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Pharmaceutics I > Exam 1 > Flashcards

Exam 1 Flashcards

1
Q

Pharmaceutics

A

Discipline of pharmacy that deals with the process of turning New Chemical Entity (NCE) into medication that can be safely used

science of dosage form and design

formulation of pure drug substance into dosage form

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2
Q

Branches of Pharmaceutics

A 
Pharmacokinetics
Pharmacodynamics
Pharmacogenomics
Bio-pharmaceutics
Pharmaceutical Technology
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3
Q

Drug

A

Agent intended to diagnose, treat, prevent, cure, or mitigate a disease

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4
Q

Drug product

A

whole pill, active ingredient (drug) plus excipients

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5
Q

Drug preparation

A

Extemporaneous compounding, compounding active ingredient into another usable form

ex. crushing tablet to be put into a solution

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6
Q

Hippocrates

A

The father of medicine, introduced scientific systematized medical knowledge

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7
Q

Dioscorides

A

author of De Materia Medica

botanist who studied naturally occurring medicinal materials

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8
Q

Galen

A

Galic pharmacy, galenicals

wrote naturally occurring vegetable drugs and formulations for patient admin

took bunch of drugs, put into one formulation (poly pharmacy), idea that body will take what needs and get rid of the rest

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9
Q

Paracelsus

A

match specific drug to specific disease

changed pharmacy from botanical science to one based on chemical science

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10
Q

Karl Wilhelm Scheele

A
  • Independently discovered lactic acid, citric acid, oxalic acid, tartaric acid, arsenic acid, glycerin, calomel, benzoic acid, oxygen
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11
Q

Friedrich Serturner

A

morphine

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12
Q

Joseph Pelletier and Joseph Caventou

A

Quinine, cinchonine, brucine

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13
Q

Joseph Pelletier and Pierre Robiquet

A

caffeine

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14
Q

Pierre Robiquet

A

codeine

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15
Q

Jonathan Roberts

A

First hospital pharmacist

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16
Q

USP

A

U.S Pharmacopeia, established drug standards

formed 1820, revised every year currently

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17
Q

proprietary name

A

brand name

registered trademark

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18
Q

Non-proprietary name

A

generic, common name

USAN Council, WHO

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19
Q

Generic Product

A

product which is a copy of brand drug product, made of the same active ingredient(s), strength, dosage form

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20
Q

Why do we need drug standards?

A

to make drugs reproducible, same ingredient, amount every time you make

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21
Q

Dr. Lyman Spalding

A

Father of the USP

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22
Q

NF

A

National formulary, included drugs denied admission to USP

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23
Q

USP-NF

A

strength, quality and purity were recognized as official. combined in 1980

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24
Q

Components of UPS-NF

A

Monographs: standards of all drug substances, dosage forms, and compound preparations (USP) and standards for excipients (NF)

General Chapters: tests/procedures described In detail ie 797 (sterile) 795 (non sterile)
General Notices: definitions of terms in monographs

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25
Q

USP <795>

A

Non sterile compounding

3 categories: simple, moderate, complex

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26
Q

Master formulation

A

“master recipe”
includes name, strength, dosage form, mixing instructions
created before compounding a preparation for the first time, followed every time it is made

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27
Q

Compounding record

A

“log book” or “Journal”
includes name, strength, dosage of prep, total quantity, name of person who prep, BUD, Lot/Exp

Defective product log must be kept in pharmacy, products reported

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28
Q

Order of ingredients

A

USP, NF = best grade

FCC and ACS

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29
Q

USP 800

A

safe handling of hazardous drugs. covers just about everything in the process, from getting it, to admin, to waste

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30
Q

Food drug act of 1906

A

drugs have to meet standards for strength, purity and quality

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31
Q

Sherley Amendement 1912

A

prohibits misleading therapeutic claims

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32
Q

Federal Food, Drug and Cosmetic Act of 1938

A

results of Sulfanilamide incident

Drugs have to show safety testing
FDA can come inspect whenever
Adequate labels and directions
Cant distribute drug without NDA filing and approval

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33
Q

Durham-Humphrey Amendment of 1952

A

no refills without valid prescription
determined what Rx only and OTC drugs are
duties of pharmacist

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34
Q

Kefauver-Harris Amendments of 1962

A

Response to Thalidomide

Need to file IND
required drug to be proven safe and efficacious
grandfathered drugs 1906 -1938
Manufacturers must record and report adverse events
established GMPs

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35
Q

Comprehensive Drug Abuse prevention and Control Act of 1970

A

5 Schedules of drugs I-IV

Schedule I - no medical use
Schedule II - medical use, high abuse potential

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36
Q

FDA Pregnancy Categories

A

Categories assigned in 1979, A,B,C,D,X

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37
Q

Black box warning

A

Used for high-risk drugs, such as antidepressants

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38
Q

Pregnancy and Lactation Labeling Rule PLLR

A

package inserts have to include new headings
Pregnancy
Lactation
Females and Males of reproductive potential

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39
Q

Drug Listing Act of 1972

A

Established NDC (4-4-2, 5-4-1, 5-3-2)

each firm that manufactures or repackages drugs must register with FDA

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40
Q

NDC

A

Labeler code: Manufacturer/distributer (segment 1)
Product code: Drug formulation (segment 2)
Package code: Package size/type (segment 3)

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41
Q

Orphan Drug Act of 1983

A

enabled FDA to promote research and marketing for drugs needed for rare disease

gave incentives to develop orphan drugs to drug companies

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42
Q

Drug price Competition and Patent Term Restoration Act of 1984

A

Increased patent to 20 years

Speed up FDA approval of generic drugs, ANDA

43
Q

Prescription Drug Marketing Act of 1987

A

Dingell Bill

prohibit drug reimportation
Sales restrictions
sample distribution
wholesaler distributors

44
Q

Dietary Supplement Health and Eduction Act of 1994

A

DSHEA

regulated labeling claims for supplements
not legally considered drugs
can choose to be USP verified, adhere to USP-NF standard

45
Q

FDA modernization act of 1997

A

Accelerated approval new drugs
Expand patient access to investigational treatment for life-treating diseases
codify FDA info

46
Q

Drug product recall

A

Class I,II,III
I: most severe, likely hood of serious adverse events or death

II: may cause temp health consequences, can be treated, most common

III: not likely to cause adverse health consequences, most likely not related to drug

47
Q

CDER

A

Watchdog

can determine what drugs are high priority, speeding up approval

48
Q

Stages of drug development

A 
Initial idea
Research
Development
regulatory approval
Marketing approval
Post launch studies
49
Q

goals of nonclinical development

A

binds to intended target
acceptable safety profile based on tolerability in animals
chance of showing efficacy in humans

data used to determine dose and dose range for clinical trials, parameters for adverse effects

50
Q

Primary Pharmacology

A

study mechanism of action of a drug

51
Q

Secondary pharmacology

A

study off target effects of a drug

52
Q

Pharmacokinetics

A

what body does to drug, ADME

53
Q

Pharmacodynamics

A

What drug does to body

54
Q

IND

A

Investigational New Drug

Primary safety doc
submit, if don’t hear from FDA 30 days, its a go to do clinical tests

Allows sponsor to legally ship unapproved drug or import from foreign country and between states

Regulatory affairs responsible for initial submission and keeping it updated

55
Q

IND required for…

A 
A new chemical entity
New dosage form
New indication
Given and new dosage level
Combo with unapproved drug
56
Q

IND contents

A

Administrative
CMC
Nonclinical
Clinical

57
Q

IND Review includes

A

Pharmacology, Chemistry, Clinical reviews

58
Q

Phase I

A

Human pharmacology

small, health group
primary goal to determine tolerability of dose and safety

59
Q

Phase II

A

Therapeutic Exploratory

Larger group, more narrow criteria

Primary goal to explore efficacy, dose and regimen

60
Q

Phase III

A

Therapeutic Confirmatory

Confirm evidence from Phase II that drug is safe, effective for use in population.

Primary goal to confirm therapeutic benefit

61
Q

Phase IV

A

not necessary for approval, good for optimizing the drug.

info on drug-drug interactions, dose-respond, and safety

62
Q

New Drug application

A

NDA

Goals:
is drug safe and effective
is labeling appropriate
are manufacturing and controls adequate

63
Q

Action following review

A

Refuse to file = need more info

will send complete response letter notifying of deficiencies

can resubmit, withdraw or appeal application

64
Q

Review types

A

Standard
non-priority app, ~10 months, not much better than current treatment

Priority
~ 6 months, if no alternate therapy exists or way better than current option

65
Q

Drug app classifications

A 
NDA 505(b)(1) contains full report
NDA 505(b)(2) contains report where some info from third party or don't have right of reference 
ANDA 505(j) shows product is identical to already approved product
66
Q

Reasons to compound

A 
Patient allergies
Varying Strengths
Patient compliance
Stability
Medication Discontinued
Veterninary
67
Q

Info included in USP <795>

A 
compounding records and documents
ingredient selection/calc
how to assign BUD
Quality control
Patient counseling
68
Q

USP container classifications

A

Well-closed: no solids in/out
Tight container: no liquids in/out
Light-resistant container
Hermetic container: no air or gaseous agents can get through, IV ampules….have to break it, sterility depends on this type of container

69
Q

Plastic container Pro vs Cons

A 
Pros
o	Lightweight
o	Durable
o	Flexible
o	Very “designable”
Cons 
o	Chemical reactions 
o	Alteration of properties
o	Permeation
o	Leaching
o	Sorption (adsorption and absorption)
70
Q

Permeation

A

penetration of gases or fluids ie nitroglycerin evaporates

71
Q

Leaching

A

something from container comes into formulation

72
Q

Adsorption

A

drug sticks to container

73
Q

Absorption

A

drug goes into container

74
Q

Polyethylene

A

HDPE and LDPE
Good water, poor gas barrier
no autoclave

75
Q

Polypropylene

A

excellent water and gas barrier

can autoclabe

76
Q

Polyvinyl Chlorine

A

PVC

used in parenteral, good oxygen barrier, permeable to water

yellows when exposed to heat

77
Q

Info on label

A 
NDC
Lot #/ Exp date
Storage info
Strength
dosage form
Name of drug
RX symbol
Quantity in package
Name and location of manufacturer
78
Q

OTC labeling

A

Labeling box

Active ingredient, purpose, warnings, directions, questions, uses, other info, inactive ingredients

79
Q

Storage temps

A 
Freezer -25 to -10 c
Cold up to 8 c
Refrigerator 2 to 8 c
Cool 8 to 15
controlled room temp 20 to 25 c, can dip to 15-30, average has to be 25
warm 30 to 40 c
excessive heat 40c+
80
Q

Considerations Dosage form Design

A 
Effectiveness
Safety
Reliability
Stability
Pharmaceutical Elegance
Physiological State of patient
Convenience
81
Q

Preformulation studies

A

Done before clinical trials to reveal…

Chemical, Physical, Biological properties

82
Q

Example Preformulation Studies

A 
Particle size (mircroscopy, DLS)
Melting point (DSC)
Crystal Structure (microscopy)
Solubility (Solubility test)
Dissolution Rate (Diss tests)
Membrane Permeabiloty (Part. Coeff EIST)
83
Q

Stability Preformulation Studies

A

Stability tests
Shelf Life estimation
Excipients
Mechanisms of Degradation

84
Q

Physical and chemical properties of drugs affected by particle size distribution

A

Reducing size = increase surface area = more solvent contact = increase solubiltiy

If reduce too much, can be irritant

if too big, cant diffuse across membrane

texture, don’t want to by gritty or abrasive ointment

uneven size = settling, stratification (ex miralax)

85
Q

Crystalline solid

A

repetitive arrangements in a lattice (set structure)

stronger, dissolve slower

temperatures, solutes, solvents impacts which form it takes

Ionic vs molecular solid (ionic stronger)

Solvate = solvent trapped in crystal
Hydrate = water trapped in crystal
86
Q

Amorphous solid

A

disordered arrangements of molecules, no structure

easier soluble

drugs can exist in both crystalline and amorphous form ie insulin (crystal = long lasting) intermediate = amorphous

87
Q

Polymorphism

A

More than one crystal form of a drug
example: Ritonavir (go from one form to another, insoluble)

melting point variation, solubility differences

88
Q

Melting point depression

A

When peaks vanish or appear somewhere else means drug and excipient are not compatible. DSC used to check compatibility

89
Q

Phase Diagram

A

Eutectic Point where melting points for combined products meets on graph.

90
Q

Solubility

A

pH can be adjusted to enhance solubility

not all drugs can benefit from pH adjustments, in which case you can…
use co-solvents,micronization,dispersion, emulsion

91
Q

Dissolution

A

process by which a particle dissolves

can be rate limiting step in absorption of poorly soluble drugs.

reduce particle size can increase dissolution

speed at which drug dissolves is dissolution rate, tested in dissolution apparatus

92
Q

Membrane permeability

A

everted intestinal sac test, take rate intestine and test

or do partition coefficient, kind ratio of molecule in octane and water, sweet spot is around 3-5

93
Q

Drug stability

A

chemical mechanisms of degradation

Hydrolysis and oxidation

94
Q

Stability testing

A

done at each stage of product development
temp and humidity studies
have to do for years

95
Q

Type 1 glass

A

Neutral glass

alkaline element largely eliminated using boric oxide, neutralize oxides of potassium and sodium

suitable for all types of products

96
Q

Type 2 glass

A

surface treated glass

treat soda glass with sulphur dioxide, ammonium sulphate or ammonium chloride

not good for solution above 8 pH

97
Q

Type 3 glass

A

soda or alkali glass

less chemically resistant

suitable for dry substances

98
Q

accelerated stability studies

A

done at exaggerated studies, used to predict how long on shelf. doesn’t replace real studies, still have to do those.

exaggerated temp, light and humidity

99
Q

DEA number check

A

First letter, A or B
Second letter first initial last name or business name.

Add 1,3,5
Add 2,4,6 and multiple by 2
Add both sums, last digit will be 7th DEA number

100
Q

shelf life

A

time for 10% of drug to degrade, to equal 90% intact drug remaining.

101
Q

shelf life

A

time for 10% of drug to degrade, to equal 90% intact drug remaining.

102
Q

Pharmacist responsibility

A

Comply Expiration date
proper storage conditions at pharmacy and educate patients
check for instability
properly treat and label products

103
Q

Pharmacist responsibility

A

Comply Expiration date
proper storage conditions at pharmacy and educate patients
check for instability
properly treat and label products

104
Q

Shelf life manufacturing vs compounding

A 
Manufacturing = 2 years
Compounding = follow USP 795

BUD = Beyond Use Date

Pharmaceutics I (11 decks)

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