PDDS LABORATORY

Post Lab Discussion

Finals
 OINTMENTS
• Usually contain a medicament or a
mixture of medicaments dissolved or
dispersed in the base.
• semisolid dosage form, usually
containing <20% water and volatiles
and >50% hydrocarbons, waxes, or
polyols as the vehicle.
• Hydrophobic ointments and water-
emulsifying ointments are intended to be
applied to the skin or certain mucous
membranes for emollient and protective.

• Hydrophilic ointments are miscible with

the skin secretion and are less emollient
as a consequence.
 CHARACTERISTICS OF AN
IDEAL OINTMENT
• It should be chemically and physically stable.
• It should be smooth and free from grittiness.
• It should melt or soften at body temperature
and be easily applied.
• The base should be non-irritant and should
have no therapeutic action.
• The medicament should be finely divided and
uniformly distributed throughout the base.
 Ointment bases
1. Oleaginous bases
- “hydrocarbon bases”
- anhydrous, water insoluble, non-water
washable
- derived from petroleum products

Examples:
• Petrolatum USP
• White Petrolatum USP
• Yellow Ointment USP
• White Ointment USP
 Petrolatum USP
• “yellow petrolatum” or “petroleum jelly”
• purified mixture of semisolid hydrocarbons
obtained from petroleum
• unctuous mass varying in color from yellowish
to light amber
• melts at 38° to 60°C
• can be used alone or in combination w/ other
bases

Vaseline (Chesebrough-Ponds)
- commercial product
 White Petrolatum USP
• “white petroleum jelly”
• purified mixture of semisolid hydrocarbons
obtained from petroleum THAT HAS BEEN
DECOLORIZED
• more aesthetically appealing

White Vaseline (Chesebrough-Ponds)

- commercial product
 Yellow Ointment USP
• “simple ointment”
• has slightly greater viscosity than plain
petrolatum

Formulation:
Yellow wax 50g
Petrolatum 950g

Yellow wax
- purified wax obtained from the honeycomb
of the bee Apis mellifera
 White Ointment USP
• differs from yellow ointment by
substitution of white wax and white
petrolatum

White wax
- purified and bleached yellow wax
 Liquid Petrolatum
• “mineral oil”
• levigating agent used for the
incorporation of powdered
substances in a hydrocarbon
base
 Ointment bases
2. Absorption bases
- oleaginous base + water +
surfactant
- used as an emollient and as a
pharmaceutical adjunct
- has no occlusion property
- not easily removed by water
washings
2 Types:
• oleaginous base + aqueous sol’n = water-
in-oil emulsion (e.g. HYDROPHILIC
PETROLATUM)
• Emulsion bases - water-in-oil emulsion
permits additional aqueous solutions
(e.g. LANOLIN)
 Hydrophilic Petrolatum
Formulation:
Cholesterol 30g
Stearyl alcohol 30g
White wax 80g
White petrolatum 860g
Stearyl alc. + white wax (steam bath) +
cholesterol + white petrolatum
Aquaphor
- commercial product
- has the capacity to absorb up to 3x its
wt. in H20
 Lanolin USP
• “hydrous wool fat”
• obtained from the wool of a sheep (Ovis
aries)
• purified wax like substance that has been
cleaned, deodorized and decolorized
• contains 25%-30% water

Modified Lanolin USP

- processed lanolin; to reduce free lanolin
alcohol contents, any detergents and
pesticides residues
 Wool fat
• “anhydrous lanolin”
• solid in nature
• Contains nmt 0.25%

COLD CREAM
 contains
white wax, spermaceti, almond oil,
and sodium borate
 Ointment bases
3. Water-Removable bases
- “water-washable bases”
- oil-in-water emulsions resembling
creams
- non-greasy & non-occlusive
- can absorb serous discharge
(e.g. HYDROPHILIC OINTMENT USP)
Hydrophilic Ointment USP
Formulation:
Methylparaben 0.25g
Propylparaben 0.15g
Sodium lauryl sulfate 10g
Propylene glycol 120g
Stearyl alcohol 250g
White petrolatum 250g
Purified water 370 mL
 Ointment bases
4. Water-Soluble bases
- “greaseless base”
- absorb water to the extent of solubility
- completely water washable
- does not contain oleaginous components
- large amount of aqueous solutions are not
effectively incorporated into this base because
they soften greatly with the addition of water
- mostly used for the incorporation of solid
substances
 Polyethylene Glycol
Ointment NF
• polymer of ethylene oxide and water
Formulation:
Polyethylene glycol (PEG) 3350
400g
Polyethylene glycol (PEG) 400
600g
600 MW = clear, colorless liquid
1000 MW = waxlike white material
» greater MW = greater viscosity
 General Methods
• FUSION
This involves melting together the bases
over a water bath before incorporating any
other ingredients.

• Hard: Paraffin BP, Beeswax BP, Cetostearyl Alcohol BP

• Soft: Yellow and White Soft Paraffi n BP, Wool Fat BP
• Liquid: Liquid Paraffin BP and vegetable oils
• INCORPORATION
The components are mixed until a uniform
preparation is attained.

• Small scale- The pharmacist may mix the components

using mortar and pestle, or a spatula may be used to
rub the ingredients together on an ointment slab.

• Large scale- The pharmacist will use the ointment mill,

an electronic mortar and pestle, or a device called an
"unguator".
 Levigation
• Process of reducing particle size of a solid
by triturating it in a mortar or spatulating in
an ointment slab with small amount of a
liquid and melted base in which the solid is
not soluble.
• Amounts of levigating agents used in
official preparations can serve as a guide,
but these vary considerably.
 EXAMPLES
• Zinc oxide Ointment calls for 15% mineral
oil to be used for 20% zinc oxide in White
Ointment USP.
• Zinc oxide Paste uses no levigating agent
for 50% solids (25% zinc oxide and 25%
starch)
• Sulfur Ointment uses 10% mineral for 10%
sulfur in white petrolatum.
 WHITE OINTMENT
-It is an ointment consisting of 5% white
wax and 95% white petrolatum
-Also called as “Simple ointment”
-White unctuous mass

Uses: Emollient, Vehicle, Protective

 SULFUR OINTMENT
-Yellow unctuous mass
-used for scabies and
seborrheic dermatitis

Precipitated sulfur- API

Mineral Oil – Levigating agent
White ointment - base
 CONTAINERS

• Ointment jars
- made up of clear or opaque glass or plastic
material
- (size) 0.5 ounce to 1 pound

• Opaque jars
- for light-sensitive products; porcelain white,
dark green, or amber
• Ointment tubes
- made of aluminum or plastic
- (aluminum) coated with an epoxy resin,
vinyl, or lacquer to eliminate any
interactions between the contents and the
tube
- (plastic) made of :
§ high- or low-density polyethylene (HDPE
or LDPE)
§ polypropylene (PP)
§ polyethylene terephthalate (PET)
§ plastic/foil/paper laminates
LDPE
- soft and resilient
- provides good moisture barrier

HDPE
- less resilient
- provides superior moisture barrier

PP
- has high level of heat resistance
PET
- offers transparency and high degree
of product chemical compatibility

Laminates
- provides excellent moisture barrier,
high durability, and product
compatibility
• Container: Collapsible tube or Ointment
Jar
• Auxiliary label: For External Use Only
 LOTIONS
• aqueous solutions, suspension or
emulsion applied to the skin

• Methods of preparation:
• Trituration
• Chemical reaction (e.g White Lotion)
 WHITE LOTION
• Zinc Sulfide Topical Solution, Lotio Alba
• Protectant, astringent, mild antimicrobial
• Zinc sulfate and Sulfurated potash
[Sulfurated Potash is sulfur with potassium
carbonate (1:2)]
• Attach “shake well” instruction, must
always be freshly prepared, for external
use only
 CALAMINE LOTION
• Lotio Calaminae
• Pink, odorless suspension
• Protectant, antipruritic
• Boston round, wide mouth amber colored
bottle
• Store in well-closed container, at
temperatures below 30°C
• Attach “shake well” instruction, For
external use only
 CALAMINE LOTION
• Calamine is composed of zinc oxide and
ferric oxide
• Glycerin as levigating agent
• Magma as suspending agent
• Lime water as astringent, vehicle
 LINIMENTS
• Once called embrocations
• Preparations of this type are also called as
BALM.
• are of a similar viscosity to LOTIONS but
unlike a lotion a liniment is applied with
friction; that is, a liniment is always rubbed
in.
• Oil or soap base provides the ease for
application.
 GENERAL USES OF LINIMENTS
• Antipruritic - used to relieve itching
• Astringents - causes biological tissue to contract
• Emollients - products that soften skin or treat dry
skin
• Analgesics
• Rubefacient- causes hyperemia by increasing
circulation, comfort and warmth
• Counterirritant- an agent applied locally to
produce superficial inflammation with the object
of reducing inflammation in deeper adjacent
structures.
 There are two types of Liniments:
ALCOHOLIC LINIMENTS OLEAGINOUS LINIMENTS

• used generally for their • Milder in their action

rubefacient, but is more useful when
counterirritant mildly massage is required
astringent, and • less irritating to the
penetrating effects skin, depending on their
• penetrate the skin ingredients
more readily than do • may function solely as
those with an oil base. protective coatings.
 ALCOHOLIC LINIMENTS OLEAGINOUS LINIMENTS

• Solvent may be a fixed

oil (almond oil, peanut
oil, sesame oil,
cottonseed oil) or volatile
.
substance ( wintergreen
oil, turpentine) or a
combination of fixed and
volatile oil
 CAMPHOR AND SOAP
LINIMENT
• Linimentum Saponis Camphoratum
• Embrocations
• Clear yellowish solution with camphor
odor
• Rubefacient, counter irritant
• Shake well before use
• Do not apply in broken skin
• FOR External use only
 PASTE
• semisolid dosage form that contains one
or more drug substances intended for
topical application

• CLASSES:
• single phase aqueous gel
(carboxymethylcellulose sodium paste)
• fatty paste (zinc oxide paste) - protective
 Fatty pastes
• appear less greasy and more absorptive
than ointments
• they tend to absorb serous secretions,
less penetrating and less macerating than
ointments
• preferred for acute lesions that have a
tendency towards crusting, vesiculation or
oozing
 Dental pastes
• e.g Triamcinolone acetonide dental paste
• Local effect
• Some paste preparations are intended for
administration to animals are applied
orally, the paste is squeezed into the
mouth of the animal, generally at the back
of the tongue, or spread into the mouth
 Zinc oxide Paste
• Lassar’s Plain Zinc Paste
(Zinc Oxide Paste)
• White thick mass
• Best used for serous
secretions

• Zinc oxide – Protective

• Starch – Filler
• White paraffin - Base
 Suppositories
• Solid unit dosage forms suitably shaped
for insertion into the rectum
• They contain one or more active
substances dispersed or dissolved in a
suitable basis which may be soluble or
dispersible in water or may melt at body
temperature.
 Advantages
• Can exert local effect on rectal mucosa.
• Used to promote evacuation of bowel.
• Avoid any gastrointestinal irritation.
• Can be used in unconscious patients (e.g.
during fitting).
• Can be used for systemic absorption of
drugs and
 Disadvantages
• May be unacceptable to certain patients.
• May be difficult to self- administer by
arthritic or physically compromised
patients.
• Unpredictable and variable absorption in
vivo.
 Suppository bases
• Cocoa butter
• Glycerinated gelatin
• Hydrogenated vegetable oils
• Mixture of polyethylene glycols of various
molecular weights
• Fatty acid esters of polyethylene glycol
 Cocoa butter
• Theobroma cacao
• Melts quickly at body temperature
• Immiscible with body fluids and it inhibits
the diffusion of fat soluble drugs to the
affected sites
• Yellowish white solid with a chocolate like
odor
 Glycerinated gelatin
• 70 parts of glycerin
• 20 parts of gelatin
• 10 parts of water
• Usually used for vaginal suppositories
 Polyethylene glycol
• Suitable for some antiseptics
• Surfactant suppository base
• Adv: Water dispersibility
• Disadv: They either increase the rate of
absorption or interact with the drug
molecule, causing decrease in therapeutic
activity
• Tablet suppositories or inserts
 Rectal suppositories
• Bullet shaped, torpedo, little finger
• Weigh about 2g tapered at one or both
ends, for children half the weight for adults
• Made from cocoa butter
• Should be stored at temperature below
30⁰C
 Vaginal suppositories
• Pessaries
• Weigh about 5g globular or oviform
• Made from water-soluble or water-miscible
vehicles such as PEG or glycerinated
gelatin
• Prepared by compression of powdered
materials into a suitable shape.
 Urethral suppositories
• Bougies
• Slender pencil-shaped suppositories
• Weigh 4g (male) and 2g (female)
 Glycerin Suppositories
• Colorless, translucent, bullet shaped solid
• Individually wrapped, placed in wide
mouth tight container
• Laxative
• Store at cool temperature
• Sodium carbonate and Stearic acid reacts
to form sodium stearate which is used as
solidifying agent