OINTMENTS MS. WAJIHA IFFAT After completing this lesson, you should be able to: Define The Term...

OINTMENTS MS. WAJIHA IFFAT

After completing this lesson, you should be able to:•Define The Term Ointment•List Down The Desirable Characteristics Of Ointment BasesClassify The Ointments &/Or Ointment Bases .• Differentiate Different Type Of Substance That Should Be Used As An Ointment Base.•Select The Procedure That Should Be Used To Prepare An Ointment Using The Fusion Method Or Incorporation Method.•Select The Auxiliary Label That Should Be Placed On A Container In Which An Ointment Is Dispensed.

OINTMENTS• DEFINITION:• “Ointments are semisolid preparation intended for

application to the skin with or without inunction. they may be oleaginous e.g., white ointment; they may be entirely free of oleaginous substances e.g., polyethylene glycol ointment, or they may be emulsions of fatty or wax like material containing relatively high proportion of water e.g., hydrophilic ointment.”

OINTMENTS

• IDEAL OINTMENT BASE:• According to BEELER, ideal ointment base should have following

physicochemical properties:1. Stability2. Neutral in reaction3. Non greasy4. Non degreasing5. Non irritating6. Nondehydrating7. Non hygroscopic8. Water removable9. Compatible with all medicaments10.Free from odors

OINTMENTS11. Nonstaining12. Efficient on all skin type13. Composed of readily available component of known

chemical composition14. Capable of holding 50% of water15. Easily compounded16. Melting & softening at body temperature 17. smoothness18. ease of application 19. Suitable base20. Properly distributed medicament

CLASSIFICATION OF OINTMENT/ OINTMENT BASES

ACCORDING TO PENETRATION: 1.EPIDEMIC OINTMENT :• Slight penetration power• Therapeutic effect on diseased epithelium• e.g,petrolatum,waxes and 1+2.2.ENDODERMIC OINTMENT:• Power of deeper penetration• e.g,vegi oils,lards,lanolin and 1+2+33.DIADERMIC OINTMENT:• Penetrate skin effectively. better absorption• e.g., emulsion type & water soluble.


CLASSIFICATION ACCORDING TO CHEMICAL COMPOSITION:

(PHYSICAL CLASSIFICATION ):They may be classified into four main groups:• Hydrocarbon Bases• Absorption Bases• Water Miscible Bases• Water Soluble Bases


• HYDROCARBON BASES:(a) Properties. 1.Anhydrous 2.Do not absorb water readily (Hydrophobic) 3. Insoluble in water 4.Not washable

(b) Examples. Fats and fixed oils such as lard, olive oil, cottonseed oil, petrolatum(soft paraffin), white ointment, Yellow Ointment (Bees Wax) and silicon bases.

(c) Advantages. Highly compatible; occlusive; good emollients.(d) Disadvantages. Difficult to remove from skin and clothing; uncertain

as to yield of medicament. May go rancid . allergies??


• ABSORPTION BASES:They may be:• Non emulsified: they absorb water and aqueous

solutions to produce w/o emulsions. Examples are wool fat (anhydrous lanolin), wool alcohols, bees wax and cholesterol.

• w/o emulsions: they are similar in properties to the previous group and are capable of absorbing more water. Examples are hydrous wool fat B.P. (lanolin) and oily cream B.P.


(a)Properties.• Anhydrous• will absorb water( hydrophillic)• Insoluble in water • most are not washable.(b)Example. Hydrophillic Petrolatum, USP;

Anhydrous Lanolin, USP.(c) Advantages. Highly compatible; relatively stable

to heat; can be used in anhydrous form or water can be added when emolliency is desired.

(d)Disadvantage. Greasy. Less occlusive.


• EMULSION BASES:A. Emulsion Ointment Base (W/O):

1. Hydrous2. Will absorb water3. Insoluble in water4. Not washable5. Water-Oil-Emulsion6. Examples—Lanolin, Rose water Ointment, Cold Cream

B. Emulsion Ointment Base (O/W):1. Hydrous2. Will absorb water3. Insoluble in water4. Washable5. Oil-in-Water Emulsion6. Hydrophilic Ointment


• Emulsion Bases. Emulsion ointment bases consist of an aqueous phase, an oleaginous phase, and an emulsifying agent. They are true, solid emulsions.

• Emulsion bases may be either oil-in-water (o/w) or water-in-oil (w/o), usually depending upon the phase in which the emulsifier is more soluble. The water phase varies from 10 percent to 80 percent of the completed ointment base.

• They can be anionic, cationic, nonionic.• Combination:30:soft paraffin50: liquid paraffin20


• (1) Preparation. Emulsion bases are made by melting the greasy and oily materials together in one container and heating the water and water-soluble materials in another container.

• At the temperature of 75° C, they are mixed together until a smooth cream results. While the mixture is still warm and thin, it may be passed through a homogenizer to improve the appearance and quality of the base.

• The mixture is then stirred until it congeals.


Summary of emulsion bases. We can sum up the important aspects of emulsion bases as follows:

(a) Properties. The w/o emulsion bases are insoluble in water and are not washable; the o/w emulsion bases are washable and nongreasy.

(b) Example:• Lanolin, USP (w/o); • Hydrophilic Ointment, USP (o/w);• Vanishing creams (o/w).


(c)Advantages:• Washable and nongreasy if oil-in-water (o/w).

(d) Disadvantages:• Subject to water loss if o/w, • greasy and unwashable if water-in-oil (w/o), • unless, a preservative is added, the emulsion bases are subject to mold growth.


• Water-Soluble Bases.• The polyethylene glycol polymers, or Carbowaxes, are of

great importance in ointments. • The names of the Carbowaxes include numbers that

roughly indicate their average molecular weight. • Carbowaxes with a molecular weight in the area of 1,000

are soft, ointment-like substances.• As the molecular weight increases, they become harder

and they finally become waxes. They are water-soluble, nonvolatile, and do not deteriorate or support mold growth.


• Properties:• Anhydrous• but will absorb water and dissolve in water;• Washable• Non-greasy.• (b) Examples. Carbowax compounds such as the

polyethylene glycol bases containing pectin, cellulose, Bentonite, and gelatin.


c) Advantages. Wide range of compatibility;• do not become rancid or support microbial

growth;• nonirritating (to the same degree as lanolin,

petrolatum, etc);• adhere well to skin;• easily washed off;• low incidence of sensitization.(d) Disadvantages. Sometimes undergo gradual

discoloration with certain drugs.• Unless cetyl alcohol is added, an aqueous solution

can be added only to the extent of 5 percent.


• LANE & BLANK CLASSIFICATION: According to physicochemical action of vehicle on

skin:1. VEHICLE ACTED AS AQEOUS MIXTURE2. VEHICLE ACTED AS OILS3. VEHICLE ACTED AS POWDERS4. VEHICLE ACTED AS ORGANIC SOLVENT


CHEMICAL CLASSIFICATION:1. Hydrocarbon2. Alcohol3. Acid4. Ester5. SOAPS6. MISCELLANEOUS


ACCORDING TO USES OR THERAPEUTIC CLASSIFICATION:

1. Emollient2. Protective3. Anti Infectives4. Anti Eczematic5. Keratolytic6. Anti Prespirants7. Anti Sebhorrics

METHOD OF PREPARATION

• MIXING BY FUSION:• In this method, the ingredients are melted

together and stirred to ensure homogeneity.• On a small scale, fusion is usually fusion is

usually carried out in an evaporating basin made of glazed porcelain or stainless steel over a water bath.

METHOD OF PREPARATION• PREPARATION OF OINTMENT BASE BY FUSION:• The constituents of the base are melted together in the

basin and stirred gently after melting until cool.• Vigorous stirring can cause aeration which should be

avoided.• Any foreign particles that are naked on melting cam be

removed by decantation or by using a warm muslin cloth.• If product is granular after cooling due to separation of

some ingredients of high MP, it may be remelted with min. heat and restirred until cold.

• Stock bases can be made successfully by pouring the melted mixture into a warmed jar, covering and allowing to stand, undisturbed on a non conducting surface, until set. (paraffin, simple or wool alcohol ointments of B.P.)

METHOD OF PREPARATION • Completely or partially soluble solids should be added in

fine powder to the molten base at very low temperature and the mixture stirred until cold.

• Liquids such as methyl salicylate and coal tar solutions and semi solids such as ichthammol should be added just as the base is thickening, at about 40C. When a solid is soluble in liquid ingredient, (menthol in methyl salicylate), its more convenient to add it in solution.

• Insoluble solids (calamine, starch, zinc oxide) should be passed through a 180 um sieve and added in small amount while stirring to melted base, when it shows first sign of thickening. Sedimentation should be prevented.

• If the product has liquid paraffin or a fixed oil, small amount can be used to levigate powder before adding to base to produce a smoother product.


• MIXING BY TRITURATION:• This is applicable when medicament is a solid

insoluble in base or a liquid present in small amount.

• Solids should be finely powdered and passed via sieve. (250 um/180 um/125 um mesh).

• Trituration can be carried out with an ointment tile and a spatula or using mortar and pestle.


• TRITURATION USING TILE AND SPATULA:Tiles should be large enough to prepare ointments.

• Spatula should be flexible and have a broad, non-tapering long blade, to provide a large rubbing surface.

• Another small spatula may be used for removing accumulated material.

• Powders for incorporation are placed on the tile and mixed gently. • Powders are levigated until mixture is smooth and homogenous.• Dispersion is then diluted with increasing amounts of base, doubling

the quantity on each addition.• Finally any liquid ingredients are incorporated, avoiding splashes.


• TRITURATION USING MORTAR AND PESTLE:• The mortar should have a flat base and the pestle is flat

headed to give best results.• Warming equipment can be helpful if the base is very stiff.• Sequence of mixing is same as for the tile method.• Splashing of liquids is easily controlled in the mortar.


• Incorporation of solids• Incorporation of gummy materials.• Incorporation of liquids.

• PACKAGING,STORAGE& LABELLING:

REFERENCES• Sprowls’ American Pharmacy By

Lewis.W.Dittert.Pg-233-277.• Pharmaceutical Practice By Diana M. Collett

pages 125-133• Ansel’s Pharmaceutical Dosage Form & Drug

Delivery System By Ansel Pg.277-293• Pharmaceutical Practice By A.J Winfeild.pg.206-

217• Pharmaceutical Pre Formulation & Formulation

Pg:515-569

OINTMENTS

• THANK YOU.• ANY QUESTION ??• Prepare an assignment on types of ointment

bases along with their official formula and method of preparation. one example each.

OINTMENTS MS. WAJIHA IFFAT After completing this lesson, you should be able to: Define The Term...

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