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140 Cards in this Set
- Front
- Back
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The study of small particles
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micrometrics
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5 methods of Particle Size Analysis
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Sieve, Microscopy, Sedimentation Rate, Laser Light, Cascade Impaction
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What is the Angle of Repose?
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how to estimate flow property
TanO= h/r |
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Powders with ______ angles of repose flow freely
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low
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What is Carr Index?
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way to determine powder flow and compressability. This can help storage needs.
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The process of particle size reduction.
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Comminution
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Name and describe 3 extemporaneously particle size reduction methods and
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Trituration- physical grinding
Pulverization- recrystallizing Levigation- adding solvent in which solid is insoluble |
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Name 2 industrial particle size reduction methods.
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Milling
Pulverization |
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True or False.
Spatulation reduces particle size. |
False. Spatulation is just the mixing of powders using a spatula.
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When would you use geometric diltution?
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When mixing two or more powders of unequal quantities to ensure adequate distribution.
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A small compressibility range indicates_______.
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excellent flow (granule)
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A large compressibility range indicates _______.
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poor flow (powder)
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Blending method in which bottles and bags are used to mix powders.
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Tumbling
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The release of water of hydration when manipulated or stored a low humidty describes which type of powder?
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Efflorescent
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Which powder type absorbs moisture from the air?
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Hygroscopic
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Hygroscopic powders that may absorb sufficient moisture from the air to dissolve and form a solution describes which powder type?
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Deliquescent
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What is a euctectic mixture?
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when two or more solids liquefy on contact.
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_________ are prepared agglomerates of powdered materials.
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Granules
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True or False.
Granules have reduced surface area in comparison to powders. |
True
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Name and describe 2 ways granules can be prepared.
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wet granulation- moistening powder then running through screen mesh.
dry granulation- dry powder through compactor, or slugging, which is the compression of powder into a slug. |
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What is the purpose of granulation?
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Improve flow properties
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When would you want to use a porcelain mortar and pestle?
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to create a finer powder
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True or False.
Large particles flow more freely than fine particles. |
True
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_________are solid dosage forms in which the drug is enclosed in a shell.
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Capsules
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True or False
Capsule shells can be made from gelatin or starch. |
True
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What are 6 advantages of capsules?
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- mask taste
-powders can be dispensed in uncompressed form -variety of administration routes - ability to combine several products into 1 capsule - easy to swallow -controlled drug release |
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What are 4 disadvantages of capsules?
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- easily tampered with
- sensitive to humidty and microbes - can be difficult for some to swallow - unsutiable for aqueous liquids |
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________is obtained from the partial hydrolysis of animal parts.
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Gelatin
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True or False.
Gelatin can be found in the form of powder, shred, flakes, and sheets. |
True
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True or False.
Gelatin capsules are stable in moisture. |
False. They are only stable in dry conditions.
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True or False.
In high humidity, capsules may lose their rigid shape. |
True.
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True or False.
In extreme dryness, capsules can become brittle. |
True
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Capsule size 000 is the _______ and 5 is the ______.
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largest; smallest
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What 2 things determine what capsule size to use?
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density and compressibilty of powder.
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True or False.
A colorant is needed as a capsule component. |
False.
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Why are diluent/fillers added to capsules?
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To produce proper fill volume.
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Name 3 excipients you could use as a diluent in a capsule.
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lactose, cellulose, starch
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___________facilitates break-up and distribution of a capsules contents.
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Disintegrant
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pregelatinized starch, croscarmellose, and sodium starch glycolate are examples of what capsule component?
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Disintegrants
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Why would you add a lubricant or glidant to a capsule?
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improve flow properties
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True or False.
Capsules consist of 3 pieces. |
False. 2; a body and cap
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Describe The Rule of Sixes and when is it needed?
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the bulk densities of many powders average 0.6 g/mL. Needed when selecting capsule size
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Describe The Rule of Sevens.
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convert to weight to grains, subtract from seven and use table to select appropriate capsule size.
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Name 2 ways to prepare capsules.
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Punch method and capsule filling machines.
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What does USP recommend as the BUD for capsules?
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25% of the time remaing to expiration date of manufacture product or 6 months ( ealiest).
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True or False.
You should only add substances to capsules if they are harmless, do not exceed minimum amounts required to provides intended effect, and don't interfere with bioavailability and assays. |
True
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True or False.
USP has specifications for packaging of capsules. |
True.
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True or False.
Disintegration, dissolution, content uniformity, and weight variation are specified by USP for capsules. |
True
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Weight variation suitable range.
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90-110% of theoretical weight
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Describe the ranges for content uniformity.
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85-115% of any ingredient of the label claim for 9 out of 10 units. No unit should be outside of 75% or 125%
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________ is performed to determine the intrinsic stability of the API and influence of enviromental factors.
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Stability Testing
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Why does the USP require a moisture permeantion test for capsules?
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to ensure appropriate containers to maintain stability.
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14 types of tablets.
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1. compressed
2. multi compressed 3. sugar coated 4. film coated 5. gelatin coated 6. enteric- coated 7. molded 8. triturates 9. hypodermic 10. dispensing 11. immediate- release 12. instantly disintegrating 13. extended-release 14. vaginal tablets |
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________ are solid dosage forms prepared with suitable excipients and a tablet machine capable of exerting great pressure in compating powders or granules.
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Compressed
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List 7 usual tablet excipients
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1. diluent/ filler
2. binder/adhesive 3. disintergrant 4. antiadherent 5. lubricants 6. glidants 7. colorant/ flavorant |
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________add bulk to a tablet.
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diluent/filler
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dibasic calcium phosphate
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tablet diluent/filler
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lactose
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tablet diluent/filler
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mannitol
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tablet diluent/filler
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microcrystalline cellulose
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tablet diluent/filler
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starch
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tablet diluent/filler
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_______promote adhesion of particles.
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binder/adhesive
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acacia
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tablet binder/adhesive
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alginic acid
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tablet binder/adhesive
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CMC
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tablet binder/adhesive
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gelatin
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tablet binder/adhesive
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glucose
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tablet binder/adhesive
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methylcellulose
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tablet binder/adhesive
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povidone
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tablet binder/adhesive
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pregelatinized starch
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tablet binder/adhesive
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_______promotes break up of tablets.
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disintergrant
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Name 3 common tablet disintergrants.
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microcrystalline cellulose, sodium starch glycolate, starch
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________improve powder flow.
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glidants
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Name 2 common glidants found in tablets.
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colloidal silica, cornstarch, talc
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_________reduce friction during tablet compression.
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Lubricants
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______prevent tablet ingredients from sticking to punches
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antiadherants
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Name 2 common tablet antiadherants.
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talc, mg stearate
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Name 3 methods to prepare compressed tablets.
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1. wet granulation
2. dry granulation 3. direct compression |
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True or False.
Wet granulation produce robust formulations. |
True
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True or False.
Wet granulation can be used to distibute low concentrations to achieve content uniformity. |
True
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True or False
increase binder, increased granule density |
True
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If wet massing time increases, ______increases
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granule density
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True or False
Too much wet massing can form paste. |
True
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What is the rate limiting step in dry granulation?
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compression into slugs
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What is the simplest tablet compression method?
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direct compression
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Name and describe 4 drying methods.
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1.tray-tray in oven
2.fluid bed- warm air passes through fluidized bed 3.vacuum- gas assisted 4. microwave- convection and vacuum |
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In the process of milling, ______ is the primary factore determing particle size.
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screen size
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In the process of milling, increasing impeller speed could ________particle size.
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decrease
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Every sample will have the same composition.
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Perfect Homogeneity
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State at which the probability of 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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Physically adsorb drug uniformity onto excipient to reduce segregation.
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Ordered Mixing
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Describe Precompression force.
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small amt of force applied to remove entrapped air in loose compact.
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Precompression force _______(increase/decrease) the chance of lamination and capping.
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decreases
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Describe Main Compression Force.
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large amt of force that bonds particles to form tablet.
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________are performed to determine the effect of increasing force on a tablet.
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Compression Profiles
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Describe Over Compression.
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excessive force that results in reduced hardness, lamination and capping.
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As compression force increases, thickness_______, disintegration time________, dissolution rate________, and tablet density_______.
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decreases; increases; decreases; increases.
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As tablet press speed increases, weight variablity may ______.
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increase
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What do thin tablets imply?
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hard or light tablets
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What do thick tablets imply?
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soft or heavy tablets
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As hardness increases, disintegration time ______, dissolution________
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increases; decreases
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______ release of drug is based on time course and/ or location to accomplish non-immediate release of drug.
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Modified release
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Release drug at a time other than right after adminstration
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Delayed Release
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Give an example of a delayed release product.
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enteric coated tablets.
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_____ are designed to release API in controlled manner at a predermined rate, duration and location.
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Extended Release
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A product that usually contains 2 single doses. First is immediate, and second is delayed.
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Repeat Action Product
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Release is directed toward isolating or concentrating a drug in a body region, tissue or site for absorbtion.
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Targeted release
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Describe the specifications for an extended release product
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1. neither very slow or very fast absorption and excretion
2. uniformly absorbed in GI 3. administered in small doses 4. safe 5. used for chronic disease |
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Describe how drug release is controlled.
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barrier coatings, drug diffusion, chemical rxn with drug and site fluids
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True or False.
Barrier coating thickness can affect rate at which fluids can penetrate coating to dissolve drug |
True
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Describe a multitablet system.
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small compressed tablet within capsule shell.
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Process of enclosing solids, liquids, or gases within microscopic particles
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Microencapsulation
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Complex formulation solubility is dependent on ______.
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pH
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Describe embedding a drug in a slow eroding matrix system.
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drug + excipient = granule leads to slow erosion
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Describe embedding a drug in inert plastic matrix system
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drug + plastic = granule, then compression to tablet causing slow release
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True or False.
resin-drug complex can be tableted, encapsulated, or suspended |
True
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Name the USP requirements for a modified release product
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Drug release, Uniformity, In-Vitro-In-Vivo correlations , Labeling
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_______are substances of high molecular weight comprised of repeating monomer units.
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Polymers
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What are oligomers?
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short chain polymers
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all monomeric units are identical.
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homopolymers
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formed from more than one monomer type.
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copolymers
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highly branched from a central core
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Dendrimers
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-increase viscosity at low concentrations
-swell -adsorb |
water-soluble polymers
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-form thin films
-encapsulate drugs |
water-insoluble polymers
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polymer shape determines____ and _____
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flow; viscosity
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viscous, cross linked polymer-solvent system that are impervious to thermal motion
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gels
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describe type I gels
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irreversible, covalent bonds
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Describe type II gels
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heat reversible, hydrogen bonds
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Type of gel with chains with differing segments which exibit different properties
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heterogels
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True or False.
Syneresis is an istability. |
True
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What is syneresis?
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Seperation of a liquid from swollen gel b.c contraction of polymeric molecules
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Describe cellulose derivatives.
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1.suspending agents
2. diluents 3. disintegrants 4. absorbents 5. water solubility depends on substitution 6. water soluble polymer |
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Describe carboxypolymethylene.
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1. suspending agent
2. binding agent 3. sustained release 4. viscosity decrease when electrolytes added 5. incompatible with phenol, resocinol, cationic polymers, strong acids, high concentrations of electrolytes 6. viscosity dependent on pH |
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acacia, tragacanth, alginate, pectin, chitosan, dextran are all_________.
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water soluble polymers that are nautral gums and mucilages.
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Describe polyvinylpyrolidone.
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1. water soluble polymer
2. suspending agent 3. dispersing agent 4. bind agent 5. granulating agent 6. disintegrant |
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Describe polyoxyethylene.
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1. water soluble polymer
2. solvents 3. suppository |
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List the polymer characteristics important in drug formulation.
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1. MW
2. glass transition temp 3. tensile strenght 4. diffusion coefficent 5. hardness 6. solubility |
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-more ordered
-less pourous -less permeable to oxygen |
More polar films
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-more pourous
-permeable to oxygen |
Less polar films
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List common water soluble polymers.
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1. carbomer
2.carbopol 3. cellulose derivatives 4. nautral gums 5. polyvinylpyrolidone 6. polyoxyethylene glycols |
