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Pharmaceutics I > Exam 1 > Flashcards

Exam 1 Flashcards

1
Q

an active ingredient intended for incorporation into a finished dosage form that meets the statutory definition of a drug (that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body)

A

drug substance, active pharmaceutical ingredient (API)

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2
Q

a finished dosage form that contains a drug substance in association with one or more other ingredients

A

drug product

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3
Q

discipline of pharmacy that deals with the process of turning a drug into a medication to be used safely and effectively by patients, drug to dosage form

A

pharmaceutics

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4
Q

pt conditions, desired effect, dose required, duration of medication, drug’s physiochemical properties

A

things the choice of dosage form will depend on

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5
Q

generic drug product nomenclature

A

generic drug name - strength - route - dosage form

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6
Q

brand name drug product nomenclature

A

brand name - generic name - strength - route - dosage form

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7
Q

path by which a drug is administered into or onto the body

A

routes of administration

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8
Q

patient, drug, dose, route, time

A

rights of correct drug administration

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9
Q

a liquid product of high strength and low volume that must be diluted before administration

A

concentrate

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10
Q

precise control of dosing, suitability for different administration routes (convenience of dosing), controlled delivery rate for optimum therapy, improved adherence, individualized products to meet different patients’ needs, protection of product quality and integrity

A

why we need dosage forms

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11
Q

reliable release, reliable bioavailability, adequate stability, manufacturability, patient adherence

A

ideal dosage form

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12
Q

clinical need, drug properties, marketability, patients’ characteristics

A

criteria for drug product development

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13
Q

substances that are included in dosage forms not for their direct therapeutic action but to aid the manufacturing process, protect/support/enhance physical/chemical/microbiological stability, improve drug release/solubility/bioavailability, enhance patient acceptability

A

excipients

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14
Q

adherence, product safety (prevent harm and assist in product identification), product quality (manufacturability and stability), therapeutic efficacy (shouldn’t impede drug release and bioavailability)

A

functions of excipients

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15
Q

animal (lactose, gelatin), plant (starch, sugar, cellulose), mineral (calcium phosphate, silica), synthesis (polyethylene glycols, polysorbates, povidone)

A

sources of excipients

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16
Q

all marketed drug products (not just drug) must be safe and pure

A

1938 Federal Food, Drug, and Cosmetic Act

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17
Q

FDA regulates excipients in drug products (pure and safe), FDA’s GRAS (generally recognized as safe) list for specified use/route/amount, new excipient or new function for GRAS excipient (safety and toxicity studies are required)

A

safety of excipients

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18
Q

_____ excipients are safe for use only in approved amounts/for approved routes and in most patients

A

GRAS

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19
Q

pharmacologically inactive, provide the desired functionality, non-toxic, compatible (does not interact with active ingredient or other excipients), stable and reproducible, cost effective

A

ideal excipient properties

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20
Q

measures the rate and extent of absorption (drug reaching the systemic circulation or available at the site of action)

A

bioavailability

21
Q

gives extent/to what degree a drug is absorbed

A

area under the curve (AUC)

22
Q

fraction of amount of drug that reaches systemic circulation compared to dose administered

A

F

23
Q

max drug concentration

A

Cmax

24
Q

method of manufacturing, crystal form of the drug substance (polymorphism), nature (type/amount) of excipients used, type of dosage form, age of product, storage conditions

A

things the bioavailability of a drug depends on

25
Q

route of administration (IV have 100%), drugs’ physiochemical properties, characteristics of dosage forms, properties of excipients used, patients’ related factors

A

factors affecting bioavailability

26
Q

water soluble drugs tend to stay in _____ and ______

A

the blood, interstitial space (fluid that surrounds cell)

27
Q

highly lipophilic drugs distribute extensively into ________

A

adipose tissue

28
Q

only _____ drugs can be absorbed across membranes, high solubility = fast _______

A

dissolved, dissolution

29
Q

particle size, molecular weight, concentration

A

things the dissolution rate of drugs depends on

30
Q

smaller molecules dissolve ______

A

faster

31
Q

increasing the release rate of a drug from a tablet could increase _____

A

absorption rate/Cmax (high Cmax means high absorption rate)

32
Q

drugs’ physiochemical properties, formulation, route of administration

A

things rate of absorption depends on

33
Q

in general _____-soluble drugs can cross cell membranes more quickly than ______-soluble drugs

A

fat, water

34
Q

optimal drug has _____ solubility but not too _____ so it is permeable

A

high, polar

35
Q

drugs with high solubility and high permeability

A

class I

36
Q

drugs with low solubility and high permeability

A

class II

37
Q

drugs with high solubility and low permeability

A

class III

38
Q

drugs with low solubility and low permeability

A

class IV

39
Q

main form of drug absorption

A

passive diffusion

40
Q

Fick’s law - diffusion across the high concentration to one of low concentration

A

Ca - Cp

41
Q

Fick’s law - molecule’s lipid solubility, size, degree of ionization

A

P (partition coefficient) and D (diffusion coefficient)

42
Q

Fick’s law - area of absorptive surface

A

A (surface area)

43
Q

Fick’s law - thickness of epithelial membrane

A

h

44
Q

carrier molecule in the membrane facilitates absorption of molecule, substrate specific, availability of carriers limits absorption process (can reach saturation), process does not require energy, transport from high to low concentration

A

facilitated passive diffusion

45
Q

selective carrier-mediated saturable, against concentration gradient, energy expenditure

A

active transport

46
Q

fluid or particles are engulfed by a cell, cell membranes encloses the fluid/particles, fuses again, forming a vesicle that later detaches and moves to cell interior, energy expenditure, small role in drug transport (except for protein drugs/large molecules)

A

pinocytosis

47
Q

bioavailability of drug product in comparison with IV administration

A

absolute bioavailability

48
Q

bioavailability comparison of two non-IV products

A

relative bioavailability

Pharmaceutics I (4 decks)

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