PCOL 355 Exam 1 Questions with Correct Answers.docx

PCOL 355 Exam 1 Questions with Correct A What is the word for materials added to a drug formulary to help maintain the stability of the drug? - Answer-Excipients (ex: plasticizes) Name the 5 forms of injection drugs and their corresponding depth. - Answer-1. Intramuscular (IM)- muscle 2.Subcutaneous (SQ)- subcutaneous 3.Intravenous (IV)- dermis 4.Intradermal (ID)- epidermis 5.Microneedles- dermis+epidermis Describe the pathway of drug development from drug discovery to the market? (total time is 10-15 years) - Answer-Discovery & Preclinical: 3-6 years 1.Discovery: 5,000-10,000 compounds 2.Preclinical: 250 compounds tested in-vivo (animals) and in-vitro (test tubes) 3.Submission of INDA Clinical Trials: 6-7 years 4.Phase I: 20-100 healthy volunteers (tolerance) 5.Phase II: 100- 500 volunteers with the disease (efficacy) 6.Phase III: 1,000-5,000 patients with the disease across institutions (tolerance and efficacy) Submission of NDA: FDA Review (0.5-2 years) 7.Phase IV: Drug approval, post market surveillance Identify 2 reasons for a compound to fail or slow down during development. - Answer- Fail: biopharmaceutial properties efficacy ities t reasons Slow down: etic complexity uous toxicity biopharmaceutial properties potency What do the following initials stand for? INDA, NCE, R&D, NDA, ANDA - Answer-INDA: Investigational New Drug Application NCE: New Chemical Entity R&D: Research and Development NDA: New Drug Application ANDA: Abbreviated New Drug Application (generics and bioequivalence) In terms of drug delivery, what do these terms mean? IR and DR - Answer-Immediate Release and Delayed Release What does MED and MTD stand for? - Answer-Minimum effective dose (MED) and Maximum tolerable dose (MTD) What is the equation for therapeutic index (TI)? - Answer-TD50/ED50 median toxic dose/median efficacious dose What are double blind and triple blind tests? - Answer-double blind: patient and physician and staff unaware triple blind: patient, physician and staff, and statistician unaware What are the goals for Phases I-IV - Answer--Phase I: establish dosing using a prototype formulation and establish TD50 -Phase II: establish ED50 and TI -Phase III: finalize efficacy claims and finalize dose and formulation, and discover new indications, warnings, and dosage forms -Phase IV: adverse reaction reporting, extend product line (additional doses and combinations), and extend efficacy claims What 4 factors affect oral drug absorption? - Answer-1. disintegration: the time it takes for drug to break up into small particles. (primarily issue for SDF- solid dosage form) lution: the process of the drug dissolving into solvent. ility: ability of drug to dissolve in 250 mL of buffer limiting step: dissolution (for low water soluble) and permeation of cell membrane (for high water soluble) Dosage forms: solution vs suspension - Answer-suspension (larger particles, turbid) and solution (smaller particles, clear) Dosage forms: capsule vs tablet - Answer-capsule: polymeric shell (soft or hard) that have immediate release, poor water solubility, and poor chemical stability. tablet: must break into granules then smaller particles, typically for controlled release medication, more chemically stable Capsules: hard vs soft - Answer-hard capsule: locking cap and body (containing drug), often used for powders, granules, and beads, and mechanically sealed. soft capsule: high plasticizes (flexible), opacifier, for liquids or semiliquids, hermetically sealed, and has water content. What is gelatin? - Answer-protein derived from collagen and bovine What is the bioavailability of a drug? - Answer-Amount of drug that is available is blood. (plasma) In relation to bioavailibity what do these stand for: Cmax, tmax, and AUC - Answer- Cmax: maximum concentration of drug in the plasma tmax: the time it takes for the drug to reach the maximum concentration in the plasma AUC: Area under curve (total concentration of drug in plasma over time) What is the most common method to measure permeability and oral drug absorption? - Answer-Cacp-2 monolayer what is Peff - Answer-Peff- effective permeability What do these stand for: BCS and USP - Answer-Biopharmaceutical classification standard (BCS) United States Pharmacopoeia (USP) What does HPMC stand for in relation to capsules? - Answer- Hydroxypropylmethylcellulose: which is the vegetarian alternative to gelatin capsule coating. Blood vs plamsa - Answer-blood: plasma plus cells cells: RBC (erythrocytes) and WBC (leukocytes), platelets (thrombocytes) plasma: water, sugar, fat, salts, and protein What is partitioning? - Answer-separation arising from differences in solubility What are the BCS classes for partitioning? - Answer-Class I: High solubility, high permeability (small molecules, excessive metabolism) Class II: Low solubility, high permeability (lipids, excessive metabolism) Class: III: high solubility, low permeability (polar molecules, poor metabolism) Class IV: low solubility, low permeability (large molecules, poor metabolism) high solubility: large dose dissolves in 250 mL of buffer at pH 1-8 high permeability: 80% absorption What is biological temperature and refrigeration temperature when storing medication? - Answer-bio temp: 37*C refridge temp: 36-46* F What is Tg? - Answer-glass transition temperature (Tg): the temperature of a material at which the material changes its behavior from being 'glassy' (hard,brittle) to being 'rubbery' (viscoelastic, flexible) What are the 7 types of tablets? - Answer-1. swallowable ble vescent (dissolve in liquid, made from sodium bicarbonate and organic acid, release carbon dioxide which produces the fizz) l and sublingual (cheek and under tongue) ges (dissolve in mouth) olled- release d Coated tablets: enteric vs film - Answer-Enteric: are polymers that protect drug from stomach acids, but readily dissolved in the intestines. Film: thin polymer layer covering compressed powder to prevent unpleasant taste. What is laser diffracting? - Answer-The measurement of primary particle size (not individual particles). Aggregates may give a shift to the right due to their larger size. Essentially, using lasers to measure primary particle size. What are the dispersing (not solvent) liquids used for laser diffraction? - Answer- Methanol, ethanol, carbon tetrachloride, Toluene, chloroform, and water. What are the different types of distribution results for laser diffraction? (Size vs percent) - Answer-Gaussian distribution (normal vs. skewed), unimodal distribution, normal distribution or wide distribution, and bimodal distribution. In relation to powder technology, what do the following initials stand for? -NF -XRPD -SEM and SEM-EXD - KFT -LOD DSC, TGA, HSM -BET, GAB - Answer-National formulation (NF) X-ray powder diffraction (XRPD) Scanning electron microscopy (SEM) and Energy Dispersing X-ray (EDX) Karl Fischer transition- measures water determination (KFT) Loss of drying (LOD) Thermal analysis (DSC- differential scanning calorimetry, and HSM- hot stage microscopy) Specific surface area (BET-Brunauer-Emmett-Teller and GAB- Geggenheim Anderson Boer) The residual water content in solids is known as the.... - Answer-Relative humidity (hygroscopicity) Coulometric vs Volumetric KFT - Answer-Coulumetric: trace and low levels of water content Volumetric: less sensitive, but good for high levels of water content What are the two equations for relative humidity (RH)? - Answer-RH= (P/P0) x 100 *P=partial vapor pressure pf H2O, P0=saturated vapor pressure of H2O RH=Aw x 100 *Aw= water activity True or False: Adsorption is particularly critical in affecting the properties of solids when the specific surface area is large. - Answer-True True or False: Large values of specific surface area are seen with solids having very small particles (e.g. solid state nanoparticles), as well as with solids having a high degree of intraparticleporosity. - Answer-True What does SW stand for? - Answer-Specific surface area. Adsorbate vs. Adsorbent - Answer-Adsorbate: a substance that is absorbed Adsorbent: a substance that absorbs another.