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262 Cards in this Set
- Front
- Back
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"the extent to which a drug product retains, within specified limits, and throughout its period of storage and use, the same properties and characteristics that it possessed at the time of its manufacture" |
drug stability |
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"susceptible to sensory impressions" |
organoleptic properties |
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the most common mechanisms of chemical degradation |
hydrolysis and oxidation
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cleavage of a molecule by reaction with water
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hydrolysis |
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functional groups that are susceptible to hydrolytic cleavage |
esters (aspirin), amides (dibucane, chloramphenicol), lactams (ampicillin, cephalosporins), lactones |
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generally refers to the removal of electrons |
oxidation |
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type of oxidation that involves the uncatalyzed oxidation of a substrate by molecular oxygen
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autoxidation |
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Molecular form of oxygen (O2) is a ________ ________ that has 2 unpaired electrons with ________ spins. |
triplet diradical, parallel |
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reactive oxygen species (3)
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superoxide, hydrogen peroxide, hydroxy radical
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free radical mechanism of oxidation involves ____ (3)
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initiation, propogation, and termination |
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"the formation of substrate free radials necessary for the propagation of the chain" |
initiation (involves hydrogen abstraction) |
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chain-initiating radicals are generated by _____ (4) |
action of light, heat, transition metals, or reactive compounds |
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functional groups susceptible to oxidation |
phenols, catechols, thiols, polyunsaturated hydrocarbons |
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"chemical breakdown caused by light" |
photolysis |
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the most common photolytic mechanism
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photoxidation
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photoxidation example |
sodium nitroprusside in aq. solution (used in IVs infusions; shelf-life of 1 year in dark, 4 hrs when exposed to light |
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"elimination of water molecule from the chemical structure"
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chemical dehydration |
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"removal of water from crystal hydrate"
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physical dehydration (type of polymorphism) |
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"conversion of a drug to its optical or geometric isomer"
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isomerization |
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estimated that _____ % of drugs are chiral compounds, with most of them being racemic mixtures
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50-60%
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example of drug marketed as a pure enantiomer that racemizes
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thalidomide; base-catalyzed racemization in aq. media |
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"two or more drug molecules combine to form a complex molecule" |
polymerization |
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2 degradation mechanisms |
polymorphism, water sorption/hygroscopicity |
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2 examples of polymorph interconversions |
digitoxin: grinding crystals can lead to amorphous form; cortisone acetate crystals suspension: metastable crystals can dissolve, then recrystallize to different types |
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____ form has repeating arrangement of the individual molecules that creates the crystal lattice |
crystalline form |
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___ form has no repeating arrangement
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amorphous form
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_______ polymorphs are generally more soluble than their more stable counterparts
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metasable polymorphs |
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those molecules with weaker molecular interactions are _____
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metastable
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"a drug may crystallize as a combination of pure drug and the solvent of crystallization"
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pseudopolymorphism |
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"release of water of hydration from a crystal hydrate"
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efflorescence
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hydrates are generally _____ soluble than their anhydrous counterparts
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LESS soluble
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"tendency of a substance to take up atmospheric moisture"
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hygroscopicity
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the dissolution of a solid upon uptake of atmospheric moisture
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deliquescence |
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aspirin degrades to...
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acetic acid and salicylic acid (vinegar) |
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the __________ of a reaction is given by the change in concentration of the species at a time t |
instantaneous rate (velocity/speed) |
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in ____ order degradation, rate varies as the first power of the concentration of the substrate and is independent of the concentration of any other substance that may be present
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first-order |
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the actual order for most hydrolytic reactions where the degradation rate is apparently independent of the concentration of one of the reactants, even though it is consumed in the reaction |
pseudo first-order |
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_____ degradation can occur when there is a reservoir of a drug to replace drug that is lost to decomposition
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zero-order |
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most often, the shelf life is defined as the time for ___ % of degradation
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10%
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shelf-life calculations for 1st and zero order |
1st order: t90 = 0.105/k1 zero order: t90 = 0.1C0/k0 |
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looking at ____ profiles, one can readily estimate the pH's that would be most suitable for formulating a product from a stability standpoint |
pH-rate profiles
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the point on a pH-rate profile where k is lowest |
pH of maximum stabiltiy
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typically a 10 degree C rise in temp produces a ____ fold decay rate increase |
2-5 fold
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the ________ equation can be used to model the effect of temp on degradation and make useful predictions of the effects of different temps on the products shelf life |
Arrhenius equation (useful for accelerated stability studies) |
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indicates how many collisions have the right orientation that lead to the product |
frequency factor (A in the Arrhenius equation) |
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the energy needed for reaction to occur |
energy of activation (Ea in the Arrhenius equation) |
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drug stabilization approaches |
store at reduced temps, formulate at stable pH, dry the product, remove/replace oxygen, use antioxidants, minimize metal content, protect from light |
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lyophilization |
freeze-drying; samples are sublimed under vacuum |
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alpha tocopherol |
(vitamin E) oil-soluble antioxidant |
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BHT |
oil-soluble antioxidant |
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ascorbic acid |
(vitamin C) water-soluble antioxidant |
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sodium sulfite
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water-soluble antioxidant |
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citric acid |
chelator |
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EDTA
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chelator
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for oral and tropical products, no more than ___ % of the light at any wavelength between 290 nm and 450 nm may be transmitted |
10% |
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high energy wavelength, absorbed by most drugs |
UV, 185-380 nm |
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"liquid preparations that contain one or more chemical substances dissolved in a suitable solvent or mixture of mutually miscible solvents" |
solution |
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"concentrated, aqueous preparations of a sugar or sugar substitute with or without added flavoring agents and medinical substances"
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syrup |
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"clear, sweetened, hydroalcoholic solutions intended for oral use, and are usually flavored to enhance their palatability"
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elixir |
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thresholds for ____ substances are the lowest, while thresholds for _____ and ____ tastes are the highest
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bitter; sweet and salty |
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"flavor blends with drug"
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blending |
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"flavor is stronger than the drug flavor"
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overshadowing |
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physical methods of flavoring |
suspensions, emulsions, effervescence, high viscosity |
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"good for salty tasting drugs"
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effervescence
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"slows drug diffusion to the taste buds" |
high viscosity
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physiological methods of flavoring |
desensitization, enhancement |
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desensitization |
"cooling" (with mannitol or xylitol) or anesthetic action (with methanol or peppermint) |
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vehicles for oral liquids |
water and syrup |
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primary solvent |
purified water (no greater than 0.001% dissolved solids) |
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alcohol - ethanol 94.9-96% |
solvent/cosolvent |
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what is disulfiram reaction used for?
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alcoholism, induces vomitting
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glycerin (glycerol)
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solvent/cosolvent |
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propylene glycol
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solvent/cosolvent, plasticizer, wetting agent |
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2 properties of syrup vehciles
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1. most are acidic 2. many have alcohol
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benzoic acid
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preservative |
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sodium benzoate
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preservative |
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methyl-, propyl-, and butyl- parabens |
preservative
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sorbic acid
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preservative (mold and yeast) |
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alcohol (15-20% v/v) |
preservative
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typical colorant concentration range |
0.005 to 0.001% |
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citrate |
buffer, chelator, electrolyte flocculating agent |
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phosphate
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buffer, electrolyte flocculating agent |
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sucrose
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nutritive sweetener |
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fructose
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nutritive sweetener
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aspartame
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nutritive sweetener
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sorbitol
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nutritive sweetener, filler |
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mannitol
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nutritive sweetener, filler
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saccharin
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nonnutritive sweetener
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sucralose
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nonnutritive sweetener |
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acesulfame potassium (used in candy)
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nonnutritive sweetener |
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usually the sucrose concentration is very _______ in syrups
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HIGH 60-80% |
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"pertaining to the formation of glycogen"
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glycogenetic |
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dextrose
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glycogenetic sucrose substitute |
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sorbitol
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glycogenetic sucrose substitute, plasticizer |
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gylcerin (glycerol)
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glycogenetic sucrose substitute, plasticizer, cosolvent, suspending agent, wetting agent |
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methylcellulose, hydroxyethylcellulose, hydroxypropylcellulose |
nonglycogenetic sucrose substitutes (not sweet, not absorbed) |
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"85% sucrose solution prepared with purified water" |
simple syrup, syrup NF
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elixirs |
similar to syrups but with the addition of alcohol to form a hydroalcoholic mixture |
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"preparations containing finely divided solid drug particles distributed uniformly throughout a vehicle in which a drug exhibits a minimum degree of solubility" |
suspension |
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aka the disperesed phase (particles) |
internal phase |
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aka the continuous (fluid) phase |
external phase
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"molecular aggregates from 0.001 to 1 micrometer" |
colloidal dispersions
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"solid particles greater than 1 micrometer"
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suspensions
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"liquid particles greater than 1 micrometer in an immiscible liquid" |
emulsions |
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suspension vs. solution |
suspensions have greater chemical stability, greater palatability, and faster onset than solutions |
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general method of production of suspensions
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the solid drug is comminuted to a fine powder, then wetted, then suspended in a suitable vehicle |
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critical consideration for oral suspensions |
dosage uniformity |
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"qualities of a product that make it pleasing to the senses"
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pharmaceutical elegance |
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3 important issues to consider when producing suspensions
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1. particle size 2. particle wetting 3. physical stability |
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goal of particle size for suspensions
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between 1 and 50 micrometers in diameter
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particles are pulverized into smaller particles, 10-50 micrometers
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micropulverization |
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particles break apart as they collide against each other in a high pressure airstream, less than 10 micrometers
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jet-milling |
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the drug is dissolved in a solvent then sent into a heated chamber as a fine spray
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spray-drying |
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3 extemporaneous methods of particle size reduction |
electric grinders, spatulation, trituration |
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process of readily dispersing poorly soluble drug particles uniformily in the continuous phase |
wetting (by levigation); makes particles more hydrophilic |
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3 main types of physical instability of suspensions |
particle settling, particle aggregation, particle growth (Oswald ripening) |
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the speed of particle settling can be described by ________ equation |
Stoke's equation |
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"surface charges arising upon dispersal in an aqueous medium" |
electrostatic repulsive forces
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"arising from electromagnetic fluctuations in surface molecules" |
van der waals attractive forces |
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"structuring of water near the interfacial region" |
repulsive hydration forces
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"arise when particles are in contact" |
adhesive forces
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"arise from molecules adsorbed in particle surfaces"
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steric repulsive forces
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curve that depicts net forces of attraction and repulsion as two particles apprach each other
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total potential energy of interaction curve
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where particles aggregate very strongly at close distances
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primary minimum
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where particles aggregrate weakly at greater distances
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secondary minimum
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"strongly bound at primary minimum", difficult to redisperse
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coagulation
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"formation of nonredispersible sediment within suspension", combination of settling and coagulation
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caking |
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meaning loose and woolly, weakly bound at secondary minimim
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flocculation
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"growth of large particles at the expense of small ones" |
Ostwald ripening (accelerated by temp fluctuations) |
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docusate sodium
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anionic surfactant: wetting agent, flocculating agent, emulsifying agent |
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polysorbates (Tweens)
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nonionic surfactant: wetting agent, flocculating agent, emulsifying agent |
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cellulose derivatives |
synthetic ploymer: wetting agent, flocculating agent, suspending agent, adhesive agent, disintegrants |
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acacia |
natural ploymer: wetting agent, suspending agent (soluble in hot or cold water), emulsifying agent |
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tragacanth |
natural polymer: wetting agent, flocculating agent, suspending agent (swells in cold water) |
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sodium salts of acetates |
electrolytes: flocculating agent |
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phosphates
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electrolytes: flocculating agent |
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citrates |
electrolytes: flocculating agent |
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PEG's
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ploymer: flocculating agent |
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Alginates
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polymers from seaweed: flocculating agent, suspending agent (several viscosity grades) |
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Rheology |
the study of the deformation and flow of materials |
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"the resistance offered when one part of a liquid flows by another" |
viscosity (n); n=F/G |
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"shear stress" |
force applied (F) |
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"shear rate"
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flow rate (G) |
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"shear rate is proportional to shear stress" (viscosity is constant) |
Newtonian Liquid e.g water, syrup, alcohol |
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"flow does not occur until a minimum shearing stress is reached"
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plastic non-newtonian liquid e.g concentrated suspensions in a viscous continuous phase |
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"flow begins as soon as stress is applied"
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pseudo-plastic non-newtonian liquid e.g. hydrocolloids |
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"a plastic liquid that, when left standing, is a restrictive network of interacting solutes" - hysteresis evident
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thixotropic liquid |
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most suspending agents work by forming a ________ network
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hydrophilic colloid network |
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xanthan gum
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most common natural polysaccharide: anionic, pseudoplastic, suspending agent |
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Carbomer (polyacrylic acid)
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synthetic polymer: suspending agent |
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Ora-plus
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commercial suspension vehicle |
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"preparations containing a mixture of two immiscible liquids, one of which is uniformly dispersed as droplets throughout the other" |
emulsion |
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"w/o" |
water droplets suspended in oil (topical) |
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"o/w"
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oil droplets suspended in water (oral) |
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an emulsion can be reversibly or irreversibly altered by ________ (2) and its possible sequelae, which include coalescence and creaming
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droplet aggregation |
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upward movement of the dispersed phase relative to the continuous phase (droplets come to the top) |
creaming |
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results from flocculation and concentration of the dispersed phase |
creaming (reversible but not desirable) |
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gelatin
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emulsifying agent |
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lecithin
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emulsifying agent (ionic surfactant) |
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SDS |
emulsifying agent (ionic surfactant) |
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bentonite |
emulsifying agent (colloidal clay) |
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veegum
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emulsifying agent (colloidal clay) |
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magnesium hydroxide
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emulsifying agent
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this system was devised to enable a rational means of surfactant selection for different formulation types
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Hydrophilic-Lipophilic Balance system of surfactant activity |
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emulsifiers with HLB range 3-8 form _____ emulsions
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w/o |
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emulsifiers with HLB range 8-16 form ______ emulsions
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o/w
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mineral oil, castor oil, cod liver oil, simethicone
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commercial oral emulsions |
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"the formulation is such that the interfacial tension is transiently negative and is near zero after emulsion formation"
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microemulsion
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Neoral (cyclosporin)
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microemulsion (self-emusifies in vivo) |
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"a mixture of finely divided drugs and/or chemicals in dry form"
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powders |
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"agglomerates of powder mixes, usually of drug plus excipients"
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granules |
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Settling and stratification can disrupt _____ _____. |
particle flow |
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an additional property of some solids is _______ formation
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eutectic e.g. camphor and menthol (are impurities of each other) |
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3 types of mortar and pestle
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Wedgwood, glazed porcelain, glass
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best mortar and pestle for comminution, not good for colored materials, meticulous cleaning
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Wedgwood
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not as good for comminution,can also become smooth with use
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glazed porcelain
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preferable when working with colored materials, can chip, smoother surface
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glass
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"wet" grinding |
levigation |
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Biaxin granules |
help powders stick together to form granules, adhesive agent |
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"prepared with an acid/base excipient mixture that liberates CO2 when combined with water" |
effervescent powders/granules; e.g, sodium bicarbonate and citric acid |
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most bulk reconstitutables are good for ________ days after being reconstituted
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14 days, Videx is 30 (if refrigerated after mixing w/ Mylanta liquid; used for antiretroviral therapy) |
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"an edible package made primarily from gelatin, which is filled with medicines to produce a unit dose"
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capsule |
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soft gel capsules were invented by a __________
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pharmacy student |
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soft gelatin capsules are usually filled with ______
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liquid |
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hard gel capsules were invented by a __________
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pharmacist
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hard gel caps are usually filled with __________
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powder; some available for liquids, not H2O |
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process of drug release from gelatin capsules |
at body temp the gelatin dissolves, followed by penetration of GI fluids, then dispersal and dissolution of the contents |
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how many hard gelatin capsules can be produced during industrial filling |
more than 150,000 per hour |
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the major component of hard shell capsules
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gelatin, cellulose derivatives available
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major sources of collagen for gelatin formation
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bovine (cow), porcine (pig), piscine (fish)
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final water content of hard capsule shell
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12-16%
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iron oxides
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colorants
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titanium dioxide
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opacifier |
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general capsule size for humans |
sizes 0 to 3 best
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tapped density |
the mass of the powder divided by the total volume it occupies, after mechanically tapping until little further volume change occurs |
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lactose |
diluent (filler/bulking agent)
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act as fillers to make up the required bulk in formation |
diluents |
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lactose |
diluent |
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starch
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diluent (filler/bulking agent), disintegrant |
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reduce friction between particles and improve flow
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glidants |
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talc
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glidant |
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silicone dioxide |
glidant
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reduce particle to metal adhesion |
lubricants
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magnesium stearate |
lubricant
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used to promote disintregration |
disintergrants |
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pregelatinized starch
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disintergrant
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starch glycolate
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disintergrant |
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T/F it is okay to casually interchange excipients
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FALSE, can lead to different bioavailability |
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dimples, grooves, spot-welding with heat, fusion, colored gelatin band around joint
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examples of techniques used for locking or sealing capsules |
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duricef, zerit, altace, axid pulvules
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examples of commercial hard gelatin capsules
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single bodies produced and filled with liquid in a single operation
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soft gelatin capsules; made by rotary die process; can appear hard because of turgor pressure |
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are in soft gel capsule shells to add softness and flexibility |
plasticizers |
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vegetable oils |
water immiscible oil in soft gel capsule eg. soybean oil |
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lanoxicaps, vepesid, zantac geldose, accutane, advil liquigel, vit e |
examples of commercial soft gel capsules |
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granules usually require some sort of ________ to combine the drug and excipients into granular form |
binding agent |
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hand-folded single doses of powders are known as ___________ (3) or _____ (1) |
extemporaneous powder packets; charts |
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Which of the following is not an advantage of Oral Powders and Granules? |
A - increased dissolution rate and body efficacy |
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Which of the following is not a disadvantage of Oral Powders and Granules? |
C - deflocculation easily occurs in reconstituted powders |
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For manufacturers, the speed in producing Powders and Granules is an important consideration; factors effecting speed are ____________, which is the process of particle size reduction, mixing, and powder flow. |
comminution |
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Both ____________ and ____________ are of paramount importance when ensuring Dosage Uniformity among Powder dosage forms. |
precision, accuracy |
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Other considerations for Powder and Granule Manufacture are ____________ which is directly related to how easy the product is to use and its palatability and ____________ which is usually not a problem with powders. |
patient acceptance, drug release |
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Dissolution Rate is given by ____________ Law |
Stoke's |
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The general rule for particles is that the smaller the size, the faster the dissolution rate, which is why most particles are ____________ before being placed in a tablet or sachet. |
micronized |
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Particle Flow affects many variables including ____________ and ____________ (the ability to move a Powder and accurately instill it in a tablet, capsules etc), the ____________ or processing of manufacture, and its ____________ and ____________, which is the process of its coming out of suspension and its forming into layers. |
mixing, pouring, speed, settling, stratification |
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Stratification occurs because of the difference in ____________ of particles. The consequence of Stratification is a ____________which leads to poor ____________. |
density (or size), non-uniform mixture, dosage uniformity |
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Both ____________ and ____________ affect a particle’s cohesiveness. |
electrostatic charge, adsorbed moisture |
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Electrostatic Charge is much more problematic in environments with |
low humidity |
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Increased micronizing (increases/decreases) ____________ electrostatic charge. |
increases |
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Increased cohesiveness is a physical instability that leads to poor ____________, difficulty in ____________, and ____________ of the powder, which occurs when the particles settle, become united, and cannot be reformulated or resolubilized. |
flow, mixing, "caking" |
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Altering a crystalline form or structure can easily affect the properties of ____________ and ____________. |
solubility, efficacy (bioavailability) |
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T/F Moisture is the big problem in Eutectic Formation |
Fasle, impurity is the problem |
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The only way to insure homogeneity is to perform a test called a ___________. |
assay |
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One of the most popular suspending agents used in the pharmaceutical industry is ___________. The suspending agent used mostly for making gels is ___________. |
xanthan gum, carbomer |
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Which one of the following is not a disadvantage or limitation of Hard Gelatin Capsule Dosage Forms? |
b. formulation may not dissolve in some patients (gelatins have very good solubility) |
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Which of the following best describes the general production of Capsule shells? |
b. pins shaped like capsules are dipped into a gelatin solution |
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The major component of capsules is gelatin which is a protein derived from ___________. The main source of this material is ___________.
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collagen, animal (skin and bones) |
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Capsule Numbers for human dosages range from: |
d. 000-5 |
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Capsule Volumes for human dosage range from:
a. 0 - 1.00 ml b. 0.50 – 1.00 ml c. 0.20 – 1.36 ml d. 0.13 – 0.95 ml e. 0.13 – 1.36 ml |
e. 0.13 - 1.36 ml |
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Tapped Bulk Density is simply the ___________ of a powder divided by the ___________ occupied by the entire amount of powder.
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mass, volume |
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Which of the following is a way in which veterinary capsules are different from capsules intended for human usage? (more than one answer is True)
a. Sizes are different (can be much larger for veterinary) b. Sizes are different (can be much larger for human usage) c. Capsule Number and Capsule Volume are directly correlated d. Capsules are made with a different gelatin polymer due to the differences in acidity between most animal Stomachs and the human stomach e. All veterinary Capsule have grooves which are specifically incorporated to prevent using it for a human patient |
a. Sizes are different (can be much larger for veterinary) c. Capsule Number and Capsule Volume are directly correlated |
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Match the following pharmaceutical term with the definition that best describes it:
a. Diluents b. Glidants c. Lubricants d. Disintegrants 1) Reduces Particle-to-Metal Friction (improves particle flow) 2) Reduces Inter-particulte Friction (improves particle flow) 3) Promotes breaking down or breaking apart (improves absorption) 4) Fillers that comprise the required bulk in formulation |
a. Diluents 4) Fillers that comprise the required bulk in formulation b. Glidants 2) Reduces Inter-particulte Friction (improves particle flow) c. Lubricants 1) Reduces Particle-to-Metal Friction (improves particle flow) d. Disintegrants 3) Promotes breaking down or breaking apart (improves absorption) |
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The two most popular Diluents are ___________ and ___________.
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lactose, startch |
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The two most popular Glidants are ___________ and ___________. Glidants make individual powder particles more ___________, so that they don’t interfere with each other, allowing improved particle flow. |
talc, silicone dioxide; spherical |
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The two most popular Lubricants are ___________ and ___________.
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magnesium stearate, dimethicone |
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The two most popular Disintegrants are ___________ and ___________.
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Pregelatinized Starch, Starch Glycolate |
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Adding too much ___________ (lubricant) to a Capsule can severely diminish the bioavailability of the drug. |
magnesium stearate |
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Capsules are sealed for all except which one of the following reasons? |
e. all of these are reasons |
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Which of the following is not a common technique for locking or sealing capsules? |
a. edible adhesives |
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Magnesium Stearate is an excipient used as a ___________ in Capsules. |
c. lubricant |
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Lactose and Starch can be used as which two of the following? |
a. diluents d. disintegrants |
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Titanium Oxide and Iron Oxides are used as which of the following? |
e. none of these, they are opacifiers |
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T/F Most Capsules on the market are Soft-Gel Capsules
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False, they are fairly rare |
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Which of the following is not a disadvantage of Soft-Gel Capsules? |
d. less accurate than hard gel capsules. Because they are filled with liquid, they are more accurate and precise |
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___________ is the fluid or water pressure that creates a rigidity in the structure of a Soft-Gel Capsule.
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turgor pressure |
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___________ is the primary ingredient for Soft-Gel Capsules but, as opposed to Hard-Gel Capsules, they also contain ___________ which are meant to make the shell softer.
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gelatin, plasticizers |
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Which of the following is not a Plasticizer utilized for making Soft-Gel Capsules?
a. Glycerol b. Glycerine c. Propylene Glycol d. Sorbitol e. All of these are Plasticizers |
b. glycerine |
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Glycerol and Propylene Glycol are used as __________ as well as Plasticizers.
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co-solvents |
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A common vehicle for Soft-Gel Capsule Drugs is ___________.
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vegetable oil
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Which of the following is not a water-miscible liquid? |
c. soybean oil |
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__________ is a very common co-solvent used in parenterals and is quite versatile (from co-solvent suppository). |
PEG's |
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Which of the following is not an anti-oxidant? |
d. PEG |
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__________ are always a potential hazard when dealing with tablets, capsules, or any solid dosage forms. This is why they should be taken with water. |
esophageal adhesion |
