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355 Cards in this Set
- Front
- Back
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____ is a complete and organized presentation of pre-clinical and clinical data with summaries of human pharmacokinetics, bioavailability, microbiology, a discussion of the benefits and risks of the drug's usage, and complete proposed product labeling
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New Drug Application
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During this phase, the drug product is continually monitored in clinical investigations
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Phase 4 Clinical Studies
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T/F The drug's sponsor is also required to review and report to the FDA all adverse effects reported to them by any internal or external sources
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True
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What is the purpose of variations in the IND process for Orphan Drugs
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To provide incentives to develop drugs where there is an insufficient market incentive
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This omits nonclinical laboratory studies and clinical studies except those pertaining to bioavailability; how generics get on the market
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Abbreviated New Drug Application
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This is required for changes in method of synthesis, formulation, analytical standards, container, manufacturing facilities...
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Supplemental New Drug Application
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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"
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drug stability
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"susceptible to sensory impressions"
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organoleptic properties
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the most common mechanisms of chemical degradation
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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?
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esters (aspirin), amides, lactams (ampicillin), lactones (spironolactone)
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generally refers to the removal of electrons
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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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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 propogation of the chain"
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inititation
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chain-initiationg radicals are generated by _____ (4)
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action of light, heat, transition metals, or reactive compounds
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functional groups susceptible to oxidation
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phenols, catecholes (E), thiols (captopril), polyunsaturated hydrocarbons (Vit. A)
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"chemical breakdown caused by light; usually by complex mechanism"
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photolysis
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the most common photolytic mechanism
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photoxidation
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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
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"conversion of a drug to its optical or geometric isomer"
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isomerization
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examples of drugs that exhibit isomerization
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tetracycline, amphotericin B
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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
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"two or more drug molecules combine to form a complex molecule"
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polymerization
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4 degradation mechanisms
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polymorphism, water sorption/hygroscopicity, vaporization, adsorption to containers
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____ form has repeating arrangement of the individual molecules that creates the crystal lattice
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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 salicytic acid (smells like vinegar)
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experience adsorption of containers...
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diazepam, insulin, isosorbide dinitrate
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the __________ of a reaction is given by the change in concentration of the species at a time t
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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
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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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looking at ____ profiles, one can readily estimate the pH's that would be good or bad for formulating a product from a stability standpoint
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pH-rate profiles
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the point on a pH-rate profile where K is at lowest point
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pH of maximum stabiltiy
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typicaly a 10 degree C rise in temp produces a ____ fold decay rate increase
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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
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Arrhenius equation
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indicates how many collisions have the right orientation that lead to the products
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frequency factor
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the energy needed for reaction to occur
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energy of activation
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another term for lyophilization
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freeze-drying
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vitamin E
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antioxidant
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BHT
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antioxidant
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ascorbic acid/vitamin C
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antioxidant
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sodium sulfite
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antioxidant
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citric acid
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chelator
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tartaric acid
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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
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10%
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high energy wavelength, absorbed by most drugs
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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"
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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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"alcoholic or hydroalcoholic solutions of volatile substances"
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spirits
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"clear, saturated aqueous solutions of volatile oils or other aromatic or volatile substnaces"
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aromatic waters eg. rose water
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"alcoholic or hydroalcoholic solutions prepared from vegetable materials or from chemical substances"
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tinctures
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"liquid preparations of vegetable drugs, containing alcohol as a solvent or as a preservative, or both, so that each ml contains the therapeutic constituents of 1 g of the standard drug that is represents"
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fluidextracts
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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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polyhydroxy compunds, - amino acids taste _____
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sweet
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acids taste ...
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sour
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metal ions taste
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salty
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bases (alkaloids)-plants taste
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bitter
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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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"good for salty tasting drugs"
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effervescence
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"slows drug diffusion to the taste buds"
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high viscosity
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suitable flavors to mask sweet are...
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vanilla, fruit, grape, bubblegum
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suitable flavors to mask sour are...
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lemon, lime, orange, cherry, grapefruit, raspberry
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suitable flavors to mask salty are...
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nut, butter, butterscotch, spice, maple
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suitable flavors to mask bitter are...
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licorice, choclate, coffee, mint, grapefruit, cherry, peach, raspberry, orange, lemon, lime
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|
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purified water
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solvent/cosolvent
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|
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alcohol - ethanol 94.9-96%
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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-, propy, and butyl- paraben
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preservative
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sorbic acid
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preservative
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alcohol (15-20% v/v)
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preservative
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citrate
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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
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nonglycogenetic sucrose substitute (not sweet, not absorbed)
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"85% sucrose solution prepared with purified water"
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simple syrup, syrup NF
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"preparations containing finely divided solid drug particles distrubited uniformly throughout a vehicle in which a drug exhibits a minimum degree of solubility"
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suspension
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aka the disperesed phase (particles)
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internal phase
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aka the continuous (fluid) phase
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external phase
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"molecular aggregates from 0.001 to 1 micrometer"
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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"
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emulsions
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"liquid particles less than 0.1 micrometers"
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microemulsions
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"lipid vesicles"
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liposomes
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"solid polymer spheres"
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microspheres
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the route of administration in which suspensions are NOT used
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IV - can lead to pulmonary embolism
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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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|
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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, fitz mill
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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, cyclone
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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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"required to uniformly disperse the particles in the continuous phase"
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wetting agents
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the speed of particle settling can be described by ________ equation
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Stoke's equation
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"surface charges arising upon dispersal in an aqueous medium" repulsive
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electrostatic repulsive forces
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"arising from electromagnetic fluctuations in surface molecules" attractive
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van der waals attractive forces
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"structuring of water near the interfacial region"
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repulsive hydration forces
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"arise from atomic orbital overlap"
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born repulsive forces
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"arise when particles are in contact"
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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"
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Ostwald ripening
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tragacanth
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wetting agent, flocculating agent, suspending agent
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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
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wetting agent, flocculating agent, suspending agent, adhesive agent, disintegrants
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acacia
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wetting agent, suspending agent, emulsifying agent
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bentonite
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wetting agent
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sodium salts of acetates
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electrolyte flocculating agent
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phosphates
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electrolyte flocculating agent
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citrates
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electrolyte flocculating agent
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PEG's
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flocculating agent
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Alginates
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flocculating agent, suspending agent
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"the resistance offered when one part of a liquid flows by another"
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viscosity
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"shear stress"
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force applied
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"shear rate"
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flow rate
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"shear rate is proportional to shear stress" (viscosity is constnat)
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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 e.g. bentonite magma
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most suspending agents work by forming a ________ network
|
hydrophilic colloid network
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|
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xanthan gum
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suspending agent
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|
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Carbomer (polyacrylic acid)
|
suspending agent
|
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Ora-plus
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suspending agent
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cherry syrup 50-100%
|
suspending agent
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sorbitol 5-10%
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suspending agent
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glycerin 2-10%
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suspending agent
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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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|
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"w/o"
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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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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
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cholesterol
|
emulsifying agent
|
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bentonite
|
emulsifying agent
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veegum
|
emulsifying agent
|
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magnesium hydroxide
|
emulsifying agent
|
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tocopherols
|
antioxidant (oil phase)
|
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this system was devised to enable a rational means of surfactant selection for different formulation types
|
Hydrophilic-Lipophilic Balance system of surfactant activity
|
|
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emulsifiers with HLB range 3-8 form _____ emulsions
|
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
|
commercial oral emulsions
|
|
|
"the formulation is such that the interfacial tension is transiently negative and is near zero after emulsion formation"
|
microemulsion
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|
|
Neoral (cyclosporin)
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microemulsion
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|
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"a mixture of finely divided drugs and/or chemicals in dry form"
|
powders
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|
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"agglomerates of powder mixes, usually of drug plus excipients"
|
granules
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an additional property of some solids is _______ formation
|
eutectic e.g. camphor and menthol
|
|
|
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
|
Wedgwood
|
|
|
not as good for comminution,can also become smooth with use
|
glazed porcelain
|
|
|
preferable when working with colored materials, can chip, smoother surface
|
glass
|
|
|
"wet' grinding
|
levigation
|
|
|
what is povidone used for?
|
help powders stick together to form granules, adhesive agent
|
|
|
"prepared with an acid/base excipient mixture that liberates CO2 when combined with water"
|
effervescent powders/granules e.g sodium bicarbonate and citric acid
|
|
|
most bulk reconstitutables are good for ________ days after being reconstituted
|
14 days, some 10
|
|
|
"an edible package made primarily from gelatin, which is filled with medicines to produce a unit dose"
|
capsule
|
|
|
soft gelatin capsules are usually filled with ______
|
liquid e.g vitamin E
|
|
|
soft gel capsules were invented by a __________
|
pharmacy student
|
|
|
hard gel capsules were invented by a __________
|
pharmacist
|
|
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hard gel caps are usually filled with __________
|
powder
|
|
|
"dissolves at pH above the acidic gastric pH"
|
enteric coating
|
|
|
how many hard gelatin capsules can be produced during industrial filling
|
more than 150,000 per hour
|
|
|
the major component of hard shell capsules
|
gelatin, cellulose derivatives available
|
|
|
major sources of collagen for gelatin formation
|
bovine (cow), porcine (pig), piscine (fish)
|
|
|
final water content of hard capsule shell
|
12-16%
|
|
|
iron oxides
|
colorants
|
|
|
titanium dioxide
|
opacifier
|
|
|
general capsule size for humans
|
sizes 0 to 3 best
|
|
|
lactose
|
diluent (filler/bulking agent)
|
|
|
starch
|
diluent (filler/bulking agent), disintegrant
|
|
|
talc
|
glidant
|
|
|
reduce friction between particles and improve flow
|
glidants
|
|
|
silicone dioxide
|
glidant
|
|
|
reduce particle to metal adhesion
|
lubricants
|
|
|
magnesium stearate
|
lubricant
|
|
|
dimethicone
|
lubricant
|
|
|
pregelatinized starch
|
disintergrant
|
|
|
starch glycolate
|
disintergrant
|
|
|
promote disintregration
|
disintegrant
|
|
|
T/F it is okay to casually interchange excipients
|
FALSE, can lead to different bioavailability
|
|
|
dimples, grooves, spot-welding with heat, fusion, colored gelatin band around joint
|
examples of techniques used for locking or sealing capsules
|
|
|
duricef, zerit, altace, axid pulvules
|
examples of commercial hard gelatin capsules
|
|
|
single bodies produced and filled with liquid in a single operation
|
soft gelatin capsules
|
|
|
are in soft gel capsule shell to add softness and flexibility
|
plasticizers
|
|
|
vegetable oils
|
water immiscible oil in soft gel capsule eg. soybean oil
|
|
|
lanoxicaps, vepesid, zantac geldose, accutane, advil liquigel, vit e
|
examples of commercial soft gel capsules
|
|
|
"a small disk-like mass of medicinal powder"
|
tablet
|
|
|
tablets are most often prepared by ___________ of powders and/or granules into hard, compact masses
|
compression
|
|
|
when the first tablet from a compressing machine was made
|
1843
|
|
|
compressed tablets are generally manufactured at very ____ speeds by tableting machines
|
HIGH speeds, 250 tablets per second
|
|
|
what is the paradox of tablets?
|
to produce a tablet sufficiently strong to withstand processing and handling, yet capable of breakdown upon administration
|
|
|
what are the 2 essential properties of powders for compressed tablets?
|
fluidity and compressibility
|
|
|
what type of excipients/method can improve fluidity?
|
glidants, lubricants, and granulation
|
|
|
what are the 3 main purposes of granulation?
|
to prevent stratification, to improve powder fluidity, to improve powder compressibility
|
|
|
what is the most common approach to tablet production?
|
wet granulation
|
|
|
what are the general steps of wet granulation?
|
form a dough, bring dough to appropriate size using a sieve, form granule, compress
|
|
|
a filler is mainly used in wet granulation when the drug is _________ mg or less
|
70 mg
|
|
|
dicalcium phosphate
|
diluent (filler/bulking agent)
|
|
|
corn starch
|
adhesive agent
|
|
|
sodium lauryl sulfate
|
lubricant
|
|
|
high MW PEGs
|
lubricant
|
|
|
what solves the tablet paradox?
|
disintegrants
|
|
|
cross-linked polyvinylprolidine
|
disintegrant
|
|
|
cation exchange resins
|
disintegrant
|
|
|
starch derivatives
|
disintegrant
|
|
|
how to disintegrants work?
|
by "wicking" GI fluids, swelling, or release from deformation
|
|
|
dry granulation is used for ______ or _________ -sensitive ingredients
|
moisture or heat-sensitive
|
|
|
microcrystalline cellulose
|
used to aid in compression
|
|
|
what are the 4 main types of tablet coating?
|
sugar, film, gelatin, and enteric
|
|
|
one of the oldest methods of tablet coating, many steps and many layers involved
|
sugar coating
|
|
|
more modern and most common method of tablet coating
|
film coating
|
|
|
this type of coating involves the deposition (usually spraying) of a thin film of polymer solution around a tablet core
|
film coating
|
|
|
this coating is used to prevent tablet core or granules from disintegration in acidic environments
|
enteric coating
|
|
|
what are the 2 main reasons for enteric coating?
|
1. to prevent acid attack on labile ingredients (erythyomycin and omperazole examples) 2. protect stomach from irritation (aspirin)
|
|
|
cellulose acetate phthalate
|
pH sensitive polymer used for enteric coating
|
|
|
capping can indicate ______ problems
|
compression
|
|
|
mottling may indicate ______ problems
|
coating
|
|
|
hardness is measured by a hardness tester which measures _________
|
crushing strength
|
|
|
"tendency of a tablet to crumble"
|
friability
|
|
|
friability is measured by a ______, which indicates ____
|
friabilitor;durability
|
|
|
USP tests include drug ____ and drug _____
|
content;release
|
|
|
weight variation is used for assessing drug content uniformity in a tablet batch when the tablet has a relatively _____ excipient fraction
|
LOW, where most of the tablet will be DRUG which can indicate dosage uniformity
|
|
|
drug content uniformity is used when coated tablets and tablets are less than ____ mg
|
50 mg, where excipient fraction is high and uniform weight does NOT mean dosage uniformity
|
|
|
measures the rate and extent of tablet disintegration
|
disintegration test
|
|
|
disintegration test measured by having no palpably firm core
|
complete disintegration test
|
|
|
USP apparatus used for measuring disintegration
|
basket-rack assembly
|
|
|
measures the rate and extent of the drug in the tablet to go into solution
|
dissolution test
|
|
|
dissolution tests are particularly important for drugs with _________ water solubility
|
LIMITED, where dissolution is the rate-limiting step for absorption
|
|
|
this dissolution test uses a wire basket that is roated at a fixed speed while immersed in a dissolution medium containted in a cylindrical vessel
|
rotating basket method
|
|
|
this dissolution test allows the dosage to sink to the bottom of the vessel and then the dissolution medium is aggitated
|
paddle method
|
|
|
T/F the dissolution medium is specified in the dissolution tests
|
TRUE
|
|
|
basic drugs protonate in the ______
|
stomach
|
|
|
acidic drugs deprotonate in the ______
|
small intestine
|
|
|
generally, 75% of the drug should be dissolved within _______ minutes according to USP dissolution tests
|
45 minutes
|
|
|
granules usually require some sort of ________ to combine the drug and excipients into granular form
|
binding agent
|
|
|
hand-folded single doses of powders are nown as ___________ (3) or _____ (1)
|
extemporaneous powder packets; charts
|
|
|
______ are potent, powdered drugs mixed with a suitable diluent, can also be used to describe the process of reducing substances into fine particles in a mortar and pestle
|
triturations
|
|
|
Topical Powders are subdivided into two categories, ____________, which are applied to the skin, and ____________ which require a type or propellant.
|
dusting powders;spray powders
|
|
|
In addition to serving as dosage forms themselves, powders also serve as the ____________ for most dosage forms
|
starting point
|
|
|
T/F very few drugs come as a liquid
|
TRUE
|
|
|
Which of the following is not an advantage of Oral Powders and Granules?
a. Increased Dissolution Rate and Body Efficacy b. Chemically more Stable than liquid forms c. Good alternative for high-dose drugs d. Easily reconstituted (convenient for use as a liquid dosage form) e. All of these are advantages |
A - increased dissolution rate and body efficacy
|
|
|
Which of the following is not a disadvantage of Oral Powders and Granules?
a. Potential misunderstanding for correct method of use b. Dosing may be less accurate than liquids or capsules/tablets c. Deflocculation easily occurs in reconstituted powders d. Requires an added step before usage e. All of these are disadvantages |
C - deflocculation easily occurs in reconstituted powders
|
|
|
In the production of Powders and Granules, a process called ____________ may be employed which involves wetting the drug/excipient mixture to form a damp mass
|
wet granulation
|
|
|
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
|
|
|
Both ____________ and ____________ are of paramount importance when ensuring Dosage Uniformity among Powder dosage forms.
|
precision, accuracy
|
|
|
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
|
|
|
Dissolution Rate is given by ____________ Law
|
Stoke's
|
|
|
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
|
|
|
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
|
|
|
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
|
|
|
Particle Cohesion is exceedingly important in ____________ dosage forms.
|
pulmonary powder
|
|
|
Both ____________ and ____________ affect a particle’s cohesiveness.
|
electrostatic charge, adsorbed moisture
|
|
|
Electrostatic Charge is much more problematic in environments with
|
low humidity
|
|
|
Increased micronizing (increases/decreases) ____________ electrostatic charge.
|
increases
|
|
|
A particle’s hygroscopicity will directly affect its ____________ and ____________ instability.
|
physical, chemical
|
|
|
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"
|
|
|
____________ is done on purpose to prevent/minimize caking in suspensions.
|
flocculation
|
|
|
____________ is also a physical instability that occurs when the dissolution of a solid (solid goes into solution) occurs in the atmospheric moisture alone.
|
deliquescence
|
|
|
An example of ____________ is when high humidity accelerates the hydrolysis of aspirin to salicylic acid and acetic acid.
|
chemical stability
|
|
|
The consequence of Chemical and Physical Instability is a decreased ____________.
|
shelf-life
|
|
|
Pre-formulation studies include ____________ the powders which means testing them under different humidity and temperatures.
|
stressing
|
|
|
Stressing and Accelerated Stability Studies are performed to rapidly determine a ____________ and ____________ without having to use real-time analysis.
|
shelf-life,storage requirements
|
|
|
Another form of Chemical Instability is when the water from a crystal hydrate (part of the crystaline form) is separated from the crystal structure; this is called ____________.
|
efflorescence
|
|
|
T/F Some hydrates can lose their water-of-hydration during grinding or handling.
|
true
|
|
|
Altering a crystalline form or structure can easily affect the properties of ____________ and ____________.
|
solubility, efficacy (bioavailability)
|
|
|
____________ is what occurs when two solid substances form a liquid when mixed at room temperature because they act as impurities for each other, lowering each of their melting points to below room temperature.
|
eutectic formation
|
|
|
T/F Moisture is the big problem in Eutectic Formation
|
Fasle, impurity is the problem
|
|
|
There are several types of ____________ used industrially to aid in comminution.
|
Mills
|
|
|
Both a mortar and pestle and a coffee grinder can be used to perform ____________.
|
comminution
|
|
|
The main advantage for a rough-surfaced mortar and pestle is its ____________ while the main disadvantage is that it requires ____________.
|
excellent grinding ability, meticulous cleaning
|
|
|
To minimize ___________, it is usually best to separately reduce particle sizes of all ingredients to the same size range.
|
stratification
|
|
|
The only way to insure homogeneity is to perform a test called a ___________.
|
assay
|
|
|
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
|
|
|
T/F Protonating a Base increases its water Solubilty
|
TRUE
|
|
|
The bottom part of a capsule (which gets filled with the medication powder or granules, etc) is called the ___________ while the top part is called the ___________.
|
body, cap
|
|
|
Which of the following cannot be placed in a capsule dosage form?
a. Semi-solids b. Liquids c. Other tables or capsule d. Ointments e. Water f. Granules g. Powders |
e. water
|
|
|
T/F Tablets and capsules are two most-liked and most-frequently used dosage forms.
|
TRUE
|
|
|
Which one of the following is not a disadvantage or limitation of Hard Gelatin Capsule Dosage Forms?
a. Potential adherence to the esophagus b. Formulation may not dissolve in some patients c. Moisture can deform capsule, causing possible chemical and physical degradation d. More susceptible to tampering than tablets e. All of these are known/major disadvantages |
b. formulation may not dissolve in some patients (gelatins have very good solubility)
|
|
|
Which of the following best describes the general production of Capsule shells?
a. Liquid gelatin solution is added to molds of both caps and bodies b. Pins shaped like capsules are dipped into a gelatin solution c. Full gelatin bodies are formed, cooled to a semi-solid state, and then the excess “internal” gelatin is removed to create a reservoir for medications d. Either of these is acceptable |
b. pins shaped like capsules are dipped into a gelatin solution
|
|
|
The major component of capsules is gelatin which is a protein derived from ___________. The main source of this material is ___________.
|
collagen, animal (skin and bones)
|
|
|
Capsule Numbers for human dosages range from:
a. 0 - 7 b. 1 - 8 c. 00 - 6 d. 000 - 5 e. 0000 - 4 |
d. 000-5
|
|
|
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
|
|
|
Tapped Bulk Density is simply the ___________ of a powder divided by the ___________ occupied by the entire amount of powder.
|
mass, volume
|
|
|
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
|
|
|
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)
|
|
|
The two most popular Diluents are ___________ and ___________.
|
lactose, startch
|
|
|
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
|
|
|
The two most popular Lubricants are ___________ and ___________.
|
magnesium stearate, dimethicone
|
|
|
The two most popular Disintegrants are ___________ and ___________.
|
Pregelatinized Starch, Starch Glycolate
|
|
|
Adding too much ___________ (lubricant) to a Capsule can severely diminish the bioavailability of the drug.
|
magnesium stearate
|
|
|
Which of the following is most important for Tablets?
a. Diluents b. Glidants c. Lubricants d. Disintegrants |
d. disintegrants
|
|
|
Capsules are sealed for all except which one of the following reasons?
a. Maintain capsule integrity b. For Tamper-Resistance c. To provide evidence of tampering if tampering occurs d. To minimize chemical and physical instability e. All of these are reasons |
e. all of these are reasons
|
|
|
Which of the following is not a common technique for locking or sealing capsules?
a. Edible adhesives (or pastes) b. Dimples c. Grooves d. Spot-Welding e. Fusion f. Gelatin Band |
a. edible adhesives
|
|
|
Magnesium Stearate is an excipient used as a ___________ in Capsules.
a. Diluent b. Glidant c. Lubricant d. Disintegrant e. None of these |
c. lubricant
|
|
|
Lactose and Starch can be used as which two of the following?
a. Diluents b. Glidants c. Lubricants d. Disintegrants e. None of these |
a. diluents d. disintegrants
|
|
|
Titanium Oxide and Iron Oxides are used as which of the following?
a. Diluent b. Glidant c. Lubricant d. Disintegrant e. None of these |
e. none of these, they are opacifiers
|
|
|
T/F Most Capsules on the market are Soft-Gel Capsules
|
False, they are fairly rare
|
|
|
___________ are structures in the GI Tract that are part of the immune system and responsible for taking up particles.
|
Peyer's patches
|
|
|
Almost all drugs are absorbed to the greatest degree in the ___________.
|
small intestines
|
|
|
Which of the following is not a disadvantage of Soft-Gel Capsules?
a. Less versatile than hard gelatin capsules b. More difficult to manufacture c. Potential drug migration from vehicle into shell d. Less accurate than hard gel capsules e. Can alter shell integrity |
d. less accurate than hard gel capsules. Because they are filled with liquid, they are more accurate and precise
|
|
|
___________ is the fluid or water pressure that creates a rigidity in the structure of a Soft-Gel Capsule.
|
turgor pressure
|
|
|
___________ 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.
|
gelatin, plasticizers
|
|
|
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
|
|
|
Glycerol and Propylene Glycol are used as __________ as well as Plasticizers.
|
co-solvents
|
|
|
A common vehicle for Soft-Gel Capsule Drugs is ___________.
|
vegetable oil
|
|
|
Which of the following is not a water-miscible liquid?
a. Low MW PEG’s b. Propylene Glycol c. Soybean Oil d. Glycerin e. All are water-miscible |
c. soybean oil
|
|
|
__________ is a very common co-solvent used in parenterals and is quite versatile (from co-solvent suppository).
|
PEG's
|
|
|
Which of the following is not an anti-oxidant?
a. EDTA b. Vitamin E c. BHA d. PEG e. All are anti-oxidants |
d. PEG
|
|
|
A compilation of properties, like a USP, is known as a ___________.
|
compendium
|
|
|
Which of the following is a test that Capsules must pass to get USP approval?
a. Disintegration Test b. Dissolution Test c. Solubility Test d. Stability Test e. Moisture Permeation Test f. Particle Flow Test g. Liquid Cohesion/Adhesion Test h. Trituration Test |
a. disintegration test b. dissolution test d. stability test e. moisture permeation test
|
|
|
Which of the following is not a route or application for tablets?
a. Buccal/Sublingual b. Effervescent tablets c. Chewables d. Vaginal Inserts e. All of these are viable routes or applications |
e. all of these are viable routes or applications
|
|
|
Which of the following is not an advantage of Oral Tablets?
a. Lower Production Cost b. Easier packaging and shipping c. More stabile d. Tamper-Proof e. Patient Acceptance f. All of these are advantages |
d. tamper-proof, they are tamper RESISTANT
|
|
|
T/F Tablets are second only to Capsules as the most popular/common Dosage Form.
|
false. tablets ARE the MOST used/popular dosage form
|
|
|
__________ 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
|
|
|
Tablet machines work at very high speeds; the material is fed into __________ which determines the tablet shape.
|
dies
|
|
|
Punches often have raised or recessed impressions for __________ and __________.
|
tablet ID, tablet scoring
|
