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z F1: Pharmaceutics > Exam 3 > Flashcards

Exam 3 Flashcards

1
Q

What are suppositories systematic action

A

Drugs delivered via suppositories bypasses the hepatic first pass metabolism

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2
Q

Physiological factors of suppositories

A

Colonic content: disssolve before being absorbed
pH: 7 to 8

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3
Q

Physio-chemical factors of suppositories

A

Partition co-efficient: how quickly the drug leaves the suppository
Particle size: undissolved drug has to be reduced
Nature of base: hydrophobic stay in lipophilic base longer

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4
Q

Fatty or oleaginous bases examples

A

Cocoa butter
Hydrogenated veggie oil
Glyceryl monosterarate
Glyceryl monopalmitate

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5
Q

Primary requisite of suppository bases

A

remain solid at room temp but melt or soften at site of absorption

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6
Q

Fatty or oleaginous bases have two polymorphs what are they

A

alpha: low melt point, metastable
beta: high melt point, stable

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7
Q

What are two water-soluble and water-miscible bases

A

Glycerinated gelatin
Polyethylene glycol

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8
Q

What are the three methods to prepare suppositories

A

Molding from a melt
Compression
Hand rolling

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9
Q

Quality control tests of suppositories

A

Melt temp range
In vitro drug release
Visual exam
Odor
Weight
Liquefaction time
Solidification time
Mechanical strength/crushing test
Content uniformity test

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10
Q

What are these examples of
Acetaminophen (feverall)
Bisacodyl (dulcolax)
Miconazole nitrate combination product (monistat 3)
Alprostadil urogenital (muse)
Mesalamine (canasa)

A

Suppositories

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11
Q

What is low microbial contamination risk levels

A

< 3 sterile ingredients
No more than 2 entries into any 1 sterile device
Limited to transferring, measuring, and mixing

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12
Q

What is medium microbial contamination risk levels

A

> 3 sterile ingredients
Multidoses, multipatients, mutibatches
Complex manipulation long duration processes

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13
Q

What is high microbial contamination risk levels

A

Non-sterile ingredients, equipment, garbing

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14
Q

Engineering control for non-hazardous sterile compounding

A

Air quality must be at least ISO 8 for positive pressure clean room

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15
Q

Engineering control for hazardous sterile compounding

A

Air quality must be at least ISO 7 for negative pressure clean room

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16
Q

Counters and floors must be cleans how often? Walls, ceilings, and storage shelving must be cleaned how often?

A

Counters and floors: daily
Walls, ceilings, and storage shelving: monthly

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17
Q

What does aseptic mean

A

Without microorganisms

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18
Q

What specific manipulations are needed for aseptic techniques

A

Syringes
Needles
Vials
Ampules
Removal of packaging
Assembling of sterile compounds
Hand placement

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19
Q

What components are involved in aseptic processing

A

Sterile environment
Sterile /non-sterile ingredients
Sterile and particle free container
Non-sterile ingredients

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20
Q

What is the most common source of infection contamination for IVs

A

Human Touch

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21
Q

What are the different risks of IV therapy

A

Infection
Air embolus
Allergic Reaction
Incompatibilities
Particulate Matter
Pyrogens

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22
Q

What are the three quality assurance of sterile dosage forms

A

Engineering controls: contamination potential
Barrier controls: contaminant transfer
Personal control: contamination events

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23
Q

Barrier controls

A

Hair cover
Face mask
Gown
Gloves
Goggles
Shoe covers

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24
Q

Buffer room

A

Area with limited access that is designated for compounding and packaging of compounded sterile preparations and is engineered to meet or exceed class 10,000 standards

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25
Q

Anteroom

A

Area adjacent to the buffer room that reduces traffic around the buffer room doors and is engineered to meet or exceed class 100,000 standards

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26
Q

Preparation room

A

Area that is designed for staging of supplies and gowning and is engineered to meet or exceed class 100,000 standards

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27
Q

Horizontal/Vertical Laminar Airflow Workbench

A

Provides no less than a Class 100 working environment for sterile compounding

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28
Q

Zone of turbulence

A

-Air turbulence created inside the critical area by the introduction of an object in the direct path of the first air
-When laminar airflow is moving on all sides of an object, the zone extends ~3X the diameter
-When placed adjacent to a vertical wall, zone of turbulence os created that may extend 6X diameter of object

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29
Q

All aspetic manipulations should be preformed at least ___ ________ within the hood to prevent possibility of contamination from room air entering the hood

A

6 inches

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30
Q

What are primary and secondary engineering controls

A

Primary: create the work zone in which aseptic processing is conducted
Secondary: Provide buffer zone in which hoods are located, and an ante room, or gowning area between buffer zone and uncontrolled enviornment

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31
Q

Critical site

A

Any direct pathway through which contaminants ma sterile product

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32
Q

HEPA filter

A

High-efficiency particulate air filter capable of removing at least 99.97% of particles larger than 0.3 micrometers from the air

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33
Q

What are the three engineering controls and laminar airflow cleanbenches

A

Horizontal flow cleanbench
Vertical flow cleanbench
Laminar flow cleanbench

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34
Q

Biological safety cabinet

A

Specifically designed workbench providing both product and operator protection in which HEPA filtered laminar air flows vertically from above the work zone, towards the work surface and is recovered

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35
Q

Barrier Isolator

A

Closed system: workers manipulate compounding through gloved ports
Removes personnel from environment where parenteral products are prepared

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36
Q

Contamination in LAFW

A

Backwash
Downstream
Cross-stream

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37
Q

How often do you clean anteroom and shelving

A

Anteroom: weekly
Shelving: monthly

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38
Q

Do not use syringes whose gradations are greater than ______ the volume being measured

A

Twice

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39
Q

Needle size is determined by what two numbers

A

Gauge
Length

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40
Q

The larger the gauge number the _________ the diameter of the needles bore

A

Finer

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41
Q

Do not break an ampule __________ hepa filter

A

Toward

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42
Q

Difference between small volume parenterals and large volume parenterals

A

Small-SVP of piggy back
Large-LVL greater than 100 ml

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43
Q

Total parenterals nutrition is used for

A

Patients who can’t eat, will not eat, should not eat, can’t eat or absorbs enough food

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44
Q

How are TPN prepared

A

Empty bag
Underfill method

45
Q

USP labeling requirements

A

Names and amounts of concentrations of ingredients
Total volume of the preparation
Beyond use date
Appropriate route of administration
Storage conditions
Padding specific labels

46
Q

Freezer temp

A

-25 to -10 Celsius

47
Q

Cold temp

A

2 to 8 degree Celsius

48
Q

Cool temp

A

8 to 15 degree Celsius

49
Q

Controlled room temp degree

A

20 to 25 degree Celsius

50
Q

Warm temp

A

30 to 40 degree Celsius

51
Q

Excessive heat temp

A

Above 40 degree Celsius

52
Q

FDA drug recall classifications 1, 2, 3

A

Class 1: most serious, could result in death
Class 2: indicated use of or exposure to a products cause adverse health effects
Class 3: not likely to cause health effects

53
Q

What activities and operations are included in QA

A

monitoring
evaluating
correcting
improving

54
Q

What are the three areas to monitor in the QA

A

Air testing
Surface testing
Personnel testing

55
Q

Proper garbing technique

A

Head to feet
occurs in ante room

56
Q

Gloved fingertip test in personnel testing

A

Initial testing prior to allowing compounding
Should be done every 6-12 months

57
Q

What is media fill testing

A

Skill of personnel to aseptically prepare CSPs

58
Q

Bacteriostatic

A

Preventing growth or multiplication of bacteria

59
Q

Bioburden

A

Level of microorganisms present as potential contaminants (higher level = harder to maintain sterility)

60
Q

What are methods of sterilization

A

steam
dry heat
filtration
gas
ionizing radiation

61
Q

Biological indicators of validation of sterility

A

A characterized preparation of specific microorganisms resistant to a particular sterilization process

62
Q

BUD for low risk compounding in segregated compounding area

A

12 hours at CRT

63
Q

BUD in low risk compounding

A

48 hours at CRT
14 days refrigerator
45 days freezer

64
Q

BUD in medium-risk compounding

A

30 hours CRT
9 days refrigerator
45 days freezer

65
Q

BUD in high-risk compounding

A

24 hours CRT
3 days refrigerator
45 days freezer

66
Q

The process of drug absorption through skin is referred to as what

A

percutaneous absorption

67
Q

What are some methods used for enhancing percutaneous absorption

A

Physical approach
Chemical
Biochemical

68
Q

Bioconvertible prodrugs

A

Modify skin permeability of a drug by altering its physiochemical properties

69
Q

Skin permeability enhancers

A

enhance transdermal permeation rate of progesterone
dependent on alkyl chain length and terminal carboxylic group

70
Q

Inotophoresis

A

process that facilitates the transport of ionic species by the application of a physiologically acceptable electrical current

71
Q

How do drug molecules diffuse through the skin

A

Stratum corneum
Hair follicle region
Sweat gland

72
Q

Intercellular versus transcellular diffusion

A

Intercellular regions in the stratum corneum are filled with lipid-rich amorphous material

73
Q

Drug reservoir

A

-Sandwiched between a drug-impermeable backing laminate and rate-controlling polymeric membrane
-Homogenous dispersion of solid drugs in a hydrophilic or lipophilic polymer matrix
-Solid drigs suspended in a aq soln of a water-miscible solubilizing agent

74
Q

Aerosol definition

A

A system that depends on the power of a compressed or liquified gas or inspiratory air to expel the contents from the container

75
Q

What factors determine lung deposition

A

Physico-chemical properties of droplets or particles delivered
Mechanical aspects of aerosol dispersion usually associated with the delivery device
Physiological and anatomical consideration of the lungs

76
Q

Areosol particle size is expressed as AED. What is AED

A

Aerodynamic equivalent diameter of a particle is the diameter of a unit density sphere that would have the identical settling velocity as the particle

77
Q

What are the mechanisms of particle deposition in lungs

A

Inertial impaction
Sedimentation
Diffusion

78
Q

What is inertial impaction

A

process of hereby a particle moving in a gas stream is unable to remain in the streamline when the gas changes direction

79
Q

Physiological and anatomical consideration of the lungs: upper airway, middle airway, alveolar region

A

upper airway: inertia
middle airway: gravitational sedimentation
alveolar region: brownian diffusion

80
Q

What are some aerosol particle characteristics that influence clearance

A

Composition
Residence time
Local/topical action
Systemic action

81
Q

Biopharmaceutic considerations in aerosol delivery

A

mucociliary transport
absorption
cell-mediated transport

82
Q

Lung retention of inhaled therapeutocs

A

very low solubility
tissue retention
positive charge
encapsulation in controlled release particles
increasing molecular size

83
Q

Particle size reduction techniques used in aerosol formulations include

A

micronization
spray drying
super critical fluid technology

84
Q

Components of MDI

A

propellants
container
valve and actuator
product concentrate

85
Q

Propellents characteristics used to assist in formulation are

A

vapor pressure
density
(they also use co-solvents and surfactants)

86
Q

Product concentrate MDI

A

Two phase systems
Three phase systems
Compressed gas systems

87
Q

When MDI manufacturing what are the two methods used

A

cold filling
pressure filling

88
Q
A
89
Q

What are no gos for breath actuated MDIs

A

No shaking, priming, or using spacers

90
Q

Powered drug and excipient mix may be packaged in various systems what are they

A

Capsules
Multi dose blister packs
Powder reservoir systems

91
Q

Components of nebulizers

A

Energy source
Site of energy input
Large droplet remover

92
Q

Quality control of pharmaceutical aerosols

A

Delivered dose uniformity
Droplet/particle size distribution

93
Q

Cyclotron

A

Particle accelerator
Uses magnetic fields

94
Q

Alpha emission

A

emission of helium nucleus

95
Q

Beta + and Beta - emission

A

+ : emission of electron
- : emission of positron

96
Q

Gamma emission

A

emission of radiation (no mass)

97
Q

99m Tc characteristics

A

Can be formulated in a variety of salt forms
Distributes to thyroid, salivary glands, gastric mucosa, CNS, kidney

98
Q

67 Ga characteristics

A

used for imaging inflamed or malignant lesions

99
Q

Positron emission tomography

A

carbon 11
nitrogen 13
oxygen 15
fluorine 18

100
Q

Sustained release dosage form

A

decrease release of therapeutic agent
plasma profile is sustained in duration

101
Q

Controlled release dosage form

A

drug release kinetics from this type of dosage form is highly predictable

102
Q

Design of rate-preprogrammed drug delivery systems

A

polymer membrane permeation-controlled drig delivery systems
(polymer achieved by nonporous or microporous)
(encapsulation achieved by injection molding, spray coating, microencapsulation)

103
Q

Activation modulated drug delivery systems

A

Physical means
Chemical means
Biochemical means
Osmotic pressure activated drug delivery systems
OROS technology

104
Q

Excipients that form Liposomes

A

DPPE
DMPC
DOPC
DOPE

105
Q

Types of liposomes

A

MLV
Unilamellar vesicles
SUV
LUV

106
Q

Modification of liposomes to modulate drug delivery

A

Stealth liposomes
Targeted liposomes
Cationic liposomes

107
Q

Microencapsulation

A

small particles
coatings applied to solid particles, liquid droplets, dispersions
can be converted to wide range of dosage forms

108
Q

Water-soluble polymers

A

Gelatin
Polyvinyl pyrrolidone
Carboxymethyl cellulose
Methyl Cellulose
Polyvinyl Alcohol

109
Q

Water-insoluble polymers

A

Ethyl cellulose
Polymetharylate
Poly (lactide-co-glycolide)

z F1: Pharmaceutics (10 decks)

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