Which of the following drug substance properties is important for capsule size selection?
Which of the following is not part of Capsule Quality Control program
The stability dating requirements of USP 795 for the extemporaneous compounding of capsules are
4 months if prepared from USP/NF ingredients or 25% of remaining expiration dating if prepared from commercial products
6 months if prepared from USP/NF ingredients or 50% of remaining expiration dating if prepared from commercial products
2 months if prepared from USP/NF ingredients or 25% of remaining expiration dating if prepared from commercial products
6 months if prepared from USP/NF ingredients or 25% of remaining expiration dating if prepared from commercial products
For human use, eight capsule sizes are available ranging from:
the smallest No. 000 to the largest No.5.
the smallest No. 5 to the largest No. 000
the smallest No. 01 to the largest No. 08.
the smallest No. 1 to the largest No. 8
The coni-snap® hard gelatin capsules have a unique design that:
Enables the two halves of the capsule shell to fit like a lock and key.
Enables the two halves of the capsule shell to be fit together by strong compression forces.
Enables the two halves of the capsule shell to be positively joined through locking grooves in the shell walls.
Enables the two halves of the capsule shell to be sealed with strong polymer adhesive
The USP content uniformity test for capsules specifies that:
9 out of 10 capsules are within 80% to 120% of labeled drug amount
9 out of 10 capsules are within 85% to 115% of labeled drug amount
9 out of 10 capsules are within 70% to 125% of labeled drug amount
9 out of 10 capsules are within 75% to 125% of labeled drug amount
Substances that absorb moisture from the air to the extent that they liquefy are called
The following property is especially important in dermatologicals
Nongrittiness of solid particles
Fast dissolution rate
Phenobartital divided powders have the advantage of
Being dispensed in sifter-top containers
Spreading uniformly, and clinging to the skin upon application
Allowing physicians to prescribe a precise amount of the drug
Having no irritant properties when applied externally
Which of the following is FALSE regarding a dusting powder?
Should flow easily, spread uniformly, and cling to the skin upon application
Would generally be dispensed in sifter-top containers
Must be able to have a systemic effect
Must be free from potential of causing local irritation
Which of the following is a natural emulsifying agent?
Sodium lauryl sulfate
The following powders when mixed are an example of a eutectic mixture
Zinc oxide and glycerin
Phenol and talc powder
Camphor and menthol
Camphor and lactose
Metered inhalation aerosols containing micronized medicated powders typically have
A particle size in the range of 18-26μm
A particle size in the range of 1-6μm
A particle size in the range of 12-18μm
A particle size in the range of 6-12μm
Which of the following is not a component of the Lacrimal Apparatus?
Aqueous humor is produced by filtration of blood plasma in the region known as the:
Which of the following statements regarding the ophthalmic insert “Ocusert” is NOT true?
Clinical acceptance of the device has been slow
It is a controlled delivery device for the drug pilocarpine
It is designed to dissolve completely in lacrimal fluids within a few days of insertion
It is more costly than traditional delivery systems such as solutions
Which layer(s) of the cornea offers the greatest barrier(s) to absorption into the eye for hydrophilic drugs?
b and c only
Cataracts are caused by
clouding of the lens caused by clumping of crystallins.
loss of elasticity of the lens with age.
sloughing (peeling) of the posterior layers of the lens caused by various diseases
destruction of the cuboidal epithelial lining on the anterior surface of the lens.
To prevent possible corneal damage, ophthalmic formulations should be buffered in the pH range of:
4.5 to 10.5
6.5 to 8.5
3.5 to 11.5
5.5 to 9.5
Which of the following is NOT an antioxidant that has been found appropriate for use in ophthalmic formulations?
Particle size can influence:
Penetrability of particles for inhalation (dry powder inhaler) for deposition deep in the respiratory tract.
Suspendability of suspensions
Uniformity of mixtures in powder dosage forms to ensure dose to dose content uniformity
All of the above
Below what pH will free phenobarbital begin to separate from a solution having an initial concentration of 2 g of sodium phenobarbital per 200 ml at 25 0C? The saturation solubility of phenobarbital is 0.005 M and the pKa =7.41 at 25 0C. Molecular weight of phenobarbital is 232 and sodium phenobarbital is 254.
The process of comminution by utilizing a SOLVENT that can be easily removed is termed:
Pulverization by intervention
Which of the following is NOT an accurate characteristic of the rectum
It is nonmotile in the resting state
It is approximately 15 to 20 cm in length
The mucosal lining contains Goblet cells which release collagen into the lumen.
When void of fecal matter it has a fluid content of 2 to 3 ml
Of the veins that drain the blood from the rectal area, which one(s) bypass the liver and deliver blood directly to the systemic circulation?
The inferior and middle rectal veins
The inferior, middle and superior rectal veins
The inferior and superior rectal veins
The middle and superior rectal veins
The names of four drugs are given blow along with their corresponding density factors for cocoa butter.
A. Aminophylline (1.1)
B. Bismuth subnitrate (6.0)
C. Menthol (0.7)
D. Iodoform (4.0)
For which drug would the greatest weight be required in order to displace 1 gram of coca butter from a formulation?
Which of the following is NOT an advantage of drug dosing via the rectal route?
Drugs are not exposed to GI membrane enzymatic activity
It can be used for unconscious or debilitated patients
Absorption from the rectal area is more rapid and predictable than from other regions of the GI tract
Hepatic first-pass metabolism may be avoided partially or completely
The maximum amount of solid that can normally be incorporated into a suppository is ______ of the blank weight.
You desire to administer a drug rectally in order to obtain a rapid onset of action. Which of the following suppositories would you use?
An oleaginous base containing the unionized form of the drug
An oleaginous base containing a salt form of the drug
A water miscible base containing the unionized form of the drug
A water miscible base containing a salt form of the drug
You are preparing a cocoa butter suppository and have added ingredients that have lowered the melting point below that of room temperature. In order to elevate the melting point of the mixture you will add:
The physical characteristics of Polyethylene glycol (PEG) polymers change with size. At what molecular weight do these polymers change from liquid to solid?
You prepared and recorded the disintegration time for salicylic acid capsules in different pH media. Which statement is TRUE?
The disintegration time of salicylic acid capsules was shortest in pH 7.4 buffer
The disintegration time of salicylic acid capsules was shortest in water
The disintegration time of salicylic acid capsules is longest in pH 1.2 buffer
The disintegration time of salicylic acid capsules was shortest in pH 1.2 buffer
Sedimentation rate of particles in suspension decreases with
Increase in the viscosity of dispersed phase
Increase in the particle size
Decrease in the viscosity of dispersed phase
Decrease in the viscosity of dispersion medium
Increase in the viscosity of dispersion medium
Shelf-life is generally based on the time when the active drug is greater than ______ of the labeled.
The pre-exponential factor, A, of the Arrhenius equation is representative of:
the probability that any given collision will result in a reaction
the total number of collisions per unit time, whether they lead to a reaction or not
the fraction of molecules in the reaction that have energies higher than that of the activation energy, Ea.
the total number of collisions per unit time that result in a reaction
A solution has a shelf-life of 10 hours at a temperature of 35oC. Use the Q10 method to estimate the shelf-life if the solution is stored in a refrigerator at 5oC. Use a value of 3 for Q10.
You are working in a pharmacy and are compounding a solid formulation in which the manufactured drug is the source of the active ingredient. The product’s expiration date is 16 months from today. What Beyond Use Date will you assign this formulation?
A pharmacist compounding a fine dusting powder typically would triturate the components of the formulation in a mortar with a pestle and subsequently pass the mixture through a (n):
#8 mesh sieve
#80 mesh sieve
#20 mesh sieve
#60 mesh sieve
Soft gelatin capsules are made of gelatin
to which polysorbate 80 has been added
to which glycerin has been added
to which mineral oil has been added
to which camphor has been added
Which one of the following has the highest aqueous solubility?
Which of the following is NOT a major factor affecting solubility?
pH of the solution
Polarity of the solvent
Polarity of the solute
Moleculare weight of the solvent
Active transport processes include all of the following except for which one?
Active transport of drug molecules may be saturated at high drug concentrations
Active transport moves drug molecules against a concentration gradient
active transport requires energy
Active transport follows fick's law of diffusion
Active transport is a carrier mediated transport system
When comparing an amorphous form of a drug to a crystalline form of a drug:
Amorphous forms dissolve more quickly
crystalline forms are more pharmacologically active
Metastable forms are more clinically effective
Amorphous forms are more chemically stable
According to the FDA Biopharmaceutics classification system, the class III type compounds are those with:
High solubility, low permiability
High solubility, high permeability
low solubility, low permeability
low solubility, high permeability
What imparts the pink color to Calamine USP
FD&C red no3
Chemicals of indeterminate quality would be labeled as
Technical or commercial
this grade of ingredients is : High purity; conforms to minimum specifications set by the Reagent Chemicals Committee of the American Chemicals Society
This grade of chemicals is :More refined than technical or commercial grade but still of unknown quality
This grade of chemicals : Meets the minimum purity standards; and conforms to tolerances set by the United States Pharmacopeia/National Formulary for contaminants dangerous to health
Which of the following is NOT true for crystal polymorphs?
May have different solubility
May have different dissolution rates
May have different physical and chemical stability
May have different chemical structures
May have different melting points
Which condition usually increases the rate of drug dissolution from a tablet?
Use of enteric coating
Use of the ionized or salt of the drug
Use of the free acid or free base form of the drug
Decrease surface area of the drug
Increase particle size of the drug
Which of the following is FALSE regarding inconsistencies in dissolution rates?
Dose units within a batch typically give consistent dissolution results
dose units within a batch typically give inconsistent dissolution results
dissolution inconsistencies can occur between batches or products from the same manufacturer
Dissolution inconsistencies can occur between batches or products from different manufacturers
All of the following factors depend on the rate of active drug dissolution within the gastrointestinal content EXCEPT:
Fraction of the administered dose that is bioavailable
Time after administration until therapeutic action begins
Intensity of systemic pharmacologic effects
site of action in the body
Which of the following is FALSE regarding the need for a dosage form?
To provide for a safe and convenient delivery of accurate dosage
To conceal the bitter, salty, or offensive taste, or odor of a drug
To protect the drug substance from the destructive influences of atmospheric oxygen or humidity
To enhance the dissolution rate of a drug substance.
What is the minimum weighable quantity with no more than 5% error for a balance with a sensitivity requirement of 6mg?
The Prescription balance needed for weighing chemicals is currently designated as a class ____ balance by the national bureau of standards
A Class III balance should have a sensitivity requirement of:
All of the following are part of the compendial requirements for tablets according to USP/NF EXCEPT:
Tablet Content Uniformity test
Tablet Weight Variation Test
Tablet Thickness Test
Tablet Dissolution test
Tablet Disintegration test
At the first sign of Angina attack the patient should reach out and:
Apply Nitro ointment to the chest
Apply a Nitro patch to the skin
Swallow a sustained release 2.5 mg Nitro capsule
Place a sublingual Nitro tablet under the tongue
The requirements for tablet content uniformity are met if the amount of active ingredient in each dose unit is within the range:
95-105% of the label claim and the standard deviation less than 6%
90-110% of the label claim with a standard deviation less than 6%
85-115% of the label claim and a standard deviation of less than 6%
80-120% of the label claim and a standard deviation of less than 6%
Which of the following excipients can NOT be used in the formulation of tetracycline antibiotics?
The partial or complete separation of the top or bottom crowns of a tablet from the main body of the tablet is known as
All of the following statements reflect the importance of in-vitro dissolution testing EXCEPT:
It guides the formulation and product development towards product optimization
It is a requirement for regulatory approval of marketed products registered with the FDA
It is important for guiding the testing of class I BCS type compounds
Consistent dissolution testing ensures bioequivalence between batch to batch
Which of the following organic esters is commonly used in enteric coating of solid dosage forms?
Which of the following is NOT a candidate for an extended release product?
Drug with narrow therapeutic index
Drug administered in relatively small doses
Drug that exhibits neither slow nor fast rate of excretion
Drug must be absorbed/excreted at a moderate rate
Drug used in the treatment of chronic conditions
Which of the following products is an osmotic oral release system?
What is a feature of Procardia XL tablets?
Tablet remains intact in the stool
Rapid disintegration to quickly release components
Protect the drug from the acidic stomach environment
Fast dissolving of the outer core of the tablet allowing the drug dose to be immediately available
Orally disintegrating tablet which releases in the mouth within 1 minute
Tablets that are characterized by disintegrating or dissolving in the mouth within 1 minute are called:
Enteric coated Tablets
Modified release tablets
Immediate release tablets
Rapidly dissolving Tablets
Which chapter in the USP/NF provides for the procedures and requirements for nonsterile type of compounding?
In which of the following kinetic processes does the value of the half-life remain constant irrespective of time or amount of reactant?
You prepare 2 plots. One you plot ln(Y) vs time. One you plot log(Y) vs time. Both plots yield straight lines. For which of these plots is the negative slope the steepest?
Plot of ln(Y) vs time
Plot of Log(Y) vs time
The slopes of the two lines are the same
The slopes depend on the amounts of Y present initially
The rate constant (k) is 0.08 moles/minute. If we begin the rxn with 10 moles of Y, how much Y will disappear in the first minute of the reaction
A ________ Dispersion has particles that range in the diameter from 1nm to 0.5micron and that are visible in an electron microscope but not an ordinary optical microscope
Which of the following types of compounds would be least susceptible to degradation via oxidation
Molecules with unsaturated linkages
The most important cause of drug decomposition is
How many half lives would it take for 90% of any initial concentration of a drug to disappear from a reaction vessel, assuming first order chemical kinetics?
In which of the following kinetic processes is the rate constant the same as the rate?
When the concentration of the drug (Y) is low (Y<<K), the process will best be described by:
An Inert system is:
Thermodynamically stable and kinetically stable
Thermodynamically unstable and kinetically unstable
Thermodynamically stable and kinetically unstable
Thermodynamically unstable and kinetically stable
Which kinetic process is linear
Both A and B
Neither a nor B