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133 Cards in this Set
- Front
- Back
who regulates compounding (vs manufacturing)? |
STATE board of pharmacy |
|
Differences b/t compounding and manufactering (2) |
1. regulated by state 2. pt specific |
|
What must be applied to each compounded product, and which guidelines are used? |
beyond use dates - USP 795 |
|
My a pharmacy advertise compounded products? |
NO |
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Do compounded products have NDCs? |
NO |
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What is the default expiration for all compounded products? |
30 days |
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What guidelines do manufactured drugs use? |
GMP (good manufacturing practices) |
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Recommended sources for compounding preps? |
USP - includes food chemicals index and NF (national formulary) |
|
Expiration date for solid compounds |
up to 6 mo or no later than 25% time left on manufacturer's date - whichever is sooner |
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expiration date liquid preps |
max 2 weeks - if stored in fridge |
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What kind of water is used in compounding - for BOTH products + rinsing equipment? |
purified (NOT tap!!) |
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What kind of EtOH should be used when compounding an Rx that does not specify? |
95% ethyl |
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What products require sterile water? |
eye, wound, and injection |
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What kind of environment is required for sterile compounds? |
1. ISO class 7 clean room OR 2. ISO class 5 clean room |
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UPS guidelines for sterile compounding
|
797 |
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Required when preparing cytotoxic agents |
1. coated gown 2. 2 pairs ASTM-tested gloves 3. NIOSH certified N95 respiratory mask |
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When are pipettes used? |
1.5 ml or less of liquids |
|
mortar and pestles required for compounding |
1. 1 glass 2. 1 wood or porcelain |
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What kind of mortar and pestle is used for reducing particle size of dry powders and crystals? |
wedgewood/porcelain |
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What kind of mortar and pestle is used for bleding or pulverizing soft materials? |
porcelain |
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mortar and pestle used for liquids or chemicals (many chemotherapies) that are oily (stain) + for mixing liquids or semi-soft dosage forms? |
glass |
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What kind of weighing paper is best to use? |
glassine |
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When should plastic spatulas be use? |
when using chemicals such as K, I - that can react with stainless steel blades |
|
compounding slab = |
ointment slab, glass/nonabsorbent |
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process of reducing the size of a particle by grinding or adding a wetting agent in which the solid does not dissolve |
levigation |
|
triturating |
grinding |
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agent that transforms a solid to a uniform paste |
levigating agent |
|
vaseline =
|
petroleum |
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levigating agents for O/W dispersions (3) |
1. glycerin 2. PEG 2. PEG 80 |
|
levigating agents for W/O dispersions (3) |
1. mineral oil 2. castor oil 3. cottonseed oil 4. Tween 80 |
|
compound prepared WITHOUT a specific formula |
extemporaneous |
|
SINGLE agent used to soften and smooth the skin (no scents, coloring, etc added) |
emollient |
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2-phase systems of 2 immiscible liquids - 1 of which is dispersed through the other as small droplets |
emulsions |
|
stay separate when combined - do NOT form suspension |
immiscible |
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Used to stabilize an emulsion |
emulsifier |
|
usually surfactants, that reduce the surface tension between 2 liquids so that the 2 different substance can move closer to each other |
emulsifiers |
|
Eg emulsifiers |
1.Arlacel 2. span 3. Myrji 4. Tween 5. PEG 6. acacia 7. glyceryl monostearate 8. sodium laurel sulfate |
|
gum is mixed rapidly with oil, then water is added all at once |
Continental/dry gum method |
|
slower process in which gum is first dissolved in water, then oil slowly added |
English/wet gum method |
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ratio of oil: purified water: gum in both methods |
4: 2: 1 |
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scale of 0-20, used to choose a surfactant when preparing an emulsion |
Hydrophilic lipophilic balance |
|
more oil-soluble |
Hydrophilic lipophilic balance <10: use Arlacel, Span |
|
more water-soluble |
Hydrophilic lipophilic balance>10: use Myrji or Tween |
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2+ components that melt at a temp lower than the melting temp of the indv components |
eutectic mixture |
|
equation used for calculating the equilibrium constant within certain thermodynamic parameters |
VanHoff |
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Used to prevent oxidation |
antioxidants |
|
reaction of a substance with oxygen |
oxidation |
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catalyze oxidation (2) |
1. light 2.temp |
|
prone to oxidation |
unsat fatty acids |
|
common preservatives/antioxidants |
1. benzlkonium chloride (BAK) 2. benzyl alcohol 3. thimerosal - mercury 4. sodium benzoate 5. benzethonium chloride 6. propylparaben |
|
Bactroban |
mupirocin |
|
Lamisil |
terbinafine |
|
highest potency |
ointment |
|
Elocon |
mometasone |
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most OTC moisturizers are mostly water (so often come in pumps), absorb quickly, easy to spread |
lotion |
|
emulsions that are 1/2 oil + 1/2 water: packaged as tubes or tubs |
Creams |
|
Abreva |
docosanol |
|
80% oil + 20% water, don NOT absorb well, difficult to use on large areas |
ointments |
|
block/trap moisture |
occlusive |
|
5 classes of ointment bases |
1. oleaginous (petroleum) 2. absorption (lanolin) 3. W/O 4. O/W 5. water soluble/immiscible (PEG) |
|
thickest ointments, used as protective barriers |
paste |
|
oil in water emulsions, usually with an EtOH base; also used as thickeners |
gel |
|
common gels used as thickeners |
1. alginates 2. agar 3. carrageenan 4. gelatin 5. carbomer 6. liqua-gel |
|
1. powder size No. 8 , would be ___ 2. powder size No. 80, would be __ |
1. very COARSE 2. very FINE |
|
2-phased system of finely divided solid in liquid medium |
suspension |
|
repulsive forces between particles predominate so that the particles in the suspension repel each other and remain as discrete, single particles |
deflocculated |
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Important elements of suspensions |
1. deflocculated 2. settle slowly 3. easy to re-dispense by gently shaking 4. uniform particles that are of small size |
|
cocoa butter base for suppositories |
theobroma |
|
clear, sweetened hydroalcoholic solutions suitable for water INsoluble drugs |
elixirs |
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Make in molds (2) |
1. troches/lozenges 2. suppositories |
|
Mycelex |
clotrimazole troche |
|
mask bitter flavor (2) |
1. salty 2. sweet |
|
used to enhance fruit flavor |
acid (citric acid) |
|
binders that hold tablets together |
excipients |
|
thickening agent in liquids, also used as a plasticizer, laxative properties (AVOID in IBS) |
sorbital
|
|
used to soften capsules |
plasticizers: gylcerol and sorbitol |
|
largest capsule size |
000 |
|
smallest capsule size |
5 |
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what human body does to drug |
PK |
|
what drug does to human body |
pharmacodynamics |
|
study of the time course of drug: absorption, distribution, metabolism, excretion |
PK |
|
MOA, drug's therapeutic benefit, toxicity profile |
PD |
|
PD or PK?...used to explain bacteriostatic vs cidal effects |
PD |
|
process by which a drug moves from site of admin to circularoty system |
absorption |
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2 main areas of drug admin |
1. intravascular 2. extravascular |
|
Is there drug absoprtion with intravascular admin? |
NO - direct systemic circulation |
|
drug is released from its dosage form |
dissolution |
|
intestine vs gut/stomach |
intestine: more basic pH |
|
methods to increase dissolution rate |
reduce particle diameter = increased SA |
|
drugs with very small particle diameters |
micronized |
|
equation that describes rate of dissolution |
Noyes-Whitney |
|
determines rate and extent to which a drug dissolves in GI fluid |
solubility |
|
T/F: ONLY dissolved drug can be absorbed into the body |
TRUE
|
|
extent to which a drug is absorbed into systemic cirucation |
BA |
|
percentage of drug absorbed form extravascular admin realtive to IV admin |
BA |
|
Are 100% BA (1:1 IV:PO) |
1. furosemide 2. linazolid |
|
F= |
absolute BA |
|
calculated using AUC |
BA |
|
F (%) = |
100 x AUCextrav/AUCIV x DoseIV/Doseextr |
|
process by which drug melecules move from systemci circulation to tissues |
distribution |
|
Factors that affects distribution (5) |
1. lipophilicity 2. molecular weight 3. solubility 4. ionization status 5. extent of protein binding |
|
primary protein responsible for drug bidning |
albumin |
|
low albumin |
<3.5 |
|
drugs that are highly protein bound (3) |
1. phenytoin 2. valproate 3. calcium |
|
If albumin is low, true levels will be __ than given on lab report |
HIGHER |
|
relates amount of drug in the body to concentration measure in plasma |
Vd |
|
Vd = |
amount drug in body/conc in plasma |
|
Why do certain drugs (like warfarin) have very small Vd? |
highly protein bound - more drug remains in intravascular space (blood compartment) vs lipophilic drugs (chloroquine) |
|
Primary sites for drug metabolism (due to high levels of metabolic enzymes) |
1. liver 2. gut |
|
irreversible removal of drugs from the body |
excretion |
|
Modes of excretion (5) |
1. kidney - urine 2. liver - bile 3. gut - feces 4. lungs - exhaled air 5. skin - sweat |
|
Can a drug that is never absorbed, be excreted? |
NO |
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rate of drug removal in a certain volume of plasma over a certain amount of time |
clearence |
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T/F: the rate of elimination occurs at a steady state, which is proportional to the amount of drug intake. |
true |
|
Cl = |
ke/concentration |
|
ke = |
rate of eliminiation |
|
F x dose = |
Cl x AUC |
|
Cl = |
dose/AUC |
|
What type of kinetics do MOST drugs follow? |
FIRST order |
|
elimination is proporational to dose |
first-order |
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constant amount of drug is removed per unit time, no matter how much drug is in body |
zero-order |
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Begins as first-order, but when metabolsim becomes sat, concentration increases disproportionately |
Michaelis-Mentin |
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begin as first-order, change to zero-order once a certain dose is reached and metabolizing enzymes are sat. |
Michaelis-Menten |
|
Drug with Michaelis-Menten kinetics |
phenytoin |
|
fraction of drug eliminated per unit of time |
elimination rate constant (ke) |
|
ke =
|
cl/Vd
|
|
When is t1/2 INDEPENDENT of drug concentration? |
first-order kinetics |
|
t1/2 = |
0.693/ke |
|
When rate of drug intake = rate of elimination |
steady staet |
|
How many t1/2 before steady state with FIRST ORDER? |
5 |
|
# of t1/2 to reach 50% of ss? |
1 |
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# of t1/2 to reach 75% of ss? |
2 |
|
# of t1/2 to reach 94% of ss? |
4 |