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API Exam 1 Questions with Verified Answers,100% CORRECT, Exams of Nursing

API Exam 1 Questions with Verified Answers

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2023/2024

Available from 07/21/2024

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API Exam 1|236 Questions with Verified Answers

Timeline for Nanomedicines rugs? - CORRECT ANSWER 1965 --> liposomes (lipid based vehicles drug inside membrane OR inside core) 1976 --> polymeric systems 1978 --> Dendrimers 1980 --> PEGylated liposomes (liposomes with PEG polymer on surface, which keeps the drug in circulation longer) 1995 --> doxil (PEGylated liposomes, one of the first drugs approved) 2013 --> Kadcyla (antibody drug) It's not necessarily that efficacy improves, but rather that toxicity DECREASES Liposomal Amphotericin B - Purpose, Mechanism of Action, and Toxicity - CORRECT ANSWER Broad-spectrum polyene antifungal agent - but very POOR solubility Mechanism of Action:

  1. Bind to ergosterol in fungal cell membranes
  2. Create transmembrane channels and lead to cellular component leakage (how it kills fungal cells)
  3. Bind to cholesterol in mammalian membranes, which forms pores in host membrane --> TOXICITY On top of Infusion-related reaction: nausea, vomiting, rigors, fever, hypertension, hypotension, hypoxia Significant Nephrotoxicity
  • direct damage of distal tubular membranes leading to wasting of Na+, K+, and Mg+
  • Tubular-glomerular feedback: further constriction of arterioles
  • constriction of the afferent arterioles leading to decreased glomerular filtration Amphotericin B Injection (Fungizone) vs Ambisome vs Abelcet - CORRECT ANSWER Amphotericin B Injection Sodium Deoxycholate --> amphiphilic molecule that forms micelle Most Toxic to Least Toxic:
  1. Fungizone
  2. Abelcet
  3. Ambisome Abelcet
  • DMPG is negative, and has interaction with positive amphotericin B Ambisome
  • HSPC = positive
  • DSPG = negative
  • cholesterol for stability *this is the SAFEST BUT no generic here in the US - but many abroad (some less efficacious and some more toxic) *Lambin (generic of ambisome) (sun pharmaceuticals) was withdrawn due to toxicity issues Amphotericin B Injection (Fungizone) - CORRECT ANSWER Colloidal Dispersion Composition
  • Amphotericin B
  • Sodium deoxycholate (solubilizer) Micellar structure
  • EASY for AmpB to dissociate after administration Abelcet - CORRECT ANSWER Composition
  • Amphotericin B
  • DMPC/DMPG Ribbon like structure Ambisome - CORRECT ANSWER Composition
  • Amphotericin B
  • HSPC, DSPG, Cholesterol, tocopherol
  • stays STABLE in phospholipid bilayer of liposomes
  • Amphotericin B interacts with DSPG to form ionic complex How is AmBisome Manufactured - CORRECT ANSWER HIGH temperature due to high transition temperature of AmBisome. Even small changes can alter the drug's toxicity. PK of Ambisome vs Fungizone - CORRECT ANSWER AmBisome has:
  • higher AUC
  • reduced nephrotoxicity
  • MUCH higher cost ($82/vial vs $3.88/vial) When compared to Fungizone. How are Tumors Targeting Via EPR0basec nanomedicine therapy? - CORRECT ANSWER EPR = enhanced permeability and retention effect Nanodrugs prevent accumulation of chemotherapy in healthy tissues, and promote accumulation at pathological sites Paclitaxel - CORRECT ANSWER Originally formulated as TAXOL, which was 50% by volume alcohol Cremophor is a solvent that often has toxicity

Abraxane - CORRECT ANSWER Nanoparticle albumin-bound (gab) Nanotech-based drug delivery platform NO surfactants/solvents Nab Pacitaxel (Abraxane) is slightly safer than Cremo-paclitaxel (TAXOL)

  • allows for greater doses of this chemotherapy Mechanism of Action of Paclitaxel formulations - CORRECT ANSWER Designed based on Paclitaxel's innate tendency to bind to albumin DOXIL - CORRECT ANSWER Stealth Liposomes DOXIL:
  • anthracycline antibiotic
  • has a well-established position in the treatment of human malignancies
  • cardiotoxicity is a MAJOR clinical handicap limiting its cumulative dosage DOXIL manufacturing - CORRECT ANSWER Suspension Definition - CORRECT ANSWER A coarse dispersion in which internal phase (therapeutically active ingredient) is dispersed uniformly throughout the external phase. Molecular Dispersion Colloidal Dispersion Coarse Dispersion - CORRECT ANSWER Dispersed systems consist of particulate matter known as dispersed phase, dispersed throughout a continuous or dispersion medium. Classified according to particle size (picture) Why are suspensions used for oral administration? - CORRECT ANSWER - Insoluble drug or poorly soluble drug
  • children, elderly, and pts with trouble swallowing
  • to overcome instability of drugs in aqueous solution (insoluble derivative formulated as suspension
  • to mask TASTE
  • Some materials are needed to be present in the GI tract in a finely divided form, to increase the surface area For example:
  • Mg carbonate and Mg trisilicate are used to adsorb some toxins (thus need large SA) Classification of Suspension - CORRECT ANSWER - Route of Admin (oral, externally applied, parenteral)
  • Size of Solid Particles (colloidal <1 micron vs coarse >1 micron)
  • Based on Proportion of Solid Particles (dilute 2-10% w/v OR concentrated suspension 50% w/v)
  • Based on Electro-kinetic Nature of Solid Particles What is the Order of Bioavailability - CORRECT ANSWER Solution > Suspension > Capsule > Compressed Tablet Theory of Suspension: Sedimentation is expressed by which law? - CORRECT ANSWER Stokes Law What are the two primary ways settling and aggregation occurs in suspensions? Which is worse? - CORRECT ANSWER 1. Suspension shall form loose networks of flocks that settle rapidly, do not form cakes, and are easily resuspended
  1. Setting and aggregation may result in the formation of cakes that is difficult to resuspend.

What factors related to the API are important for suspensions? - CORRECT ANSWER - Size of particles

  • Size distribution of the powder
  • Ease of wetting
  • Surface electric charge of the particles in the suspension
  • Chemical stability of the drug, and possible interactions and incompatibilities with other suspension constituents How are surface free energy, total surface area, and interfacial tension related? - CORRECT ANSWER What are common suspending mediums or vehicles? - CORRECT ANSWER 1. Water
  1. Water - Organic solvent Mixture (alcohol, glycerol)
  2. Non-aqueous vehicles (topical use) Purpose of Wetting Agents (Surfactants) - CORRECT ANSWER 1. Difficult to disperse solid particles in a liquid vehicle due to layer of adsorbed air on the surface --> this causes particles (even w/ high density) to float on the surface of the liquid until the layer of air is displaced completely --> Use of wetting agent allows to remove this air from surface _ easily penetrate the vehicle into pores
  3. Powders, which are NOT easily wetted by water (and accordingly show a large contact angle) such as sulfur, charcoal, and magnesium stearate are called hydrophobic
  4. Powders which are readily wetted by water are called hydrophilic (zinc oxide, talc)
  5. The "wettability" of a powder may be ascertained easily by observing the contact angle and spreading coefficient. What is a good contact angle for wetting of powders? - CORRECT ANSWER Poor Wetting: angle > 90

Good Wetting: 90 > angle > 0 Complete Wetting: angle --> 0 Spreading Coefficient - CORRECT ANSWER For convenient wetting, the value of spreading coefficient (Sc) should be positive This could be achieved by modification of the values of surface tension of several surfaces involved until + value of spreading coefficient is reached. Surfactants - CORRECT ANSWER Reduce the interfacial tension between the solid particles and a vehicle. As a result of the lowered interfacial tension the Sc will be positive and the contact angle is lowered, air is displaced from the surface of particles, and wetting is promoted. --> disadvantage is surfactants have foraming tendencies Three categories of wetting agents? - CORRECT ANSWER 1. Surfactants

  1. Glycerin and Similar Hydroscopic Substances
  2. Hydrophilic Colloids Glycerin and Similar Hydroscopic Substances - CORRECT ANSWER Hydrophilic Colloids - CORRECT ANSWER How do we control Stability and Sedimentation? - CORRECT ANSWER What are common suspending agents and co-solvents? - CORRECT ANSWER Flocculating Agents - CORRECT ANSWER Electrolytes as Flocculating Agents - CORRECT ANSWER Zeta potential is the potential difference between the ions in the tightly bound layer and the electroneutral region.

Zeta potential governs the degree of repulsion between adjacent, similar charged, solid dispersed particles. Nernst vs Zeta Potential - CORRECT ANSWER Nernst layer is defined by the concentration of negative particles Flocculating Agents: Surfactants - CORRECT ANSWER Flocculating Agents: Polymers - CORRECT ANSWER Sedimentation Volume - CORRECT ANSWER Suspensions are evaluated by determining their physical stability.

  1. Sedimentation volume: (F), sedimentation volume of a suspension is expressed by the ratio of the equilibrium volume of the sediment, Vu, to the total volume, Vo of the suspension. F = Vu/Vo The value of F provides a qualitative knowledge about the physical stability of the suspension. F= 1 No sedimentation, no clear supernatant F =0. 50% of the total volume is occupied by sediment F > 1 Sediment volume is greater than the original volume due to formation of floccules which are fluffy and loose Degree of flocculation - CORRECT ANSWER

Re-Dispersibility - evaluation of suspension - CORRECT ANSWER This is determined by the number of upside down inversions of the suspension contained in a measure. The smaller the number, the easier it would be to re-disperse the sediment. A number greater than 15 inversions indicates caking. Rheological Characteristics of Suspension - CORRECT ANSWER What is important when considering matching drug/dosage form? - CORRECT ANSWER 1. Physical properties (solubility, MP)

  1. Chemical properties (stability)
  2. Route of admin
  3. Drug delivery profile (instantaneous, immediate, delayed, controlled)
  4. Biological barriers to overcome (absorption) 6.Manufacturability Why are dosage forms needed? - CORRECT ANSWER 1. Achieve rapid onset of action
  5. Mask undesirable taste
  6. Protect drug following oral administration (capsule, coated tablet)
  7. Stabilize the drug under specified storage conditions (powders for reconstitution)
  8. Provide useful dosage forms for poorly water-soluble or insoluble drugs (suspension)
  1. Prolong the therapeutic effect (modified release tablets, capsules, and suspensions.) Blister Packaging - CORRECT ANSWER Primary Component: Cavity or Pocket Usually made from thermoformed plastic and backing membrane or using aluminum foil Polyvinyl Chloride (PVC) is used for forming cavity or pocket. Strip packaging - CORRECT ANSWER An alternative form of packaging for unit dose Made from regenerated cellulose, paper, plastic, foil, or combo of these The use of high barrier material like aluminum foil or saran-coated film. Bottle with Dropper Assembly - CORRECT ANSWER Collapsible Tubes - CORRECT ANSWER Metals: aluminum, tin, and lead Plastics: low density polyethylene Cap: high density polyethylene, polypropylene, and PVC Aerosol Spray - CORRECT ANSWER Container: to withstand pressure 140-180 psig
  2. Tin Plate Container:
  3. Aluminum Container:
  4. Stainless Steel Container
  5. Glass Container: Valve:
  1. Mounting cup/ferrule - tin plate steel, aluminum, brass
  2. Valve body/housing - nylon or delrin Pre-filled syringe - CORRECT ANSWER Used for small volume parenteral preparation Reduction of medication errors like drug overfill Give increased assurance of sterility Irrigation Solution Container - CORRECT ANSWER Made of LDPE, polyolefin, polypropylenes AVOID hanging breakage glass Lightweight, transparent, impermeable to water What types of medications MUST be administered in a clinic? - CORRECT ANSWER Chemo (IV)
  • Route: IV infusion
  • Hospital or infusion center Vaccination
  • SQ, IM, or intradermal
  • doctors office or pharmacist Pregnancy Injections:
  • Medications for preventing pregnancy, preterm labor, or autoimmune rxns
  • injection or infusion
  • doctor's office or hospital Osteoporosis IV medications What is another word for lozenge? - CORRECT ANSWER Troches are small lozenges that dissolve between the cheek and gum over a period of about 30 minutes

can he hard or SOFT GUMMY as long as location + takes time to dissolve What is Intravitreal injection? - CORRECT ANSWER Intravitreal Injection:

  • substance is delivered into the vitreous humor of the eye via injection What are the various parenteral dosage forms? - CORRECT ANSWER - Solutions
  • Suspensions
  • Emulsions
  • Reconstituted Lyophilized Powders What are the ~general~ requirements for parenteral dosage forms? - CORRECT ANSWER - sterility
  • pyrogen free
  • no particulate matter
  • stability
  • clarity
  • isotonicity ALSO
  • vehicles/cosolvents must meet special purity standards
  • restrictions on buffers, stabilizers, and preservatives
  • Must be prepared under aseptic conditions
  • Specific packaging Advantages of parenteral drug products? - CORRECT ANSWER Disadvantages of parenteral drug products? - CORRECT ANSWER What classes of vehicles and co-solvents are common as parenteral excipients? - CORRECT ANSWER 1. Aqueous vehicles
    • Water for Injection (WFI)
  1. Water miscible vehicles
  • Ethanol, PEG, Glycerine, Propylene Glycol
  1. Non aqueous solvents
  • fixed oils (vegetable origin, liquid, and rancid resistance, unsaturated) What are Aqueous vehicles examples (for parenteral administration) - CORRECT ANSWER Aqueous vehicles
  • Water for Injection (WFI) only ?? pH of 5- WFI may be prepared by either distillation or reverse osmosis When are water miscible vehicles used? What are challenges with these agents? (parenterally) - CORRECT ANSWER Water miscible vehicles
  • Ethanol, PEG, Glycerine, Propylene Glycol Used when:
  • drug is water insoluble
  • drug is susceptible to hydrolysis Challenges:
  • tissue irritability/pain at injection site
  • hemolysis
  • toxicity
  • drug precipitation (don't use water to dilute) Propylene Glycol considerations (parenterally) - CORRECT ANSWER Challenges with Propylene Glycol
  • Metabolizes to lactic acid (causes lactic acidosis)
  • Causes cardiotoxicity
  • should be infused SLOWLY In Phenytoin Infusion, Diazepam and Lorazepam

Propylene Glycol Cardiotoxicity (parenterally) - CORRECT ANSWER Propylene Glycol metabolizes to lactic acid, leading to elevated lactic acid levels Can result in:

  • anion gap metabolic acidosis
  • osmolar gap
  • hypernatremia (high sodium) When are non-aqueous solvents used (parenterally). - CORRECT ANSWER Non aqueous solvents Used When:
  • Drug is unstable in aqueous system
  • When some oil-soluble IM preparations are not properly soluble in water (testosterone) Includes:
  • fixed oils (vegetable origin, liquid, and rancid resistance, unsaturated)
  • NOTE: mineral oils can NOT be used as they are not absorbed by body tissues Buffering agents parenterally - CORRECT ANSWER - Adjust and maintain pH
  • Increase stability, solubility, and adsorption of API humira citrate-free causes less pain causing injection Examples:
  • acetates
  • citrates
  • glutamate
  • phosphate
  • tartrate Antioxidants (parentally) as excipients - CORRECT ANSWER Functions:
  1. prevent or inhibit oxidation of drug
  2. protect components of dosage form
  3. should be effective at low concentrations
  4. should not alter solubility of API

Reducing Agents:

  • Ascorbic acid
  • Sodium Bisulfite
  • Sodium metabisulphite
  • Thiourea Blocking Agents:
  • Tocopherol (Vit E)
  • BHA (butylated hydroxyanisole)
  • BHT (butylated hydroxytoluene) Preservatives in parenteral solutions - CORRECT ANSWER Function:
  • added to protect drug from microbial contamination
  • mostly used in MULTIPLE dose containers Examples:
  • phenol, benzyl alcohol, methyl and ethyl parabens, benzalkonium chloride Challenges:
  • may cause drug instability (proteins, peptides)
  • toxicities What are the challenges with Benzyl Alcohol as a preservative in parenteral solutions? - CORRECT ANSWER Safe up to 5% in adults, but can cause DEATH in infants What are some examples of tonicity-adjusting agents in parenteral dosage forms?
  • CORRECT ANSWER Function:
  • make formulation isotonic
  • prevent osmotic shock at site of injection buffers may act as tonicity contributor Examples:
  • saline
  • glycerin
  • mannitol
  • dextrose
  • trehalose What does a solubilizing agent do in a parenteral form? - CORRECT ANSWER Function:
  • increase solubility of poorly water-soluble drugs
  • used where pH and salt formation are NOT adequate Examples:
  • Cremophor
  • Glycerin
  • DMA
  • PEG 300, 400
  • Polysorbate 80
  • Propylene glycol Cyclodextrin is also KEY solubilizing agent Cyclodextrins. What drugs USE cyclodextrins? - CORRECT ANSWER Structure: Sugars connected together in circle Use: Forms complex with API to increase solubility Challenges:
  1. IV use causes build up in patients with decreased renal clearance --> nephrotoxicity
  2. Because of formation of complex with cyclodextrins there is lower free concentration of drug. This affects PK/Pd of API Examples of drugs using cyclodextrins: Voriconazole, Televancin, Alprostadil, Mitomycin, Prostaglandin E Niemann-Pick C Disease - CORRECT ANSWER Rare inherited genetic mutation (progressive disorder) Lysosomal Storage Disease:
  • Characterized by an inability of the body to transport cholesterol and lipids INSIDE of cells This causes cholesterol and other fats to accumulate in liver, spleen, lungs, and brain. NPC2 or NPC1 are nonfunctional Niemann-Pick Type C Disease Treatment - CORRECT ANSWER Administration of cyclodextrin (CYCLO) rapidly overcomes the C transport defect seen in NPC1 and NPC2 disease and allows the sterol to move to the cytosolic compartment of cells, to be transported to the liver, and ultimately to be excreted from the body as bile acid. Renal toxicity of Cyclodextrin when used in Voriconazole - CORRECT ANSWER Voriconazole --> broad spectrum antifungal agent limited aqueous solubility In HEALTHY subjects --> eliminated with half life = 1.6 h In renally impaired ---> mean Cmax and AUC increased by 50% and 4-fold respectively Cremophor is used as what? - CORRECT ANSWER Cremophor Use: increase solubility of poorly water-soluble drugs (example: Taxol chemotherapeutic ) Challenges:
  1. P-glycoprotein inhibition: cremophor can module PGP activity changing overall kinetics of drug product
  2. Hypersensitivity: 3-5% of patients have reactions (low BP, hives, difficulty breathing, anaphylaxis) due to reactivity to cremophor Chelating Agents Use + Controversy - CORRECT ANSWER - Form a complex w/ metallic ions
  • Prevent the oxidation process enhanced by metal ions
  • Also used alone in treating lead poisoning

Example: EDTA, Disodium edetate, tetrasodium edetate Controversially and fatally used as a 'treatment' for autism to remove heavy metals due to vaccines. What excipients are commonly in Lyophilized Products? - CORRECT ANSWER 1. Bulking agents:

  • often used in low dose formulations (solid < 2%) and as stabilizers, tonicity agents, and help in cake formation
  1. Collapse Temperature Modifiers
  • higher collapse Temp is preferred 3.Lyo/CryoProtectants
  • Amino acids, sugars, polyols, sucrose, trehalose, glycine, arginine, sorbitol, mannitol
  • protect from freezing and drying stresses What is angle of injection for IM vs SQ vs IV vs ID? - CORRECT ANSWER IM: 90 deg SQ: 45 deg IV: 25 deg ID: 10 deg What ionic reactants when mixed pose a significant threat of forming insoluble substances? - CORRECT ANSWER Mixing solutions containing divalent Ca2+ or Mg2+ has SUBSTANTIAL risk of forming insoluble calcium or magnesium salt IM Injection Volumes + Placement - CORRECT ANSWER Volume 2 mL --> deltoid Volume up to 6 mL --> glutes Infants --> thigh

IV administration considerations + infusion pump - CORRECT ANSWER Air or particulate matter injected directly into bloodstream may cause embolism, blockage in a vessel, or severe painful reaction at the injection site Braun Pump: IV infusion in which a programmable infusion pump is used Intraspinal injection (injection into Cerebrospinal Fluid) - CORRECT ANSWER - Inserting a needle into the lower back to reach into the spinal cord's subarachnoid space

  • Mainly for diagnostic purpose
  • administer drugs, such as local anesthetics, spinal analgesics, anti-inflammatory corticosteroids, and chemotherapeutics. Sterility - CORRECT ANSWER MOST important safety specification Should be prepared in aseptic surrounding and free from any kind of microorganisms Raw materials used to prepare should have low bioburden Packaging materials have to be pre-washed Aseptic Technique - CORRECT ANSWER Aseptic technique guideline for manual operation in a biological safety cabinet, under laminar flow hood or in a clean bench The underlying principle of laminar flow hood is that a constant flow of HEPA filtered air at a rate of approximately 90 linear feet per minute physically sweeps the work area and prevents the entry of contaminated air Heat Sterilization (Steam vs Dry Heat) - CORRECT ANSWER Most widely used and reliable method, involving destruction of enzymes and other essential cell constituents.

Only applied to the THERMO STABLE PRODUCTS (121 °C), but it can be used for MOISTURE-SENSITIVE MATERIALS. Steam Sterilization: bacteria is destroyed at LOWER temperature when MOISTURE is present! Greater pressure = higher temp = less time required Dry heat sterilization is generally used for substances NOT effectively sterilized by moist heat (oils, glycerin, petroleum products) ALSO used for glassware and surgical instruments Sterilization by Filtration - CORRECT ANSWER Does NOT destroys but removes the microorganisms by a sieving mechanism Commercially available filters are produced with a variety of pore size specifications. Drugs administered in low doses might have chances of being absorbed by the filter membrane.

  • MUST be careful not to filter out the drug!! What happened with preservative-free methylprednisolone acetate? - CORRECT ANSWER WHO
  • 753 patients across 20 states diagnosed with fungal infections after epidural injections
  • 64 deaths CAUSES
  • Improper sterilization
  • Improper testing to verify sterility
  • Concealing mistakes and shipping untested vials
  • Dirty facility!
  • Expired ingredients RESULTS •18 different types of fungi in vials •Spinal/paraspinal infections and/or meningitis, peripheral-joint infections, strokes

Endotoxins and the Pyrogenic Response - CORRECT ANSWER Pyrogens come from Gram-NEGATIVE bacteria NOTE: medical equipment that has been sterilized may still contain endotoxins Particulate Matter: USP acceptable limits - CORRECT ANSWER These are SUB visible particles Particulate Contamination: Extrinsic vs Intrinsic vs Inherent - CORRECT ANSWER Extrinsic

  • Environmental Contaminants (insect parts, hair, ribers, paint, rust) Intrinsic (within the process)
  • processing equipment, primary package (stainless steel, glass, rubber, silicone oil) Inherent (part of formulation)
  • Protein agglomerates How can glass contamination occur? - CORRECT ANSWER Pharmacopeias describe the glass to be used for pharmaceutical containers as its composition is varied. "It is either borosilicate glass or soda-lime-silica glass" Borosilicate glass - high hydrolytic resistance and high thermal shock resistance Soda-lime-silica glass - moderate hydrolytic resistance Isotonicity - CORRECT ANSWER In the range of osmotic pressure 250-350 mOsm/kg Deviation of the isotonicity of the formulation from the respective body fluid may cause some adverse effects What is a Small volume parenteral (SVP) - CORRECT ANSWER A solution volume of 100 mL (as defined by USP) or less that is intended for intermittent intravenous

administration (usually defined as an infusion time not lasting longer than 6-8 hours) Mostly given as multiple doses. Different packaging:

  • ampules, vials, dry powders, prefilled syringes What is a large volume parenteral (LVP) - CORRECT ANSWER LVP are supplied for single dose having more than 100 ml They are designed to provide fluid, calories (dextrose solution) and electrolytes. Packaging: typically bags or bottles containing large volume of IV solutions. Difference between SVP & LVP - CORRECT ANSWER Components of Parenteral Nutrition - CORRECT ANSWER - Carbohydrates
  • Parenteral Lipid Emulsion
  • Single Dose Amino Acid Solution
  • Trace Elements
  • Vitamins & Minerals Types of Parenteral Nutrition - CORRECT ANSWER IVFE: intravenous fat emulsions 2-in-1: dextrose and amino acids with electrolytes, vitamins, minerals, and trace elements for IV infusion (sugars + protein, but no lipids) TNA or 3-in-1: Total Nutrition Admixture
  • Combo of all macronutrients (dextrose, amino acids, IVFE) with electrolytes, vitamins, minerals, trace elements all in 1 IV solution (sugars, proteins, lipids) Safety considerations with parenteral nutrition - CORRECT ANSWER All components must be aseptically compounded by pharmacy

Bacterial growth over long infusion times Stability and compatibility IVFE Stability - CORRECT ANSWER IVFE is most stable at its manufactured pH ~8, surface pot. -35 mV Factors affecting stability

  • pH, temperature, lipid globule, light exposure, container size, storage
  • Dextrose addition --> decrease in pH and affects IVFE stability
  • Medication incompatibility Results
  • "cracking" or coalescence of lipid globules- destruction of lipid emulsion and Precipitation Stages: creaming --> oiling --> cracking "Creaming" of IVFE is usually reversible What are the challenges with mixing and co-infusions of parenteral drugs and nutrition? - CORRECT ANSWER Amount of electrolytes Trivalent (iron) > divalent (calcium, magnesium) > monovalent (sodium, potassium) cations may all cause a decrease in the surface potential of the lipid droplets leading to aggregation and coalescence Calcium or phosphate precipitation •Due to higher pH of IVFE Co-infusion compatibility
  • Consider Precipitation Solution- 1.2um filter to reduce risks of precipitate issues What drug interactions can occur with plastics? - CORRECT ANSWER

What kind of plastic should diazepam NOT be put through? Why? - CORRECT ANSWER PVC shows high sorption of Diazepam What are things to consider when deciding if you should mix two products? - CORRECT ANSWER Insoluble drugs formulated in propylene glycol/ethanol precipitate when mixed with aqueous solutions (Diazepam, digoxin, clonazepam, phenytoin, amiodarone) Precipitation upon pH shift with dilution. Weak organic acids (benzylpenicillin sodium) are formulated at high pH to increase solubility. Lowering pH reduces solubility. The salts of monovalent cations (Na and K) are more soluble than those of divalent cations (Ca and Mg). --> Mixing solutions containing calcium or magnesium ions has a substantial risk of forming an insoluble calcium or magnesium salt. Needle Length by Type of Injection - CORRECT ANSWER Needle Gauge by Type of Injection - CORRECT ANSWER Vial with Stopper for Parenteral Solutions - CORRECT ANSWER Mainly used for multiple dose parenteral preparations Provided with closure followed by aluminum seal to ensure the perfect air tight packing Closure:

  • made from butyl rubber, nitrile rubbers, neoprene, silicone rubbers Has compression recovery, coring resistance, solvent resistance, heat resistance, radiation resistance with very low water absorption and permeability properties

What is a Polymer? - CORRECT ANSWER Simply a material composed of many repeating molecular units called monomers that link together into chains or branches. Copolymer - CORRECT ANSWER Formed from two or more different monomers Homopolymer - CORRECT ANSWER Formed from identical monomers What are the THREE types of polymer chains? - CORRECT ANSWER Linear polymers - the smallest repeating unit arrange in straight line path. Example: polyvinyl chloride (PVC) Branched polymers - contain linear chains having some branches. Cross-linked polymers - formed from bi-functional and trifunctional monomers and contain strong covalent bonds. What are the pharmaceutical applications of polymers? - CORRECT ANSWER 1. Modify drug release

  1. Stabilize amorphous drugs
  2. Binders (particles in tablets)
  3. Disintegrants
  4. Coating materials
  5. Suspending agents
  6. Emulsifying agents How can we modify drug release using polymers? - CORRECT ANSWER Reservoir (coated in polymer) vs Matrix (crug dispersed as solid in polymer --> solid dispersion) vs