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pharmaceutics exam 1 > Part 5 > Flashcards

Part 5 Flashcards

1
Q

What are 4 measures of the level of bioequivalence

A

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

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2
Q

What are pharmaceutical equivalents

A

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

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3
Q

What are pharmaceutical alternatives

A

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

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4
Q

What are biological equivalents (bioequivalents)

A

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

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5
Q

what are therapeutic equivalents

A

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

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6
Q

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 ________

A

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

bioequivalent

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7
Q

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

A

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

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8
Q

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

A

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

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9
Q

Explain the starting steps of conducting a bioequivalence study

A

-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

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10
Q

Is a bioequivalence study blinded?

A

yes —- it is double blinded.

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

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11
Q

Explain how a double blinded bioequivalence study is conducted

A

-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)

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12
Q

Explain how the results of a bioequivalence study are analyzed

A

-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

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13
Q

What are 2 ways to control the plasma profile

A

-formulation

-administration (dosage form?)

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14
Q

Oral

A

mouth

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15
Q

Peroral

A

gastrointestinal tract via mouth

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16
Q

sublingual

A

under the tongue

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17
Q

parenteral

A

other than the gastrointestinal tract (by injection)

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18
Q

intravenous

A

vein

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19
Q

Intra-arterial

A

artery

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20
Q

intracardiac

A

heart

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21
Q

intraspinal/intrathecal

A

spine

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22
Q

intraosseous

A

bone

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23
Q

intra-articular

A

joint

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24
Q

intrasynovial

A

joint fluid area

25
Q

intracutaneous/intradermal

A

skin

26
Q

subcutaneous

A

beneath the skin

27
Q

intramuscular

A

muscle

28
Q

epicutaneous (topical)

A

skin surface

29
Q

transdermal

A

skin surface

30
Q

conjunctival

A

conjunctiva

31
Q

intraocular

A

eye

32
Q

intranasal

A

nose

33
Q

aural

A

ear

34
Q

intrarespiratory

A

lung

35
Q

Name the dosage forms available for nitroglycerin

A

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

36
Q

What dosage form has the fastest onset time

A

IV/SL (also buccal!)

37
Q

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

A

transdermal infusion system

38
Q

Name some advantages of the oral route of administration

A

-natural
-uncomplicated
-convenient
-safe

39
Q

name some disadvantages of the oral route of administration

A

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

40
Q

What is the purpose of enteric coating on tablets

A

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

41
Q

Tablets are formed by ___ or _____

A

compression or molding

42
Q

What are diluents in oral tablets?

A

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

43
Q

What are disintegrants in oral tablets

A

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

44
Q

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

A

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

45
Q

Which absorbs faster — capsules or tablets?

A

capsules

46
Q

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

A

gelatin

47
Q

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

A

000-5
000 being the largest size

48
Q

What are caplets

A

capsule-shaped and coated tablets

49
Q

capsules are a __ dosage form

A

solid

50
Q

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

A

INSOLUBLE

51
Q

What is a major advantage of suspensions over tablets and capsules

A

-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

52
Q

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

A

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

53
Q

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

A

because disintegration and dissolution are not required

54
Q

What are elixirs?

A

solutions sweetened by a hydroalcoholic vehicle

55
Q

What are syrups?

A

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

56
Q

what are magmas

A

very viscous

57
Q

Powders are similar to suspensions in that….

A

its easy to adjust the dosage

58
Q

what is the alimentary tract

A

another name for GI tract

59
Q
A

pharmaceutics exam 1 (8 decks)

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