PHD 211 – SEMISOLID DOSAGE

FORMS

PASTES
Nursyuhada Azzman
BPharm, Msc Pharm Sc,RPh.
Faculty of Pharmacy
UiTM Pulau Pinang (Bertam campus)
 LECTURE OUTLINE

1. Introduction to pastes
2. Definition of pastes
3. Physical characteristics of pastes
4. The pharmaceutical uses of pastes
5. Indications for pastes
6. Drugs/bases/excipient used in pastes
7. Types of pastes
8. Method of preparing pastes
9. Containers/packaging and storage
10. Labeling and shelf-life
 LEARNING OUTCOMES
After this lecture, students should be able to :
• CO1 : Define pastes.
• CO2 : Identify the pharmaceutical uses and
characteristics of pastes.
• CO3: Carry out the calculation involved in paste
compounding.
• CO4 : Explain the method of preparing pastes.
• CO5 : Related the theoretical knowledge in the
preparation of pastes.
HAVE YOU SEEN OR USED
PASTES BEFORE?
 INTRODUCTION : PASTES
• Paste are semi-solid preparations for external
application.
• They usually consist of a high proportion of
finely powdered medicaments mixed with
soft or liquid paraffin (fatty base) or with
a non-greasy basis made with glycerol,
mucilage, or soap.
• Incorporation of solid is by mixing on an
ointment slab.
 DEFINITION : PASTES
• Pastes are semisolid preparations in which the
solid drug is contained in a suitable base
(ointment base), which is itself semisolid and
either hydrophobic.
• Pastes are dispersions of high concentrations
of solid (20 -50%) in either an aqueous or
oily vehicles.
• Pastes are vehicles (aqueous or oily) with a
high concentration of added solid for topical
application (skin or mucous membrane).
 EXAMPLES : COMMERCIALLY-
MANUFACTURED PASTES

For human use For animal use

 PHYSICAL CHARACTERISTICS
OF PASTES
Pastes contain more solid materials than do
ointments and are therefore stiffer and less
penetrating.
This makes them thick so they do not spread
and so localizes drug delivery.
They do not flow at body temperature.
Pastes are usually employed for their
protective action.
 PHYSICAL CHARACTERISTICS
OF PASTES
• When protective rather than therapeutic action
is desired, the formulation pharmacist will favor
a paste, but when therapeutic action is required
he will prefer ointments and creams.
• Pastes have a similar properties with an
ointment but more thicker, less greasy and
more absorptive (concentration of solid that
absorb water is higher).
 CHARACTERISTICS OF FATTY
PASTES AS COMPARED TO
OINTMENTS
 Non-greasy or less greasy.
 Very thick and stiff texture.
 More absorptive.
 Less penetrating and less macerating.

Paste Ointment
 PHARMACEUTICAL USES :
PASTES
• Pastes are used principally as antiseptic,
protective or soothing dressings which are
often spread on lint before being applied.
• They can be used to treat infections by
making use of their high osmotic pressure,
or as very thick materials to prevent irritant
drugs (e.g dithranol and salicylic acid)
spreading over the skin surface.
• Pastes can also be used for sun blocks  a
thick, unbroken, impermeable opaque film is
 PHARMACEUTICAL USES :
PASTES
• Because of the stiffness of pastes, they remain
in place after application and are effectively
employed to absorb serous secretions
(watery and contains enzyme).
• Because of their stiffness and impenetrability,
pastes are not suited for application to
hairy parts of the body.
 INDICATIONS FOR PASTES
Antiseptics
Protective: sun filter  e.g. use by skiers as sun blocker and
to prevent excessive dehydration of the skin (wind burn).
Soothing dressing
Absorbing harmful chemicals, such as the ammonia that is
released by bacterial action on urine  e.g. often used in
nappy products.
Use to absorb wound exudates due to high powder
content.
Prevent irritant drug (e.g: salicylic acid) by applying at
surrounding area
 DRUGS THAT ARE USUALLY
FORMULATED AS PASTES

• Zinc oxide
• Coal tar
• Aluminium hydroxide
• Magnesium sulphate
• Dithranol
• Triamcinolone
• Salicylic acid
BASES THAT ARE USUALLY
USED IN PASTES
• Fatty base :
• White/ Yellow soft paraffin
• Liquid paraffin
• Non-greasy base :
• Glycerol / glycerin Glycerol
• Mucilage
• Soap

Soft Mucilage
 EXCIPIENTS USED IN PASTES
• As absorption enhancer.

1. Solvents
• Water
• Alcohols (methanol, ethanol, 2-propanol)
• Alkyl methyl sulfoxides (dimethyl sulfoxide, decylmethyl
sulfoxide, tetradecyl methyl sulfoxide)
• Pyrrolidones (2-pyrrolidone, N-methyl-2-pyrrolidone, N-(2-
hydroxyethyl pyrrolidone)
• Laurocapram
• Miscellaneous (acetone, dimethyl acetamiformamide,
tetrahydrofurfuryl alcohol)
 EXCIPIENTS USED IN PASTES

2. Amphiphiles
• Anionic surfactants (docusate sodium, sodium lauryl sulfate)
• Cationic surfactants (quaternary ammonium salts)
• Amphoteric surfactants (lecithins, cephalins,
alkylbetamines)
• Nonionic surfactants (mono, di-, and triglycerides)
• Fatty acids and alcohols (lauryl, cetyl, and stearyl alcohols,
sucrose, sorbitan, PEG)
• Miscellaneous (Urea; N,N-diethyl-m-toluamide)
 TYPES OF PASTES
1) Fatty/Oleaginous paste
• Has similar properties with ointment but more
thicker and less greasy, also more absorptive.
• E.g. Zinc oxide paste, Zinc oxide and salicylic acid
paste.
2) Non-oleaginous paste
• Carboxymethylcellulose sodium paste (contains
16-17% Sodium CMC).
• Magnesium hydroxide paste (contains 29% to
33% w/w Magnesium hydroxide).
• E.g: Triamnicolone acetonide dental paste (0.1%
Triamnicolone acetonide in a paste of pectin,
gelatin, sodium CMC, polyethylene, mineral oil,
guar gum and tragacanth).
 ADVANTAGES OF PASTE

absorb wound exudates due to high powder content

because of the stiffness, they remain in place after
application and are used effectively to absorb serous
secretions
pastes make good protective barriers due to
disperse phase of insoluble ingredients (e.g: starch,
zinc oxide, and calcium carbonate) and due to
impermeable/opaque film
do not ordinarily flow at body temperature
good adhesion and less greasy to the skin
 DISDVANTAGES OF PASTE

not suited for application to hairy parts of the body.

stiff  not easily spread
less or poorly occlusive than ointments 
unevenly distribution of powder content
less penetrating,macerating and heating compare
to ointment
may cause irritant to patient due to high solid content
less stable compare to solid dosage form
TECHNIQUES OF PASTES
COMPOUNDING

Pastes
compoundin
g techniques

Levigation /
Spatulation Fusion / Heat
(Preferable)
 METHODS OF PREPARATION :
PASTES
• Pastes can be prepared in the same manner as ointments,
by direct mixing or the use of heat to soften the base
prior to incorporating the solids, which have been
comminuted and sieved.
• However, when a levigating agent is to be used to render
the powdered component smooth, a portion of the base
is often used rather than a liquid, which would soften the
paste.
 METHODS OF PREPARATION :
PASTES
• Levigation is commonly used in small-scale
preparation of pastes to reduce the particle size and
grittiness of the added powders.
• A mortar and pestle or an ointment tile may be
used.
• Powders may be sifted by using sieve before
incorporation.
• A paste is formed by combining the powder and a
small amount of melted or soften lipophilic base.
 METHODS OF PREPARATION :
PASTES
• The paste is then triturated, reducing the particle size.
• No liquid (as levigating agent) is required as a very
thick, stiff formulation is desired.
• The levigated paste may then be added to the
remaining semisolid hydrophobic base and the
mixture made uniform and smooth by rubbing them
together with a spatula on the ointment tile.
 FUSION METHOD
• Most suitable for making ointment bases or paste.
• Most efficient with drugs that are
 soluble in hydrocarbon base
 dissolved in water and added to molten absorption base
• Incorporation powders into ointment base by using fusion
technique does not
 give an elegant finished product unless high shear mixing
can be used to
 remove the powder lumps.
 METHODS OF PREPARATION :
PASTES
(FUSION METHOD)
1.  All solid powders must be sifted and triturated.

2. Melt soft bases (e.g: paraffin) in an evaporating basin on

a water bath.
3. Take some powders and stir into melted base.
4. As the first base cools, add the ingredients with
decreasing melting points at the respective
temperatures, stirring continuously to ensure a
homogeneous mix before leaving to set.
5. Pack into brown/amber jar or collapsible plastic tube
SIFTING POWDERS
LEVIGATING PASTE
 CONTAINERS AND STORAGE :
PASTES
• Pastes should be stored and supplied in glass or
plastic jars fitted with screw caps with impermeable
liners or with close-fitting slip-on lids to prevent the
absorption and diffusion of the contents.
• Collapsible metal or plastic tubes may be use as
alternative.
 LABELING AND SHELF-LIFE
• Same as ointment labeling.
• Direction of use.
• For external or topical use only.
• Keep out of the reach of children.
• Shelf-life :
• Generally 3 months for extemporaneous.
• 2 weeks for extemporaneous with chemical instability.
• 2 weeks for water containing formula.
• 4 weeks for non-water containing formula.
• up to 6 months (if non-aqueous).
 EXAMPLE :
DITHRANOL IN LASSAR’S PASTE
Rx Dithranol Paste BP

Send 100g of weak dithranol paste.

Master formula For 100g

Dithranol 1g 0.1g

Lassar’s paste 999g 99.9g

Lassar’s paste : Master formula For 100g

Zinc oxide 240g 26.4g

Salicylic acid 20g 2.2g

Starch 240g 26.4g

White soft paraffin 500g 55g

DITHRANOL
LASSAR’S PASTE
DITHRANOL IN LASSAR’S PASTE

• Dithranol is used to treat psoriasis.

• Two strength available : “weak” (0.1%) and “strong”
(1%).
• Dithranol is prone to oxidation Avoid contact with
metal.
• Lassar’s paste has to be made first then incorporation of
dithranol by spatulation.
• Glove should be worn during compounding  irritant
to skin.
PSORIASIS
 DITHRANOL PASTE BP :
METHOD OF PREPARATION

1. All solid powders (zinc oxide and salicylic acid)

must be sifted through 180µm sieve before
weighing.
2. Melt soft paraffin in an evaporating basin on a
water bath.
3. Take some powders and stir into melted base.
4. Weight out the Lassar’s paste.
 DITHRANOL PASTE BP :
METHOD OF PREPARATION

5. Weight out dithranol.

6. Place it on a slab and incorporate it in small portion
of the paste using a plastic spatula.
7. Spatulate until a smooth, even product is produced.
8. Dilute gradually with the remainder of paste.
9. Pack in a 120g (4 oz) brown ointment jar or plastic
collapsible tube.
OINTMENT SLAB & PLASTIC
SPATULA
GRITTY AND SMOOTH PASTES
 DITHRANOL PASTE BP :
SUITABLE CONTAINERS

• Brown/Amber ointment jar

• Collapsible plastic tube

 DITHRANOL PASTE BP :
LABELING
• Direction of use : “To be spread thinly”
• For external use only
• Keep out of the reach of children
 DITHRANOL PASTE BP :
SHELF LIFE AND STORAGE
• Keep in a cool place.
• Protect from light.
• Expiry date : 2 weeks (because of chemical instability)
PRE-LAB DISCUSSION:

PRACTICAL 3
(OINTMENTS & PASTE)
# Prescription 1: Practical 3
Methods of preparation

1. Triturate finely 0.9 g zinc oxide and 5.7 g starch.

2. Melt 0.75 g emulsifying wax at 70°C, and add 0.9 g
coal tar solution and
approximately half of 6 g of yellow soft paraffin.
3. Stir at 70°C until completely melted and add the
remainder of yellow soft paraffin.
4. When completely melted, remove from heat and cool to
30°C, add the zinc oxide
and the starch with constant stirring, and mix until
becomes smooth paste.
5. Package 10 g of this paste into ointment jar.