Celtics II
What physical and chemical properties determine a drug's ability to carry out its biologic activity?
Uptake/efflux proteins
Lipid solubility
Molecular size
Protein binding
Degree of ionization
Blood flow
The absorption could be influenced by pH of the GI fluid that could change the following...
Solubility
PH-partition hypothesis
Chemical stability
Molecular size
What can happen if you increase the dissolution rate constant k?
Decrease diffusion coefficient
Increase intensity of the agitation of the solvent
Increase the partition coefficient
Increase the diffusion coefficient
Reasons it is not always good to increase surface area?
Drug particles may have wetting issues
Depending on size, may not dissolve well
Powders may entrap or absorb air
Fine particles could generate poor flow of powders
How to increase saturated solubility?
Particle size
Protein binding
Physical form of drugs
PH
Salt formation
Complexation
Lipophilicity
What can increase solubility?
PEG-3000
Surfactant
What can increase retention time?
PEG-3000
Surfactant
In emulsion, what does the rate depend on?
Diffusion coefficient
Partition coefficient
T/F: Food intake is not important for drug absorption
True
False
Where is the optimum site for drug absorption?
Ileum
Duodenum
Jejunum
What is the theory that links surface area and absorption?
Noyes-Whitney
Fick's 1st Law
How does bile salt increase absorption?
Forming complex drugs
Enhancing dissolution rate
How does bile salt decrease absorption?
Forming complex drugs
Enhancing dissolution rate
What in the GI tract can cause oral drugs to be efficiently absorbed?
Intestines
Anatomic absorption window
Transit time of the drug in the GI tract depends upon...
Type of dosage forms
Food
Various physiological factors
Drug's pharmacologic properties
What are factors that delay movement of the drug from the stomach to the small intestine?
GI motility
Anticholinergic drugs
Cold beverages
High fat meals
Under normal circumstances, how long will drug remain in stomach?
1-3 hours
4-10 hours
2-4 hours
6-8 hours
Under normal circumstances, how long will the drug remain in the small intestines?
2-4 hours
4-8 hours
4-6 hours
4-10 hours
T/F: Food effect could be positive or negative?
True
False
T/F: absorption of drug through oral mucosa can provide a way for systemic administration that avoids the GI tract
True
False
What is the optimal logP?
1.1-2.5
5-7.3
1.6-3.3
4.5-8.1
If lop P is too low...
Poor diffusion
Poor solubility
If log P is too high...
Poor diffusion
Poor solubility
T/F: Bioavailability is the rate at which the an active ingredient or therapeutic moiety is absorbed from a drug product and become available at the site of action
True
False
T/F: Rate of absorption depends on rate of dissolution
True
False
When do we do a bioequivalence study?
Change in active ingredient
Change in formulation
Change of process or manufacturing
Generic formulations
Clinical service form for market form
Test of Bioequivalence...
80-115%
85-125%
80-125%
80-120%
What is the bioequivalence confidence interval?
70%
60%
100%
90%
Bioequivalent drugs must meet same batch to batch requirements for...
Efficacy
Cost
Identity
Purity
Quality
Strength
Increase bulk?
Lubricants
Binders
Fillers
Glints
Lubricants...
Prevent adhesion
Impart cohesive qualities
Reduce inter particle friction
Facilitate ejection
Impart cohesive qualities?
Diluents/fillers
Binders
Lubricants
Coating agents
Facilitate break up?
Lubricant
Glidant
Filler
Disintegrant
Improve flow?
Glidant
Filler
Lubricant
Coating agent
Coat the tablet after compression?
Filler
Coating agent
Glidant
Binder
Which of these are examples of disintegrating agents?
Colloidal silicon dioxide
Sodium starch glycollate
Crospovidone
Croscarmellose
Which of these are examples of coating agents?
Colloidal silicon dioxide
Wincoats
Hydroxylpropyl methyl cellulose
Talc
Dry granulation..
Slugging
Roller compaction
Both
T/F: A higher percentage of fines cause a higher yield and segregation during compression
True
False
Limitations of dry granulation is that it requires drugs or excipients with ______ properties
Adhesive
Cohesive
Drug loading for dry granulation?
<50%
<30%
<40%
<60%
Limitations to Wet granulation?
Multiple steps
Prevent segregation
Not suitable for heat or moisture sensitive drugs
Difficult process to control
Overwetting?
Too soft
Too hard
Underwetting?
Too soft
Too hard
Lamination...
Over compressing
Over drying
Over lubrication
Granulate too fine
Insufficient bonding
Insufficient plastic deformation
Chipping/sticking
Insufficient bonding
Sticking to punch surface
Adhering to die wall
Over mixing
Picking/stress cracking
Insufficient bonding
Adhering to die wall
Sticking to punch surface
Insufficient plastic deformation
How many tablets are weight during compression?
15
20
30
25
T/F: the tablets are weighed all together.
True
False
Friability is generally...
<4%
<1%
<5%
<6%
Content uniformity is...
Content variation
Weight variation
How many tablets are weighed for uniformity?
10
20
15
25
What is the uniformity limit?
80-125%
85-115%
80-115%
85-125%
What is the uniformity standard deviation?
<4%
<6%
<10%
<5%
T/F: a desiccant prevents decomposition by moisture
True
False
Stability is how many months if prepared from USP/NF ingredients?
12 months
8 months
6 months
4 months
How much of expiration period remaining if prepared from commercial products?
25%
50%
15%
20%
Purpose of sugar coated tablets?
To protect API
To mask drug taste
To prevent cohesion
To prevent contact with moisture
Release drug in a predetermined manner over a period of time...
Immediate release
Extended release
2 pieces:
Hard gelatin caps
Soft gelatin caps
T/F: HGCs contain colorants and opaquants to make them distinctive
True
False
How much moisture do HGCs contain?
10-20%
13-16%
12-17%
14-19%
Is high humidity good or bad for HGCs?
Good
Bad
Which of these is the smallest capsule size?
000
2
00
5
Most SGCs are prepared by...
Rotary
Plate
T/F: No dosage unit can be outside the range of 70-125%
True
False
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