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z F1: Pharmaceutics > Exam 3 > Flashcards

Exam 3 Flashcards

(109 cards)

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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
Anteroom
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
26
Preparation room
Area that is designed for staging of supplies and gowning and is engineered to meet or exceed class 100,000 standards
27
Horizontal/Vertical Laminar Airflow Workbench
Provides no less than a Class 100 working environment for sterile compounding
28
Zone of turbulence
-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
29
All aspetic manipulations should be preformed at least ___ ________ within the hood to prevent possibility of contamination from room air entering the hood
6 inches
30
What are primary and secondary engineering controls
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
31
Critical site
Any direct pathway through which contaminants ma sterile product
32
HEPA filter
High-efficiency particulate air filter capable of removing at least 99.97% of particles larger than 0.3 micrometers from the air
33
What are the three engineering controls and laminar airflow cleanbenches
Horizontal flow cleanbench Vertical flow cleanbench Laminar flow cleanbench
34
Biological safety cabinet
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
35
Barrier Isolator
Closed system: workers manipulate compounding through gloved ports Removes personnel from environment where parenteral products are prepared
36
Contamination in LAFW
Backwash Downstream Cross-stream
37
How often do you clean anteroom and shelving
Anteroom: weekly Shelving: monthly
38
Do not use syringes whose gradations are greater than ______ the volume being measured
Twice
39
Needle size is determined by what two numbers
Gauge Length
40
The larger the gauge number the _________ the diameter of the needles bore
Finer
41
Do not break an ampule __________ hepa filter
Toward
42
Difference between small volume parenterals and large volume parenterals
Small-SVP of piggy back Large-LVL greater than 100 ml
43
Total parenterals nutrition is used for
Patients who can’t eat, will not eat, should not eat, can’t eat or absorbs enough food
44
How are TPN prepared
Empty bag Underfill method
45
USP labeling requirements
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
Freezer temp
-25 to -10 Celsius
47
Cold temp
2 to 8 degree Celsius
48
Cool temp
8 to 15 degree Celsius
49
Controlled room temp degree
20 to 25 degree Celsius
50
Warm temp
30 to 40 degree Celsius
51
Excessive heat temp
Above 40 degree Celsius
52
FDA drug recall classifications 1, 2, 3
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
What activities and operations are included in QA
monitoring evaluating correcting improving
54
What are the three areas to monitor in the QA
Air testing Surface testing Personnel testing
55
Proper garbing technique
Head to feet occurs in ante room
56
Gloved fingertip test in personnel testing
Initial testing prior to allowing compounding Should be done every 6-12 months
57
What is media fill testing
Skill of personnel to aseptically prepare CSPs
58
Bacteriostatic
Preventing growth or multiplication of bacteria
59
Bioburden
Level of microorganisms present as potential contaminants (higher level = harder to maintain sterility)
60
What are methods of sterilization
steam dry heat filtration gas ionizing radiation
61
Biological indicators of validation of sterility
A characterized preparation of specific microorganisms resistant to a particular sterilization process
62
BUD for low risk compounding in segregated compounding area
12 hours at CRT
63
BUD in low risk compounding
48 hours at CRT 14 days refrigerator 45 days freezer
64
BUD in medium-risk compounding
30 hours CRT 9 days refrigerator 45 days freezer
65
BUD in high-risk compounding
24 hours CRT 3 days refrigerator 45 days freezer
66
The process of drug absorption through skin is referred to as what
percutaneous absorption
67
What are some methods used for enhancing percutaneous absorption
Physical approach Chemical Biochemical
68
Bioconvertible prodrugs
Modify skin permeability of a drug by altering its physiochemical properties
69
Skin permeability enhancers
enhance transdermal permeation rate of progesterone dependent on alkyl chain length and terminal carboxylic group
70
Inotophoresis
process that facilitates the transport of ionic species by the application of a physiologically acceptable electrical current
71
How do drug molecules diffuse through the skin
Stratum corneum Hair follicle region Sweat gland
72
Intercellular versus transcellular diffusion
Intercellular regions in the stratum corneum are filled with lipid-rich amorphous material
73
Drug reservoir
-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
Aerosol definition
A system that depends on the power of a compressed or liquified gas or inspiratory air to expel the contents from the container
75
What factors determine lung deposition
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
Areosol particle size is expressed as AED. What is AED
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
What are the mechanisms of particle deposition in lungs
Inertial impaction Sedimentation Diffusion
78
What is inertial impaction
process of hereby a particle moving in a gas stream is unable to remain in the streamline when the gas changes direction
79
Physiological and anatomical consideration of the lungs: upper airway, middle airway, alveolar region
upper airway: inertia middle airway: gravitational sedimentation alveolar region: brownian diffusion
80
What are some aerosol particle characteristics that influence clearance
Composition Residence time Local/topical action Systemic action
81
Biopharmaceutic considerations in aerosol delivery
mucociliary transport absorption cell-mediated transport
82
Lung retention of inhaled therapeutocs
very low solubility tissue retention positive charge encapsulation in controlled release particles increasing molecular size
83
Particle size reduction techniques used in aerosol formulations include
micronization spray drying super critical fluid technology
84
Components of MDI
propellants container valve and actuator product concentrate
85
Propellents characteristics used to assist in formulation are
vapor pressure density (they also use co-solvents and surfactants)
86
Product concentrate MDI
Two phase systems Three phase systems Compressed gas systems
87
When MDI manufacturing what are the two methods used
cold filling pressure filling
88
89
What are no gos for breath actuated MDIs
No shaking, priming, or using spacers
90
Powered drug and excipient mix may be packaged in various systems what are they
Capsules Multi dose blister packs Powder reservoir systems
91
Components of nebulizers
Energy source Site of energy input Large droplet remover
92
Quality control of pharmaceutical aerosols
Delivered dose uniformity Droplet/particle size distribution
93
Cyclotron
Particle accelerator Uses magnetic fields
94
Alpha emission
emission of helium nucleus
95
Beta + and Beta - emission
+ : emission of electron - : emission of positron
96
Gamma emission
emission of radiation (no mass)
97
99m Tc characteristics
Can be formulated in a variety of salt forms Distributes to thyroid, salivary glands, gastric mucosa, CNS, kidney
98
67 Ga characteristics
used for imaging inflamed or malignant lesions
99
Positron emission tomography
carbon 11 nitrogen 13 oxygen 15 fluorine 18
100
Sustained release dosage form
decrease release of therapeutic agent plasma profile is sustained in duration
101
Controlled release dosage form
drug release kinetics from this type of dosage form is highly predictable
102
Design of rate-preprogrammed drug delivery systems
polymer membrane permeation-controlled drig delivery systems (polymer achieved by nonporous or microporous) (encapsulation achieved by injection molding, spray coating, microencapsulation)
103
Activation modulated drug delivery systems
Physical means Chemical means Biochemical means Osmotic pressure activated drug delivery systems OROS technology
104
Excipients that form Liposomes
DPPE DMPC DOPC DOPE
105
Types of liposomes
MLV Unilamellar vesicles SUV LUV
106
Modification of liposomes to modulate drug delivery
Stealth liposomes Targeted liposomes Cationic liposomes
107
Microencapsulation
small particles coatings applied to solid particles, liquid droplets, dispersions can be converted to wide range of dosage forms
108
Water-soluble polymers
Gelatin Polyvinyl pyrrolidone Carboxymethyl cellulose Methyl Cellulose Polyvinyl Alcohol
109
Water-insoluble polymers
Ethyl cellulose Polymetharylate Poly (lactide-co-glycolide)

z F1: Pharmaceutics (10 decks)

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