Exam 1 Questions Flashcards by Darren Jacks

Acrylic acid and terephthalic acid can both form polymers (T/F)

True

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Human serum albumin is heterodisperse (T/F)

False (monodisperse)

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Molar substitution is used instead of substitution whenever hydroxylated derivatives of cellulose are produced, and MS cannot exceed 3 (T/F)

False: can exceed 3

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Cellulose is a linear polymer consisting of D (+)-glucose residues that are linked by alpha-1,4 glycosidic bonds (T/F)

False: beta linkages, or starch instead of cellulose

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Polycarophil is an example of a crosslinked polymer (T/F)

True

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Cholestyramine Resin USP in a cation-exchange resin in the chloride form, consisting of styrene-divinylbenzene copolymer with quaternary ammonium functional groups (T/F)

False: anion-exchange

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Styrene is a monofunctional monomer (T/F)

False: bifunctional

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A branch is formed (grafted) at the site of free radical through the addition of monomer molecules (T/F)

True

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Crosslinked polymers are thermosetting because they can be softened or melted by heat and dissolved in appropriate solvents (T/F)

False: thermosetting is insoluble and infusible

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Most linear and branched polymers are thermoplastic because they are insoluble and infusible (T/F)

False: thermoplastic can be softened or melted by heat and dissolved in appropriate solvents

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Polaxamer NF is a block copolymer of ethylene oxide and propylene oxide (T/F)

True

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There are three types of copolymers; Random, Alternating, and Block (T/F)

True

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Polyvinylpyrrolidone and many naturally occurring polymers such as cellulose and natural rubber are considered copolymers (T/F)

False: homopolymers

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The process of Addition or Chain-reaction polymerization is started by a free radical formed by thermal decomposition of an initiator such as benzoyl peroxide (T/F)

True

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The number n of repeat units per macromolecule is called degree of polymerization (DP) (T/F)

True

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Vinylpyrrolidone, a monomer, is polymerized to form the linear polymer polyvinylpyrrolidone (Povidone USP) (T/F)

True

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Heterochain polymers backbone contains more than one atom, whereas Homochain polymers backbone is a long chain of covalently bonded carbon, silicon, sulfur atoms (same atom) (T/F)

True

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Felxible bags of plasticized polyethylene used to hold blood and intravenous solutions (T/F)

False: not polyethylene, polyvinyl chloride (PVC)

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Both methylcellulose and carboxymethylcellulose sodium are anionic in aqueous solutions (T/F)

False

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Fructose is primarily used in the sugar coating process (T/F)

False

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Sucrose produces a rough, low-quality coating that is moist and tacky at completion (T/F)

False

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The popularity of sugar coating has declined in recent decades (T/F)

True

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The order of steps for sugar coating (6 steps)

Sealing, subcoating, smoothing, color coating, polishing, printing

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The purpose of the sealing step of sugar coating is to enhance the elegance of the final product (T/F)

False

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Alcoholic solutions of water soluble resins such as shellac, zein, and cellulose acetate phthalate are used to seal the drug and other ingredients (T/F)

False

Subcoating often results in a 50-100% increase in weight (T/F)

True

Subcoating is done using a sticky solution of _____, ______, and ______ followed by a ______, _______, application

gelatin, acacia and sucrose; dusting powder

Smoothing is done via an application of 60-70% _____ _______ and 1-5% _____ ____.

sugar solids; titanium dioxide

Color coating is the most critical step in the sugar coating process (T/F)

True

Coloring materials used are water-insoluble dyes or water soluble inorganic pigments (i.e. titanium oxide, iron oxides) and lakes (T/F)

False

In the polishing step of sugar coating, mixtures of ____ in polishing pan are applied to the tablets as powders or as dispersion in organic solvents

waxes

The preferred modern method of table coating is _____ coating

film

Nonpareils are: A. Granulated cellulose cubes (French for "without solubility) B. Micronized starch balls (French for "without permeability") C. Sugar coated tablets (French for "without digestion") D. Sugar and starch spheres (French for "without equal")

D: sugar and starch spheres

One advantage of film coating is that there is a greater weight increase for tablets compared to sugar coating (T/F)

False

All of the following are examples of advantages of film coating compared to sugar coating except A. Much shorter processing time B. Decreased process output C. Increased flexibility in formulations D. Improved resistance to chipping of the coat

B: Decreased process output

Celluose ethers like HPMC and methylcellulose are preferred in film coating (T/F)

True

Plasticizers are typically rich in hydroxyl groups and contain materials like glycerin, propylene glycols, and citrate esters (T/F)

True

From smallest to largest amount, the composition of the total solid used in a film coating is: A. Pigment, plasticizer, polymer B. Polymer, pigment, plasticizer C. Plasticizer, pigment, polymer

C: Plasticizer, pigment, polymer

When using an enteric-coated table, the coating dissolves slowly in the stomach, releasing the contents to the intestine (T/F)

False

To make a repeat-action coated tablet, one would apply an additional amount of drug under the enteric coat (T/F)

False

Most currently used enteric coatings are weak acids that are undissociated in the stomach, but readily ionize when the PH is above 5 in the intestine (T/F)

True

Phthalate derivatives like cellulose acetate phthalate and polyvinyl acetate phthalate are commonly-used weak base polymers used in enteric coating (T/F)

False

Sustained-release coatings are made of water insoluble materials like mixtures of waxes with fatty acids, fatty alcohols, and monoglycerides, shellac and zein, and ethylcellulose (T/F)

True

A latex/pseudolatex is A. Waxes dispersed in alcohol B. Inorganic or organic particles dispersed in water C. HPMC dispersed in oil

A latex/pseudolatex is B: inorganic or organic particles dispersed in water

In film coating, the coating liquid is dripped onto the drug in the form of large particles to ensure uniform coverage of the tablet surface (T/F)

False

Hardness is a USP requirement (T/F)

False

Force generated by manually operated air pump and is applied diametrically to the tablet

Strong-Cobb

Electrically operated (eliminates operator variablility)

Schleuniger

Uses the same mechanical principle as ordinary pliers to apply force diametrically to the tablet

Pfizer

Force generated by a coil spring is applied diametrically to the tablet

Stokes-Monsanto

Friability is applicable to most compressed (uncoated/coated) tablets

Uncoated

The apparatus used to measure friability works by:

Exposing the tablets to repeated shocks resulting from free-fall

The amount of weight lost by the tablets in a friabilator is a direct measurement of friability (T/F)

False

For tablets with a weight of 650mg or less, 10 whole tablets are used. For tablets with a weight more than 650mg, the sample should weigh as close as possible to 6.5g (T/F)

False

In a shipping test, the package is simply sent to distant points and back to determine the product's ability to withstand the stress of transportation (T/F)

True

Tablet thickness is not a USP specification (T/F)

True

One method of measuring tablet thickness is measuring a column containing a known number of tablets (T/F)

True

What determines the weight of the tablet?

The amount of drug formulation that fills the volume of the die cavity

An uncoated or film coated tablet must fit within a weight tolerance dictated by the USP (T/F)

True

The weight tolerance is applicable when what two of the following conditions are met? A. Tablet contains 25mg or less of drug B. Tablet contains 25mg or more of drug C. Drug comprises 25% or more of the tablet weight D. Drug comprises 25% or less of the tablet weight

B & C Tablet contains 25mg or more of drug Drug comprises 25% or more of tablet weight

Other coated tablets are exempt from a USP weight tolerance requirement (T/F)

True

``` The USP Content Uniformity Test, along with USP Weight Variation Test, ensures A. Uniformity of Drug Requirements B. Uniformity of Tablet Thickness C. Uniformity of Dosage Units D. Uniformity of Capsule Variation ```

C: Uniformity of Dosage Units

The Content Uniformity Test is applicable to coated, but not uncoated tablets (T/F)

False

Tablets with a Content Uniformity Requirement must also undergo a Weight Variation Test (T/F)

False

The Disintegration test is a measure of the time required for a group of tablets to disintegrate into A. Particles B. Molecules C. Smallest

A: Particles

The Tablet Disintegration test is (used/not used) for sustained release formulations

Not used

The rack in a tablet disintegration apparatus moves A. from side to side B. up and down D. around and around

Up and down

Most uncoated tablets take how long to disintegrate?

30 minutes

Most coated tablets take how long to disintegrate?

Up to 2 hours

Either the Dissolution or the Disintegration Test may be used on a particular tablet (i.e. the test does not have to be specific to the tablet) (T/F)

False

Which two of the following are advantages of hard gelatin capsules? A. Tasteless B. Tasty C. Easier to swallow than tablets for some patients D. Orally-dissolving to avoid swallowing

A & C Tasteless Easier to swallow for some patients

From the greatest percentage to the least, what is the distribution of solid dosage forms prepared by the pharmaceutical industry?

1. Compressed tablets 75% 2. Hard gelatin capsules 23% 3. Soft elastic capsules 2%

What solid dosage form do consumers prefer the most? A. Soft elastic capsules B. Tablets C. Hard gelatin capsules

A: Soft elastic capsules

``` What is the primary material used in the manufacture of capsules? A. Methylcellulose B. Gelatin C. Starch D. Calcium alginate ```

B: gelatin

``` Titanium dioxide is a(n) A. Binding agent B. Glidant C. Bulking agent D. Opacifier ```

D: opacifier

USP allows the inclusion of 0.15% magnesium hydroxide to prevent decomposition during manufacturing (T/F)

False

When humidity is low, capsules become _____. When humidity is high, capsules become _____. A. flaccid; brittle B. brittle; flaccid

B: brittle; flaccid

Because moisture cannot diffuse through the shell wall, gelatin capsules protect hygroscopic substances from humidity (T/F)

False

``` Gelatin is obtained through the _____ of _____. A. Decomposition of starch B. Combustion of animal dung C. Hydrolysis of collagen D. Neutralization of cellulose ```

C: Hydrolysis of collagen

Match Type A gelatin and Type B gelatin to their respective sources 1. Obtained from bones and animal skin by alkaline processing 2. Derived mainly from porcine skin by aid processing

``` Type A (1): derived mainly from porcine skin by aid processing Type B (2): derived mainly from porcine skin by aid processing ```

Some filling methods do not require the gelatin capsules to be cleaned (T/F)

False

``` If one varies the temperature of fluidity of gelatin solution being used to manufacture capsules, what property of the gelatin solution will change? A. Solubility B. Polymorphism C. Hardness D. Viscosity ```

D: viscosity

In extemporaneous filling methods, ingredients are mixed by trituration, reducing them to a fine and uniform powder. However, granules do not pack well in capsules, and crystals are not easily fitted into capsules (T/F)

True

Eutectic mixtures must be mixed with an absorbent like calcium carbonate before filling (T/F)

False

Gelatin capsules may be made in two separate pieces to accommodate filling; however, it is easier to use the modern method of one-piece capsules through a hole laser drilled in the capsules (T/F)

False

the weight of a gelatin capsule should be checked frequently during production (T/F)

True

The weight variation test for uniformity of dosage units is applied when the capsule contains ____ of a single active ingredient _____ the capsule has a single active ingredient comprising ______ of the capsule. The content uniformity test for uniformity of dosage units is applied when the capsule contains _____ of a single active ingredient ______ the capsule contains a single active ingredient comprising ______ of the capsule. ``` Use: less than 25% w/w 25mg or more less than 25mg 25% w/w or more Or And ```

``` 25mg or more AND 25% w/w or more less than 25mg OR less than 25% w/w ```

A disintegration test is required for enteric coated capsules (T/F)

True

A dissolution is required for which of the following? (select all that apply) A. Ascorbic acid USP B. Erythromycin estolate C. Omeprazole Immediate Release Capsules USP D. Aspirin Capsules USP

D: Aspirin capsules

Soft elastic capsules (SECapsules) are slightly _____ than the hard gelatin capsules A. thicker B. thinner

A: thicker

What type of ingredient used to plasticize gelatin is also found as a sweetener in food products?

Polyols (sugar alcohols) such as sorbitol, xylitol, maltitol

``` SECs are a convenient dosage form for formulations with a(n) _______ vehicle A. aqueous B. oily C. viscous D. alcoholic ```

B: oily

``` What are two examples of preservatives used to prevent fungal growth in SECs A. ascorbic acid B. sorbic acid C. methyl- and propylparabens D. sodium metabisulfite E. hydroxybenzoic acid ```

B & C Sorbic acid Methyl- and propylparabens

``` Generally, the seam of an SEC opens with _____ minute(s) of ingestion A. 1 B. 2 C. 5 D. 10 ```

C: 5