Ointments, Creams and Gels Flashcards
semisolid preparations intended for external application to the skin or mucous membrane
Ointments
Latin for ointment
Unguentum
unmedicated ointments are used for the physical effects they provide as
Protectants, emollients and lubricants
May be used for their physical effects or as vehicles for medicated ointments
Ointment Bases
Other name for Oleaginous Bases
Hydrocarbon base
Oleaginous Bases effects on the skin
✓ Protect against escape of moisture
✓ Effective as occlusive dressings
✓ Remain on the skin for long periods without drying out
✓ Difficult to wash off
Examples of Oleaginous Bases
Petrolatum, USP
White Petrolatum, USP
Yellow Ointment, USP
White Ointment, USP
Petrolatum, USP aka
Yellow petrolatum/ petroleum Jelly
Commercial product of Petrolatum, USP
Vaseline
Obtained from petroleum and may be used alone or in combination
Petrolatum, USP
Petrolatum, USP color and meting point
Color: from yellowish to light amber
Melts at 38°C to 60°C
White Petrolatum, USP aka
White petroleum jelly
it has a lighter color, and considered as more aesthetically pleasing
White petrolatum, USP
Commercial product of white petrolatum, USP
White Vaseline
Has been wholly or nearly decolorized
White petrolatum, USP
Yellow ointment, USP aka
Simple ointment
Purified wax obtained from the
Honeycomb of the bee (Apis mellifera)
Slightly greater viscosity than plain petrolatum
Yellow ointment, USP
Differs from yellow ointment by substitution of white wax and white petrolatum in the formula
White ointment, USP
When powdered substances are to be incorporated into hydrocarbon bases, this may be used as the levigating agent.
liquid petrolatum (mineral oil)
Not easily removed from the skin with water washing, because the external phase of the emulsion is
Oleaginous
Useful as pharmaceutical adjuncts to incorporate small volumes of aqueous solutions into hydrocarbon bases. This is
accomplished by incorporating the aqueous solution into the absorption base and then incorporating this mixture into the hydrocarbon base
Absorption Bases
Commercial products of hydrophilic petrolatum
Aquaphor and Aquabase
have the capacity to absorb up to 3
times their weight in water and are useful to help incorporate water-soluble drugs
Hydrophilic petrolatum
Example of water-soluble drugs
Tobramycin sulfate
Hydrophilic petrolatum concept is used in the preparation of
Ophthalmic ointments
Lanolin, USP obtained from
Wool of Sheep (Ovis aries)
Purified wax-like substance that has been cleaned, deodorized and decolorized
Lanolin, USP
Lanolin, USP contains what?
NMT 25% water
a lanolin processed to reduce the contents of free lanolin alcohols and any detergents and pesticide residues
Modified Lanolin, USP
Since the external phase is aqueous (O/W), they are easily washed from the skin and are often called
Water-washable bases
Oil-in-water (O/W) emulsion commonly called
Creams and Ointment
They can absorb serous discharges
Water-removable Bases
Example of water-removable Bases
Hydrophilic Ointment, USP
Does not contain oleaginous bases. Completely water washable and often referred to as greaseless
Water-soluble Bases
they soften greatly with the addition of water, large amounts of aqueous solutions are not effectively incorporated into these bases.
Water-soluble Bases
Example of Water-soluble bases
Polyethylene Glycol (PEG) ointment, NF
Selection of the Appropriate Base
✓ Desired release rate of the drug substance from the ointment base
✓ Desirability of topical or percutaneous drug absorption
✓ Desirability of occlusion of moisture from the skin
✓ Stability of the drug in the ointment base
✓ Effect, if any, of the drug on the consistency or other features of the ointment base
✓ Desire for a base easily removed by washing with water
✓ Characteristics of the surface to which it is applied
Ointment, Cream and Lotion are applied to
Ointment is generally applied to dry, scaly skin
Cream is applied to weeping or oozing surfaces
Lotion is applied to intertriginous areas where friction may occur.
The components are mixed until a uniform preparation is attained
Incorporation
Preparation of Ointment
Incorporation
Spatulation
Levigation
Pulverization by Intervention
Incorporation of liquid
Adding Small Volumes of Alcoholic Solution
What kind of spatula is being used when preparing the ointment by spatulation
Stainless steel spatula
In a small scale, the pharmacist may mix the components using a mortar and pestle, or a spatula may be used to rub the ingredients together on an ointment slab. What kind of ointment slab?
large glass or porcelain plate or pill tile
Some pharmacists use (blank) to cover the working surface
non absorbable parchment paper
Allows a pharmacist to place the ingredients in a plastic ointment jar with a special lid that allows for a mixing blade to be used to mix the ingredients in the dispensing container.
Unguator
The ointment is prepared by thoroughly rubbing and working the components together on the hard surface until
the product is smooth and uniform.
Spatulation
Reduce the particle size of a powder or crystalline material before incorporation into the ointment base
Levigation
Purpose of Levigation
The final product will not be gritty and be smooth
This is usually used for levigation
Mortar and Pestle
Pulverization by Intervention is done when incorporating a gummy material such as
Camphor
The material is dissolved in a solvent and spread out on the pill tile. The solvent is allowed to evaporate, leaving a
thin film of material onto which the other ingredients are spread. The material is then worked into the ingredients
by trituration with a spatula
Pulverization by Intervention
Liquid substances are added to an ointment only after due consideration of an ointment base’s capacity to accept the volume desired
Incorporation of liquid
Alcoholic solutions of small volume may be added easily to oleaginous vehicles or emulsion bases.
Adding Small Volumes of Alcoholic Solution
Example of Natural Balsams
Peru Balsam
are usually mixed with an equal portion of castor oil before incorporation into a base. This reduces the surface tension of the balsam and allows even distribution of the balsam throughout the base
Peru Balsam
All or some of the components of an ointment are combined by being melted together and cooled with constant stirring until congealed
Fusion
Compendial Requirements for Ointments
Microbial Content
Minimum fill
Packaging, storage and Labeling
Example in microbial content
Betamethasone Ointment, USP must meet the requirements for the tests for absence of Staphylococcus aureus and
Pseudomonas aeruginosa.
dermatologic products should be examined for
Pseudomonas aeruginosa and Staphylococcus aureus
intended for recta, urethral or vaginal use should be tested for
Yeasts and molds
used for the determination of the net weight or volume of the contents of filled containers to ensure proper contents compared with the labeled amount.
Minimum Fill Test
Ointments and other semisolid preparations are packaged in
large mouth ointment jars
metal or plastic tubes
Light sensitive preparations are packaged in
opaque or light-resistant containers
Semisolid preparations are stored in
Stored in well-closed containers to protect against contamination and in a cool dry place to protect against product separation in heat