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Presented By:-

Guided By:-

Pavan Folane

Prof.S.V.Deshmane
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
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INTRODUCTION
TYPES
PROPERTIES
MARKETED PRODUCTS SURVEY
FORMULATION
EVALUATION
REFERENCE




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.




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.


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






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
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



Emulsifying bases
e.g. emulsifying wax, cetrimide



Vegetable oils
e.g. olive oil, coconut oil, sesame oil, almond oil
and peanut oil
Among the products that contain one
or more of these ingredients are
Bactroban (a prescription item )
Neosporin, Polysporin, and Triple
Antibiotic Ointment or Cream
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
bacitracin A

Neomycin

Polymyxin B

clenosin

mupricon

CONCLUSION:- Hence 95% of antiboitic
ointment formulations contains Bacitracin A as
active ingredient
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%
66% water
24% bentonite
9% jojoba oil and
0.88% tetrasilver tetroxide
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







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
BACITRACIN A






Stability
Penetrability
Solvent property
Irritant effects
Ease of application and removal







Drug content
Release of medicament from base
Medicament penetration
Consistency of the preparation
Absorption of medicament into blood stream
Irritant effect
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

%
 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.


The theory and practice of industrial pharmacy
by leon lachman 3 rd edition
The text book of product developed by Jain



www.slideshare.com


 antoboitic ointment

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antoboitic ointment

  • 1. Presented By:- Guided By:- Pavan Folane Prof.S.V.Deshmane
  • 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 
  • 8.  Emulsifying bases e.g. emulsifying wax, cetrimide  Vegetable oils e.g. olive oil, coconut oil, sesame oil, almond oil and peanut oil
  • 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
  • 12. bacitracin A Neomycin Polymyxin B clenosin mupricon CONCLUSION:- Hence 95% of antiboitic ointment formulations contains Bacitracin A as active ingredient
  • 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%
  • 14. 66% water 24% bentonite 9% jojoba oil and 0.88% tetrasilver tetroxide
  • 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  www.slideshare.com 