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114 Cards in this Set
- Front
- Back
What is Micromeritics?
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The study of small particles
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What are the five (5) methods of particle size analysis?
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(1) sieve analysis, (2) microscopy, (3) sedimentation rate (4) laser scattering or diffraction, (5) cascade impaction
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How is microscopy used in particle size analysis?
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Particle size is determined by visual observation with the use of a calibrated grid background or other measuring device.
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Which method of particle size analysis would you use when looking at particles for aerosals?
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Anderson Cascade Impactor
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(T/F) Powders with large angles of repose flow freely.
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False
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(T/F) Powders with low angles of repose free freely.
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True
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Which method is useful in determining powder flow and compressibility?
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Carr Index
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Which method is useful in determining storage needs?
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Carr Index
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What is the formula for Carr Index?
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% Compressibility= ((Tapped Density- Bulk Density)/ (Tapped Density)
X100 |
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(T/F) A powder with a Carr Index with a compressibility range of >40 is extremely poor (cohesive powders)
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True
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What is Comminution?
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The process of particle size reduction?
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What is Spatulation?
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The mixing of powders on an ointment slab or pad using a spatula; no particle size reduction.
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What is Trituration?
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The continued rubbing of a solid in a mortar with a pestle to reduce the particle size.
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What is Tumbling?
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The use of clear glass or plastic bottles and zipper sealed plastic bags to mix powders.
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When is Geometric Dilution used?
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It is used when blending two or more powders of unequal quantities to ensure that small quantities of usually potent drugs are uniformly distributed thoughout the powder mixture.
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What are the kind of powders that release water of hydration from drugs or chemicals when they are manipulated or stored under conditions of low relative humidity
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Efflorescent Powders
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What are the kind of powders, drugs or chemicals that absorb moisture from the air?
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Hygroscopic Powders
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What are the kind of powders that are hygroscopic powders that may absorb sufficient moisture from the air to dissolve and form a solution?
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Deliquescent Powders
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What are the kind of powders, mixture of tow or more solid substances that may liquefy when intimately mixed at room temperature?
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Pharmaceutical Eutectic Mixtures
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What are the four kind of powders that require special handling?
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Efflorescent, Hygroscopic, Deliquescent, and Pharmaceutical
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What is a comminution method that involves dispursing powders in insoluble solvent?
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Levigation
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What are two methods used industrially to reduce particle size?
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Milling and Pulverization
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(T/F) Granules reduce surface area compared to powders
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True
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What are prepared agglomerates of powdered materials called?
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Granules
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What are the three methods that granules are prepared by?
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Wet Granulation, Dry Granulation, and Slugging
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Capsule shells are usually made from ______________?
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Gelatin
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(T/F) Capsules are suitable for aqeous liquid.
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False
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(T/F) Capsules are sensitive to humidity and microbial contamination
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True
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Capsules range in size _ to _?
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00, 5
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(T/F) The capsulse size 5 is the largest.
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False
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(T/F) Capsules in size 000 are the largest
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True
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What is The Rule of Sixes?
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The bulk densities of many powders aveage about 0.6g/mL.
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What is The Rule of Sevens?
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Convert formulation weight to grains; subtract from seven; Use table to determine appropriate size (only works if calculated values are between -3 and 5)
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Weight Variation: Capsule shall not be less than __% and __% of the theoretical value
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Capsule shall not be less than 90% and not more than 110% of the theoretical calculated weight of each unit.
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Content Uniformity: The amount of active ingredient should be within __% to __% of the label claim for 9 of 10 dosage units assayed, with no unit outside of 75% to 125% of label claim
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Content Uniformity: The amount of active ingredient should be within 75% to 125% of the label claim for 9 of 10 dosage units assayed, with no unit outside of 75% to 125% of label claim
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What is the type of tablet that accounts for ~95% of tablets?
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Compressed
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Which type of tablet have a very potent drug?
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Triturates
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Which is a natural product used as an excipient in tablets that promotes adhesion of particles?
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Acacia
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What is the purpose of a lubricant?
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Reduces friction during tablet compression
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What is the purpose of antiadherents?
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Anitadherents prevent tablet ingridients from sticking to punches and dies during production
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What are three methods for the preparation of compressed tablets?
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Wet granulation, Dry granulation, direct compression
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Which type of method of preparation of tablets produces robust formulations?
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Wet granulation
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Which type of method of preparation of tablets can be used to distibute low concentrations of drug to achieve acceptable content uniformity?
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Wet granulation
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What is the rate limiting step in the dry granulation process?
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The compression into slugs or roll compaction.
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Which is the simplest process for preparation of compressed tablets?
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Direct compression
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What are the four types of drying techniques?
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Tray, Fluid Bed, Vacuum (could be gas assisted), and Microwave
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When milling does the impeller speed increase or decrease particle size?
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increasing can decrease particle size
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During milling what is the primary factor that determines particle size?
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screen size
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Does precompression force increase or decrease the chance of lamination and capping?
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decrease
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Does over-compression result in increase or decrease hardness?
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decrease
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Does over-compression result in lamination and capping?
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yes
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As compression force increases, friability
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decreases, but can then increase
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As compression force increases, dissolution rate
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decreases
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As compression force increases, tablet density
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increases
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Does short dwell time in the tablet press lead to capping/lamination?
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yes
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What is capping and lamination?
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Ask Carlos
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(T/F) Capping and lamination is due to improper improper formulation design and malfunction of machinery.
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True
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According to the USP method. How many units are individually assayed for their content uniformity
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Ten (10)
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What are the extemporaneous methods of preparing capsules?
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punch method and capsule filling machines
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What is the industrial method of preparing capsules?
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capsule filling machines
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What is the purpose of enteric coating?
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They are designed to pass unaltered through the stomach, later to release their active ingredients within the intestinal tract.
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What are repeat action products?
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Usually contain two single doses of medication, one for immediate release and the second for delayed release.
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Is a drug that exhibits very slow or very fast rates of excretion and absorption a good drug candidate for extended-release?
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neither
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Are drugs used in the treatment of chronic diseases good drug candidates for ER products?
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yes
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Are drugs used in the treatment of acute diseases good drug candidates for ER products?
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no
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Are drugs that are administered in relatively small doses, good candidates for extended-release products?
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yes
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Are drugs that posses a good margin of safety good drug candidates for extended-release?
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yes
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Are drugs that are uniformly absorbed from the GI tract good drug candidates for extended release?
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yes
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What is microencapsulation?
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The process of enclosing solids, liquids, or gases within microscopi particles by forming thin coatings of wall materials around the substance
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What is complex formation?
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chemical combination of substances with other agents to form complexes that may be only soluble in body fluid, depending on the pH of the envoironment
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What is a dendrimer?
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A dendrimer is a highly branched copolymer formed from a central core which defines its orignal geometry.
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______ are formed from more than one monomer type.
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Copolymer(s)
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Water soluble polymers tend to increase the viscosity of solvents at (high/low) concentrations?
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at low concentrations
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Water soluble polymers tend to increase viscosity by _____________?
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(1) swelling or changing shape
(2) at low concentrations (3) adsorbing at surfaces |
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Polymer solutions: Solvent induced shape change may lead to significant changes in __________.
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viscosity
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A _____is a viscous, cross linked polymer-solvent system containing a three dimensional network of stable bonds that are impervious to thermal motion.
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Ans: Gel
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What type of gel is an irreversible system with a 3-D network formed by covalent bonds between the macromolecules?
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Type 1 Gels
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What type of gels are heat-reversible gels that are held together by intermolecular bonds such as hydrogen bonds?
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Type 2 Gels
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Type 2 Gels are held together by what kind of bonds?
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intermolecular bonds such as hydrogen bonds
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Type 1 Gels are held together by what kind of bonds?
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covalent bonds
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______are macromolecular chains with different segments which exhibit different properties.
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Heterogels
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How are cross-linked polymeric systems useful?
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They are useful in implants that swell in the presence of water, ex. poly(HEMA)s
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________ is the separation of a liquid from a swollen gel thought to occur because of the elastic contraction of the polymeric molecules.
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Syneresis
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What is Polyvinylpyrolidone (povidone)?
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a water soluble polymer used as a suspending agent and dispersing agent, binding and granulating agent, and disintegrant
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Polyethylene glycols (PEGs) serve as______?
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solvents and suppository bases
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What is the osmotic pump drug delivery system?
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A system composed of a core tablet with a tiny hole, through which drug is released by osmotic pressure.
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The release of drug from an osomotic-pump drug delivery system is driven by ______.
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osmotic pressure
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What is the purpose of in-vitro and in-vivo correlations?
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We need to make sure what we see in the lab is the same thing we see in the body.
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What are the five types of natural gums and mucilages?
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acacia, tragacanth, alginate, pectin, chitosan, dextran
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Permeability of Polymers: Does having more polar films, increase the permeability of oxygen?
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No, it decreases the permeability b/c more polar films tend to be more ordered, and less porous, hence less permeable to oxygen
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Does having less polar films, permit the permeation of oxygen?
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yes less polar films, means a more porous polymer, thus permitting permeation, BUT NOT NECESSARILY WATER MOLECULES
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Why are we moving away from using gelatin capsules?
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b/c gelatin is an animal product (allergies, vegetarians, microbial contamination=diseaase, and kosher)
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Where does gelatin come from?
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Gelatin is obtained from the partial hydrolysis of collagen from the skin, white connective tissue,and bones of animals
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Hard gelatin capsules contain about __% to __% moisture
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13% to 16%
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Which type of tablet can have a potent drug?
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Triturates
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Which diluent or filler makes very high or dense tablets?
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Dibasic calcium phosphate
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During wet granulation, (increasing/decreasing) amount of binder increases granule density.
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increasing
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Granulating time (increases/decreases) granule density.
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Granulating time increases granule density but too much time can cause paste formation.
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What is friability?
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Friability is the measure of how fragile the tablets are,how likely they are to chip in the bottle.
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Tablet disintegration tests cannot be performed on what two type of tablets?
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chewable and modified release tablets
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How many tablets are used in the disintegration test?
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6 tablets in disintegration basket
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The FDA has a policy to have dissolution profiles be generated in water, 0.1 N HCl, and USP buffer media at what pHs?
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4.5, 6.5, 7.5
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The _______is the change from solid ridgid state to more fluid, less ridgid state.
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glass transition strength
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What are the characteristics that are important for drug formulation of polymers?
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MW, glass transition strength, tensile strength, diffusion coefficient, hardness (cystallinity), and solubility
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What is tensile strength
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the force required to break the "hardness" of something
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What will impact the permeability of polymers?
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Diffusion: viscosity, thickness of membrane, surface area, partion coefficient, concentration gradient
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How can the degree of porosity of polymers be useful?
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Degradation
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Can polymers in drugs have an affinity for plastics?
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yes, such as packaging materials, IV, tubing, etc.
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Is Miralax (PEG 3350) a hydrophilic or hydrophobic polymer?
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hydrophilic polymer that swells in the lower part of the small intestine and large intestine
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Do hydrophobic or hydrophilic matrices cause the entry of water into the polymer, which causes swelling and the formation of a gel through which the drug must diffuse to be released.
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hydrophilic
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Do (hydrophilic/hydrophobic) matrices cause the mechanism of drug release to be passing through pores or diffusing slowly through the polymer wall?
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hydrophobic
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Would you want a drug with a a very water-soluble polymer?
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no
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would you want a drug with a very water-insoluble polymer?
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no
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What is a poly(HEMA)?
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A cross-linked polymer system that swells in the presence of water and forms a hydrogel. The polymer cannot dissolve since the cross links are stable.
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