3.
An ointment is a homogeneous, viscous,
semi-solid preparation, most commonly a
greasy, thick oil (oil 80% - water 20%) with a
high viscosity, that is intended for external
application to the skin or mucous membranes.
They are used as emollients or for the
application of active ingredients to the skin for
protective, therapeutic, or prophylactic
purposes.
4.
Ointments are used topically on a variety of body
surfaces. These include the skin and the
mucous membranes of the eye (an eye ointment),
and nose.
Ointments are usually very moisturizing, and good
for dry skin. They have a low risk of sensitization
due to having few ingredients beyond the base oil
or fat, and low irritation risk.
5.
The medicaments are dispersed in the base, and
later they get divided after the drug penetration
into the living cells of skin.
Ointments are formulated using hydrophobic,
hydrophilic, or water-emulsifying bases to provide
preparations that are immiscible, miscible, or
emulsifiable with skin secretions. They can also
be derived from hydrocarbon (fatty), absorption,
water-removable, or water-soluble bases
6.
Topical antibiotics help prevent infections
caused by bacteria that get into minor cuts,
scrapes, and burns.
Treating minor wounds with antibiotics allows
quicker healing.
If the wounds are left untreated, the bacteria
will multiply, causing pain, redness, swelling,
itching
7. Absorption bases:- anhydrous & emulsion
e.g. wool fat, beeswax
Water soluble bases
e.g. macrogols 200, 300, 400
Hydrocarbon bases
e.g. hard paraffin, soft paraffin,
microcrystalline wax and ceresine
9. Among the products that contain one
or more of these ingredients are
Bactroban (a prescription item )
Neosporin, Polysporin, and Triple
Antibiotic Ointment or Cream
10.
11. Market Sur vey
A market survey of the existing antiboitic ointment were to
be done
TRADE NAME
ACT.ING &
MFG. COMPANY
PRICE/QTY.
ADDITIVES
BACTROBAN
OINTMENT
MUPICROCIN
TORRENT
RS 30.90/10gm
NEOSPORIN
OINTMENT
POLYMAXIN B,
BACITRACIN
WIN MEDICARE
Rs 35.90/20 Gm
POLYSPHORIN
OINTMENT
-----------------------------------
UNIQUE
Rs20.47/20 gm
TRIPLE ANTIBIOTIC
OINTMENT
POLYMAXIN B
GERMAN REMEDIES
RS 40.50/ 30 gm
CLINDAMYCIN
OINTMENT
CLEOCIN
KNOLL
Rs45.50/30 gm
BENZYL PEROXIDE
----------------------------------
ELDER
Rs28/20 gm
SILVER
SULPHADAZINE
----------------------------------
TORRENT
Rs 35/20gm
13. Oleaginous Base (White Ointment)
Water Soluble Base
White Wax
5%
Polyethylene
Glycol 400
60%
White Petrolatum
95%
Polyethylene
Glycol 3350
40%
Absorption Base
Cholesterol
3%
Stearyl
Alcohol
3%
Emulsion Base (Hydrophilic Ointment)
Propylene Glycol
12.%
25.%
White Petrolatum
White
Petrolatum
1.0%
Stearyl Alcohol
White Wax
Sodium Lauryl Sulfate
25.%
Purified Water
37.%
8%
86%
15. an oil and/or liquid wax ester such as jojoba oil is heated
preferably to around 80 C.
A wax such as beeswax is preferably melted into the oil or liquid
wax ester.
The material may be mixed thoroughly as it is cooled, typically
below about 60 C. Optionally, an essential oil such as palmarosa
oil may be added.
Mixing may be continued as the tetrasilver tetroxide is introduced,
and further mixing may ensue, typically for 0.5 to 2 hours, during
cooling of the mixture to below about 40 C.
A smectite (such as bentonite) and zinc oxide may be introduced
along with the tetrasilver tetroxide, or sometime therebefore or
thereafter.
The formulation may then be poured into storage containers
16.
17.
Primarily used against gram positive bacteria S.
aureus and Streptococci spp.
Most gram negative organisms are resistant
Bacitracin interferes with bacterial cell wall
synthesis
Acts by blocking a step in the process whereby
the key subunits are transferred from the
cytoplasm
20.
Drug content
Release of medicament from base
Medicament penetration
Consistency of the preparation
Absorption of medicament into blood stream
Irritant effect
21. Consistency:
The measurement of consistency of the prepared ointment was done by dropping
a cone attached to a holding rod from a fix distance of 10cm in such way that it
should fall on the centre of the glass cup filled with the ointment. The penetration
by the cone was measured from the surface of the ointment to the tip of the cone
inside the ointment. The distance traveled by cone was noted down after10sec.
PH
Consistency
(60 sec)
Homogeneity
Skin irritation test Drug
Content
6.8
5mm
Good
Nil
99.95
6.8
5mm
Good
Nil
99.94
6.8
5mm
Good
Nil
99.98
6.8
10mm
Good
Nil
99.90
%
22. Skin irritation test:
Test for irritation was performed on human volunteers. For each
ointment, five volunteers were selected and 1.0g of formulated
ointment was applied on an area of 2 square inch to the back of hand.
The volunteers were observed for lesions or irritation.
Accelerated stability studies:
All the selected formulations were subjected to a stability testing for
three months as per ICH norms at a temperature of 40º ± 2º. All
selected formulations were analyzed for the change in appearance, pH
or drug content by procedure stated earlier.
RESULT & CONCLUSION :
The new Antiboitic
ointment formulation containing bacitracin should have to
produce better spreadability and consistency as compared to
other marketed bacitracin.The developed ointment should have
to show good homogenecity, no skin irritation, good stability
comparable with marketed gel. Then it will have wider prospects
to be used as a topical drug delivery system.
23.
The theory and practice of industrial pharmacy
by leon lachman 3 rd edition
The text book of product developed by Jain
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