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76 Cards in this Set

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What is a mixture of immiscible phases (solid/liquid/gas)?
Disperse Systems
What are some reasons why we need disperse systems?
1. Poorly soluble drugs
2. Taste masking
3. Stability
4. Dose flexibility
5. Ease of administration
What type of dispersion would have 10-50 micrometer particles?
Coarse dispersions (Suspensions/emulsions)
Most common
What type of dispersion would have 0.5 to 10 micrometer particles?
Fine dispersion (magma/gels)
What type of dispersion would have 1.0 nanometer - 0.5 micrometer particles?
Colloidal dispersions
What type of dispersions would have < 1.0 nanometer particles?
Solutions
True or False?
A Suspension is a saturated solution of the solid always..
True
What is sticking of particles and increasing diameter? This also creates bigger particles and faster settling.
Aggregation
What is the formation of tightly packed sediment that cannot be redispersed?
Caking
What is the deposition of drug on particle surface of a saturated solution? It increases particle size and sedimentation.
Crystal growth
What are ways to determine physical instability in suspensions?
1. Particle Size/Shape/Distribution
2. Determination of sedimentation Rate
3. Subject material to freeze/thaw cycle
What is an assumption about drug degradation?
Drugs in solid form are generally stable. Degradation occurs only in solution.
********Know order of degradation reactions*********
********Know order of degradation reactions*********
When preparing a suspension, what are 3 ways to reduce the particle size distribution?
Micronizing, micropulverization, and spray drying
What are some things needed to disperse a drug in a medium?
-Wetting/dispersing agents
-alcohol
-glycerin
-propylene glycol
-surface acting agents
What is controlled aggregation to prevent caking?
Flocculation
What are some flocculating agents?
1. Electrolytes
2. Polymers
3. Surfactants
What are some things that should be avoided when making compounds for pediatric patients?
Benzyl Alcohol, Propylene Glycol, most flavorants and preservatives
What are four common emulsions?
1. Milk (o/w) with Protein casein as the emulsifier
2. Mayo (w/o) with egg yolk as the emulsifier
3. IV emulsions (o/w)with phospholipids as the emulsifier
4. Cold cream (w/o) with no specfic emulsifier
Why are surfactants and emulsifiers needed in emulsions?
Dispersions tend to coalescence and fuse together.
What does the HLB scale tell?
It shows the hydrophilic-lipophilic balance.
True or False?
Increase in HLB means a decrease in Hydrophilicity
False.
An increase in HLB will increase the hydrophilicity
What are the 4 ways to classify emulsions by charge?
Anionic, cationic, amphoteric, and non-ionic
True or False?
Mucous and membranes are usually positively charged.
False
They are negatively charged
What are the 3 theories on Emulsification?
1. Surface tension theory
2. Interfacial film theory
3. Oriented-wedge theory
What are the two mehtods for preparing emulsions?
1. Continental or dry gum method
2. Wet gum method
What is the ratio for emulsions?
4:2:1
oil:water:gum
What is inversion of Emulsions?
Reversal of internal phase to external phase.
Why does inversion occur?
Use of the wrong surfactant, temperature, phase volume ratio
What are micro emulsions?
1. These are stable systems
2. Smaller than conventional emulsiosn (.1 micrometers)
3. o/w emulsions
emulsifier = HLB 15-18
4. Form spontaneously, absorbed rapidly
What is a solution?
Mixture or dispersion of two or more constituents at the molecular level (solid or liquid)
If drug A has a solubility of 20 mg in 100 ml and 50 mg is dissolved in 100 ml water, what is the concentration in %w/v?
Max concentration is 20% w/v.
Weight/molecular unit
Mole
What is the difference between molarity and molality?
Molarity = moles of solute/liters of solvent

Molality = moles of solute/Kg of solvent.
Also molarity is a function of temperature where molality is not.
Moles of solute/total moles in solution
Mole fraction
What are some Aqueous solution?
Aromatic waters, mouthwashes, nasal solutions, otic solutions, and syrups
What are some properties of water?
1. Contains intermolecular forces of attraction
2. High Polarity
Type of water that contains becarbonate and sulfates of Ca and Mg. It is unsuitable for pharmaceutical purposes.
Hard Water
Type of water with salts removed with ion exchange resins, but still unsuitable for pharmaceutical purposes.
Soft water/deionized water
Type of water that meets EPA standards used for non-sterile purposes.
Purified water
Distilled hard or soft water. Some volatile organic matter and salts may still be present
Distilled water
Type of water where microbes are destroyed but toxins may be present. Not suitable for injections. May be used for opthalmic preparations.
Sterile Water
Best Category of Water.
Suitable for large volume parenterals, should not contain preservatives, should not contain more than 0.25 USP units of pyrogen/10mL.
Pyrogen-free Sterile water
Small volume parenterals
0.5 USP units of pyrogen/10ml
Contains preservatives to control microbial growth
Bacteriostatic water for injection
What are the five types of alcohols?
1. Ethanol
2. Glycerol
3. Propylene glycol
4. methanol
5. Propanol
What are ketone solvents for gums/resins?
Acetone and methyl Isobutyl Ketone
What are the 3 types of Solutes?
Volatile Non-electrolytes
Non-volatile - Non-electrolytes
Electrolytes
Temperature at which Vapor pressure of a solvent equals one atmosphere.
Boiling point
Why can't suspensions be given IV?
Because particles might clog vessels.
What are some common parenteral routes?
IV, IM, SQ, ID
What are some less common parenteral routes?
1. Intra arterial
2. Intra spinal
3. Intrathecal
4. Intraarticular
5. Intraperitoneal
6. Intracardiac
What are powder forms of official Types of Injections?
For Injection
For Injectable Suspensions
What are liquid forms of official types of Injections?
Injection, Injectable emulsion, and Injectable suspension
What are important considerations for sterilization?
Destruction of living organisms and their spores. Removal of these organisms fromthe system and removal of metabolites and toxins
Choice for aqueous products
MOA is protein coagulation
Employs steam under pressure, uses autoclave
Steam sterilization
Usually carried out in ovens
Temperature: 150-170C for 2 hours
MOA: dehydration
Size of units should be small
Use for oils, heat stable powders and glassware
Dry Heat Sterilizaiton
MOA: physical removal of microorganisms, useful for heat-sensitive materials, method of choice for small volumes of aqueous materials
Filtration
Use this sterilization with heat and moisture sensitive materials. Expose materials to ethylene oxide or propylene oxide for 4-16 hours.
Gas sterilization
use gamma and cathode rays to sterilize.
Ionizing Radiation
What are some quality control/Validation tests?
-Monitor sterilization cycle with a "Biologic Indicator"
-Pyrogen Test
-LAL test
What is the normal volume of tear fluid in cul-de-sac?
7-8 microliters
What is the maximum volume in cul-de-sac?
30 microliters
What is the normal volume of a drop?
50 microliters
What is the average bioavailability of an eyedrop?
1% or less
What are the pharmaceutical requirements for eyedrops?
1. Sterility and preservation
2. Isotonicity
3. Buffering (vials that sit for a while decrase pH)
4. Viscosity
5. Ocular/Bioavailability
6. Packaging (adding preservatives)
7. patient counseling
True or False?
Nasal Solutions are intended for deep lung absorption?
False. They are intended for Upper Respiratory Tract.
What are nasal solutions used for?
Mostly adrenergics used for decongestion.
What is the capacity and surface area of nasal cavity?
20 mL capacity and 180 cm2 surface area.
What is used in otic preparations to maximize contact time?
Propylene glycol
What are the 3 main reasons for using otic preparations?
Wax removal, anti-infectives, anti-inflammatory/analgesic
What is TPOC?
Triethanolamine Polypeptide Oleate Condensate
in propylene glycol emulsifies ear wax
What are chloramphenical, neomycin, and nystatin used for in otic preparations?
Anti-infectives
What are hydrocortisone and dexamethasone used for in otic preparations?
Anti-inflammation
What are anti-pyreene, benzocaine, and dibucaine in otic preparations?
Analgesics
Which otic suspensions have acidic pHs?
Polymixin B Sulfate, Neomycin Sulfate, and Hydrocortisone
What is a solution to acidic preparations for otic suspensions?
Pediotic suspensions - suspension in a non-aqueous vehicle