Seminar on

DISPERSE SYSTEM PRODUCTION

by
Nayala Firdous
(170713886005)

MASTER OF
Under The Guidance Of
PHARMACY
DR.MUQTADER DEPARTMENT OF
AHMED PHARMACEUTICS
M.Pharm,Ph.D DECCAN SCHOOL
Head Of Department Of OF PHARMACY
Pharmaceutics Dar-us-salam, Aghapura,
Hyderabad-01. A.P. India

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INTRODUCTION

 A disperse system is defined as a heterogenous, two phase

system in which the internal (dispersed, discontinuous) phase
is distributed or dispersed within the continuous (external)
phase or vehicle.

 Based on the particle size of the dispersed phase,

dispersions are generally classified as

 Molecular dispersions

 Colloidal dispersions and

 Coarse dispersions.

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Classification of dispersed system by
particle size

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FORMULATION ADDITIVES

 Surfactants

 Protective Colloids and Viscosity-Imparting Agents

 pH-Controlling Agents

 Preservatives

 Antioxidants

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COARSE DISPERSION

 Coarse dispersions are heterogeneous dispersed systems, in

which the dispersed phase particles are larger than 1000 nm.
Coarse dispersions are characterized by relatively fast
sedimentation of the dispersed phase caused by gravity or
other forces. Dispersed phase of coarse dispersions may be
easily separated from the continuous phase by filtration.

 Includes:

a. Suspensions and

b. Emulsions

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SUSPENSION

 Typically, the suspensions with particle size greater than ~1

µm are classified as coarse suspension, while those below 1
µm are classified as colloidal suspension. When the particles
constituting the internal phase of the suspension are
therapeutically active, the suspension is known as
pharmaceutical suspension.

 Ideally, the internal phase should be dispersed uniformly

within the dispersion medium and should not sediment during
storage.

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Sedimentation and Stokes’ Law

 A flocculated suspension sediments faster and is

easy to redisperse, whereas a deflocculated
suspension sediments slowly and is difficult to
redisperse. The rate of sedimentation of particles
can be determined by Stokes’ law:

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Important Considerations in Formulation
of Suspension

 Nature of suspended material

 Size of suspended particles
a) Micropulverization
b) Fluid energy grinding
 Viscosity of the dispersion
medium

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EMULSION

 An emulsion is a dispersion of at least

two immiscible liquids, one of which is
dispersed as droplets in the other
liquid, and stabilized by an emulsifying
agent. Two basic types of emulsions
are the oil-in-water (O/W) and water-in-
oil (W/O) emulsion. Depending upon
the need, more complex systems
referred to as “double emulsions” or
“multiple emulsions” can be made,
water-in-oil-in-water (W1/O/W2) or oil-in-
water-in-oil (O1/W/O2).

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Mechanism of Emulsification

 When two immiscible liquids are in contact with each other,

the molecules at the interface experience an imbalance of
perpendicular forces. The interfacial tension tend to minimize
the surface area of individual liquids.

 The process of dispersion of one liquid in the other results in

an increase in surface area between the dispersed droplets
and dispersion medium, and surface free energy, which can
be expressed as follows:

∆W = γ∆ A

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HLB ranges of surfactants

 The amphiphilc nature of surfactants can be expressed in

terms of an empirical scale of so-called hydrophile–lipophile
balance (HLB) system, established by Griffin. The HLB
system provides a scale of hydrophilicity (0–20) and the
relationship between HLB values and the expected activity
from surfactants
HLB range is Application
1–3 Antifoaming
3–6 W/O emulsifier
7–9 Wetting agent
8–18 O/W emulsifier
13–15 Detergent
15–18 Solubilizer

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COLLOIDS AND COLLIODAL DISPERSION

 A colloid is defined as a system consisting of discrete particles in

the size range of 1 nm to 1 mm, distributed within a continuous
phase.

 Molecules of a hydrophilic colloid have an affinity for water

molecules and when dispersed in water become hydrated.
Hydrated colloids swell and increase the viscosity of the system,
thereby improving stability by reducing the interaction between
particles and their tendency to settle.

 A hydrophobic colloid has little or no affinity for water

molecules in solution and produces no change in system
viscosity. Department of Pharmaceutics 12
GELS AND MAGMAS

 Gels in which the  When the gel mass

macromolecules are
distributed so that no
apparent boundaries exist
between them and the
liquid are called single-
phase gels.
consists of floccules of
small, distinct particles, the
gel is classified as a two-
phase system and
frequently called
a magma or a milk.

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Parenteral Emulsions
 In addition to the general
requirements for parenteral
products (e.g., sterility,
nontoxicity, and stability),
particular attention must be paid
to the droplet size and surface
charge of parenteral emulsions,
since these parameters can
directly affect both toxicity and
stability.
administration.
PARENTERAL DISPERSE SYSTEMS
Parenteral Suspensions
 Parenteral suspensions
consist of a solid phase, which
is dispersed within a liquid
phase.
 Because of particle sizes in
the micrometer range,
parenteral suspensions are
generally limited to either
subcutaneous or
intramuscular routes of
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EQUIPMENTS
PROPELLER MIXERS ROTOR/STATOR MIXER

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STATIC MIXER
 A static mixer is a precision engineered device for the continuous
mixing of fluid materials.

 The energy needed for mixing comes from a loss in pressure as

fluids flow through the static mixer.

 The typically helical elements can simultaneously produce patterns

of flow division and radial mixing.

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MICROFLUIDIZER TECHNOLOGY

 The interaction
chamber consist of
microchannels as
narrow as 50 microns
and cause the flow of
product to occur as
very thin sheets.

 Used to prepare
unilamellar liposomes
and micro emulsions.

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HIGH PRESSURE HOMOGENIZER

 The use of high pressure

homogenizers is
recommended when a
disintegration down to the
nano range is required.

 The pressure build-up within

the HPH occurs by means of
piston pump ensure(s) a
volume flow that is
independent of pressure and
virtually pulsation free.
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THREE ROLL MILLS

 A three roll mill is a

machine that uses shear
force created by three
horizontally positioned rolls
rotating in opposite
directions and different
speeds relative to each
other, in order to mix,
refine, disperse, or
homogenize viscous
materials fed into it.
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COLLOID MILL

 Colloid Mill is an ideal

and perfect
homogenizer-cum-
emulsifier. It finds its
application in various
processes like
grinding,
homogenizing,
emulsifying,
dispersing, mixin,
extracting etc.
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PHYSICAL STABILITY CHEMICAL STABILITY

 Particle-particle interaction  Most of the drug materials

and its behaviour although insoluble, when

 Interfacial properties of solids suspended in a liquid medium

has some intrinsic solubility,
 Poly-dispersity: (variation in
which triggers the chemical
particle size)
reactions such as hydrolysis,
to occur leading to
degradation.

SUSPENSIONS STABILITY

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PHYSICAL INSTABILITY
 Creaming (sedimentation)
and its avoidance.
 Flocculation prevention.
 Coalescence (breaking,
cracking)
EMULSIONS STABILITY
CHEMICAL INSTABILITY
 Oxidation
The rancidity is manifested by
the formation of degradation
products of unpleasant odour
and taste. These problems
can occur with certain
emulsifying agents, such as
wool fat or wool alcohols.
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REFERENCE
• Modern pharmaceutics, Forth edition Revised and
expanded edited by Gilbert S. Banker University of Iowa
Iowa City, Iowa Christopher T. Rhodes University of Rhode
Island Kingston, Rhode Island, Marcel Dekker, New York.
• Alok K Kulshreshtha, Onkar N. Singh, G. Micheal Wall
Pharmaceutical Suspension from formulation development
to manufacturing, Springer
• Pharmaceuticals dosage forms: disperse systems volume
2,3; Herbert A. Lieberman, Martin M. Rieger and Gilbert S.
Banker, informa health care.
• Ansel's Pharmaceutical Dosage Forms and Drug Delivery
Systems ninth edition, Loyd V. Allen, Jr. Nicholas G.
Popovich, Howard C. Ansel,
• Modern Pharmaceutics Volume 1 Basic Principles and
Systems edited by Alexander T. Florence Juergen
Siepmann, informa health care.

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