CHAPTER 14: DISPERSE SYSTEM
1. A properly prepared suspension should settle slowly &
Suspension
 Is a two-phase system consisting of a finely divided solid
dispersed in a liquid vehicle. The finely divided particles
are also referred to as ‘Suspensoids” .
 In these preparations, the substance distributed is
referred to as dispersed phase and the vehicle is
termed the dispersing phase or dispersion medium.
Together, they produce a dispersed system.
 Dispersions containing coarse particles, usually 10 to 50
um in size, are referred to as coarse dispersion.
 Dispersions containing particles of smaller size are
termed fine dispersions (0.5 to 10 um)
 In general sense, Suspension may include:
1. Gels
2. Lotions
GeLoMaMi
3. Magmas & Milk
4. Mixtures
Characteristics of Oral Suspension
 Particles should be small uniform sizes that do not settle
rapidly
 The particles that do settle to the bottom of the
container should not pack in to a hard cake & should
be re-dispersed completely and evenly with a minimum
amount of agitation
Characteristics of Suspension
 Should not be too viscous to pour freely from the mouth
of the bottle
 Should have an agreeable odor, color and taste &
must not decomposed or support mold growth during
storage
 Must have therapeutic efficacy
 Suspensions for injections must contain particles size
such that they can pass freely through the syringe
needle called “syringeability”.
 Ophthalmic suspension should be formulated such that
the particles do not exceed 10 microns. Below this size,
the patient experiences no pain when instilled into the
eyes.
 For Topical use, fine particles are desired to avoid
grittiness when applied to the skin. The smaller the size,
the greater the covering and protective power of the
preparation
Reasons for Suspension
 Certain drugs are chemically unstable when in solution
but stable when suspended.
 Suspension insures chemical stability while permitting
liquid therapy.
 Many patients prefer liquid form than solid forms for
swallowing.
 Convenience in administration of usually large doses
 Safety and convenience of liquid doses for infants and
children.
 Disagreeable taste of certain drugs when given in
solution is negligible when the drug is administered as
undissolved particles of a suspension, e.g
chloramphenicol
Features Desired in a Pharmaceutical Suspensions
should be readily redispersed upon gentle shaking of
the container.
2. The characteristics of the suspension should be such
that the particles size of the suspensoid remains fairly
constant throughout long periods of undisturbed
standing.
3. The suspension should pour readily & evenly from its
container
- Good pharmaceutical suspensions, the
particle diameter is between 1 to 50.
- Particle size reduction is generally
accomplished by dry-milling prior to the
incorporation of the dispersed phase into the
dispersion medium.
- One of the methods of producing fine drug
powders of about 10 to 50 um size is
micropulverization.
- For still finer particles, under 10 um, the
process of fluid energy grinding, sometimes
referred to as jet-milling or micronizing.
Dispersion Medium
 Suspending agents are added to the dispersion
medium to lend its structure to assist in the suspension of
the dispersed phase
 Examples:
- Carboxymethylcelulose
- Methylcellulose
- Microcrystalline cellulose
- Polyvinyl pyrolidone
- Xanthan gum
- Bentonite
 The amount of the suspending agent must not be such
to render the suspension too viscous to agitate (to
distribute the suspensoid) or to pour. The study of the
flow characteristics is termed rheology.
Sustained-Release Suspension
 In liquid preparations (suspensions) of the coated
particles, the drug remains adsorbed onto resin, but
slowly released by the ion-exchange process when
taken into gastrointestinal tract. The use of a
combination of ion-exchange resins complex and
particle coating is called Pennkinetic system.
 Examples:
- Hydrocodone polistirex =Tussionex
- Pennkinetic Extended-Release Suspension
Packaging and Storage of Suspensions
 All suspensions should be packaged in containers
having:
1. Adequate airspace above the liquid to permit
adequate shaking.
2. Should be provided in wide mouth containers to
permit the prompt and ease of removal of the
suspension.
3. Store in tight containers protected from freezing,
excessive heat and light.
4. Suspensions should be shaken before use.
Page 1 of 12
 Suspension
Example of preparation:
Aluminum Hydroxide Compressed
Gel 326.8 g Diuretic Chlorothiazide Oral Suspension - Diuril Oral
Sorbitol Solution 282.0 mL Suspension

Syrup 93.0 mL Nonsteroidal Indomethacin Oral Suspension - Indocin Oral

Glycerin 25.0 m Anti- Suspension
Methylparaben 0.9 g inflammatory
Propylparaben 0.3 g
Flavor q.s
Antacid Oral Suspension
Purified water, to make 1000.0 mL
 Are intended to counteract the effects of gastric
USE: ANTACID
hyperacidity and such are employed by persons, as
Preparation…
peptic ulcer patients, who must reduce the level of
 methylparaben & propylparaben - preservatives; syrup
acidity in the stomach. Also referred to as “acid
and sorbitol - viscosity and sweetness.
indigestion”, “heartburn”, and “sour stomach”
 In the preparation, the parabens are dissolved in a
 Example:
heated mixture of the sorbitol solution, glycerin, syrup
- Sodium Bicarbonate
and a portion of the water. The mixture then cooled
- Aluminum hydroxide
and the aluminum hydroxide added with stirring. The
- Aluminum phosphate
flavor is added and sufficient purified water to
- Dihydroxyaluminum aminoacetate
volume. The suspension is then homogenized, using
- Calcium carbonate
hand homogenizer, homomixer, or colloid mill
- Calcium phosphate
- Magaldrate
Examples of Oral Suspensions by Category
- Magnesium carbonate
Antacids Alumina, Magnesia and Simethicone - Mylanta - Magnesium oxide
liquid - Magnesium hydroxide
Magaldrate Oral Suspension - Riopan Oral
Suspension
Antibacterial Oral Suspension
Magnesia and Alumina Oral - Maalox
Suspension  The antibacterial oral suspensions include preparations
Aluminum Hydroxide and Magnesium of antibiotic substances
Carbonate - Gaviscon liquid Examples:
- Antibiotics ( Chloramphenicol
Anthelminitics Pyrantel Pamoate - Antiminth Oral Suspension
palmitate, Erythromycin derivatives,
Thiabenzadole Oral Suspension - Mintezol Oral
and tetracycline and its derivatives)
Suspension
- Sulfonamides (Sulfamethoxazole,
Antibacterial Chloramphenicol Palmitate - Chloromycetin sulfisoxazole acetyl)
(Antibiotics) Palmitae Oral Suspen. - other chemotherapeutic
Ertythromycin Estolate - Ilosone Oral Suspension agents(methanamine mandelate &
nitrofurantoin)
Antibacterial Methenamine Mandelate - Mandelamine - combination of these
(non-antibiotic Suspension/Forte
(sulfamethoxazole - trimethoprim)
Anti-infectives) Sulfamethoxazole and Trimethoprim - Bactrim,
Septra Susp.
Sulfamethoxazole - Gantanol Suspension Otic Suspension
Sulfisoxazole Acetyl Oral Suspension- Gantrisin  Examples:
Syrup/Pedia - Polymixin B sulfate
- Neomycin sulfate
Anticonvulsants Pimidone Oral Suspension - Mysoline
- Hydrocortisone - pH 3.0 to 3.5
Suspension
- Cortisporin Otic Suspension - pH 4.8 to 5.1
Antidiarrheal Bismuth Subsalicylate - Pepto-Bismol liquid - PediOtic - pH of 4.1
 Note: Pharmacist must be aware that there may be
subtle differences in the formulation of some otic
Antiflatulent Simethicone Oral Suspension - Mylicone Drop
suspensions that could be potentially bothersome to
the patient
Antifungals Nystatin Oral Suspension - Nystatin Oral Susp
Griseofulvin Oral Suspension -Grifulvin Oral Susp Rectal Suspensions
 Examples:
Antihypertensive Methyldopa Oral Suspension - Aldomet Oral
- Barium sulfate for Suspension, USP may be
Suspension
employed orally or rectally for the diagnostic
Antipsychotics, Hydroxyzine Pamoate Oral Suspension - Vistaril visualization of the GIT.
Sedatives, Oral Suspension
Antiemetic Thioridazine Oral Suspension - Mellaril-S Oral

Page 2 of 12
 - Mesalamine (5-aminosalicylic acid) - for 2. Probenecid/ampicillin for reconstitution - treatment for
treatment of Crohn’s disease, distal ulcerative uncomplicated infections (urethral, endocervical or
colitis, proctosigmoiditis, and proctitis. rectal) - Neisseria gonorrhoeae

Dry Powders for Oral Suspension

 Preparations consist of dry powder mixtures or granules, EMULSIONS
which are intended to be suspended in water or some  The word emulsion, came from emulgio, “meaning to
other vehicle prior to administration. milk out”.
 The dry products contain  Is a dispersion in which the dispersed phase is
1. Antibiotic composed of small globules of a liquid distributed
2. Colorant (FD and C dyes) throughout a vehicle in which it is immiscible.
3. Flavorants
4. Sweeteners - sucrose or sodium saccharin Emulsion terminology
5. Stabilizing agents - citric acid and sodium citrate  The dispersed phase is referred to as the Internal phase
6. Suspending agents - guar gum, xanthan gum,  The dispersion medium as the External or Continuous
methylcellulose phase
7. Preserving agents - methylparaben, sodium  Emulsions having an oleaginous internal phase and
benzoate aqueous external phase are referred to as oil-in-water
 NOTE: When called on to “RECONSTITUTE” and (o/w) emulsions
dispense, the pharmacist loosens the powder at the  Emulsions having an aqueous internal phase and an
bottom of the container by lightly tapping it against a oleaginous external phase are termed water-in- oil
hard surface, and then adds label designated amount (w/o) emulsions.
of purified water, usually in portions, and shakes well  Unless a third component - the emulsifying agent - is
until all of the powder has been suspended. present the dispersion is unstable, and the globules
undergo coalescence to form two separate layers of
Examples of Antibiotics for Oral Suspension (Reconstitution) water and oil
 Because the external phase of an emulsion is
Amoxicillin for Oral Suspension AMOXIL FOR ORAL SUSPENSION continuous, an O/W emulsion may be diluted with
water or an aqueous preparation, & W/O emulsion with
Ampicillin for Oral Suspension OMNIPEN FOR ORAL SUSPENSION an oleaginous or oil miscible liquid
 The aqueous phase may contain water-soluble drugs,
Bacampicillin for Oral Suspension FOR ORAL SUSPENSION preservatives, coloring and flavoring agents
SPECTROBID  The oil phase frequently consists of fixed oil or volatile
and drugs that exist as oil, such as oil-soluble vitamins
Cefaclor for Oral Suspension FOR ORAL SUSPENSION and antiseptic
CECLOR  It is necessary to add antioxidant to prevent
autoxidation of the oil and rancidity/and or destruction
Cefixime for Oral Suspension FOR ORAL SUSPENSION of any vitamin present.
SUPRAX POWDER
Purpose of Emulsification
Cephadrine for Oral Suspension FOR ORAL SUSPENSION 1. Pharmaceutically
KEFLEX a. The pharmacist can prepare relatively stable
and homogenous mixture of 2 immiscible
Dicloxacillin Sodium for Oral Suspension FOR ORAL SUSPENSION liquids
(PATHOCIL) b. Emulsification can permit the administration of
liquid drug in the form of minute globules
Doxycycline for Oral Suspension FOR ORAL SUSPENSION rather than in bulk
VIBRAMYCIN MONOHYDRATE 2. Therapeutically
a. Beneficial to the rate and degree of
Erythromycin Ethylsuccinate for Oral FOR ORAL SUSPENSION absorption of the drug after administration by
Suspension any of the usual route
E.E.S. GRANULES b. O/W emulsions may also be useful as vehicle
to develop the bioavailability of poorly
Penicillin V for Oral Suspension absorbed drugs
c. For orally administered emulsion the O/W type
permits the palatable administration of an
Other examples (Combination) otherwise distasteful oil by dispersing it in a
1. Erythromycin ethylsuccinate/acetylsulfisoxazole sweetened, flavored vehicle.
granules - treatment for acute middle ear infection - d. The reduced particle size of the oil globules
Hemophilus influenza may render the oil more digestible and more

Page 3 of 12
 readily absorbed and therefore more
effective
e. Emulsion to be applied externally can be
made such that the medicinal agent that are
irritating to the skin surface may be
incorporated in the internal phase than in the
external phase since the latter is in direct
contact with the skin
f. On the unbroken skin, a W/O emulsion can
usually be applied more evenly since the skin
is covered with a thin film sebum, and this
surface is more readily wetted by oil than by
water. On the other hand, if it is easily
removed from the skin, O/W is preferred.
Theories of Emulsification
1. Surface Tension Theory
- A property of liquids in which the exposed
surface tends to contract to the smallest
possible are. In a spherical drop of liquid there
are internal forces that tend to promote the
association of the molecule of the substance
to resist the distortion of the drop into a less
spherical form
- The use of substances as emulsifiers &
stabilizers
- Results in the lowering of the interfacial tension
of the 2 immiscible liquids, reducing the
repellant force between the liquids and
diminishing each liquids attraction for its own
molecules. These tension lowering substances
are referred to as surface active (surfactants)
or wetting agents.
2. Oriented-Wedge Theory
- Assumes monomolecular layers of emulsifying
agent curved around a droplet of the internal
phase of the emulsion.
- It is based on the presumption that certain
emulsifying agents orient themselves about
and within a liquid in a manner reflective of
their solubility in that particular liquid.
- An emulsifying agent having a greater
hydrophilic character than hydrophobic
character will promote an O/w emulsion and
a W/O emulsion results through use of more
hydrophobic than hydrophilic emulsifiers.
3. Plastic or Internal Film Theory
- Places the emulsifying agent at the interface
between the oil and water, surrounding the
droplets of the internal phase as a thin layer of
film adsorbed on the surface of the drops.
- The film prevents the contact and the
coalescence of the dispersed phase, the
tougher and more pliable the film, the greater
the stability of the emulsion.
4. Viscosity Theory
- States that the viscosity of an emulsion aids
emulsification by the mechanical hindrance
to coalescence of the globules although it is
not the cause of emulsification.
Emulsifying Agents
1. Natural emulsifying agent
- These materials form hydrophilic colloids when
added to water and generally produced
O/W emulsions. Acacia is most frequently use.
Tragacanth and Agar - thickening agents in
Acacia emulsified products.
- These substances produce O/W emulsions.
The disadvantage of gelatin is that the
emulsion prepared from it is too fluid
- Carbohydrates: acacia, tragacanth, agar,
chondrus, pectin
- Proteins: gelatin, egg yolk, casein
2. High Molecular Weight alcohols
- These materials employed primarily as
thickening and stabilizing agents for O/W
emulsions such as lotion and ointments
- Cholesterol may also be employed in
externally used emulsion and promote W/O
emulsions.
- E.g. stearyl alcohol, cetyl alcohol, glyceryl
monostearate
3. Finely divided solids
- These materials generally form O/W emulsions
when the insoluble material is added to the
aqueous phase if there is greater volume of
the aqueous phase than of the oleaginous
phase
- Colloidal clays including: Bentonite,
Magnesium hydroxide, Aluminum hydroxide
4. Synthetic
- (wetting agents), which may be:
a. Anionic: triethanolamine oleate and
sodium lauryl sulfate
b. Cationic: benzalkonium chloride
c. Nonionic: sorbitan esters (span);
polyethylene glycol 400 monostearate;
polyoxyethylene sorbitan esters (Tweens)
Qualities Required for Emulsifiers
 Must be compatible with other ingredients in the
formula
 Must not interfere with the stability and efficacy of the
therapeutic agent
 Must be stable to microorganisms
 Must be non-toxic
 Must possess little or no odor, taste or color
 Must promote emulsification and maintain stability of
the emulsion for intended shelf-life
The HLB or Hydrophilic- Lipophile Balance
 Each emulsifying agents has a hydrophilic portion
(water-loving) and a lipophilic portion (oil-loving) with
one or other being more or less predominant and
influencing
 A method indicative of the substances polarity devised
and lead to the assigning of an HLB value for each
agent. The usual range is between 1 to 20.
 Materials that are highly polar or hydrophilic have
assigned higher numbers than materials that are less
polar and were lipophilic
Page 4 of 12
  Surfactants having an assigned HLB value from 3 to 6 added in preparing the initial or primary
are greatly lipophilic and produce W/O emulsions and emulsion.
those HLB values of from about 8 to 18 produce O/W  For instance, if 40 mL of oil are to be
emulsions. emulsified, 20 mL of water and 10 g of gum
 In selecting an Emulsifier for an emulsion, choose one would be employed, with additional water or
having the same or nearly the same HLB value as the other formulation ingredients being added
oleaginous phase afterward to the primary emulsion
 Ex.: Mineral oil has assigned HLB of 4 if a W/O emulsion a. The acacia or other O/W emulsifier is
is desired and a value of 10.5 if O/W emulsion is triturated with the oil in a perfectly dry
prepared Wedgewood or porcelain mortar until
 Therefore, use surfactant SPAN 80 (Sorbitan monoleate) thoroughly mixed.
with HLB 4.3 for W/O emulsion and methylcellulose with b. After the oil and gum have been mixed,
HLB of 10.5 for O/W. the two parts of water are then added all
at once, and the mixture is triturated
Examples of HLB Values for Selected Emulsifiers immediately, rapidly, and continuously
 Ethylene glycol distearate .5 until the primary emulsion that forms is
 Sorbitan tristearate (Span 65) 2.1 creamy white and produces a crackling
 Propylene glycol monostearate 3.4 sound to the movement of the pestle
 Triton X-15 3.6 c. Generally, about 3 minutes of mixing are
 Sorbitan monooleate (Span 80) 4.3 required to produce such a primary
 Sorbitan monostearate (Span 60) 4.7 emulsion
 Diethylene glycol monolaurate 6.1 d. . Other liquid formulative ingredients that
are soluble in or miscible with the external
Examples of HLB Values for Selected Emulsifiers phase may then be added to the
 Sorbitan monopalmitate (Span 40) 6.7 primary emulsion with mixing.
 Sucrose dioleate 7.1 e. 5. Solid substances such as preservatives,
 Acacia 8.0 stabilizers, colorants, and any flavoring
 Amercol L-101 8.0 material are usually dissolved in a suitable
 Polyoxyethylene lauryl ether (Brij 30) 9.7 volume of water and added as a solution
 Gelatin 9.8 to the primary emulsion
 Triton X-45 10.4 NOTE: A mortar with a rough rather than
 Methylcellulose 10.5 smooth inner surface must be used to
 Polyoxyethylene monostearate (Myrj 45) 11.1 ensure proper grinding action and the
 Triethanolamine oleate 12.0 reduction of the globule size during the
 Tragacanth 13.2 preparation of the emulsion. A glass
 Triton X-100 13.5 mortar has too smooth a surface to
 Polyoxyethylene sorbitan monostearate (Tween 60) produce the proper size reduction of the
14.9 internal phase.
 Polyoxyethylene sorbitan monooleate (Tween 80) 2. English or wet gum method
15.0 3. Bottle or Forbes bottle method (G+O+W)
 PSM (Tween 20) 16.7  For the extemporaneous preparation of
 Pluronic F 68 17.0 emulsions from volatile oils or oleaginous
 Sodium oleate 18.0 substances of low viscosities, the bottle
 Potassium oleate 20.0 method is used. (2:2:1)
 Sodium lauryl sulfate 40.0  Preparation:
a. The powdered acacia is placed in a dry
Activity and HLB Value of Surfactants bottle
Activity Assigned HLB b. Two parts of oil is then added, and the
1. Antifoaming 1 to 3 mixture is thoroughly shaken in the
2. Emulsifiers (W/O) 3 to 6 capped container.
3. Wetting agents 7 to 9 c. A volume of water approximately equal
4. Emulsifiers (O/W) 8 to 18 to the oil is then added in portions
5. Solubilizers 15 to 20 d. The mixture being thoroughly shaken
6. Detergents 13 to 15 after each addition
e. When all of the water has been added,
Methods of Preparation the primary emulsion thus formed may be
1. Continental or Dry gum method diluted to the proper volume with water
 The method is also referred to as the “4:2:1” or other an aqueous solution of other
method because for every 4 parts (volumes) formulative agents
of oil, 2 parts of water and 1 part of gum are

Page 5 of 12
 NOTE: This method is not suited for
viscous oils, because they cannot
thoroughly agitated in the bottle.
4. Auxiliary method
 An emulsion by either the wet gum or dry gum
methods can generally be increased in
quality by passing it through a hand
homogenizer.
 In this apparatus, the pumping action of the
handle forces the emulsion through a very
small orifices which reduces the globules of
the internal phase to about 5 um and
sometime less
5. In SITU soap method
 Two types of soap developed by this method
are Calcium soaps and Soft soaps.
 Calcium soaps
 water - in - oil emulsions which contain
certain vegetable oil (e.g. Oleic acid) in
combination with lime water ( Syn: Calcium
Hydroxide Solution USP) and prepared by
mixing equal volumes of the oil and lime
water
 Example: Calamine Liniment (itchy, dry skin,
sunburn)
Calamine………………………
Zinc Oxide ……………………. 80.0 g
Olive oil …………………………
Calcium Hydroxide Sol’n aa q.s ad 1000.0 mL
6. Microemulsions
 Thermodynamically stable, optically
transparent, isotropic mixtures of a biphasic
oil-water system stabilized with surfactants.
 The diameter of droplets in a microemulsion
may be in the range of 100 A (10 microns) to
1000 A whereas in a microemulsion the
droplets may be 5000 angstroms in diameter.
 Both O/W and W/O microemulsions may be
formed spontaneously by agitating the oil and
water phases with carefully selected
surfactant.
 Advantages:
a. More rapid and efficient oral
absorption of drugs than through
solid dosage forms
b. Enhance transdermal drug delivery
through increased drug diffusion into
the skin
c. The technique potential application
of microemulsion in the
development of artificial red blood
cells and in the argeting of cytotoxic
drugs to cancer cells
Example of Microemulsion
1. Turpentine Oil Emulsion
Rectified Turpentine oil 150 mL
Acacia powder 50 g
Purified water, q.s to make 1000 mL
2. Liquid Petrolatum Emulsion - Mineral oil Emulsion;
Liquid Paraffin
Mineral oil………………………………… 500 mL
Acacia …………………………………….. 125 g
Syrup ……………………………………… 100 mL
Vanilla …………………………………….. 40 mg
Alcohol ……………………………………. 60 mL
Purified water, q.s to make 1000 mL
3. Cod liver Oil Emulsion - laxative with empty stomach
Cod liver oil …………………………….. 500 mL
Acacia ……………………………………… 125 g
Syrup ………………………………………. 100 mL
Methyl salicylate ……………………….. 4 mL
Purified water, q.s to make 1000 mL
Emulsion Stability
A stable emulsion is characterized by the following:
1. Absence of flocculation and creaming
2. Absence of coalescence of globules & separation of
the layers
3. Absence of deterioration due to microorganisms
4. Maintenance of elegance with respect to
appearance, odor, color and consistency
Emulsion is considered physically unstable if:
 The internal or dispersed phase upon standing tends to
form aggregates of globules.
 Large globules or aggregates of globules rise to the top
or fall to the bottom of the emulsion to forconcentrated
layer of the internal phase.
 If all or part of the liquid of the internal phase becomes
“unemulsified” and forms a distinct layer on the top or
bottom of the emulsion as result of the coalescing of
the globules of the internal phase
Terminology
1. Flocculation - is the joining together of globules to form
large clumps or floccules which rise or settle in the
emulsion more rapidly than do the individual particles
2. Creaming - is the rising (upward creaming) or settling
(downward creaming) of globules or floccules to form
a concentrated layer at the surface or to the bottom of
the emulsion
3. Coalescence & breaking - unlike creaming, the
coalescence of globules and the subsequent breaking
of an emulsion are irreversible processes. In creaming,
the globules are still surrounded by a protective
coating or sheath of emulsifying agent and may
redispersed simply by agitating the product.
4. Detoriation by Microorganism - Molds, yeast and
bacteria may bring about decomposition and
contamination of the emulsion. Preservatives should be
more fungistatics than bacteriostatic
5. Miscellaneous Physical & Chemical Change - Light and
rancidity affect the color and the odor of oils and may
destroy their vitamin content. Freezing and thawing
Page 6 of 12
 and high temperature result in the coarseness and - used as thickening agent in concentrations of
breaking of an emulsion. 1 to 5%
6. Imbibition - is taking up of a certain amount of liquid - swells in water to about 200 to 300 times its
without a measurable increase by a gel with an own weight without dissolving
increase volume 11. Carbomer
7. Swelling - is the taking up of a liquid by a gel with an - resins with high molecular weight
increase in volume. Only those liquid that solvate a gel allylpentaerythritol-cross-linked acrylic acid-
can cause swelling. The swelling of protein gels is based polymers modified with C10 to C30alkyl
influenced by pH and the presence of electrolytes acrylates
8. Syneresis - is when the interaction between particles of - fluffy white powders with large bulk density
the dispersed phase becomes so great than on (0.5 and 1% aqueous dispersion)
standing, the dispersing medium is squeezed out in - Ex.: Carbomers 910,934,934P,940 and 1342
droplets and the gel shrinks. Syneresis is a form of 12. Cetostearyl Alcohol
instability in aqueous and nonaqueous gels 13. Ethylcellulose
9. Thixotrophy - is a reversible gel-sol formation with no 14. Guar gum
change in volume or temperature-a type of non- 15. Hydroxypropryl cellulose
Newtonian flow. 16. Magnesium aluminum silicate
10. Xerogel - is formed when the liquid is removed from a 17. Methylcellulose
gel and only the framewok remains. Examples: gelatin 18. Povidone
sheet, tragacanth ribbons and acacia tears 19. Sodium alginate
20. Sodium starch glycolate
Classification and Types of Gels 21. Starch
Two general classification 22. TragacanthX
1. Inorganic hydrogels - are usually two phase systems 23. Xanthan gum
such as Aluminum Hydroxide Gel and Bentonite
Magma Other examples:
2. Organic Gels - are usually single phase systems and
may include such as gelling agents as Carbomer and 1. Carboxymethylcellulose - concentrations of 4 to 6% of
Tragacanth and those that contain an organic liquid, medium viscosity can be used to produce gel; glycerin
such Plastibase. may be added to prevent drying; incompatible with
Second classification Scheme alcohol
1. Hydrogels - include ingredients that are dispersible as 2. CMC sodium - soluble in water at all temperature
colloidals or soluble in water and include organic 3. Colloidal silicone dioxide - can be used with other
hydrogels, natural and sythetic gums and inorganic ingredients of similar refractive index to prepare
hydrogels transparent gels
Ex.: silica, bentonite, tragacanth, pectin, sodium 4. Gelatin - dispersed in hot water and cooled to form
alginate, methylcellulose, sodium gels
carboxymethylcellulose and alumina 5. Magnesium aluminum silicate (Veegum)
2. Organogels - include the hydrocarbons, animal and - concentrations of about 105 forms a firm
vegetable fats, soap base greases and the hydrophilic thixotropic gel
organogels. - material is inert and has few incompatibilities
Ex.: Hydrocarbon - Jelene, or Plastibase but is less used above pH 3.5
6. Plastibase (Jelene) - mixture of 5% low molecular
Preparation of Magmas and Gels weight polyethylene and 95% mineral oil
1. By freshly precipitating the disperse phase 7. Poloxamer (Pluronic)
2. By direct hydration in water - concentrations ranging from 15 to 50% to form
gel
Examples of Gelling Agents - poloxamers 124 (L-44 grade), 188 (F-68 grade),
1. Acacia 237 (F-87 grade), 338 (F-108 grade) and 407
2. Bentonite (F-127 grade) types are freely soluble in water
3. Carbocymethylcellulose sodium F = refers to flake form
4. Colloidal silicon dioxide L = refers to liquid form
5. Gelatin 8. Magnesium aluminum silicate (Veegum)
6. Hydroxyethylcellulose - concentrations of about 105 forms a firm
7. Hydroxypropryl methylcellulose thixotropic gel
8. Polyvinyl alcohol - material is inert and has few incompatibilities
9. Propylene carbonate but is less used above pH 3.5
10. Alginic acid 9. Polyvinyl alcohol (PVA)
- obtained from seaweed, prepared products is - used at concentrations of about 2.5% in the
tasteless, odorless, yellowish-white colored preparartion of various jellies that dry rapidly
fibrous powder when applied to the skin

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 - borax is a good agent that will gel PVA
solutions
- for best result, dispersed PVA in cold water,
followed by hot water. It is less soluble in cold.
10. Povidone
- about 10% in concentrations to prepare gels
- also increase solubility of poorly soluble drugs
11. Sodium alginate
- 10 % to produce gels
- aqueous preparations are most stable at pH 4
to 10; below pH 3, alginic acid is precipitated
12. Tragacanth gum
- used to prepare gels that are most stable at
pH 4 to 8
- must be preserved with 0.1% benzoic acid or
.17% methylparaben and 0.03% propyl
paraben
13. Methylcellulose
- 5% to form gels; dispersed with high shear in
about 1/3 of water
MAGMAS and MILK
 Are aqueous suspensions of insoluble, inorganic drugs
and differ from gels mainly in that the suspended
particles are larger. When prepared, they are thick
and viscous, so need of a suspending agent
 Preparations
1. By Hydration –
Ex.: Hydration of Magnesium oxide
MgO + H2O Mg(OH)2
2. Chemical Reaction
Milk of Bismuth is made by reacting Bismuth
subnitrate with Nitric acid and Ammonium
carbonate with Ammonium solution and then
mixing the resulting two solutions
2NaOH + MgSO4 Mg(OH)2 + Na2SO4
(direct hydration)
dispersion of liquid and/or solid materials in gaseous
medium
 The term Pressurized package is commonly used when
referring to the aerosol container or completed
product. Pressure is applied to the aerosol system
through the use of one or more liquefied or gaseous
propellants.
 Aerosols used to provide an airborne mist are termed
space sprays.
Ex.: room disinfectants, room deodorizers, and space
insecticides.
 Aerosols intended to carry the active ingredient to a
surface are termed Surface sprays or surface coatings.
Ex: dermatologic aerosols, pharmaceutical aerosols, as
personal deodorant sprays, cosmetic hair lacquers and
sprays, perfumes and cologne sprays, shaving lathers,
toothpaste, surface pesticide sprays, paint sprays and
others.
Advantages of the Aerosol Dosage Forms
1. A portion of medication may be easily withdrawn from
the package without contamination or exposure to the
remaining material.
2. Hermetic character, the aerosol container protects
medicinal agents from atmospheric oxygen, moisture
and even from light.
3. Topical medication may be applied in a uniform, thin
layer to the skin, without touching the affected area
thus, reducing irritation.
4. By proper formulation and valve control, the physical
form and the particles size of the emitted product may
be controlled which may contribute to the efficacy of
a drug. Example: the fine controlled mist of an inhalant
aerosol. Through the use of metered valves, dosage
may be controlled.
5. Aerosol application is “clean” process, requiring little or
no “wash-up” by the user.

Examples of Magmas and Gels The Aerosol Principle

Bentonite Magma NF
Sodium Fluoride &
USP
Phosphoric Acid gel
Fluocinonide Gel
USP
Tretinoin Gel
Erythromycin and Benzoyl
peroxide Gel
Clindamycin Topical Gel
Hydroquinone Gel
Salicylic acid gel
Desoximethasone gel
Alumnium phosphate gel
(Amphogel)
Alumnium hydroxide gel
Dihydroxyalumninum
Aminoacetate Magma
Milk of Magnesia
(Magnesia Magma)
AEROSOLS
 Are pressured dosage forms containing one or more
active ingredients which upon actuation emit a fine
suspending agent As aerosol formulation consists of 2 components:
1. The product concentrate is the active ingredient of the
dental care prophylactic
aerosol combined with the required adjuncts, such as
Anti-inflammatory antioxidants, surface-active agents, and solvents, to
corticosteroid
prepare a stable and efficacious product.
USP treatment for acne
2. The propellant when the propellant is a liquefied gas or
a mixture of liquefied gases, it frequently serves the
dual role of propellant and solvent or vehicle for the
Hyperpigmented skin product concentrate
Keratolytic
Anti-inflammatory and anti- Examples of Propellants
pruritic agent 1. Carbon dioxide
2. Nitrogen
USP Antacid
3. Nitrous oxide
USP Antacid
4. Fluorinated Hydrocarbons:
USP Antacid Trichloromonofluoromethane;
Dichlorodifluoromethane;
USP Antacid; laxative Dichlorotetrafluoroethane;
Chlorpentafluoroethane;
Monochlorodifluoroethane;
Octafluorocyclobutane

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Aerosol Container and Valve Assembly
 The effectiveness of the aerosol depends on:
1. proper combination of formulation,
2. container
3. valve assembly.
 The formulation must not chemically interact with the
container or valve components to avoid unstability of
the formulation.
 The container and the valve must be capable of
withstanding the pressure required by the product
 It must be corrosive resistant
 Valve must contribute to the form of the product to be
emitted.
AEROSOL SYSTEMS
 SPACE AEROSOLS usually operate at pressures between
30 to 40 psig (pounds per square inch gauge) at 700F
and may contain as much as 85% propellant
 SURFACE AEROLSOLS commonly contain 30 to 70%
propellant with pressures between 25 to 55 psig at 700F
 FOAM AEROSOLS usually operate between 35 and 55
psig at 700F and may contain only 6 to 10% propellant
 TWO PHASE SYSTEM = comprised (1) the liquid phase –
propellant and product concentrate (2) the vapor
phase
 THREE PHASE SYSTEM = comprised (1) layer of water
immiscible liquid propellant, (2) layer of highly aqueous
product concentrate, and (3) vapor pressure
 COMPRESSED GAS SYSTEM = compressed rather
liquefied, gases may be used to pressure aerosols. The
pressure of the compressed gas contained in the
headspace of the aerosol container forces the product
concentrate up the dip tube and out of the valve
Examples: Nitrogen; carbon dioxide; nitrous oxide
Containers
1. Glass, uncoated or plastic coated
2. Metal, including tinplated steel, aluminum, and stainless
steel
3. Plastics
The selection of containers for an aerosol product is based on
1. Its adaptability to production methods
2. Compatibility with formulation components
3. Ability to sustain the pressure intended for the product
4. The interest in design and aesthetic appeal on the part
of the manufacturer
5. Cost
VALVE ASSEMBLY
 The function of the valve assembly is to permit the
expulsion of the contents of the can in the desired
form, at the desired rate, and, in the case of metered
valve, in the proper amount or dose.
 The materials used in the manufacture of valves must
be inert and approved by BFAD.
 Among the materials used in making valve parts are
plastic, rubber, aluminum, and stainless steel
Metered Dose Inhalers (MDIs)
Ex.: Allupent. Each metered dose is delivered through the
mouthpiece upon actuation of the aerosol unit’s valve
Nitrolingual spray - permits a patient to spray droplets onto or
under the tongue for acute relief of an attack, or prophylaxis, of
angina pectoris due to coronary artery disease. The product
contains 200 doses of nitroglycerin in a propellant mixture of
dichlorofluoromethane and dichlorotetrafluoroethane
Filling Operations
Fluorinated hydrocarbon gases may be liquefied by
cooling below their boiling points or by compressing the gas at
room temperature. These 2 features are utilized in the filling of
aerosol containers with propellant.
Cold Filling
Both the product concentrate and the propellant must
be cooled to temperatures of -300 to -40 0F. This temperature is
necessary to liquefy the propellant gas. The cooling system may
be a mixture of dry ice and acetone.
Pressure Filling
The product concentrate is quantitatively placed in the
aerosol container, the valve assembly is inserted and crimped
into place, and liquefied gas, under pressure, is metered into the
valve stem from a pressure burette.
Parts of Aerosol Valve
1. The actuator is the button which the user presses to
activate the valve assembly for the emission of the
product.
2. The stem supports the actuator and delivers the
formulation in the proper form to the chamber of the
actuat
3. The gasket, placed snugly with the stem, serves to
prevent leakage of the formulation when the valve is in
closed position
4. The spring holds the gasket in place and also is the
mechanism by which the actuator retracts when
pressure is released, thereby returning the valve to the
closed position
5. The mounting cup, which is attached to the aerosol
can or container, serves to hold the valve in place.
6. The housing, located directly below the mounting cup,
serves as the link between the dip tube and the stem
and actuator. With the stem, its orifice helps to
determine the delivery rate and the form in which the
product is emitted.
7. The dip tube, which extends from the housing down
into the product, serves to bring the formulation from
the container to the valve.
Testing the Filled Containers
Container is tested under various environmental conditions
1. Leaks
2. Weakness in the valve assembly or container
3. Proper function s of the valve
4. The valve discharge rate - determine by discharging a
portion of the contents of a previously weighed aerosol
during a given period of time, and calculating, by the
difference in weight, the grams of contents discharged
per unit of time.
5. Particle size distribution of the spray
6. For accuracy and reproducibility of dosage when using
metered valves
Page 9 of 12
Topical Aerosols
 Aerosols packages for topical use on the skin which
include:
- Antiinfectives: Povidone - iodine, Tolnaftate
and Thimerosal
- Adrenocortical steroids: Betamethasone and
Triamcinolone Acetonide
- Local anesthetic: Dibucaine hydrochloride
 Preparations frequently used in the ear, with
suspensions or ointments also finding some application.
 Usually placed in the ear canal by drops or small
amounts for the removal of excessive cerumen (ear
wax), or treatment of ear infections, inflammation, or
pain.
Examples of Some Commercial Otic Preparations

Vaginal and Rectal Aerosols Americaine Benzocaine local anesthetic

 Aerosols foams are commercially available containing
estrogenic substances and contraceptives agents. Auralgan Antipyrine, Acute otitis
Ex.: ProctoFoam Benzocaine media
- contains pramoxine hydrochloride
Cerumenex Triethanolamine Cerumenolytic
- use to relieve inflammatory anorectal
drops agent
disorder
Chloromyc Chloramphenicol Anti-infective
Examples of Inhalation Aerosols etin
Albuterol Inhalation Proventil
Cortisporin Polymyxin B sulfate, antibacterial
inhalation Beta-adrenergic
aerosol solution neomycin sulfate
Beclomethasone Beclovent Adrenocortical
Dipropionate inhalation beconace steroid Debrox Carbamide Ear wax remova
Cromolyn Sodium Antiasthmatic, drops Peroxide
Intal inhaler
antiallergy
Ipratropium bromide Atrovent Anticholinergic Pediotic Polymyxin B sulfate - Antibacterial
Isoetharine Mesylate Sympathomimetic - neomycin sulfate
Bronkometer
brochial asthma
Metaproterenol sulfate Alupent Sympathomimetic Metreton Prednisolone Antiinflammatory
Salmeterol Xinafoate Beta-adrenergic sodium phosphate
Serevent
agonist
Terbutaline sulfate Beta-adrenergic Otobiotic Polymyxin B Sulfate, Antibacterial
Brethaire solution hydrocortisone
agonist
Triamcinolone acetonide Corticosteroids for
Azmacort Vosol Acetic acid Antibacterial/An
asthma
solution tifungal
NASAL PREPARATIONS
 aqueous preparations, rendered isotonic to nasal fluids MUCILAGES
(approximately equivalent to 0.9% sodium chloride)  The official mucilages are thick, viscid, adhesive liquids,
buffered to maintain drug stability while approximating produced by dispersing gum in water or by extracting
the normal pH range of the nasal fluids (pH 5.5 to 6.5), with water mucilagenous principle from vegetable
and stabilized and preserved as required. substances.
 Mucilages are used primarily to aid in suspending
Examples of Some Commercial Nasal Preparations insoluble substances in liquids due to their (1) colloidal
Afrin Nasal nasal character and (2) viscosity which prevents the
Oxymetazole
Spray/ drops decongestant/adrenergic
immediate sedimentation
Beconase AQ Bechlomethasone
synthetic corticosteroid
Nasal Spray diproprionate
Diapid Nasal antidiuretic; prevention of Example of Mucilage
Lopressin
Spray diabetes
Nasalcrom Cromolyn
allergic rhinitis
Spray
Ocean Mist Isotonic sodium restore moisture/relieve
chloride dry
Privine HCl Naphazoline HCl nasal
Solution adrenergic/decongestant
Syntocinon Tetrahydrozoline
adrenergic/decongestant
Spray HCl  Method: Place acacia in wide mouth graduated bottle
Neo- Oxymetazoline nasal with capacity not exceeding 1000 mL. Wash the drug
Synephrine HCl adrenergic/decongestant with cold water, drain and add sufficient quantity of
Nasalide purified water in which benzoic acid has been
Flunisolide perennial/seasonal rhinitis
Nasal Solution
dissolved to make 1000 mL, Stopper and lay the bottle,
rotate occasionally, and when acacia has been
OTIC SOLUTIONS
dissolved, strain the mucilage
 sometimes referred to as ear or aural preparations.
Page 10 of 12
  Uses: Demulcent, suspending agent, excipient in  Since the finely powdered substances are insoluble in
making pills and troches,and as emulsifying agent for the dispersion medium, the use of suspending agents
cod liver oil and dispersion agent is made.
 If the substance is immiscible, an emusifying agent is
used. Most commonly, the vehicles of lotions are
aqueous.

CHARACTERISTICS OF GOOD LOTION

 Dries quickly and provides a protective film that will not
rub off easily. It should not run off the surface of the
skin.
 The particles settle or rise only slowly and solid do not
form a hard cake at the bottom of the vessel.
 Method : Mix 75 mL of purified water with glycerin in a
 The lotion should pour freely from the bottle and apply
tared vessel, heat to boiling, discontinue application of
evenly over the affected area.
heat, add Tragacanth and the Benzoic acid and
 Should have an acceptable color and odor.
macerate during 24 hours, stirring occasionally. Add
 Must remain physically and chemically stable
sufficient quantity of purified water to make the
 Free from contamination during storage
mucilage 100 g, stir actively until uniform consistency
and strain through muslin cloth
Methods Of Preparation
 Uses: excipient for pills or troches, suspending agent for
1. Trituration Ex.: Calamine lotion
insoluble substances for internal mixtures and as
2. Chemical Reaction Ex.: White lotion
protective agent
Types Of Lotion According To Use
INHALANTS
1. Medical Lotions
 Are drugs or combinations of drugs that by virtue of
a. Antiseptic and germicidal
their high vapor pressure can be carried by an air
b. As cooling and mildly anesthetic for skin irritations
current into the nasal passage where they exert their
Ex.:Benzyl Benzoate Lotion
effect.
Benzyl Benzoate 250 mL; Triethanolamine 5 g; Oleic
 The device in which they are administered is termed an
acid 20 g; water 750 mL - emulsion type lotion
inhaler.
Use: for scabies
 Examples:
1. Amyl Nitrite Inhalant - treatment of anginal pain
Calamine Lotion, USP
2. Propylhexedrine Inhalant - nasal decongestant
liquefied phenol 10 mL; Calamine lotion 990 mL to make 1000 mL
Uses: anesthetic and antiseptic
INHALATIONS
Lotio Alba; Lotio Sulfurata
 Inhalations are drugs or solutions of drugs administered
Uses: for acne and antiseptic since it has sulfur
by the nasal or oral respiratory route.
 A widely used instrument capable of producing fine
Example:
particles for inhalation therapy is the NEBULIZERS.
Calamine Lotion
 When volatile medication is added to the water in the
Calamine 80 g
chamber, the medication is volatilizes and also inhaled
Zinc Oxide 80 g
by the patient, HUMIDIFIERS will be used.
Glycerin 20 mL
 The common household VAPORIZER, produces a fine
Bentonite Magma 250 mL
mist of steam that may be used to humidify a room
Calcium Hydroxide solution q.s.
will be used also.
to make 1000 mL
 ULTRASONIC HUMIDIFIERS are also available.
Uses: relieves itching and pain of sunburn, insect bites
 Ex.:
1. Isoetharine inhalation - bronchial asthma
2. Cosmetics Lotions - are applied to hair, scalp, face and
2. Isoproterenol Inhalation - bronchial asthma
hands. They are common as sunscreen preparation. Contain
glycerin, perfume and preservatives.
LOTIONS
Examples Of Medicated Lotions
 Also called “WASHES” or meaning “LOTIO” or “LAVARE”
1. Ammonium Lactate - Lac-Hydrin- Promotes hydration,
to wash. Lotions are liquid suspension or dispersion
removal of excess keratin dry skin, hyperkeratolytic
intended for external application to the skin, frequently
conditions
containing suspended particles or emulsified liquid
2. Benzoyl Peroxide - Sulfoxyl Lotion - antibacterial
droplets.
(Propionibacterium acnes)
 Depending therefore, whether they are solid-liquid or
3. Betamethasone Diproprionate - Diprolene - Anti-
liquid-liquid dispersions, some lotions can also classified
inflammatory
as suspension or emulsion.
4. Betamethasone Valerate- Betatrex - Anti-inflammatory
 Characteristics:
5. Calamine Lotion -Topical protectant

Page 11 of 12
 6. Clotrimazole - Lotrimin - dermal infections tinea pedis,
tinea cruris, and tinea corporus
7. indane - Kwell Lotion - Pediculicide; scabicide (twice a
week)
8. Hydrocortisone - Hytone - Adrenocortical steroid and
anti-inflammatory
9. Permethrin Rinse - Nix Crème Rinse - a synthetic
pyrethroid which is active against lice, i.e. pediculosis
10. Selenium Sulfide - Selsun and Selsun Blue - Anti-fungal,
antiseborrheic. Used principally in the treatment of
dandruff and seborrheic dermatitis
11. Urea Lotion - Ureacin 10 Lotion - Promotes hydration
and removal of excess keratin dry skin and
hyperkeratotic conditions.

Calamine Liniment/Lotion. Oily BPC

Calamine 50 g
Wool fat 10 g
Oleic acid 5 mL
Arachic oil 500 mL
Ca(OH)2 solution to make 1000 mL
Triturate the calamine with the wool fat, the arachis oil and oleic
acid, previously melted together. Transfer to a suitable
container, add the Ca(OH)2 solution and shake vigorously.

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