non sterile compounding

most compounded drugs are prepared for

an individual based on a prescription

the dose cannot be commercially available

usp 795

nonsterile compunding

usp 797

sterile compounding

usp 800

hazardous drugs

nonsterile preparations are administered cia

orally via tube, rectally, vaginally, topically, nasally or in the ear

nonsterile compounding is primarily used to (3)

prepare a dose or formulation that is not commercially available

avoid an excipient

add a flavor

space requirements for nonsterile compounding

can be performed in room air but must be separated from the dispensing part of the pharmacy, the space must be specifically designated

ingredients and equipments must be stored off the floor

temperature should be monitored daily or continuously

easily accessible sink

purified water for rinsing equipment and utensils

nonsterile compounding personnel and training

there must be a designated person

training should be documented

training with demonstrated proficiency must be completed inititially and every 12 months

core competencies include hand hygiene and garbing

a compounder must notify

the designated person if they have any issues with contamination

when entering the compounding area the compounder must complete

hand hygiene with soap and water

gloves are required

compounding equiment must be

calibrated regularly to confirm accuracy

all measures should be in the

metric system

metal spatula should not be used with

compounds containing metal ions

what are the two types of balances

class iii torsion balance ( also called a class A balance)

electronic balance (analytical balance or scale)

an electronic balance has a higher

higher sensitivity

tare or zero out the balance to ensure only the ingredients are weighed

torsion balances have a what and what

sesnsitivity requirement and minimum weighable quantity

what is the acceptable error rate of torsion balances

0.05 or 5%

how to calculate MWQ

SR/acceptable error rateu

what are graduates

an equipmemt with lines on the glass used to measure volume

what is a graduated cylinders

same diameter from top to bottom and provides more accurate measurements

the wider the mouth the lower the accuracy

measuring volumes that are <20% of the graduates capacity can cause

a measuring error

how to read the volume in a graduate

place on a flat surface and read at eye level

the curve the liquid in the cylinder makes is called

the meniscus

how is the measurement read in a cylinder

at the bottom of the meniscus at the center

another name for hypodermic syringe

injection or parenteral syringe

syringes are most accurate for

measuring small volumes and useful for measuring viscous (thick) liquids

how should you label syringes

safety measures - clearly label for oral use only sticker over the syringe cap

what are pipetttes

thin plastic or glass tubes

two types of pipettes

mohr (graduated) and volumetric

glass mortars are used for

liquids and compounds that are oily or can stain

wedgewood mortars have a

rough surface

pocelain mortars have and are used for

a smooth surface and are preferred for blending powders and pulverizing gummy consistencies

spatulas are used to

mix and transfer ingredients

the flat part of a spatula can

flatten and grind down ingredients

most commonly used spatulas are

stainless steel and disposable plastic spatulas

ointment slabs are used as

a work surface for other purposes for example to form pills in which case can be called pill tiles

powder sieves

sifters that insure a uniform particle size

types of electronic mixing equipments (3)

homogeinizers, grinders, oil mills

another name for homogenizers

electric mortar and pestles

a grinder is useful for

grinding hard tablets into a rough powder

oinment mills do what?

draws the ointment between rollers that grind and homogenize

a water bath is helpful when

the temperature needs to be carefully controlled

a hot plate with a ____ can save time

magnetic stirrer

soft delivery vehicles are often dispensed in___

__ also helps soft products retain shape

dispensable plastic molds

refrigeration

capsules can be what or what.

the shells are made of ___ an animal prduct which is___ or from ___ a similar plant dereived product

soft gels or hard shells

gelatin; pork derived; hypromellose

all medications whether compunded or not include two things what are they

active pharmaceutical ingredients and excipients

ingredients for compounding should come from where

usp national formulary

ingredients degrade and expiration dates are important to

if there is an ingredient without an expiration date ,

ensure products retain potency and is non toxic

the pharmacist will assign a conservative date

surfactant is the contraction os what words

surface, active, agent

what do surfactants do

lower the surface tension between two ingredients in a preparation to make them more miscible (easier to mix together)

surfactants are

ampiphilic

adding a surfactant to a suspension leads to

delivery of a more consistent dose by keeping the drug dispersed for longer

what are other names for surfactants

wetting agents/levigating agents, suspending agents

what are wetting agents

reduce the surface tension between a liquid and a solid

levigating is a technique used to

grind particles (make them smaller)

mineral oil is a common levigating agent for what kind of compunds

lipophilic

glycerin or propylene glycol is used for what kind of compund

aqueous (water soluble) compounds

what is a suspension

it is a solid dispersed in a liquid

what are suspending agents

added to suspensions to prevent solid particles from settling

suspensions must be ____ to ___ the solid

shaken; redisperse

suspending agents can also be called

dispersants or dispersing agents

what are the commecially available suspending agents

ora-plus: keeps drug particles suspended and prevents settling; bland taste

ora sweet: provides flavor

ora-blend: combination of both

example of anti foaming agent

simethicone

what are polyethylene glycol and poloxamer

they are both delivery vehicles and surfactants. they have both hydophylic and hydrophobic parts

what us an emulsion

two or more liquids which cannot be blended together

what are emulsifiers

added to emulsion to keep the liquid droplets dispersed throughout the liquid vehicle

selecting the surfactant depends on

whether the emulsion is a water in oil or oil in water

surfactants with a low HLB value <10

more lipid soluble and used in w/o

surfactants with a high HLB value >10

more water soluble and used in water in oil

examples of excipients

binders, diluents and fillers, disintegrants, flavorings and coloring agents, lubricants

binders purpose

allow the content of a tablet to stick together . they provide stability and strength

example of binders

starch paste

diluents and fillers purpose

they add size to small dosages

diluent and fillers example

tablet/capsules: lactose, starches, calcium salts, cellulose

topicals: petrolatum

disintegrants purpose

oral products have to be dissolved in order to be absorbed

alignates and cellulose absorb water causing the tablet to swell and release its contents

disintegrants examples

alignic acid

cellulose products

starches

flavoring examples

aspartame, sucralose, glycerin, dextrose, mannitol, sorbitol, xylitol, stevia

lubricants purpose

prevent ingredients from sticking to each other. glidants improve powder flowability

lubricants example

magnesium stearate

preservatives purpose

prevent microbial growth

do not use preservatives in neonates

preservatives examples

chlorhexidine in surgical scrubs

povidone-iodine

sodium benzoate/benzoic acid, benzalkonium chloride

sorbic acid/potassium sorbate

methyl/ethyl/propyl parabens

EDTA

thimerosal

cetylpyridinium chloride

what are buffers

they keep the pH within a certain range

adsorbent examples

magnesium oxide/carbonatem kaolin

coatings example

shellac, gelatin, gluten

cellulose acetate phthalate

gelling (thickening) agents examples

agar, alginates, various gums (guar, xanthan, acacia), gelatins, bentonite, cellulose, starches, poloxamer (pluronic) gels

humectants examples

glycerin or glycerol, propylene glycol, PEG

what are types of purification

distillation, deionization, and reverse osmosis

distilled water is used for ___ to prepare ____ and in _____ preparations

reconstitution; oral suspensions';non sterile compounding preparations

potable water is safe to drink and used for

handwashing

purified water has been___ to remove chemicals and contaminants

treated

alcohol have high

misibility with water and can be used to dissolve solutes that would be insoluble in water

polyethylene glycol is used as a

surfactant, solvent, lubricant, it is water soluble and water miscible

when peg is linked to a protein it does what

increases the half-life

benzyl alcohol is used as what

preservative and fragrance

what is the preferred disinfectant for sterile compounding equipment

sterile IPA 70%

polybase is used as

a suppository base; emulsifier

the ingredient in baby oil is

mineral oil

an emollient refers to a product that

softens and soothes the skin

ointments are best for

extremely dry skin and thick skin

creams are used for

normal to dry skin