none-sterile compounding

7/24/2019 None-Sterile Compounding

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Pharmacist's Letter

Online Continuing Education and Webinars

Non-Sterile Compounding for the Community Pharmacy:

Topical Preparations and Oral Liuid !osage "orms

#olume $%&$' Course No( )&*Self-Study Course +&$%)&*

Compounding ,est Practices: Topical PreparationsCompounding ,est Practices: Oral Liuid

PreparationsCalculations and Con.ersionsPre.enting Errors Test /our 0no1ledge Wrapping 2t 3p

4eferences

Lisa drops off a prescription for a compounded topical

product 5sildenafil &6 topical cream7(

/ou find the follo1ing recipe and 8no1 that all theingredients are stoc8ed in your pharmacy(

Sildenafil citrate tablets & g

Propylene glycol &% g

Oil-in-1ater emulsion base s &%% g

!o you feel comfortable ma8ing the compound9

Pharmacy compounding helps fill the gaps 1hen commercially a.ailableproducts dont fit the bill( This can occur for a .ariety of reasons in the

community setting' including lac8 of a.ailability of a specific dose 5e(g('small doses for pediatric patients' high concentrations of analgesic drugs

for chronic pain patients7 or lac8 of a.ailability of a specific dosage form5e(g(' liuids for patients 1ho cant ingest tablets or capsules' topical

formulations of drugs that can ha.e a local effect7( "or additional

information' get our Technician Training TutorialCompounding(

Oral liuids and topical preparations are t1o of the most commonlyreuested types of pharmacy compounds in the community pharmacy

setting( This continuing education re.ie1 pro.ides basic information on

compounding topical products and oral liuids' along 1ith some sampleproblems to test your 8no1ledge(
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Compounding ,est Practices: Topical Preparations

Compounded topical preparations include creams' gels' lotions'

ointments' and pastes( These can be relati.ely simple to prepare on a

small scale for pharmacies that ha.e some basic compounding euipment

and supplies a.ailable(

;a.e the different formulations of topical productscaused confusion9 Can you describe the differences

bet1een formulations and 1hen they might be used9

for safetyreasons(

d( ma=imi?e

reimbursementfor the

pharmacy(
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phase' by an emulsifying agent(

Whereas creams can ha.e a drying effect' lotions can ha.e a lubricating

effect( Creams of the oil-in-1ater type can often be made into lotions'through the gradual addition of 1ater or an aromatic 1ater' li8e rose

1ater(&'$

Common Ingredients of Creams and Lotions

Common acti.e ingredients in compounded creams include retinoic acid'triamcinolone' and urea( Preparation of creams and lotions 5or any

emulsion7 typically in.ol.es input of energy to brea8 up and disperse one

liuid in another 5for e=ample' mechanical agitation .ia mortar and pestle

or simple sha8ing .ia the @bottle method@7(

;a.e you e.er 1ondered 1hy ingredients for a compound

must be mi=ed together in a specific order9 ;a.e you e.ercompounded a product and 1ondered 1hy it 1ouldnt go into

solution or couldnt be incorporated into a cream9

>n emulsifier 5e(g(' acacia' glyceryl monostearate' polyethylene glycol

APEgents 1ith a lo1er ;L, .alue are

more oil-soluble' and those 1ith a higher ;L, .alue are more 1ater-

soluble( The .alue of ten is considered to be the brea8ing point bet1eenoil- and 1ater-soluble( >n emulsifier thats oil-soluble is appropriate for

preparing a 1ater-in-oil emulsion' 1hereas an emulsifier thats 1ater-

soluble is appropriate for preparing an oil-in-1ater emulsion(

"or e=ample' glyceryl monostearate has an ;L, .alue of )(( 2t 1ould be

best for a 1ater-in-oil emulsion li8e

an ;L, .alue of &$( 2t 1ould be best for an oil-in-1ater emulsion li8e

Dermabase( Often' more than one emulsifying agent is used to prepare anemulsion so all ingredients are properly mi=ed(

;L, .alues for substances can often be found in compounding references

and te=ts' se.eral of 1hich are listed in the reference section of this

continuing education re.ie1(

> le.igating agent' li8e mineral oil or glycerin' or a 1etting agent' li8e


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alcohol' might be needed 1hen an acti.e ingredient is being incorporated

into a prepared or commercially a.ailable cream base( The 1etting agent

helps increase contact bet1een solid particles and liuids( Le.igatingagents help reduce particle si?e( !ecreasing particle si?e helps the

ingredient be e.enly mi=ed throughout the base(

Some commercially a.ailable cream bases include

Vanicream5both oil-in-1ater7 and

in-oil7( 2ts important to use the correct base 1hen compounding so theingredients are properly incorporated(

!efinitions

Levigating agent: @a liuid used as an inter.ening

agent to reduce the particle si?e of a drug po1der bygrinding together' usually in a mortar and pestle(@ The

le.igating agent must be compatible 1ith the base' and

the substance to be le.igated should not be soluble inthe liuid()

Wetting agent: @aids in attaining intimate contact

bet1een solid particles and liuids(@

2n the sildenafil topical cream e=ample' the

propylene glycol 1ould be used as a le.igating

agent(

Equipment for Preparing Creams and Lotions

What euipment do you use to ma8e creams

and lotions in your pharmacy9

To prepare a cream base' 1hich is an emulsion' a liuid phase 1ill need

to be dispersed' or bro8en up( This can be accomplished manually' 1ith a

glass mortar and pestle' or 1ith an electric mi=er' hand homogeni?er' or

sha8er(&

When acti.e ingredients are being incorporated into a prepared or

commercially a.ailable cream base' a pill tile and spatula might benecessary( >.oid using ointment papers because they can tear 1hen they

become moist( Deasuring de.ices might also be reuired' li8e a

prescription balance and graduates(

Question #

Which of the

follo1ingstatements are

T43E concerning

the use ofcompounded

products9

a( Creams are

often used aslubricants(

b( Pastes can be

used as aprotecti.e

co.ering(

c( Lotions

should be used1hen a product

must be

insoluble in1ater(

d( Ointments

should not beapplied to

mucous

membranes(


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To learn more about compounding terms and

euipment thats used' get our

Principles of Non-Sterile Compounding for theCommunity Pharmacy

Compounding Tec!niques for Creams and Lotions

The 1et gum 5English7 or dry gum 5continental7 method can be used to

prepare an oil-in-1ater emulsion( The 1et gum method in.ol.es the use

of a gum 5li8e acacia' for e=ample7 dissol.ed in 1ater 5hence' 1et gum7(The oil is added gradually' and then more 1ater is slo1ly added( The dry

gum method in.ol.es mi=ing a gum rapidly 1ith oil' and then adding the

1ater all at once 1ith rapid trituration(

!efinition

Trituration: the process by 1hich an ingredient is ground in amortar and pestle in order to reduce particle si?e( This termmay also refer to the mi=ing of t1o or more drug substances

1ith a mortar and pestle(

The bottle method is similar to the dry gum method' e=cept theingredients are sha8en in a bottle instead of mi=ed in a mortar and pestle(

The bea8er method is another option for preparing an emulsion( ,oth theoil and 1ater phase are gently heated' and then the internal phase is added

to the e=ternal phase 1ith constant stirring(

When the acti.e ingredient is being incorporated into the prepared orcommercially a.ailable cream base' its important that the particle si?e is

.ery fine( The particles should be crushed into a fine po1der of uniform

si?e( /ou shouldnt see any large pieces that ha.ent been completelycrushed( This 1ill pre.ent any gritty feel' 1hich could irritate the s8in(

Lets loo8 again at the sildenafil cream e=ample( 2n order toget the tablets into solution so they can be e.enly distributed

in the emulsion base' they 1ould need to be triturated( This

1ould be accomplished by using a mortar and pestle to grind

the tablets into a fine po1der( >fter le.igating 1ith propyleneglycol' you can combine all the ingredients on a pill tile using

a spatula( >.oid using ointment papers since the 1ater in the

cream may cause the paper to tear(

Ot!er Considerations for Creams and Lotions

Question #"> patient calls

your pharmacysaying the

compounded

cream theyrecently pic8ed up

doesnt seem right(
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,eyond-3se !ate

Thebeyond-use datefor most creams and lotions 5if they contain 1aterand are prepared from solid dosage forms7 1ill be & days 1hen stored in

the refrigerator at @cold temperatures@ 5e(g(' bet1een )F and F degrees

"ahrenheit7( This can be e=tended if there are scientific stability data forsupport(&

Some physical signs of instability of creams and lotions include brea8ageof the emulsion' crystal gro1th' shrin8age caused by e.aporation of

1ater' and gross microbial contamination(

3SP 4euirements for ,eyond-3se-!ating

These are general rules that apply to most non-sterile dosage forms:

olid and non$aqueous %non &ater$containing' liquid

preparations:

o 2f the source of acti.e ingredient is a manufactured

product:

Not later than $*6 of the time left on the

manufacturers e=piration date' O4 F monthsfrom the day the compound is made

51hiche.er is sooner7(

o 2f the source of acti.e ingredient is a 3SP or N"

product:

Not later than F months from the day the

compound is made(

(queous %&ater$containing' liquid preparations

o 2f the source of acti.e ingredient is a solid dosage

form 5tablet' contents of a capsule' etc7

Not later than & days from the day thecompound is made if the preparation is storedunder refrigeration 5bet1een )FG and FG "7(

(ll ot!er preparations

2t seems gritty and

doesnt spread as

smoothly as it hasin the past( Which

of the follo1ing

may be the causeof this9

a( 2ngredients

from a different

manufacturermay ha.e a

different te=ture(

b( The creammay be past its

beyond-use

date(

c( The patientdidnt

thoroughly

sha8e theproduct before

applying it(

d( The 1et gummethod may

ha.e been used

during

compounding(
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o Not later than the intended duration of therapy O4 )%

days from the day the compound is made 51hiche.eris sooner7(

>u=iliary Labels

3se the follo1ing au=iliary labels for most compounded creams and

lotions:

4efrigerate

E=ternal use only

Sha8e before using 5lotions only7

Since the sildenafil cream is compounded in an oil-in-1ater

emulsion base' gi.e it an e=piration date of & days( Thiscould be e=tended if there is information to support a longer

stability( /oull also 1ant to be sure to include au=iliary labels

for refrigeration and e=ternal use only(

Considerations for Preparing Topical Ointments and Pastes

Ointments and pastes can be good for hydrating the s8in' and forprotecting the s8in(&

There are different types of ointments( Theres the oleaginous ointment'1hich is insoluble in 1ater( White petrolatum and 1hite ointment are

both e=amples of oleaginous ointment bases( The absorption ointment is

also insoluble in 1ater' but can absorb 1ater(

e=amples of absorption ointment bases( Water-soluble ointments absorb1ater' but are non-occlusi.e and non-greasy( >n e=ample of a 1ater-

soluble ointment base is polyethylene glycol ointment(

Common Ingredients of Ointments

le.igating agent is often necessary( Dineral oil 1or8s 1ell 1ith

oleaginous ointment bases( !epending on the formulation' 1ater'glycerin' alcohol' propylene glycol' or mineral oil can be used as

le.igating agents 1ith absorption bases( Polyethylene glycol and


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propylene glycol are good for incorporating insoluble po1ders into 1ater-

soluble bases( Water or glycerin can also be used 1ith 1ater-soluble

bases(&

Equipment for Compounding Ointments

Small amounts of ointment can be prepared on a pill tile or ointment slab'

1ith a spatula( Ointment papers may also be used' but you must be

careful not to tear these or the paper 1ill become mi=ed 1ith theointment' reuiring the compound to be destroyed( > balance may be

reuired for measuring ingredients( > mortar and pestle may be reuired

for particle si?e reduction( 5Particle si?e reduction is important for

ointment preparation' to a.oid a gritty feeling' 1hich could be irritating tothe s8in(7

Ointment mills can also be used for preparing ointments(

> 1ater bath might be helpful in preparing ointments that reuire gentle

heating of some ingredients(&

Compounding Tec!niques for Ointments

Often' compounding an ointment 1ill reuire reducing the particle si?e of

the acti.e ingredient5s7 and le.igating the acti.e ingredient 1ith a small

amount of the base or other liuid( The rest of the ointment base can then

be added using geometric dilution to ensure the acti.e ingredient ise.enly distributed(&

!efinition

Geometric dilutionhelps ensure that an acti.e ingredient is

e.enly distributed through a .ehicle( @


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u=iliary Labels

Label ointments 1ith @E=ternal use only(@

Considerations for Preparing Topical Gels


10/25

,eyond-3se !ate


11/25

1ater or cosol.ent-1ater mi=tures(@

olutions: Solutions are liuid preparations containing

one or more drug substances molecularly dispersed in

a suitable sol.ent or mi=ture of mutually misciblesol.ents(&Syrups and eli=irs are both types of

solutions(

uspension: Suspensions are s1eetened' fla.ored'

liuid preparations containing the acti.e drug 5or

e=cipients' 1hen the suspension is prepared fromcommercially a.ailable drug products7 as insoluble

materials(&

@/rupsare concentrated' aueous preparations of a

sugar or sugar substitute 1ith or 1ithout fla.oringagents and medicinal substances( Syrups can ser.e as

pleasant-tasting .ehicles for acti.e drugs(@

Considerations for Preparing Oral olutions

Oral solutions are prepared as either syrups or eli=irs( The difference

bet1een syrups and eli=irs is that syrups can be used for drugs that are

1ater soluble' and eli=irs are good for both 1ater-soluble and alcohol-

soluble drugs( The reason for this is that eli=irs are mi=tures of alcoholand 1ater( 5Syrups sometimes contain alcohol' but at a .ery lo1

concentration7(&

Common Ingredients of Oral olutions

There is a long list of commercially a.ailable .ehicles for syrups( These

include cherry syrupH Ora-Seet

and 1ild cherry syrup( The p; 5or measure of acidity7 and alcohol

content of these .ehicles .aries' 1hich may be the reason that one ispreferred o.er another for a particular recipe(

Equipment for Compounding Oral olutions

"or compounding solutions' a glass mortar and pestle is often needed( >

balance might be necessary to 1eigh dry ingredients( Deasuring de.ices'li8e graduates' are li8ely to be necessary as 1ell(

Compounding Tec!niques for Oral olutions

contain the

acti.e drug in aninsoluble form(

d( Syrups and

suspensions are

both types ofsolutions(

Question #0

>n eli=ir is a

suitable 1ay to

prepare a solutionof a drug that is

a( 1ater-soluble(

b( alcohol-

soluble(

c( eitheralcohol- or

1ater-soluble(

d( 1ater-insoluble(

Question #1

Which of the

follo1ing is T43Eto get a drug to

dissol.e intosolution9

a( ;eating 1ill

help a drugdissol.e faster(


12/25

The most common 1ay to ma8e a solution is to dissol.e an acti.e

ingredient in a sol.ent( This can usually be accomplished by stirring(Sometimes' heat might be reuired(

When eli=irs are made' the 1ater-soluble component is usually dissol.edin 1ater' or the alcohol-soluble component is dissol.ed in alcohol( The

aueous phase is added to the alcohol solution( This 1ay' the highest

alcohol concentration possible is al1ays maintained( Other1ise' thestability of the solution might be compromised(

Theres actually a long list of considerations for preparing oral liuids(

Some of the more practical tips include the follo1ing:

Small particles dissol.e faster than larger particles(

Stirring helps dissol.e a drug more uic8ly(

!rugs 1ill dissol.e more slo1ly in a more .iscous solution(

2ncrease in temperature 1ill help a drug dissol.e more uic8ly(

Ot!er Considerations for Oral olutions

,eyond-3se !ating

The beyond-use date for syrups prepared from solid dosage forms

shouldnt be more than & days from preparation' 1hen refrigerated( Thebeyond-use date for eli=irs can be up to si= months( These times can bee=tended 1ith scientific stability data to support(

Some physical signs of instability that apply for all oral liuids includeprecipitation' discoloration' ha?iness' and gas formation resulting from

microbial gro1th(

>u=iliary Labels

"or many compounded solutions' you 1ill use a @4efrigerate@ stic8er(

"la.or-Das8ing

>s you might guess' one of the main complaints of parents 1ho areadministering medications to children is the disagreeable taste(

mas8ingcan help ma8e medications more palatable for young ones(

There are some basic techniues that can be used(

b( Larger

particles go intosolution more

uic8ly than

smaller

particles(

c( >dding a drug

to a .iscous

solution 1illma8e it dissol.e

more uic8ly(

d( Stirring 1ill

increase theamount of time

it ta8es for a

drug to dissol.e

into solution(

Question #11

> suitable fla.or-
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,itterness can be complemented 1ith an acceptable bitter fla.or'

li8e coffee' chocolate' or maple( Salty' s1eet' or sour tastes can

also be used to blend 1ith a bitter taste(

ObIectionable tastes can be mas8ed 1ith the cooling effect of mintand the anestheti?ing effect of spices(

>cids' li8e tartaric' citric' and maleic' can be used to enhance fruit

fla.ors(

>dding a little bit of saltiness may enhance the s1eetness of a

sour taste(

Note that suspending a bad-tasting drug can help( > drug thats not in

solution cannot be tasted( > bad-tasting drug can also be used as the

internal phase of an emulsion' 1hich is less li8ely to be in contact 1iththe oral mucosa than the e=ternal phase( ;igh-.iscosity liuids' or those

that are thic8' are li8ely to ma8e the fla.or linger in the mouth longer(

Consider using these fla.ors for specific drug classes:

(nti2iotics: Cherry' maple' pineapple' orange'

raspberry' banana-pineapple' banana-.anilla'

stra1berry-.anilla

(nti!istamines: >pricot' blac8 currant' cherry'cinnamon' custard' grape' honey' lime' peach-orange'

raspberry' root beer' 1ild cherry

3ar2iturates: ,anana-pineapple' banana-.anilla'

blac8 currant' cinnamon-peppermint' lime' orange'

peach-orange' root beer

4econgestants and e-pectorants

blac8 currant' butterscotch' cherry' stra1berry' lemon'maple' orange' orange-lemon' orange-peach'

pineapple' raspberry' stra1berry' tangerine

Electrol/tes: ,lac8 currant' lime' root beer' 1ild

stra1berry

3se the follo1ing fla.ors for mas8ing basic tastes:

mas8ing agent for

a drug that tastes

salty 1ould be9

a( #anilla

b( ,utterscotch

c( Coffee

d( Peppermint

Question #1

,esides fla.or-mas8ing' 1hich of

the follo1ing can

help reduce apatients e=posure

to the bad taste of

a drug9

a( Preparing it as

a solution

b( Preparing it

as an eli=ir

c( 3sing a

.iscous .ehicle

to help thefla.oring 5not

the taste of the

drug7 linger in

the mouth

d( 3sing heat to

dissol.e the

drug intosolution more

rapidly

Question #1"

Suspensions can

be administered bya .ariety of routes(

Which of the

follo1ing routesD3ST be sterile9

5>nd' therefore'


14/25

(cid5sour: Lemon' lime' orange' cherry'

grapefruit' raspberry

3itter: >nise' coffee' chocolate' mint'

grapefruit' cherry

6etallic: ,erry' mint' grape' marshmallo1

Oil/: Peppermint' anise' 1intergreen

alt/: Nut' butter' butterscotch' spice' maple

&eet: #anilla' fruit' grape' bubble gum' berry

2ts important to consider ho1 a fla.oring agent can affect drug stability(2n fact' the product labeling for some commercially a.ailable oral liuids

gi.es information on 1hich fla.oring products should or should not be

used(

Considerations for Preparing Oral uspensions

Suspensions are a good option 1hen the drug for administration is notsoluble in a sol.ent 5solution7 or co-sol.ent 5eli=ir7 system(

can be administered by se.eral different routes' including nasal 5sterile

only7' ophthalmic 5sterile only7' oral' otic'topical( This discussion 1ill focus on the preparation of oral suspensions(

Characteristics of a good suspension:

Settles slo1ly

4eadily redispersed 1ith gentle sha8ing

Prepared from small' uniform' particle-si?e po1ders

Pours easily from its container into administration de.ices

Common Ingredients for uspensions

> good suspending agent 1ill ha.e the ability to maintain drug particles

in suspension 5.iscosity7 but be fluid enough for easy pouring(

prepared only in a

clean room

en.ironment asspecified by 3SP

Chapter JKJ(7

a( Oral

b( Ophthalmic

c( Otic

d( Topical

Question #1)

>n appropriately

compoundedsuspension 1ill

ha.e 1hich of the

follo1ing


15/25

,esides the acti.e drug to be suspended' a suspending agent is needed(

E=amples of suspending agents include acacia' carbomer resins'

methylcellulose' and tragacanth( These agents are mi=ed to specifiedconcentrations in order to ser.e as suspending agents( Sometimes' a

fla.oring agent is also needed(&

2n some cases' the suspending agent 1ill already be fla.ored(

Commercially a.ailable suspending agents that are .ery commonly used

for compounding suspensions include

Equipment for Compounding uspensions

"or compounding suspensions' a mortar and pestle' pill tile' and spatulaare commonly needed to reduce particle si?e of the acti.e ingredient( >

balance might be necessary to 1eigh dry ingredients( Deasuring de.ices'

li8e graduates' are li8ely to be necessary as 1ell(

Compounding Tec!niques for uspensions

Particle Si?e 4eduction

> good suspension is prepared from small' uniform' particle-si?epo1ders( Often' tablets or the contents of a capsule 1ill need to be

triturated to reduce the particle si?e(

Wetting

Wetting in.ol.es gradually adding a 1etting agent to the dry ingredients

of a suspension( The smallest amount of 1etting agent should initially beadded to the dry ingredients to form a thic8 paste( Then' the .ehicle can

be added' a portion at a time' 1ith constant stirring' to form the

suspension(&

The 1etting agent reuired to ma8e a suspension can .ary' depending on

the ualities of the dry ingredients 5the acti.e drug7( 2f the drug is

hydrophilic or can be dissol.ed in 1ater' a 1ater-miscible liuid 51ater'for e=ample7 can be used( 2f the drug is hydrophobic' a non-polar liuid

or surfactant 5glycerin' for e=ample7 1ill be needed( Sometimes' the

1etting agent and the suspension .ehicle are the same thing(

Ot!er Considerations

,eyond-3se !ating

The beyond-use date for a suspension should not be longer than & days'

1hen refrigerated( With scientific stability data for support' the e=piration

attributes9

a( > beyond-use

date of morethan & days

b( Easy to pour

c( uic8 settling

of suspended

particles

d( > pleasant

taste


16/25

date may be e=tended beyond & days(

>u=iliary Labels

Li8e commercially a.ailable suspensions' label compounded suspensions

1ith @Sha8e before using(@ Dany 1ill also reuire a @4efrigerate@ label(

Practical tips for preparing oral solutions and suspensions:

!ont @s@ 1ith a stirring rod in the container of oral

liuid youre preparing( Once you ta8e out the stirringrod' youll see that you need to add more liuid to

account for the .olume that the stirring rod occupied(

Constantly stir 1hen youre adding t1o liuids

together(

Stir smoothly and dont sha8e an oral liuid 1hen its

being prepared( This could cause foaming(

>dd thic8er 5high-.iscosity7 liuids to less .iscous

liuids(

Da8e sure that particle si?e of the acti.e drug is

reduced to minimi?e the grittiness of the formulation(

Tal8 to your colleagues about your

compounding uestions at

Calculations and Con.ersions

Correct calculations and pre.enting errors are e=tremelyimportant 1hen compounding( > $ year-old man 1as

hospitali?ed due to a life-threatening error caused by apharmacy during compounding( While compounding a little-used drug' the capsules 1ere compounded 1ith ten-times the

intended dosage(

Conversions

/ou may remember learning the apothecary and a.oirdupois


17/25

measurement systems in your training( >pothecary units li8e the @dram@

5&Mthof an ounce7' the @minim@ 5&M%

5&M%thof an ounce7' and a.oirdupois units li8e the grain 5about &M)of an ounce7 1ere used($

2t should be noted that the 2nstitute for Safe Dedication Practicesad.ocates e=clusi.e use of the metric system' and a.oidance of these

units( ,eing so rarely used' these symbols can be mista8en for more

commonly used abbre.iations(*

Dost modern recipes and formulation records 1ill follo1 the metric

system( 2f you encounter a recipe or formulation that uses another system'

consider con.erting it to metric' 1ith another staff member double-chec8ing your calculations( This is a good idea from the perspecti.e of

both con.enience and safety(

"ollo1ing are some con.ersions that you might find useful:

Weight& 8ilogram $($ pounds 5a.oir7

& pound * grams

& ounce 5a.oir7 $()* grams& gram &*()$ grains

Liuid

& fluid ounce $K(*J milliliters& pint J) milliliters

& gallon )J* milliliters

Calculations in.ol.ed in compounding can range from simple to

comple=( ;o1e.er' for the most basic compounded products' youre most

li8ely to encounter simple algebra and con.ersions(

Calculations

"ollo1ing are some formulas that can come in handy for compounding(

Percentage con.ersions might be reuired for determining the percentage

concentration of ingredients in a compounded product that gi.es only the1eight of each ingredient( "ormulas that can be used for percentage

con.ersions include the follo1ing:

#olume percent 5.M.7 .olume of solute

.olume of solution

Weight percent 51M17 1eight of solute


18/25

1eight of solution

Weight in .olume percent 51M.7

;eres an e=ample:

2sotonic saline' or normal saline' is %(K6 sodium chloride( ;o1 many

grams of sodium are in *% mL of normal saline9

%(K6 7 g sodium chloride

*% mL of normal saline

7g sodium chloride *% %(K6

&%%6

7 %(* g of sodium chloride

!ilution is another calculation that might be reuired( ,oth liuids andsolids can be diluted( "ollo1ing are formulas you can use for figuring out

dilutions:

uantity of solution & concentration of solution &

uantity of solution $ concentration of solution $

/ou ha.e probably used this euation many times( 2ts a simpleproportion' and is handy in many situations( ;eres an e=ample:

/ou need to prepare a pediatric dose thats .ery small 5* mg7( The drugproduct that you ha.e a.ailable is .ery concentrated 5F$(* mgMmL7' so

that measuring a .ery small dose is not practical( /oud li8e to ma8e a

dilution thats * mgMml' and you need $% mL( So you set up the follo1ingeuation:

* mgMmL $% mL F$(* mgMmL

7 &(F mL of the F$(* mgM mL product

Proportions can be used for many different pharmacy calculations'including figuring the amount of drug in a salt form' and reconstituting

drugs using .olumes other than those on the label(

4educing and enlarging formulas

> recipe 1ont al1ays be 1ritten for the amount of a compounded

product that is actually needed( >gain a simple proportion can be used(

;eres an e=ample:


19/25

> recipe for *% mL of a medicated gel reuires &($ gm of the acti.e

ingredient( ;o1e.er' the prescription is 1ritten for $ ounces 5F% mL7 ofgel( /ou can set the euation up as follo1s:

&($ gm acti.e ingredient 7*% mL

F% mL &($ gm 7gm acti.e ingredient *% mL

7 &( gm acti.e ingredient

To get more practice 1ith pharmacy calculations' get one of

ourPL C!s for technicians'

or"ath and "easurements Part #

Pre.enting Errors

3SP Chapter JK*' Pharmaceutical Compounding-Non-sterile

Preparations' defines the responsibilities of the compounder in ensuring

the uality of compounded products( These include 5but are not limitedto7 the follo1ing:&

The compounding en.ironment is suitable for its intended

purpose(

There is assurance that processes are al1ays carried out as

intended or specified and are under control(

Compounding conditions and procedures are adeuate for

pre.enting errors(

>deuate procedures and records e=ist for in.estigating and

correcting failures or problems in compounding' testing' or in the

preparation itself(

Steps are also suggested to minimi?e error( There are &) steps' and they

are listed here' .erbatim' from 3SP Chapter JK*:

&( udge the suitability of the prescription to be compounded in

terms of its safety and intended use( !etermine 1hat legal

limitations' if any' are applicable(

$( Perform necessary calculations to establish the amounts of
http://pharmacistsletter.therapeuticresearch.com/ce/cecourse.aspx?pc=11-411http://pharmacistsletter.therapeuticresearch.com/ce/cecourse.aspx?pc=11-411http://pharmacistsletter.therapeuticresearch.com/ce/cecourse.aspx?pc=11-411


20/25

ingredients needed(

)( 2dentify euipment needed(

( !on the proper attire and 1ash hands(

*( Clean the compounding area and needed euipment(

F( Only one prescription should be compounded at one time in a

specified compounding area(

J( >ssemble all necessary materials to compound the prescription(

( Compound the preparation follo1ing the formulation record or

prescription' according to the art and science of pharmacy(

K( >ssess 1eight .ariation' adeuacy of mi=ing' clarity' odor' color'

consistency' and p; as appropriate(

&%( >nnotate the compounding log' and describe the appearance of

the formulation(

&&( Label the prescription containers to include the follo1ing items:

a( the name of the preparationH

b( the internal identification numberH

c( the beyond-use dateH

d( the initials of the compounder 1ho prepared the labelH

e( any storage reuirementsH

f( any other statements reuired by la1(

&$( Sign and date the prescription affirming that all procedures 1ere

carried out to ensure uniformity' identity' strength' uantity' andpurity(

&)( Thoroughly and promptly clean all euipment' and store properly(

The 2nstitute for Safe Dedication Practices 52SDP7 cites an instance of a

pharmacist disco.ering that his partner had been improperly

compounding a medication o.er a four-year period' as a result of


21/25

ambiguous instructions 1ritten by the original pharmacist 1ho filled the

prescription( >s a result' 2SDP recommends institution of a process to

ensure that all compounding recipes undergo a documented appro.alprocess before use( > double-chec8 process should be used for all

calculations completed each time a compound is made( 2SDP

recommends 1ee8ly re.ie1 of a logboo8 of all compounds prepared' as1ell as using each refill as an opportunity for a uality control chec8(

Test /our 0no1ledge

> prescriber calls to as8 if you can ma8e ashe 1ants to try it for .aginal administration for one of her patients' 1ho

is a long-time patient at your pharmacy(

/ou chec8 your resources and find a recipe for sildenafil topical cream(

The recipe 1ith the heading @sildenafil topical cream@ contains thefollo1ing ingredients:J

Sildenafil citrate tablets & g Propylene glycol &% g

Oil-in-1ater emulsion base s &%% g

The prescriber says thats e=actly 1hat she 1ants and that shell send thepatient your 1ay(

The follo1ing prescription is presented:

> prescriber calls you 1ith a special reuest( ;e needs to prescribe

spironolactone liuid for a ) month-old male' D0( D0 1as hospitali?edfor se.eral 1ee8s follo1ing birth' and 1as recei.ing spironolactone to

impro.e lung function( The dose of spironolactone for D0 is &

mgM8gMdose e.ery eight hours' and D0 1eighs *(* 8g( The hospital

pharmacy 1as preparing the spironolactone 1hen D0 1as an inpatient'but no1 the pediatrician is ha.ing a hard time figuring out ho1 to get it

for D0 as an outpatient( Can you help9

The prescription reads as follo1s:

Question #1*

/our recipe does

not indicate thepercentage of

sildenafil in thecream( /ou

double-chec8 the

recipe and find

that it contains

a( Sildenafil &6

b( Sildenafil

&%6

c( Sildenafil%(&6

d( Sildenafil

&(*6

Question #1+

/ou ha.e thefollo1ing bases

a.ailable( Which

one 1ould you

choose for thisrecipe9

a( White

petrolatum

b($%uaphor

c(Dermabase


22/25

/ou chec8 through the a.ailable recipes in your pharmacy( /ou do not

ha.e a recipe for spironolactone liuid(

/ou call the hospital pharmacy and the pharmacist is glad to share the

recipe for spironolactone liuid( /ou recei.e a fa= copy of the recipe' andits actually uite simple( The recipe is as follo1s:

Spironolactone * mgMmL

Spironolactone &%% mg tabs = &%Sterile 1ater &% to&* mL

Cherry syrup' s to $%% mL

Wet tabs in sterile 1ater until coating dissol.es

Crush tablets>dd cherry syrup to ma8e a total .olume of $%% mL

E=piration: $ months>u=iliary label: 4efrigerate

Source: e1 40' Dullen 4' Soo-;o W(

&ormulations( Washington' !C: >merican Society of ;ospital

Pharmacists' $%%)(

/ou chec8 that you ha.e the necessary supplies' and indeed you do(

;o1e.er' you do not ha.e any spironolactone &%% mg tablets( ,ut you do

ha.e plenty of spironolactone *% mg tablets(

d($%uabase

Question #1,

2f you could notfind a recipe for

spironolactone

liuid in thereferences that are

a.ailable to you'1hich of thefollo1ing are

potential resources

for a recipe forspironolactone

liuid9

a( The

manufacturer ofspironolactone'

or the pac8age

insert for thedrug

b( The

pharmacy at the

hospital 1hereD0 1as a

patient

c( > druginformation

center

d( >ll of the

abo.e

Wrapping 2t 3p

>lthough reuests for compounded drugs might not be an e.eryday

occurrence' pro.iding this ser.ice can be a real con.enience for patients1ho need it( Stay on top of compounding basics' so that you can be ready

to help patients 1hose needs arent met by commercially a.ailable drug

Question #1.

>fter you recordthis recipe for

spironolactone'

you 8no1 that@best practice@ is


23/25

products(

;eres a list of compounding resources:

8ecipes

When loo8ing for recipes for e=temporaneous dosage forms prepared

from commercially a.ailable products' consider chec8ing the productspac8age insert' or contacting the manufacturer' a local pharmacy school'

or a drug information center(JThe

te=ts' li8e Trissel's Stability of Compounded &ormulations

Science and Technology of Pharmaceutical CompoundingCompoundingToday(comis a good source for recipes as 1ell(

Ot!er Compounding 8esources

111(pcab(org

o Pharmacy Compounding >ccreditation ,oard 5PC>,7

o > .oluntary program to impro.e compounding acti.ity

111(usp(org

o 3nited States Pharmacopeial 53SP7 Con.ention

o 3SP establishes standards for compounding medications

111(pccar=(com

o Professional Compounding Centers of >merica 5PCC>7

o Pro.ides compounding education and training' as 1ell

pharmaceutical ingredients' euipment' de.ices' bases' andformulations(

111(fda(go.M!rugsMs acti.ities that

pertain to pharmacy compounding

to

a( ma8e sure

theres a secondchec8 of the

recipe before its

used in yourpharmacy(

b( file the recipe

immediately(

c( alter therecipe to include

only the

supplies andeuipment that

you ha.e

a.ailable(

d( determinebeyond-use

dating for this

patientsprescription(

Question #10

Whats the most

appropriate.olume of

spironolactone

suspension to beprepared for this

patient9

a( % mL

b( &%% mL

c( $%% mL

d( $% mL

Question #

;o1 many

spironolactone *%

mg tablets areneeded to prepare

the .olume of
http://www.compoundingtoday.com/http://www.pcab.org/http://www.usp.org/http://www.pccarx.com/http://www.pccarx.com/http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/default.htmhttp://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/default.htmhttp://www.compoundingtoday.com/http://www.pcab.org/http://www.usp.org/http://www.pccarx.com/http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/default.htmhttp://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/default.htm


24/25

111(iacpr=(org

o Website managed by the 2nternational >cademy of

Compounding Pharmacists

CompoundingToday(com

o > .ery comprehensi.e subscription 1ebsite by the

(nternational )ournal of Pharmaceutical Compounding

8ecent Information fromPharmacist's Letter

Compounding

>lcohol Products: ;o1 !o They !iffer9

Compounding 02 for 4adiation E=posure

"!> Ta8es >ction >gainst Compounded ,ioidentical ;ormones

Dagic Douth1ash

Tri"i*-gel for Erectile !ysfunction

We also ha.e a letter that you can gi.e to pro.idersyou are glad to pro.ide compounded products for their patients(

spironolactone

suspension for this

patient9

a( "our tablets(

This calculation

should bedouble-chec8ed

before the

prescription is

dispensed' andthe strength of

the tablets used

should be notedon the

compounding

record(

b( Ten tablets(This calculation

should be

double-chec8edbefore the

prescription is

dispensed(

c( Ten tablets(

This calculation

should bedouble-chec8ed

before theprescription is


tablets used

should be notedon the

compounding

record(

d( "i.e tablets(This calculation

should bedouble-chec8edbefore the

prescription is


the tablets used

should be noted
http://www.iacprx.org/http://www.compoundingtoday.com/http://pharmacistsletter.therapeuticresearch.com/ce/ceCourseLinks.aspx?page=view_ddpu&dd=241005http://pharmacistsletter.therapeuticresearch.com/ce/ceCourseLinks.aspx?page=view_ddpu&dd=270402http://pharmacistsletter.therapeuticresearch.com/ce/ceCourseLinks.aspx?page=view_ddpu&dd=240209http://pharmacistsletter.therapeuticresearch.com/ce/ceCourseLinks.aspx?page=view_ddpu&dd=251103http://pharmacistsletter.therapeuticresearch.com/ce/ceCourseLinks.aspx?page=article&dd=250378http://pharmacistsletter.therapeuticresearch.com/ce/ceCourseLinks.aspx?page=article&dd=250378http://pharmacistsletter.therapeuticresearch.com/ce/documents/ce_09014-01.dochttp://www.iacprx.org/http://www.compoundingtoday.com/http://pharmacistsletter.therapeuticresearch.com/ce/ceCourseLinks.aspx?page=view_ddpu&dd=241005http://pharmacistsletter.therapeuticresearch.com/ce/ceCourseLinks.aspx?page=view_ddpu&dd=270402http://pharmacistsletter.therapeuticresearch.com/ce/ceCourseLinks.aspx?page=view_ddpu&dd=240209http://pharmacistsletter.therapeuticresearch.com/ce/ceCourseLinks.aspx?page=view_ddpu&dd=251103http://pharmacistsletter.therapeuticresearch.com/ce/ceCourseLinks.aspx?page=article&dd=250378http://pharmacistsletter.therapeuticresearch.com/ce/documents/ce_09014-01.doc


25/25

on the

compoundingrecord(

4eferences

&( +SP Pharmacists' Pharmacopeia( 4oc8.ille' D!: The 3nited States Pharmacopeial

Con.ention' &KK*(

$( /oung L' Ed( The $rt Science and Technology of Pharmaceutical Compounding( $nded( Washington' !C: >merican Pharmaceutical >ssociation' $%%$(

)( >nsel ;C( 2ntroduction to Pharmaceutical !osage "orms' thedition( Philadelphia'

P>: Lea and "ebiger' &K*(

( >non( The 3NC School of Pharmacy Compounding Lab( http:MMpharmlabs(unc(edu5>ccessed "ebruary &*' $%&$7(

*( 2nstitute for Safe Dedication Practices( Error-prone >bbre.iation List( 111(ismp(org

5>ccessed "ebruary &*' $%&$7(

F( >non( 2SDP >mbulatory Care >ction >genda( 2nstitute for Safe Dedication Practices(

111(ismp(org5>ccessed "ebruary &*' $%&$7(

J( >non( Sildenafil &6 topical cream((nt ) Pharm Compound$%%&H*:)JK(

( Sch1am E( Se.ere accidental o.erdose of -aminopyridine due to a compoundingpharmacy error() !merg "ed $%%KH&:*&-(
http://pharmlabs.unc.edu/http://www.ismp.org/http://www.ismp.org/http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=19443164http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=19443164http://pharmlabs.unc.edu/http://www.ismp.org/http://www.ismp.org/http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=19443164

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