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178 Cards in this Set
- Front
- Back
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A dry substance composed of finely divided particles
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powder
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What are methods of particle size analysis?
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Sieve Analysis
Microscopy Sedimentation rate Laser Light Scattering or Diffraction Cascade Impaction |
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When particle size is determined based on weight (seive)
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Sieve Analysis
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Particle size id determined b visual observation with the use of a calibrated grid background or other measuring device.
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Microscopy
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Particles are in a solvent and light is refracted , this refraction will tell you about particle size
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Laser Light Scattering
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What impacts powder flow?
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Size
Shape Porosity |
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What is powder flow characterized by?
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Angle of Repose
Carr Index (Compressibility Index) |
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What size angle of repose will powders flow freely?
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low angle
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A method to determine powder flow and compressibility
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Tapped and bulk density
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this is useful in determining storage needs of powders
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bulk density
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This is the process of particle size reduction
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Comminution
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How do you extemporaneously reduce particle size
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Trituration
Pulverization by intervention Levigation |
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How is particle size reduced industrially
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Milling
Pulverization |
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What are the ways that powders can be blended
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Spatulation
Trituration Tumbling Geometric Dilution |
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Mixing of powders on an ointment slab or pad using a spatula, NO particle size reduction
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Spatulation
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Continued rubbing if a solid in a mortar with a pestle to reduce the particle size
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Trituration
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uses a clear glass or plastic bottles and zipper sealed plastic bags to mix powders
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Tumbling
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used when blending 2 or more powders of unequal quantities to ensure that small quantities of usually potent drugs are uniformly distributed throughout the powder mixture
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geometric dilution
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What types of powders require special handling
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Efflorescent
Hygroscopic Deliquescent Pharmaceutical Eutectic |
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these powders 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
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these powders are drugs or chemicals that absorb moisture from the air
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hygroscopic
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these are hygroscopic powders that may absorb sufficient moisture from the air to dissolve and form a solution
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deliquescent
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this is a mixture of 2 or more solid substances that may liquefy when intimately mixed at room temp
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pharmaceutical eutectic mixture
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What are powders used for
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medicated powders
to prepare other dosage forms |
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what are prepared agglomerates of powdered materials
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granules
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How does the surface area of granule particles compare to powder particles
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granules have reduced surface area
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How are granules prepared
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wet granulation
dry granulation slugging |
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what are granules used for
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to prepare tabs
as a dosage form |
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This method involves moistening the powder mixture and then passing a it through a screen of the desired mesh size and allowing granules to dry on trays
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wet granulation
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particles are placed in a conical piece of equipment in which they are dispersed and suspended while a liquid binding agent is sprayed onto granules and the product is dried
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fluid bed processing (wet granulation)
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Pass dry powder through a roll compactor and then through a granulating machine
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dry granulation
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compression of a powder mixture into large tablets or slugs which are then granulated into the desired particle size
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slugging
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solid dosage form in which the drug id enclosed w/in a hard or soft soluble container or shell
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capsule
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what are the shells of capsules usually made from
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gelatin , sugar and water
(or starch) |
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What will happen to a gelatin shell it absorbs additional moisture
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it will lose its rigid shape
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What determines the size of capsule that will be chosen
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density and compressibility of the powder
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What is the largest and the smallest capsule size for human use?
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000 - largest
5 - smallest |
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What are the formulation components of caps?
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API
Diluent/ filler Disintegrant Lubricant/ Glidant |
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This increases bulk and will produce the proper fill volume for a cap
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diluent/ filler
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lactose (caps)
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diluent/ filler
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microcrystalline cellulose (caps)
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diluent/ filler
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starch
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diluent/ filler
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this will facilitate the break-up and distribution of the caps contents
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disintegrant
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pregelantinized starch (caps)
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disintegrant
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croscarmellose (caps)
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disintegrant
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sodium starch glycolate (caps and tabs)
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disintegrant
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What will improve powder flow in caps?
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lubricant/ glidant
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fumed silicon dioxide (caps)
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lubricant/ glidant
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magnesium stearate (caps)
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lubricant
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calcium stearate (caps)
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lubricant/ glidant
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stearic acid (caps)
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lubricant/ glidant
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talc (caps)
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lubricant/ glidant
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how are appropriate capsule size selected
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compare characteristics to other known drugs
the rules of six the rules of seven |
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What are the extemporaneous ways caps are prepared?
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punch method
cap filling machine |
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what is the industrially ways caps are prepared?
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cap filling machine
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How is BUD assigned for caps?
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25% of time remaining to exp date of the product is prepared using man product, or 6 mo
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What containers should be used to repackage or dispense caps and tabs?
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light, well closed and light resistant
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cap should not be less than 90% and not more than 110% of theoretical calculated weight of each unit
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weight variation
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the amount of active ingredient should be w/in 85% to 115% of the label claim for 9/10 dosage units assayed, w/ no unit outside of 75%-125% of label claim
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content uniformity
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Why is stability testing performed on caps?
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to determine the intrinsic stability of the API and the influence of environmental factors (temp, humidity, light, formulation components, and container and closure sys)
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What are tablet excipients?
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diluents/fillers
binders or adhesives disintegrants antiadherents lubricants glidants colorants, flavorants |
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These add the necessary bulk to a formulation to prepare tablets of the desired size.
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diluents/ fillers
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dibasic calcium phosphate (tabs)
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diluents/ fillers
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mannitol (tabs)
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diluents/ fillers
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powdered cellulose (tabs)
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diluents/ fillers
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starch (tabs)
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diluents/ fillers
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will promote adhesion of the particles of tabs
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binders or adhesives
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acacia (tabs)
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binders or adhesives
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alginic acid (tabs)
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binders or adhesives
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carboxymethylcellulose (tabs)
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binders or adhesives
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gelatin (tabs)
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binders or adhesives
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liquid glucose (tabs)
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binders or adhesives
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methylcellulose (tabs)
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binders or adhesives
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povidone (tabs)
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binders or adhesives
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pregelatinized starch (tabs)
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binders or adhesives
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This promotes the breakup od tablets after administration to smaller pieces for ready drug availability
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disintigrants
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what component of tabs help improve flow
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glidants
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colloidal silica (tabs)
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glidants
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what reduces friction during tablet compression
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lubricants
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zinc stearate (tabs)
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lubricants
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prevent tablet ingredients from sticking to punches and dyes during production
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antiadherants
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talc (tabs)
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antiadherants
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what are the methods for preparing compressed tabs
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wet granulation
dry granulation direct compression |
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components are mixed with granulating fluid, dried and milled to produce granules w/ good flow and compression properties (tabs)
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wet granulation
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T/F - is wet granulation used to distribute low conc of drug to achieve acceptable content uniformity
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True
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This promotes the breakup od tablets after administration to smaller pieces for ready drug availability
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disintigrants
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what component of tabs help improve flow
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glidants
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colloidal silica (tabs)
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glidants
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what reduces friction during tablet compression
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lubricants
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zinc stearate (tabs)
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lubricants
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prevent tablet ingredients from sticking to punches and dyes during production
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antiadherants
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talc (tabs)
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antiadherants
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what are the methods for preparing compressed tabs
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wet granulation
dry granulation direct compression |
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components are mixed with granulating fluid, dried and milled to produce granules w/ good flow and compression properties (tabs)
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wet granulation
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T/F - is wet granulation used to distribute low conc of drug to achieve acceptable content uniformity
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True
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This promotes the breakup od tablets after administration to smaller pieces for ready drug availability
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disintigrants
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what component of tabs help improve flow
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glidants
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colloidal silica (tabs)
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glidants
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what reduces friction during tablet compression
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lubricants
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zinc stearate (tabs)
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lubricants
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prevent tablet ingredients from sticking to punches and dyes during production
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antiadherants
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talc (tabs)
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antiadherants
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what are the methods for preparing compressed tabs
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wet granulation
dry granulation direct compression |
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components are mixed with granulating fluid, dried and milled to produce granules w/ good flow and compression properties (tabs)
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wet granulation
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T/F - is wet granulation used to distribute low conc of drug to achieve acceptable content uniformity
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True
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What will increasing the amount of binder during the wet granulation process do
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increase granule density
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how is a binder added during the wet granulation process
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as a fine spray uniformly moving bed to avoid over-wetting areas
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what will happen when the granulating (wet massing)time is increased during the wet granulation process
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granule density increases
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what is the old technology for drying tabs
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tray
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what drying process passes warm air through a fludized bed
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fluid bed
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what drying process could use gas
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vacuum
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what drying process involves convection and vacuum drying
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microwave
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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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when milling what will increasing the impeller speed do to particle size
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increase particle size
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what type of powder mixing will every sample have exactly the same composition as all other samples from the blend
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perfect homogeneity
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what type of powder mixing will the probability if finding a particle of a given component is the same at all points in the mixture
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random mixing
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what type of powder mixing will physically absorb uniformly onto excipient to reduce segregation
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ordered mixing
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what is the small amount of force applied to material to remove entrapped air, forming a loose compact
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precompression force
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a larger amount of force applied to material, bonding particles together to form the tablet
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main compression force
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this is preformed to determine the effect if increasing force on the physical properties of the tabs
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compression profiles
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excessive force applied resulting in reduced hardeness, lamination and capping
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over-compression
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as compression increases
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thickness decreases
hardness increase friability decreases disintegration time increases dissolution rate decreases tab density increases |
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T/F as tablet press speed increases weight variability decreases
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F, increases (especially for poor flowing blends)
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T/F as tablet press speed increases dwell time increases
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F, decreases which could exacerbate lamination and capping (results in decreased hardness and increased friability
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the measure if how fragile tab is (will it chip in the container)
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friability
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what are the in-process controls for tabs
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appearance
weight thickness hardness friability disintegration dissolution |
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What are USP testing for tabs
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Tablet Weight
Weight Variation Content Uniformity Friability Disintegration Dissolution Compression |
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As hardness increases:
disintegration ? dissolution ? friability? |
disintegration time increases
dissolution decreases friability decreases, then may increase |
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What is the limit of friability
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0.3-0.5%
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What factors can affect dissolution (tabs)?
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milling conditions
granulaiton process lubrication time compression parameters |
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compress a tab w/ in a tab
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compression coating
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why do compression coating
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to minimize the contact area b/w 2 incompatible drugs
and can encase a toxic drug in an inert outer coat |
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2nd oe 3rd layer if material is compressed onto the original core
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layered tabs
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why do layered tabs
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to minimize contact area b/w incompatible drugs
provides a unique market image |
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release of drug is based on time, course and/or location designed ti accomplish therapeutic convenience obj not offered by conventional or immediate-release dosage forms
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modified release
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release drug at a time other than promptly after administration
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delayed release products
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most are enteric coated tabs or caps designed to pass unaltered through the stomach, later to release their active ingredients w/in the intestinal tract
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delayed release products
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designed to release the active ingredients in a controlled manner at a predetermined rate, duration and location to achieve and maintain optimum therapeutic blood levels of drug
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Extended release products
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dosage form that allows a reduction in dosing frequency from that necessitated by a conventional dosage form
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extended release products
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contain 2-single doses of medication, one for immediate release and the 2nd for delayed release
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repeat action products
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drug release is directed or concentrating a drug region, tissue, or site for absorption or for drug action
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targeted release
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small spheroid compressed tabs w/ varying drug release characteristics are placed w/in gelatin capsule shells
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multitablet systems
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process of enclosing solids, liquids or gases w/in microscopic particles by forming thin coatings around the substance
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microencapsulation
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Drug substance is combined and made into granules with an excipient material that slowly erodes in body fluids, progressively releasing the drug for absorption
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Embedding Drug in Slowly Eroding or Hydrophilic Matrix Systems
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Drug is granulated with an inert plastic material and the granulation is compressed into tablets; drug is slowly released from the matrix by diffusion
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Embedding Drug in Inert Plastic Matrix
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Chemical combination of drug substance with other agents to form complexes that may be only soluble in body fluid, depending on the pH of the environment
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complex formation
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Solution of a cationic drug may be passed through a column containing an ion exchange resin, forming a complex by the replacement of the halogen atoms
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ion exchange resins
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System composed of a core tablet surrounded by a semi-permeable membrane coating having a 0.4 mm diameter laser-produced hole through which drug is released by osmotic pressure
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osmotic pump
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substances of high molecular weight comprised of repeating monomer units
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polymers
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short chains (polymer)
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oligomers
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Properties of polymers are due to what?
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their size (MW)
3-dimensional shape asymmetry |
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The chemical reactivity of polymers depends on their
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their monomer units and
how they are put together |
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what type of polymer has all identical monomer units
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homopolymers
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What polymer is formed from more than one monomer type
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copolymers
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These are highly branched polymer constructs formed from a central core which defines their initial geometry
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dendrimers
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water soluble polymers have what effect on viscosity of solvents at low concentration
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increases viscosity
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what happens to water soluble polymers in solvent
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increase viscosity at low conc
to swell or change shape adsorb to surfaces |
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What are water-insoluble polymers used for?
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form thin films, matrices for encapsulating drugs or as packaging materials
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what is useful in controlling the release rate of water soluble drugs
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combination of slow rate solution and formation of a viscous surface layers that make hydrophilic polymers
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What is a large determinant of flow properties of polymers
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molecular shape
and reducing cross linking |
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solvent induced shape change may lead to what in polymers
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changes in viscosity
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this is a viscous, cross-linked polymer solvent system containing a 3D network of stable bond that are impervious to thermal motion
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gel
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What happen when the viscosity is increased above the gel point
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start seeing cross linking
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this is an irreversible system with a 3D network formed by covalent bonds b/w the macromolecules
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type 1 gels
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this is a heat-reversible gels held together by intermolecular bonds such as hydrogen bonds
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Type 2 gels
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what will be formed when water-soluble polymer chains are covalently cross linked, when these dry materials mix with water
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gels
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these are macromolecular chains with differing segments which exhibit properties
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heterogel
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this is a separation of a liquid from a swollen gel thought to occur b/c of the elastic contraction of the polymeric molecules
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syneresis
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Carboxypolymethylene (carbomer, carbopol) are water-soluble polymers used as
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suspending agents
binding agents sustained release dosage form |
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cellulose derivatives (ethylcellulose, methylcellulose) are water soluble polymers used for
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suspending agents
diluents disintigrants absorbents |
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what are natural gums and mucilages that are water soluble polymers
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acacia
tragacanth alginate pectin chitosan dextran |
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polyvinylpyrolidone (povidone) are water soluble polymers used for
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suspending agents
dispersing agents binding and granulating agent disintegrant |
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polyethylene glycols is a water soluble polymer used for
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solvent
suppository bases |
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these are polymer characteristics important for drug formulation
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MW (viscosity)
glass transition temp tensile strength diffusion coefficient hardness (crystallinity) solubility |
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encapsulation of small particles or solution of drug in a polymer film or coat
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microencapsulation
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solid particles which can entrap drug
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microspheres
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these can be used as rate-limiting membranes and devices
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implants
patches |
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the rate of drug release is determined by erosion of the polymeric membrane in which a drug id dissolved and dispersed
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eroding systems
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