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Prof Prac
Final Exam Prof Prac Flashcards
| Question | Answer |
|---|---|
| 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 |
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