Part 5

Question 1

What are 4 measures of the level of bioequivalence

Answer 1

-pharmaceutical equivalents
-pharmaceutical alternatives
-biological equivalents (bioequivalents)
-therapeutic equivalents

Question 2

What are pharmaceutical equivalents

Answer 2

Drug products are considered to be equivalents if they contain the same active ingredient and are identical in strength or concentrations, dosage form, and route of administration

Question 3

What are pharmaceutical alternatives

Answer 3

pharmaceutical alternatives are those drug products that contain the same therapeutic components, but are different salts, esters, or complexes of that moeity, OR are different dosages or strengths

Question 4

What are biological equivalents (bioequivalents)

Answer 4

bioequivalents ARE PHARMACEUTICAL EQUIVALENTS that exhibit comparable bioavailability when studied under similar experimental conditions

Question 5

what are therapeutic equivalents

Answer 5

therapeutic equivalents are pharmaceutical equivalents that can be expected to have the same clinical effect when administered to patients under the conditions specified in the label

Question 6

Bioequivalence means equivalence of bioavailability of two or more ____ (or _____) of the same drug.
If the products have similar bioavailability when tested under similar conditions, they are considered ________

Answer 6

bioequivalence means equivalence of bioavailability of 2 or more PRODUCTS (or dosage forms) of the SAME DRUG

bioequivalent

Question 7

What is evaluated to determine if 2 different products or dosage forms of the same drug are bioequivalent?

Answer 7

the parameters of bioavailability are evaluated for bioequivalence
(Cmax, Tmax, and AUC)

Question 8

100mg Ibuprofen and 100mg salt ibuprofen – what is the term for these

Answer 8

these are pharmaceutical alternatives because they contain the same therapeutic moiety but are different salts of that moeity

Question 9

Explain the starting steps of conducting a bioequivalence study

Answer 9

-a panel of 24 or more subjects is used

-usually HEALTHY subjects are selected

-subjects should be a similar age and weight

-all subjects are evaluated by a physician to assure they are suitable for participation in the study

Question 10

Is a bioequivalence study blinded?

Answer 10

yes —- it is double blinded.

Neither the researcher nor the subject knows what product is being given to the subject

Question 11

Explain how a double blinded bioequivalence study is conducted

Answer 11

-the subjects are divided into 2 groups. All subjects receive both products, but one product at a time.

-blood samples are collected at predetermined times and the concentration of drug in each blood sample is determined.

• a washout period is used (baseline) to assure that the 1st product is virtually eliminated from the body before the 2nd product is administered

(DOUBLE BLIND)

Question 12

Explain how the results of a bioequivalence study are analyzed

Answer 12

-the data is analyzed by an IMPARTIAL researcher or agency to avoid bias

-Average plasma-drug concentration vs time for each product is plotted

-Cmax, Tmax, and AUC for both products is determined.

-these 3 parameters are compared to determine bioequivalence

Question 13

What are 2 ways to control the plasma profile

Answer 13

-formulation

-administration (dosage form?)

Question 14

Oral

Answer 14

mouth

Question 15

Peroral

Answer 15

gastrointestinal tract via mouth

Question 16

sublingual

Answer 16

under the tongue

Question 17

parenteral

Answer 17

other than the gastrointestinal tract (by injection)

Question 18

intravenous

Answer 18

vein

Question 19

Intra-arterial

Answer 19

artery

Question 20

intracardiac

Answer 20

heart

Question 21

intraspinal/intrathecal

Answer 21

spine

Question 22

intraosseous

Answer 22

bone

Question 23

intra-articular

Answer 23

joint

Question 24

intrasynovial

Answer 24

joint fluid area

Question 25

intracutaneous/intradermal

Answer 25

skin

Question 26

subcutaneous

Answer 26

beneath the skin

Question 27

intramuscular

Answer 27

muscle

Question 28

epicutaneous (topical)

Answer 28

skin surface

Question 29

transdermal

Answer 29

skin surface

Question 30

conjunctival

Answer 30

conjunctiva

Question 31

intraocular

Answer 31

eye

Question 32

intranasal

Answer 32

nose

Question 33

aural

Answer 33

ear

Question 34

intrarespiratory

Answer 34

lung

Question 35

Name the dosage forms available for nitroglycerin

Answer 35

-sublingual -buccal -oral -ointment -transdermal infusion system

Question 36

What dosage form has the fastest onset time

Answer 36

IV/SL (also buccal!)

Question 37

between the dosage forms of nitroglycerin, which has the longest duration and the slowest onset of action?

Answer 37

transdermal infusion system

Question 38

Name some advantages of the oral route of administration

Answer 38

-natural -uncomplicated -convenient -safe

Question 39

name some disadvantages of the oral route of administration

Answer 39

slow drug response (parenteral is much faster) irregular absorption (food, stomach acid, enzymes)

Question 40

What is the purpose of enteric coating on tablets

Answer 40

to prevent the drug from being released into the stomach. instead, it dissolves in the intestines. This allows the tablet to safely pass through the acidic environment of the stomach, where certain drugs may be destroyed

Question 41

Tablets are formed by ___ or _____

Answer 41

compression or molding

Question 42

What are diluents in oral tablets?

Answer 42

diluents are fillers that are used to prepare tablets of the proper size and consistency

Question 43

What are disintegrants in oral tablets

Answer 43

used for the break up of compressed ingredients in the tablet. this ensures prompt exposure of drug particles to the dissolution process, ENHANCING DRUG ABSORPTION

Question 44

Besides enteric coatings, what is the use of other coatings on oral tablets

Answer 44

to protect the tablet against moisture, light, and air destruction during storage, OR to conceal the bitter taste from the taste buds of a patient

Question 45

Which absorbs faster --- capsules or tablets?

Answer 45

capsules

Question 46

The shell of a capsule is hard or soft, usually composed of ______

Answer 46

gelatin

Question 47

capsules vary in size from ___ to ___. Which is the largest size

Answer 47

000-5 000 being the largest size

Question 48

What are caplets

Answer 48

capsule-shaped and coated tablets

Question 49

capsules are a __ dosage form

Answer 49

solid

Question 50

In suspensions, the the drug particles must be ___ in the vehicle

Answer 50

INSOLUBLE

Question 51

What is a major advantage of suspensions over tablets and capsules

Answer 51

-a large dosage of the drug can be administered. easier to adjust the dose of a suspension rather than a tab or cap -absorption is faster in suspensions because the particles are readily available for dissolution (HIGH DISSOLUTION RATE) therefore, higher bioavailability

Question 52

Which has the largest surface area -- tablet, capsule or suspension? what does this mean?

Answer 52

suspension therefore, suspensions have the highest dissolution rate and thus the highest bioavailabilty

Question 53

Why are solutions absorbed much more rapidly than those administered in solid form?

Answer 53

because disintegration and dissolution are not required

Question 54

What are elixirs?

Answer 54

solutions sweetened by a hydroalcoholic vehicle

Question 55

What are syrups?

Answer 55

type of solution which use a sucrose solution as the sweet vehicle, resulting in a viscous solution

Question 56

what are magmas

Answer 56

very viscous

Question 57

Powders are similar to suspensions in that....

Answer 57

its easy to adjust the dosage

Question 58

what is the alimentary tract

Answer 58

another name for GI tract