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bdt 2024 handout
bdt 2024 handout
other.
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Water is the
dispersed phase
Oil is the
dispersed phase
1. Reduce the interfacial tension between oil and water, thus aid in dispersion of one liquid in the other.
2. Envelop the globules in a sheath to prevent coalescence and separation of dispersed liquid as a
distinct layer.
Pharmaceutically acceptable emulsifiers must also:
Be stable.
Be compatible with other ingredients.
Be non –toxic.
Possess little odor, taste, or color.
Not interfere with the stability of efficacy of the active agent.
Emulsifying agents can be divided into three groups (Natural, synthetic and finely divided solids)
Emulsifying Agents:
1.Natural Emulsifying Agents: e.g. acacia (Arabic gum), tragacanth, starch and pectin. These materials
form hydrophilic colloids when added to water and generally produced O/W emulsions. Acacia is
most frequently use. Tragacanth and Agar - thickening agents in Acacia emulsified products. These
substances produce O/W emulsions. The disadvantage of gelatin is that the emulsions prepared from
it are too fluid.
a. a. Natural Emulgents from vegetable sources (Carbohydrate Materials): - These are anionic in
nature & produce o/w type emulsions. These exhibit considerable variation in emulsifying
properties. They act as primary emulsifying agents as well as secondary emulsifying agents
(emulsion stabilizers). Acacia, Tragacanth, Agar, Pectin, starch. Since carbohydrates acts a good
medium for the growth of microorganism, therefore emulsions prepared using these emulsifying
agents have to be suitable preserved in order to prevent microbial contamination.
b. Protein Substances: -Gelatin, Egg yolk, Caesin o/w emulsion.
2.Synthetic Emulsifying Agents are superior to natural gums and proteins in that they not susceptible to
decomposition by micro -organisms. Furthermore, the ratio of hydrophilic to lipophilic groups in the
molecule may be altered supply a wide range hydrophilic to lipophilic groups in the molecule may be
altered to supply a wide range of emulsifying agents.
Only a limited number of synthetic agents are safe for internal use among these are the sorbitan esters
(Spans), polyoxyethylene sorbitan esters (Tweens) and glyceryl monostearate.
a. High Molecular Weight Alcohols: -Stearyl Alcohol, Cetyl Alcohol, Glyceryl Mono stearate o/w
emulsion, cholesterol w/o emulsion.
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4. Gradually dilute the primary emulsion with small volumes of the vehicle.
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According to the HLB number, surfactants may be utilized for different purposes:
ACACIA EMULSIONS:
These are the emulsions prepared by using acacia gum as emulsifying agent. Unless other specified
generally prepared emulsions for internal use are made with acacia gum; generally, prepared using a
pestle and mortar.
First thick primary emulsion is prepared later it is diluted to its required amount by using vehicle.
Methods used for preparation of these types of emulsions are Dry gum method and Wet gum method.
Examples:
RX1
Castor oil 20 ml
Acacia Q.S.
Water Q.S. 40 ml
Calculations:
Oil= 20 ml
Water= 2/4 *20= 10 ml
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RX3
Castor oil fƷii
Bismuth carbonate gr x
Purified water Q.S. f℥ i
Ft. emulsion
Sig. f℥ss o.n
Calculations (primary emulsion)
2*4 = 8 ml of oil
¼ *8 = 2 g of acacia
½ *8 = 4 ml of water
Notes:
Castor oil is used internally as cathartic and externally as emollient.
Bismuth carbonate is used for mild irritant skin , duodenal ulcer.
Bismuth carbonate (insoluble diffusible solid ) is added or spread on the surface of the primary
emulsion with continuous trituration.
RX3
Almond oil fƷii
Ferric ammonium citrate gr x
Water Q.S. f℥i
Ft. emulsion
Calculations (primary emulsion)
2*4= 8ml of oil
¼ *8 =2 g acacia
1/2 *8 = 4 ml water
Method:
Put the acacia in dry mortar then add oil phase all at once with trituration, then add water at once with
trituration , until you have a crackling sound of primary emulsion, dissolve ferric ammonium citrate in
part of water to get a solution then add the remaining water or dilution (gradually also with trituration
then add ferric solution gradually also with trituration)
Notes:
Almond oil is used as nutritive.
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○ Ca(OH)2 q.s 30 ml
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○ Ft. emulsion
○ Procedure:
○ Ca(OH)2+ oleic acid Ca oleate(E.A.) to prepare w/o emulsion By nascent soap method
STABILITY EMULSIONS:
An emulsion is said to be stable if it remains as such after its preparation i.e. dispersed globules are
uniformly distributed throughout the dispersion medium during its storage. The emulsion should be
chemically stable and there should not be any bacterial growth during its shelf life.
Coalescing is the process in which the similar particles in the emulsions come together to form larger
and bulkier particles leading to the separation of the dispersed phase and dispersion medium.
Emulsifiers help in preventing coalescing by forming a physical barrier between the dispersed phase and
dispersion medium. The following three changes usually occur during the storage of emulsion:
1. Creaming.
2. Cracking.
3. Phase inversion.
1. Creaming
Creaming can be defined as the upward movement of dispersed globules to form a thick layer at the
surface of emulsion. An emulsion is said to cream when the oil or fat rises to the surface, but remains in
the form of globules, which may be redistributed throughout the dispersion medium by shaking. An oil
of low viscosity tends to cream more readily than one of high viscosity. Increasing the viscosity of the
medium decreases the tendency to cream. Creaming is a reversible phenomenon which can be
corrected by mild shaking.
The following approaches can be used for decreasing Creaming
• Reduction of globule size: rate of creaming is directly proportional to the size of globules. Bigger
is the size of the globules, more will be the creaming. Therefore in order to minimize creaming, globule
size should be reduced by homogenization.
• Increasing the viscosity of the continuous phase: Rate of creaming is inversely proportional to
the viscosity of the continuous phase i.e. more the viscosity of the continuous phase, less will the
problem of creaming. Therefore to avoid creaming in emulsions, the viscosity of the continuous phase
should be increased by adding suitable viscosity enhancers like gum acacia, tragacanth etc.
2. Cracking
Cracking means the separation of two layers of dispersed phase and continuous phase due to
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Formula:
1. Phenol Glycerin – 5 ml
2. Amaranth solution – 1 ml
3. Purified water - q.s. To 100 ml
Method of Preparation
Gargles are prepared by adding amaranth solution (1% w/v in chloroform water) to a comparatively less
quantity of water and then mix phenol glycerin (16% w/w phenol & 84% w/w glycerin) to it. Then stir the
solution to make up to the volume with purified water. Dilute with an equal quantity of water before
use.
Container: Strong damp-proof and water-proof with a leak-proof plastic cap.
Labeling: The label should clearly indicate:
1. Proper Prescription for diluting the Gargle.
2. Secondary label- "FOR EXTERNAL USE ONLY"
3. Auxiliary label- "NOT TO BE SWALLOWED"
Direction:
Dilute 1 ml to 20 ml or as per directions by the physician with water, gargle for 30 seconds, repeat 3
to 4 times a day.
Dispensed in concentrated form with warm water.
Make contact with the mucous membrane of the throat and let it sit there for few moments.
Warning: Read the instructions on the label carefully. Avoid contact with eyes, nose etc.
Storage:
Store at room temperature
Keep out of the reach of children.
Store away from direct sunlight, heat and moisture.
Mouth wash
These are aqueous solutions with pleasant or acceptable taste & odor
These are used to make clean & deodorize the buccal cavity or used for oral hygiene and to treat
infections of the mouth.
They mainly contain antibacterial agent, alcohol, glycerin, sweetening agent, flavoring agent &
coloring agent.
These are similar to gargles but are used for oral hygiene and to treat infections of the mouth.
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Definition of Mouthwash:
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Medicated liquid with pleasant taste and odor used to clean and deodorize the buccal cavity, contain
antibacterial agents, glycerol, and sweetening agent, flavoring agent, coloring agent and astringent. E.g.
1. Antiseptic such as Phenolic Mouthwash
2. Analgesic such as Lidocaine Hydrochloride
3. Bactericidal such as Fluoride Mouthwash
4. Anticavity such as Fluoride Rinse
Preparations of Mouthwash: Instructions are as follows;
Add a flavor, e.g. eucalyptol or menthol.
Sodium benzoate as preservative
Water as vehicle
Sodium saccharin and sucralose as sweeteners.
Colorants
Fluoride as an antiseptic agent
Detergent
Method:
Needed Items:
1. Sodium Bicarbonate – 10 g
2. Sodium Chloride – 15 g
3. Chloroform – 500 ml
4. Peppermint oil – 25 ml
5. Water – 1000 ml
Method of Preparation
Mix sodium bicarbonate and sodium chloride in 10ml.
Add chloroform and peppermint oil.
Add water to fill the required volume.
Dispense the solution.
Container: Clear fluted plastic bottles with a narrow neck with a leak-proof plastic cap.
Storage: Stored at room temperature away from children and not to be exposed to sunlight.
Labeling: The label should clearly indicate:
Proper prescription for diluting the mouthwash use.
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Packaging and storage— Preserve in tight containers, at a temperature not exceeding 30, remote
from fire.
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Packaging and storage— Preserve in tight containers, at a temperature not exceeding 30, remote
from fire.
Labeling— The label bears a caution statement to the effect that Collodion is highly flammable.
Liniments:
Liniments are liquid or semi- liquid preparations meant for external application to the skin.
Liniments are fluid, semi-fluid or, occasionally, semi- solid preparations intended for application to
the skin.
Liniments can be divided into:
1. Alcoholic solutions
2. Oily solutions
3. Emulsions and suspensions
Alcoholic solutions: alcohol and hydroalcoholic mixtures are used widely as vehicles for liniments,
not only because alcohol is a good solvent for many drugs but also because it can penetrate the skin
and it is in itself a mild rubefacient, counterirritant and astringent.
Frequently soaps and oils are added to alcoholic liniments to make slippery and thus facilitate the
rubbing action involved in their application. The official liniments that fall into this class should be
clear solutions.
E.g. camphor and soap liniments (soap liniment or camphorated of soap): prepared by making a
solution of camphor, rosemary oil and green soap in hydroalcoholic solvent.
This liniment makes an excellent base for other liniments (i .e.it can be used as a solvent for many
substances).The percentage of alcohol present (62 -66 %) aiding in this respect .The small amount of
camphor present gives only a mild rubefacient action.
• Chloroform liniments: are made by mixing chloroform with camphor and soap liniment, the
addition of chloroform makes these liniments strong, quick acting rubefacient and counterirritants.
Oily solutions of medicinal agents in fixed or volatile oils are used as liniments .Fixed oils are good
solvents for some rubefacient drugs and also they give the necessary lubricant action for the rubbing
of a liniment.
Their ability to penetrate the skin is not as great as that of alcoholic liniments, consequently their
action is milder.
Cottonseed, seed, olive, almond and other oils such as methyl salicylate and turpentine oil are
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rubefacient and irritant in themselves. They may be used alone or as solvents for r other drugs. Like
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liniments of class one, they should be free from insoluble materials. E.g. Camphor liniments
(camphorated oil) are 20 % solution of camphor in cotton seed oil. Cottonseed oil is preferred for
making this liniment because of its lower cost. Camphorated oil is very popular counterirritant for
minor sprains and also for chest colds.
Emulsions and suspensions: liniments may contain insoluble materials or they may consist of
mixtures of immiscible liquids, when such condition exist it is best that an emulsion be formed to
prevent rapid separation of the ingredients and to improve the appearance of the product.
Emulsification of liniments usually is accomplished by the formulation a soap which acts as the EA. In
addition to the usual label (for external use only), liniments which are emulsions or suspensions
should bear the label (shake well) to ensure equal distribution of all constituents. e.g. Ammonia
liniments and calamine liniments
Most are massaged into the skin (e.g. counter-irritant).
They are usually applied to the skin with friction & rubbing of the skin.
Are usually alcoholic and oily liquid preparations (monophasic) or emulsion (biphasic).
Alcoholic liniments are used generally for their rubefacient and counterirritant effects. Such
liniments penetrate the skin more readily than do those with an oil base.
The oily liniments are milder in their action and may function solely as protective coatings
Liniments should not be applied to skin that are bruised or broken.
Liquid or semi liquid preparations meant for application to the skin with friction or rubbing.
Alcoholic or oily solutions or emulsions.
Alcohol helps in penetration of medicament into the skin and also increases its counter irritant and
rubefacient action. In oily liniments arachis oil is commonly use which spreads more easily on the
skin.
Use of soap may ease application.
Generally liniments contain medicaments possessing analgesics, rubefacient, soothing and counter
irritant or stimulating properties.
Rubefacient - A medicine for external application that produces redness of the skin e.g. by causing
dilation of the capillaries and an increase in blood circulation.
Counterirritant -A medicine applied locally to produce superficial inflammation in order to reduce
deeper inflammation.
A liniment should not be applied on broken skin as it may cause excess irritation.
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Containers: color fluted bottle in order to distinguish it from preparations meant for internal use.
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Labeling: For External Use only, shake well before use and with a warning of not to be applied on
broken skin or open wound.
Storage: air-tight containers in a cool place.
alcoholic or oleaginous solutions or emulsions of various medicinal substances intended to be
rubbed on the skin
Once called Embrocation
Fixed oils as vehicles
Labels such as “For external use” or “Shake well”
Applied to intact skin
Container: Amber fluted bottle with CRC
Auxiliary labels: For external use only. Shake the bottle. Avoid broken skin
Turpentine liniment I.P
• Soft soap 90g
• Camphor 50g
• Turpentine oil (freshly rectified) 650ml
• Purified water up to 1000ml
• Method –
Mix the soft soap with small quantity of purified water. Prepare a solution of the camphor in the freshly
rectified turpentine oil. Gradually add the camphor solution to the soap mixture with trituration till a
thick creamy emulsion is formed. Add sufficient purified water to produce the required volume. Mix
thoroughly. Transfer the preparation to a bottle, label and dispense.
Lotions:
These are fluid preparations (aqueous) for external application without friction.
They are either dabbed on the skin or applied on a suitable dressing and covered with a waterproof
dressing to reduce evaporation.
Are usually aqueous, alcoholic or oily liquid preparations.
They are intended for external application without friction or rubbing to the affected area
Usually applied with the help of some absorbent material such as cotton wool or gauze.
It is generally used to provide cooling, soothing and protective & antiseptic action.
Liquid preparations meant for external application without friction.
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