Integrated Physical

Course Title:
Pharmacy and Pharmaceutics II

Û Course Code: Phar3121

Û Course ECTS: 7
Û Year III, Semester I
Û Prerequisite: Integrated Physical Pharmacy
and Pharmaceutics I
Chapter I:

Semisolid Dosage
Forms
 Chapter 1: Semisolid dosage forms
Session 1: learning objectives
At the end of this session, students should able to
 differentiate different types of semisolid dosage
forms
 describe the ideal properties of semisolid dosage
forms
 describe common types of ointment bases
 list the criteria for selection of ointment base
 describe methods to incorporate active ingredient(s)
Introduction
Dosage forms
 pharmaceutical products that are particular mixtures
of drug and excipients
introduction ………………………….

Semisolid dosage forms

 dosage forms that have properties in between solid
& liquid state
o neither solid nor liquid
o mixture or combination of both
Ä Topical preparation

o for application to/through the skin or accessible

mucous membranes
 in/through the mouth, eye, nose, ear, vagina,
rectum, buccal tissue
introduction ………………………….

Semisolid dosage forms can be

1. Medicated
 contain  1 API dissolved and/or suspended
 e.g. antiseptics, local anesthetics, corticosteroids,
acne products, antibiotics, …
o for localized effects

• treatment of dermal disorder

o for systemic effects

• percutaneous absorption
introduction ………………………….

2. Non-medicated: used as
 protectants,
 emollients,
 lubricants,
 adsorbents or cleansing agents
introduction ………………………….

Classification of semisolid dosage forms

1) ointments,
2) creams,
3) gels,
4) pastes,
5) lotions
introduction ………………………….

Desired properties of semisolids

1. Physical properties: should
 have a smooth texture
 be elegant in appearance
 be non-dehydrating
 be non-gritty
 be non-greasy and non-staining
 non-hygroscopic
introduction ………………………….

2. Physiological properties:
 should be non-irritating
 do not alter membrane or skin functioning
 should be miscible with skin secretion
 should have a low sensitization index
introduction ………………………….

3. Application properties: should

 easily applicable with efficient drug release
 have a high aqueous washing ability
 stay in physical contact with the surface of
application
for a reasonable duration of time
4. Storage properties: store
 temperature should not exceed 25 °C
 not be allowed to freeze
 in a well-closed container
I. Pharmaceutical ointments
Ointment ………………………….

Pharmaceutical ointments
 viscous homogeneous semisolid dosage forms that
are intended for external application to:
 skin
 mucous membranes
Ä may be:

a) Medicated: may contain a API or mixture of APIs

dissolved or dispersed in suitable base
b) Unmedicated: emollients, protective, vehicle in
which to incorporate medication
Ointment ………………………….

Designing ointments
 to soften or melt at body temperature,
 to spread easily,
 have a smooth, non-gritty feel, etc.
Ointment ………………………….

Components of ointment
 usually contains
 < 20% water & other volatile ingredients, such as
ethanol, &
 > 50% hydrocarbons, waxes, or polyols
Ointment ………………………….

Advantages of ointment
 good absorbent,
 retain at the site of application,
 prevent moisture loss from the skin

o as an occlusive layer on the skin

 enhance chemical stability of therapeutic agents

o reduce hydrolysis
Ointment ………………………….

Disadvantages of ointment
 generally greasy and difficult to remove
 staining of clothes
 viscosity may be problematic in ensuring spreading
 drug release rate depends on drug solubility in the
ointment base
Ointment ………………………….
Ingredients used in ointment preparation
a) API
b) ointment base
c) preservatives
d) antioxidants
e) buffer
f) chelating agent
g) permeation enhancer
h) humectant
i) thickening agent
Ointment ………………………….

1. Ointment base
 forms the body of any ointment
 most essential ingredient
Ä work as
 carriers for pharmaceuticals,
 regulate the amount of absorption of
medicaments incorporated
Ointment ………………………….

Ideal properties of the ointment base:

 should be inert, non-irritating & non-sensitizing
 should be compatible with the skin pH & drug
 should be a good solvent and/or emulsifying agent
 should be emollient, protective, non-greasy, & easily
removable
 should release medicaments readily at the site of
application
 pharmaceutically elegant & possess good stability
Ointment ………………………….

Classification of ointment
 can be classified into four general groups

i. oleaginous bases,
ii. absorption bases,
iii. emulsion or water-removable bases, and
iv. water-soluble bases
Ointment ………………………….

i. oleaginous bases
 chemically inert, anhydrous/ hydrocarbon, greasy
base derived from petroleum
Importance: have
 emollient effect
 occlusive effect

o protect the escape of moisture  hydrate the skin

 protective to H2O labile drugs

o such as bacitracin & tetracycline

Ointment ………………………….

Demerit of ointment base

 difficult to wash off from the skin by water
 difficult to apply to (spread over) wet surfaces
 can stain clothing
Ointment ………………………….

Common hydrocarbon bases or their components

a) hard paraffin,
b) white/yellow soft paraffin
c) liquid petrolatum (mineral oil), &
d) microcrystalline wax
Ointment ………………………….

a) Hard paraffin
 mixture of solid saturated hydrocarbons
 forms an occlusive film on the skin
 absorbs less than 5% water under normal conditions
 e.g. colourless / white petrolatum, yellow petrolatum
or their combination
 melts at 47°C- 65°C
Ointment ………………………….

b) White/yellow soft paraffin

 purified mixture of semisolid hydrocarbons
 melting range between 38 & 60 °C

c) Liquid paraffin (liquid petrolatum, mineral oil

 liquid at room temperature
 used as a levigating agent to incorporate lipophilic
solids into ointments
Ointment ………………………….

d) Microcrystalline wax
 solid mixture
 used to enhance the viscosity of ointments
Ointment ………………………….

ii. Absorption bases

 contain an oleaginous base & a water-in-oil (w/o)
emulsifier
 oleaginous base + w/o surfactant
 can absorb water to form or expand w/o
emulsions
 useful as emollients
 may be used to reduce the dryness of skin
 greasy & not easily removed from the skin with
water
Ointment ………………………….

Types of absorption bases

1. non-emulsified bases: anhydrous bases
2. water in oil emulsions
Ointment ………………………….

1. non-emulsified bases
 non-aqueous formulations that permit the
incorporation of aqueous phase to produce a water
in oil emulsion
 commonly composed of one or more paraffins &
Simple ointment B.P
emulsifying agent
Hard paraffin ………
 e.g., hydrophilic petrolatum
50g
 cholesterol: 30 g
Cetosteryl alcohol….
 stearyl alcohol: 30 g
50g
 white wax: 80 g
Wool fat……………..
Ointment ………………………….

Examples of emulsifying agents used in absorption

bases
 facilitate the incorporation of an aqueous phase

1. Lanolin: wool fat

 chemically a wax obtained from sheep wool
 consisting of high molecular weight alcohols (e.g.,
sterols) & fatty acids
Ointment ………………………….

2. water in oil emulsions ointment base

 can accommodate a greater concentration of water

o includes lanolin alcohols (wool alcohols): hydrous

lanolin
o mixture of lanolin & circa 25-30% water
 e.g., Oily Cream BP

o composed of wool alcohols (50% w/w) and water

(50% w/w)
Ointment ………………………….

iii. water-miscible/removable bases

 o/w emulsions ointment bases

 easily H2O washable from skin & clothes

 can absorb serous discharges from abrasions &

wounds
 not occlusive, may be readily applied to (and
removed from) hair
 aesthetically pleasing & have a better cosmetic
appearance
 composition:
Ointment ………………………….

Types of emulsifying wax (o/w surfactant)

1. anionic
 composed of cetostearyl alcohol 90 g + sodium

lauryl sulphate 10 g + purified H2O 4 ml

2. non-ionic
 Cetomacrogol Emulsifying Wax BP: cetostearyl
alcohol 800 g + cetomacrogol 1000 (macrogol
cetostearyl ether 22) 200 g
3. cationic
 Cetrimide Emulsifying Wax BP: cetostearyl alcohol
Ointment ………………………….

Example of water-miscible/removable bases

Hydrophilic ointment
 white petrolatum (25%) + stearyl alcohol (25%)
+ propylene glycol (12%) + sodium lauryl sulfate
(1%) + water (37%)
ointment ………………………….

iv. Water-soluble bases

 oil free & non/less occlusive

 completely H2O washable

 miscible with exudates from inflamed sites

 absorb H2O from the skin  dehydrate skin  may

hinder percutaneous absorption

 made of carbowax or polyethylene glycol (PEG) as
the base
Ointment ………………………….

Polyethylene glycols
 polymers of ethylene oxide & water

H(OCH2CH2)nOH

 n represents the average number of

oxyethylene groups
Polycondensation

C2H4O + H2O Poyethylene glycol

(Macrogol )
Ointment ………………………….

 Polyethylene glycols chain length may be varied to

achieve polymers having desired viscosity and

physical form
 @ room temperature

 PEG with Mwt <600 (200,300 ,400) - clear,

colorless liquids
 PEG with Mwt between 800 -2,000 - Semi-solid
 Macrogols with Mwt > 2000 (6000) - waxy
white solids
Ointment ………………………….

Example
PEG ointment, NF
 PEG 3350 ……… 400 g
 PEG 400 ………. 600 g
Ointment ………………………….

Advantages of water- soluble bases

Ä water solubility
 easily removal from the skin
 readily miscible with tissue exudates
Ä good solvent properties
 for some water soluble dermatological e.g.
hydrocortisone
Ä freedom from greasiness
Ointment ………………………….

Summary
Properties Oleaginous Absorption H 2O H 2O
bases bases removable soluble
bases bases
Composition oleaginous oleaginous oleaginous PEGs
compounds base ±w/o base +
surfactant H2O + o/w
surfactant
Solubility in insoluble insoluble insoluble soluble
H 2O
Affinity for hydrophobic hydrophilic hydrophilic hydrophi
Water lic
H 2O not not washable washabl
Washability e
H 2O not absorb absorbs absorbs absorbs
absorption
Vehicle for hydrolyzable non- non- drugs
drugs hydrolyzabl hydrolyzab
e drugs le drugs
Examples White Hydrophilic Hydrophilic PEG
Ointment ………………………….

Selection of the appropriate base

Factors that to be considered include
Ä desired release rate of the drug substance from the
ointment base
Ä desirability of topical or percutaneous drug
absorption
Ä desirability of occlusion of moisture from the skin
Ä stability of the drug in the ointment base
Ä desire for a base easily removed by washing with
water
Ointment ………………………….
Miscellaneous excipients
Preservatives

 ointment that do not contain H2O do not usually

require the addition of a preservative

 e.g., phenol, methylparabens, propylparabens,
benzyl alcohol, benzoic acid,
Ointment ………………………….

antioxidants
 to prevent or reduce oxidation of either the non-
aqueous components of the ointment base and/or
the therapeutic agent
 e.g.,
 butylated hydroxyanisole, butylated
hydroxytoluene, propyl gallate, sodium
metabisulphate, sodium sulphite
Ointment ………………………….

Chelating agent
 have the ability to bind metal ions
 prevents auto-oxidation phenomena frequently
catalyzed by metal ions
 enhances action of preservatives by binding iron &
copper ions essential to microbial growth
 some common examples
 ethylenediaminetetraacetic acid (EDTA), citric
acid
Ointment ………………………….

Buffer
 acid-conjugate base mixture employed to control pH
 control ionization state of drug & impart stability
 examples:
 citrate buffer, phosphate buffer, tartarate buffer
Ointment ………………………….

Emulsifying agent
 helps in reducing the surface tension of two phases
in an emulsion  preventing coalescence of
individual phases
 e.g.:
 emulsifying wax, cetostearyl alcohol, polysorbate
20
Ointment ………………………….

Humectant
 promotes retention of water in a mixture
 examples: glycerin, propylene glycol, polyethylene
glycols (low MW)
Permeation enhancer
 facilitates diffusion process of active ingredient
across the stratum corneum by chemical
modification
 examples: ethanol, oleic acid, propylene glycol,
polyethylene glycol (400)
ii. Pharmaceutical paste
Pharmaceutical paste
 stiff preparation containing a high proportion of
finely powdered solids (i.e., 20-50%) dispersed in
ointment base
 for external application to the skin
 not suited for application to hairy parts of the
body
 examples: toothpastes & zinc oxide paste
Pa s t e … … … … … … … … … … .

Characteristics
 good protective barrier when placed on the skin
 impenetrability
 do not spread easily
 good for localizing drug delivery

o does not compromise the integrity of healthy

skin
 have good adhesion
 effectively absorb watery solutions/ serous
secretions  used around oozing lesions
Pa s t e … … … … … … … … … … .
Difference between paste and ointment
Characteristics ointments
Pastes
finely less amount large amount
powdered
solids content
nature greasy less greasy
mostly oil-based mostly water-based
formulations products
soft stiff and thick
product
usually less more viscous
viscous
spreadability more easily less easily
macerating more less
Preparation of ointments and pastes
 Characteristics of well-made ointment:
 uniform throughout

 free from grittiness, insoluble powders

manufacturing ………………………….

 Both at large and small scale, two methods of

incorporating drugs into ointment bases
 depending primarily on nature of ingredients,

i. Incorporation/ levigation and

ii. Fusion method
manufacturing ………………………….

i. Levigation
 involves mixing of the components of the ointment
until a uniform preparation formed
 before incorporation the ingredient should be
grinded into small particles
manufacturing ………………………….

a) Levigation at small scale

 mix the components using

1. mortar and pestle, or

2. metal or hard rubber spatula and ointment slab
(large glass, porcelain plate or pill tile)
 used to rub the ingredients together
manufacturing ………………………….

3. Others instrument to prepare ointment in small scale

a. ointment mill,
b. electronic mortar and pestle (unguator
manufacturing ………………………….

b) Levigation at large scale

 in stainless steel tank
 using electrically operated propeller mixer in a
suitable mixing vessel
Ointment ………………………….

Incorporation of solids
Ä reducing to the fine powder  thoroughly rubbing &
mixing the components together  smooth & uniform
 ointment base is placed on one side of the
working surface
manufacturing ………………………….

Ä levigation facilitated by the use of

 melted base or
 small quantity of compatible levigation aid such
as mineral oil or glycerin
Ä water-soluble salts of drugs are incorporated by
 dissolving in a small volume of water &
incorporating the aqueous solution into a
compatible base
manufacturing ………………………….

Incorporation of liquids
Ä any liquids ingredients should be incorporated at the
end of levigation
 mortar and pestle is preferred when large
volumes of liquid are added
manufacturing ………………………….

ii. Fusion method

 all or some of the components are combined by
melting together & cooled with constant stirring until
congealed
 used when
 components are stable at fusion temperatures
 base contains solids that have higher melting
points
 such as paraffin, stearyl alcohol, white wax,
yellow wax, high molecular weight PEGs
manufacturing ………………………….

Ä components not melted are added to the congealing

mixture as it is being cooled and stirred
Ä heat-labile substances and any volatile components
are added last
 at temperature not causing decomposition or
volatilization of the components
manufacturing ………………………….

At small scale
 the fusion process may be conducted in a porcelain
dish or glass beaker

 At large scale; it is generally carried out in large

steam-jacketed kittles
manufacturing ………………………….

Ä Once congealed, the ointment may be passed

through:
 an ointment mill (in large-scale manufacture)
 rubbed with a spatula or in a mortar (in small
scale ppn) to ensure a uniform texture
manufacturing ………………………….

Evaluation of ointment & paste

1. Evaluation for visual appearance, colour, odour, labelling,
and homogeneity
2. pH
3. minimum fill test
Ä determination of the net weight or volume of the
contents of filled containers to ensure proper contents
compared with the labeled amount
4. microbial content
5. viscosity
6. in vitro drug release
package ………………………….

Packaging, storage, and labeling of ointments

preparations
 packaged either in large-mouth ointment jars or in
metal or plastic tubes
Ointments are usually packaged either
 Jars
 Tubes
Jars
Ä May be made of
 glass, uncolored, dark green, amber, or blue or
 plastic, or porcelain
Tubes:- are made of tin or plastic (collapsible tube)
package ………………………….

 Storage should
 be completely filled containers
 be stored in tightly closed/ well-closed containers
to protect against contamination
 a cool place (below 25 °C)

o to prevent the softening and liquefying

o to protect against product separation in heat
 opaque or light-resistant containers for light
sensitive preparations
package ………………………….

Tube-filled ointment predominate over jar-filled

ointments primarily b/s:
Ä more convenient for the patient
Ä less exposed to air and to potential contaminants
likely to be more stable
package ………………………….

Filling of the ointment into jars (small scale)

 by means of a flexible spatula & forcing the
ointment down and along the sides of the jar to
avoid the entrapment of air
 ointments prepared by fusion may be poured
directly into the ointment jars for congealing with
in the jar
package ………………………….

Ä In the large-scale manufacture of ointments,

pressure fillers force a specified amount of an
ointment in to a jar
Ä Tubes are generally filled by pressure fillers from the
open back and (opposite and from the cap end) of
the tube which is then closed and sealed
package ………………………….

Labeling:
 for external use only
 caution: not to be taken.
 storage: below 25 °C.
 expiry: 28 days from date of preparation unless
otherwise specified
Thank you!
II. C r e a m s & Gels
Creams
Ä semi-solid preparations containing one or more
medicinal agents dissolved or dispersed in either
1. water-in-oil (w/o) emulsion or
2. oil-in-water (o/w) emulsion
 whitish, creamy appearance
 relatively soft & have better fluidity compared to
ointment
 easier to spread & remove

o satisfy preference of patient & physician

cream ………………………….

Creams application
Ä primarily formulated for application to skin &
mucous membranes
 such as rectally & vaginally
 for protective, therapeutic, or prophylactic
purposes
Ä E.g., applicable to weeping or oozing surfaces
 essentially miscible with skin secretion
cream ………………………….

Classification of creams
1. Medicated
 contains active APIs: antibacterial, antifungal,
antipruritic
2. non-medicated
 for cosmetic purposes: to moisturize, beautify,
nourish the skin
 increases hydrophilic properties of skin 
rehydrate
 reduces surface roughness
cream ………………………….

Creams depending on continuous phase nature

i. hydrophilic creams (oil-in-water creams)
 aqueous creams
ii. hydrophobic creams (water-in-oil creams)
 oily creams
NB:
Ä either water washable or nonwashable
 depends on emulsion external continuous phase
(aqueous or non-aqueous)
cream ………………………….

1. Hydrophilic creams (oil-in-water creams)

Ä contain large amounts of H2O in their external phase

Ä if properly designed
 provide a good feeling after application
 less greasy

 quickly washed off with H2O

 suitable for oozing wounds

cream ………………………….

Ä upon rubbing hydrophilic creams on skin

 continuous aqueous phase evaporates 
increased concentration of a water-soluble drug
in the oily/ thin residue film  adheres to the skin
 effectively deliver medicaments to body
surfaces

 presence of H2O in aqueous creams may

 reduce stability of many medicaments &

 encourage growth of microorganisms

o need inclusion of suitable preservatives

cream ………………………….

Example: vanishing cream

 spread easily & disappear rapidly when rubbed on
skin
Components
1. stearic acid: protective & provides non-greasy film 
emollient
2. glycerin: maintain consistency & enhance spreading
ability
3. water: dispersion medium
4. preservative: methyl parahydroxy benzoate, propyl
cream ………………………….

ii. Hydrophobic creams (water-in-oil creams)

Ä composed of small droplets of H2O dispersed in

continuous oily phase

 provide oily barrier that slow H2O evaporation

o  moisturizing & cooling sensation

 not H2O washable

 emollient in nature
Ä mostly hydrophobic drugs incorporated  released
more readily
Ä uses for cleansing:
cream ………………………….

Example: cold cream

 proportion of fatty & oily material (oil phase)
predominates
 oil-based semisolid preparation
 contains bees wax , liquid paraffin , white soft
paraffin , hard paraffin , borax , water , perfume
o soothing & cleansing cosmetic typically of oily
and heavy consistency
cream ………………………….

Components of creams
1. variety of oils
2. emulsifying agents
3. preservative(s)
cream ………………………….

Preparation of creams
A. General principles
1. separating formula components into two portions:
lipid & aqueous portion
2. dissolving or melting solid excipients at the time of
preparation
a) lipid portion:
 contains all water-insoluble components
 melt at T above the mp of highest melting
component
cream ………………………….

b. the aqueous portion

 contains the water-soluble components
 dissolve methylparaben, propylparaben,
tween-80, borax, and glycerin in water in
another beaker at high T
cream ………………………….

3. Mixing the two phases

 aqueous phase to lipid phase or reverse procedure
 continuously stir during the cooling process until
reaching ambient temperature or the mixture has
congealed
4. Homogenization
1. to reduce particle or droplet size by a
homogenizer & improve the physical stability of
the preparation
5. Filling, labeling, and packaging
cream ………………………….

II. Creams preparation methods

1) trituration/ levigation method : wet grinding
2) fusion method
cream ………………………….

1) Trituration/ levigation method

Involves Incorporation of
Ä finely divided insoluble powder particles or liquid by
geometric dilution
o using glass slab or mortar and pestle
Ä insoluble coarse powder by rubbing with molten base
or liquid or a semi solid base
cream ………………………….

2) Fusion method
Involves
Ä base liquefied  soluble components dissolved in
the molten base  mixture congealed by cooling 
spatulated or triturated to obtain smooth texture
Ä performed using steam - jacketed vessels or a
porcelain dish
cream ………………………….

Note:
1. APIs can be added
 to the phase in which it is soluble at the beginning
of the process, or
 after the cream is prepared by a suitable
dispersion process
2. Rapid cooling may result in separation of high
melting point components
3. Excessive aeration caused by vigorous stirring may
lead to a granular product
cream ………………………….

Containers and storage of creams:

 should be stored & supplied in
 well-closed containers which prevent evaporation
 wide-mouthed squat jars
 collapsible tubes of metal or suitable plastics
 rectal creams are packaged with special perforated
plastic tips for products application
cream ………………………….

creams
 should be kept below 25 °C
 the expiry date is 28 days unless otherwise specified
cream ………………………….

Labelling:
 if the product is for topical use, the container should
be labeled
 for external use only
 if the product is for nasal, otic, vaginal or rectal use,
the container should be labeled
 caution: not to be taken
Gel
Gels
Ä semisolid consisting of dispersions of small or large
molecules in either hydrophilic or hydrophobic liquid
vehicle
 rendered jellylike by addition of gelling agent
 liquid particles dispersed in the solid medium
 transparent or translucent semi-solid
gel ………………………….

Gelling agents
Ä usually polymer with a few percent concentration
gives either physical or chemical cross-linking 
semisolid consistency
o provides gel structure (hardness) & adhesive stick
nature
o modify viscosity
 increase stability and suspension
Ä have a high degree of physical or chemical cross-
linking  form a 3D system
gel ………………………….

Ä includes
 synthetic macromolecules: carbomer 934;
cellulose derivatives, such as CMC or HPMC;
 natural gums: tragacanth
gel ………………………….

liquid phase
Ä constrained within a 3D polymeric matrix
Ä solvents are oil-free or water-miscible  viscous
preparations
 used for the application of water-soluble
medicaments to body surfaces
 may contract on standing & squeeze some of the
solvent out
 if the solvent comes out of a swollen gel, it is said
to exhibit syneresis, or to bleed
gel ………………………….

Gels used for

Ä lubrication
Ä vehicles for drugs aimed at skin & mucosal
 e.g., eye, nose, vagina, & rectum administration

o carriers for spermicidal agents to be used

intravaginally with diaphragms
gel ………………………….

Components of gel propylparaben, or

1. gelling agent chlorhexidine gluconate)

2. Water 6. buffers

 most widely used 7. flavours/sweetening

dispersion medium agents

3. drug substance, 8. hygroscopic agents

4. cosolvents: alcohol ( humectant): to prevent

and/or propylene glycol), skin formation

5. antimicrobial 9. stabilizers: such as the

preservatives: chelating agent edetate

disodium
gel ………………………….

Types of gel
Ä based on existence of apparent boundary between
the macromolecules & liquid
1. single phase or
2. biphasic system
gel ………………………….

a) Single-phase gels
 in which the macromolecules are uniformly
distributed throughout a liquid
 no apparent/ definite boundaries exist between
dispersed macromolecules & liquid
gel ………………………….

b) Biphasic gels
 consist of floccules of small distinct particles with
higher viscosity
 contain a gelatinous, cross-linked precipitate of
one substance in the aqueous phase
o e.g. precipitates of inorganic salts, such as
magnesium hydroxide, as gelling agents
 not always stable & may thicken on standing
 shake before use to liquefy the gel & enable
pouring
gel ………………………….

Types of gels based on the solvent phase of the gels

i. hydrogels or
ii. organogels
gel ………………………….

i. Hydrogels

 contain H2O or mixture of hydrophilic fluids (such as

H2O , glycerol, propylene glycol and alcohol) as the

main continuous phase solvent
 contain significant amounts of water but remain
as water insoluble
ii. Organogels/ hydrophobic gels
 contain organic liquid
 organic solvent, mineral oil, or vegetable oil
gel ………………………….

Gels preparation
Involves
 dispersing the molecule in the continuous phase

o cross-linking the dispersed molecules

 initiated by heat, pressure, change in pH, or
 vigorous mixing or milling or
 shaking if the preparation is less viscous
gel ………………………….

Gels preparation method

1. cold method
2. fusion method
3. dispersion method
gel ………………………….

1. Cold method

Ä H2O cooled at 4-10 OC  pour to mixing vessel 

slowly add gelling agent with agitation  solution 

API & other ingredients added with gentle mixing 
warm in container to room T  clear gel
gel ………………………….

2. Fusion method
Ä Involves waxy materials as gelling agent in non-polar
medium
 melted & drugs added to melts with slow stirring
until uniform gel formation
3. Dispersion method
 Stirring gelling agent in water  add & dissolve drug
in non-aqueous solvent & other IAs with continuous
stirring  gel
gel ………………………….

Containers and storage of gels

 should be stored in tight containers
 store below 25 °C unless specified
 avoid freezing gels
 should be discarded 28 days after manufacture
unless indicated
 package light sensitive preparations in opaque or
light-resistant containers
 shaken before use to liquefy gel & enable pouring
 may thicken on standing, forming a thixotrope
gel ………………………….

Quality attributes of semisolid dosage forms of drug

1. physical stability
2. drug identity, purity, content, and uniformity of
content
3. drug release rate using in vitro test
4. viscosity of the formulation
5. minimum fill in the container and deliverable volume
or doses
6. microbial content/ sterility
7. packaging, storage ocndition, and labeling
Case Studies
1. Mr. Abebe needs to purchase a prescription
of 0.25% (w/w) steroid cream to treat
eczema on his infant son’s cheeks. He asks
the pharmacist about a prescription he got
from his doctor two weeks ago for the same
steroid but at a higher concentration and
ointment(1%). Since the cost of this topical
formulation is very high, he wants to know
why he needs to purchase the 0.25% cream
for his son when she could use the leftover
1. Can Mr Abebe use the leftover 1% ointment instead
of the prescribed one? why?
2. If the 0.25% of the cream is not available on the
market at all, and only 1% cream exist, how do you
help the patient?
3. If you decided to prepare 0.25% cream from 1% by
dilution with vanishing cream (cream base) to
dispense the total of 50 g, how many gram of 1%
cream base do you use?
Thank you!