Ointments are used topically for several purposes, e.g., as protectants, antiseptics, emollients, antipruritics, kerotolytics, and astringents. The vehicle or base of an ointment is of prime importance if the finished product is expected to function as any one of the above categories.
4. Introduction
Introduction:
Ointments are used topically for several purposes, e.g., as protectants,
antiseptics, emollients, antipruritics, kerotolytics, and astringents. The vehicle or
base of an ointment is of prime importance if the finished product is expected to
function as any one of the above categories. In the case of a protective
ointment, it serves to protect the skin against moisture, air, sun rays and other
external factors. It is necessary that the ointment neither penetrates the human
skin barriers nor facilitates the absorption of substances through this barrier. An
antiseptic ointment is used to destroy or inhibit the growth of bacteria.
Frequently bacterial infections are deeply seated; a base which has the
capacity to either penetrate or dissolve and release the medication effectively is
therefore desired. Ointments used for their emollient effect should be easy to
apply, be non-greasy and effectively penetrate the skin .
5. Below is a list of penetration enhancers
used in dermatological formulations.
(reference 1) Other commonly used
enhancers include DMSO (dimethyl
sulfoxide), urea, and triethanolamide.
7. Ointment Bases:
There are five (5) classes or types of ointment bases which
are differentiated on the basis of their physical
composition. These are:
oleaginous bases
absorption bases
water in oil emulsion bases
oil in water emulsion bases
water soluble or water miscible bases
Each ointment base type has different physical
characteristics and therapeutic uses based upon the nature
of its components. The following table summarizes the
composition, properties, and common uses of each of the
five types. For more information consult Remington's.
8. Preparation of Ointment Bases
Prepare 120 g of each of the
following five ointments on a w/w
basis. One partner should prepare
bases #1, 3 and 5 while the other
prepares #2 and 4. Make sure that
you follow closely the procedures for
preparation.
9. General Comments About Compounding
Ointment Bases :
Between 2 and 4 grams of an ointment may be lost in the
compounding process. The ointment is lost as it adheres to
beakers, ointment tiles, or ointment pads. To compensate for
this loss, make an excess of the ointment. Some general rules
might be to add 10% or 3 grams excess to the prescribed
amount.
When heat is used to melt ingredients, use a water bath or
special low temperature hotplate. Most ingredients used in
ointment bases will liquefy around 70°C These two heating
devices provide adequate control over the heating and will
ensure that the ingredients are not over heated. A water bath
will only heat to the boiling point of water which is 100°C.
Special "low temperature" hotplates (full range is 25°C to 120°C)
are not a standard laboratory type hotplate; those hotplates
heat at 125°C to 150°C at their lowest setting.
10. •
When both an oil and aqueous phase are being mixed together to
make an ointment, it is helpful to heat the aqueous phase a few
degrees higher than the oil phase prior to mixing. The aqueous
phase tends to cool faster than the oil phase and may cause
premature solidification of some ingredients. However, use the
lowest temperature possible and keep the time of heating as short
as possible. This will minimize the quantity of water lost through
evaporation
•
When melting a number of ingredients, melt the ingredient with
the highest melting point first. Then gradually reduce the heat to
melt the ingredient with the next lowest melting point. Continue
this process until all ingredients have been added. This will ensure
that the ingredients were exposed to the lowest possible
temperature and thus enhance the stability of the final product
11. •
The cooling step in an ointment's preparation is an important part of the
compounding process
•Do not accelerate the cooling process by putting the melt in water or ice. This
will change the consistency of the final product making it more stiff than
desired.
•If adding volatile ingredients such as oils, flavors, or drugs, add them when the
product is "cool to the back of the hand." The melt will still be fluid enough for
adequate mixing but not hot enough to evaporate the ingredient.
•Ointments should be cooled until just a few degrees above solidification before
they are poured into tubes or jars. They should be thick, viscous fluids. This will
minimize "layering" of the ointment in the packaging container. However, this is
not the preferred method of packing an ointment tube or jar.
Most bases achieve their final consistency and texture several hours after they
are compounded .
12. BASE NO. I: Oleaginous Base
(
White Ointment
)
Whit wax
White petrolatum
Procedure for Preparation :
a.Melt the white wax on a hot plate. No need to heat beyond
70 – 75 °C
b.When the wax has completely melted, add the petrolatum
and allow the entire mixture to remain on the hot plate until
liquefied .
c.Following liquefication, remove from heat and allow the
mixture to congeal. Stir the mixture until it begins to congeal .
13. BASE NO. II: Absorption Base
Cholesterol
Stearyl alcohol
White wax
White petrolatum
Procedure for Preparation:
Melt the stearyl alcohol, white wax, and petrolatum
together on a hot plate.
Add the cholesterol to the mixture; stir until
completely dissolved.
Remove the mixture from the hot plate and stir
until congealed.
14. BASE NO. III: W/O Emulsion Base Cold Cream type base
)
White wax
Cetyl Esters Wax (or Spermaceti)
Mineral Oil (Sp Gr = 0.9)
Sodium Borate
Water
Procedure for Preparation :
a.Melt the white wax and spermaceti on a hot plate .
b.Add the mineral oil to this mixture and bring the temperature to 70°C .
c.Dissolve the sodium borate in water .
d.Heat the sodium borate solution to 70°C .
e.When both phases have reached the desired temperature, remove both
phases from the hot plate and add the aqueous phase slowly and with constant
stirring to the oil phase .
f.Stir briskly and continuously until congealed .
15. BASE NO. IV: O/W Emulsion Base )Hydrophilic Ointment(
Sodium Lauryl Sulfate
Propylene Glycol (SP Gr = 1.035)
Alcohol
Stearyl
White Petrolatum
Purified Water
Procedure for Preparation :
a.Melt the stearyl alcohol and white petrolatum on a hot plate .
b.Heat this mixture to 70°C .
c.Dissolve remaining ingredients in water and heat the solution to
70 °C .
d.Add the oleaginous phase slowly to the aqueous phase, stirring
constantly .
e.Remove from heat and stir the mixture until it congeals .
16. BASE NO. V: Water Soluble Base
Polyethylene Glycol 400 (SP Gr = 1.12)
Polyethylene Glycol 3350
Procedure for Preparation :
a.Melt the PEG 400 and Carbowax 3350 on a hot plate .
b.Warm the mixture to about 65°C .
c.Remove from the hot plate and stir until congealed .