Exam 2 Flashcards
1
Q
_____ coating gives a smooth, rounded tablet without indentations or scores
A
sugar
2
Q
There are ____ g in one oz
A
28.4
3
Q
Stratification of powder mixes can occur because different particles in the mix may have different ___ properties
A
flow
4
Q
Complete disintegration is…
A
In USP tablet test, defined as that state in which any residue of the unit (except fragments of insoluble coating or capsule shell remaining on the screen of the test apparatus) is a soft mass having no palpably firm core.
5
Q
Triturating a colored powder in a glazed porcelain can cause the mortar to _____
A
stain (color, potent powders can get embedded in the pores)
6
Q
For a USP dissolution test for weak base drug salt, such as propranolol hydrochloride, the medium’s pH would be expected to be on the (acidic or basic) side of neutral
A
acidic
to keep the drug in its more soluble ionized form, which is more likely to dissolve in the stomach
7
Q
For compounding with hazardous drugs C-SECs must be (positive or negative) pressure to all adjacent areas
A
negative
8
Q
API stands for…
A
Active Pharmaceutical Ingredient
9
Q
Enteric coating can be applied to either granules within a tablet or capsule, or to a whole tablet in order to prevent disintegration and exposure of the drug in an _____ environment
A
acidic
10
Q
For empty capsule shells, the greater the capsule number, the (larger or smaller) the size
A
smaller
11
Q
Disintegrant is…
A
type of excipient helps to solve the tablet paradox of need to be hard, yet fall apart easily in the body
12
Q
The low pH of the stomach can enable rapid dissolution of weak (acid or base) drugs
A
base
13
Q
The category of compound for nonsterile preparations that require special training, facilities, equipment, or procedures is….
A
Complex
14
Q
Fast-dissolving / Orally disintegrating tablets generally must be well-protected, because they can be____ and sensitive to moisture
A
brittle
15
Q
In tablet disintegration assessment for some tablets, medium is changed from ( basic to more acid or acid to more basic) to stimulate GI passage
A
acid to more basic
16
Q
The two main claims for fast-dissolving/ orally disintegrating tablets are:
A
- Easier to take + Swallow
2, Possible faster onset of action, but often not true
17
Q
A capsule diluent with this property can draw in GI fluids, thereby increasing dispersion and thus dissolution rate.
A
Hydrophilicity
18
Q
A tablet hardness tester measures the _____
A
crushing strength
19
Q
A chart is…
A
old term used to describe folded powder papers
20
Q
A trituration is…
A
defined as a potent powdered drug mixed with suitable diluent.
21
Q
A _____ is used to assess the durability of the tablet
A
friabilator
22
Q
According to Compounding Quality Act, Section ____ addresses the “traditional pharmacies”
A
503a
23
Q
According to Compounding Quality Act, Section ____ addresses the outsourcing facilities
A
503b
24
Q
Active Pharmaceutical Ingredients that can be used in compounding appear on this list issued by the FDA called…
A
positive list
25
Camphor and menthol can liquefy when mixed together because the melting points are lowered to below room temperature. This is an example of _____
eutectic formation
| occurs because each substance is an impurity to the other
26
Geometric dilution is ...
defined as successive equal volume additions of diluent to a concentrate, with thorough mixing between each addition
27
Communition is....
the process of particle size reduction
28
Compressing tablets directly from powdered material without modifying their physical nature is called ...
direct compression
29
_____ is defined as a tablet or capsule excipient used to reduce particle to metal adhesion, thereby assisting free flow of the particles
lubricant
30
Disintegrants can significantly improve drug dissolution from a tablet by increasing exposed _____
surface area
31
Drugs on FDA (positive or negative) list may be not used in compounding, due to problems with safety or efficacy
negative
32
Food, liquid, and medications are emptied into the small intestines by the opening of the _____
pyloric sphincter
33
Gelatin is derived from this animal-based protein called ____
Collagen
34
Glycerin and propylene glycol are two examples of water ______ liquids used as vehicles in softgel caps
miscible
35
Hard gelatin capsule can contain liquids but not aqueous liquids
Turgor Pressure ???
36
If there is not enough of ____ in a gelatin capsule shell, it can become brittle
water
37
In chewable tablets, xylitiol or mannitol are often included to give a _____ sensation
cooling
38
In compounding, the _____ record provides a consistent source document for step-by-step preparation of the compound and is not for a specific patient, for first-time preparation.
Master Formulation
39
In compounding, ____ is the name given to the practitioner/patient/pharmacist/compounder relationship.
Triad
40
In the manufacture of tablets, the process of granulation helps to prevent stratification, and improve powder ____ and ____
Fluidity + Compressibility
41
In the small intestines, the ___is the major site for passive drug absorption, because of high ___ + and high ____
Duodenum
HIgh- Surface Area + Perfusion
42
In the stomach, ___ and small particles are generally emptied faster than digest and undigested solids (including non-disintegrated tablets)
liquids
43
In USP disintegration tablets, specific fluids and disintegration times are found in ____ in the USP
monographs
44
Magnesium stearate is a common example of this type of capsule and tablet diluent
Lubricant
45
One potential advantage of liquid-filled softgel caps over powder-filled hard gel caps is an improvement in ________ as exemplified by methoxsalen products.
bioavailability
46
One potential misunderstanding of the correct method of oral powder use is that some may choose to take it ____
dry
47
Oral powders can be a good alternative for (high or low) dose drugs
high
48
Sodium bicarbonate and citric acid are powder excipients that combine to produce ______ when the powders dissolve
effervescence
49
Softgel caps can appear hard because of this property...
Turgor Pressure
50
Soybean oil is an example of a water-(miscible or immiscible) liquids used as vehicles in softgel caps
immiscible
51
Tablet capping or splitting can indicate _____ problems
compression
52
Tablet ____ may indicate coating problems
mottling
53
Tablets prepared from enteric coated granules will ______ but will not dissolve in the stomach
disintegrate
54
The basket rack assembly is used to assess tablet ...
disintegration
55
The behavior of enteric coating is because on their backbone, they have carboxyl groups that (ionized or do not ionized) until the higher pH of the intestines, enabling the coating to dissolve
do not ionized
56
The judgement of BUD must be based on the specific drug and ____
preparation
57
The most common granulation approach in tablet manufacture is ______granulation
wet
58
The most common method of tablet coating is called ____ coating, which leaves ____and ____ visible
film,
| indentation + scores
59
The name of the finished dosage form in compounding, product or preparation.
preparation
60
The two main purposes of enteric coating are:
(1) To prevent acid attack on labile ingredients
| (2) To protect the stomach from irritation
61
The two main reasons for locking or sealing capsules are:
(1) To ensure that they will not easily come apart during handling
(2) To provide tamper-resistance or tamper-evidence
62
The USP BUD for Water-Containing Oral Formulations is not later than ____ days when stored at controlled cold temp
14
63
The USP BUD for Water-Containing Topical/Dermal and Mucosal Liquid and Semisolid Formulations is not later than ____ days
30
64
The ____ is the date after which a compounded preparation shall not be used and is determined from the date that the preparation is compounded
beyond use date (BUD)
65
____is a detailed information document prepared by the manufacturer or importer of a chemical that describes important safety considerations
Material Safety Data Sheet
66
There are ____ mL in one fluid ounce
29.6 or 30
67
There are ___ mg in one grain
65
68
This tablet excipient helps to produce a smooth granule surface
Glidant
69
Uptake of moisture in powders can increase chemical degradation and can cause powder _____
agglomeration
70
USP Chapter ____addresses nonsterile compounding
795
71
USP Chapter ____ is best practice recommendations and mandates for reducing occupational exposure to healthcare workers who handle nonsterile and sterile hazardous drugs
800
72
USP tablet tests for drug content are:
Weight variation, Drug content uniformity
73
USP tablet tests for drug release are:
Disintegration test, dissolution test
74
When making by hand or machine, only this part of the capsule shell is filled
Body
75
Whether using an electronic balance or a torsion balance, it is important to know how to do this properly with an empty capsule shell
Tare
76
Levigation can be described as _____
wet grinding
77
ʒ or ℨ is the symbol for ____ and it comes from Apothecary to Avoirdupois
dram (teaspoon)
78
Specific gravity of water is
1
79
Specific gravity of propylene glycol is
1
80
Specific gravity of ethanol is
0.8
81
Specific gravity of Glycerin is
1.25
82
What is the units used for percentage calculations?
g/100 mL
83
All should be avoided except:
Trailing zero (5.0)
Number at or above 1000 w/o commas
Writing "Unit"
Naked Decimal points (.5)
writing "unit"
84
____ increased the role of the federal government in compounding practice
DQSA - HR 3204- Drug Quality and Security Act
85
___ sets standards addressing a broad array of issues related to compounding
USP/NF
86
____ is the most acceptable range for most compounded preparations.
+/- 10%
87
Beyond use date for a compound capsule lacking specific stability information is...
6 months or earliest expiration date of any API (non-aqueous formulations-- powders, capsules, ointments)
88
_____ compounded product would be considered moderate level.
preps with a special calculation or procedure
89
____ compounded product would be considered simple level
preps with USP monographs or found in peer-reviewed articles
90
_____ compounded product would be considered complex level
Preps requiring special training, procedures, or equipment
91
____ type of mortar and pestle is best for comminution (rough surface area and highly porous)
Wedgewood
92
_____ is the wet form of comminution
levigation
93
____ is the primary material for most capsule shells.
gelatin
94
_____ is the common alternative material to gelatin for capsule shells.
cellulose
95
Most common diluent for compounded capsules are...
lactose
96
USP ____ provides quality control for capsules made by filling machines
1163
97
_____ are plasticizers (substance added to achieve softness/flexibility).
glycerol
propylene glycol
sorbitol
98
In tablet formation, wet granulation is the most common approach in production of tablets. What is the fourth step?
drying
Blending-Wetting-Granulation-Drying-Sizing -Blending-Compression
99
What is an example of disintegrant?
corn starch
Colloidal silica
povidone
Answer: Corn starch
Colloidal silica (glidant)
Povidone (adhesive/binding agent)
100
____ USP chapter sets the standard for handling hazardous drugs in healthcare settings.
800
101
____ defined as a tablet or capsule excipient used to reduce interparticulate friction.
glidant
102
_____ is a process in tablet manufacturing that helps prevent stratification, improve powder fluidity, and improve powder compressibility.
Granulation
103
A drug available as a softgel capsule has the following inactive ingredients: Citric acid, glycerin, PEG400, Purified water. Which is least likely purpose of glycerin in formulation?
To serve as vehicle for drug
To serve as cosolvent for drug
To make shell opaque
To soften the shell
to make shell opaque
104
Title 2 of DQSA: Drug supply chain security act requires...
tracing of pharmaceutical products throughout supply chain
105
(States or federal) are primary regulators of section 503a pharmacies
Answer: States
if pharmacies deviate from section 503a then they become subject to federal inspection or enforcement action
106
Requirements of 503a include...
Compounded medication must be for identified pt on receipt of order/Rx.
Have limited quantity of allowed anticipatory compounding (not a warehouse full)
Drugs taken off market CANNOT be used in compounding (negative list)
May not be a "essentially a copy" of FDA-approved drug unless preparation produce significant difference (removal of excipient)
CANNOT compound on "demonstrably difficult to compound" list (e.g. patch, MDIs inhalers)
APIs must: comply with USP/NF monograph, component of FDA-approved drug, or appeared on the positive list
107
USP/NF stands for...
U.S. Pharmacopeia/ National Formulary
108
According to Compounding Quality Act, Section ____ can produce and ship large numbers of sterile preps without a prescription
503b
109
Main regulators of Outsourcing Facilities (503b) are (state or federal/FDA), they are not required to obtain patient-specific prescription, may not be licensed pharmacy, must comply with cGMP (just like manufacturer) requirements.
Answer: Federal
FDA is heavily involved in this
110
The USP BUD for Nonaqueous Formulations is no later than ____
6 months or earliest expiration date of any API (whichever is first)
111
In absence of supporting literature (BUD) , stability testing must be performed using a stability indicating assay which is...
to identify intact drug verses degradants and use this assay to get extended beyond use date.
an assay that can accurately and selectively differentiate an intact drug from its potential decomposition products and other components of the formulations
112
In compounding, when you compound for particular patient, for each preparation and including first-time preparation, you produce this _____ record for that specific time you compound the preparation
Compounding Record
patient- specific
113
Unit for Molecular Weight...
mg/mmol
114
Percentage of w/v, v/v, and w/w ...
x g/100mL
x mL/100mL
x g/ 100g
115
Unit for Osmolarity...
mOsm/mmol
116
Determine osmolarity by ..
number of ions
ex. NaCl will be 2 mOsm/mmol
ex. CaCl2 will be 3 mOsm/mmol
117
Determine milliequivalents and the unit used is...
determine by highest valence electron; unit used is mEq/mmol
118
Typical documentation needed for quality assurance program: _____= documents that describe how to perform routine and expected tasks in the compounding environment.
Standard Operating Procedures (SOPs)
119
(Master Formulation or compounding) record is not for a specific preparation for a patient
Master Formulation
120
MSDS (Material Safety Data sheets) are...
a detailed information document prepared by manufacturer or importer of a chemical that describes important safety considerations.
Documentation that comes with imported chemical includes reactivity data, health hazard, precaution with handling etc.
121
Extemporaneous methods are done ...
at the time of preparation (comminution with mortar and pestle)
122
___ type of mortar is most preferred when working with colored and potent materials.
Glass
123
Sodium benzoate
preservative
124
Sodium citrate
buffering agent
125
Effervescent powders/granules are prepared with acid/base excipient mixture that liberates ____ when combined with water, and aid in taste-masking.
CO2 (create gas/fizz)
126
Questran Powder (Cholestyramine Resin) is a major ___ product
bulk
127
(weak base or acid) becomes bitter if added to acidic liquid
weak base; bc it dissolves more readily, becomes protonated and reach taste buds quicker
