SEMISOLID DOSAGE FORMS

Prepared by: Dr. Tara A. Abdulla

 Topics:

● - Ointment
● - ideal ointment base
● - ointment bases

2
Semisolid dosage forms
● Ointments,
● Creams ,
● Gels , and
● Suppositories
● are semisolid dosage forms intended for
topical application. They may be applied
to the skin, placed onto the surface of
the eye, or used nasally, vaginally or
rectally.
 Ointments
● Ointments may be:
● medicated
● nonmedicated ointments (Ointment
bases), may be used for their
● physical effects as:
● protectants,
● emollients
● lubricants
● as vehicles in the preparation of
medicated ointments.
what are Ideal Ointment Base?
 Ideal Ointment Base
● An ideal ointment base should possess the
following properties:
● It should not retard wound healing.
● It should have a low sensitization index.
● It should be pharmaceutically elegant.
● It should release the medicament efficiently at
the site of application.
● It should have a low index of irritation.
 Ideal Ointment Base (cont.)

● It should be non-dehydrating, non-greasy, and

neutral in reaction.
● It should possess good keeping qualities.
● It should be compatible with common
medicaments.
● It should be easily washable with water.
● It should be easy to compound and remain
stable on storage.
Ointment base:
● Are classified by the USP into four
general groups:

● 1) Hydrocarbon bases,
● 2) Absorption bases,
● 3) Water-removable bases, and
● 4) water-soluble bases.
 1- Hydrocarbon Bases
also termed oleaginous base, on application to
the skin, they have an emollient effect, protect
against the escape of moisture, and effective
as occlusive dressings, can remain on the skin
for prolonged periods of time with-out drying
out, and because of their immiscibility with
water are difficult to wash off.
e.g.
Petrolatum, white ointment, white Petrolatum,
and yellow Ointment
 Petrolatum USP:
❖ purified mixture of semi-solid hydrocarbons
obtained from petroleum.
❖It is varying in color from yellowish to tight
amber.
❖It melts at temperatures between 38 - 60°C
❖used alone or in combination with other
agents as an ointment base.
❖Petrolatum is also known as "Yellow
Petrolatum" and Petrolatum jelly a
commercial product is Vaseline
11
 White Petrolatum, USP:
❖Is a purified mixture of semisolid hydrocarbons
from Petrolatum that has been wholly or nearly
decolorized.
❖ It is used for the same purpose as Petrolatum,
but due to its lighter color it is considered more
esthetic by some pharmacists and patients.
White Petrolatum is also known as "White
Petroleum Jelly." A commercial product is White
Vaseline.
13
 Yellow Ointment, USP
● This ointment has the following formula for the
preparation of 1000 g:
● Yellow Wax 50 g
● Petrolatum 950 g
● Yellow wax is the purified wax obtained from the
honeycomb of the bee. The ointment is prepared
by melting the yellow wax on a water bath, adding
the petrolatum until the mixture is uniform, then
cooling with stirring until congealed. The ointment
also has been called "Simple Ointment."
15
White Ointment, USP
● This ointment differs from Yellow

Ointment by substituting White Wax

(bleached and purified Yellow Wax) and
White Petrolatum in the formula.
17
 2- Absorption Bases
● Absorption bases are of two types:
● 1) those that permit the incorporation of aqueous
solutions resulting in the formation of water-in- oil
emulsions (e.g. hydrophilic petrolatum),
● 2) those that are water-in-oil emulsions (e.g.
emulsion base) and permit the incorporation of
additional quantities of aqueous solutions (e.g.
Lanolin). Absorption bases are not easily removed
from the skin with water washing since the
external phase of the emulsion is oleaginous.
 Hydrophilic Petrolatum, USP
❖ Hydrophilic Petrolatum, USP has the following
formula for the preparation of 1000 g:
Cholesterol 30 g
Stearyl Alcohol 30 g
White Wax 80 g
White Petrolatum 860 g
❖ It is prepared by melting the stearyl alcohol and the
white wax on a steam bath, adding the cholesterol
with stirring until dissolved, adding the white
petrolatum and allowing the mixture to cool while
being stirred until congealed.
20
Lanolin, USP

● Lanolin, USP, obtained from the wool of

sheep is a purified, wax-like substance

that has been cleaned, deodorized, and
decolorized. It contains not more than
0.25% water.
22
 3- Water-removable Bases
● Water-removable bases are oil-in-water
emulsions resembling creams in appearance.
Because the external phase of the emulsion is
aqueous, they are easily washed from skin and
are often called "water-washable" bases. They
may be diluted with water or aqueous solutions.
 Hydrophilic Ointment, USP
● Hydrophilic Ointment has the following formula for the
preparation of about 1000 g:

● Methylparaben 0.25 g
● Propylparaben 0.15 g
● Sodium Lauryl Sulfate 10 g
● Propylene Glycol 120 g
● Stearyl Alcohol 250 g
● White Petrolatum 250 g
● Purified Water 370 g
25
4- Water-soluble Bases
● Water-soluble bases do not contain
Oleaginous components they are completely
water-washable and often referred to as
"greaseless."
● Because soften greatly with the addition of
water
● large amounts of aqueous solutions are not
incorporated into these bases.
● They mostly are used for the incorporation of
solid substances.
 Polyethylene Glycol Ointment, NF
● Polyethylene glycol PEG is a polymer of ethylene
oxide and water represented by the formula
● H (OCH2CH2)n OH in which (n) represents the average
number of oxyethylene groups. The numerical
designations associated with PEGs refer to the
average molecular weight of the polymer.
● PEGs having average molecular weights below 600
are clear, colorless liquids;
● those with molecular weight above 1000 are wax-like
white materials; and those with molecular weights in
between are semisolids.
● The greater the molecular weight the greater viscosity.
● The general formula for the preparation of 1000g
of Polyethylene Glycol Ointment is:

● Polyethylene Glycol 3350 400 g

● Polyethylene Glycol 400 600 g
29
Factors Governing Selection of the
Ointment Base

❖(A) Dermatological Factors

❖ (1) Absorption and penetration:

'Absorption' indicates actual entry into the

blood stream i.e. systemic absorption,
whereas 'penetration' Indicates passage
through the skin i.e. cutaneous absorption.
31
 Following generalizations can be made from the
various studies:
❖ 1- Paraffin does not readily penetrate the skin. but
Animal and vegetable oils and wood fat, especially
when combined with water, normally penetrate the
skin.
❖ 2- Absorption into the blood stream is essentially a
function of the medicament and not of the vehicle.
❖ 3- Substances soluble in both oil and water are also
readily absorbed.
❖ 4- Water-soluble substances are more readily
absorbed from aqueous bases.
❖ 5- Medicaments are released more readily from o/w
emulsion bases than from greasy bases or w/o
emulsion bases.
 (A) Dermatological Factors (cont.)
● 2- Effect on skin function: Greasy bases interfere
with normal skin function like heat radiation and sweat
excretion and may be irritant to the skin. Water-
miscible bases and o/w emulsion bases have a
cooling rather than heating effect and mix readily with
skin secretions.
● 3- Compatibility with skin secretions: Ointment
bases should have a pH around 5.5 which is the
average pH of the skin secretions. Usually neutral
ointment bases are preferred as they do not cause
discomfort in use and are compatible with majority of
medicaments.
 (A) Dermatological Factors (cont.)
● 4- Miscibility with skin secretion and serum: Skin
secretions are more readily miscible with emulsion
bases as compared to greasy bases. This miscibility
causes a rapid and more complete release of
medicament and hence lesser proportion of the
medicament is needed.
● 5- Freedom from irritant effect: Ointment bases
should be non-irritant. Greasy bases may cause
edema. All bases should be of a high standard of purity
and bases used in preparing ophthalmic ointment
especially should be non-irritating and free from foreign
particles.
 (A) Dermatological Factors (cont.)
● 6- Emollient properties: Humectants like glycerin and
propylene glycol keep the skin surface moist and soft.
Wool fat, lard and paraffin keep the skin by preventing a
rapid loss of moister and this how emolliency is achieved.

● 7- Ease of application and removal: Stiff and sticky

ointment base may cause damage to the newly-formed
tissue hence emulsion type base are preferable as they
are softer and spread more readily over the area.
● Emulsion bases, particularly o/w type are easily water-
removable.
 B/Pharmaceutical Factors
● 1 .Stability:
❖ The fats and oils obtained from animal and
vegetable sources are liable to undergo oxidation.
This can be prevented by incorporating a suitable
antioxidant in desired concentration in the
ointment base.
❖ o/w type emulsion bases are liable to microbial
growth and ' needs a proper preservative .
❖ Emulsified bases are liable to phase separation
due to improper formulation or under the influence
of temperature.
 B/Pharmaceutical Factors(cont.)
● 2- Solvent properties:

❖ medicaments used in the preparation of ointments are

generally insoluble in the ointment bases. Hence,
for the uniform distribution, it is necessary to mix finely
powdered drug in the ointment base.
❖ Phenol in solid form is quite caustic and if present in a
finely divided form in an ointment base it may cause
blisters Therefore, it must be dispensed in a suitable
base which should keep the phenol in solution form. .
 B/Pharmaceutical Factors(cont.)
● 3 .Emulsifying properties:
❖ Hydrocarbon bases can absorb only a small
amount of water in comparison to animal fats
which can absorb large quantities of water. For
example, wool fat can absorb about 50% of
water,
❖ Hence, wool fat is included for the preparation of
base meant for eye ointments .Similarly certified
emulsifying ointment is capable of absorbing
considerable amount of water forming o/w
creams.
 B/Pharmaceutical Factors(cont.)
● 4 .Consistency :
❖ The ointments should be of suitable consistency .It
should neither be too hard nor too soft.
❖ The consistency of an ointment base should be such,
that it withstand wide variation in temperature
conditions .
❖ The consistency of an ointment can be adjusted in
such a way that it contains a suitable quantity of high
melting point substances like hard paraffin, beeswax
etc., in soft ointments and low melting point
substances like liquid paraffin
Preparation of Ointments

● The ointments can be prepared by any one of the

following methods:
● 1. Trituration method

● 2 .Fusion method

3 .Chemical reaction method

● 4 .Emulsification method
In compounding ointment the following
rules should be observed:

● 1- insoluble substance should be in the

impalpable powder form.
● 2- insoluble substance are best
incorporated when first levigated.
● 3- water soluble salt should be
incorporated by dissolving them.
 1- Trituration method:
● The method is used when the base is soft and the
medicament is insoluble in the base . The following
procedure is used to get a uniform ointment:
● a - Finely powder the solid medicaments.
● b- Weigh the required quantity of an ointment base.
Triturate the solid medicaments with a small amount of
the base on an ointment slab with the help of spatula.
● C- Add remaining quantities of the base until the
medicament (s) is uniformly mixed with it .
● When large quantity of liquid is to be incorporated, pestle
and mortar should be used.
Trituration method (cont):

● The pestle and mortar method of

trituration is not preferable as compared
to slab method, why?
 Trituration method (cont):

● The sides of the pestle and mortar will be

required to scrap from time to time.

● There are chances of improper mixing of

particles of medicament(s) which are
usually slipped out from under the pestle
during trituration.
45
 2 .Fusion method
● When an ointment base contains a number of solid
ingredients of different melting points, such as white
beeswax, stearic acid, hard paraffin and cetyl-
alcohol,
● it is necessary to melt them in decreasing order to
their melting point .
● This will avoid the overheating of substances having
low melting points.
● The medicament is incorporated slowly to the
melted mass, stirred thoroughly until the mass cools
down and homogenous product is formed.
 2 .Fusion method (cont.)

● In case any liquid ingredient or aqueous substance is

also to be incorporated, that should be heated to almost
to the same temperature as the melted bases.

● The rapid cooling should be avoided to get a uniform

product

● In order to remove the dust or foreign particles from the

melted base, it is strained through muslin piece .The
clarified liquid is collected in another hot container.
 3 .Chemical reaction method:
Chemical reactions are involved in the preparation of
several ointments .For example, iodine ointment .
● Ointments containing free iodine
● Iodine is only slightly soluble in most of the fats and
vegetable oils.
● But it is readily soluble in concentrated potassium iodide
solution in water, due to the formation of poly iodides
KI.I2, KI.2I2, KI.3I3 .
● These poly iodides are readily soluble in water, alcohol
and glycerin.
● These solutions may be incorporated with the
absorption type ointment base .For example, strong
iodine ointment which is used to treat ringworm infection
in cattle's.
 4 .Emulsification method:
● the fats, oils and waxes are melted together
on a water bath at a temperature of 70°C .
● The aqueous solution of all of the heat stable
water soluble components is also heated
almost at the same temperature as that of the
melted bases .
● The solution is slowly added to the melted
bases with continuous stirring until the product
cools down and semi-solid mass known as
ointment is prepared.
 Emulsification method (cont.)
● An emulsifying agent is needed to make a stable
emulsion, for a long time .Water soluble soaps are
commonly used as emulsifier for semisolid o/w
emulsions.
● Sometimes the emulsified ointments require a
combination of emulsifiers.
● A combination of triethanolamine stearate soap and
cetyl alcohol is used as an emulsifier in o/w
emulsions and
● a combination of beeswax and divalent calcium ions
is used as an emulsifier for w/o emulsions.
 Additives Used in Ointments
● During the dispensing of ointments, the
● Preservatives: Methyl paraben or propyl
paraben
● Antioxidants:
● humectant: to prevent the loss of moisture
from the preparation such as, glycerin,
propylene glycol or sorbitol may be added
● chelating agents: to prevent the catalytic
'oxidative degradation of trace elements.
● Perfumes: to give pleasant odor.
 Storage of Ointments
● Ointments are dispensed in glass or plastic jars
having screw caps with impermeable liners.
Nowadays, ointments are generally supplied in;
plastic or metallic collapsible tubes.
● The ointments should be stored in well closed
container so as to prevent the loss of volatile
constituents .
● The ointments should be placed in a cool place.
● A secondary label "For external use only should be
fixed on the container.
 Creams
● Pharmaceutical creams are semisolid preparations
containing one or more medicinal agents dissolved or
dispersed in either an oil-in-water emulsion or in
another type of water-washable base.

● Creams find primary application in topical skin

products and in products used rectally and vaginally.

● Pharmaceutical manufacturers frequently

manufacture topical preparations of a drug in both
cream and ointment bases to satisfy the preference of
the patient and physician.
Cream (cont.)
● Many patients and physicians prefer
creams to ointments. Why?

● because they are easier to spread and

remove than many ointments.
Cream (cont.)
● Cream became more official with the
introduction of formula for sun cream.
● Sun cream are designed to prevent
sunburn, but at the same time, to permit
tanning.
● E.g. of sun screening agent, benzocaine
and phenyl salisylate, incorporated in an
o/w emulsion
● TYPES OF CREAMS:
● A. Cleansing cream
● B. Massage creams
● C. Night creams
● D. Moisturizing creams
● E. Foundation creams
● F. Vanishing creams
● G. All purpose creams
● A) CLEANSING CREAM:- Cleansing cream is
required for removal of facial make up, surface
grime, oil.

● Characteristic of a good cleansing cream:-

● 1) Be able to effectively remove oil soluble & water

soluble soil, surface oil from skin.
● 2) Should be stable &have good appearance.
● 3) Should melt or soften on application to the skin
● 4) Should spread easily without too much of drag.
● Type of cleansing cream:-
● I.) Anhydrous type:- It contains mixture of
hydrocarbon, oils and waxes. It also contains cetyl
alcohol, spermaceti, cocoa butter, fatty acid esters
etc.
● II.) Emulsified type:- They can be either o/w or w/o
type.
● Common Ingredients:-
● Oil phase…………………..Spread easily
● Waxes…………………..Give appropriate thixotropy
● Emollient material…………likes cetyl alcohol,
spermaceti, lanolin
● Water phase with preservative
● Different types:-
● (1) Cold Cream:- Cooling effect is produced due to slow
evaporation of the water contained in the formulation.
These are w/o type.
●
● (2) Beeswax Borax type:- These contain high
percentage of mineral oil. These are o/w type. After the
cream is being rubbed into the skin sufficient quantity of
water evaporates to impart a phase inversion to the w/o
type. The solvent action of the oil as external phase
imparts cleansing property. In this type of cream borax
reacts with free fatty acids present in the bees wax and
produces soft soap which acts as the emulsifying agent
and emulsifies the oil phase.
● B) NIGHT & MASSAGE CREAM:-
● These are generally applied on the skin and left for
several hours say overnight and assist in the repair of
skin which has been damaged by exposure to various
elements or exposure to detergent solution or soap.
The mostly have a moisturizing & a nourishing effect of
affected skin. These also contain vitamins and
hormones basing on the application. This cream give
better look to the skin and prevent dryness.
● A typical formulation
● • Mineral oil-38gm Borax 1gm
● Petroleum jelly-8gm Water 35gm
● White bees wax-15gm Paraffin wax – 1.0gm
● Lanolin 2gm Perfume & preservative
q.s
● C) VANISHING CREAM:-
● These are named so as they seem to vanish when
applied to the skin. High quantity of stearic acid as oil
phase used. This provides an oil phase which melts
above body temp, so as to invisible in use and give a
non greasy film.
● Main component is emollient esters ,stearic acids
● Part of stearic acid is saponified with an alkali & rest of
stearic acid is emulsified this soap in large quantity of
water.
● The quality of cream depends on the amount of acid
saponified & nature of alkali used.
● NaoH makes harder cream than koH.
● Borax makes cream very white but product has
tendency to grain.
● Pearliness can be attained using liq.paraffin, cocoa
butter, starch, castor oil, almond oil.
● Ammonia solution has a tendency to discolor creams
made with it after some time.
● Cetyl alcohol improves texture and stability at low
temperature without affecting sheen.

● A typical formulation
● Stearic acid 15gm Glycerin 5gm
● KOH 0.5 gm water 75.82 gm
● NaOH 0.18 gm preservative &perfume q.s
● Cetyl alcohol 0.50 gm Propylene glycol 3.0gm
● Stearic acid has whiteness like snow so some times the
preparation is called as SNOW.
● D) FOUNDATION CREAM:-
● Applied to skin to provide a smooth emollient base
or foundation for the application of face powder &
other make up preparations. They help the powder
to adhere to skin. They are almost o/w type.
● A typical formulation
● Lanolin 2 gm Propylene glycol 8gm
● Cetyl alcohol 0.50 gm water 79.10 gm
● Stearic acid 10gm
● Perfume &preservative q.s
● KoH 0.40 gm
● E) HAND & BODY CREAM:-
● • _The repeated or constant contact with soap and
detergent damages & removes film of sebum thus
this cream is used to impart following functions to the
skin.
● • _The function of these creams are :
● - Replace/reduce water loss.
● - Provide oily film to protect the skin.
● - Keep the skin soft, smooth but not greasy.
● Type:-
● a) Liquid cream:-consistency is of liquid nature
● b) Solid creams:- Consistency is higher
● c) Nonaqueous type:-Not containing any aqueous
medium.
● A typical formulation
● a.) Isopropyl myristate - 4 gm Mineral oil -- 2 gm
● Stearic acid – 3.gm Emulsifying wax - .275 gm
● Lanolin - 2.5 gm
● b.) Glycerin -3.0 gm Triethanolamine – 1 gm
● Water -84.225 gm Perfume and Preservative -q.s
● (F) ALL PURPOSE CREAMS:- All purpose means
it is suitable for hands, face and body. They are w/o
types.
● Formula:-
● Water phase Oil phase
● Mineral oil 18%
Water 61.3%
● Lanolin 2%
Glycerol 5%
● Petroleum jelly 2%
Magnesium sulphate 0.2%
● Ozokerite 7 %
Perfume, preservative q.s
● Paraffin wax 3%
 Gels
● Gels are sometimes called jellies.
● Gels are semisolid systems consisting of dispersions of
small or large molecules in an aqueous liquid vehicle
rendered jelly-like through the addition of gelling agent.
Some gel systems are as clear as water, and others are
turbid because the ingredients may not be completely
molecularly dispersed (soluble or insoluble),
● Medicated gels may be prepared to administered by
various routes including topically to the skin, to the eye,
nasally, vaginally, and rectally.
 Gels (cont.)
● gelling agents used are:

● 1- synthetic macromolecules as arbomer

934, cellulose derivatives as
carboxymethyl-ceIlulose or
hydroxypropymethyl –cellulose

● 2- natural gums as tragacanth.

 Gel (cont.)
● Single-phase gels: the macromolecules
are uniformly distributed throughout a liquid
with no apparent boundaries between the
dispersed macromolecules and the liquid.
● two-phase system: gel mass consists of
floccules of small distinct particles, often
referred to as a magma. Milk of magnesia
(or magnesia magma), which is comprised
of a gelatinous precipitate of magnesium
hydroxide, is an example of such a system.
 Gel (cont.)
● In addition to the gelling agent and water gels
may be formulated contain:
● drug substance,
● co solvents as alcohol and/or propylene glycol,
● antimicrobial preservatives as methylparaben
and propylparaben or chlorhexidine gluconate,
● stabilizers as edetate disodium.
 Miscellaneous Semisolid Preparations:
Pastes, Plasters and glycerogelatins
● PASTES
● Pastes are semi-solid preparations intended for
external application to the skin.
● The pastes are generally very thick and stiff.
● Less greasy and more absorptive, why.
● Because of their high proportion of powdered
medicaments, such as starch and zinc oxide,
calcium carbonate, etc.
Paste (cont.)
● They do not melt at ordinary temperature
and thus form a protective coating over
the area where they are applied.
● They are used mainly as antiseptic
protective or soothing dressings which
are often spread on lint before being
applied.
 Paste (cont.)
● Bases Used for Pastes
● 1- Hydrocarbon bases
● 2- Water miscible base
● 3-Water soluble base.

● 1- Hydrocarbon bases: ointment like mixture

of starch and zinc oxide and calcium
carbonate with liquid petrolatum, white
petrolatum, anhydrous lanolin, white wax,
etc..
Bases Used for Pastes (cont.)
● 2- Water miscible base:
● To form jellies containing glycerin with
starch.
● 3-Water soluble base:
● Are glycerogelatins which containing
pectin, tragacanth, glycerin, etc…
Tooth paste
uses
● Used on acute lesions especially those
which are oozing.
● Provide a protective layer which its
difficult for the patents to scratch his
skin.
● Pectin and tragacanth paste used for
treatment of ulcer and bedsores.
● Plasters
● Plasters are solid or semisolid adhesive masses spread
upon a backing material of paper, fabric, moleskin or
plastic. The adhesive material used is a rubber base or
synthetic resin.
● Glycerogelatins
● Glycerogelatins are plastic masses containing
gelatin (15%), glycerin (40%) water (35%) and an
added medicinal substance (10%) as zinc oxide
Thanks for
your
attention