Module 5 - Comprehensive Exam

Proverbs 16:3

B) Pharmaceutical aerosols

A product containing active ingredients in a propellant and intended for oral or topical administration into the nose, eyes, ears, rectum, vagina
A. Sprays
B. Pharmaceutical aerosols
C. Insufflation
D. A and B

B) II only

Cocoa butter:
I. Is a water-soluble base
II. Exhibits marked polymorphism
III. Phenol and chloral hydrate have a tendency to increase its melting point
A. I only
B. II only
C. I and II
D. II and III

B) II and III

Which of the following statements is correct about Simple Syrup?
I. 85% w/w
II. A sucrose-based syrup
III. A highly viscous vehicle
A. I and II
B. II and III
C. I and III
D. I, II and III

B) 1 alcohol: 3 ether

Collodions are prepared by dissolving pyroxylin in ______ solvent mixture.
A. 3 alcohol: 1 ether
B. 1 alcohol: 3 ether
C. 3 alcohol: 1 water
D. 1 alcohol: 3 water

E) 15-20

HLB value to make solubilizers
A. 1-3
B. 3-6
C. 7-9
D. 8-18
E. 15-20

A) Simple ointment

Ointment base made from yellow wax and petrolatum
A. Simple ointment
B. Yellow petrolatum
C. Cold cream
D. Petroleum jelly

B) 1.3 mL

The usual volume of injection administered using the subcutaneous route
A. 0.1 mL
B. 1.3 mL
C. 2 mL
D. 5 mL

C) Bevel

The portion of the needle that is ground for sharpness
A. Lumen
B. Cannula
C. Bevel
D. Hub

D) Elixirs

Clear, pleasantly flavoured, sweetened hydroalcoholic liquids intended for oral use as flavours and vehicles for substances
A. Extracts
B. Fluidextracts
C. Tinctures
D. Elixirs

A) Gargles

Aqueous solutions used for treating the pharynx and nasopharynx by forcing air from the lungs through the solution which is held in the throat
A. Gargles
B. Mouthwashes
C. A and B
D. None of the above

C) Sorbitol

What substance is added to render soft gelatine capsules elastic or plastic like?
A. Carnauba wax
B. Mineral oil
C. Sorbitol
D. Polyethylene glycol

B) Type II

Treated soda-lime glass
A. Type I
B. Type II
C. Type III
D. Type NP

D) 1000 mL

USP specifies this volume as the upper limit for single-dose parenterals
A. 20 mL
B. 30 mL
C. 100 mL
D. 1000 mL

D) Unibase

A nongreasy emulsion base with pH close to that of the skin is
A. Dermovan
B. Lanolin
C. Hydrophilic petrolatum
D. Unibase

B) Behenic acid

Which of the following is used as an opacifying agent in the formulation of shampoos?
A. Terpineol
B. Behenic acid
C. Propylene glycol
D. Selenium sulfide

D) Aerosol containers

The only true tamper resistant packaging:
A. Shrink seals
B. Sealed tubes
C. Breakable caps
D. Aerosol containers

A) 000

Which of the following capsule sizes is the largest?
A. 000
B. 0
C. 1
D. 5

D) III, I, II, VI, IV, V

Arrange the following dosage forms from highest to lowest bioavailability:
I. Emulsions
II. Suspensions
III. Solutions
IV. Uncoated tablets
V. Coated tablets
VI. Granules
A. V, IV, VI, II, I, III
B. IV, V, I, VI, II, III
C. III, II, VI, I, V, IV
D. III, I, II, VI, IV, V

A) Absorption base

Classify Hydrophilic Petrolatum as ointment base.
A. Absorption base
B. Water-removable base
C. Hydrocarbon base
D. Water-soluble base

D) Glazed, transparent, moisture-resistant paper

Glassine paper
A. Thin, semi-opaque, moisture-resistant paper
B. Opaque paper with no moisture-resistant properties
C. Transparent waterproof paper
D. Glazed, transparent, moisture-resistant paper

B) To store and release the drug at the skin site

TDDSs may be constructed of a number of layers, the drug reservoir or matrix system is used for which of the ff:
A. To protect the system from environmental entry and from loss of drug from the system or moisture from the skin
B. To store and release the drug at the skin site
C. To be removed before application to enable drug release
D. To maintain contact with the skin after application

D) II, III

Flocculated suspensions:
I. Slow sedimentation rate
II. High sedimentation rate
III. Ease of redispersability
IV. Problem of caking
A. I, III, IV
B. II, III, IV
C. I, IV
D. II, III

D) Flocculating agent

Select the substance which decreases the zeta potential of the suspended charged particles and thus causes agglomeration of the particles.
A. Emulsifying agent
B. Viscosity-enhancing agent
C. Surface-active agent
D. Flocculating agent

D) Lozenge

Dichlorobenzyl alcohol + amylmetacresol is intended to dissolve slowly in the mouth as which of the following dosage form?
A. Emulsion
B. Buccal
C. IV
D. Lozenge

A) Lip balms, mouthwashes, antiperspirants, diaper ointments

Identify cosmetics which are regulated as drugs.
A. Lip balms, mouthwashes, antiperspirants, diaper ointments
B. Skin moisturizers, perfumes, nail polishes
C. Hair colors, toothpaste
D. Shampoos, lipsticks

A) Daytrana

Which of the following transdermal patches is used for ADHD?
A. Daytrana
B. Deponit
C. Climar
D. Duragesic

C) Methacrylic acid copolymer type B (Eudragit S)

Which polymer is enteric and dissolves only at an alkaline pH of 7.0 or higher in the terminal ileum/colon?
A. Cellulose acetate phthalate (CAP)
B. Polyvinyl acetate phthalate (PVAP)
C. Methacrylic acid copolymer type B (Eudragit S)
D. Methacrylic acid copolymer type L (Eudragit L)

B. Polyvinyl chloride (PVC) tubing

Which container material is prone to leaching, where components of the container binds to the drug product?
A. Type I borosilicate glass
B. Polyvinyl chloride (PVC) tubing
C. Stainless steel tanks
D. Aluminum foil seals

B) Dimethyl sulfoxide (DMSO)

Which penetration enhancer acts primarily by fluidizing the intercellular lipid lamellae of the stratum corneum?
A. Glycerin
B. Dimethyl sulfoxide (DMSO)
C. Propylene glycol
D. Water

C) Lanolin

Which hydrocarbon base has the highest water-holding capacity and is greasy?
A. Yellow ointment
B. Petrolatum
C. Lanolin
D. Mineral oil

A) Capping

What is a primary manufacturing defect in tableting caused by the expansion of trapped air when compression pressure is released?
A. Capping
B. Sticking
C. Mottling
D. Picking

C) Water for Injection (WFI)

What type of water must be used for final rinsing of equipment used in parenteral manufacturing?
A. Purified Water USP
B. Tap water
C. Water for Injection (WFI)
D. Potable water

B) Superdisintegrant functioning via rapid wicking and swelling

What is the primary function of croscarmellose sodium when used extra-granularly in a direct compression tablet formulation?
A. Glidant to improve hopper flow
B. Superdisintegrant functioning via rapid wicking and swelling
C. Binder to increase plastic deformation
D. Anti-adherent to prevent punch face filming

B) Moisture adhering the granulation to the punch faces due to inadequate drying or high punch temperature

What is the primary cause of "picking and sticking" during tablet compression?
A. Excessive lubrication causing low punch friction
B. Moisture adhering the granulation to the punch faces due to inadequate drying or high punch temperature
C. Low compression force applied by the eccentric press
D. High concentration of insoluble disintegrants

D) Sticking

Refers to tablet material adhering to the die wall.
A. Mottling
B. Capping
C. Picking
D. Sticking
E. Lamination

D) Type A gelatin has higher bloom strength than type B gelatin

The following are true about gelatin except:
A. Gelatin is product of partial hydrolysis of collagen
B. Type A gelatin is produced from acid hydrolysis of pork skin
C. Type B gelatin is produced from alkaline hydrolysis of bovine bones
D. Type A gelatin has higher bloom strength than type B gelatin

D) Quality assurance department is responsible for ensuring that all operations meet required standards for safety and efficacy

Select the correct statement about manufacturing departments and process.
A. Quality assurance department test compliance of raw materials, packaging materials, and finished products to specifications
B. Validation is the action of proving that premises systems or equipment work correctly and actually lead to expected results
C. Qualification is the action of proving and documenting that any process, procedure, or method actually and consistently leads to the expected results
D. Quality assurance department is responsible for ensuring that all operations meet required standards for safety and efficacy

C) III

Which of the following is not a result of inadequate binder?
I. Soft granules
II. Too much fines
III. Hampered disintegration and dissolution
A. I, II, III
B. I, II
C. III
D. None of the given choices

D) I, II, III

This is a granulation method wherein powder mixture is compacted into large pieces and subsequently broken down into granules. This suitable for moisture and heat-sensitive materials.
I. Dry granulation method
II. Double compression method
III. Pre-compression method
A. I, II
B. III
C. I, III
D. I, II, III

D) I, II, III

Direct compression is a tablet processing without granulation and this is suitable to which of the following?
I. KCl
II. NaCl
III. NaBr
A. I, II
B. III
C. I, III
D. I, II, III

B) Rapid evaporation of solvent trapped beneath the film layer, often caused by excessively high drying air temperature

What defines the defect known as "blistering"?
A. Localized flaking of the film due to poor adhesion at the tablet edge
B. Rapid evaporation of solvent trapped beneath the film layer, often caused by excessively high drying air temperature
C. Chemical interaction between the core disintegrant and the polymer
D. Shrinkage of the core during cooling cycles

A) Insufficient atomization or an excessively high viscosity/high solids spraying liquid

"Orange peel" (roughness) appearance on a tablet film coat is most frequently caused by:
A. Insufficient atomization or an excessively high viscosity/high solids spraying liquid
B. Rapid drying causing the polymer chains to shrink
C. Migration of soluble dyes during the drying phase
D. Over-wetting of the tablet bed due to a low drying air temperature

B) Blooming

Hazing or Dulling or Fading of the Film
A. Blushing
B. Blooming
C. Blistering
D. Mottling

C) Alcoholic shellac solution

What is the typical polymer or resin traditionally used in the sealing operation of sugar coating?
A. Hydroxypropyl methylcellulose (HPMC)
B. Polyvinyl pyrrolidone (PVP)
C. Alcoholic shellac solution
D. Aqueous ethylcellulose dispersion

B) Gum-sucrose syrup and dusting powder

During the subcoating phase, alternate applications of which two components are classically used to build up the tablet weight and round the edges?
A. Sealant solution and talc
B. Gum-sucrose syrup and dusting powder
C. Color syrup and polyethylene glycol
D. Carnauba wax and beeswax

B) To cover the rough, uneven surface created by the subcoating layer

What is the primary purpose of the smoothing stage in the sugar-coating process?
A. To seal the core against acidic degradation
B. To cover the rough, uneven surface created by the subcoating layer
C. To introduce active pharmaceutical ingredients into the shell
D. To reduce the overall drying time of the batch

B) Solution by chemical reaction

Method of preparation of Burow’s solution
A. Simple solution
B. Solution by chemical reaction
C. Solution by extraction
D. AOTA

B) Gravimetric filling

Which filling method measures the product by its mass or weight using a scale?
A. Volumetric filling
B. Gravimetric filling
C. Constant level filling
D. Overflow filling

C) Cracking (breaking)

The complete separation of an emulsion into two distinct layers is called:
A. Creaming
B. Flocculation
C. Cracking (breaking)
D. Phase inversion

B) Tween materials

Between Span and Tween materials, which group tends to be more water-soluble?
A. Span materials
B. Tween materials
C. They have identical solubility
D. Neither is water-soluble

A) W/O (Water-in-Oil) emulsifier

An HLB value that is very low (e.g., 3 to 6) typically indicates what type of surfactant?
A. W/O (Water-in-Oil) emulsifier
B. O/W (Oil-in-Water) emulsifier
C. High foaming detergent
D. Wetting agent

C) 150°C–170°C

Dry heat sterilization is typically performed in an oven at what temperature range for 2 hours?
A. 100°C–110°C
B. 121°C–130°C
C. 150°C–170°C
D. 250°C–300°C

B) 121°C at 15 psi for 15 minutes

What temperature and pressure are typically used in a standard steam autoclave?
A. 100°C at 15 psi for 15 minutes
B. 121°C at 15 psi for 15 minutes
C. 160°C at 20 psi for 30 minutes
D. 180°C at atmospheric pressure for 1 hour

C) 99.97% removal of 0.3 µm particles

What type of HEPA filter efficiency is required in aseptic processing cleanrooms?
A. 85% removal of 0.3 µm particles
B. 95% removal of 0.3 µm particles
C. 99.97% removal of 0.3 µm particles
D. 50% removal of 1.0 µm particles

C) From the back of the cabinet toward the operator

In a horizontal laminar flow hood, in which direction does the air move?
A. From top to bottom
B. From bottom to top
C. From the back of the cabinet toward the operator
D. From the sides to the center

C) Hermetic container

Which type of packaging container completely protects the contents from the effects of gases and vapors under normal conditions?
A. Well-closed container
B. Light-resistant container
C. Hermetic container
D. Single-unit container

B) Aluminum foil

Which material is best known for providing an absolute barrier against light, moisture, and oxygen in blister packs?
A. Polyvinyl chloride (PVC)
B. Aluminum foil
C. Polystyrene
D. Glass

B) 2oC and 8oC

Refrigerator temperature
A. -25oC and -10oC
B. 2oC and 8oC
C. 8oC and 15oC
D. <8oC

C) Maceration

Method of preparation for peppermint spirit
A. Simple solution
B. Chemical reaction
C. Maceration
D. Distillation

C) Bentonite is used as a suspending agent

Select the correct statement about formulation of suspension.
A. Veegum is used as a wetting agent
B. Buffers can be employed in suspension
C. Bentonite is used as a suspending agent
D. Suspending agents displaces air from cervices of hydrophobic solids to allow penetration of water

C) Increasing viscosity of the dissolution medium

According to the Noyes-Whitney equation, which parameter does not directly increase the dissolution rate of a crystalline drug?
A. Decreasing particle size
B. Increasing temperature
C. Increasing viscosity of the dissolution medium
D. Increasing the agitation speed

B) Pseudoplastic

Which rheological behavior shows a decrease in viscosity with an increasing shear rate, followed by a constant viscosity at very high shear rates?
A. Dilatant
B. Pseudoplastic
C. Thixotropic
D. Plastic

B) Doubling the dispersion medium viscosity

According to Stokes' Law, which adjustment slows down the sedimentation rate of particles in a pharmaceutical suspension the most?
A. Doubling the particle radius
B. Doubling the dispersion medium viscosity
C. Doubling the density difference between particle and medium
D. Halving the gravitational constant

B) Temperature

The Clausius-Clapeyron equation relates vapor pressure to:
A. Density
B. Temperature
C. Viscosity
D. pH
E. Volume

B) Critical solution temperature

A two-component system with a liquid phase that completely separates into two liquid layers exhibits a:
A. Triple point
B. Critical solution temperature
C. Eutectic point
D. Glass transition

B) 2

The van 't Hoff factor (i) for a completely dissociated NaCl solution is theoretically:
A. 1
B. 2
C. 3
D. 4

A) 40.83 mL isotonic soln

How many milliliters of an isotonic sodium chloride solution should be used to prepare 50 mL of a 1.5% w/v isotonic solution of fentanyl citrate (E = 0.11)?
A. 40.83 mL isotonic soln
B. 9.17 mL isotonic soln
C. 8.3 mL isotonic soln
D. 91.7 mL isotonic soln

B) Creating a hydrophilic exterior and hydrophobic interior cavity

Inclusion complexes using cyclodextrins typically improve drug solubility by:
A. Creating a hydrophobic exterior and hydrophilic interior
B. Creating a hydrophilic exterior and hydrophobic interior cavity
C. Increasing the crystal lattice energy
D. Changing the covalent structure of the drug

A) Shear stress to shear rate

Viscosity (η) is defined mathematically as the ratio of:
A. Shear stress to shear rate
B. Shear rate to shear stress
C. Force to unit area
D. Velocity gradient to pressure drop

B) Complete spreading / total wetting

A contact angle (θ) of 0° between a liquid drop and a solid surface indicates:
A. Complete non-wetting
B. Complete spreading / total wetting
C. Partial wetting
D. Hydrophobic repulsion causing the droplet to bead up

B) Void volume divided by bulk volume

Porosity (ε) of a powder bed is defined as:
A. Bulk volume minus true volume
B. Void volume divided by bulk volume
C. True volume divided by bulk volume
D. Weight divided by apparent density

A) Higher solubility and faster dissolution rate than crystalline forms

Amorphous forms of drugs typically exhibit:
A. Higher solubility and faster dissolution rate than crystalline forms
B. Lower energy state and higher melting point
C. Zero chemical reactivity
D. Complete insolubility in polar solvents

A) Enantiotropic systems

The transition temperature where one polymorph converts to another reversibly is characteristic of:
A. Enantiotropic systems
B. Monotropic systems
C. Amorphous systems
D. Eutectic mixtures

B) Intermolecular attractive forces

The van der Waals constant 'a' corrects for:
A. Finite volume of gas molecules
B. Intermolecular attractive forces
C. Temperature fluctuation
D. Kinetic energy dissipation

B) 1

If a two-component condensed system has two phases, what is the degree of freedom (F)?
A. 0
B. 1
C. 2
D. 3

B) Two-component system composed of solid and liquid

The phase diagram below is an example of:
A. One-component system
B. Two-component system composed of solid and liquid
C. Two-component system composed of liquid phases only
D. Three-component system
E. Not enough information to identify

B) Pseudopolymorphs

What do you call crystalline forms that incorporate solvent molecules into their crystal lattice?
A. Polymorphs
B. Pseudopolymorphs
C. Supercooled liquids
D. Cocrystals
E. Polymeric substances

C) Ritonavir

Which of the following is an example of a monoclinic crystal system?
A. Sodium chloride
B. Iodine
C. Ritonavir
D. Boric acid
E. Urea

B) 28 g/mol

What is the molar mass of a gas if 0.25g of it occupies 200mL at STP?
A. 14 g/mol
B. 28 g/mol
C. 32 g/mol
D. 44 g/mol

B) Helium effuses 2.83 times faster

Which gas effuses faster: Helium (MW=4g/mol) or Oxygen (MW=32g/mol)? How much faster?
A. Oxygen effuses 2 times faster
B. Helium effuses 2.83 times faster
C. Helium effuses 8 times faster
D. Helium effuses 8 times faster

B) 0.18

Dextrose has a molecular weight of 180 g/mol and a dissociation factor i of 1.0 (non-electrolyte). Its approximate E-value is closest to:
A. 0.10
B. 0.18
C. 0.006
D. 0.01
E. 0.09

D) 4.17 g

If dextrose (in #81) is used as a tonicity adjusting agent, how much of it is needed to adjust 100 mL of a 0.5% drug solution (E=0.30) to isotonicity?
A. 0.90 g
B. 0.15 g
C. 5.62 g
D. 4.17 g
E. 0.75 g

B) Debye force

When a polar molecule induces a temporary dipole in a nonpolar molecule, what force is created?
A. Keesom force
B. Debye force
C. London force
D. Ion-induced dipole
E. H-bonding

C) 26 days

A suspension is to contain 6.5 g/100 mL. The solubility of the drug is 325 mg/100 mL. The 1st order rate constant for the drug degradation is 4.5 x 10-6 / sec. What is the half-life of the preparation?
A. 10 days
B. 5 days
C. 26 days
D. 31 days
E. 2 days

B) 5 days

What is the shelf-life of the preparation?
A. 7 days
B. 5 days
C. 26 days
D. 30 days
E. 6.5 hours

C) AO 2012-0008

Adoption and Implementation of the PIC/S Guide for Good Manufacturing Practice for Medicinal Products
A. AO 220 s. 1974
B. AO 63 s. 1989
C. AO 2012-0008
D. AO 90 s. 1990

B) 10 grams

The minimum amount of marijuana resin in possession which would result to the person being subjected to life imprisonment to death penalty and a fine of P500,000 pesos to P10,000,000
A. 50 grams
B. 10 grams
C. 1 gram
D. 0.5 grams
E. NOTA

A) 50 grams

The minimum amount of shabu in possession which would result to the person being subjected to life imprisonment to death penalty and a fine of P500,000 pesos to P10,000,000
A. 50 grams
B. 10 grams
C. 1 gram
D. 0.5 grams
E. NOTA

A) RA 3720

This Republic Act provides for the certification of batches of drugs composed wholly or partially of any kind of antibiotic
A. RA 3720
B. RA 5921
C. RA 8203
D. RA 9165
E. NOTA

A) 1 year

The copy of prescription of dangerous drug is retained by the pharmacist for a period of ____ from the date of sale or delivery of such drug
A. 1 year
B. 2 years
C. 3 years
D. 4 years
E. 5 years

B) Adulterated

According to RA 3720, if a drug bears or contains any poisonous or deleterious substance which may render it injurious to health, it is deemed to be:
A. Poisonous
B. Adulterated
C. Misbranded
D. Counterfeit
E. Hazardous

D) AOTA

This a method of secret writing or use of characteristic style or symbol by substituting other letter/s or character/s for the letter/s intended, for the purpose of misleading the consumer.
A. Code
B. Cipher
C. Secret Keys
D. AOTA

D) A and C only

All prescriptions dispensed in the drugstore shall be recorded in the books kept for the purpose indicating the
A. Name of manufacturer
B. Address of the manufacturer
C. Lot and control numbers of the main ingredients of the prescription
D. A and C only
E. AOTA

B) 30 days

If counterfeit drugs were found, the business establishment must be directed for preventive closure for a period of
A. 15 days
B. 30 days
C. 60 days
D. 90 days
E. NOTA

B) 3 years

For how many years shall the chairman and the members of the Board of Pharmacy hold office after appointment?
A. 2 years
B. 3 years
C. 5 years
D. 7 years
E. NOTA

E) NOTA

Generics Act of 1988
A. RA 9502
B. RA 8423
C. RA 9711
D. RA 8981
E. NOTA

B) 75%

In order to pass the board examination, a candidate must obtain a general average of
A. 80%
B. 75%
C. 70%
D. 65%
E. NOTA

B) 40%

The principal display panel comprises ___ of the total surface area of the container
A. 30%
B. 40%
C. 50%
D. 60%

B) No

The pharmacist may allow his certificate of registration rented provided he/she visits the drugstores frequently
A. Yes
B. No
C. Depends on the frequency
D. I don’t know

A) Detailmen

Persons who are not considered to be practicing pharmacy
A. Detailmen
B. Drugstore pharmacist
C. Faculty of a college of pharmacy
D. NOTA