PCOL 355 Exam 1 Questions with Complete Solutions.docx

PCOL 355 Exam 1 Questions with Complete S what is biological temp and refrigeration temp? - Answer-biological: 37 C (98.6 F) refrigeration: 4 C list 2 non intravenous (IV) types of injection - Answer-intramuscular (IM), subcutaneous (SQor SC), intradermal (ID), intraarterial (IA) what is the main component of biological bilayer membranes? a. proteins b. phospholipids c. fatty acids - Answer-b. phospholipids what is the property of the inner core of biological layer membranes? a. hydrophobic inner core b. hydrophilic inner core c. both - Answer-a. hydrophobic inner core which statement is correct for a tablet for oral drug delivery? a. no disintegration is needed b. dissolution first followed by disintegration c. disintegration first followed by dissolution - Answer-c. disintegration followed by dissolution which statement is correct for passive diffusion? a. driven by concentration gradient b. driven by energy c. driven by transporters - Answer-a. driven by drug concentration gradient true or false? solutions have solid suspended particles - Answer-false true or false? solutions have no solid particles - Answer-true true or false? hard gelatin capsules have less plasticizer than soft capsules - Answer- true true or false? soft gelatin capsules are used in liquigel capsules - Answer-true true or false? higher plasticizer content raises the glass transition temp of a polymer - Answer-false true or false? clinical trials involve animals - Answer-false true or false? phase 1 clinical trials involve patients - Answer-false true or false? phase 2 clinical trials involve patients - Answer-true true or false? phase 3 clinical trials involve patients - Answer-true coated tablets - Answer--enteric coating are polymers, protect from stomach acid decompositions -film coating is composed of polymer as a thin layer covering the compressed powder, prevent decomposition or minimize unpleasant taste effervescent tablet - Answer--disintegrates and dissolves in water before oral administration as liquid drink -disintegration by carbon dioxide gas please which produces effervescence -excipients are sodium bicarbonate and an organic acid such as citric acid chewable tablet - Answer--faster dissolution starting in the mouth -flavored and sweetened buccal (cheek pouch) and sublingual (under tongue) tablets - Answer--fast dissolution and absorption in the oral cavity for acute diseases such as angina attack -avoids 1st-pass effect -no disintegrant -lightly compressed powder creating a soft tablet lozenge - Answer--no disintegrant -dissolves in mouth with saliva for local effects in the mouth and throat tablet excipients - Answer--sweeteners and flavorings -diluents (bulking agents) -binding agents (adhesives) -glidants (help granules flow) -lubricants (help particles flow, magnesium stearate) -disintegrants what are the 2 types of capsules? - Answer-hard gelatin and soft gelatin how and where is gelatin degraded? - Answer-in the gut by proteolytic enzymes hard gelatin - Answer--the body vs the capsule -ridges and dimples for mechanical interlocking b/w the body and the capsule soft gelatin - Answer--used for liquicaps containing a liquid formula or semisolid -one-unit capsules -hermetically sealed -has water content -opacifier -has plasticizer (glycerin or sorbitol) what is blood? - Answer-plasma + cells what is plasma? - Answer-a mixture of water, sugar, fats, salts and protein what are cells? - Answer-RBC's (erythrocytes), WBC's (leukocytes), platelets (thrombocytes) what is partitioning? - Answer-using passive diffusion to pass through the cell or gut wall Biopharmaceutical drug classification system (BCS) - Answer-Class 1: HIGH sol- HIGH perm Class 2: LOW sol- HIGH perm Class 3: HIGH sol- LOW perm Class 4: LOW sol- LOW perm how to identify high solubility - Answer-largest dose dissolves in less than or equal to 250 ml of water over a pH range of 1-8 how to identify high permeability - Answer-extent of absorption is greater than or equal to 80% reasons for failure of compound in FDA development - Answer-- poor biopharmaceutical properties -lack of efficacy -toxicity -market reasons reasons for slow down in FDA development - Answer-- synthetic complexity -ambiguous toxicity finding -poor biopharmaceutical properties -low potency -inherently time-intensive target indication drug product development stages - Answer-INDA: investigational new drug application Phase I - tolerance Phase II - efficacy Product candidate Phase III - broad scale efficacy & safety NDA - new drug application ANDA - abbreviated new drug application (generics and bioequivalence) post market - Answer-- adverse action reporting Extend product line -additional doses -additional dosage forms -combinations Extend efficacy claims Determine need for additional warnings or restrictions how do you receive post market feedback? - Answer-reports from healthcare providers, pharmacies, and patients to company and FDA -surveys -sampling -testing -inspections by the FDA controlled release drug delivery (two types) - Answer-1. time controlled delivery -release rate and duration of action specified precisely 2. spatial controlled delivery -drug delivery solely to site of action properties of controlled release drug delivery - Answer-1. predictable & reproducible release ined drug release e form maintains a constant drug plasma level over a long period of time es that the release rate from the dosage unit must be equal to the elimination rate from plasma or target tissue advantages of controlled release drug delivery - Answer-- sustained release of drug at a constant rate -maintain therapeutic levels in plasma for long periods of time -reduce dosing frequency -minimize drug level fluctuation; reduce side effects & enhance efficacy -improve patient compliance -improve disease state management MTD - Answer-maximum tolerated dose MED - Answer-minimum effective dose Phase I - tolerance - Answer-- dosing -prototype formulation -drug & placebo -triple blind -establish TD-50 TD-50 - Answer-median toxic dose -the dose at which toxicity occurs in 50% of cases Phase II - efficacy - Answer-- learn generally what the drug really does -product candidate + placebo + market standard -triple blind -select dose for phase III -establish ED50 ED-50 - Answer-median effective dose -dose that produces a specific effect in 50% of cases therapeutic index - Answer-TD50/ED50 Phase III - extensive broad scale studies - Answer-- finalize efficacy claims -learn exactly what drug does & finalize dose -finalize formulation -NDA approval patent lifetime - Answer-20 years from date of filing in U.S. laser diffraction - Answer--based on a population of particles, therefore a distribution of particle sizes (wide vs. narrow) -not a direct size measurement on individual particles -capable of detecting diffraction from populations dispersing liquids for solid state particles include: - Answer-methanol, ethanol, carbon tetrachloride, toluene, chloroform, surfactant mixture, water speed of laser diffraction - Answer-rapid (under 10 seconds), real-time, no chemical analysis necessary describe the distribution that results from a particle population - Answer--Gaussian distribution (normal is equal on both sides, skewed is unequal) -unimodal or bimodal distribution (how many modes or "peaks") -(bimodal only) if first peak is higher than second peak, higher population of particles fall into first size distribution -narrow vs. wide distribution of particle size (narrow is favored) Characterization of Crystalline and Partially Crystalline Solids by X-Ray Powder Diffraction - Answer-(XRPD) Scanning Electron Microscopy - Answer-(SEM and SEM-EDX spectroscopy) Water Determination - Answer-(KFT) Loss on Drying - Answer-(LOD) Thermal Analysis - Answer-(DSC) Specific Surface Area - Answer-(BET,GAB) United States Pharmacopeia - Answer-(USP) National Formulary - Answer-(NF) Hydrostatic Microscopy - Answer-(HSM) drugs strive for shelf life of how many years? - Answer-2 years