CITY COLLEGE OF HEALTH SCIENCES AND TECHNOLOGY ZARIA

BASIC DISPENSING THEORY BDT351

300 LEVEL PHARMCY STUDENTS

Introduction

Creams are considered an important part of cosmetic product as topical

preparations from time immemorial due to their ease of application to the skin and

also their removal.

Pharmaceutical creams have a variety of applications such as cleansing,

beautifying, altering appearance, moisturizing etc. to skin protection against

bacterial, fungal infections as well as healing cuts, burns, wounds on the skin.

These semi solid preparations are safe to use by the public and society. The human

skin is easily vulnerable to injury but it has the capability to heal on its own.

However, the natural healing process can take time and there is also risk of

infection especially in the early stages of injury. In such cases, medicated creams

can be applied to the site of injury to speed up the healing process as well as

protect the wound from infection. In this lecture, we will be focusing on the use of

topical drug delivery system i.e. pharmaceutical creams for wound healing with

detailed discussion relating to the wound healing process, suitable methods of

preparation of creams, their classification based on their function, their advantages

and disadvantages, characteristics and the various types of creams, ingredients

used in the formulation of creams and their various evaluation parameters.

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The word ‘Cosmetic’ derived from a Greek word – ‘kosmesticos’ that means to

adorn. From that time any materials used to beautification or promoting

appearance is known as cosmetic.

Cosmetics are used to enhance appearance. Makeup has been around for many

centuries. The first known people who used cosmetics to enhance their beauty were

the Egyptians. Makeup those days was just simple eye coloring or some material

for the body. Now-a-days makeup plays an important role for both men and

women. The importance of cosmetics has increased as many people want to stay

young and attractive. Cosmetics are readily available today in the form of creams,

lipstick, perfumes, eye shadows, nail polishes, hair sprays etc. Other cosmetics like

face powder give glow to the skin after applying the base cream. Then we have

lipsticks, which are applied by many women of all ages. They are made from wax

and cocoa butter in the desired amount.

Cosmetics like creams, gels, and colognes are used on a daily basis by both women

and men. Creams act as a cleanser for the face in many circumstances. More

recently anti-ageing creams have been manufactured which can retain younger

looking skin for many years. The best cleansing agents are cleansing cream, soap

and water. Cosmetic creams serve as a skin food for hard, dry and chapped skin. It

mainly lubricates, softens and removes unwanted dirt from the skin. Some popular

fat creams that are used include Vaseline and Lanolin. Dry creams are used in the
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manufacture of soap and gelatin which is used as a base for the skin. Hair care has

become one of the fastest developing markets in the beauty industry. Many young

men turn to oils and gels to maintain and style their hair. Products like hair gels,

oils, and lotions have been introduced in the market to help protect hair fall and

dandruff. Some professions, like the show business industry, focus on the

importance of the outer appearance. Many personalities and artists have utilized

makeup to beat the harsh lights and the glare of camera flashes

Creams is reserved for external preparation. Creams are viscous semi solid

emulsions for external use.medicament can be suspended or dissolved in creams. A

Cream may be” water in oil” or “oil in water” cream. Creams are formulated to

provide preparations that are essentially miscible with skin secretion.they are

intended to be applied to the skin or certain mucous membrane for protective,

therapeutic, or Prophylactic purposes especially when occlusive effect is not

necessary.”

Creams are also defined as semi solid emulsion of either oil in water or water in oil

type.” Intended for external application.

IDEAL PROPERTIES OF A CREAM BASES

1) It should not react with drugs and additives.

2) It should have good emulsifying and wetting property.

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 3) It should have acid value less than 0.2 or zero

4) It should have iodine value less than 7.

5) It should have saponification number range between 200-245.

CREAMS

1. Aqeous cream; aqeous cream, cetrimide cream, cetomacrogol cream.

2. Oily creams: oily creams/hydrous ointment

3. Cosmetic creams

4. All purpose cream, baby cream barrier, bleaching cream, cleansing

cream,cold cream,hair cream,hand cream,vanishing cream.

5. Medicate cream

 Creams are reserved for external preparation,

a. Water in oil creams contains emulsifying agents of natural origin(bees

wax,wool alcohols,wool fat)

Properties; Emollient.

 Creamy,white or translucent and stiff.

b. Creams; oil in water, contains synthethic waxes. E.g; Cetomacrogols and

macrogols.

Properties
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  Causes rapid absorption and penetration.

 Thin, white and smooth consistency.

METHOD OF PREPARATION:

 Trituration:

 Used for finely divided insoluble powder particles or liquids.

 Insoluble powder are added by geometric dilution.

 Liquids are added by making well in centre.

 Air pocket formation avoided.

 Involves the use of glass lab when small quantities are used.

 Mortar and pestle used when we have large quantities.

Levigation; Incororation of insoluble coarse particles.

Also known as wet grinding, insoluble coarse powder is rubbed with molten bases.

A considerable shearing force is applied to avoid grittiness.

Hygience; Aseptic Condition.

All equipment and spatula to be cleaned by IMS.(70% Ethanol should be used)

Determine the miscibility of the substances being incorporated.

Melt the fatty base substances with the highest melting point to be the first

melt.these base then cooled to 60~oc.

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The dispers phase to be incorporated to the continuous phase at room temp.

Avoid air pockets and hasty cooling.

Solid particles can be incorporated after base cools.

Soluble solids added to molten cream at the lowest possible temperature and the

mixtures stirred until cold.

Insoluble solids incorporated using tiles and spartular or mortar and pestle using

doubling up technique.

Coarse Powder; minimum quantity of cream should be placed in the centre of tiles

and used to lavigate powders.

Fine powders may be triturated to into other wise finished creams on ointment

tiles.(Geometric dilution)

CREAMS: Incorporation of liquids:

Non volatile,miscible liquids may be mixed with molten cream in an evaporating

basin.if a prepared based is used,then follow procedure for volatile or immiscible

liquids.

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Volatile or immiscible liquids:e.g coal tar should be triturated with creams on a

tile. A very small amount of creams should be placed on a tiles and well made in

the centre.small quantities are folded gently to avoid splashing.

Creams:

Diluted creams:

If the diluent is stated in the manufacturer data sheet

Freshly prepared

No heating should be involved

Should be carried out in aseptic condition

Should not be used more than 2 weeks

Difference Between Cream And Ointment

CREAMS OINTMENT

Less than 50% hydrocarbon more than 50% hydrocarbon

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 More than 20% water less than 20% water

Consistency light,easy to spread thicker consistency,greasy,difficult

to spread

Skin dry faster Stay longer on skin surface

Preferred for oily skin preferred for dry skin

Topical Drug Delivery

Over the last decades the treatment of illness have been accomplished by

administrating drugs to human body via various routes namely oral,

sublingual ,rectal, parental ,topical ,inhalation etc. Topical delivery can be defined

as the application of a drug containing formulation to the skin to directly treat

cutaneous disorder or the cutaneous manifestations of a general disease (eg.

psoriasis) with the intent of containing the pharmacological or the effect of drug to

the surface of the skin or within the skin semisolid formulations in all their

diversity dominate the system for topical delivery, but foams, spray , medicated

powders, solutions and even medicated adhesive systems are in use.

Advantages of topical drug delivery system

 Avoidance of first pass metabolism.

 Convenient and easy to apply.

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 Avoid of risk.

 Inconveniences of intravenous therapy and of the varied conditions of absorption

like Ph changes presence of enzymes gastric emptying time etc.

Achievement of efficacy with lower total daily dosage of drug by continuous drug

input.

 Avoid fluctuation of drug levels inter and intra patent variations.

 Skin irritation or dermatitis may occur due to the drug or excipients.

 Most drugs have a high molecular weight and are poorly lipid soluble, so are not

absorbed via skin or mucous membranes.

 Very slow absorption.

 It can be used only for those drugs which need very small plasma concentration

for action.

 Can be used only for drugs which require very small plasma concentration for

action

 Possibility of allergic reactions.

 Drugs of larger particle size not easy to absorb through the skin

Physiology Of Human Skin

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Epidermis The epidermis is the most superficial layer of the skin and is composed

of stratified keratinised squamous epithelium, which varies in thickness in different

parts of the body. It is thickest on the palms of the hands and soles of the feet.

There are no blood vessels or nerve endings in the epidermis, but its deeper layers

are bathed in interstitial fluid from the dermis, which provides oxygen and

nutrients, and drains away as lymph.

Dermis

The dermis is tough and elastic. It is formed from connective tissue and the matrix

contains collagen fibres interlaced with elastic fibres. Rupture of elastic fibres

occurs when the skin is overstretched, resulting in permanent striae, or stretch

marks, that may be found in pregnancy and obesity. Collagen fibres bind water and

give the skin its tensile strength, but as this ability declines with age, wrinkles

develop. Fibroblasts, macrophages and mast cells are the main cells found in the

dermis. Underlying its deepest layer there is areolar tissue and varying amounts of

adipose (fat) tissue. Subcutaneous gland These consist of secretory epithelial cells

derived from the same tissue as the hair follicles. They secrete an oily substance,

sebum, into the hair follicles and are present in the skin of all parts of the body

except the palms of the hands and the soles of the feet. They are most numerous in

the skin of the scalp, face, axillae and groins. In regions of transition from one type

of superficial epithelium to another, such as lips, eyelids, nipple, labia minora and
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glans penis, there are sebaceous glands that are independent of hair follicles,

secreting sebum directly onto the surface. care products.E.g. Almond oil, germ oil,

avocado oil, sunflower oil etc.Waxes: Which are used in preparation of cream

includes beeswax, carnauba wax, ceresin, spermaceti, etc. Waxes are used in

cosmetics because it helps to keep an emulsion from separation of oil and liquid

components. These waxes also increase the thickness of the lipid portion and sticks

on the surface of the skin.  Fats: Different types of fats are used in the preparation

of creams. These materials can be obtained from animals, plants or mineral origin.

Glyceride oils and fats may be of animals or vegetable origin. They consist of

combinations of higher fatty acids and glycerin. When saponified they form soap,

or fatty acid and glycerin, depending upon process used. The most common of

these fatty acid are lauric, margaric, plamitic, stearic, saturated group. Oleic acid is

liquid and most popular unsaturated fatty acid. More specially the oil most

commonly used in other cosmetics are olive oil, almond oil, seasame oil, peanut

oil, coca butter fat, mutton tallow, lard and beef stearine.[18]  Lanolin: It is

derived from wool fat of a sheep. Lanolin are of two types- the hydrous lanolin

contains between 25%- 30% water. Anhydrous lanolin has point of 38°C42°C and

has a slight odour. These ingredients act as a lubricant on the skin surface, which

gives the skin soft and smooth appearance. Lanolin helps to form emulsion and

blends well with other substances used in cosmetic and personal care products. 

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Colours: Before the development of the modern technology, colours primarily

came from substances found in nature such as turmeric, saffron, indigo, etc. After

the 19th century, colours were made in the laboratory and were found

Functions of Skin

Skin performs the following functions:

a) Protection: An anatomical barrier from pathogens and damage between the

internal and external environment in bodily defence, Langerhans cells in the skin

are part of the adaptive immune system.

b) Sensation: Contains a variety of nerve endings that react to heat and cold,

touch, pressure, vibration, and tissue injury, see somato sensory system and

haptics.

c) Heat regulation: The skin contains a blood supply far greater than its

requirements which allows precise control of energy loss by radiation, convection

and conduction. Dilated blood vessels increase perfusion and heat loss, while

constricted vessels greatly reduce cutaneous blood flow and conserve heat.

d) Control of evaporation: The skin provides a relatively dry and semi-

impermeable barrier to fluid loss. Loss of this function contributes to the massive

fluid loss in burns.

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e) Aesthetics and communication: Others see our skin and can assess our mood,

physical state and attractiveness.

f) Storage and synthesis: Acts as a storage centre for lipids and water, as well as

a means of synthesis of vitamin D by action of UV on certain parts of the skin.

g) Water resistance: The skin acts as a water resistant barrier so essential

nutrients aren't washed out of the body.

General Ingredients Used In Skin Creams

The raw materials which are used in a manufacturing of skin creams include:

 Water: This is the most important and widely used raw material in any

cream formulation. These are the cheapest and easily available. In skin

creams, water is used as solvent to dissolve other ingredients of creams.

Water, which is free of any toxins, pollutants, microbes, etc. is used in

preparation of creams. Water can also form emulsions, it depends upon how

much quantity of water is used in the formulation and sometimes referred to

as oil-in-water emulsions and sometimes water-in-oil emulsions depending

upon the quantities of oil phase and water phase used.

 Oil, fates and waxes: Oil, fats and waxes and derivatives there form

comprise an essential portion of creams. Waxes act as an emulsifier, fats act

as a thickener and oil act as a perfuming agent, preservative, etc. according

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 to its function .Oil may be two types’ mineral and glyceride Mineral oil:

Mineral oil consists of hydrocarbons derived from petroleum oil .Mineral oil

is clear, odorless, and heavily refined oil and it is widely used in cosmetics.

Mineral oil rarely causes allergic reactions and it cannot become solid and

clog pores of the skin. It is light weight and inexpensive, it helps to reduce

water loss from the body and keeps body moisturized. A number of mineral

oils are used in cream formulation. Examples:  Light liquid paraffin , Heavy

liquid paraffin ,Liquid petroleum 

 Glyceride oil: Glyceride oil is mostly vegetable oils. Examples of glyceride

oils are almond oil, arachis oil, castor oil, coconut oil, olive oil etc. 

 Vegetable oil: Form a barrier on the surface of the skin and slow down the

loss of water, helping to maintain plumpness of skin. Vegetable oils may

also be used to increase the thickness of the lipid or oil portion of cream or

personal to be much more stable with greater colouring intensity. They also

could be produced without using plants harvested in the wild.

 Emollients: Emollients, also commonly referred to as moisturizers, are

products that help to soften skin or to treat skin that has become dry. Most

emollients are forms of oil or grease, such as mineral oil, squalene, and

lanolin. They work by increasing the ability of the skin to hold water,

providing the skin with a layer of oil to prevent water loss, and lubricating

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 the skin.[20]  Humectants: These are important multi-functional ingredients

found in most skin care formulations. Humectants are hydroscopic organic

compounds. These are the materials that can absorb or retain moisture.

These has many benefits such as moisturization, exfoliation, etc. Examples

of humectant are glycerin, Hydroxyethyl urea, betaine, sodium PCA,

Sodium-LLactate, etc.[21]  Perfumes: Perfume is a substance that imparts a

scent t or order, including a sweet and pleasant smell. Examples of natural

perfumes used in creams are-  White Blossoms: Rosy Dreams  Orange

Blossom[22]  Vitamins: Vitamins plays an important role in maintaining

the physiological function of whole body and the skin. Vitamin A, B, C, E

etc. are generally used in formulation of the creams.  Preservatives: The use

of preservatives in cosmetics is essential to prevent alteration caused by

microorganism and contamination during formulation, shipment, storage and

consumer use. Antioxidants can also be used to protect alteration caused by

exposure to oxygen. Synthetic preservatives when used in low concentration

effectively preserve the products.

RELEVANT METHODS OF PREPARATION OF CREAMS FOR WOUND-

HEALING:
Preparation of o/w emulsion cream The oil soluble components and the emulsifier

are taken in one beaker and melted in a water bath at 75°C. And in other beaker

water, preservatives and water soluble components are taken and melted at 75°C.
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After heating, the oil phase was taken in a mortar and pestle and slowly the water

phase was added and triturated till clicking sound was heard. Finally, when the

temperature cools down, perfuming agents and/or preservatives are added. In this

preparation, water content will be more than the oil.  Preparation of w/o emulsion

creams The oil soluble components and the emulsifier are taken in one beaker and

melted at 75°C. And in another beaker water and water soluble components are

taken and melted at 75°C. After melting, water phase are taken in mortar and pestle

and slowly oil phase was added and triturated till clicking sound was heard. And

when the temperature of the cream will get cooled, then the perfuming agent are

added. In this preparation, water phase will be less and oil phase will be more.

EVALUATION PARAMETERS OF CREAMS:

1. Determination of pH: The pH of the cream can be measured on a standard

digital pH meter at room temperature by taking adequate amount of the

formulation diluted with a suitable solvent in a suitable beaker.

2. Physical appearance: The physical appearance of the cream can be

observed by its colour, roughness and graded.

3. Spreadability: Adequate amount of sample is taken between two glass

slides and a weight of 100gm is applied on the slides for 5 minutes.

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 Spreadability can be expressed as, S= m*l/t Where, m = weight applied to

upper slide. l = length moved on the glass slide. t = time taken.

4. Saponification value: 2gm of substance refluxed with 25ml of 0.5 N

alcoholic KOH for 30min, to this 1ml of phenolphthalein added and titrated

immediately, with 0.5N HCl, note the reading as ‘a’. Repeat the operation

omitting the substance being examined. Note the reading as ‘b’.

Saponification value = (b-a)*28.05/w Where, w = weight of substance in

gram.

5. Acid value: 10gm of substance is dissolved in accurately weighed 50ml

mixture of equal volume of alcohol and solvent ether, the flask was

connected to reflux condenser and slowly heated, until sample was dissolved

completely, to this 1ml of phenolphthalein added and titrated with 0.1N

NaOH, until faintly pink colour appears after shaking for 30 seconds. Acid

value = n*5.61/w Where, n = the no. of ml of 0.1 N KOH solution. w = the

weight of substance in gram.

6. Viscosity: Viscosity of formulated creams can be determined by using

Brookfield Viscometer

7. Homogeneity: The formulation was tested for the homogeneity by visual

appearance and by touch.

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 8. Removal: The ease of removal of the creams applied was examined by

washing the applied part with tap water.

9. Dye test: The scarlet dye is mixed with the cream. Place a drop of cream in

a slide and cover with a cover slip and examine it under a microscope. If the

disperse globule appears red and the ground colourless then it is o/w type

and the reverse condition appears in w/o type of creams.

10. After feel: Emolliency, slipperiness and amount of residue left after the

application of fixed amount of cream was checked.

11.Type of smear: After application of cream, the type of film or smear formed

on the skin were checked.

12.Irritancy study: Mark an area of 1sq.cm on the left hand dorsal surface. The

cream was applied to the specified area and time was noted. Irritancy,

erythema, edema was checked, if any, for regular intervals upto 24hrs and

reported. Chauhan et al Journal of Drug Delivery & Therapeutics. 2020;

10(5-s):281-289 ISSN: 2250-1177 [288] CODEN (USA): JDDTAO 13.

Accelerated Stability Study: Accelerated stability study is conducted for

formulation according to ICH

Trituration:

This is applied to the incorporation of finely divided insoluble powders or liquids

into bases.
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The powders are placed on a tile and the base is incorporated using doubling up

technique

Liqui1`ds are usually incorporated by placing a small amount of ointment based on

a tile and making a well in the centre.small quantities of liquid are added and then

mixed in.Trituration can be successfully achied using a mortar but this method is

usually reserved for Large quantities.

Lavigation:

This is the term applied to the incorporation of insoluble coarse powders into a

base

It is often termed wet grinding.

It is a process where the powder is rubbed down with either the molten base or

semi solid base.

A considerable shearing force is applied to avoid a gritty product.

Bases Used For Cream

1)Oleaginous bases

2)Absorption bases

3) Water Removable Bases

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4)Water Soluble Bases

-Oleaginous Bases(hydrocarbon bases)

 On application to skin they have an emollient effect

 Protect against escape of moisture

 Effective as occlusive dressing

 Immiscible with water and difficult to wash off.

 They can remain on skin for longer periods without drying out.

 Water and aqeous solution In small amount can be incorporated with small

difficulty.

 When powdered substances are to be incorporated liquid,petrolatum is used

as lavigating agent.

 Example: petrolatum,white petrolatum,yellow ointment,white ointment

Adsorption bases:

TWO TYPES:

Those that permit incorporation of aqeous solution resulting in formation of W/O

Emulsion.

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Those that are already W/O Emulsion and permit incorporation of additional

quantity of aqeous solution.

PROPERTIES:

These Bases may be used as emollient.

 Difficult to water washing

 These Bases are not easy to remove from skin since the external phase of

emulsion is oleaginous.

 They do not provide degree of occlusion

 They form a greasy film on skin surface.

Example

Cold cream

Lanolin

Anhydrous lanolin

WATER REMOVABLE BASES( EMULSIFYING BASES)

They are oil in water emulsion having an emulsifier which makes them readily

miscible with water.

They may be diluted with water or aqeous solution

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Because of their surface active property,they facilitate contact between skin

medicament.

Example; Vanishing creams

Water Soluble Bases (Greasless bases)

Unlike other bases, they contain only water soluble components.

They are completely water washable

Aqeous solution cannot be incorporated efficiently because they soften greatly

with water addition.

They are mostly used for incorporation of solid substances.

Example; PEG OINTMENT

SELECTION OF APPROPRIATE BASE:

1) Desired release of drug substance from base

2) Desirability of topical absorption

3) Stability of drug in base

4) Should have a suitable PH.

5) No dehydrated Effect.

6) Non irritant and non sensitizing

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 7) Compatible with large number of drug

8) Miscible with skin secretion,e.g;sebum,sweat

PREPARATION PROCESS

A) Preparation of oil phase

B) Hydration of Aqeous phase ingredient

C) Forming the emulsion

D) Dispersion of the ingredient

GENERAL METHOD OF PREPARATION

1 )As with other types of emulsion,hygience is extremely important and all

surfaces,spatulas and other equipment must be thoroughly cleaned with IDA.

2) Always make an excess as it is never possible to transfer the entire cream into

the final container.

3) Determine which of the ingredient are miscible with the aqeous phase and which

with the oily phase.

4)Dissolve the water soluble ingredient in aqeous phase.

5) Melt the fatty bases in an evaporating dish over a water bath at lowest possible

temperature.

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start with base with the highest meltin point.these should be cooled to 60^oc.

6)Substance that are miscible with oily phase should then be stirred into the melt.

7)The temperature of the aqeous phase should then be adjusted to 60~oc

8)The disperse phase should then be added to continuous phase at the same

temperature.

9) Incorporation of solid ingredient to the prepared emulsion.

The incorporation of ingredient into a cream base

Soluble Solid

Should be added to the molten cream at the lowest possible temperature and the

mixture stirred until cold.

Insoluble solids

Should be incorporated using glass tile and spatula.if there is more than one

powder to be added,these should be triturated together in a mortar using doubling

up techniques prior to transfer to a glass tiles.

Coarse powders. A Minimum quantity of cream should be placed in the centre of

the glass tile and used to lavigate the powders.

Non volatile,miscible liquids:

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May be mixed with the molten cream in an evaporating basin.

Alternatively, if a prepared based is used,then incorporate as for volatile or

immiscible liquisds.

Volatile or immiscible liquids:

Coal tar solutions,should be triturated with the cream on glass tile.

ADVANTAGE:

1)They give prolong contact in their site of application than any other

pharmaceutical semisolid dosage forms.

2)Injured area can be dried quickly by creams than other semisolid

preparation.

3)Non irritating when applied to the skin.

4)Easily water washable, easy to wipe away.

5)less greasy compared to ointment

6) Easy to spread on the skins surface(i.e easy to apply)

Disadvantages:

1)Stability is not as good as ointment.

2)They are less hydrophobic than other semi solid preparation, so risk of

contamination is high than others.

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 Ideal Characteristics Of A Cream

1)it should liquefy at room temperature.

2) it should penetrate the epidermis.

3) it viscocity should be low enough to permit easy spreading

4) it should be non toxic

5) it should be non inflammatory.

Preservation;

Among the antimicrobial preservatives used to inhibit microbial growth in topical

preparation:

Methyl parabens, propyl parabens, phenols, benzoic acid, sorbic acid.

Containers used for creams

A) Wide mouthed jars.

B) Collapsible metals

C) Flexible plastic tubes

D) Alluminium tubes

FILLING IS DONE BY TWO WAYS: HAND FILLING AND

MECHANICAL FILLING

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Hand Filling;Weighted Amount Of Cream placed in a jar with the help of flexible

spatula

Cream is forced down to bottom and along walls of jars to avoid entrapnment

We can also filled tube by hande.

Mechanical Filling

In this methods cream can be filled in the jars and polyethene tubes

Filling is done by pressure filler which consist of nozzle piston from which oozes

out on apply in pressure on piston

Tubes are filled from back side and are sealed

Vaccum fillers are also available in which nozels is attached to vacuum pump

DISCARD DATE:

Some official texts suggested that creams are given a four week discard date.

This is officialy shorter than ointment which is three months because of

susceptibility of creams to microbial contamination

Diluted creams would normally be given a two week discard date

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Instead of expiry date apply the term discard after or do not use after followed by a

definite date and or time.

STORAGE AND LABELLING

 In a large mouth ointment jars or in metal or plastic tubes

 In a well closed containers to protect against contamination and in a cool

place to protect against product separation due to heat.

 When required light sensitive preparation are packaged in light resistant

containers.

 In addition to usual labeling requirement for Pharmaceutical product, the

USP directs that the labeling for each ointments and creams include the type

of bases used (e.g: Water-soluble or water insoluble)

FOR EXTERNAL USE

OINTMENT

 Ointment are semi solid preparation for application to skin

 Types of ointment; medicated and non medicated ointment

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  Medicated Ointment contains either dissolved or dispersed in the

vehicle as fine powders or in the form of micronized powder.eg;

Gentamicin ointment

 Non medicated ointment;

 These are used as vehicles for preparation of medicated ointment or can

be used for their physical effect.e.g:

 Soft paraffin

PROPERTIES OF AN IDEAL OINTMENT

1. Non sensitizing

2. Non irritating

3. Pharmaceutically elegant

4. Efficient release of medicament at the site of application

5. Water washable

6. Ointment Bases

7. Ointment bases are generally classified by the USP Into four groups:

A)Oleaginous bases

B)ABSORPTION BASES

C)WATER REMOVABLE BASES

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D)WATER SOLUBLE BASES)

A. OLEAGINOUS BASES; Also termed hydrocarbon bases,on application to

skin have emollient effect,occlusive dressing,protect against escape of

moisture.e.g: petrolatum,white petrolatum,yellow ointment(USP),White

ointment(USP)

B)ABSORPTION BASES ; Permit the incorporation of aqeous solution resulting

in formation of water in oil emulsion(e.g: hydrophilic petrolatum)

Those that are water in oil emulsion and permit the incorporation of additional

quantities of aqeous solutions(e.g: Lanolin)

EXAMPLE OF ABSORPTION BASES

a)Hydrophillic petrolatum: hydrophilic petrolatum USP has the following formular

for the preparation of 1000g

Cholesterol……………….30g

Steary alcohol……………..30g

White wax……………………80g

White petrolatum……………..860g

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b)Lanolin: obtained from the wool of sheep..is a purified,wax like substances that

has been cleaned,deodorized,and decolorized.

C)WATER REMOVABLE BASES:

Are oil in water emulsion resembling creams in appearance.the external phase of

the emulsion is aqeous,easily washed from the skin and often called water

washable bases

Diluted with water or aqeous solution

D) WATER SOLUBLE BASES: These do not contains oleaginous

components,completely water washable and often regarded as

greaseless.e.g:polyethylene glycol ointment.they soften greatly with the addition

of water,large amount of aqeous solution are not effectively incorporated into these

bases,used foer incorporation of solid substances

SELECTION OF APPROPRIATE BASE

 Release rate

 Topical drug absorption

 OCCLUSSION

 Stability of drug

 Effect of drug on ointment base

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  Easily removable

 Characteristics of surface for application

PREPARATION OF OINTMENT

2 methods; Incorporation and Fusion method

INCORPORATION: The components are mixed until a unirfoam preparation is

attained,the ointment based is placed on one side of the working surface and the

powdered component,previously reduced to fine powders and blended in mortar.

FUSION METHOD:

The procedure of liquefying or melting by heat application.

All the component of an ointment are combined by melted together and cooled

with constant stirring until congealed

Heat labile substances added last and when temp of a mixture is low enough not to

cause decomposition of ingredients.

PACKAGING,STORAGE AND LABELLING

 Larged mouth ointment jars or in metal or plastic tubes

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  Well closed containers to protect against contamination and in cool place to

protect against product separation due to heat

 Light sensitive preparation packaged in light resistant containers.

 In addition to pharmaceutical labeling requirement,the USP direct labeling

for certain ointment and creams include types of based used

PASTES

Pastes are usually prepared by incorporating solids directly into congealed system

by levigation with a proportion of base to form paste like mass.

Contains high percentage of insoluble solid usually 50% or more which are finely

dispersed into a suit able vehicle.

Pates adhere well to skin and are prepared for treatment of chronic lesion

Characteristic of pastes

1) Stiffer than other semi solid dosage form,and maintains stability at site of

application

2) Because of high powder content,pates are porous, hence perspiration can

escape

3) Less greasy when compared to ointment

4) Good adhesive property to skin

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5) Unsuitable for treating scalp,because they are difficult to remove from skin

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