Presented By:- Guided By:- Pavan Folane Prof.S.V.Deshmane

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 Survey

A market survey of the existing antiboitic ointment were to be doneTRADE NAME ACT.ING &

ADDITIVESMFG. COMPANY PRICE/QTY.

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

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TORRENT Rs 35/20gm

CONCLUSION:- Hence 95% of antiboitic ointment formulations contains Bacitracin A as active ingredient

bacitracin A Neomycin Polymyxin B clenosin mupricon

White Wax 5%

White Petrolatum 95%

Oleaginous Base (White Ointment)

Cholesterol 3%

Stearyl Alcohol

3%

White Wax 8%

White Petrolatum

86%

Absorption Base

Sodium Lauryl Sulfate 1.0%  

Propylene Glycol 12.%

Stearyl Alcohol 25.%  

White Petrolatum 25.%  

Purified Water 37.%

Emulsion Base (Hydrophilic Ointment)

Water Soluble Base

Polyethylene Glycol 400

60%

Polyethylene Glycol 3350

40%  

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

PH Consistency(60 sec)

Homogeneity Skin irritation test

DrugContent %

6.8 5mm Good Nil 99.956.8 5mm Good Nil 99.94

6.8 5mm Good Nil 99.98

6.8 10mm Good Nil 99.90

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.

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

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