1. Why is the preparation called “cold cram”?

Cold creams were usually made as water-in-oil (W/O) emulsions. After the creams are applied to the
skin much of the water evaporates leaving the remaining oil to act as a solvent which cleanses the skin of
cosmetics and other grime. There may also be some surfactant activity. Some chemists suggested that as
the water evaporated it cooled the skin which is why the creams are called ‘cold creams’. An alternative
explanation is that in the days before mineral oil or petrolatum were used, the creams needed to be
stored in a cool place to stop them going rancid. This made them cold to the touch and so gave them their
name.

2. Identify the use of sodium borate in the preparation

Sodium borate is a colorless, transparent crystal or a white, crystalline powder and is odorless. The
crystals are often coated with white powder due to efflorescence, in the preparation of cold cream. It is
used as a preservative because of its alkalinizing property and as a buffer for alkaline solutions.

3. In a tabulated manner, give several types of ointment base with their respective characteristics and
formulation.
 Ointment Bases
There are five (5) classes or types of ointment bases which are differentiated on the basis of their
physical composition. These are:
o oleaginous bases
o absorption bases
o water in oil emulsion bases
o oil in water emulsion bases
o water soluble or water miscible bases

Each ointment base type has different physical characteristics and therapeutic uses based upon the
nature of its components. The following table summarizes the composition, properties, and common uses
of each of the five types. For more information consult Remington's.

SUMMARY CHART: PROPERTIES OF OINTMENT BASES

Oleaginous Absorption Water/Oil Oil/Water Water-miscible

Ointment Ointment Emulsion Emulsion Ointment Bases
Bases Bases Ointment Ointment Bases
Bases
Composition oleaginous oleaginous oleaginous oleaginous base Polyethylene Glycols
compounds base + w/o base + water + water (> 45% (PEGs)
surfactant (< 45% w/w) w/w) + o/w
+ w/o surfactant
surfactant (HLB >9)
(HLB <8)
Water anhydrous anhydrous hydrous hydrous anhydrous, hydrous
Content
Affinity for hydrophobi hydrophilic hydrophilic hydrophilic hydrophilic
Water c
Spreadability difficult difficult moderate to easy moderate to easy
easy
Washability nonwashabl nonwashabl non- or poorly washable washable
e e washable
Stability oils poor; oils poor; unstable, unstable, stable
hydrocarbo hydrocarbo especially especially alkali
ns better ns better alkali soaps soaps and
and natural natural colloids;
colloids nonionics better
Drug solids or solids, oils, solids, oils, and solid and solid and aqueous
Incorporatio oils (oil and aqueous aqueous solutions
n Potential solubles aqueous solutions solutions (small
only) solutions (small amounts)
(small amounts)
amounts)
Drug poor poor, but > fair to good fair to good good
Release oleaginous
Potential*
Occlusivenes yes yes sometimes no no
s
Uses protectants, protectants, emollients, emollients, drug vehicles
emollients emollients cleansing vehicles for solid,
(+/-), (+/-), creams, liquid, or non-
vehicles for vehicles for vehicles for hydrolyzable
hydrolyzabl aqueous solid, liquid, or drugs
e drugs solutions, non-
solids, and hydrolyzable
non- drugs
hydrolyzabl
e drugs
Examples White Hydrophilic Cold Cream Hydrophilic PEG Ointment,
Petrolatum, Petrolatum, type, Hydrous Ointment, Polybase™
White Anhydrous Lanolin, Rose Dermabase™,
Ointment Lanolin, Water Velvachol®,
Aquabase™ Ointment, Unibase®
, Hydrocream™,
Aquaphor® Eucerin®,
, Polysorb® Nivea®
*Varies depending upon specific content of the ointment base and the relative polarity of the
drug(s) incorporated. This table refers more generally to the release of a typical nonelectrolyte
(primarily lipophilic) drug.

4. What are the properties of an ideal ointment base?

 Ideal Ointment Base sould consists of the following things:

a) should not retard wound healing,
b) have a low sensitization index,
c) pharmaceutically elegant,
d) release the medicament efficiently at the site of application,
e) have a low index of irritation,
f) non-dehydrating, non-greasy and neutral in reaction,
g) possess good keeping qualities,
h) compatible with common medicaments,
i) easily washable with water,
j) have minimum number of ingredients,
k) easy to compound and remain stable on storage, and
l) economic and easy to transport

5. What is the main difference of White and Yellow Ointment?

White ointment differs from yellow ointment by substitution of white wax (bleached and purified
yellow wax) and white petrolatum (purified mixture of semisolid hydrocarbons from petroleum that has
been wholly or nearly decolorized) in the formula. Wherein yellow ointment contains yellow wax (purified
wax obtained from the honeycomb of the bee, Apis mellifera) and petrolatum (purified mixture of
semisolid hydrocarbons obtained from petroleum) in the formula.

6. Describe how an ointment is prepared by levigation. When is this applied?

Levigation is commonly used in small-scale preparation of ointments to reduce the particle size and
grittiness of added powders. A mortar and pestle or an ointment tile may be used. A paste is formed by
combining the powder and a small amount of liquid (the levigating agent) in which the powder is
insoluble. The paste is then triturated, reducing the particle size. The levigated paste may then be added
to the ointment base and the mixture made uniform and smooth by rubbing them together with a spatula
on the ointment tile. A figure-8 track is commonly used to incorporate the materials. Mineral oil and
glycerin are commonly used levigating agents.

Levigation involves simple mixing of base and other components over an ointment slab using a
stainless steel ointment spatula. An ointment slab is a ground-glass plate and two 5 or 6 inches full blade
stainless steel spatulas are needed. When there are possibilities of reaction between the steel spatula and
the constituents of an ointment such as incorporation of mercury salts and iodine, hard rubber or tested
plastic spatulas are used. The spatula is held so that it as a roller passing over any particles in the
ointment. A slight twist of the wrist is required at the end of each stroke in order to reverse the position of
the spatula. It is very convenient to use two spatulas, one for the actual mechanic of rubbing, the other as
an instrument to remove stubborn, adhering particles or accumulating ointments from the manipulating
spatula. Slightly warm the base to soften expendites the incorporation of insoluble powders. Avoid
overheating of emulsified water-containing bases as this will result in water loss which in turn alters the
consistency of the base and increases the percentage of the medicinal substances.

Levigation, together with fusion process, is used in preparation for oleaginous ointments. Small
quantities of powders are incorporated into hydrocarbon bases with the aid of a levigating agent such as
liquid petrolatum, which helps in wetting of powders. The powder component is mixed with the levigating
agent by trituration and is then incorporated into the base by spatulation. All solid components are milled
to finer size and screened before incorporating into the base to avoid gritty sensation of the final product.
Roller mills are used for producing large quantities of ointments in pharmaceutical industries. Uniform
mixing can be obtained by geometric dilution procedure, which usually involves stepwise dilution of solids
into the ointment base.

7. What are the compendial requirements for ointments? How are ointments packed, stored, and labeled?
Compendial Requirements for Ointments Ointments and other semisolid dosage forms must meet USP
tests for microbial content, minimum fill, packaging, storage, and labeling. Ophthalmic ointments must
also meet tests for sterility and metal particles content. Microbial Content With the exception of
ophthalmic preparations, topical applications are not required to be sterile. They must, however, meet
acceptable standards for microbial content, and preparations prone to microbial growth must contain
antimicrobial preservatives. Microbial limits are stated for certain articles in the USP.

 Ointment Packaging
 Jars: Glass, Plastic: Do not pour in while hot!
 Disp. Jars: Plastic
 Tubes: Plastic, tin, aluminum
 Syringes: Individually dosed, good protection of the product
 Labeling and Storage
 Labeling
o Protect with tape
o Dual labels
o Creativity often required
 Storage
o Store in a cool place

8. What are the advantages of using paste over ointments?

 The paste are usually less greasy and more absorptive.
 They have good adhesion on skin & they do not melt at ordinary temperature opposite to
ointments.
 Pastes contain more solid materials than do ointments and are therefore stiffer and less
penetrating.
  Pastes are usually employed for their protective action thus, when protective rather than
therapeutic action I desired, the formulation favored will be pastes.
 Pastes remains in place after application and are effectively employed to absorb serous secretions
 It offers even greater occlusion and are more effective than ointments at absorbing serous
discharge.
 It forms an unbroken, impermeable, opaque film on the skin compare to ointments.
 Pastes are generally less impermeable, less penetrating, less macerating, less heating.

References:
 (n.d.). Retrieved from https://pharmlabs.unc.edu/labs/ointments/bases.htm.
 Allen, & Ansel. (n.d.). Ansel’s Pharmaceutical Dosage Forms and Drug Delivery Systems (10th ed.).
 Bennett, J. (2019). Cold Creams. Retrieved from https://cosmeticsandskin.com/aba/cold-
cream.php
 Dayco, & Hernandez. (n.d.). General Pharmacy.
 Howard C. Ansel, L. V. (2014). Pharmaceutical Dosage Forms and Drug Delivery Systems. In S.
Howes (Ed.). Lippincott Williams & Wilkins, a Wolter Klower business. Retrieved November 11,
2019
 Ideal Ointment Base sould consists of the following things. (2011, December 23). Retrieved from
http://www.preservearticles.com/education/ideal-ointment-base-sould-consists-of-the-following-
things/16989.
 Remington. (n.d.). Pharmaceutical Sciences (19th ed.).