Topic:- OINTMENTS

Presented To:- Presented By:-

Dr. Sonali Singh Priyanka
Singh
Assiatant Professor Chaudhary
M. Pharm I year

Department of Pharmaceutical Science

BBAU (Central University)
Lucknow U.P.
 TABLE OF CONTENTS
What is Ointments ?
Types of ointment
Advantages & Disadvantages
Medicinal Applications
GMP Guidelines
Ointment bases
Preparation
Packaging , Storage and Dispensing
Quality Control Tests
Evaluation Test
References
 ?What is Ointments
Any greasy or oily semi-solid
preparation, usually medicated, that
can be applied externally to the skin in
order to heal, soothe or protect it.
It is a viscous semisolid preparation
used topically on a variety of body
surfaces.
 Drug ingredients can be dissolved,
emulsified or suspended in the
ointment base.
 The word ointment comes from the
Latin ungere meaning anoint with oil.
 Types of Ointments
The various types of ointments are:
 Unmedicated ointments
 Medicated ointments

UNMEDICATED OINTMENTS
These ointments do not contain any drugs. They are
useful as emollients, protectants .
Example: Petroleum jelly.
 MEDICATED OINTMENTS
These ointments contain drugs which show local or
systemic effects.
These are of several sub-types:
 Dermatologic ointments
 Opthalmic ointments
 Rectal ointments
 Vaginal ointments
 Nasal ointments
 DERMATOLOGIC OINTMENTS
 These ointments are applied topically on the external skin. The
ointment is applied to the affected area as a thin layer and
spread evenly using gentle pressure with the fingertips. These
are of three types:
 (1) Epidermic ointments: The drugs present in these type of
ointments exert their action on the epidermis of the skin.
Example: Ketoconazole ointment.
 (2) Endodermic ointments: The drugs present in these types of
ointments exert their action on the deeper layers of cutaneous
tissue.
Example: Demodex ointment.
 (3) Diadermic ointments: The drugs present in these types of
ointments enter into the deeper layers of skin and finally in the
systemic circulation and exert systemic effects.
Example: Nitroglycerine ointment.
OPTHALMIC OINTMENTS
These are sterile preparations which are applied
inside the lower eye lid. Only anhydrous bases are
used in their preparation. The ointment is applied as
a narrow band of approximately 0.25 - 0.5 inch.
Example: Sulfacetamide sodium ointment.

RECTAL OINTMENTS
These are the ointments to be applied to the peri-
anal or within the anal canal. The bases used are
combinations of PEG 300 and PEG 3350, cetyl
alcohol and cetyl esters, wax, liquid paraffin and
white paraffin.
Example: Benzocaine ointment.
VAGINAL OINTMENTS
These ointments are applied to the vulvo-vaginal
area or inside the vagina. As vagina is more
susceptible to infections, the ointment should be
free from micro-organisms, moulds and yeasts.
Example: Candicidin ointment.

NASAL OINTMENTS
These are used in the topical treatment of nasal
mucosa. Drugs get absorbed into the general
circulation through the rich blood supply of
the nasal lining.
Example: Ipratropium bromide ointment.
 ADVANTAGES
 Handling of ointments is easier than bulky liquid dosage
forms.
 They are chemically more stable than liquid dosage
forms.
 They facilitate application of the directly to the effected
body part and avoid exposure of other parts to the drug.
 They are suitable for patients who find it difficult to take
the drugs by parenteral and oral routes.
 They prolong the contact time between the drug and
effected area.
 The bioavailability of drugs administered as ointments is
more since it prevents passage through liver.
 DISADVANTAGES
 They are bulkier than solid dosage forms.
 When applications of an exact quantity of ointment to
the affected area is required, it is difficult to ascertain
the same.
 They are less stable than solid dosage forms.
Medicinal application
of the Ointment
Ointments are used topically for several
purposes, e.g., as protectants, antiseptics,
emollients, antipruritics, kerotolytics, and
astringents.

 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.
 Good Manufacturing Practices and
Requirements of Premises, plant and
Equipment for Pharmaceutical Products
[SCHEDULE M]
(Rules 71, 74, 76, and 78)
PART ID
SPECIFIC REQUIREMENTS FOR MANUFACTURING OF
TOPICAL PRODUCTS i.e. EXTERNAL PREPARATIONS
(CREAMS, OINTMENTS, PASTES, EMULSIONS,
LOTIONS, SOLUTIONS, DUSTING POWDERS AND
IDENTICAL PRODUCTS)
1. The entrance to the area where topical products are
manufactured shall be through a suitable airlock.
Outside the airlock, insectoctors shall be installed.
2. The air to this manufacturing area shall be filtered
through at least 20 air filters and shall be air-
conditioned. The area shall be ventilated.
3. The area shall be fitted with an exhaust system of
suitable capacity to effectively remove vapours, fumes,
smoke, floating dust particles.
4. The equipment used shall be designed and maintained
to prevent the product from being accidently
contaminated with any foreign matter or lubricant.
5. No rags or dusters shall be used in the process of
cleaning or drying the process equipment or
accessories used.
6. Water used in compounding shall be Purified Water
IP.
7. Powders, whenever used, shall be suitably sieved
before use.
8. Heating vehicles and a base like petroleum jelly
shall be done in separate mixing area in suitable
stainless steel vessels, using steam, gas, electricity,
solar energy etc.
9. A Separate packing section may be provided for
primary packaging of the products.
Ointment bases
 There are five (5) classes or types of ointment
bases which are differentiated on the basis of
their physical composition. These are:
1. Oleaginous bases.
2. Absorption bases.
3. Water in oil emulsion bases.
4. Oil in water emulsion bases.
5. Water soluble or water miscible bases.
 Oleaginous O.B.
 These bases are fats, fixed oils, hydrocarbon or
silicones.
They are anhydrous, greasy, non-washable does not
absorb water and occlusive (form a film on skin so it
increases the skin hydration by reducing the rate of
loss of surface water.
They should not be applied to infected skin.
 they are used as protectants, emollients , vehicles for
hydrolysable drugs.
 Example: White Petrolatum,
White Ointment
 Absorption O.B.

 Oleaginous base + w/o surfactant.

 Anhydrous but hydrophilic ointment bases, they can
absorb several times their weight of water to form
water-in-oil emulsion.
 They are non-washable, not water soluble
 They used as protectants, emollients (+/-), vehicles for
aqueous solutions, solids, and non-hydrolyzable
drugs.
 Example: Hydrophilic Petrolatum,
Anhydrous Lanolin, Aquabase™,
Aquaphor®, Polysorb®
 W/O emulsion O.B.
These are anhydrous, hydrophilic, absorbs water and
non water removable, with low thermal conductivity
and occlusive.
They have the same properties as the absorption
bases.
They are used as emollients, cleansing creams,
vehicles for solid, liquid, or non-hydrolysable drugs .
Examples: Cold Cream type, Hydrous Lanolin,
Rose Water Ointment, Hydrocream™, Eucerin®,
Nivea® .
 O/W emulsion O.B.

 These bases are anhydrous, water soluble, absorb

water and water washable.

 They are either carbowaxes Polyethylene Glycols

(PEGs) or hydrated gums (bentonite, gelatin,
cellulose derivatives).

 They are used as drug vehicles.

 Examples: PEG Ointment, Polybase™

 Water miscible O.B.

 These bases are anhydrous, water soluble, absorb

water and water washable.

 They are either carbowaxes Polyethylene Glycols

(PEGs) or hydrated gums (bentonite, gelatin,
cellulose derivatives).

 They are used as drug vehicles.

 Examples: PEG Ointment, Polybase™

 Choice of the O.B.

Selection of the Appropriate Base Based on:

1. Desired release rate.

2. Desirability for enhancement of per-cutaneous
absorption.
3. Advisability of occlusion.
4. Short-term or long-term stability.
5. Influence of drug on consistency or other features
of ointment base.
6. Patient factor - dry or weeping (oozing) skin.
 Ideal O.B.
Among the properties which an
Ideal ointment base should possess are:

1. Does not retard wound healing.

2. Low sensitization index.
3. Pharmaceutical elegance.
4. A low index of irritation.
5. Non dehydrating.
6. Non greasy.
7. Neutral in reaction.
8. Good keeping qualities.
9. Compatible with common medicaments.
10. Efficient release of medicament at site of
application.
11. Washable (easily removed with water).
12. Minimum number of ingredients.
13. Ease of compounding.
Preparation of the Ointments
Mix together (mortar & pestle, spatula & slab)
roller mill
"levigating" the powder (reduction of particle size in
suspending agent compatible with the ointment
base)

Ointment Mill Electric Mortar and Pestle

 In porcelain dish all or some components of an
ointment melted together and cooled with constant
stirring until congealed, add non-melting substances as
the ointment is being cooled and stirred.
 Prepare the ointment. Select an ointment jar that
will just hold all of the formulation.
 Begin by taking some ointment and fill the bottom
of the ointment jar.
 Use the spatula to put ointment into the crevices.
 Storage and dispensing
 Ointments should be stored in tightly closed and
completely filled containers
 Changes in temperature can lead to the crystallization of
the drug and to changes in the ointment base.
 They are usually dispensed in jars of glass or plastic
material or in collapsible tubes.
 Sterile ointments must be dispensed in tubes or single dose
units in order to protect the product against contamination
during use.
 With tin tubes, there is a risk of corrosion with hydrophilic
ointments.
 Continue adding ointment to the jar again using
the spatula to put the ointment along the sides of
the jar.
 As you fill the jar, stab the spatula into the
ointment a couple of times. This will reveal air
pockets that may have formed.
 Put the spatula halfway across the filled jar, and
tilt in slightly . Rotate the jar and this is make a
professional looking finish on the top of the
ointment.
 Wipe off ointment from the threads of the jar.
 Cap the ointment jar.
 Test for rate of absorption
The diadermatic ointment should be evaluated for
the rate of absorption of drug into the blood
stream.
This test can be done in-vivo only.
The ointment should be applied over a definite
area of the skin by rubbing.
At regular intervals of time, serum and urine
samples should be analyzed for the quantity of
drug absorbed. The rate of absorption i.e., the
amount of drug absorbed per unit time should be
more.
 Test of Non-irritancy
 The bases used in the formulation of
ointments may cause irritation or
allergic reactions.
 Non-irritancy of the preparation is
evaluated by patch test.
 In this test 24 human volunteers are
selected.
 Daily the type of pharmacological
action observed is noted. No visible
reaction or erythema or intense
erythema with edema and vesicular
erosion should occur.
 A good ointment base shows no visible
reaction.
 Test of rate of penetration
 The difference between the initial and the final weights of
the preparation gives the amount of preparation penetrated
through the skin and this when divided by the area and
time period of application gives the rate of penetration of
the preparation. The test should be repeated twice or
thrice. The rate of penetration of a semisolid dosage form is
crucial in the onset and duration of action of the drug.
 Weighed quantity of the preparation should be applied
over selected area of the skin for a definite period of time.
 Then the preparation left over is collected and weighed.
 REFERENCES

 "Dispensing pharmacy", R.M. Mehta, pg 217-230.

 L. Lachman, H.A, Lieberman and J.L. Kanig, Theory &
Practice of
industrial pharmacy, Lea & Febieger, Philadelphia
Latest Edn