Compounding Flashcards by Sara Bojarski

CNSPs include

oral, via tube, rectal, vaginal, topical, or nasal

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nonsterile compounding is used to

prepare dose/formulation not commercially available
avoid excipient
add a flavor

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training for nonsterile compounding with proficient core competencies must be completed initially then how often

every 12 months
hand hygiene and garbing

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2 types of balances

class III torsion balance (class A balance)
electronic/analytical balance (scale)

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typical sensitivity requirement (SR) of torsion balance?

acceptable error rate?

SR = 6mg

acceptable error rate = 0.05 or 5%

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minimum weighable quantity (MWG)=

for torsion balance

SR / acceptable error rate

usually 6 mg/0.05

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measuring volumes < ___% of the graduates capacity can cause a measuring error

<20%

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what type of pipette is graduated? which draws up only a set volume?

Mohr is graduated
volumetric draws up set volume

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which mortar is used for liquids and for oily compounds or can stain

glass

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which mortar has a rough surface preferred for grinding

wedgewood

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which mortar has a smooth surface preferred for blending powders and pulverizing gummy consistencies

porcelain

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2 things used to make capsule shells

gelatin - pork based
hypromellose - plant derived

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lower the surface tension between two ingredients in a preparation to make them more miscible; amphiphilic

surfactant

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types of surfactants

wetting/levigating agent, suspending agent, foaming agent, glycols & gels, emulsifiers

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type of surfactant that reduces surface tension between a liquid and a solid

wetting/levigating agents

use with levigation to make the product smaller

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examples of wetting/levigating agents

mineral oil for lipophilic compounds
glycerin, propylene glycol for aqueous compounds

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type of surfactant added to a suspension to prevent solid particles from settling

suspending agents (dispersants)

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two brands of suspending agent

ora-plus - bland
ora-sweet - provides flavor

also available in combo

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example of an anti-foaming agent for compounding

simethicone

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type of surfactant that is also a delivery vehicle with both hydrophilic and hydrophobic parts

examples?

glycols and gels

polyethylene glycol (PEG) and poloxamer

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type of surfactant added to an emulsion to keep the liquid droplets dispersed throughout the liquid vehicle

emulsifiers

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value that determines which type of surfactant is required to make an emulsion

what is the scale range?

hydrophilic-lipophilic balance (HLB)

0-20 , midpoint is 10

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what does low HLB mean

<10
more lipid soluble, used in w/o emulsions

ex) Span 65

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what does high HLB mean

> 10
more H2O soluble, used in o/w emulsions

ex) PEG400 and Tween 85

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excipient that allows contents of a tablet to stick together while permitting contents to be released when ingested provide stability

binders

example of a binder

starch paste acacia, sucrose syrup, compressible sugar

excipient that adds size to small dosages

diluents and fillers

examples of diluents/fillers for tabs/caps? topicals?

tab/cap - lactose, starches, calcium salts, cellulose powder topicals- petrolatum

excipient that facilitate breakup of a tablet to dissolve to be absorbed

disintegrants

examples of disintegrants

alginic acid, cellulose products, starches

examples of sweeteners added as excipients

glycerin, dextrose, Stevia sugar alcohols- mannitol, sorbitol, xylitol non-caloric/artificial - aspartame, sucralose

excipient that prevents ingredients from sticking together ; improve powder flowability

lubricants (glidants)

example of lubricants

magnesium stearate

excipient that prevents microbial growth

preservatives

examples of preservatives

chlorhexidine (surg scrubs), povidone iodine, sodium benzoate/benzoic acid, benzalkonium chloride, sorbic acid/potassium sorbate, methyl/ethyl/propyl parabens, EDTA, thimerosal, cetylpyridinium chloride

what population should preservatives be avoided in

neonates

excipient that keeps pH in a certain range ionized = polar = more water soluble henderson hasselbach to determine pH of system

buffers

examples of adsorbents

magnesium oxide/carbonate, kaolin

example of anti-foaming agent

simethicone

examples of coatings (regular)

shellac, gelatin, gluten, cellulose acetate phthalate

excipient that increases viscosity and can stabilize

gelling (thickening) agent

examples of gelling agents (3 most common)

*gelatin, cellulose, bentonite* agar, alginates, various gums, starches, poloxamer gels

examples of humectants

glycerin or glycerol, propylene glycol, PEG

water that has been treated to remove contaminants methods include distillation, deionization, and reverse osmosis

purified

drinking/tap water that is safe to drink and for hand washing

potable water

water used for reconstitution to prepare suspensions in nonsterile compounding

distilled

water that is free of bacterial endotoxins (pyrogens) that inhabit water

sterile water

what type of water is used for reconstitution of sterile drugs or washing/rinsing/diluting products used for irrigating body cavities, wounds, urinary catheters, or surgical drainage tubes

sterile water

solvent that has high miscibility with water and can be used to dissolve solutes that are insoluble in water alone

alcohol

example of an alcohol used as a solvent, preservative, and for fragranes

benzyl alcohol

preferred disinfectant for sterile compounding equipment

sterile IPA 70%

examples of glycol solvents

PEG, Polybase (for suppositories, also an emulsifier)

PEG is a glycol used as

surfactant, solvent, lubricant water soluble and water miscible

what happens when PEG is pegylated (linked to a protein drug)

increases half life

example of a oil/fat solvent

mineral oil (ingredient of baby oil)

product that softens and soothes the skin

emollient

type of emollient that is best for extremely dry and thick skin

ointments

type of emollient that are used for normal and dry skin

creams

type of emollient that has the most water and is best for oily skin

lotions

excipient that prevents preparations from becoming dry and brittle; used in emollients

humectant

emollient that forms a protective barrier to prevent loss of water

occlusive ointment

examples of occlusive ointments

petroleum jelly (white petrolatum), theobroma oil (cocoa butter), waxes

what % water are ointments

0-20%

examples of ointments

petrolatum, Polybase, Aquaphor, Aquabase

type of ointment base that is called oleaginous ointments (no water)

hydrocarbon based ointment

examples of hydrocarbon base ointments

petrolatum (Vaseline petroleum jelly)

creams are what % water

20-50%

which emollient contains the most water

lotions

which emollient is usually w/o or o/w emulsions

creams

what can be added to lotions to solubilize ingredients

alcohol

aqueous solutions of what gelling agent are liquid when refrigerated or gel at room temp? what is this good for?

poloxamer (PLO gel) - contain a hydrophobic chain with two hydrophilic chains good for transdermal drug delivery

examples of suppository bases

polybase, hydrogenated vegetable oils, PEG, gelatin

avoid alcohol excipient in

children - hypoglycemia, acidosis, CNS depression

avoid aspartame (contains phenylalanine) excipient in

PKU - cannot metabolize to phenylalanine

avoid gelatin excipient in

vegan use hypermellose shells instead

avoid gluten excipient in

celiac disease or those avoiding use a different starch

avoid lactose excipient in

lactose intolerance

avoid sugar alcohol (mannitol, sorbitol, xylitol) excipient in

IBS - GI distress

avoid sucrose excipient in

diabetes - can raise BG

avoid xylitol excipient in

dogs - can cause toxicosis (hypoglycemia and hepatotoxicity)

excipient used with powders to neutralize static charge example?

surfactant sodium lauryl sulfate

3 methods of comminution

trituration levigation pulverization by intervention

mixture where the combo of ingredients melts at a lower temp than either individual components melting temperatures

eutectic mixture

solute dissolved in solvent 4 examples?

solution syrups, elixirs, tinctures, spirits

solid dispersed in a liquid, two phase heterogenous wetting/levigating agent is the surfactant used to incorporate

suspension

liquid dispersed in liquid, two phase heterogenous mixture emulsifier is surfactant used to prevent them from separating

emulsion o/w or w/o

precipitation/sedimentation can occur in which 2 dosage forms

suspensions, emulsions - shake

calculation used to determine time for a solute to dissolve to make a solution

Ficks first law of diffusion

5 steps of the continental (dry gum) method to make an emulsion

1. levigate the gum with oil 2. add water all at once 3. triturate until a cracking sound is heard and mixture is creamy white 4. add other ingredients by dissolving first 5. homogenize

3 steps of english (wet gum) method to make an emulsion

1. triturate the gum with water to form a mucilage 2. add oil slowly while shaking 3. add other ingredients as in dry gum

2 excipients used as plasticizers to make caps less brittle and more flexible

glycerol sorbitol

3 bases commonly used for lozenges

sucrose or syrup for hard lozenges PEG for soft lozenges

method of heating ointments to mix components well

fusion method

what is the water soluble suppository bases? oil soluble?

water- PEG and gelatin oil- hydrogenated vegetable oils

water activity (Aw) of an aqueous preparation

Aw >= 0.60

water activity (Aw) of a nonaqueous preparation

Aw < 0.60

BUD if nonpreserved aqueous

14 days in fridge

BUD if preserved aqueous

35 days

BUD if nonaqueous oral liquid

90 days

BUD if other nonaqueous dosage form

180 days

maximum extended BUD if stability data

180 days

BUD for unit dose repacking

manuf expiration date or 6 months from repacking date

documents recipe followed? log book of products made?

recipe- MFR log- compounding record

what is sterile compounding used to prepare

injections, eye drops, irrigations, pulmonary inhalations, baths/soaks for live organs, implants

CSP

COMPOUNDED STERILE PRODUCT

SVP / LVP

SMALL VOLUME PARENTERAL <100ml LARGE >100 ml

PPE

PERSONAL PROTECTIVE EQUIPMENT

PEC /SEC

PRIMARY ENGINEERING CONTROL

LAFW

LAMINAR AIRFLOW WORKBENCH

SCA

SEGREGATED COMPOUNDING AREA

CAI

COMPOUNDING ASEPTIC ISOLATOR

RABS

restricted access barrier system

ISO rating in critical areas/inside PEC

iso 5

ISO rating in the SEC/buffer room

iso 7

ISO rating in the anteroom where hand washing and garbing occur *remember line of demarcation clean v dirty*

iso 8 if it opens into a positive pressure buffer area

how many air changes per hour (ACPH) must occur in ISO 7 air

30 ACPH

what is the air pressure in the PEC and SEC

positive - protects CSPs

one or more ISO5 PECs inside an ISO 7 buffer room that is entered through an adjacent anteroom

cleanroom suite

iso5 PEC, usually an isolator (glovebox) with a closed front located in a segregated space with unclassified air

segregated compounding area (SCA)

space in front of the HEPA filter HEPA recertified how often?

direct compounding area recertified HEPA Q6M

open front PEC with horizontal laminar airflow

laminar airflow workbench

closed front PEC usually located in a SCA

compounding aseptic isolator (CAI)

how often is training for sterile compounding

initial then continuous Q12M

assessment of aseptic technique for hand hygiene, garbing, and gloving how often?

gloved fingertip test initial then Q6M for category 1 &2 CSPs

assessment of aseptic technique in sterile drug preparation how often?

media fill test initial then Q6M for category 1 &2 CSPs

how to pass gloved fingertip test? fail?

pass with 3 consecutive samples with 0 CFUs fail is CFUs form indicating contamination

how to pass media fill test? fail?

pass if clear after 14 days fail if turbidity is present

how often is air sampling done? surface sampling?

air - Q6M surface - every 30 days

what to do if the PEC stops running

clean, disinfect, then 70% IPA, then run for 30 minutes before use

how to clean the PEC? what with?

clean with detergent disinfect 70% IPA - use throughout day top to bottom, back to front ceiling, back, bar, side walls, equipment, bottom

how often to clean PEC, pass throughs, work surfaces outside PEC, floors?

daily

what garb is required for sterile compounding

head cover (facial hair), shoe covers, gown, gloves, face mask

steps to garb for sterile compounding

head cover, face mask, shoe covers over demarcation, hand hygiene w/ soap and water, clean under nails, wash up to elbows for 30 seconds, gown, apply alcohol surgical scrub (chlorhexidine, povidone iodine), don gloves, sanitize gloves with 70% IPA regularly

can a sterile compounding gown be reworn

if not soiled then yes kept in anteroom during THAT SHIFT

what is required to draw liquid from an ampule

filter needle or filter straw

example of a ready to use vial bag system

ADD-vantage

device used to transfer ingredients into a sterile final container than interfaces with the EHR

automated compounding devices

what to do with items before putting into the hood? how far into hood do you work?

wipe with 70% IPA 6 inches into hood

to avoid blocking the HEPA filter in horizontal flow, place all items

side by side in horizontal airflow

occurs when a small piece of rubber from the stopper is aspirated into the needle

coring

what to look for on visual inspection against a dark background of a CSP

particulates, cored pieces, precipitates, cloudiness lightly squeeze to check for holes

what can be done to ensure absence of contamination in a CSP and is required for certain CSP categories

sterility testing

what is required for CSPs made with nonsterile ingredients? examples?

terminal sterilization steam, (autoclave), dry heat filtration with 0.22 micron filter for heat-labile CSPs

how to avoid endotoxins (pyrogens; bacteria and fungi)? where do they come from?

come from tap water rinse glassware and utensils with sterile water and depyrogenate

category of CSPs prepared in ISO5 PEC in a SCA with shorter BUD

category 1

category of CSPs prepared in a cleanroom suite with longer BUDs

category 2

category of CSPs made with specific requirements which allow for longer BUD up to 180 days and requires sterility testing

category 3

immediate use category CSP BUD?

4 hours

category 1 CSP room temp BUD?

12 hours

category 2 CSP room temp BUD?

1-45 days

category 3 CSP room temp BUD?

60-90 days

category 1 CSP fridge BUD?

24 hours

category 2 CSP fridge BUD?

4-60 days

category 3 CSP fridge BUD?

90-120 days

category 2 CSP freezer BUD?

45-90 days

category 3 CSP freezer BUD?

120-180 days

temps of room temp, fridge, freezer

room 20-25 c fridge 2-8C freezer -25 - -10

BUD of single dose containers opened in ISO5?

up to 12 hours from opening ampules = discard

BUD of multi dose container opened in ISO5

up to 28 days

when is a drug considered hazardous?

carcinogenic, teratogenic, genotoxic, toxic to organs, toxic to reproduction

hazardous NIOSH drugs

chemo dutasteride, finasteride mifepristone/misoprostol warfarin cidofovir, ganciclovir, valganciclovir carbamazepine, oxcarbazepine, fosphenytoin, phenytoin, topiramate, valproate clonazepam, temazepam exenatide lomitapide spironolactone ribavirin ambrisentan, bosentan, macitentan, riociguat tretinoin paroxetine methimazole, propylthiouracil cyclosporine, mycophenolate, tacrolimus, sirolimus acitretin, azathioprine, fingolimod, leflunomide, teriflunomide androgens, estrogens, oxytocin, progestins, SERDs/SERMs, ulipristal

hoods and buffer rooms for hazardous meds use what work?

containment

sterile and nonsterile hazardous meds must be made in a

CPEC located in a CSEC or CSCA

type of hazardous CPEC with vertical laminar airflow, must be class II for steril HD compounding

biological safety cabinets (BSCs)

type of hazardous CPEC used for nonsterile compounding only

containment ventilated enclosures (CVEs)

type of hazardous CPEC that are closed front

compounding aseptic containment isolators (CACIs)

what are exceptions to separating nonsterile and sterile HD compounding

CSEC maintains ISO7 air separate sterile and nonsterile CPECs 1 meter apart no particle generating activity at the same time

air pressure for C-SECs and C-SCAs? anteroom? iso?

negative positive anteroom so maintain ISO7

required ACPH for nonsterile HDs

12 ACPH

required ACPH in a sterile C-SEC

30 ACPH

required ACPH in a C-SCA

12 ACPH

what must happen with air contaminated with HDs

externally exhaust, cannot recirculate alt. redundant HEPA filters

required pressure and ACPH for HD storage

negative pressure 12 ACPH

garb for HD compounding

respirator (N95), face mask, head cover, chemo gown, 2 shoe covers, 2 chemo gloves, eye/face protection when risk for HD spills or working outside C-PEC

requirements for gloves with HD compounding

change every 30 minutes 2 pairs- 1 under cuff and 1 over powder free meet ASTM standard D6978

requirements for chemo gowns for HD compounding

disposable impermeable close in back, long sleeve, closed cuffs change every 203 hours or immediately after a spill or splash

garb for admin of HD meds?

2 pairs chemo gloves for antineoplastics 1 pair gloves for intact tabs/caps gown for injectable HDs

garb for storage/transport of HD? what cannot be used to transport liquid HDs or neoplastics

1 pair gloves no use pneumatic tubes

should you transfer air into the vial for HDs

no use negative pressure technique or closed system transfer devices (CSTD)

what do closed system transfer devices (CSTD) do? when to use

built in valve equalizes air pressure recommended for compounding (reconstitution) required for administering

outer chemo gloves, gown, and show covers are disposed in which bin?

yellow trace chemo bin

trace hazardous waste (empty vials, syringes) are disposed in which bin

yellow trace chemo bin

bulk hazardous waste (unused or partially empty vials, syringes, bags) are disposed in which bin

black Black = Bulk

steps of once daily HD area sanitization (3 steps, 4 for sterile)

1. deactivation 2. decontamination 3. cleaning 4. disinfection (sterile only)

what can be used for both deactivation and decontamination for HD sanitization?

bleach (sodium hypochlorite) or peroxide

what is used for cleaning and disinfection for HD sanitization?

cleaning- germicidal detergent disinfection- EPA disinfectant or 70% IPA

how often is wipe sampling done for HD compounding

Q6M

what is contained in a spill kit for HDs

gown, gloves, N95 respirator, goggles, HD waste bag, chemo pads, scoop and scraper, HD spill report exposure form

where is HD spills disposed

black bin

Compounding Flashcards

(189 cards)