Compounding, Pk

who regulates compounding (vs manufacturing)?

Differences b/t compounding and manufactering (2)

What must be applied to each compounded product, and which guidelines are used?

My a pharmacy advertise compounded products?

Do compounded products have NDCs?

What is the default expiration for all compounded products?

What guidelines do manufactured drugs use?

Recommended sources for compounding preps?

Expiration date for solid compounds

expiration date liquid preps

What kind of water is used in compounding - for BOTH products + rinsing equipment?

What kind of EtOH should be used when compounding an Rx that does not specify?

What products require sterile water?

What kind of environment is required for sterile compounds?

Required when preparing cytotoxic agents

When are pipettes used?

mortar and pestles required for compounding

What kind of mortar and pestle is used for reducing particle size of dry powders and crystals?

What kind of mortar and pestle is used for bleding or pulverizing soft materials?

mortar and pestle used for liquids or chemicals (many chemotherapies) that are oily (stain) + for mixing liquids or semi-soft dosage forms?

What kind of weighing paper is best to use?

When should plastic spatulas be use?

compounding slab =

process of reducing the size of a particle by grinding or adding a wetting agent in which the solid does not dissolve

triturating

agent that transforms a solid to a uniform paste

levigating agents for O/W dispersions (3)

levigating agents for W/O dispersions (3)

compound prepared WITHOUT a specific formula

SINGLE agent used to soften and smooth the skin (no scents, coloring, etc added)

2-phase systems of 2 immiscible liquids - 1 of which is dispersed through the other as small droplets

stay separate when combined - do NOT form suspension

Used to stabilize an emulsion

usually surfactants, that reduce the surface tension between 2 liquids so that the 2 different substance can move closer to each other

Eg emulsifiers

gum is mixed rapidly with oil, then water is added all at once

slower process in which gum is first dissolved in water, then oil slowly added

ratio of oil: purified water: gum in both methods

scale of 0-20, used to choose a surfactant when preparing an emulsion

more oil-soluble

more water-soluble

2+ components that melt at a temp lower than the melting temp of the indv components

equation used for calculating the equilibrium constant within certain thermodynamic parameters

Used to prevent oxidation

reaction of a substance with oxygen

catalyze oxidation (2)

prone to oxidation

common preservatives/antioxidants

Bactroban

Lamisil

highest potency

Elocon

most OTC moisturizers are mostly water (so often come in pumps), absorb quickly, easy to spread

emulsions that are 1/2 oil + 1/2 water: packaged as tubes or tubs

Abreva

80% oil + 20% water, don NOT absorb well, difficult to use on large areas

block/trap moisture

5 classes of ointment bases

thickest ointments, used as protective barriers

oil in water emulsions, usually with an EtOH base; also used as thickeners

common gels used as thickeners

1. powder size No. 8 , would be ___

2. powder size No. 80, would be __

2-phased system of finely divided solid in liquid medium

repulsive forces between particles predominate so that the particles in the suspension repel each other and remain as discrete, single particles

Important elements of suspensions

cocoa butter base for suppositories

clear, sweetened hydroalcoholic solutions suitable for water INsoluble drugs

Make in molds (2)

Mycelex

mask bitter flavor (2)

used to enhance fruit flavor

binders that hold tablets together

thickening agent in liquids, also used as a plasticizer, laxative properties (AVOID in IBS)

used to soften capsules

largest capsule size

smallest capsule size

what human body does to drug

what drug does to human body

study of the time course of drug: absorption, distribution, metabolism, excretion

MOA, drug's therapeutic benefit, toxicity profile

PD or PK?...used to explain bacteriostatic vs cidal effects

process by which a drug moves from site of admin to circularoty system

2 main areas of drug admin

Is there drug absoprtion with intravascular admin?

drug is released from its dosage form

intestine vs gut/stomach

methods to increase dissolution rate

drugs with very small particle diameters

equation that describes rate of dissolution

determines rate and extent to which a drug dissolves in GI fluid

T/F: ONLY dissolved drug can be absorbed into the body

extent to which a drug is absorbed into systemic cirucation

percentage of drug absorbed form extravascular admin realtive to IV admin

Are 100% BA (1:1 IV:PO)

F=

calculated using AUC

F (%) =

process by which drug melecules move from systemci circulation to tissues

Factors that affects distribution (5)

primary protein responsible for drug bidning

low albumin

drugs that are highly protein bound (3)

If albumin is low, true levels will be __ than given on lab report

relates amount of drug in the body to concentration measure in plasma

Vd =

Why do certain drugs (like warfarin) have very small Vd?

Primary sites for drug metabolism (due to high levels of metabolic enzymes)

irreversible removal of drugs from the body

Modes of excretion (5)

Can a drug that is never absorbed, be excreted?

rate of drug removal in a certain volume of plasma over a certain amount of time

T/F: the rate of elimination occurs at a steady state, which is proportional to the amount of drug intake.

Cl =

ke =

F x dose =

Cl =

What type of kinetics do MOST drugs follow?

elimination is proporational to dose

constant amount of drug is removed per unit time, no matter how much drug is in body

Begins as first-order, but when metabolsim becomes sat, concentration increases disproportionately

begin as first-order, change to zero-order once a certain dose is reached and metabolizing enzymes are sat.

Drug with Michaelis-Menten kinetics

fraction of drug eliminated per unit of time

When is t1/2 INDEPENDENT of drug concentration?

t1/2 =

When rate of drug intake = rate of elimination

How many t1/2 before steady state with FIRST ORDER?

# of t1/2 to reach 50% of ss?

# of t1/2 to reach 75% of ss?

# of t1/2 to reach 94% of ss?