ch 15 nonsterile compounding

pg 251 - 273

USP _______ - nonsterile preparations

795

USP _______ - sterile preparations

797

USP _______ - hazardous drugs

800

compounded nonsterile preparations (CNSPs)

administered:

orally

via tube

rectally

vaginally

topically

nasally

into the ear

nonsterile compounding is primarily used to _________

prepare a dose or formulation that is not comercially available

-changing a solid tablet to a liquid

-diluting

avoid an excipient

-gluten

-red dye

add a flavor

T/F nonsterile compounding can be performed in ambient air (room air), and can be in the same part of the pharmacy as dispensing

FALSE

can be performed in room air

must be SEPARATED from dispensing part and specifically designated

for nonsterile compounding, where do ingredients, equipment, and containers need to be stored?

off the floor

when should temperature be monitored in nonsterile compounding areas?

daily or continuously

what kind of water is needed for rinsing equipment and utensils used in nonsterile compounding?

purified water

distilled water

reverse osmosis water

when does training for nonsterile compounding need to be done?

initially

every 12 months

what garbing is required for nonsterile compounding?

remove jewelry, personal garments, and headphones

hand hygiene with soap and water for ≥ 30 seconds

gloves

how should all measurements be made?

metric system

what type of balance is simple to use, has higher sensitivity, and does not require a MWQ?

a. class III torsion balance

b. top-loading electronic balance (analytical balance or scale)

b. top-loading electronic balance (analytical balance or scale)

what does the minimum weighable quantity (MWQ) tell you?

minimum amount that can be weighed based on the sensitivity requirement (SR) and acceptable error rate

what makes a graduated cylinder more accurate?

same diameter from top to bottom

thinner mouth

measuring volumes that are ______ of the graduate’s capacity can cause a measuring error

< 20%

_______ are most accurate for measuring small volumes and viscous liquids

syringes

what needs to be put on oral syringes?

“for oral use only” sticker over the syringe cap

______ pipette draws up a set volume

a. Mohr

b. volumetric

b. volumetric

_______ mortars are used for liquids and mixing compounds that are oily or can stain

a. glass

b. wedgwood

c. porcelain

a. glass

_______ mortars have a rough surface and are preferred for grinding dry crystals and hard powders

a. glass

b. wedgwood

c. porcelain

b. wedgwood

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

a. glass

b. wedgwood

c. porcelain

c. porcelain

what kind of spatula should not be used if making a mixture that contains metallic ions?

a. stainless steel

b. disposable plastic

c. rubber

a. stainless steel

what is used to separate out larger particles and ensure uniform particle size?

powder sieves

list electric mixing equipment

homogenizer

grinder

ointment mill

a _________ is helpful when the temperature needs to be carefully controlled?

a. water bath

b. hot plate with magnetic stirrer

c. microwave oven

a. water bath

what are hard shells of capsules made from?

gelatin: pork-derived

hypromellose

plant-derived product

______ lower the surface tension between two ingredients (or phases) to make them more miscible (easier to mix together)

surfactants

surfactants are _________

a. hydrophilic

b. lipophilic

c. amphiphilic

c. amphiphilic

wetting agents/levigating agents

reduce surface tension between a liquid and solid

levigation: make particles smaller

what type of excipient is mineral oil?

levigating agent for lipophilic (oil-soluble) compounds

what type of excipient is glycerin or propylene glycol?

levigating agent for aqueous (water-soluble) compounds

_________ are added to suspensions to prevent the solid particles from settling

suspending agents/dispersants/plasticizers

what kind of excipient is Ora-Plus?

suspending agent

(bland taste)

what kind of excipient is Ora-Sweet?

suspending agent

provides flavor to Ora-Plus

what kind of excipient is Ora-Blend?

suspending agent

combination of Ora-Plus and Ora-Sweet

what kind of excipient is simethicone?

anti-foaming agent

what kind of excipients are polyethylene glycol (PEG) and poloxamer?

delivery vehicles and surfactants

a ________ is a mixture of 2 or more liquids which cannot be blended together (immiscible)

emulsion

why are emulsifiers added to an emulsion?

keep the liquid droplets dispersed throughout the liquid vehicle

prevents the two liquids from separating

surfactants with a low HLB value (< 10) are more lipid-soluble and are used in ________ emulsions

a. water-in-oil

b. oil-in-water

a. water-in-oil

low HLB = more lipid soluble

surfactants with a high HLB value (> 10) are more water-soluble and are used in ________ emulsions

a. water-in-oil

b. oil-in-water

b. oil-in-water

higher HLB = more water soluble

what kind of excipient is starch paste?

binder

what kind of excipient is lactose, starches, calcium salts, and cellulose powders?

diluents and fillers for tablets/capsules

what kind of excipient is petrolatum?

diluent and filler for topicals

what kind of excipients are alginic acid, cellulose products, and starches?

disintegrants

non-caloric, artificial sweeteners

aspartame

saccharin

sucralose

sweeteners

glycerin

dextrose

sugar alcohols (mannitol, sorbitol, xylitol)

stevia

aspartame

sucralose

what kind of excipient is magnesium stearate?

lubricant

what kind of excipients are chlorhexidine, povidone-iodine, sodium benzoate/benzoic acid, benzalkonium chloride, sorbic acid/potassium sorbate, methyl/ethyl/propyl parabens, EDTA, thimerosal, cetylpyridinium chloride?

preservatives

T/F you should not use preservatives in neonates

TRUE

what kind of excipients are magnesium oxide/carbonate and kaolin?

adsorbents

keep powders dry and prevent hydrolysis reactions

what kind of excipient is simethicone?

anti-foaming agent

what kind of excipients are shellac, gelatin, and gluten?

coatings

what are enteric coatings made of?

cellulose acetate phthalate

what kind of excipients are gelatin, cellulose, and bentonite?

gelling (thickening) agents

what kind of excipients are glycerin/glycerol, propylene glycol, and PEG?

humectants

prevent preparations from becoming dry and brittle

________ water is used for reconstitution (nonsterile)

distilled

________ water is used for hand washing

potable

_________ is used for preparation and reconstitution of sterile drugs

sterile water

sterile water for injection (SWFI) must be free from _________ produced by microorganisms that inhabit water

bacterial endotoxins (pyrogens)

________ is used as a solvent, preservative, and aroma (fragrance)

benzyl alcohol

what is the preferred disinfectant for sterile compounding equipment?

sterile IPA 70%

_______ is a PEG mixture used as a suppository base

polybase

what increases the half-life of PEG?

PEG linked to a protein drug (pegylated)

______ are best for extremely dry and thick skin

a. ointments

b. creams

c. lotions

a. ointments

______ are used for normal and dry skin

a. ointments

b. creams

c. lotions

b. creams

________ have the most water and are best for oily skin

a. ointments

b. creams

c. lotions

c. lotions

________ form a protective barrier to prevent the loss of water molecules from the top layer of the skin

occlusive ointments

-petroleum jelly

-theobroma oil (cocoa butter)

-waxes

ointments have ______% water

0-20

describe oleaginous ointments

oil-containing

no water

hydrocarbon base emollient

ex: white petrolatum, vaseline

creams have ______% water

20-50%

creams are _______ emulsions

water-in-oil or oil-in-water

aqueous solutions of poloxamers are _____ when refrigerated and form a ______ at room temperature

liquid when refrigerated

gel at room temperature

_______ for each bulk ingredient provide safety procedures, including the recommended PPE

safety data sheet (SDS)

when compounding you should make the product according to the _________

master formulation record

where do you document all compounding steps, ingredients, and other details?

compounding record

powders often include excipients, such as _______ to improve flowability of powder

glidant/lubricant

-magnesium stearate

powders often include excipients, such as _______ to neutralize static charge and prevent powder from dispersing

surfactants

-sodium lauryl sulfate

how do we reduce particle size?

comminution

3 main methods of comminution

trituration

levigation

pulverization by intervention

trituration

mix thoroughly

grinding tablets into a fine powder

levigation

triturating the powder with a mortar and pestle and incorporating a small amount of liquid to help with the grinding process

pulverization by intervention

used for crystalline powders that will not crush easily

crystals are dissolved with an intervening solvent and mixed until the solvent evaporates

geometric dilution

small amount of drug mixed into an equal amount of diluent

repeat

if melting ingredients, melt the ingredient with the ______ melting point before adding other ingredients

highest

eutectic mixture

combination of ingredients melts at a lower temperature than either of the individual component’s melting temperature

types of solutions

syrups

elixirs

tinctures

spirits

continental (dry gum) method

1. levigate the gum with oil

2. add the water all at once

3. triturate until a cracking sound is heard and mixture is creamy white

4. add other ingredients by dissolving them first in solution and add QS water to final volume

5. homogenize

english (wet gum) method

1. triturate the gum with water to form a mucilage

2. add oil slowly while shaking or mixing

3. add other ingredients as in the dry gum method

_________ deliver medication that acts locally in the mouth

lozenges/troches

a hard lozenge contains the active drug in a base of _______

sucrose or syrup

a soft lozenge contains the active drug in a base of _______

polyethylene glycol (PEG)

what is the BUD for a nonpreserved aqueous dosage form (Aw ≥ 0.6)?

14 days

refrigerator

what is the BUD for a preserved aqueous dosage form (Aw ≥ 0.6)?

35 days

what is the BUD for an oral liquid nonaqeuous dosage form (Aw < 0.6)?

90 days

what is the BUD for a nonaqeuous dosage form (Aw < 0.6)?

besides oral liquids

180 days

unit-dose

package that contains one dose of a medication

does unit-dose repackaging require a BUD?

YES

manufacturer’s expiration date or 6 months from repackaging date