Brainscape's Knowledge GenomeTM


Top Flashcards (Certified)
All Flashcards

Pharmaceutics 2 > Up to the final > Flashcards

Up to the final Flashcards

(85 cards)

Start Studying
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
BUDs for compounded prescriptions are assigned based on?
Professional experience careful interpretation of literature and laws worksite policies and SOPs
26
NECC Case study
product caused fungal meningitis resulted in a lot of deaths 14 people indicted
27
Drug Quality and Security Act
Amended FD&C Act to grant FDA more authority to regulate and monitor the manufacturing of compounded drugs
28
Compounded sterile preparations examples
injections, infusions irrigations for internal body cavities ophthalmic preparations for pulmonary inhalation baths/soaks for live organs and tissues implants
29
Category 1 CSPs stored at CRT BUD
12 hours or less
30
Category 1 CSPs refrigerated BUD
24 hours or less
31
Category 2 CSPs stored at CRT BUD
more than 12 hours
32
Category 2 CSPs when refrigerated BUD
more than 24 hours
33
BUD is not to exceed
shortest expiration date or BUD of any components
34
Potassium Cyanide in Tylenol capsule is
hygroscopic, changes capsule appearance
35
Solid dosage forms instability signs
appearance of fog/liquid droplets clumping of product formation of crystals on outside of dosage form/on cap/vial
36
Sticking and Picking
removal of tablet surface material due to sticking to die wall or a punch face
37
Binding
improper tablet ejection due to the tablet sticking to the die
38
Double Impression
additional impression on tablet face due to the free rotation of the punches
39
Mottling
Unequal distribution of color on a tablet with light or dark areas
40
Chipping
breaking of tablet edges while tablet leaves the press or during subsequent handling
41
Cracking
small fine cracks on the upper and lower central tablet surface or very rarely on the sidewall
42
Capping
partial/complete separation of top or bottom crowns from main tablet body
43
Lamination
separation of a tablet into two or more distinct horizontal layers
44
Visual defects in tablets could be related to imperfections in?
tableting process formulation design machine multiple factors
45
Lamination cause and remedy
caused by rapid decompression fixed with reduced turrent speed
46
Capping cause and remedy
improper/deep concave tooling use flat face punches
47
Picking cause and remedy
too much moisture in granulated materials dry granules properly, adjust humidity conditions
48
Binding Cause and Remedy
insufficient or improper lubricant fix by increasing amount/change lubricant type in formulation
49
signs of instability in hard and soft capsules
consistency, softening of capsule cracking/drying of capsule release of gas distended seal
50
Signs of instability for uncoated tablets
excessive powder/pieces from abraded, crushed/broken tabs cracks/chips swelling mottling discoloration fusion of tablets crystals
51
Signs of instability coated tablets
cracks mottling tackiness crumpling tablet-to-table color variation abrasion/chipping on edges
52
signs of instability dry powders and granules
hard cakes color change unusual caking fog/liquid droplets odor difficult with reconstitution
53
What is the optimal route of administration for first line drugs that treat asthma and COPD?
pulmonary
54
Salbumatol
used for symptomatic treatment of asthma and COPD
55
What are 200 million alveoli good for?
vast/large surface area for drug delivery/diffusion
56
What is the main function of the lung and respiratory system?
maintain normality of arterial blood gasses O2 and CO2
57
Advantage of pulmonary delivery of drugs
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
What does MDI stand for
metered dose inhaler
59
Metered dose inhaler
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
Advantages of aerosol application
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
Challenges of aerosol application
coordination of patient is difficult to ensure deposition of drug to lower airways may be impeded by high volumes of mucus
62
Therapeutic benefit of inhalers depends on adequate and consistent drug deposition in?
the lower respiratory tract
63
Deposition is a function of
particle size
64
What is the main criterion by which pulmonary formulations are judged?
size of inhaled particles
65
Upper respiratory tract
nasal cavity, pharynx, larynx
66
lower respiratory tract
trachea, bronchus, bronchiole, alveoli
67
Inhaled particles 5-10 micrometers end up where?
in the trachea/bronchi regions
68
Inhaled particles greater than 10 micrometers end up?
in the oropharynx
69
Aerodynamic diameter
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
MMAD
in a log normal distribution of particles, the diameter at 50% of the particles by mass are larger and 50% are smaller
71
MMAD> 10 micrometers
trap in trachea
72
MMAD 10-1 micrometers
settle into bronchioles and alveoli
73
MMAD < 1 micrometers
easily exhaled
74
Bronchi and Trachea have ?
high air velocities and turbulence
75
inertial impaction
predominant mechanism of particle deposition in upper airways
76
gravitational sedimentation
predominant mechanisms for particles to transit towards the bronchioles
77
Solid dosage form BUD at CRT
180 days
78
Preserved Aqueous Dosage forms BUD at CRT
30
79
Non-preserved aqueous dosage forms BUD at refrigeration
14 days
80
Nonaqueous dosage forms BUD at CRT
90 days
81
What are the types of inhalers?
metered dose dry powder nebulizer
82
Purpose of propellant
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
dry powder inhalers
deliver API only when the patient inhales through them no propellant has a mechanical actuator to break an enclosure
84
Lactose is an inert…
carrier of API
85
nebulizers
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.
© 2025 Bold Learning Solutions. Terms and Conditions