Final Exam Prof Prac Flashcards
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| what is pharmaceutical compounding? | the physical and/or chemical modification of a substance (drug or raw chemical) resulting in a drug/dosage form which is suitable for administration to a patient
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| what is extemporaneous compounding? | Compounding pursuant to 1) a specific patient, 2)for a specific prescription and 3) for one dispensing of the medication (does not apply to batching, manufacturing, or refills compounded at the same time)
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| What is batching? (in terms of pharmaceutical compounding) | compounding 'ahead of time' in anticipation of outstanding refills or unfilled oral prescriptions
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| What is manufacturing? (in terms of pharmaceutical compounding) | compounding for long-term inventory and sale. (NOT pursuant to a particular patient, prescription, or within the scope of pharmacy practice)
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| Which pharmaceutical dosage forms, discussed in class, are commonly prepared extemporaneously? | lozenges, pills, tablets (uncommon), charts, powder capsules, liquid capsules (uncommon)
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| What are the valid justifications for pharmaceutical compounding? (3) | 1) drug or dosage form not commercially available
2)dose unavailable
3)patient comfort and compliance (taste)
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| What are the prohibitions to pharmaceutical compounding? | cannot "manufacture" = making more than you need. You can only batch up to a 30 day supply of what you will anticipate needing
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| What is stability? | the extent to which a prescription preparation remains within specified limits in terms of: chemical composition, physical composition, and microbiologic activity/contamination
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| What general considerations must be taken into account when formulating and assigning expiration dates to extemporaneously compounded pharmaceutical preparations? | Expiration is a function of stability and storage conditions. Base it on published formulation data and stability tests whenever possible
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| What is the most important consideration with respect to the storage of pharmaceutical preparations? | keep out of reach of children
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| What is an active ingredient? | substances present in the formulation which exist for their direct effect on the patient
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| What is an inactive ingredient? | substances present in a formulation which exist solely for their effect on the product
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| Can an ingredient have both active and inactive properties? If so how should it be classified? | Yes, if it exerts both direct effects on the patient and for the benefit to the product, it is said to be an active ingredient
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| What is refinement? | particle size reduction. (has different ranges of particle sizes than pulverization)
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| What is trituration? | verb: refining and mixing of powders
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| What is a trituration? | noun: mixed powder product
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| What is geometric combination? | visually duplicating an equivalent mass and combining.
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| When is geometric combination warranted? | Indicated when mass of powders to be mixed differs by a factor GREATER THAN 3 (if =3 do not need to)
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| What is a eutectic? | a combination of 2 or more substances where the melting point is less than that of any part when taken alone
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| What factors must be optimized in order to yield a eutectic combination with the lowest possible melting point? | optimum ratio of masses, room temperature, substance melting points, fineness of particle size
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| What is the basic principle at play (and responsible for) eutectic formation? | interference with crystalline structure
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| What is efflorescence? | contains waters of hydration (stoichiometric). due to hydrogen bonding. The delicate crystal structures may be altered when exposed to stress, humidity, or temperature. ex: cocaine, terpin hydrate, quinine HCl
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| What is deliquescence? | hygroscopic (subject to moisturization) but will dissolve and form a water based solution. Ex: lithium bromide
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| What is hygroscopicity? | powders subject to moisturization from ambient humidity. (affinity for water, will absorb water from air)
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| Be able to derive the Sensitivity of a balance from MWQ and vice versa for a given desired tolerance | Sensitivity/MWQ = %/100
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| Ideal Body weigh Equation (IBW) | Male: 50 + (2.3* inches over 5')
Female: 45.5 + (2.3* inches over 5')
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| lb to kg conversion | 2.205 lb = 1 kg
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| inch to cm conversion | 1 in = 2.54 cm
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| Creatinine Clearance equation | M: (140-age)*IBW / 72*SCr
F: M eq * 0.85
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| Know the BSA equation and how to use a BSA nomogram | sqrt((height in cm * weight in kg)/3600)
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| Which pharmaceutical dosage forms are composed of powders? | bulk powders, capsules, charts, tablets(compressed powder)
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| Which pharmaceutical dosage forms represent unit dose powders? | capsules, charts, tablets (compressed powders)
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| basic characteristics of lozenges | -dissolve/disintegrate in mouth
-local (oral) drug delivery usually
-pastilles (soft, high sugar)
-troches (relatively small)
-analgesics, anesthetics, antimicrobial
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| basic characteristics of pills | -small, round, spherical, hard
-cut up a long spherical dough, roll into balls, dry
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| basic characteristics of tablets | -compressed unit dose powder
-solidification mold (less common, extemporaneous)
-can extemporaneously prepare, but uncommon
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| basic characteristics of charts | -contains specific dose of medication
-loose powder in a paper envelope
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| basic characteristics of powder capsules | -solid and non-rigid
-shell usually molded gelatin
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| basic characteristics of liquid capsules | -nonsolid and non-rigid
-can extemporaneously compound, but not common
-need to use liquid that will not dissolve capsule - some alcohols (not EtOH, fixed oil, volatile oil)
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| basic characteristics of gel capsules | - cannot be extemporaneously prepared
-semisolid and non-rigid
-beads of gel inside
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| Rule of 7s (backward and forward) | 7 - grains = capsule size, 1 g = 15.43 gr
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| Active ingredients in an oral, unit dose powder should have what units? | mass/dose
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| Active ingredients in a topical powder should have what units? | mass of drug/mass of product (concentration, %w/w)
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| What physical forms may potentially be found as ingredients in commercially available capsules? | powders, liquids, gels
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| what physical forms are commonly used as ingredients in commercially available capsules? | powders. liquids are uncommon
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| What general advantages do capsules have over other solid oral dosage forms? | custom dosing, multiple drugs in one capsule, easy to swallow, taste concealment, rapid drug release
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| What is an excipient? | inactive ingredient with a purpose to the preparation: fillers, binders, glidants, disintegrants, coloring agents, flavoring agents
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| What is ratio strength? | X g of drug in Y g or ml of product (X:Y)
1: Y = 1 g of drug for every Y g or ml of product
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| % w/v | g/100 ml
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| % w/w | g/100g
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| % v/w | ml/100g
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| % v/v | ml/100ml
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| Freezer/frozen temperature | -20 to - 10 degrees C
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| Cold temperature | 8 degrees C or less
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| Refrigerated** temperature | 2 - 4 degrees C
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| Cool temperature | 8 = 15 degrees C
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| Room temperature ** | 20 - 25 degrees C
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| warm temperature | 30 - 40 degrees C
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| excessive heat | above 40 degrees C
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| all liquid dosage forms | suspensions (lotions), solutions (syrups, elixirs, spirits, tinctures, lotions), emulsions (O/w, w/o)
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| the basic characteristics of a simple solution | all ingredients are molecularly dispersed, does not need to be maintained by shaking.
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| definition of a solute | substance which is dissolved in a solvent
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| definition of solvent | base liquid, pure or mixture of miscible liquids, contains no active ingredients
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| USP definition of solution | liquid preparations that contain one or more chemical substances dissolved in a suitable solvent or mixture of mutually miscible solvents
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| functional definition of solution | molecular dispersion of a solute in solvent
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| Basic characteristics of a true pharmaceutical syrup | concentrated aqueous preparation of sugar or sugar substitute, highly concentrated = viscous. sugar at near saturation
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| advantage of liquid over solid dosage forms (3) | -dose determined by volume measurement
-precise dosing (custom dosing)
-nonstandard dosing easy (ex: pediatric)
-easy to swallow
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| dosage for examples, which are solutions | solutions = syrups, elixirs, tinctures, lotions, non-solutions = suspensions and emulsions
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| disadvantages of liquid dosage forms compared to solid (5) | -inconvenient dosing (need to teach pt.)
-prone to error
-unpleasant taste difficult to mask
-specific storage conditions
-drug is often less stable than dry form
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| stability of active ingredients in a liquid dosage form compared to dry dosage forms or suspensions | theoretically maximum surface area of the drug in contact with solvent = less stable
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| examples of water soluble dissociable ionic substances | potassium citrate, sodium chloride, potassium chloride
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| water soluble non dissociable substnaces | glucose
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| definiition of solubility | the degree or extent to which a solute will dissolve in a solvent
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| general solubility notations | freely soluble, sparingly soluble, very slightly soluble
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| exact solubility notation | 1 g of X in ___ ml of Y
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| What is a eutectic | a combination of 2 or more substances where the melting point is less than that of any part when taken alone
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| can a solution be part of a suspension | yes, a suspension can contain dissolved things
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| can a suspension be part of a solution | no, a solution cannot contain undissolved things. not molecularly dispersed
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| can a syrup be part of a suspension? | yes, a suspension may have some soluble components
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| can a suspension be part of a syrup? | no, syrups are solutions, and they need to be molecularly dispersed
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| various routes of administration for solution | IV, IM, Sq, epidural, intrathecal, rectal, ophthalmic, otic, topical
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| various routes of administration by which liquid dosage forms in general can be administered | Sq, IM, rectal, ophthalmic, otic, topical
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| routes of administration inappropriate or dangerous for some specific dosage forms | IV,intrathecal, epidural = not safe for suspensions
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| In which particular case is the use of preservatives dangerous and tragic? | intrathecal preparations, never use bacteriostatic water for injection. preservatives will destroy motor neurons and permanently paralyze
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| advantages of solutions over suspensions | suspending agents not required, easily absorbed
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| disadvantage of solutions in respect to suspensions | generally less stable
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| what is the general effect of temperature on a solution system | increasing solubility with increasing temperature
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| what is meant by saturation in a solution system | cannot dissolve anymore: maximum concentration acheived
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| what is miscibility? | 2 liquids soluble in each other in all proportions
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| Exact composition of alcohol USP | 94.9% w/v ethyl alcohol
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| FDA ruling march 1995 | Maximum alcohol content in OTC products: Children <6 years old = 0.5%, 6-12 years = 5%, >12 years 10%
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| mg % | x mg/100 ml
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| shaking solutions and simple syrups? | not needed for patients but RPh may need to shake to prepare
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| Shaking suspensions? | always!
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| 20% rule? | smallest volume that can be measured is 20% of its full rated volume
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| difference between a volumetric measuring device and a holding vessel | measure precisely vs just use to hold the liquid. ex: graduated cylinders vs beakers
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| be able to convert between mg % and ratio strength | mg% = x g/100 ml, ratio strength = 1 g//x ml
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| what is the simplest form of ratio strength | X:Y
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| what is parts strength? | X parts + Z parts = Ytotal
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| convert between ratio strength and parts strength | X:Y, and X:Z where X parts + Z parts = Y total
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| know the concept of equivalence | MW = g/mol, valence = Eq/Mol, EW=MW/valence = g/Eq
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| units for molecular weight | g/mol
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| units for equivalent weight | g/Eq
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| what is an equivalent? | a unit once dissolved
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| isotonic | same osmolarity
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| hypotonic | less osmolarity
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| hypertonic | more osmolarity
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| preservation paradox for syrups | contain a lot of sugar, but are actually a preservative. this is because there is not a lot of free water
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| free water | water available that is not involved in solubilizing the sugar
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| know the effect of temperature on free water | as temp increases, free water increases
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| know the effect of increasing solute concentrations on dissolution time | increasing solute concentration increases dissolution time
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| effect of increasing sugar content of a syrup | -sugar may precipitate
-drug may precipitate
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| effect of decreasing the sugar content of a syrup | -increase in free water
-microbial growth
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| be able to predict free water values in a solution/syrup system: Example if 89.14 g of sucrose in 100 ml of water is saturation how much free water is in syrup usp (85%w/v)? | 4.64 ml. 89.14g/100ml-85g/100ml = 4.14 g/100 ml. how much water is represented by 4.14 g : 4.14 g* 100ml water/89.14 g = 4.64 ml
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| Syrup USP | 85% w/v sucrose in water
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| Cherry Syrup USP | 80% w/v sucrose, 47.5% v/v cherry juice, 2% v/v EtOH
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| know the concept of specific gravity | mass of x / mass of water for equiv volume
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| units of specific gravity | unitless
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| units of density | g/ml
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| convert between specific gravity and dencity | add units g/ml to specific gravity
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| utility of alcohol as an ingredient in liquid pharmaceutical dosage forms | preservative, emulsifier, sedative (usually undesired side effect), rarely included for pharmacological effect
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| cautions of EtOH in liquid dosage forms | cant have too much in pediatric formulations
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| examples of syrup vehicles | simple syrup (50-1005 v/v), Cherry Syrup, Cologel, Sorbitol, glycerin (2-10% v/v)
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| USP definition for suspension | liquid preparations that consist of solid particles dispersed throughout a liquid phase in which particles are not completely soluble
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| Purpose for suspensions as liquid dosage forms | provide a liquid form of a drug that is otherwise insoluble in water. An alternative to alcohol solutions
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| Example when something would be a suspension instead of a solution | when using a capsule or tablet drug source
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| Suspending agent | increases the product's viscosity thus decreasing the particle settling rate
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| examples of suspending agents | acacia, bentonite, methylcellulose, xanthan gum, tragacanth, carbomer
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| micron gauge (hedgeman wedge) | determines the smallest particle diamter size you are able to achieve
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| nested sieves | separates particles of different diameters
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| Factors that affect sedimentation rate/time | particle size (increase rate), density (increase rate), viscosity (decrease rate)
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| relationship between settling rate and settling time | inverse. as settling rate decreases settling time increases
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| stokes law | velocity proportional to g * radius * (difference in densities) all over viscosity
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| deflocculation | long sedimentation time, but difficult to break up if a cake is formed
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| flocculated | short sedimentation time, but redisperses easily
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| Know the USP definition for lotions | Not listed, liquid preparation intended for external application
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| Know the British pharmacopeia definition for lotions | Liquid or semiliquid preparations which contain one or more active ingredient in a suitable vehicle
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| In what set(s) of liquid dosages forms may lotions potentially be found | Suspensions
Emulsions
solutions
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| Solutions | liquid preparation containing 1+ chemical substances dissolved(molecularly dispersed) in a suitable solvent or mixture of mutually miscible solvents
Solute dissolved in a solvent
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| Suspensions | liquid preparation that consists of solid particles dissolved throughout a liquid phase in which particles are not completely soluble
Pure solvent with solid particles
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| Emulsions | two phase system in which one liquid is dispersed throughout another in the form of small droplets
Oil and water
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| What are intertriginous areas | ? Where skin touches skin
Gluteal fold, abdominal fold, between breasts. Antifungal agents or lubrication
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| What is levigation | Applies to powders which are insoluble in the qs media
The wetting of an insoluble powder agent in a minimal amount of qs media or levigating agent forming a smooth homogenous paste
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| What is quantitative transfer | Facilitated transfer of a substance from one vessel to another through a series of repeated washings with the qs media.
Always done prior to qsing
Applies to agents both soluble and insoluble in the qs media
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| What is creaming? | Migration of droplets – surfacing or settling
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| What is cracking? | Merging of droplets, separation of phases
Usually irreversible
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| Be familiar with some common ingredients that could be found in a lotion | Water
Hydrocortisone
calamine
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| What does the “internal phase” of an emulsion mean? | The droplets, or micelles
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| What does the “external phase” of an emulsion mean? | The suspension medium that the droplets float around in
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| What is an oil in water emulsion | Oil droplets in a water phase
Passes conductivity test
When oil added to it, it is not additive
When water added to it, it is additive
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| What is an water in oil emulsion | Water droplets in an oil phase
Fails conductivity test
When oil is added to it, it is additive
When water is added to it, it is not additive
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| what is an emulsifier? | Promotes the formation of micelles and their charge based separation
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| how do emulsifiers work? | They have polar and nonpolar sides that line up at the water and oil interfaces
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| Know the definition for emulsification | Added energy through trituration or homogenization creating small droplets of one liquid phase in another and static charge around those droplets
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| Know the definition for homogenization | Forcing two immiscible liquids through an orifice under high pressure for the purpose of mixing
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| Know some examples of commercially available pharmaceutical emulsions | Lotions, gels, TPN lipid formula, amphotericin-B, propofol
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| Know the composition of and the order of incorporation for 4:2:1 emulsions | 4 parts mineral oil
2 parts water
1 part acacia
Refine acacia in mortar, add oil to acacia (2secs) and mix, add water, mix rapidly until viscous
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| Know how to use the electrical conductivity test in the analysis of emulsions | Oil in water passes
Water and oil fails
Only a water continuous phase will conduct
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| Know how to use the drop dissolution test in the analysis of emulsions | Water will be additive to the oil in water, but not the water in oil
Oil will be additive to the water in oil but not that oil in water
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| What factors contribute to the viscosity of an emulsion? | Micelle diameter
Weak hydrogen bonding between micelles
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| avogadros number | 6.022 * 10^23
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| When should a substance be incorporated into the internal phase of an emulsion in general? | PO: active ingredients usually in internal phase (mask taste)
Internal use = oil in water (because body is made of water)
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| When should a substance be incorporated into the external phase of an emulsion in general? | External: active ingredients usually in external phase (touch skin)
External use = water in oil (want emollient effect)
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| Know the composition of lime water | Calcium hydroxide solution 3g/1000ml
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| What does HLB stand for? | Hydrophile-lipophile balance
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| Soaps | Calcium oleate
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| Gums | Acacia
Tragacanth
Xanthan gum
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| Surfactants | Tween 80, span 80
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| What range of HLB values tend to form water in oil emulsions | 1 – 9 LOW END = water in oil
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| What range of HLB values tend to form oil in water emulsions | 9 – 20 HIGH END = oil in water
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| 1 pt = x oz | 1 pt = 16 oz
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| 1 qt = x pts = x ozs | 1 qt = 2 pts = 32 ozs
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| 1 gallon = x qts = x pts = x ozs | 1 gallon = 4 qts = 8 pts = 128 ozs
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| 1 apoth oz = x g | 1 apoth oz = 31.10 g
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| 1 avoir oz = x g | 1 avoir oz = 28.35 g
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| 1 oz = x ml | 1 oz = 29.57ml
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| x gr/g | 15.43 gr/g
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| valence of potassium citrate | 3
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| valence of magnesium chloride | 2
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| valence of magnesiumsulfate | 2
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