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Prof Prac

Final Exam Prof Prac Flashcards

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
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)
What is batching? (in terms of pharmaceutical compounding) compounding 'ahead of time' in anticipation of outstanding refills or unfilled oral prescriptions
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)
Which pharmaceutical dosage forms, discussed in class, are commonly prepared extemporaneously? lozenges, pills, tablets (uncommon), charts, powder capsules, liquid capsules (uncommon)
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)
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
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
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
What is the most important consideration with respect to the storage of pharmaceutical preparations? keep out of reach of children
What is an active ingredient? substances present in the formulation which exist for their direct effect on the patient
What is an inactive ingredient? substances present in a formulation which exist solely for their effect on the product
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
What is refinement? particle size reduction. (has different ranges of particle sizes than pulverization)
What is trituration? verb: refining and mixing of powders
What is a trituration? noun: mixed powder product
What is geometric combination? visually duplicating an equivalent mass and combining.
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)
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
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
What is the basic principle at play (and responsible for) eutectic formation? interference with crystalline structure
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
What is deliquescence? hygroscopic (subject to moisturization) but will dissolve and form a water based solution. Ex: lithium bromide
What is hygroscopicity? powders subject to moisturization from ambient humidity. (affinity for water, will absorb water from air)
Be able to derive the Sensitivity of a balance from MWQ and vice versa for a given desired tolerance Sensitivity/MWQ = %/100
Ideal Body weigh Equation (IBW) Male: 50 + (2.3* inches over 5') Female: 45.5 + (2.3* inches over 5')
lb to kg conversion 2.205 lb = 1 kg
inch to cm conversion 1 in = 2.54 cm
Creatinine Clearance equation M: (140-age)*IBW / 72*SCr F: M eq * 0.85
Know the BSA equation and how to use a BSA nomogram sqrt((height in cm * weight in kg)/3600)
Which pharmaceutical dosage forms are composed of powders? bulk powders, capsules, charts, tablets(compressed powder)
Which pharmaceutical dosage forms represent unit dose powders? capsules, charts, tablets (compressed powders)
basic characteristics of lozenges -dissolve/disintegrate in mouth -local (oral) drug delivery usually -pastilles (soft, high sugar) -troches (relatively small) -analgesics, anesthetics, antimicrobial
basic characteristics of pills -small, round, spherical, hard -cut up a long spherical dough, roll into balls, dry
basic characteristics of tablets -compressed unit dose powder -solidification mold (less common, extemporaneous) -can extemporaneously prepare, but uncommon
basic characteristics of charts -contains specific dose of medication -loose powder in a paper envelope
basic characteristics of powder capsules -solid and non-rigid -shell usually molded gelatin
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)
basic characteristics of gel capsules - cannot be extemporaneously prepared -semisolid and non-rigid -beads of gel inside
Rule of 7s (backward and forward) 7 - grains = capsule size, 1 g = 15.43 gr
Active ingredients in an oral, unit dose powder should have what units? mass/dose
Active ingredients in a topical powder should have what units? mass of drug/mass of product (concentration, %w/w)
What physical forms may potentially be found as ingredients in commercially available capsules? powders, liquids, gels
what physical forms are commonly used as ingredients in commercially available capsules? powders. liquids are uncommon
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
What is an excipient? inactive ingredient with a purpose to the preparation: fillers, binders, glidants, disintegrants, coloring agents, flavoring agents
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
% w/v g/100 ml
% w/w g/100g
% v/w ml/100g
% v/v ml/100ml
Freezer/frozen temperature -20 to - 10 degrees C
Cold temperature 8 degrees C or less
Refrigerated** temperature 2 - 4 degrees C
Cool temperature 8 = 15 degrees C
Room temperature ** 20 - 25 degrees C
warm temperature 30 - 40 degrees C
excessive heat above 40 degrees C
all liquid dosage forms suspensions (lotions), solutions (syrups, elixirs, spirits, tinctures, lotions), emulsions (O/w, w/o)
the basic characteristics of a simple solution all ingredients are molecularly dispersed, does not need to be maintained by shaking.
definition of a solute substance which is dissolved in a solvent
definition of solvent base liquid, pure or mixture of miscible liquids, contains no active ingredients
USP definition of solution liquid preparations that contain one or more chemical substances dissolved in a suitable solvent or mixture of mutually miscible solvents
functional definition of solution molecular dispersion of a solute in solvent
Basic characteristics of a true pharmaceutical syrup concentrated aqueous preparation of sugar or sugar substitute, highly concentrated = viscous. sugar at near saturation
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
dosage for examples, which are solutions solutions = syrups, elixirs, tinctures, lotions, non-solutions = suspensions and emulsions
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
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
examples of water soluble dissociable ionic substances potassium citrate, sodium chloride, potassium chloride
water soluble non dissociable substnaces glucose
definiition of solubility the degree or extent to which a solute will dissolve in a solvent
general solubility notations freely soluble, sparingly soluble, very slightly soluble
exact solubility notation 1 g of X in ___ ml of Y
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
can a solution be part of a suspension yes, a suspension can contain dissolved things
can a suspension be part of a solution no, a solution cannot contain undissolved things. not molecularly dispersed
can a syrup be part of a suspension? yes, a suspension may have some soluble components
can a suspension be part of a syrup? no, syrups are solutions, and they need to be molecularly dispersed
various routes of administration for solution IV, IM, Sq, epidural, intrathecal, rectal, ophthalmic, otic, topical
various routes of administration by which liquid dosage forms in general can be administered Sq, IM, rectal, ophthalmic, otic, topical
routes of administration inappropriate or dangerous for some specific dosage forms IV,intrathecal, epidural = not safe for suspensions
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
advantages of solutions over suspensions suspending agents not required, easily absorbed
disadvantage of solutions in respect to suspensions generally less stable
what is the general effect of temperature on a solution system increasing solubility with increasing temperature
what is meant by saturation in a solution system cannot dissolve anymore: maximum concentration acheived
what is miscibility? 2 liquids soluble in each other in all proportions
Exact composition of alcohol USP 94.9% w/v ethyl alcohol
FDA ruling march 1995 Maximum alcohol content in OTC products: Children <6 years old = 0.5%, 6-12 years = 5%, >12 years 10%
mg % x mg/100 ml
shaking solutions and simple syrups? not needed for patients but RPh may need to shake to prepare
Shaking suspensions? always!
20% rule? smallest volume that can be measured is 20% of its full rated volume
difference between a volumetric measuring device and a holding vessel measure precisely vs just use to hold the liquid. ex: graduated cylinders vs beakers
be able to convert between mg % and ratio strength mg% = x g/100 ml, ratio strength = 1 g//x ml
what is the simplest form of ratio strength X:Y
what is parts strength? X parts + Z parts = Ytotal
convert between ratio strength and parts strength X:Y, and X:Z where X parts + Z parts = Y total
know the concept of equivalence MW = g/mol, valence = Eq/Mol, EW=MW/valence = g/Eq
units for molecular weight g/mol
units for equivalent weight g/Eq
what is an equivalent? a unit once dissolved
isotonic same osmolarity
hypotonic less osmolarity
hypertonic more osmolarity
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
free water water available that is not involved in solubilizing the sugar
know the effect of temperature on free water as temp increases, free water increases
know the effect of increasing solute concentrations on dissolution time increasing solute concentration increases dissolution time
effect of increasing sugar content of a syrup -sugar may precipitate -drug may precipitate
effect of decreasing the sugar content of a syrup -increase in free water -microbial growth
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
Syrup USP 85% w/v sucrose in water
Cherry Syrup USP 80% w/v sucrose, 47.5% v/v cherry juice, 2% v/v EtOH
know the concept of specific gravity mass of x / mass of water for equiv volume
units of specific gravity unitless
units of density g/ml
convert between specific gravity and dencity add units g/ml to specific gravity
utility of alcohol as an ingredient in liquid pharmaceutical dosage forms preservative, emulsifier, sedative (usually undesired side effect), rarely included for pharmacological effect
cautions of EtOH in liquid dosage forms cant have too much in pediatric formulations
examples of syrup vehicles simple syrup (50-1005 v/v), Cherry Syrup, Cologel, Sorbitol, glycerin (2-10% v/v)
USP definition for suspension liquid preparations that consist of solid particles dispersed throughout a liquid phase in which particles are not completely soluble
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
Example when something would be a suspension instead of a solution when using a capsule or tablet drug source
Suspending agent increases the product's viscosity thus decreasing the particle settling rate
examples of suspending agents acacia, bentonite, methylcellulose, xanthan gum, tragacanth, carbomer
micron gauge (hedgeman wedge) determines the smallest particle diamter size you are able to achieve
nested sieves separates particles of different diameters
Factors that affect sedimentation rate/time particle size (increase rate), density (increase rate), viscosity (decrease rate)
relationship between settling rate and settling time inverse. as settling rate decreases settling time increases
stokes law velocity proportional to g * radius * (difference in densities) all over viscosity
deflocculation long sedimentation time, but difficult to break up if a cake is formed
flocculated short sedimentation time, but redisperses easily
Know the USP definition for lotions Not listed, liquid preparation intended for external application
Know the British pharmacopeia definition for lotions Liquid or semiliquid preparations which contain one or more active ingredient in a suitable vehicle
In what set(s) of liquid dosages forms may lotions potentially be found Suspensions Emulsions solutions
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
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
Emulsions two phase system in which one liquid is dispersed throughout another in the form of small droplets Oil and water
What are intertriginous areas ? Where skin touches skin Gluteal fold, abdominal fold, between breasts. Antifungal agents or lubrication
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
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
What is creaming? Migration of droplets – surfacing or settling
What is cracking? Merging of droplets, separation of phases Usually irreversible
Be familiar with some common ingredients that could be found in a lotion Water Hydrocortisone calamine
What does the “internal phase” of an emulsion mean? The droplets, or micelles
What does the “external phase” of an emulsion mean? The suspension medium that the droplets float around in
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
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
what is an emulsifier? Promotes the formation of micelles and their charge based separation
how do emulsifiers work? They have polar and nonpolar sides that line up at the water and oil interfaces
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
Know the definition for homogenization Forcing two immiscible liquids through an orifice under high pressure for the purpose of mixing
Know some examples of commercially available pharmaceutical emulsions Lotions, gels, TPN lipid formula, amphotericin-B, propofol
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
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
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
What factors contribute to the viscosity of an emulsion? Micelle diameter Weak hydrogen bonding between micelles
avogadros number 6.022 * 10^23
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)
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)
Know the composition of lime water Calcium hydroxide solution 3g/1000ml
What does HLB stand for? Hydrophile-lipophile balance
Soaps Calcium oleate
Gums Acacia Tragacanth Xanthan gum
Surfactants Tween 80, span 80
What range of HLB values tend to form water in oil emulsions 1 – 9 LOW END = water in oil
What range of HLB values tend to form oil in water emulsions 9 – 20 HIGH END = oil in water
1 pt = x oz 1 pt = 16 oz
1 qt = x pts = x ozs 1 qt = 2 pts = 32 ozs
1 gallon = x qts = x pts = x ozs 1 gallon = 4 qts = 8 pts = 128 ozs
1 apoth oz = x g 1 apoth oz = 31.10 g
1 avoir oz = x g 1 avoir oz = 28.35 g
1 oz = x ml 1 oz = 29.57ml
x gr/g 15.43 gr/g
valence of potassium citrate 3
valence of magnesium chloride 2
valence of magnesiumsulfate 2
Created by: HugsAndKisses