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Pharmaceutics II Lab Exam I Review:

Suspensions and Lotions:


• Suspension is a preparation containing finely dispersed particles
distributed uniformly throughout a vehicle where the drug is
maximally soluble
• Coarse dispersions: suspensions and lotions  10-50 microns
• Fine dispersions: gels and magmas  0.5-10 microns
• Suspensions are easier to swallow and have flexibility of
administered doses compared to solids
• Suspensions must have SHAKE WELL auxiliary label
• Suspensions must easily redisperse, have consistent particle size
and pour readily and evenly
• Suspensions are more stable and better tasting than solutions
• Pharmaceutical lotions must have EXTERNAL USE ONLY auxiliary
label
• Water is the most common vehicle in a pharmaceutical lotion
• Wetting agents are used to reduce surface tension (glycerin and
alcohol)
• Calamine is used to treat dermatitis, hives, chicken pox and
poison ivy
• Suspending agent-used to avoid formation of a cake
Bentonite Magma-made from clay; works best at
alkaline pH
Methylcellulose-synthetically derived from plants; very
inert/consistent
OraPlus-commercially available suspending agent;
cellulose based
• Calcium Hydroxide is Lime Water; do not shake
• Zinc Oxide is the main ingredient in Calamine powder
• Menthol: drying agent
• Calamine is a color protectant and astringent

Emulsions:
• Emulsions are dispersions in which the dispersed phase is
composed of small globules of a liquid distributed in an
immiscible liquid
• Internal phase-dispersed phase
External phase-continuous phase/dispersion medium
Emulsifying agent-surfactant/gum
• A good emulsifying agent must:
1. be compatible w/ other ingredients
2. not interfere w/ stability or efficacy
3. non-toxic
4. have little odor, taste or color
5. be stable

• HLB: hydrophile-lipophile balance; HLB numbers define a


substance’s polarity
• Creaming: migration of one substance to the top of the emulsion;
movement of aggregated droplets
• Cracking: destruction of emulsion system; irreversible separation
of internal phase in emulsion
• Coalescence: union of two different particles; happens when
emulsion is shaken  irreversibly fused
• Aggregation: droplets first clump together
• Thixotrophy: when fluids resume a solid state after agitation by
remaining undisturbed
• Interfacial tension-force needed to oppose natural pull of the
molecules
• Emulsions must have SHAKE WELL auxiliary label
• O/W emulsions: 1° Emulsion: 4-2-1 (Oil-Water-Gum)
-ex. Mineral Oil emulsion
• W/O emulstions (aka Lime Water Emulsion): need one part
VEGETABLE OIL and one part LIME WATER (calcium hydroxide
soln.)
• Emulsifier is formed by the oleic acid and calcium hydroxide;
together they form calcium oleate
• 3 Methods of Emulsion Compounding:
a. Continental/dry gum b. English/wet gum c.
Bottle/Forbes bottle
• Emulsions become physically unstable when:
a. internal/dispersed phase forms aggregates of globules
b. large globules/aggregates form concentrate layer in internal
phase
c. if all or parts of internal phase separate as result of coalescing
• Stability of emulsion increased by:
a. Reducing particle size (d2)
b. Adjusting viscosity of external phase (η)
c. Reducing the density of differences between the phases (ρ1-
ρ2)
• Mineral Oil Emulsion-lubricating carthartic
-pure mineral oil 15ml; mineral oil emulsion 30ml

Hand Lotion:
• Triethanolamine and stearic acid form the emulsifier
triethanolamine stearate
• Mineral oil acts as a protectant; lanolin is an emollient/softener

Ointments:
• Aquaphor may take up to 3 times its weight in water
• Alcohol should NOT be used to dissolve substances that will be
incorporated into an ointment. When the alcohol evaporates,
sharp crystals may form
• Do NOT use metal spatulas w/ corrosive substances (salicylic
acid)

• Drugs that should be mixed with another substance before


incorporation:
1. LCD: none
2. Peru Balsam: Castor Oil
3. Coal Tar: Tween 80
4. Iodine Crystals: NaI or KI
• Four classes of ointment bases w/ examples:
1. Oleaginous: petrolatum
2. Absorption: hydrophilic petrolatum
3. Water removal: hydrophilic ointment
4. Water soluble: polyethylene glycol ointment
• Levigation is used to reduce particle size
• Incorporation is mixing together of various items (one ointment
is incorporated into another)
-levigation is done prior to incorporation
• P. auerginosa and Staph aureus are two main microorganisms
whose presence must be controlled in topical preparations
• LCD: liquoris carbonis detergens
• Tween 80 is also called polysorbate 80
-an oily liquid that is a nonionic surfactant
-effective in dispersing the water-insoluble components of
coal tar upon admixture with an aqueous preparation
• Coal Tar is used to treat eczema and psoriasis
• Trituration-reducing substances to fine particles using mortar and
pestle
• Pulverization-reduction of particle size of a substance using a
second substance which can be removed (ex. Camphor and
alcohol)

Reconstitution of Powders and Dose Meassurement:


1. Calculate volume powder takes up
2. Calculate amount of drug in bottle
3. Calculate new volume needed
4. Calculate amount of water needed

Chemical Description
Triethanolamine Stearate Emulsifying agent
Methylparaben Anti-microbial preservative
Sulfur Scabicide, Keratolytic
Bentonite Magma Clay based suspending agent
Mineral Oil Levigating agent; laxative
Calamine Astringent; protectant
Hydrocortisone Anti-inflammatory
Petrolatum Ointment base (or vehicle)
Lanolin Emollient/softener

Basic Rules for Compounding Ointments


1. A good ointment contains the required drug in a uniform distribution throughout and is free
of grittiness. It must be neatly finished and packaged.
2. When compounding an ointment on a tile, confine the ointment to as small an area as
possible to prevent loss of ointment over the edge.
3. When packaging an ointment, pack it firmly from the bottom of the jar up to avoid air
pockets. The top of the ointment should be neatly finished (smoothed) and the lip and threds
of the jar wiped clean. Upon opening a jar, no ointment should be visible on the inside lid.
4. To achieve uniform distribution of insoluble powders (zinc oxide, precipitated sulfur, talc)
in an ointment, it is often necessary to use a small amount of a levigating agent compatible
with the base. Only enough levigating agent is added to make a thick past so that the
insoluble powder may be properly levigated. One of the best agents is liquid petrolatum
(mineral oil.) A small portion of the base may also be acceptable. It is impossible to levigate
a substance once it has been added to the bulk of an ointment.
5. Water soluble substances (resorcinol, urea) may be dissolved in a small amount of water,
taken up into aquaphor or wool fat and then incorporated into the base. Aquaphor may take
up to 3 times its weight in water. (We generally recommend equal parts.) It may be used in
amounts up to equal portions of the amount of liquid to be taken up. (ex. If 6ml of an
aqueous solution is to be incorporated into an ointment the amount of aquaphor to be used for
this purpose should be between 2 and 6g.) An aqueous solution may be directly incorporated
into the base if it is a water absorbable base. *Chemicals that are not stable in water (most
antibiotics) must only be put in oleaginous bases and may not be dissolved in water
regardless of solubility.*
6. Single ingredients soluble in mineral oil (menthol, camphor, or thymol) may be dissolved
in a small amount prior to incorporation into an oleaginous base. If two (or more) ingredients
that form a eutectic are in a formula the eutectic should be allowed to form a liquid on the
ointment tile and then be taken up with the base.
7. Alcohol should NOT be used to dissolve substances that will be incorporated into an
ointment. When the alcohol evaporates sharp crystals may form.
8. Do NOT use metal spatulas with corrosive substances (salicylic acid, iodine, phenol) or
chemicals that may cause discoloration (resorcinol, tannic acid, organic dyes.) These will
corrode (ruin) the stainless steel.
9. Certain substances require special handling techniques:
a. Iodine crystals should never be incorporated directly into an ointment base. The
iodine crystals should first be dissolved in a solution containing potassium iodide, or sodium
iodide. This soln is then incorporated into aquaphor, wool fat, or and appropriate absorption
base.
b. When coal tar is to be incorporated into an oleaginous base it should be first mixed
with an equal amount of polysorbate 80 (tween 80) to permit uniform dispersion into the
product. This is not true of LCD (Coal Tar Soln which contains 20% coal tar) which may be
incorporated directly into a base using an absorption base when necessary.
c. When peru balsam (which isn’t used much anymore) is to be incorporated into an
oleaginous base, it should be first mixed with an equal amount of castor oil to permit uniform
dispersion into the product.
10. Do not add colors or perfumes unless specified by the prescriber. Bases should not be
changed unless absolutely necessary. (keep changes to a minimum)