:
Carboxymethylcellulose:
pH 7 to 9
medium stabile.
Bentonite:
So, we can see from the discussions above that these are the important properties of any ten
gelling agents.
References
1. Luckham, P. F. (1989). The physical stability of suspension concentrates with particular
reference to pharmaceutical and pesticide formulations. Pesticide Science, 25(1), 25-34
2.