Dosage forms that can be used orally and topically: (Select all that apply)

Clausius-Clapeyron equation expresses the heat of solute in a solution.

A brand name company for the approval of a NCE needs the approval of FDA for a IND and a NDA:

Agents needed to create an immediate release dosage form: (Select all that apply)

Heat of vaporization:

Difussion:

Small the particle size means an increase in surface area and lower specific surface.

What influences IV route and Extravascular route. Select all that apply:

If a drug is very lipophilic, the volume of distribution will be lower.

Units of extent:

Which of these is unitless:

Clausius-Clapeyron equation express:

If a patient has a clearance below 50 what you should do?

135ml of a drug in 70% with 1.29 of Specific gravity. Whats the weight?

True density influence the space per cc.

What are strong adsorptive agent? Select all that apply.

Phase I studies are conducted by pharmaceutical companies interest in filing an ANDA, such studies include administration of new drug to a small number of human volunteers who are healthy adults .

Which of these is for topical use only:

5, 39, 121. How many cycles?

Which of this profile will exhibit directly proportional relationship?

Which of these one needs to be made in a logarithmic technique to obtain a straight line:

Which of the following physical chemical properties plays an important role in the formulation of an emulsion dosage form of a drug?

Which of these factors is very important in pharmacokinetics of a drug?

Which of the following adjuvants are needed for immediate release form: Select all that apply.

Which of these therapeutic agents in oral dosage form is immiscible and poor soluble in water?

After which phase a brand company submit the NDA.

The lower the pka relates to:

You have 750mg of Keppra, how many milligrams would be excreted in urine?

Which of these therapeutic agents are weak acid drugs? Select all that apply.

Which of these relates true density and bulk density?

If only the rate of drug absorption is adversely affected by administering (drug) with food to a healthy subject it will be reflected in: l

Which of the following must be submitted to the FDA by a generic company:

Solutions and elixirs are two liquid dosage forms used for the administration of drugs orally; the striking difference is the presence of alcohol in elixirs.

Which of these dosage forms is used to contain powder material?

Which one is an intrinsic property?

Glycine is an amino acid and inhibitory neurotransmitter in CNS, the most possible taste is:

Crystallization is an endothermic process:

Packaging the drug product that is known to degrade by oxidation, in a heavy metal container or foil protect the drug product from oxidative degradation? Is the above statement is true or false.

When moisture is absorbed to a compound solid to the extent that delinquency takes place , the compound concentration in the liquid film surrounding the solid is equal to the compound solubility ( Cs) :

When the temperature is lower than the eutectic point for mixture of compound A and compound B both of them will stay as liquid:

Effect of solvent on degradation rate constant is being observed. The charges on the drug ion and the interacting species are the same. Replacing water with a solvent of lower dielectric constant (€)will result in:

Thermolidalometry (TD) is a special type of Thermomechanical analysis (TMA), TD measurement ,the external force acting on a sample can be considered as zero.

The shelf life of a drug is 3 years at 25degrees Celsius. Approximately how long will the drug be stable at 37 degrees Celsius?

A drug was found to be stable for 1 year at room temperature. How long may the drug be theoretically stable at refrigerator temperature?

Ampicillin monograph states that reconstituted suspension is stable for 14 days in refrigerator (5 degrees Celsius) . If the product is left at room temperature for 12 hours and put back in the refrigerator, what is the new expiration period?

Weak basic drug:

Agents that are miscible with water and used to oral solutions:

Which statements are true about Hydrogen bonds?

Non polar agents (Select all that apply):

Efflorescence is the opposite of deliquescence, which occurs when the crystal loses water....

Enantiotropic have irreversible phase transition and Monotropic have reversible phase transition.

When decrease the particle size what increases? (Select all that apply):

Which is the flavor for polyhydroxyl?

Which statement is true about glass temperature?

The difference in polymorphs is present in liquid and vapor phase:

The ampicillin monograph states that the reconstituted suspension is stable for 14 days in a refrigerator (5 degrees Celsius). If the product is left at room temperature for 12 h, what is the reduction in the expiration period?

Which of the following equations is used to predict the stability of a drug product at room temperature from experiments at accelerated temperature?

Half life of a pseudo order reaction depends on the initial concentration of the reactant?

Degradation of a drug in an aqueous suspension is analyzed. The solubility of the drug in water is 2.857 mg/ml (Csoln) and the first-order rate constant for degradation of the drug is 3.9*10^-6 sec^-1. Calculate the pseudo zero-order rate constant of the drug?

The stokes radius of a molecule or ion is the radius of a theoretical hard sphere which is at the same size as this ion when they are in a solution.

The factors affecting the polymorphism behavior of powder include?

The melting point and molar heat of fusion for a compound are 75 degrees Celsius and 4885 cal/mol, respectively. Which of the following is true regarding the solubility of this compound at 25 degrees Celsius in an ideal solution?

The liquid film constitutes a stationary diffusion layer in which the concentration of the drug is:

The refractive index(n) of a material is a dimensionless number that describes how light propagates through that material. The refractive index (n) for a material besides the air is:

Both the lag time (LT) and the burst time (TB) are dependent on the diffusion coefficient of the drug and the thickness of the membrane. This statement about the lag-time and burst time effect is true or false?

The permeability coefficient of a weak electrolyte through a biological membrane will increase if:

500mg of a non-electrolyte drug (MW=250) was shaken with 100 ml 1:1 (V/V) of octanol/water mixture. The concentration of the drug in the aqueous layer was found to be 1*10^-2M. Calculate the apparent partition coefficient of this drug at pH=2.

A zero-order reaction is one in which:

According to the Bronsted Bjerrum theory of effect of ionic strength on degradation rate if the charges of the reacting species are the same, adding an electrolyte to a liquid formulation may cause stability problems.

The octanol-water distribution plot (1/Papp vs 1/(H+) for a weak acid has a Y-axis intercept of 5*10^-3 and a slope of 5*10^-6. Calculate the logP and pKa for this weak acid.

Effect of solvent on degradation rate constant is being observed. The charges on the drug ion and the interacting species (different charges) Replacing water with a solvent of lower dielectric constant will result in:

Composition for a compound A and compound B when the temperature is lower than the eutectic point?

Degradation of a drug was analyzed to be first order. The formulation initially contained a concentration of 10% w/v of the drug. The half-life of a drug was found to be 7h. Compute the half life of the same drug formulation with an initial concentration 30% (w/v).

The rate constant for degradation of a drug 1.5x10^-3 h-1 at 70 degrees Celsius and 1.80x10^-5h-1 at 25 degrees Celsius. Calculate the activation energy of the drug.

The rate depends on the concentration of one of the reactants, which is either very large or is a constant. A pseudo zero-order reaction is one in this sentence.

Acetaminophen has a solubility of 1.4 g/100ml at 25 degrees Celsius. It is a sparingly soluble drug according to the USP?

Using the Arrhenius plot, the reaction rate was determined as 0.02mg.ml.-1 day-1 for a zero order reaction at 25 degrees Celsius. The initial concentration of the drug was 500 mg.ml-1. Determine the expiration period.

Which two parameters have linear correlation according to the August equation?

Calculate the total concentration if an acid preservative that must be added to preserve an emulsion composed of equal volumes of oil and water and the aqueous phase is buffered at pH 7. The minimum effective concentration for this acid preservative is 0.1 mg/ml. Ka=2.7x10^-5, P=29.

Which statement is true about polymorphism?

Which technique is usually used to investigate the dimensional change of a compound when the temperature changes?

The logP value of a weak acid was experimentally determined to be 1.5. Calculate the apparent partition coefficient (Papp) of the drug at pH 5.8 assuming the pKa of the drug is 3.6.

Warfarin a blood thinner, what happens when drugs that bind to a receptor displacing Warfarin?

Cocaine is a weak base drug, going through partition coefficient studies. If there's a change in pH the apparent partition coefficient.

Light powder has a heavy density and a light bulk volume.

Diffusion coefficient, D of diffusant depend on?

Diffusion coefficient depends on properties of diffusants and the properties diffusional barrier.

What is the slope of a graph with sink conditions (J=DM/dt)?

Only non-electrolyte drugs and the unionized forms of electrolytes can go passive diffusion through cell membranes.

True density of a powder depends primarily on the particle size, size distribution, particle shape, and the tendency of the powder particles to adhere to each other.

The angle of repose for a powder.. The higher the angle the more it is able to flow freely. The lower the angle the poorer it flows.

The matrix follows Ficks Law:

Zero order rate:

Pseudo zero order depends on:

Decreasing the size of the particles of a powder sample increases bulk volume of the powder:

Rate of diffusion is directly proportional to the thickness:

A steroid permeates through am EVA membrane with and area of 10.25cm^2 and thickness of 0.075 on at 25 degrees Celsius. The concentration of steroid in the donor compartment is 0.004mmol/ml. The amount of steroid across the membrane at steady state is 3.5x10^-3 mmol in 4.5h. The lag time is 0.4h. Calculate the permeability coefficient P?

You have a rate of 0.02 mg.ml.day initial concentration of drug is 500 mg/ml. Drug follows zero order. What is the expiration time?

What determines the degree of movement of a drug between body compartments?

For a drug available as a tablet taken orally, to reach the systemic circulation, it has to undergo the process of dissolution and absorption. The rate at which the drug reaches the systemic circulation is determined by the slower step in the sequence (rate limiting step) Dissolution rate limiting step for hydrophilic drug.

A partition coefficient experiment was carried out with a non-electrolyte drug. Drug was added to an n-octanol-water system that contained 100ml of each solvent and allowed to equilibrate. At equilibrium, the concentration of the drug in octanol phase was 0.52 M and in the aqueous phase was 0.33M. What is the partition coefficient of the drug?

Changing the pH of the aqueous medium in the above experiment would change the partition coefficient?

Degradation rate constant was found to be 0.75 days^-1. The initial concentration if the drug was 20mg/ml. What is the order of this degradation reaction?

Calculate the diffusivity or diffusion coefficient, D for the above steroid?

The influence of temperature on the degradation rate constant was studied for a drug following first order degradation. Degradation rate constant was plotted against the reciprocal of absolute temperature. The slope from the equation of the line of the semi log plot was found to be -7648. Determine the energy of activation.

Only non-electrolytes and unionized, lipophilic drug molecules cross the lipid bilayer by passive diffusion

In general, dissolution rate of a crystalline form of a drug is greater than that of the amorphous form?

Dissolution of a drug from which of the following dosage form follow Higuch square root kinetics?

A dissolution profile was plotted for a drug with amount of drug dissolved in the y-axis and time on the x-axis. Under sink condition. What would the slope of the line be equal to?

In a consecutive or series reaction, the rate of formation of B is expressed as:

Which statement is true about crystallization or crystal?

Which statement is true about crystallization or crystal?

Frequency factor (A) is independent of temperature? (Arrhenius equation Ea)

Hydrogen ions (specific base catalysis) as observed in high pH range or alkaline pH range

Zero order w/w initial concentration 10% half life of 7 hr, shelf life of initial concentration 30% find the shelf life.

In zero order reaction, if Ao=0.47 mole/L and K=8.2x10^-4 L/mole/h what is the half life of the drug?

Half life of a drug that follows zero order degradation is found to be 6 months. Calculate the shelf life of the drug assuming same initial concentration?

Presence of food in the stomach increases viscosity and thereby decreasing the rate of dissolution. This statment is true or false?

The log P value of a weak acid was experimentally determined to be 2.5. Calculate the apparent partition coefficient (Papp) of the drug at pH 4.9, assuming that the pKa of the drug is 3.8.

Activation energy (Ea) is an important factor determining the speed of a reaction or degradation of a drug. If the Ea required for the molecules to become activated is low, the degradation rate is low.

Effect added electrolytes (increase in ionic strength) on degradation is being studied for 4 drug products. One of the interacting species in the degradation reaction is a neutral molecule. Increasing the ionic strength by adding more electrolytes to the drug product would result in:

A formulation used in a nebulizer begins its existence at 100 mg/ml of active substance. Ten months later its concentration has fallen to 75 mg.m. Calculate the drugs half life (T ½) if the order is one.

Which of the following statements concerning zero-order degradation is false?

According with logP which drug may have the lowest aqueous solubility?

Which equation or law represents the correlation among the interplanas distance (d), the scattering angle and the wave length of the light in a longht diffraction?

Calculate the total concentration of an acid preservative that must be added to preserve an emulsion composed of equal volumes of oil and water and the aqueous phase is buffered 7. The minimum effective concentration for this acid representative is 0.05 mg/ml. K=3.8x10^-5 and P=25.

Which functional group can increase the partition coefficient (P) of a compound?

The degradation rate constant of a reaction is 3.45 mg/ml*s. What would the order of the reaction be?

Differential scanning calorimetry (DSC) is a thermoanalytical technique:

The octanol-water distribution plot (1/Papp vs 1/[H+] for a weak acid has a Y-axis intercept of 4.5x10^-4 and a slope of 5.8x10^-6. Calculate logP and pKa for this weak acid:

A liquid medicine having an initial drug concentration of 1000 mg/ml undergoes zero-order kinetics with a rate constant of 100 mg/ml per day. How long it would take before the product is completely degraded.

The most possible taste of Leucine is?

The most possible taste of asparagine is?

The most possible taste of H+ is?

The most possible taste of Anions and Cations is?

The most possible taste of High-MW salts is?

The most possible taste of Carbohydrates is?

A smaller ion may have a greater Stokes radius than a larger ion when they are in the solution.

An individual solute molecule can move from lower concentration to higher concentration region in solution.

Which of the following is the Units for Diffusion coefficient?

Which statement is true? Assume the drug molecule is a hard sphere and all the conditions are ideal and identical.

Crystallization is...

COMPOUNDS HAVE A LOWER HEAT CAPACITY ABOVE THE GLASS TRANSITION TEMPERATURE THAN THEY DO BELOW IT.

A completely amorphous compound does not show any crystallization dip, but does show the melting peak in a DSC graph.

TGA can measure the ____ change of the materials when the temperature changes.

The Unit for the Linear Expansion Coefficient is…

Melting Point is…

The purer the compound, the Narrower the MP range?

The purer the compound, the Higher the MP range?

For the same compound the purer the compound the higher the melting point…

Which of the followings are types of polymorphism.?

Who is the Father of Polymorphism.?

The difference between polymorphs exist in all the states of matter.

Amorphous Solids have a greater solubility compared to crystalline solids.

Which of the following is an example of Enantiotrophs?

Which of the following is an example of Monotrophs?

The factors affecting the polymorphism behavior of a powder include: Select all that apply.

Which method can be used to both determine the melting point and study the polymorph of a solid material?

Minocycline has a solubility of 50mg/ml. It is a ____ drug according to the definition is USP?

The melting point and molar heat of fusion for naphthalene are 80.2°C and 4540cal/mole, respectively. Calculate the solubility of this compound at 20°C in an ideal solution

A solid is to be comminuted so as to increase its solubility by 10%. What must be the final particle size, assuming that the surface tension of the particles is 100 dynes/cm and the volume per mole is 50 cm3? The temperature is 27 °C.

A solid is to be comminuted so as to increase its solubility by 15%. What must be the final particle size, assuming that the surface tension of the particles is 120 dynes/cm and the volume per mole is 45 cm3? The temperature is 22 °C.

The final particle size of a grinded solid is 0.05um. The temperature is 27°C. What is the percentage of increasing on the solid solubility? Assuming that the surface tension of the particles is 110 dynes/cm and the volume per mole is 50cm3?

A pharmacist prepares a 3.0% solution of an antibiotic as an ophthalmic solution and dispenses it to a patient. A few days later the patient returns the eye drops to the pharmacist because the preparation contains a precipitate. The pharmacist, checking the pH of the solution and finding it to be 6.0, reasons that the problem may be pH related. The physicochemical information of interest on the antibiotic includes the following: Pharmacist determined what the molarity of the 3% solution was. Also determined what the molarity of the acid form of the solution was:

A pharmacist prepares a 2.0% solution of an antibiotic as an ophthalmic solution and dispenses it to a patient. A few days later the patient returns the eye drops to the pharmacist because the preparation contains a precipitate. The pharmacist, checking the pH of the solution and finding it to be 6, reasons that the problem may be pH related. The physicochemical information of interest on the antibiotic includes the following:

A compound has the enthalpy of fusion more than 0. When we increase the temperature of the solution, the solubility of the compound always decreases.

What is the difference between log P and logPapp?

The octanol-water distribution studies summarized in the figure below are for codeine (methyl morphine) which is a monovalent tertiary amine. Calculate the coefficient P and the base dissociate constant Kb of the drug:

100 mg of a non-polar drug X (MW = 510) was shaken with 100 mL of 1:1 (v/v) of octanol/water mixture for a P-value determination. The concentration of the drug in the aqueous layers was found to be 5.2 x 10 -4 M. Calculate: partition coefficient (P), Log P, Papp

The logP value of the NSAID drug Sulindac was experimentally determined to be 3.34. Calculate the apparent partition coefficient (Papp ) of the drug at pH 4.9, assuming that the pKa of the drug is 3.88.

According to logP, which drug may have the highest aqueous solubility?

Calculate the total concentration of benzoic acid that must be added to preserve an emulsion composed of equal volumes of oil and water and the aqueous phase is buffered at pH 4.4. The minimum effective concentration for benzoic acid is 0.25 mg/mL. Ka = 6.3 x 10 -5 , P = 6. (ANSWER NOT CONFIRMED IN CLASS)

If 0.15g of succinic acid in 100mL of octanol is shaken with 10mL water, how much succinic acid is left in the octanol layer? The partition coefficient(P)=0.125 at 25°C.

The octanol-water distribution plot (1/Papp vs 1/[H + ]) for a weak acid has a Y-axis intercept of 4.5*10 -4 and a slope of 5.8*10 -6 . Calculate logP and pKa for this weak acid.

The log P value of a weak acid was experimentally determined to be 2.5. Calculate the apparent partition coefficient (Papp ) of the drug at pH 4.9, assuming that the pKa of the drug is 3.8.

Calculate the total concentration of an acid preservative that must be added to preserve an emulsion composed of equal volumes of oil and water and the aqueous phase is buffered at pH 7. The minimum effective concentration for this acid preservative is 0.05mg/mL. Ka = 3.8 x 10 -5 , P = 25.

The melting point and molar heat of fusion for a compound are 75°C and 4885cal/mol, respectively. Calculate the mole fraction solubility of this compound at 25°C in an ideal solution.

The melting point and molar heat of fusion for a compound are 175°C and 4540cal/mole, respectively. Calculate the solubility of this compound at 25°C in an ideal solution: