Ointments, Pastes and

Jellies

1
OINTMENTS
Semi-solid greasy preparations for application to the
skin, rectum or nasal mucosa. The base is usually
anhydrous and contains the medicament in
solution or suspension

Used mainly for:

 Emollient effect

 Protection of lesions

 Topical Medication
2
CHARACTERISTICS OF AN IDEAL OINTMENT
1. It should have high physicochemical stability.
2. It should be smooth and not gritty.
3. It should melt or soften at body temperature.
4. It should be easy to apply.
5. Base(s) should be nonirritant and should have no
therapeutic action.
6. It should be thixotropic in nature.

3
ADVANTAGES OF OINTMENTS

1. Handling is comparatively easier than bulky liquid

dosage forms.
2. They promote direct application to the affected body
part and avoids unnecessary exposure of other parts
to the medication.
3. They are suitable for patients sensitive to
parenteral and oral routes.
4. They prolong the contact time between the
medicament and affected region.
5. Drugs with extensive first-pass metabolism by oral
route can be formulated as topical dosage forms.
4
EXAMPLES
 Acne treatment- resorcinol, sulphur

 Antibiotics- bacitracin, neomycin

 Antifungal agents- benzoic acid, salicylic acid

 Antiinflammatory agents- betamethasone, flucitasone

 Antipruritics- benzocaine, coal tar

 Antiseptics

 Astringents- calamine, zinc oxide

 Counter irritants- methyl salicylate

 Eczema treatment- coal tar, corticosteroids

5
 Psoriasis
 OINTMENT BASE
 The ointment base is an integral part of an ointment
preparation and serves as a carrier or vehicle for the
medicament.
 Ideal Properties of a Base

1. Physically, chemically, and pharmacologically inert

2. Nonirritating and nonsensitizing
3. Compatible with skin pH and drug
4. Good solvent and/or emulsifying property
5. Emollient, protective, nongreasy, easily spreadable and
removable
6. Able to release medicament readily at the site of action
7. Pharmaceutically elegant and should possess good stability
6
8. Easily available and economical
TYPES OF OINTMENT BASES

 Hydrocarbon Bases
 Absorption Bases
 Non-Emulsified Bases
 Water in oil emulsions
 Water Miscible Bases
 Water Soluble Bases
7
HYDROCARBON BASES
1. Not absorbed by the skin- forms occlusive layer

 Emollient, restricts water loss and keep the skin soft

 Retains body heat

 May produce uncomfortable feeling of warmth

 May lead to water logging with consequent

maceration of the skin, if application is prolonged

4
HYDROCARBON BASES
2. Immiscible with water
 Rubbing into the skin and removal is difficult

3. Sticky
 Ensures prolonged contact

 Unpleasant and leads to contamination of clothes

4. Inert
 Few incompatibilities and little tendency to rancidify

 Stable to dry heat sterilization

 Rarely encourage growth of micro-organisms,

4
preservative is unnecessary
HYDROCARBON BASES
5. Low water absorption
 Only 5-10% of aqueous liquid can be incorporated,
high percentage tend to separate

 Careful trituration in mortar is necessary

 Capacity to absorb exudate from moist lesions is poor

 Suitable for the conditions in which the skin is dry

6. Readily available and cheap

Examples: Soft paraffin, Liquid paraffin and hard

paraffin 4
HYDROCARBON BASES
Soft Paraffin
 Purified mixture of semi-solid hydrocarbons obtained from
petroleum or heavy lubricating oil

 Yellow and white (bleached form)

 White form is used when the medicament is colorless, white or

pastel shade

 Translucent, soft, greasy and odorless

 Melting point range: 38-56ºC

 Physical properties vary due to differences in source, methods

of refinement and blending

 Eg- Dithranol Ointment B.P., Ammoniated Mercury and Coal11

Tar Ointment B.P., Calamine Ointment B.P.C.
HYDROCARBON BASES
 Liquid Paraffin
 Liquid hydrocarbons obtained from petroleum

 Liable to oxidation- thus antioxidant (NMT 10 ppm of

tocopherol or BHT) is added

 Hard Paraffin
 Colorless or white, wax like substance

 Melting point of 50-57oC

12
HYDROCARBON BASES
 Paraffin substitutes are used now a days
 For soft paraffin polythene (M. Wt 21 000) dissolved in
liquid paraffin,

 Consistency varies very little

 Release of water soluble medicament is facilitated

 For hard paraffin Cosmolloids (microcrystalline waxes)

(Astor Pharmaceuticals)

13
ABSORPTION BASES (NON-EMULSIFIED
BASES)
 Hydrophilic and thus can absorb considerable
amount of water to produce w/o emulsions
 Consists of mixture of sterol type emulgents
 Less occlusive but good emollients
 Assist oil soluble medicaments to penetrate skin
 Easier to spread
 Wool Fat (Anhydrous lanolin)
 Simple Ointment, B.P. and Eye Ointment
basis, B.P.
 Beeswax
 Wool alcohol
14
 Cholesterol
ABSORPTION BASES (WATER IN OIL
EMULSIONS)
 Same properties as non-emulsified bases

 Hydrous wool fat (Lanolin) contains 70% wool fat and

30% water

15
 1. Wool fat (Anhydrous lanolin):
 This is obtained from the wool of sheep as a purified
anhydrous fat.
 It is practically insoluble in water but can absorb
water up to 50% of its own weight.
 It is used along with other bases in the preparation of
a number of ointments.
 For example, simple ointment I.P. contains 5% and
eye ointment base B.P. contains 10% of wool fat.

 2. Hydrous wool fat (Lanolin):

 This is a mixture of 70% w/w of wool fat and 30% w/w
of purified water. It is a w/o type of emulsion. Hence,
aqueous liquids can be emulsified with it. Examples16
are hydrous wool fat ointment B.P.C. and calamine
coal tar ointment.
 3. Wool alcohol:
 This is an emulsifying fraction of wool fat. Wool
alcohol is obtained by treating wool fat with alkali,
with the separation of the fraction containing
cholesterol and other alcohols.
 Normally, it contains not less than 30% of cholesterol.

 It is pharmaceutically employed as an emulsifying

agent and to improve texture, stability and emollient
properties in the preparation of w/o emulsions and
absorb water in ointment bases.
 For example, wool alcohol ointment B.P. contains 6%
wool alcohol.

17
 4. Beeswax:
 This is obtained from the honey comb of bees as a
purified wax, which is available as yellow beeswax and
white beeswax.
 It is used in ointment preparations as a stiffening
agent. For example, paraffin ointment B.P.C. contains
beeswax.
 5. Cholesterol:

 Animals are the main source for cholesterol as it is

extensively distributed in them. Wool fat is also used as
an alternative source of cholesterol.
 It is mainly used to increase the water-absorbing
capacity of an ointment base.
 For example, hydrophilic petroleum U.S.P. contains 3%
cholesterol, 3% stearyl alcohol, 8% white beeswax and 18

86% white soft paraffin.

WATER MISCIBLE BASES
 Water uptake is high to result in o/w emulsions
 Greasy so act as emollients
 Easily removed after use
 Emulsifying Ointment, B.P.
 Cetrimide Emulsifying Ointment, B.P.
 Cetomacrogol Emulsifying Ointment, B.P.
 Compound benzoic acid ointment (Whitfields
ointment)
 Contains
 Appropriate anionic, cationic, non-ionic emulsifying wax (30%)
19
 White soft paraffin (50%)
 Liquid paraffin (20%)
WATER SOLUBLE BASES

 These bases primarily consist of water-soluble

ingredients such as polyethylene glycol (PEG),
which are popularly known as “carbowaxes” and
commercially known as “macrogols.”
 Their water solubility promotes complete removal
from the skin.
 Water-soluble bases are a range of compounds
with the general formula CH2OH(CH2 OCH2 ) n
CH2 OH.

20
WATER SOLUBLE BASES
 Macrogols, poly ethylene glycol, PEG

 Macrogols 200, 300, 400 Liquids

 Macrogols 1500 Semi solid
 Macrogols 4000, 6000 Waxy solids
 Soluble in water (1 in 3) and alcohols (1 in 2)
 Solidifying points: 40-60ºC
 Good absorption by skin
 Good solvent properties
 No greasiness
 Macrogol ointment B.P.C.- 65% macrogol 300 and 35%21
macrogol 4000
 WATER SOLUBLE BASES
Disadvantages

 Limited uptake of water

 Less bland than paraffins

 Reduction in activity of preservatives

 Solvent action on polythene and bakelite

OTHER INGREDIENTS
 Vegetable oils

 Synthetic esters of higher fatty acids

 Higher fatty acids 22

 Silicones
PREPARATION OF OINTMENTS
 Properties

 Uniform

 Free from grittiness (smooth)

 Methods

 Fusion-Paraffin ointment B.P.C., Simple ointment B.P.

 Trituration-Ammoniated mercury and coal tar

ointment B.P.C., Whitfield’s Ointment

 Chemical Reaction- Strong Iodine Ointment B.Vet.C.,

Non-staining iodine ointment B.P.C. 23
FUSION METHOD
Grate the waxy base

Melt using water bath

High M.P base 1st Melt base together

Mix low M.P base in it

Dissolve oil soluble drug

Add small volume phase in large volume phase

Cooling under stirring

Soft mass at 40ºC

24
Homogenization

Filling
 Hard paraffin and cetostearyl alcohol in grated form are
introduced into the preheated china dish placed over a water
bath. Wool fat and white soft paraffin are mixed and stirred
until all the ingredients are melted completely. If necessary,
they are decanted or strained and stirred until cold and packed
in a suitable container.
25
TRITURATION METHOD:
 This method is applicable for the preparation of most
of the medicated ointments containing insoluble drug
substances.
 Finely powdered solids are passed through sieve #85.

 The medicament is taken on an ointment slab and

triturated lightly with a small amount of the base.
 A steel spatula with long, broad blade is used for this
purpose. To this, additional quantities of the base are
incorporated and triturated until the medicament is
fully mixed with the base.
 Finally, liquid ingredients are incorporated to this
semisolid mass.
26
Trituration method
Size reduction

Levigation

Mixing with base

Spatulation or Trituration

Mixing base to produce final

weight

Homogenization

27
Filling
Benzoic acid and salicylic acid are sieved through #85
sieve.
They are mixed on the tile with small amount of base and
levigated until smooth and diluted gradually.

28
CHEMICAL REACTION METHOD:
 Several famous ointments of the past were prepared
by chemical reactions. An example is the strong iodine
ointment B. Vet. C.(British Veterinary
Pharmacopoeia), which is used to treat ringworm in
cattle.
 It contains free iodine.

 Earlier, were used as counterirritants in rheumatic

diseases.
 A limitation is that these ointments stain the skin
with a deep red color. The water dries up due to
improper storage and the iodine crystals irritate the
skin.
 Hence, instead of water, glycerol is sometimes added29
to dissolve the iodine–potassium iodide complex.
Dissolve iodine in aqueous potassium iodide solution. Melt
the wool fat and yellow soft paraffin together and maintain
the temperature to about 40°C. Slowly add iodine solution
with stirring and continue until room temperature attained.
The product is stored in a wide-mouthed amber-colored glass
jar.

30
 Alternative method of preparation:
 Iodine is effectively reacted with unsaturated fatty
acids of the fixed oils. The free iodine gets complexed
with the double bonds of the unsaturated
constituents.

31
 Iodine is finely powdered in a glass mortar and the required
amount is added to a glass-stoppered conical flask containing
arachis oil and stirred well.
 The mixture is cautiously heated at 50°C in a water bath in a
closed condition, preventing the sublimation of iodine.
 Heating is continued until the initial brown color is changed to
greenish-black, which concludes the chemical reaction process.
 From this preparation, 0.1g of the substance is weighed and the
amount of iodine is determined by B.P.C. method.
 The amount of soft paraffin base is calculated suitably to give
the product the required strength. Soft paraffin is warmed to
40°C. The iodized oil is added and mixed well.
 The final preparation is packed in a warm, wide-mouthed, and
amber-colored glass bottle. It should be allowed to cool without
32
further stirring.
 EMULSIFICATION:
 An emulsion system contains an oily phase, an
aqueous phase, and an emulsifying agent, complying
with the basic requirements for the formation of a
stable emulsion. For oil-in-water (o/w) emulsion
systems, the following emulsifying agents are used:
1. Water-soluble soap
2. Cetyl alcohol
3. Glyceryl monostearate
4. Combination of emulsifiers, for example:
triethanolamine stearate and cetyl alcohol
5. Nonionic emulsifiers, for example: glyceryl
monostearate, glyceryl monooelate, propylene glycol
stearate. 33
 Emulsification method

All the components are taken in required quantity

The fats , oils and waxes are melted together on water

bath at a temperature of 70 C

The aqueous solution of all heat stable components are

heated at same temperature

The solution is added to melted bases with continuous

stirring untill cool down and semi solid mass i.e ointment 34
is prepared.
PREPARATION OF OINTMENTS

Paraffin ointment B.P.C.

Bees wax

Hard paraffin

Cetostearyl alcohol

Soft paraffin

35
PREPARATION OF OINTMENTS
Compound methyl salicylate ointment B.P.C.
Methyl salicylate

Cajaput oil

Cineole

Water

Menthol

Wool fat

White bees wax

36
PREPARATION OF OINTMENTS
Calamine and coal tar ointment B.P.C.
Calamine, finely sifted

Strong coal tar solution

Zinc oxide

Hydrous wool fat

White soft paraffin

37
PREPARATION OF OINTMENTS
Ammoniated mercury and coal tar ointment B.P.C.
Ammoniated mercury

Strong coal tar solution

Yellow soft paraffin

38
PREPARATION OF OINTMENTS
Whitfield’s ointment B.P.C.
Benzoic acid, in fine powder

Salicylic acid, in fine powder

Emulsifying ointment

39
PREPARATION OF OINTMENTS
Resorcinol ointment, compound B.P.C.
Resorcinol

Cade oil

Zinc oxide, Finely sifted

Bismuth subnitrate, finely sifted

Starch, Finely sifted

Sodium metabisulphite

Hard paraffin

Water

Wool fat 40

Yellow soft paraffin

 PREPARATION OF OINTMENTS
Strong iodine ointment B. Vet. C.
Iodine

Wool fat

Yellow soft paraffin

Potassium iodide

Water

41
 PREPARATION OF OINTMENTS
Non-staining iodine ointment B. P. C.
Iodine

Arachis oil

Yellow soft paraffin

42
PASTES
 Large amount of solids (50%) thus are stiff

 More Viscous

 Emollient but more porous

 Less macerating

 Less greasy

Hydrocarbon bases- Compound Zinc Paste B.P., Coal tar

paste B.P.C.

Water Miscible bases- Rescorcinol and Sulphur paste B.P.C.

Water soluble bases- Triamcinolone Dental Paste B.P.C. 43

JELLIES
 Transparent or translucent

 Non greasy

 Semi-solid gels

 Contain considerable amount of water

 Less satisfactory for insoluble powders

44
JELLIES-FORMULATION
 Gelling Agents
 Tragacanth
 Sodium alginate
 Pectin
 Starch
 Gelatin
 Cellulose Derivatives
 Carbomers
 Polyvinyl alcohols
 Preservatives
 Other ingredients-glycerol, Propylene glycol or sorbitol
45
Evaluation Tests for Ointments
The formulated ointments should be subjected to the
following evaluation tests before being considered for
the batch process.
1. Penetration test:
This test is carried out by the following methods:
(a) A weighed quantity of ointment under test is
rubbed on a particular area of skin. After a
particulate time period, the ointment is scrapped
and weighed. The difference between the initial and
final weights will give the rate of penetration of
ointment. However, this is a crude method and the
results obtained may not be reproducible.
(b) It can be tested by using a semipermeable cellulose
membrane as diffusion membrane.
(c) Franz diffusion cell method I
: In vitro instrument for the study of drug penetration.
The diffusion membrane used can be a synthetic
semipermeable membrane, animal skin membrane or
cadaver skin. The study simulates the physiological
conditions of human and the results obtained are
reproducible.
(d) The cup plate method is also used. If the ointment
contains any antimicrobial substance, then 2% w/v agar
culture media with susceptible microorganism is taken in a
petri dish. Bores are made and a preweighed sample of the
ointment is introduced aseptically and incubated at 37°C.
At frequent intervals of time, the petri dish is taken out and
the zone of inhibition is measured, using which the rate of
penetration can be calculated.
2. Absorption of a drug: This test is performed for
ointments (systemic circulation). A weighed quantity
of ointment is applied to the skin (or mucous
membrane). At frequent intervals of times, either the
blood or the urine samples are collected and analyzed
for drug content, from which the rate of absorption of
drug is estimated.
3. Test for sensitivity or irritability: A known amount of
ointment is applied to the skin of a rabbit or human
and checked for any lesions, patches, redness or any
other allergic manifestations for a period of 2–3
weeks. The ointment passes the test if it does not
produce any allergy or sensitivity.
 Quality Control Tests for Ointments:
1. Leak test: Randomly 10 sealed ointment tubes are
selected and cleaned with an absorbent cloth. The
samples are placed in a horizontal position on a sheet
of absorbent blotting paper. This is placed in an oven
and maintained at a temperature 60°C for eight hours.
All the ointment tubes should pass the test without
any leakage.
2. Spreadability test to check for particles: Randomly
10 ointment tubes are selected and each ointment
tubes is extruded into a flat-bottomed petri dish,
melted and allowed to solidify, which is then scanned
under a low power microscope. The requirements are
met if the total number of particles in all the petri
dishes does not exceed fifty and not more than one
petri dish contains more than eight particles.
3. Drug content: From the weighed quantity of the
test ointment, the drug is extracted by suitable
method and assayed by suitable analytical techniques
to determine the percentage of medicament present
in the sample ointment. This is compared with the
amount claimed in the label claim.
4. Viscosity test: Depending upon the internal
standards of the formulator, the viscosity of the
formulation is set. The viscosity of the preparation is
determined by using “Brookfield viscometer.”
5. Microbial limit test: This test is conducted for both
raw materials and finished products. The formulation
should be free from viable microorganisms. The total
aerobic count must not be more than 5000
microorganisms per gram of the ointment. It should
not contain more than 100 moulds per gram of
ointment. It should also not contain more than 100
yeast per gram and 90 coliforms per gram of
ointment.
LINK FOR OINTMENT PREPARATION
 https://www.youtube.com/watch?v=RNdQFjfR1YQ
 https://www.youtube.com/watch?v=CjL_dQ5HAAg

 https://www.youtube.com/watch?v=dHZ7h4F8fzQ

 https://www.youtube.com/watch?v=AhoyvJKUp1g

 https://www.youtube.com/watch?v=9s4rCgz2GeE

 https://www.youtube.com/watch?v=SblKax4sY6c

 https://www.youtube.com/watch?v=o9twC_-MZ1w

52