Pharmacy Technicians Course. LaGuardia Community College
Introduction to CompoundingCompounding in Pharmacy refers to the
special preparation of drug products that are uniquely tailored to
a patients needs medically and otherwise.Extemporaneous is often an
adjective that describes this unique characteristic of
compounding.What is compounding?, what is Manufacturing?According
to the FDA, compounding isMade to dispense a product on the basis
of a Rx for a specific patients needsPharmacist can not compound a
copy of a commercial available productPharmacist can not sell
his/her product without an RxCant advertise the product (i.e. they
can advertise their compounding service but not the product
itself)
Extemperaneous CompoundingPharmacy makes a unique product dose
form for a specific patient, i.e acetaminophen 2% creamUSP 795 says
that expiration dating for these products should not exceed 25% of
the time remaining among the manufacturer drug product or six
months into the future which ever is earliestAny product where
water is add to a solid dosage form is given 14 days under
refrigeration unless published data state otherwiseCompounded items
can be: creams, ointment, solutions, suspensions, intravenous
solutions, capsules, suppository, etc.Solutions are homogenized
mixtures of drug in aqueous medium.Suspensions are heterogeneous
mixtures of a drug in aqueous medium. These mixtures often require
the shaking of the drug before the suspension can be
given.Intravenous solutions are aqueous drug mediums that are free
of particles; they are sterile and pyrogen freeCapsules are oral
dosage forms that are enclosed in a gelatin casing that dissolves
in the stomach and small intestine Gelatin capsules come in sizes
from 000 to 13.00o is the largest size13 is the smallest
sizeSuppositories are dosage forms that are applied rectally. They
are usually made of material like glycerin which melts at slightly
below body temperature. Used for patients that cant swallow due to
neurological disorders (dysphagia)Special Compounded Dosage
FormsEmulsions are mixture of two non mixable liquids in a
stabilized medium. Normally, oil in water do not mix; however, a
compound can be made (an emulsion) where the two liquids can be
mixed with each other.Examples in pharmacy are creams and
lotions.Examples in food are mayonnaise and milk (fat mixed in
water)Two types of emulsion are oil in water (o/w) or
(w/o)References for CompoundingRemingtons Pharmaceutical
SciencesTrissels Stability of Compounded FormulationsDrug Facts and
ComparisonsUnited States PharmacopeiaThe International Journal of
Compounding Pharmacists
Compounding Equipment A more complete list is mention in the
textThe more important ones are followingBalance, class A, required
in every pharmacy by the state boardBeakersFilter papersGraduated
cylindersHotplatesMoldsMortar and pestleOintment
slabSpatulasWeighing paperMortar and PestleVery important in
compoundingrepresents a symbol of the pharmacy profession. Shown
as
Used to comminutate or triturate a substance to smaller particle
sizes. Smaller particle sizes are a key to make certain compounds
more appealing to the touch and taste.Glass mortar is used to mix
liquids with powder and porcelain is used for granular powders
SolutionsAqueous or Hydroalcoholic mixtures that are solvents
for homogenized solute/solvent systemSolute : drug that is mixed
into the systemSolvent: the vehicle or medium used to carry the
soluteSolvents include:Purified water USP: contains no more than 10
ppm solidsSterile water for injection USP: same as purified water
except for sterility and pyrogen free state: used to mix IV
drugsSterile water for Irrigation USP: used to make oral
solutionsTypes of solutionsSimple Syrup USP: 85% w/v sucrose in
water.Excellent vehicle for a sweeten drug dosage form for
childrenSelf Preserving: no antibacterialsElixirsWater and alcohol
cosolvent systemsTypically as some sugar alsoUsually about 10%w/v
to 40% w/v alcoholAromatic WatersMixture of water, alcohol, and a
volatile oilJasmine water is water, alcohol and jasmine oilSpirits
or EssenceMixture of water, alcohol and volatile oil where alcohol
content is 50% to 90%TincturesHydroalcoholic mixtures where
concentration of drug is 10% 10% is the concentration of the whole
plant source; 1% is the active drugIe. Opium Tincture is 10% in
opium and 1% or morphineCharacteristics of
SolutionsBenefitsProvides an easy way to measure doses for small
patients and babiesProvides a way to increase bioavailability of
the drugDrugs can be sweeten and flavored to mask bad
tasteDisadvantagesBulky dosage formSusceptible to hydrolysis with
water
SuspensionsHeterogeneous mixture of drug into a medium that
normally it does not dissolve in.System consists of water, drug
powder, sweetener, flavorants, colorants and an agent called an
surfactant which thickens the medium to allow particles of drug to
remain suspendedIn systems with no surfactant the drug particles
quickly settle to the bottom and aggregate.Surfactants allow the
system to be uniform long enough to measure a doseShake before
using is normally require as an auxiliary
labelSurfactantsAcaciaMethylcelluloseCarboxymethylcelluloseXanthan
gumCarrageenanAmylopectinBentonite magma 5% (exhibit thixotropy:
gels on standing and liquefies on shaking)Other name for
surfactants are Suspending agentsA Common commercially available
suspending agent is OraPlus EmulsionA pharmaceutical system where
two immiscible liquids are mixed together to form a stable
systemNormally two immiscible liquids like water and canola oil
dont mix and the less dense oil beads to the topPurpose of
EmulsionIncreased drug stability (drug that under hydrolysis in
water may be more stable in emulsion)Better applicability in
topical administrationTwo phase of the emulsionInternal phase- the
dispersed liquidExternal phase-the dispersion medium liquidIf water
is the dispersed liquid you have a w/o emulsionIf oil is the
dispersed liquid you have a 0/w emulsionThe type of emulsion formed
depends on the phase volumes and the type of surfactant or
emulsifier used to stabilize this systemEmulsion TypesA classic o/w
emulsion is vanishing creamA classic w/0 emulsion is a
lotionEmulsifying AgentsEmulsifier or surfactants are agents that
stabilize an emulsion.As emulsions age, they destabilize and
separate in two phase (i.e. milk that is old separates). This is
called cracking and means the emulsion is destabilizedEmulsifiers
can be natural or syntheticHLB (hydrophilic Lipophilic Balance)
Scale is measure of what type of an emulsion is created when used a
given emulsifierHLB9 tend to form
0/wEmulsifierNaturalAcaciaTragacanthAgarMethylcelluloseCarboxylmethylcelluloseSynthethicSodium
Lauryl Sulfate medium HLBSorbitan esters (Spans) low
HLBPolysorbates (Tweens) high HLBs (o/w)
Popular non medicated Emulsion basesAlamay Base0/wVanishing
cream (moisturizer)Cetaphil0/wNon soap
cleanerEucerinw/0Moisturizing creamKeri Lotion0/w Moisturizing
creamOintment BasesOintment are semisolid mixture of a drug (in
liquid) incorporated into a oily stiffen base.Oleaginous
basePetrolatum is a high hydrocarbon mixture base used to carry
water insoluble drug into the skinPetrolatum is not washable and
cant absorb any waterForms occlusive layer and used as an
emollientFor example : Vaselin Absorption baseCan absorb water
Hydrophilic Petrolatum (Aquaphor )Water soluble baseCan absorb
waterCan wash easily with soap and waterConsists of PEG 3350 and
PEG 400, which are water soluble basesPropylene glycol-ethanol
systems when mixed with 2% hydroxypropyl cellulose forms a clear
gelA gel is emulsion system where a solid is the dispersed phase
and water is dispersion mediumExhibit thixotrophy: shaking and
agitation causes the honey like substance to flow more easily (like
water)Absorbs considerable water into the gel sponge effectUsed in
wound care to sieve pusIncorporation of drug into ointments or
emulsions involves the following:ComminutionBreak down and crushing
solid particles into smaller particle sizes to increase its surface
areaTrituration is comminution by frictional shear force
(rubbing)In practice comminution is done in a porcelain wedgewood
mortar and pestleLevigation is the process of increasing particle
size by an a small amount of mineral oil to the reduced drug
powder. This act wets the powderThe drug/levigating oil mix is then
incorporated into the base when heated to near molten state (Fusion
method)Alternatively the drug/oil mix is incorporated little by
little into the base via geometric dilution on an ointment
slabGeometric dilution
PLO Organogel SystemPLO Organogel Systems are o/w type emulsion
systemHas excellent skin penetration abilityDrugs can be
incorporated into the organic phase or the aqueous phaseThe organic
phase is a lecithin emulsifierThe aqueous phase contains a
poloxamer polymer in waterPLO stands for Pluronic Lecithin
Organogel. Pluronic is the trade name for poloxamer(s) compounds
which were synthesize for the first time in the 1970sPrepacking and
Unit dose systemsHelps in inventory management in
hospitalsPrepacked and unit dose blister cards by law are permitted
to be return to inventory upon returnExpiration dating are one of
two systems50% of the expiration date on the manufacturer drug or 1
year whichever is sooner (my hospital uses this)25% or six months
whichever is soonerMedications that should not be prepacked (unit
dose)The standard unit dose prepackage machine as a mechanical dial
that rotates between metal plates that are heated to high
temperatures. Oral dose forms are placed on the dial and the metal
plates seal the blister pack material around the medication with
heatSome medications should not be prepacked with a standard
machine because the machine will become contaminated with dust
particles from these drugsAt times a dedicated machine can be used
for some of these drugsCommon highly allergic potential drugs
include:Penicillins, Cephalosporins, sulfa drugsMoisture Sensitive
medicationsHIV medicationsPraxada Pyridostigmine
(Mestinon)Prasugrel (Effluent)EmtrivaMost orally melting tablets :
Risperdal M
CapsulesMost gelatin capsules will melt when exposed to
heatRitonovirOmega 3 Fatty Acids capsulesChemotherapy drugs and
Teratogenic drugsChlorambucil (Leukeran)Cyclophosphamide
(Cytotaxan)Cyclosporin (Gengraf)Bosentan (Tracleer): Pregnancy
category XIn general, always inquire about the pregnancy rating and
the cytotoxic potential of drugs before you are asked to prepack
anything. (especially if you are a woman of childbearing
potential)For a more complete listing
visit:http://www.ashp.org/s_ashp/docs/files/MedNO_unit-dosedpackage.pdfIntroduction
to Sterile ProductsA sterile product is a product that is free of
contamination, microorganism free, and pyrogen freeExamples of
sterile products are intravenous products (IV), ophthalmic products
(for the eye), and nasal products (for the nose), Intramuscular
(into the muscle) and subcutaneous (under the skin)Aseptic
technique refers to the procedure of properly performing the
preparation of sterile products.Includes the environment,
equipment, and personnel garbProvides guidelines for the
procedureNormally any agent that bypasses the skin or the
gastrointestinal tract must be both sterile and pyrogen free. This
is because the skin and the GI tract have a protective role in
filtering out damaging foreign substances or microorganisms.The
blood is a sterile body fluid that requires sterile drug products.
Blood is filtered by the spleen and then by the lymph nodes as its
becomes lymph; however, when a drug is introduced directly into the
blood it must be sterile.Consequences of contaminated IV products
can be seriousMost IV drug products are contaminated by touch
contamination.Bacteria, fungus, and other microorganism colonize
the skinCommon skin microorganisms are: Candida, Dermatophytes, and
Staphylococcus bacteria. Others are common as well. Contaminated
products can colonize the blood and produce bacteremia and
fungemia. Infections can evolve into septic shock and death.Watch :
http://www.youtube.com/watch?v=KC8qgxNB2FAEnvironment for Sterile
Products PreparationClass 100 environment is an environment that
has air that contains no more than 100 particles (0.5 microns) or
larger in one cubic foot of air.Laminar flow hoods provide this
environment.Horizontal flow hoods filter air and pass it through a
HEPA filter and outward out of the hood.Vertical flow hoods blow
filtered air down towards the surface of the hood.Biological Safety
Cabinets are vertical flow hoods that pulls air through vents in
the front and back of the hood to prevent the preparer from
receiving this air. It is used to make chemotherapy drugs.USP
797Introduced in 2004 by the US Pharmacopeia.Consists of standards
for the environment to be considered in the preparation of sterile
productsEndorsed by JCAHO and other regulatory agenciesFollowed in
most hospitals with others moving towards compliance.Standards
include wall/ceiling, wall/wall and wall/floor junction
specifications, etc
In general, sterile products are prepared in laminar flow hoods
in similarly compliance air quality roomsSuch rooms are called
clean roomsUsually have partitions that separate areas of the room
for storage of IV products, gloves, and needle and syringesRooms
are usually positively pressurized to push contaminates out and to
keep other particles from being pulled in.Other Sterile Product
EquipmentNeedle are sterile puncturing devices meant to access drug
solutions in vials and to administer drugs to patients.Normally are
3/8 of an inches to 3.5 inches in lengthThe diameter, or bore, of
the needle is determined by its gauge.The larger the gauge the
smaller the bore of the needleIn general, 25 or 27 gauge needles
are under for subcutaneous injections, 22 gauge for IM injections
with 18 gauge and 16 gauge meant for pharmacy compounding of IV
products. 13 gauge is typically the larger bore needle you will
find.Syringes are the containers that hold the drug solution after
its been drawn from a vial.Consists of a tube with graduations
marks, a piston, a plunger with grip collar and at the other end a
luer lok tip (most syringes).This luer lok tip is designed to be a
twist on to attached to a needle or to a injection port on a
catheter to administer an injection
Author: William Rafti of the William Rafti Institute from
Wikipedia
Source: wikimedia commons pageIntravenous SolutionsNormal saline
(0.9%) is one of the most common because its isotonic with plasma.
Isotonic means equal to it in terms of tonicity. i.e. plasma has a
tonicity valve of about 290 mOsm. Normal saline or NS is about 300
mOsm. Tonicity of a solution determines if bodily fluid shifts will
occurDextrose 5% in water (D5W) is the second most common type.
Consists of glucose or dextrose in water to make it 285 mOsm
(isotonic)D5WNS is a combination of the two and is used when some
calories in the form of glucose is needed. Hypertonic (580 mOsm
about) but it is Ok to use.3 % Saline (NaCL) is only used to treat
certain brain conditions. Very hypertonic and can cause death if
used improperly23.4% saline (NaCL) used only in certain rare
conditions and in small volumes. Will cause death if used
improperly (remember Emily Jerry?)Type of IV therapyIV primary
infusion consists of a drug that is given continuously through a
large volume parenteral solutionIV Piggyback is a IV administration
of a drug that is normally piggybacked to another primary IV via a
Y site connection on the primary IV tubing.IV Piggyback sets are
designed to be small in volume usually 50 ml to 100 ml and are hung
above the primary bag on the IV pole. (see next page)Rate of
infusion can be controlled by gravity and a roller clamps or by an
electronic pump
Picture of IV Piggyback set up
A word about filtersAt times a filter is needed to filter IV
solutionsi.e. when breaking an ampule you need to use a filter
needle to draw the solution to prevent glass particles from
entering the IV.A 0.22 micron filter is a special filter that is
called a sterilizing filter that can sterilize a fluid as it is
passed through the filter.