biopharm exam 3 - powders and granules

powders

______ are defined as a single solid or a mixture of solids in a finely divided state

false

T/F: powders used as pharmaceutical dosage forms may contain one or more drug substances and can be used as is or can be mixed with a suitable vehicle for administration

granules

_______ are solid dosage forms that are composed of agglomerations of smaller particles.

flexible

these multicomponent composititons (granules) are prepared for oral administration and are used to facilitate _______ dosing regimens .

true

T/F: industrially, most powders are filled into capsules or compressed into tablets

-oral

-topical

-inhaled

types powder products include

-particle size distribution

-flow

-blending

-compressibility

-dissolution rate

-aerosolization

properties of powders include

false

T/F: particle in a powder are all exactly the same size and shape

qualitative

particle size distribution is the _______ measure of different sizes in the powder

-sieve analysis

-microscopy

-automated powder analysis

particle size measurement methods include

Sieve

_____ may be used to remove excessively large or small particles from a starting material or blended mixture before packaging or further processing.

sieve

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microscopy

the following image is showing

microscopy

-shape parameters

-combined with image analysis

microscopy

the following image is showing

size and shape

dynamic image analysis uses ______ parameters to measure particle size distribution.

true

T/F: with dynamic image analysis, the particle can be dry or dispersed in a liquid.

false

T/F: powders and granules do not need to flow through pipes/tubes in manufacturing and packaging.

glidant

A _____ may be needed to improve flow of the mixture.

low concentration; <1%

glidants are effective at ______ concentration, usually _____

-colloidal silicon dioxide

-Talc

some examples of glidants we talked about in class are

false (they tend to flow well without glidants added)

T/F: Granules tend to flow poorly without glidants

rat-holing

______ is partial impaction

blending

______ is the process of different powders dispersing throughout a mixture

flow properties

blending is strongly affected by the _____ of each individual powder

false

T/F: powder blends are homogenous

small (e.g. 10mg of blend)

variability in the concentrations of each component is greater when comparing _____ sample sizes.

-comminution

-mortar and pestle

-grinding mill

grinding all powders to similar size distribution to improve blending include:

-spatulation

-mortar and pestle

-bench scale (V-blender)

-centrifugal blender (FlakTek)

pharmacists accomplish small scale blending by

geometric dilution

_____ is a method to disperse a small amount of one powder throughout a much larger mixture.

compressibility

_____ is an important powder property for tablet and capsule manufacturing

binder

______ may be needed to improve compressibility of the mixture

true

T/F: granules may compress better than fine powder in some cases.

DSCs/h

dissolution rate =

smaller; larger

for a fixed mass of solid, ______ particle dissolve faster than ______particles

false

T/F: wetting with liquid is not required before dissolution can occur

wetting agent

for powder and granule dissolution, ____ may be required for the API particle to disperse in water

true

T/F: granules tend to wet quickly; which may improve dissolution rate for hydrophobic drugs

hygroscopic

many powders are ______ meaning that they absorb water vapor from the air onto the particle surface.

-room humidity

-surface area of powder

water vapor adsorption depends on

effervescent

______ products tend to be hygroscopic

atmospheric humidity

powders are susceptible to _______

PVP (polyvinylpyrrolidone)

_______ is a hygroscopic solid

deliquescent

______ solids adsorb enough water vapor from the air to from liquid droplets and dissolve

true

T/F: hygroscopic and deliquescent materials have potential stability issues if they are stored in a humid environment, not tightly closed, etc

-caking

-product can become moist or wet

physical stability issues with deliquescent and hygroscopic materials include

-adsorbed water molecules may cause hydrolysis of the drug

-effervescent salts may react to release CO2

chemical stability issues with deliquescent and hygroscopic materials include

water tight and air tight

powder packing must be _______ as possible

a cool dry place

we should store powders and other solid dosage forms in ______

close container quickly

for bulk powders, we must ____ after measuring the dose

desiccant

a ______ preferentially adsorbs water to decrease the amount that adsorbs onto the drug product

-oral doses are easily customized

-may be administered with patient's preferred flavored liquid

-lower shipping cost than liquids

-solids are more stable than liquid

-unit dose products are portable (some advertised as no water needed)

advantages of powders and granules include

-bulk powders require dose measurement

-packaging must protect product from humidity

-oral flavoring required

-fine powders can be easily aerosolized and accidentally inhaled

disadvantages of powders and granules include

-have a lower SA per gram of material

-can be prepared to have lower hygroscopicity

-lower tendency to aerosolize

-may compress better than fine powders

-flow better than fine powders

-wet quickly and dissolve faster than fine powders

advantages of granules over powders include

-increase mass of powder

-give a more accurate dose measurement for potent drugs

diluents are intended to _____ and ____

-lactose

-sucrose

-mannitol

-maltodextrin

-microcrystalline cellulose

oral diluents include

-talc

-cornstarch

topical diluents include

granulating agent

________ is a sugar or polymer solution to hold granules together

disintegrating agent

_______ promotes powder or granule dispersion in water

true

T/F: pharmacists may be able to compound small amounts of powder safely and accurately