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DDS > Exam 1 > Flashcards

Exam 1 Flashcards

1
Q

Large Volume Parenteral

A

more than 100 ml

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2
Q

Small Volume Parenteral

A

equal or less than 100ml

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3
Q

Common standard filter that filters all fungi and bacteria

A

0.22 microns

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4
Q

What is the rated pore size that filters particulates?

A

1-5 microns

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5
Q

IND for patients with life-threatening or severely debilitating illnesses, where no satisfactory alternative exist–

A

Expanded Access IND

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6
Q

Crystalline form of drug more likely to change over time– (Metastable or stable)

A

metastable

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7
Q

Drugs of what polarity are more likely to be reabsorbed in the kidney?

A

Non-polar

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8
Q

The intradermal injection volume is

A

0.1 mL

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9
Q

Intraosseous- route

A

into bone marrow cavity

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10
Q

Intraperitoneal- route

A

into space between layers of parietal+visceral peritoneum

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11
Q

The larger the catheter + needle gauges, the ____ will be the diameter

A

smaller

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12
Q

The ideal IV tonicity range is

A

240-340 mOsm/L

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13
Q

Intrapleural- route

A

into pleural cavity ( space between parietal + visceral layers of pleura)

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14
Q

Embolism is …

A

obstruction of blood vessel

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15
Q

Efflorescence is…

A

the release of water if hydration from a crystal hydrates.

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16
Q

Type of infusion where a 2nd IV fluid is placed through a connection (Y-port) in the primary IV infusion set is…

A

Piggyback infusion

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17
Q

Biopharmaceutics is…

A

the study of physical and chemical properties of drugs and their proper dosage related to the onset, duration, and intensity of drug action.

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18
Q

In aqueous solution, these type of excipients called _____, help solubilize drugs by reducing solvent polarity to better match solute polarity.

A

Cosolvents

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19
Q

If IV is > 500 mOsm/L, consider _____ administration because of possible phlebitis.

A

Central

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20
Q

The unionized form of a drug will have a (larger or smaller) P than ionized form.

A

Larger

Unionized= Nonpolar=lipophilic=larger P

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21
Q

Intra-articular…

A

into the synovial sacs of joints

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22
Q

This preservative cannot be given to neonates (newborns)

A

Benzyl alcohol

liver too immature to detoxify preservative

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23
Q

granuloma…

A

a mass of granulation tissue produced in response to chronic infection, inflammation, a foreign body, or unknown causes.

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24
Q

Bacterial endotoxin…

A

lipopolysaccharide (LPS) associated with outer membrane of gram-negative bacteria (pyrogen)

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25
Q

Bacterial endotoxin are too (small or large) for sterilizinng filters

A

too small

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26
Q

The critical portion of bacterial endotoxin is …

A

Lipid A

cause shock/fever

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27
Q

Pyrogen is difficult to eliminate because they are ….

A

small, soluble, and inanimate

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28
Q

Effective inactivation of pyrogens are …

A

Dry Heat + Alkylation

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29
Q

Vehicle is …

A

a carrying agent for a drug substance (no therapeutic activity and nontoxic)

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30
Q

Hypodermic route of administration called _____, the fat tissue below the dermis (composed of connective and adipose tissue)

A

Subcutaneous (SC)

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31
Q

Bolus (push) is …

A

a concentrated medication/solution given rapidly (1-5 minutes)

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32
Q

In the pre-clinical stage of drug development, what is the term for the area of investigation that involves studying the biochemical and physiological effects of the drug?

A

Pharmacodynamics

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33
Q

The degree of a drug’s ionization can be important for ….

A

drug’s absorption, dissolution, and receptor interactions

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34
Q

What best explains why a metastable crystalline form of a solid drug exhibited greater bioavailability than its stable counterpart?

A

metastable form had greater solubility

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35
Q

_____ is an expedited program for a serious condition where preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint.

A

Breakthrough therapy

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36
Q

____ would be the best choice of agent for altering the solubility of a drug if the goal is to reduce solvent polarity to better match solute polarity.

A

Glycerin

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37
Q

In the FDA’s expedited programs for serious conditions, a marker that is thought to predict clinical benefit is called…

A

Surrogate Endpoint

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38
Q

The more lipophilic the drug the (greater or lesser) the partition coefficient (P)

A

greater

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39
Q

The (more or less) lipophilic the drug the greater the partition coefficient

A

more

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40
Q

The partition coefficient is calculated by…

A

the concentration of the drug in the organic phase (nonpolar) divided by the concentration in the aqueous phase (polar).

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41
Q

Renal excretion of drugs– albumin-bound drug (is or is not) readily filtered through the capillaries of the glomeruli

A

is not

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42
Q

Renal excretion of drugs– some drugs experience active reabsorption into the bloodstream by …

A

uptake transporters in the proximal tubules

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43
Q

Renal excretion of drugs– some drugs experience active secretion into the proximal tubules by…

A

various efflux transporters

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44
Q

Renal excretion of drugs– nonpolar and relatively lipophilic drugs tend to (remain in or diffuse out) the filtrate.

A

Diffuse out

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45
Q

_____ is an Intravenous administration of fluid over 1-5 minute time period.

A

Bolus

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46
Q

____ is a Noyes-whiney equation parameter that is most likely affected when a pharmacist agitates the medium in order to speed the dissolution of a drug.

A

H, thickness of the static boundary layer

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47
Q

In the oxidation of drugs, chain-initiating radicals can be generated by …

A

Light, Heat, Transition Metals

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48
Q

Parenteral routes of CNS drug administration that involve administering the medication directly into the CSF are ….

A

Intrathecal or intraventricular

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49
Q

A highly concentrated solute layer around a dissolving solid where solute movement is stagnant relative to movement in the bulk liquid is …

A

static boundary layer

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50
Q

phlebitis is …

A

the inflammation of a vein (injury to endothelial cells)

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51
Q

Most common site for self-injection is…

A

Subcutaneous

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52
Q

____ a controlled method of prolonged drug infusion that includes the ability to control delivery rate.

A

continuous infusion

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53
Q

Cosolvents are blended with ____ to achieve optimal polarity

A

water

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54
Q

type of plastic that is transparent, flexible, has high water and oxygen permeability, and plasticizer leaching as a problem

A

Polyvinylchloride (PVC)

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55
Q

Polyvinylchloride has ____ as a problem

A

plasticizer leaching (release of components into content)

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56
Q

(Multiple or single) dose parenteral products must have preservatives.

A

Multiple

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57
Q

Dry heat sterilization is better for

A

heat stable, moisture-labile entities

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58
Q

____ an IV catheter inserted into a peripheral vein but with its tip in central IV site

A

PICC line

Peripherally inserted central catheter

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59
Q

____ cuts off flow of primary line to prevent mixing

A

back-check valve

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60
Q

___ is the patient population used for Phase 1 clinical trials.

A

Healthy volunteers

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61
Q

Thrombus is a…

A

blood clot

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62
Q

IM + SC pH range is …

A

4 - 9

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63
Q

IM injection sites are …

A

Gluteal (buttocks)
Deltoid (upper arm)
Vastus Lateralis (lateral thigh)

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64
Q

IM injection site suitable for children under 3 years old is …

A

Vastus lateralis

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65
Q

Accelerated stability studies are used by manufacturers to predict …

A

shelf-life

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66
Q

Intrathecal …

A

into subarachnoid space in lumbar region of spinal cord (between pia + arachnoid that contains CSF)

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67
Q

Cellulitis…

A

an acute, inflammation of connective tissue of the skin resulting from staph, strep, or other bacterial infection

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68
Q

Embolus is…

A

a mass of undissolved matter present in blood or lymphatic vessel brought here by the blood or lymph current (may be solid, gas, or liquid)

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69
Q

Most common vehicle for parenteral is…

A

water

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70
Q

3 Major processes involved in renal excretion is ….

A
  1. Glomerular filtration
  2. Secretion
  3. Reabsorption
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71
Q

Epidural…

A

space between dura mater and connective tissue lining the vertebral canal (on or over dura mater)

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72
Q

Ideal pH range for parenteral are …

A

7 - 7.8

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73
Q

Intraoccular…

A

injection into the eyeball

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74
Q

_____ an expedited program allows drug approval based on surrogate endpoint.

A

accelerated approval

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75
Q

Accelerated approval is an expedited program that allows drug approval based on ______

A

surrogate endpoint

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76
Q

Some examples of chelators are…

A

citric acid, tartaric acid, EDTA

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77
Q

Chelators are …

A

synergistic/antioxidant agents that minimize metal content

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78
Q

Surfactants are..

A

amphiphilic molecules that have a tendency to accumulate (absorb) at the interface between 2 phases

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79
Q

NDA phase that occurs after the drug is approved by FDA is…

A

Phase 4/ Post-Marketing

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80
Q

_____ type of interaction allows poorly soluble drugs to fit within the hydrophobic core of the cyclodextrin.

A

noncovalent interaction

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81
Q

Amorphous form is…

A

no repeating (periodic) arrangement, most readily soluble crystal form

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82
Q

_____ are colloidal-size structure, formed by surfactants, helps solubilize nonpolar drugs within its hydrocarbon core.

A

Micelle

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83
Q

ADME Studies… Stands for..

A

Absorption, Distribution, Metabolism, Excretion

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84
Q

Drug metabolism that occurs before reaching the systemic circulation is called…

A

first-pass metabolism

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85
Q

The internal structure of the crystal determines its…

A

habit

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86
Q

Propagation of free radicals….

A

free radicals grow in number

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87
Q

The purpose of Phase 2 clinical trials is ….

A

mainly effectiveness + short-term safety

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88
Q

Lyophilization…

A

to make “solvent loving” freeze-drying

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89
Q

Cyclodextrin solubilization…

A

“Host” lipophilic “guest compounds (drugs)” in their hydrophobic core

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90
Q

Drugs distribute (faster or slower) to well-perfused organs such as liver, kidney, + brain

A

faster

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91
Q

____ preferred administered injection if you want the drug to be directly administered into circulation.

A

Intravascularly (Intravenous IV-most common)

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92
Q

Thickness of the static boundary layer can be decreased by ….

A

agitation

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93
Q

Contents of glass ampules must be ____ after breaking.

A

filtered

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94
Q

The pharmacy has run out of Drug X (monohydrate) and instead fills Drug X (Dihydrate). Is this acceptable?

A

NO,

Because hydrates are less soluble than their anhydrous counterparts

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95
Q

Are hydrates (less or more) soluble than their anhydrous counterparts?

A

less

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96
Q

____ type of NDA for generic drug products

A

Abbreviated New Drug Application (ANDA)

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97
Q

____ + _____ are two primary locations where First-pass metabolism may occur following oral drug administration.

A

Enterocytes + Hepatocytes

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98
Q

Cyclodextrin…

A

type of excipient, molecule composed of glucose subunits that helps to solubilize drugs within its hydrophobic cavity.

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99
Q

solubility is…

A

the concentration of a solute in a saturated solution at a certain temperature (amount dissolved per volume)

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100
Q

Prior to FDA approval, drug manufacturing facilities will be inspected to ensure they are in compliance with…

A

FDA’s Current Good Manufacturing Practice Standards

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101
Q

_____ must be filed with the FDA after clinical trials before a drug can be considered for approval.

A

New Drug Application (NDA)

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102
Q

Coring is…

A

plugging the needle with a piece of rubber

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103
Q

The melting point of two polymorphs of a drug will be (same or different)…

A

different, because of different molecular arrangements within the crystal

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104
Q

Organoleptic properties are…

A

susceptible to sensory impressions (ex. smell, color, taste)

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105
Q

Examples of Reactive Oxygen Species (ROS) are…

A

Superoxide
Hydrogen Peroxide
Hydroxyl Radical

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106
Q

Metastable is…

A

being in an unstable and transient but relatively long-lived state of a chemical/physical system (may change over time to a more stable form)

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107
Q

Liberation…

A

release of the drug from its dosage form

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108
Q

____ has an important role in restricting easy passage of drugs into CNS interstitium.

A

tight junctions

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109
Q

Indication…

A

specific (FDA approved) use for a drug

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110
Q

Partition is the …

A

movement of a molecule from one phase into another phase (between polar and nonpolar phases)

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111
Q

Benefits for drug manufacturers developing drugs for orphan diseases include…

A

Tax incentive
Financial support (clinical trials)
7 year exclusivity

112
Q

A 10 degree Celsius rise in temperature produces a ___ fold decay rate increase.

A

2 to 5

113
Q

Stability would be greater if the degradation rate constant was (also greater or lower)

A

lower

114
Q

ADME properties depend largely on ____ properties of the drug.

A

physiochemical

115
Q

Which would more easily be formulated as an aqueous solution, naproxen or naproxen sodium?

A

Naproxen Sodium

because salt form is ionized in crystalline state, thus more easily go into solution

116
Q

Cosolvents are…

A

solvents used in combination to increase solute’s solubility (“like dissolves like”)

117
Q

Stratification…

A

process of arranging in layers

118
Q

It takes ____ months to get a response on an NDA.

A

10

119
Q

Effective pH range of buffers are determined by …

A

buffer’s pKa

120
Q

Hit (Drug Discovery) is…

A

when a molecule interacts with its target

121
Q

Size of Solid particle and exposed surface area (inversely or proportionately) related.

A

Inversely

Inc. Size = Dec. SA

122
Q

Crystal Habit is…

A

description of the outer appearance of a crystal

123
Q

Where does drug have the most difficulty passing into the interstitial fluid?

A

CNS- efflux transporters and tight junctions between endothelial cells restrict easy passage of drugs

124
Q

The nature of a drug (weak acid or weak base) can be made into a maleate salt.

A 
Weak base 
(positively charged)
125
Q

To be considered a chronic disease, it must last at least ___

A

3 months

126
Q

Noyes-Whitney equation describes …

A

dissolution rate

solid –> liquid

127
Q

Two main purposes of using buffer (adjust to pH) …

A
  1. Solubility

2. Stability

128
Q

What patient population is used in Phase 2 and 3 in clinical trials?

A

patients suffering from indicated condition

129
Q

EDTA (chelator) binds to ____ to prevent creation of chain-initiating radicals.

A

trace metals

130
Q

It takes ___ months to get a response on an NDA with Priority Review

A

6

131
Q

Example of Water-soluble antioxidants are…

A

ascorbic acid (vitamin C), sodium sulfite

132
Q

99.9% of drug will be fully ionized at 3 pH units (below or above) pKa for Bases

A

below

133
Q

99.9% of drug will be fully ionized at 3 pH units (below or above) pKa for Acids

A

above

134
Q

3 drug targets that do not require systemic circulation to reach….

A
  1. Intestinal Lumen (oral)
  2. Dermis (Topical)
  3. Bronchioles (Inhalation)
135
Q

Bioavailability less than 100% for extravascular routes, reasons includes…

A
  1. Incomplete dissolution
  2. Incomplete absorption (epithelia)
  3. Bypass absorptive area
  4. Pre-systemic metabolism (first-pass)
  5. Chemical degradation
136
Q

Most drugs, Shelf-life is the time for ____% degradation

A

10%

137
Q

Most prodrugs are created with ____ linkage

A

ester

138
Q

After passing through the glomeruli, drugs that are _____ tend to remain in the filtrate and are subsequently excreted into the urine

A

polar or ionized

139
Q

With lower aqueous solubility, less drug is dissolved in gastric fluid and there is (more or less) drug that is susceptible to chemical degradation

A

less

140
Q

First Order degradation, the conc. vs. T graph is ____

A

not a straight line ??

141
Q

Subcutaneous injection volume is ….

A

up to 2 mL

142
Q

____ administration catheter tip reside mainly in the basilic, cephalic, or branchial veins.

A

Midline

143
Q

Lead (Drug Discovery) is…

A

a prototype chemical that has the desired biological or pharmacological activity.

144
Q

Extravasation is…

A

the escape of fluids into surrounding tissue

145
Q

KVO (Keep-Vein-Open) is…

A

slow intravenous infusion of a fluid for the purpose of keeping the vein open in anticipation of future therapy

146
Q

Drug must have enough ____ to pass through membrane.

A

lipophilicity

147
Q

Dissolution rate (Fastest to slowest) for solid form is…

A

Amorphous>Metastable>Stable

148
Q

___ group at the entrance of cyclodextrins are responsible for interacting with water.

A

hydroxyl (-OH)

149
Q

____ type of IV administration has advantages of no repeated venipunctures, no x-ray needed to confirm placement, longer term than peripheral, better dilution, good if limited to peripheral access

A

Midline

150
Q

Laminar flow is …

A

air that moves with a uniform velocity along parallel lines to reduce turbulence

151
Q

Amber is the common color of pharmaceutic containers that can help limit photooxidation by blocking ____ light

A

Ultraviolet

152
Q

Zero-order degradation can occur when …

A

there is a reservoir of drug to replace drug that is lost to decomposition.

153
Q

Y-port…

A

connect a secondary administration set or inject fluids with a syringe

154
Q

Worst type of glass to be used for parenterals….

A

NP- General purpose soda-lime glass

155
Q

Pseudo first-order degradation…

A

when the degradation rate is apparently independent of the concentration of one of the reactants, even though it is consumed in the reaction

156
Q

Purpose of Phase 3 Clinical Trials is ….

A

confirm effectiveness and longer-term safety

157
Q

Purpose of Phase 1 Clinical Trials is…

A

Determine safety and dosage

158
Q

Candidate (Drug Discovery) is…

A

the lead that is most suitable for further investigation

159
Q

____ is the application that must be submitted to the FDA prior to beginning clinical studies.

A

Investigational New Drug Application (IND)

160
Q

FDA programs that exist to expediate development and review of drugs to address an unmet medical need are …

A
  1. Fast Track
  2. Breakthrough Therapy
  3. Accelerated Approval
  4. Priority Review
161
Q

Vesicants…

A

any agent that produces blisters (or other tissue injury)

162
Q

UV light is mainly limited to air and surfaces because of ______

A

poor penetration

163
Q

Upon dissolution of the salt of the weak acid such as phenytoin sodium in water, the resulting pH of the solution be (alkaline or acidic)

A

Alkaline,

because negatively charged drug will remove protons from the water molecules upon dissolution, therefore rise in pH

164
Q

____ type of NDA for changes in labeling, method of synthesis, formulation, analytical standards, container, manufacturing facilities, and adding a new indication.

A

Supplemental New Drug Application (SNDA)

165
Q

The pH at which a drug is 50% ionized ….

A

pKa

166
Q

The letter a pharmaceutical company receives from the FDA indicating that the application is not ready for approval is the …

A

complete response letter

167
Q

SC injection sites include…

A

outer surface of upper arm, lower portion of abdomen, anterior surface of thigh

168
Q

Steps of free radical oxidation are…

A
  1. initiation
  2. propagation
  3. termination
169
Q

Size of particulate that can get lodge in arterioles or capillaries are…

A

8 microns or larger

170
Q

Septicemia is….

A

presence of pathogenic bacteria in the body (via bloodstream)

171
Q

Ringer’s Components …

A

NaCl, KCl, CaCl2

172
Q

Pseudopolymorph…

A

describes a drug (or excipient) that can crystallize as a combination of pure durg plus the solvent of crystallization

173
Q

Polymorphism…

A

capacity for appearing in many forms (drugs may exist in different molecular arrangements)

174
Q

pH of maximum stability is the point in which K is the (lowest or highest)

A

lowest

175
Q

Osmotic pressure…

A

pressure that develops when two solutions of different concentrations are separated by a semipermeable membrane

176
Q

Orphan disease are….

A

rare disease or condition that affects fewer than 200,000 patients in the U.S.

177
Q

On the InK vs pH graph, base catalysis has a _____ slope

A

positive

178
Q

On the InK vs pH graph, acid catalysis has a _____ slope.

A

negative

179
Q

Examples of oil-soluble antioxidants includes…

A

alpha-tocopherol (Vitamin E), buylated hydroxytoluene (BHT), propyl gallate

180
Q

Oil cannot be administered ____

A

IV (droplets are emboli)

181
Q

Mass Transport…

A

the movement of molecules of solutes or solvents from one region to another

182
Q

Major nerve in dorsogluteal region is…

A

Sciatic Nerve

183
Q

Main difference between needles and catheters are …

A

flexibility

184
Q

Lactated Ringer’s Components are…

A

NaCl, KCl, CaCl, Sodium Lactate

185
Q

Intraventricular …

A

into lateral ventricles of the brain

186
Q

Intrathecal pH range …

A

7 - 7.6 (avoid aseptic meningitis)

187
Q

Intradermal injection site is…

A

between epidermis and dermis

188
Q

Intra-aterial injection site is …

A

into the artery

189
Q

Intermittent infusion…

A

IV therapy administered at prescribed intervals with intermediate infusion time (30-60mins)

190
Q

Infiltration is…

A

the process of seepage or diffusion into tissue of intravenous infusate

191
Q

IND filed during Phase 1 or 2 to allow treatment of desperately ill before full FDA approval is….

A

Treatment Protocol for Compassionate Use

192
Q

In the termination stage of free radical mechanisms of oxidation, free radicals …

A

combine to form chemically inert products

193
Q

The IM injection site that can withstand the largest volume is …

A

gluteal (buttocks) – 5mL per buttock (up to 10mL)

194
Q

IM and SC pH range is…

A

4 - 9

195
Q

Hypodermoclysis is the term for continuous ____ infusion used to maintain hydration (e.g. used in nursing home patients)

A

subcutaneous

196
Q

Hygroscopicity is…

A

the tendency of a substance to take up atmospheric moisture

197
Q

How do micelles help solubilize nonpolar drugs?

A

dissolve within lipophilic pool within hydrocarbon core

198
Q

How do micelles help solubilize amphiphilic drugs?

A

will intersperse among surfactants ???

199
Q

Prodrug are…

A

synthetic derivative of a drug that is transformed in vivo to liberate an active drug molecule

200
Q

Solvate are…

A

crystal containing solvent molecules within the crystal lattice

201
Q

Drug must be in ____ form to leave the vasculature.

A

Free (unbound)

202
Q

Amphoteric is…

A

having an acidic and basic moiety

203
Q

Micelle…

A

aggregate formed from self-association of surfactant monomers.

204
Q

Critical Micelle Concentration is…

A

the concentration of surfactant at which surfactant molecules will self-associate to form micelle

205
Q

Drug Stability

A

“the extent to which a drug product retains, within specified limits, and throughout its period of storage and use (shelf-life), the same properties and characteristics that it possessed at the time of its manufacture”

206
Q

Functional groups that make the drug susceptible to hydrolytic cleavage are ….

A

Esters, amides, lactams, lactones

207
Q

Autoxidation is…

A

type of oxidation that involves the uncatalyzed oxidation of a substrate by molecular oxygen (slow)

208
Q

Functional groups that make the drug susceptible to oxidation are…

A

phenols, catechols, thiols, tertiary amines, polyunsaturated hydrocarbons

209
Q

Deliquescence is..

A

the dissolution of a solid upon uptake of atmospheric moisture

210
Q

Zero-order degradation, the concentration vs time graph is a ____line

A

straight

211
Q

Central IV administration site …

A

catheter tip is located in superior vena cava, or right atrium

212
Q

Advantage of Central IV over Peripheral IV is…

A

rapid dilution (large vessel) and less risk of irritation

213
Q

Peripheral IV administration site…

A

hand, lower/upper arm, anticubital fossa (inner elbow) and scalp (under 6 months old)

214
Q

Peripheral IV administration site for patient under 6 months old is ___

A

the scalp

215
Q

Heparin or Saline Lock …

A

a small intermittent infusion device that remains in the vein between uses. It is flushed with heparin or saline to maintain patency (keeps vein ready for the next infusion)

216
Q

HEPA Filters …

A

high efficiency particulate air filter.., removes 99.97% of particles 0.3 microns and larger.

217
Q

Gas Sterilization used for surgical supplies, disposable syringes, etc. because it _____ well

A

penetrates

218
Q

USP sterility test, different growth conditions are used to detect…

A

different microbes

219
Q

Two USP Sterility test methods are …

A

Direct transfer + membrane filtration

220
Q

Direct Transfer (USP Sterility Test)…

A

sample of sterile culture media

221
Q

Membrane Filtration (USP Sterility Test)…

A

important for antibiotics and preserved products, filter through 0.45 micron

222
Q

Not common rated pore size filtration that fills fungi and most bacteria (but used in membrane filtration/USP) is …

A

0.45 microns

223
Q

Filtration sterilization is mainly used for …

A

solutions

224
Q

Why is ampicillin sodium is very soluble in water, whereas ampicillin is slightly soluble in water…

A

ampicillin sodium is salt form where ampicillin is more polar charged state within crystal lattice, therefore will go to aqueous solution more readily due to salt form.

225
Q

Central IV pH range is…

A

3 - 10.5

226
Q

Best type of glass is…

A

Type 1- Borosilicate

227
Q

Based on Noyes-Whitney equation, taking medication with large glassful of water can increase dissolution rate of solid by (decreasing or increasing) concentration of solute in bulk liquid.

A

decreasing

228
Q

Based on Noyes-Whitney equation, (increasing or decreasing) the liquid viscosity can slow dissolution by reducing diffusion of the solute in the dissolution medium.

A

increasing

229
Q

Based on the Noyes-Whitney equation, agitation can (increase or decrease) dissolution rate of a solid by decreasing the thickness of the stagnant boundary layer.

A

increase

230
Q

Bacteriostatic…

A

inhibiting/retarding growth of bacteria

231
Q

Air in the sterile area has (positive or negative) pressure compared to surrounding areas.

A

positive, so we don’t recycle dirty air or allow dirty air to flow into sterile area

232
Q

ABC Transporters…

A

active transporters that utilize ATP for energy

233
Q

Weak Acid would be expected to have (increase or decrease) water solubility as the pH rises above the pKa

A

increase,

more will be in the ionized form

234
Q

Weak Base would be expected to have (increase or decrease) water solubility as the pH rises above the pKa

A

decrease,

more will be less polar, non-ionized form

235
Q

Main mechanisms of antioxidants are…

A

stop propagation and preferentially oxidized

236
Q

Types of pyrogen tests are …

A

Rabbit + Limulus Amebocyte Lysate (LAL) Test

237
Q

1 - 5 microns removes …

A

particulates

238
Q

0.45 microns removes…

A

fungi and most bacteria

239
Q

0.22 microns removes…

A

all fungi and bacteria

240
Q

Arrhenius Equation determines the effect of ______ on degradation rates, helps predict product’s shelf-life at these different _____

A

Temperature(s)

241
Q

Accelerated stability studies predict shelf-life by using _____

A

Arrhenius Equation

242
Q

Most common solvate is a …

A

hydrate

243
Q

Hydrates are generally (more or less) soluble than their anhydrous counterparts.

A

less

244
Q

Salt formation can significantly improve a drug’s water solubility, due to (greater or lesser) degree of ionic dissociation of salt molecules…

A

greater

245
Q

Increase dielectric constant = (greater or lesser) polarity of medium

A

greater

246
Q

Dielectric constant is …

A

ability of solvent to separate oppositely charged ions

247
Q

Higher dielectric constant, polarity of molecules (reduces or increase)

A

reduces polarity

248
Q

IV injects (more or less) volumes compared to IM

A

More
IV : 1ml - 3 L
IM: 1ml - 10mL

249
Q

An example of solubilizing agent is…

A

polysorbate

250
Q

____ describes a drug’s pharmacodynamics.

A

Drug action

251
Q

Purpose of Phase 1 of Clinical Trial is …

A

Mainly safety

252
Q

Which will not support an explanation as to why a drug (taken as a tablet) will not reach adequate blood levels in the patient?

  • Drug was a substrate for enzyme found in hepatocyte
  • Drug exhibits degradation in acidic conditions
  • Drug did not dissolve completely
  • Patient has gastrointestinal hypermotility
  • Drug was a substrate for uptake transporter found in enterocytes
A

Drug was substrate for uptake transporter found in enterocytes

All other answers are correct explanations as to why the drug will not reach adequate blood levels however last statement describes reason why it does reach adequate levels.

253
Q

Ionized Drug = more polar = (more or less) lipophilic

A

less lipophilic (harder to pass through membrane)

254
Q

Higher Partition Coefficient = (more or less) lipophilic

A

more

255
Q

Partition Coefficient can be useful for predicting the ____ of a drug across a lipid membrane

A

passive diffusion

256
Q

First Pass Metabolism can significantly (limit or increase) an oral drug’s bioavailability

A

limit

257
Q

Injectable drugs (can or cannot) bypass first pass metabolism.

A

can, because injectables goes straight into blood

258
Q

____ is the main metabolic site

A

Liver

259
Q

Phase 1 (Drug Metabolism): ______ is the adding or uncovering a polar functional group (OH, N)

A

Functionalization Reactions

260
Q

Phase ___ (Drug Metabolism): Conjugation reactions is the covalent conjugation of a polar functional group onto parent compound

A

2

261
Q

____ is the main excretory organ for drugs and metabolites

A

Kidney

262
Q

Protein-bound drugs (can or cannot) be filtered in the glomerulus in the kidneys

A

cannot

too large to pass fenestrations

263
Q

Metastable polymorphs leads to (higher or lower) bioavailability.

A

higher

264
Q

Ionized form (is or is not) water soluble

A

is

265
Q

Acid (donates or accept) hydrogen

A

donates, wants to be ionized

266
Q

(Weak Acid or Weak Base) as you increase pH, solubility increase pH > pKa = deprotonation

A

weak acid

loses H= donates proton

267
Q

(Weak Acid or Weak Base) as you decrease pH, solubility increases pH < pKa = protonation

A

weak base

gains H= accepts proton

268
Q

pH > pKa (deprotonated or protonated)

A

deprotonated

269
Q

Agitation can (increase or decrease) the stagnant boundary layer and speed up dissolution.

A

decrease

270
Q

(increasing or decreasing) the medium viscosity tend to increase dissolution rate

A

decreasing

271
Q

(First or zero) order degradation
Rate is Constant
Decay is Linear

A

Zero

272
Q

(First or zero) order degradation
Rate is proportional to concentration
Exponential Decay

A

First

273
Q

Lyophilization–Freeze drying to make the drug (more or less) solvent loving

A

more

274
Q

_____ boiling process that removes oxygen then purged with inert gas

A

Distillation

275
Q

Intralesional is a (local or systemic) action

A

local

DDS (29 decks)

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