A topical medication is a medication that is applied to a particular place on or in the body. Most often topical administration means application to body surfaces such as the skin or mucous membranes to treat ailments via a large range of classes including creams, foams, gels, lotions, and ointments

1. Ointments 2
Md. Saiful Islam
BPharm, MPharm (PCP)
North South University
Fb Group: Pharmacy Universe

2. Selection of the appropriate base
Selection the base to use in the formulation of an ointment
depends on careful assessment of a number of factors,
including the following:
- Desired release rate of the drug substance from the ointment base
- Desirability of topical or percutaneous drug absorption
- Desirability of occlusion of moisture from the skin
- Stability of the drug in the ointment base
- Effect, if any, of the drug on the consistency or other features of the
ointment base
- Desire for a base that is easily removed by washing with water
- Characteristics of the surface to which it is applied

3. Preparation of ointments
• Since ointments are applied primarily to irritated areas, it
is an unbreakable rule that these preparations must not
contain granular or gritty particles which might cause
further irritation
• Regardless of the skin condition, ointments must be
smooth and free from granular or gritty particles
• In compounding ointments, the following rules should be
observed:
1) Insoluble substances to be incorporated in ointment
bases should always be in the impalpable powder form

4. 2) Insoluble substances are best incorporated when first
levigated with a small portion of the base to form a
smooth nucleus and then incorporated into the
remainder of the base
3) Water-soluble salts should be incorporated by
dissolving them in a small amount of water and
incorporating with the base, using anhydrous lanolin, if
necessary, to absorb the aqueous solution. This method
produces a smooth ointment with a minimum of
levigation

5. When substances incorporated into ointment bases must
be reduced to a fine state of subdivision. Three methods
are generally available:
1) Use of an ointment slab and spatula
2) Use of the mortar and pestle
3) Use of an ointment mill
These methods may or may not involve fusion, depending
on the nature of the medicament to be incorporated into the
base and the base itself

10. Use of an ointment slab and spatula
• The usual technique consists of rubbing the powder with
a small amount of base until it is thoroughly distributed in
a finely subdivided state
• Then this concentrated ointment is incorporated into the
remainder of the base
• Mineral oil or a vegetable oil can be used as a levigating
agent if small quantities of medicaments are to be
incorporated in the base
• The use of large amounts of levigating agents may result
in undue softening of the finished ointment

11. • A stainless-steel spatula with a long, broad, flexible
blade is essential to the preparation of good ointments
• Two spatulas usually are used, one to levigate the
ointment, the other to remove accumulating ointment
from the levigating spatula
• Where danger of chemical reaction between the steel
spatula and active ingredients ( e.g. iodine, mercury
salts, salicylic acid) is a possibility, a hard rubber spatula
or wodden tongue depressor should be used

12. Use of the mortar and pestle
• When large quantities of liquid are to be incorporated
into a base or when exceptionally large quantities of
ointment are to be made, then mortar and pestle should
be used
• 5 minutes of actual rubbing time was necessary to
produce homogeneity in products
• The use of mortar and pestle is considered not as
efficient as the spatula in reducing the size of the
particles incorporated in
• The particles have a tendency to ‘ride’ out from under
the pestle and the grinding effect is limited

13. Use of an ointment mill
• The ointment mill is convenient and ideal for making
ointments in lots of 5 lbs. or more, although small mills
are available for use in the community pharmacy
• Small mills are available with stainless steal rollers or the
more chemically resistant clay rollers
• The ointment is prepared in the usual manner and then
run through the mill until smooth and free from gritty
particles

14. • When making ointments on a larger scale, the powdered
medicaments are shifted into the softened or melted
base
• The mixture is stirred until it has congealed and then it is
run through an ointment mill until smooth
• In some instances, the powdered medicament is mixed
with a small portion of the base to make a concentrate
which is run through an ointment mill several times
• Then the concentrate is mixed with the remainder of the
base in a change can mixer

15. Fusion
Fusion is necessary when-
- waxes, paraffins, fatty alcohols, fatty acids or any
hard waxlike materials are included in the formula
- a medicament is soluble in the melted base
- most emulsion and absorption bases are prepared by
fusion

16. • In preparing ointments by fusion, the substance having
the highest melting point is placed in an evaporating dish
or beaker on a water bath and melted at the lowest
temperature possible
• Other substances are added in order of decreasing
melting points
• In this way, the entire base is not heated to the highest
temperature
• Medicaments soluble in the melted base should be
added to the base just before it congeals

17. • Insoluble medicaments should be levigated with a small
quantity of the melted base
• After the remainder of the base has congealed, it can be
incorporated with the levigated medicament
• Water and water-soluble ingredients such as glycerin or
propylene glycol must be heated to approximately the
same temperature as the melted oleaginous phase
before mixing the two phases
• Cold water will cause the separation and crystallization
of the higher melting substances

18. Packaging of ointments
Topical dermatologic products are packaged in either jars
or tubes
Ointment jars:
- made of clear or opaque glass or plastic. Some are
colored- green, amber or blue
- opaque jars are used for light sensitive products
- commercially available empty ointments jars vary in size
from about 0.5ounce to 1 pound

19. Tubes in packaging ointments are gaining
popularity over jars
• They are light in weight
• Relatively inexpensive
• Convenient for use
• Compatible with most formulative components
• Provide greater protection against external
contamination and environmental conditions

20. Ointment tubes:
• Made up of aluminum or plastic
• Ointment to be used for different purposes are packaged
with special applicator tips
• Tubes of aluminum generally are coated with an epoxy
resin, vinyl or lacquer to eliminate any interactions
between the contents and the tube
• Plastic tubes are made of high or low-density
polyethylene or a blend of each, polypropylene,
polyethylene terephthalate and various plastic, foil or
paper laminates, sometimes 10 layers thick

21. Plastic tube offers special features and
advantages
• Low-density polyethylene is soft and resilient and
provides a good moisture barrier
• High-density polyethylene provides a superior moisture
barrier but it is less resilient
• Polypropylene has a high level of heat resistance
• Polyethylene terephthalate offers transparency and a
high degree of product chemical compatibility

22. • In commercial manufacture and packaging of topical
products, the jars and tubes are first tested for
compatibility and stability for the intended product
• This includes stability testing of filled containers at room
temperatures (e.g.20°C) as well as under accelerated
stability testing conditions (e.g. 40 and 50°C)

23. Filling ointment jars
• On a small scale, the ointments jars are filled carefully by
transferring the weighed amount of ointments with a spatula
• The ointment is packed on the bottom and along the sides of the jar,
avoiding entrapment of air
• The jar size should allow the ointment to reach near the top of the
jar but not so high as to touch the lid when closed
• Ointments prepared by fusion may be poured directly into the
ointment jar to congeal in it
• In large scale manufacture of ointments, pressure fillers force the
specified amount of ointment into the jars
• Electric mortars and pestles can be used to prepare an ointment in
the dispensing container

24. Filling ointment Tubes
• Tubes are filled from the open back end of the tube,
opposite from the cap end
• Ointments prepared by fusion may be poured while still
soft but viscous directly into the tubes with caution to
prevent stratification of the components
• The filled tubes are closed and sealed
• Manual filling of an ointment tube requires a number of
steps:
- the prepared ointment, placed on waxed or parchment
paper and rolled into a cylindrical shape, is inserted into
the open end of the tube and pushed forward as far as
allowed

25. - With a spatula pressing against the lower portion of the
tube and making a crease below the ointment fill, the
paper is slowly removed, leaving the ointment in the tube
- the bottom of the tube is flattened, folded and sealed
with a crimping tool or clip
Industrially , automatic filling, closing, crimping and
labeling machines are used for large scale tube
packaging of semisolid pharmaceuticals
- plastic and laminate tubes are closed and sealed by
heat and crimping
- metal tubes are sealed by folding and crimping with or
without a vinyl, latex or lacquer sealant