ceutics 4 exam 1

category 1 sterile compounding

segregated compounding area

sterility testing not required

category 2 sterile compounding

cleanroom suite

sterility testing required for some BUDs

category 1 and 2 sterile compounding

gown can be reused in same shift

air sampling every 6 months

surface sampling monthly

media fill testing every 6 months

category 3 sterile compounding

no exposed skin

gowns sterile and single use

air sampling monthly

surface sampling weekly

media fill testing every 3 months

BUD category 2 room temp only sterile components

4 days

BUD category 2 room temp at least one non sterile starting component

1 day

BUD category 2 refrigerator all sterile

10 days

BUD category 2 refrigerator at least 1 non sterile

4 days

non sterile aqueous BUD non preserved

14 days refrigerator

non sterile aqueous BUD preserved

35 days room temp or fridge

non sterile non aqueous oral liquid BUD

90 days refrigerator or room temp

non sterile non aqueous BUD

180 days refrigerator or room temp

3 ways for a drug to be illegal under FD&C act

adulterated

misbranded

unapproved new drug

result of violating CGMP

legally adulterated

CGMP meaning

current good manufacturing practices

FDA 483 form

list of significant violations presented at the end of an inspection

concerns in inspections

sterility

pyrogens

particles

6 general coverage systems

quality

facilities and equipment

materials

production

packaging and labeling

laboratory

largest reason for recalls

packaging and labeling

drugs not as stable as they thought

evidence to collect

records

labeling

statements

observations

photographs

video

significance of a warning letter

more official form of FDA 483

dosage form fundamentals

bioavailability

stability

compliance

marketing

API

excipients

packaging

administration device

factors influencing stability

oxidation

hydrolysis

photolysis

solution definition

solute dissolved in solvent

will not separate

can’t be filtered out

best solvent for solute

similar polarity (like dissolves like)

suspension

2 phase system of solid particles dispersed through liquid phase

stokes law (factors affecting settling)

particle size

particle density

medium density

viscosity

gravitational constant

methylcellulose levigating agent

glycerin

emulsion

2 phase system in which one liquid (internal phase) is dispersed throughout another liquid (external phase) in small droplets

emulsifiers

Tween 80

Span 20

HLB

hydrophilic-lipohilic balance

higher = more water soluble

low = more lipid soluble

phase ratio

relative amounts of oil and water

flocculation

reversible

globules cluster together but are easily broken once shaken

creaming

reversible

merging of droplets of the internal phase due to difference in density to the top or bottom

coalescence

irreversible (bad)

merging of small droplets to large droplets to complete separation

dry gum method (continental)

4 oil

2 water

1 gum

added in that order

wet gum method (English method)

4 oil

2 water

1 gum

water and gum added together first

forbes bottle method

add everything together in one bottle and shake

oleaginous ointment base example

petrolatum

white ointment

absorption ointment base example

aquaphor

water removable base (oil in water emulsion) example

vanishing cream

hydrophilic ointment

water soluble cream base example

PEG ointment

polybase

water in oil ointment base example

eucerin

water in oil base acts similar to other ointments except

it is hydrous

when to use ointment

dry scaly skin

when to use cream

weeping lesions

when to use lotions

skin rubs together

methods of ointment preparation

incorporation and fusion

how to do fusion for ointment

highest melting point ingredients heated lowest required temperature

add lower melting point stuff in cooling phase

lowest melting point or liquids added last

fusion method in creams

separate into oil soluble and water soluble

both phases heated above melting point of highest melting point component

add aqueous phase to oil phase

add api last or to miscible phase if stable to heat

gels

dispersion of small or large molecules in aqueous liquid vehicle rendered jellylike by addition of gelling agent

gelling agents

carbomers

methylcellulose

tragacanth

single phase gels

uniform distribution

2 phase gels

floccules of small distinct particles referred to as magma

melting

liquify due to body temp

dissolve

requires moisture from body cavity

benefit of rectal suppositories

bypass first pass metabolism

oleaginous suppository base

cocoa butter

fattibase

fattyblend

disadvantages of cocoa butter

low melting point

polymorphic

water soluble suppository base

glycerinated gelatin

PEG

water soluble suppository base characteristics

dissolves

magnesium oxide

adsorbent

keeps powders dry

ascorbic acid

antioxidant

prevents oxidation

shellac/gelatin

coatings

prevent degradation due to oxygen, light, moisture and mask unpalatable taste

starches/lactose/cellulose

diluents

add size to small dosages

saccharin/mannitol/sorbitol

flavoring agent/sweetener

masks bitter flavor, gives sweetness

magnesium stearate

lubricant/anti adherent

keeps ingredients from sticking to each other and equipment

sodium benzoate/benzoic acid/benzalkonium chloride

preservative

prevent growth of bacteria and other pathogens

target weight for divided powder

250 mg

max amount of colored lactose

1:1 ratio max 100 mg

most versatile dosage form

capsule

weight of filled capsule

300 mg (within 5%)