OINTMENTS MS. WAJIHA IFFAT

1. OINTMENTS MS. WAJIHA IFFAT After completing this lesson, you should be able to: Define The Term Ointment List Down The Desirable Characteristics Of Ointment Bases Classify The Ointments &/Or Ointment Bases . Differentiate Different Type Of Substance That Should Be Used As AnOintment Base. Select The Procedure That Should Be Used To PrepareAn Ointment Using The Fusion Method Or Incorporation Method. Select The Auxiliary Label That Should Be Placed On AContainer In Which An Ointment Is Dispensed.

2. 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.”

3. OINTMENTS • IDEAL OINTMENT BASE: • According to BEELER, ideal ointment base should have following physicochemical properties: • Stability • Neutral in reaction • Non greasy • Non degreasing • Non irritating • Nondehydrating • Non hygroscopic • Water removable • Compatible with all medicaments • Free from odors

4. OINTMENTS • Nonstaining • Efficient on all skin type • Composed of readily available component of known chemical composition • Capable of holding 50% of water • Easily compounded • Melting & softening at body temperature • smoothness • ease of application • Suitable base • Properly distributed medicament

5. 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+3 3.DIADERMIC OINTMENT: • Penetrate skin effectively. better absorption • e.g., emulsion type & water soluble.

6. CLASSIFICATION OF OINTMENT/ OINTMENT BASES 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

7. CLASSIFICATION OF OINTMENT/ OINTMENT 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??

8. CLASSIFICATION OF OINTMENT/ OINTMENT BASES • 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.

9. CLASSIFICATION OF OINTMENT/ OINTMENT BASES (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.

10. CLASSIFICATION OF OINTMENT/ OINTMENT BASES • EMULSION BASES: A. Emulsion Ointment Base (W/O): 1. Hydrous 2. Will absorb water 3. Insoluble in water 4. Not washable 5. Water-Oil-Emulsion 6. Examples—Lanolin, Rose water Ointment, Cold Cream B. Emulsion Ointment Base (O/W): 1. Hydrous 2. Will absorb water 3. Insoluble in water 4. Washable 5. Oil-in-Water Emulsion 6. Hydrophilic Ointment

11. CLASSIFICATION OF OINTMENT/ OINTMENT BASES • 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

12. CLASSIFICATION OF OINTMENT/ OINTMENT BASES • (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.

13. CLASSIFICATION OF OINTMENT/ OINTMENT BASES 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).

14. CLASSIFICATION OF OINTMENT/ OINTMENT BASES (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.

15. CLASSIFICATION OF OINTMENT/ OINTMENT BASES • 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.

16. CLASSIFICATION OF OINTMENT/ OINTMENT BASES • 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.

17. CLASSIFICATION OF OINTMENT/ OINTMENT BASES 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.

18. CLASSIFICATION OF OINTMENT/ OINTMENT BASES • LANE & BLANK CLASSIFICATION: According to physicochemical action of vehicle on skin: • VEHICLE ACTED AS AQEOUS MIXTURE • VEHICLE ACTED AS OILS • VEHICLE ACTED AS POWDERS • VEHICLE ACTED AS ORGANIC SOLVENT

19. CLASSIFICATION OF OINTMENT/ OINTMENT BASES CHEMICAL CLASSIFICATION: • Hydrocarbon • Alcohol • Acid • Ester • SOAPS • MISCELLANEOUS

20. CLASSIFICATION OF OINTMENT/ OINTMENT BASES ACCORDING TO USES OR THERAPEUTIC CLASSIFICATION: • Emollient • Protective • Anti Infectives • Anti Eczematic • Keratolytic • Anti Prespirants • Anti Sebhorrics

21. 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.

22. 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.)

23. 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.

24. METHOD OF PREPARATION • 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.

25. METHOD OF PREPARATION • 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.

26. METHOD OF PREPARATION • 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.

27. METHOD OF PREPARATION • Incorporation of solids • Incorporation of gummy materials. • Incorporation of liquids. • PACKAGING,STORAGE& LABELLING:

28. 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

29. 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.