TopicTopic:-:- OINTMENTSOINTMENTSPresented 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 CONTENTSWhat is Ointments ?Types of ointment Advantages & DisadvantagesMedicinal Applications GMP GuidelinesOintment basesPreparationPackaging , Storage and DispensingQuality Control TestsEvaluation TestReferences

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.

What is Ointments?

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 OintmentsThe various types of ointments are: Unmedicated ointments Medicated ointments

UNMEDICATED OINTMENTSThese ointments do not contain any drugs. They are useful as emollients, protectants .Example: Petroleum jelly.

MEDICATED OINTMENTSThese ointments contain drugs which show

local or systemic effects. These are of several sub-types:Dermatologic ointmentsOpthalmic ointmentsRectal ointmentsVaginal ointmentsNasal 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 ofointments enter into the deeper layers of skin and finally in thesystemic circulation and exert systemic effects.Example: Nitroglycerine ointment.

OPTHALMIC OINTMENTSThese 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 OINTMENTSThese 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 OINTMENTSThese 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 OINTMENTSThese are used in the topical treatment of nasal mucosa. Drugs get absorbed into the general circulation through the rich blood supply ofthe 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.

DISADVANTAGESThey 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.

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

Oleaginous O.B.Oleaginous 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®

Absorption O.B.Absorption 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® .

W/O emulsion O.B.W/O 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™

O/W emulsion O.B.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.Water miscible 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.

Choice of the O.B.Choice of the 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.

Ideal O.B.Ideal O.B.

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 OintmentsPreparation 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)

Electric Mortar and PestleElectric Mortar and PestleOintment MillOintment Mill

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.

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.

Storage and dispensingStorage and dispensing

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 absorptionThe 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 ofindustrial pharmacy, Lea & Febieger, Philadelphia Latest Edn