Brainscape's Knowledge GenomeTM

Browse over 1 million classes created by top students, professors, publishers, and experts.


See full index

Pharmaceutics 2 > Up to the final > Flashcards

Up to the final Flashcards

1
Q

Beyond use date

A

used for compounded prescriptions

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

Expiration dates

A

used by pharmaceutical manufacturers

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

<795>

A

non sterile compounding

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

<797>

A

sterile compounding

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

<1178>

A

good repackaging practices
use suitable containers with an equivalent closure system
label has appropriate storage conditions and BUD
include lot number

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

<1191>

A

stability considerations in dispensing practice

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

Stability

A

capacity of a drug product to remain within specifications established to ensure its identity, strength, potency, quality and purity

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

Signs of lack of stability

A

change in performance or appearance
efficacy failure

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

Assay

A

strength
indicates the amount of API in dosage form

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

Does stability apply to homeopathic drugs, allergenic extracts, and new drugs for investigational use?

A

no

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

What from the environment affects stability?

A

pH, temp, light, oxygen, CO2

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

How do drugs and excipients affect stability?

A

particle size
relative purity of excipients

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

How does microbial contamination affect stability?

A

API, excipients, processing

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

Trace metals and catalysts can affect?

A

stability

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

How do closure systems affect stability?

A

moisture in containers

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

Chemical stability

A

each active ingredient retains its chemical integrity and labeled potency within the specified limits

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
17
Q

Physical stability

A

the original physical properties, including appearance, palatability, uniformity, dissolution, and suspendability, are retained

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
18
Q

Microbiological Stability

A

Sterility or resistance to microbial growing is retained according to the specified requirements; retain effectiveness within the specified limits

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
19
Q

Therapeutic Stability

A

therapeutic effect remains unchanged within shelf life

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
20
Q

Toxicological stability

A

no significant increase in toxicity occurs

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
21
Q

Common pathways for chemical degradation

A

hydrolysis, oxidation, photodegradation, dehydration, isomerization, decarboxylation

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
22
Q

For official compounded preparations, use ingredients that meet requirements of ?

A

compendial monograph

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
23
Q

USP or NF grade or what substances should be used for preparations?

A

Analytical Reagents
Certified American Chemical Society
Food Chemical Codex

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
24
Q

Manufactured containers are labeled with the expiration date and?

A

batch control number

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
25
Q

BUDs for compounded prescriptions are assigned based on?

A

Professional experience
careful interpretation of literature and laws
worksite policies and SOPs

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
26
Q

NECC Case study

A

product caused fungal meningitis
resulted in a lot of deaths
14 people indicted

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
27
Q

Drug Quality and Security Act

A

Amended FD&C Act to grant FDA more authority to regulate and monitor the manufacturing of compounded drugs

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
28
Q

Compounded sterile preparations examples

A

injections, infusions
irrigations for internal body cavities
ophthalmic
preparations for pulmonary inhalation
baths/soaks for live organs and tissues
implants

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
29
Q

Category 1 CSPs stored at CRT BUD

A

12 hours or less

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
30
Q

Category 1 CSPs refrigerated BUD

A

24 hours or less

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
31
Q

Category 2 CSPs stored at CRT BUD

A

more than 12 hours

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
32
Q

Category 2 CSPs when refrigerated BUD

A

more than 24 hours

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
33
Q

BUD is not to exceed

A

shortest expiration date or BUD of any components

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
34
Q

Potassium Cyanide in Tylenol capsule is

A

hygroscopic, changes capsule appearance

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
35
Q

Solid dosage forms instability signs

A

appearance of fog/liquid droplets
clumping of product
formation of crystals on outside of dosage form/on cap/vial

36
Q

Sticking and Picking

A

removal of tablet surface material due to sticking to die wall or a punch face

37
Q

Binding

A

improper tablet ejection due to the tablet sticking to the die

38
Q

Double Impression

A

additional impression on tablet face due to the free rotation of the punches

39
Q

Mottling

A

Unequal distribution of color on a tablet with light or dark areas

40
Q

Chipping

A

breaking of tablet edges while tablet leaves the press or during subsequent handling

41
Q

Cracking

A

small fine cracks on the upper and lower central tablet surface or very rarely on the sidewall

42
Q

Capping

A

partial/complete separation of top or bottom crowns from main tablet body

43
Q

Lamination

A

separation of a tablet into two or more distinct horizontal layers

44
Q

Visual defects in tablets could be related to imperfections in?

A

tableting process
formulation design
machine
multiple factors

45
Q

Lamination cause and remedy

A

caused by rapid decompression
fixed with reduced turrent speed

46
Q

Capping cause and remedy

A

improper/deep concave tooling
use flat face punches

47
Q

Picking cause and remedy

A

too much moisture in granulated materials
dry granules properly, adjust humidity conditions

48
Q

Binding Cause and Remedy

A

insufficient or improper lubricant
fix by increasing amount/change lubricant type in formulation

49
Q

signs of instability in hard and soft capsules

A

consistency, softening of capsule
cracking/drying of capsule
release of gas
distended seal

50
Q

Signs of instability for uncoated tablets

A

excessive powder/pieces
from abraded, crushed/broken tabs
cracks/chips
swelling
mottling
discoloration
fusion of tablets
crystals

51
Q

Signs of instability coated tablets

A

cracks
mottling
tackiness
crumpling
tablet-to-table color variation
abrasion/chipping on edges

52
Q

signs of instability dry powders and granules

A

hard cakes
color change
unusual caking
fog/liquid droplets
odor
difficult with reconstitution

53
Q

What is the optimal route of administration for first line drugs that treat asthma and COPD?

A

pulmonary

54
Q

Salbumatol

A

used for symptomatic treatment of asthma and COPD

55
Q

What are 200 million alveoli good for?

A

vast/large surface area for drug delivery/diffusion

56
Q

What is the main function of the lung and respiratory system?

A

maintain normality of arterial blood gasses O2 and CO2

57
Q

Advantage of pulmonary delivery of drugs

A

high drug concentrations directly to disease site
bypass first pass metabolism
achieve a superior therapeutic effect at a fraction of the dose
smaller diffusion barrier

58
Q

What does MDI stand for

A

metered dose inhaler

59
Q

Metered dose inhaler

A

aerosol/product that depends on the power of a propellant to dispense an API in the form of finely dispersed particles/droplets

pressurized container having a meter dose valve that allows an exact amount of the dose to be delivered

60
Q

Advantages of aerosol application

A

portable
removes the dose from the device without contaminating the remaining drug dose
MDI protects drug against degradation by exposure to light, moisture, or O2 oxidation
container is tamper proof

61
Q

Challenges of aerosol application

A

coordination of patient is difficult to ensure
deposition of drug to lower airways may be impeded by high volumes of mucus

62
Q

Therapeutic benefit of inhalers depends on adequate and consistent drug deposition in?

A

the lower respiratory tract

63
Q

Deposition is a function of

A

particle size

64
Q

What is the main criterion by which pulmonary formulations are judged?

A

size of inhaled particles

65
Q

Upper respiratory tract

A

nasal cavity, pharynx, larynx

66
Q

lower respiratory tract

A

trachea, bronchus, bronchiole, alveoli

67
Q

Inhaled particles 5-10 micrometers end up where?

A

in the trachea/bronchi regions

68
Q

Inhaled particles greater than 10 micrometers end up?

A

in the oropharynx

69
Q

Aerodynamic diameter

A

eliminates the effects of varying particle shapes/geometry and allows us to control for particle density

diameter of a spherical particle of unit density that possess the same gravitational settling velocity as the aerosol/any particle used for lung delivery

70
Q

MMAD

A

in a log normal distribution of particles, the diameter at 50% of the particles by mass are larger and 50% are smaller

71
Q

MMAD> 10 micrometers

A

trap in trachea

72
Q

MMAD 10-1 micrometers

A

settle into bronchioles and alveoli

73
Q

MMAD < 1 micrometers

A

easily exhaled

74
Q

Bronchi and Trachea have ?

A

high air velocities and turbulence

75
Q

inertial impaction

A

predominant mechanism of particle deposition in upper airways

76
Q

gravitational sedimentation

A

predominant mechanisms for particles to transit towards the bronchioles

77
Q

Solid dosage form BUD at CRT

A

180 days

78
Q

Preserved Aqueous Dosage forms BUD at CRT

A

30

79
Q

Non-preserved aqueous dosage forms BUD at refrigeration

A

14 days

80
Q

Nonaqueous dosage forms BUD at CRT

A

90 days

81
Q

What are the types of inhalers?

A

metered dose
dry powder
nebulizer

82
Q

Purpose of propellant

A

provide driving pressure to force the therapeutic agent from the MDI to the upper respiratory tract

exhibit the required evaporation rate to facilitate particle delivery to the required site within the respiratory tract

83
Q

dry powder inhalers

A

deliver API only when the patient inhales through them
no propellant
has a mechanical actuator to break an enclosure

84
Q

Lactose is an inert…

A

carrier of API

85
Q

nebulizers

A

takes a solution and turns it into ultra fine, micron-sized particles
may be single dose pump/continuous flow depending on treatment
droplets: 1-5 micrometers in size

Pharmaceutics 2 (6 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2024 Bold Learning Solutions. Terms and Conditions