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DDS Exam 3 Study Guide | 326 Questions
and Answers With Complete Solutions 2023-
In this course, it is acceptable and scientifically founded to use the term pill when referring to a tablet. Question options: True False False Which of the following drug delivery systems can be compounding in a typical community pharmacy? Choose all correct answers. Question options: Hard shell capsule Soft gelatin capsule Modified release compressed tablet Molded tablet Compressed tablet Hard shell capsule Molded tablet A molded tablet is also called a tablet triturate Which one of the following parts of a tablet press will be the FIRST to encounter (touch) the tablet blend? Question options: Discharge chute Top punch Main compression roller Bottom (lower) punch Pre compression roller Bottom (lower) punch The top punch has the longer extension on its end because it is located so far from the die. Question options: True False False
What dose API mean? (i.e. the literal meaning of the acronym) Active Pharmaceutical Ingredient An ingredient in a tablet that helps in processing, may add stability, may be part of product identification and can contribute to overall safety of the DDS but is NOT the API is termed a/an: Excipient Which one of the following excipients is included in a compressed tablet to give the tablet it desired/necessary size (or mass or bulk)? Question options: Glidant (antiadherent) Binder Lubricating agent Wetting agent Diluent Color and/or flavor Disintegrant Diluent Which one of the following excipients is included in a compressed tablet formulation to minimize the wear of the punches and dies? Question options: Glidant (antiadherent) Diluent Lubricant Color and/or flavor Disintegrant Wetting agent Binder Lubricant Which one of the following excipients is included in a compressed tablet formulation to promote the breakup of the tablet after ingestion? Question options: Lubricating agent Glidant (antiadherent) Wetting agent Diluent Binder Color and/or flavor Disintegrant Disintegrant
FD&C Yellow #6 Aluminum Lake Which of the following functions could pregelatinized corn starch have in a granulated tablet formulation? Question options: Binder Solubilizer Glidant Disintegrant Diluent Binder x Glidant x Disintegrant x Diluent x Which of the following tablet formulation processes is the fastest (has fewer processing steps)? Question options: Dry granulation Wet Granulation Direct Compression Direct Compression Which one of the following pieces of tablet press tooling may have a key or slot on its side to facilitate lining up properly for compression? Question options: Lower punch Cam Upper punch Die Upper punch Which of the following are tablet problems that have to be avoided or overcome? Question options: Capping Lamination Picking Sticking All the above All the above Which type of tablet is designed to rapidly dissolve and release drug when administered under the tongue? Question options: Sublingual
Buccal Effervescent Chewable Sublingual Compressed tablets can be coated with sugar, a polymer film, gelatin, or an enteric coat. Question options: True False True Which of the following compendial evaluations are conducted on tablets but not capsules? Question options: Dissolution Weight Friability Content Friability Choosing all that are correct, which of the following are among the reasons for developing and using a MR DDS? Question options:
- Create more costly therapy
- Achieve and maintain a more constant therapeutic blood concentration
- Reduce the number of administration times per day
- Increased patient convenience and compliance
- Achieve and maintain a more constant therapeutic blood concentration
- Reduce the number of administration times per day
- Increased patient convenience and compliance The therapeutic index (or range) is a concentration range between the minimum effective concentration and the minimum toxic concentration in the blood. Question options: True False True A potential disadvantage of a MR DDS when compared to an IR regiment is the cost for the medication can be higher. Question options: True False True
Osmotic pump Ion exchange resin Coated beads in a capsule Osmotic pump Any drug can be incorporated into a MR DDS. Question options: True False False Which one of the following is NOT a necessary/desired property for a drug so that it can be incorporated into a MR DDS? Question options: Single IR dose regimen is 750 mg every 6 hours Used to treat a chronic condition Half-life less than about 6 hours Has a relatively wide therapeutic index Single IR dose regimen is 750 mg every 6 hours When comparing a dissolution test for a MR DDS to that of an IR DDS: Question options: The IR test is for a longer period of time The MR test requires multiple samples (usually at least 3) IR DDS dissolution profile shows zero order release A typical MR DDS dissolution test seldom runs for more than 3 hours The MR test requires multiple samples (usually at least 3) What is the name of the organization that makes available the list "Oral Dosage Forms that Should Not be Crushed"? Question options: USP FDA HHS ISMP ISMP When a tablet or other solid DDS is introduced into the human GIT and the drug begins the transformation from the solid state to a liquid state of matter in an aqueous environment is termed: Question options: Melting Disintegration Dissolution Granulation
Dissolution Drug shortages and/or recalls can be as a result of a batch or batches of a manufactured product not meeting dissolution specifications (either immediately or later during it's shelf life). Question options: True False True A dissolution test is designed to somewhat mimic what will occur with a DDS when introduced into a patient. Which one of the following processes will not occur within a standard dissolution test? Question options: Absorption Deaggregation Dissolution Disintegration Absorption In the Noyes-Whitney version of the diffusion layer model of dissolution, the concentration gradient is represented by which term? Question options: Ct - Cs Cs-Ct h Cs CG x Ct Cs-Ct The various constants (most notably the K) found in the explanation of the dissolution process equations each have a different subscript because: Question options: The atmospheric pressure at sea level changes No reason The system assumptions are different Each represents a different drug The system assumptions are different According to experimental observations involving dissolution, sufficiently intense mixing or stirring can reduce the saturated layer around a particle to zero. Question options: True False False
All of the other six choices Dissolution apparatuses are designed to evaluate drug dissolution: Question options: in vivo in the small intestine in vitro in the small intestine in vitro in a beaker in vivo in a beaker in vitro in a beaker The standard beaker (vessel) volume used in most dissolution tests is: Question options: 100 mL 2000 mL 500 mL 1000 mL 300 mL 200 mL 1000 mL The standard temperature used for an oral product dissolution test is: Question options: 32 deg F 37 deg C 32 deg C 37 deg F 37 deg C The standard temperature used for a topical or transdermal product dissolution test is: Question options: 37 deg C 32 deg C 32 deg F 37 deg F 32 deg C The standard range within which the vast majority of dissolution tests are conducted is a pH of 6.8 to 12.5. Question options:
True False False Which one of the following is the most commonly used dissolution media in standard dissolution tests? Question options: 50 % alcohol acetonitrile Water Normal saline 5% Dextrose in water Water Match the seven USP dissolution apparatus numbers with its official name. Question options: 4 5 2 7 1 6 3
Flow-through cell
Paddle over disk
Reciprocating holder
Paddle
Reciprocating basket
Apparatus 1 Apparatus 4 Apparatus 4 Which type of DDS is evaluated for drug release using a diffusion cell? Question options: Cream Rectal Tablet Pill - now, you KNOW this is not correct Capsule Cream According to the introductory dissolution video, which one of the following was used as the media for the dissolution demonstration that used canning jars as vessels? Question options: Hand sanitizer Cold water 15 % v/v alcohol in water 3% hydrogen peroxide Warm water Warm water The pharmacy definition of a solution is a liquid preparation that contains one or more chemical substances dissolved in a suitable solvent or a mixture of mutually miscible solvents. Question options: True False True Choosing all that apply, which of the following are defined in the USP as Bulk Water? Question options: Sterile water for injection Ground water Sterile purified water Purified water Drinking water Water for hemodialysis Sterile water for irrigation Water for injection Pure steam Sterile water for inhalation
Purified water Water for hemodialysis Water for injection Pure steam Choosing all that apply, which of the following are defined in the USP as Packaged Water? Question options: Sterile purified water Purified water Sterile water for inhalation Sterile water for injection Ground water Water for injection Sterile water for injection Water for hemodialysis Sterile water for irrigation Pure steam Drinking water Sterile water for irrigation Sterile water for injection Sterile purified water Sterile water for injection Sterile water for inhalation Which of the following USP types of water is packaged in single or multiple dose containers usually less than 30 mL in size and should not be used for dosing infants? Question options: Pure steam Water for injection Bacteriostatic water for injection Sterile water for irrigation Sterile water for injection Purified water Bacteriostatic water for injection Which of the following USP types of water is used when sterile water is required but when the application dose not have a particulate matter specification (and is packaged in sizes greater than 1 L)? Question options: Purified water Bacteriostatic water for injection Sterile water for injection Sterile water for irrigation Pure steam Water for injection
All the other choices Antiseptic Preservative Antibiotic The effect of change in temperature on the effect of biocides can be explained by their temperature coefficients or Q10 values. Question options: True False True The concentration exponent of a biocide is 2.0. If the concentration is change by a factor of 1.0, how much change will occur in the kill rate? Enter a unitless numerical answer (use 2 decimal places).
The concentration exponent of a biocide is 3.0. If the concentration is change by a factor of 3.0, how much change will occur in the kill rate? Enter a unitless numerical answer (use 2 decimal places).
Which of the following factors can affect (influence) the activity of a biocide? Question options: pH Aqueous solubility Packaging materials Excipients All the above All the above The minimum inhibitory concentration of a biocide is the: Question options: Saturation solubility for the biocide Concentration that forms the most colonies Impossible to determine Lowest concentration that inhibits growth of a microorganism Lowest concentration that inhibits growth of a microorganism The agar diffusion method uses a paper filter disc treated with a biocide and checks for: Question options: Increase in the cfu Color change indicating cell death Zone of inhibition Diffusion coefficient
Zone of inhibition A kill curve is determined by measuring the surviving cfu's and graphing the log of this value as a function of the time of treatment. Question options: True False True The effectiveness of a preservative is determined by testing the product: Question options: Using a one time sample at 60 minutes Uses various samples all spiked (or inoculated) with the same concentration of microorganisms Has no relationship with kill-curve methodology In its final container In its final container Choosing all correct answers, which of the following tests are used to evaluate the effectiveness of a disinfectant? Question options: Suspension test Dissolution text Disintegration test Surface test Capacity test Friability test Surface test Capacity test Suspension test Which of the following may be included as a preservative in simple syrup, NF? Question options: Sodium benzoate Propyl paraben Methyl paraben No preservative needed. High concentration of sucrose acts as a preservative by itself. No preservative needed. High concentration of sucrose acts as a preservative by itself. Alcoholic or oleaginous solution or emulsions containing the medication intended for counterirritant and penetrating action are collodions. Question options: True False False, this definition defines LINIMENTS
thin layer of a polymer designed to quickly rupture film coated coat is water soluble, quickly dissolves disadvantage- difficult, time-consuming process and significant increase in size sugar coated coat does not dissolve in acid of the stomach, only in higher pH of the intestine enteric coated/ delayed release -assist in processing and manufacturing DDS -part of production identification (color) -stability, bioavailability, patient acceptability -contribute to overall safety and efficacy excipients the following are functions of _______ -provide content uniformity -add bulk dor compression -improve cohesion -enhance flow diluents/fillers the following are functions of _______ -promote cohesiveness -used to convert powders to granules -some may have direct compression properties binders types of diluents/fillers -organic/inorganic -water soluble/insoluble types of binders -natural -synthetic/semisynthetic examples of diluents/fillers -lactose -calcium or dicalcium phosphate -mannitol -microcrystalline cellulose
-crosprovidone -talc -starch examples of binders -cellulose -gelatin -aracia -liquids -starches -combinations induce break up of tablet when in contact with aqueous solution disintegrates _______ improves the spread of water around the particles wetting agent See More
