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27 Mineral Oil Emulsion

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#27 Mineral Oil Emulsion

 Emulsion
- 2 phase system in which one liquid is dispersed in the form of small globules throughout
another liquid in which it is immiscible
- Emulgio – “To milk out”

3 components

1. Dispersed liquid/ internal phase/ discontinuous phase


2. Dispersion medium/external phase/ continuous phase
3. Intermediate agent/ emulsifying agent/ dispersing or stabilizing agent

Absence of emulsifier

1. Dispersion is unstable
2. Globules undergo coalescence
3. Separate layers of water and oil

Qualities required for emulsifiers

1. Compatible with other ingredients


2. Does not interfere with therapeutic agent’s stability and efficacy
3. Stable
4. Non-toxic
5. With little or no odor, taste or color
6. Promote emulsification and maintain stability for intended shelf-life

Types of emulsions

1. Simple
- o/w ; w/o
2. Multiple
- o/w/o ; w/o/w
3. Microemulsion
- Most stable of the 3
- Dispersed phases in very small globules (100-1000A) (1A=0.1nm)

 O/W emulsion – diluted with water/ aqueous preparation


 W/O emulsion – oleaginous/ oil miscible liquid
 Aqueous phase – contains: water-soluble drugs, preservatives, coloring and flavouring agents
 Oil phase – contains: fixed/ volatile drugs (oil-soluble vitamins and antiseptic)
 Antioxidant – added to prevent autooxidation of the oil and rancidity or destruction of any
vitamin present
Purpose of emulsification

1. Pharmaceutically
a. For a stable and homogenous mixture of 2 immiscible liquids
b. Permits administration of liquid drug in minute globules form rather than in bulk

2. Therapeutically
a. For the rate and degree of absorption of the drug
b. O/W emulsions – as vehicle to develop the bioavailability of poorly absorbed drugs
O/W – for palatable administration of distasteful oil (dispersed in a sweetened,
flavoured vehicle)
c. Reduced particle size of oil globules
- more digestible and readily absorbed and more effective
d. Applied externally
- medicinal agent irritating to the skin surface
- Incorporated in the internal phase (in direct contact with the skin)
e. W/O efmulsion
- applied more evenly on the unbroken skin
- skin covered with a thin sebum, more readily wetted by oil than by water

O/W – easily removed from the skin

Emulsifying agents

1. Natural Emulsifying Agents


 Carbohydrates
- Acacia - most frequently used
- Tragacanth and agar – thickening agents in Acacia emulsified products
- Chondrus
- Pectin
- Form hydrophilic colloids with water and produce O/W emulsions

 Proteins
- Gelatin – emulsion prepared from it, too fluid
- Egg yolk
- Casein
- Produce O/W emulsions

2. High molecular weight alcohols


 Cholesterol
- Employed in externally used emulsion
- Promote W/O emulsions

 Examples: stearyl alcohol, cetyl alcohol, and glyceryl monostearate


- Thickening and stabilizing agents for O/W emulsions (ex. Lotion and ointments)
3. Finely divided solids
 Examples; Colloidal clays including Bentonite, Magnesium hydroxide, and Aluminum
hydroxide
- Form O/W emulsions when the insoluble material is added to the aqueous phase
(greater volume than of the oleaginous phase)

4. Synthetic (wetting agents), which may be Anionic, Cationic, Nonionic


 Anionic – triethanolamine oleate and sodium lauryl sulphate
 Cathionic – benzalkonium chloride
 Nonionic – sorbitan esters (span); polyethylene glycol 400 monostearate;
polyoxythylene sorbitan esters (tweens)

Method of preparation

1. Wet or English
- E + W + O or G W O
- 4 (oil): 2 (water): 1 (emulsifying agent/ gum)
- Emulsifying agent and water first then add oil slowly
- Triturate in one direction, creamy, sticky mixture with crackling sound

2. Dry or Continental
- O + E + W or G O W
- 4 (oil): 2(water): 1(emulsifying agent/gum)
- Oil with emulsifying agent first then add water at once
- Triturate in one direction, creamy, sticky mixture with crackling sound

3. Bottle or Forbes
- 2 (oil): 2(water): 1(emulsifying agent/gum)
- Shaking vigorously

4. Auxillary method
- Hand homogenizer

5. In Situ Soap or nascent oil


- Calcium soap and soft soap

6. Microemulsion
- Dispersed phase in very small globules (100-1000A)

Problems in preparing

1. Creaming
- temporary separation of 2 phase
- Shake again
2. Cracking
- Total separation of 2 phase with coalescence

3. Phase inversion
- O/W -> W/O
- evaporation of water

Method of Identifying Emulsion

1. Drop dilution test


- Add water ->homo -> o/w

2. Dye solubility
- Oil-soluble - sudan red – w/o
- Water-soluble – amaranth green – o/w

3. Electronic conduction test


- o/w

4. Fluorescence test
- Oil can absorb UV light
w/o

Ingredients OA CA
Mineral oil 500 mL
Acacia 125 g
Vanillin 40 mg
Syrup 100 mL
Alcohol 60 mL
Pur. Water q.s. ad 1000 mL 30 mL

 Mineral oil – Cathartic


 Acacia – emulsifier/ suspending agent
 Vanillin – flavorant
 Syrup – sweetening agent
 Alcohol – preservative
 Water – vehicle

 Procedure
1. The appropriate amount of acacia is put in a mortar, and a small amount of water miscible
wetting agent, such as syrup, is added to “wet” the acacia
2. The calculated amount of water is then gradually added in portions with trituration
3. The oil is then gradually added with trituration until all the oil has been added and the
primary is formed
4. Add the external phase miscible components
5. Transfer to a graduated cylinder and q.s. ad water
Category: Oral emulsion

Synonym: Liquid Petrolatum Emulsion

Description: Creamy whitish yellow color

Use: Lubricating catarthic with dose of 30 mL

Method of prep: Dry or Continental

White label , *Shake well label, 30 mL wide amber bottle

Things to remember

1. Use clean & dry apparatus


2. Follow the order of mixing ratio
3. Trituration technique (hard and fast)
4. From center to side
5. One direction
6. Use sterile container
2. Different Methods in Emulsion Preparation

a. Continental or Dry Gum Method

Also known as the 4:2:1 method, this method involves triturating 4 parts by volume of oil, 2 parts of
water, and 1 part of gum to form the primary emulsion. The mixture should be triturated until a thick
white cream with a ‘cracking’ sound is produced and water is eventually added to form the final
emulsion.

b. English of Wet Gum Method

This method is more difficult to perform but produces a more stable emulsion than the dry gum method
as it uses the same proportions of oil, water, and gum as in the continental method but with a different
order and technique of mixing (gum and water are triturated first to form a mucilage).

c. Bottle of Forbes Method

This method is a variation of the continental method that involves shaking one part of the gum and four
parts of oil together and is also suitable for preparing emulsions of volatile oils or oleaginous substances
of low viscosity.

d. Auxiliary Method

This method is less efficient for very thick emulsions and should not be used for emulsions with high
proportions of solid matter and is less efficient for very thick emulsions and thus, should not be used for
emulsions with high proportions of solid matter.

e. In Situ Soap Method

This method may be prepared in a bottle or mortar depending on whether the ingredients are soluble or
not and is commonly employed in making calcium soap and soft soap.

f. Microemulsions

This method produces droplets ranging from 100 A to 1000 A in diameter and the properties of the oil
and surfactants usually dictate the type of emulsion produced.

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