1.
A direct compression process to make tablets can only be used for drugs that are heat sensitive, light sensitive or moisture sensitive.
Correct Answer
B. False
Explanation
Direct compression CAN"T be used for potent or low dose drugs
2.
Patients should not take an antacid product along with an enteric coated tablet.
Correct Answer
A. True
Explanation
Patients should not take an antacid product along with an enteric coated tablet because antacids can neutralize the stomach acid, which is necessary for the enteric coating to dissolve and release the medication properly. Enteric coated tablets are designed to pass through the stomach and dissolve in the intestines, where they can be absorbed. Taking an antacid along with an enteric coated tablet can interfere with the intended release and absorption of the medication, reducing its effectiveness. Therefore, it is recommended to avoid taking antacids at the same time as enteric coated tablets to ensure proper drug delivery.
3.
A non-steroidal anti-inflammatory drug, such as aspirin, is enterically coated to stabilize the aspirin against degradation in the acidic environment of the stomach.
Correct Answer
B. False
Explanation
Enteric coating on NSAID protects patient in this case.
4.
A drug must first dissolve in the GI fluid before absorption from a tablet dosage form can occur. Soft gelatin capsules may contain oily solutions of drugs
Correct Answer
A. True
Explanation
Soft gelatin capsules are commonly used to encapsulate drugs that are dissolved in oily solutions. The gelatin shell of the capsule is designed to dissolve in the gastrointestinal (GI) fluid, allowing the drug to be released and dissolved in the fluid as well. This dissolution is necessary for the drug to be absorbed into the bloodstream from the tablet dosage form. Therefore, the statement that a drug must first dissolve in the GI fluid before absorption from a soft gelatin capsule can occur is true.
5.
The Pellicle effect seen with hard gelatin capsules is not a problem with HPMC. Drugs are typically more stable in aqueous solution than they are in the dry state.
Correct Answer
B. False
Explanation
The statement suggests that the Pellicle effect is not a problem with HPMC, which implies that HPMC capsules do not experience the formation of a thin film on their surface. However, the answer states that the statement is false, indicating that the Pellicle effect can indeed occur with HPMC capsules. Additionally, the explanation mentions that drugs are generally more stable in aqueous solution than in the dry state, which is unrelated to the Pellicle effect and does not provide a clear explanation for the correct answer.
6.
Allegra D is a bilayer tablet product whereas Effexor XR is an extended release capsule product containing coated pellets.
Correct Answer
A. True
Explanation
The explanation for the given correct answer is that Allegra D is indeed a bilayer tablet product, meaning it is composed of two layers with different release profiles. On the other hand, Effexor XR is an extended release capsule product that contains coated pellets, which allows for a controlled and prolonged release of the medication. Therefore, the statement is true as it accurately describes the formulation of these two products.
7.
The results of the Phase 1 clinical trial need to be approved by the FDA before an IND is submitted for review to the FDA.
Correct Answer
B. False
Explanation
At the end of the clinical trials an NDA is submitted.
8.
Lactose and dicalcium phosphate are the two most common diluents presently in commercial tablet and capsule formulations.
Correct Answer
B. False
Explanation
lactose and methylcrystal cellulose are the top 2 diluents
9.
Enteric polymers are insoluble in acid and dissolve at pH 5.5 and above release the contents of the coated pellet, tablet or capsule in the duodenum and the upper small intestine.
Correct Answer
A. True
Explanation
Enteric polymers are designed to be resistant to the acidic environment of the stomach, but they dissolve and release their contents in the duodenum and upper small intestine where the pH is around 5.5 and above. This property allows for targeted drug delivery and protection of the drug from degradation in the stomach. Therefore, the statement that enteric polymers are insoluble in acid and dissolve at pH 5.5 and above is true.
10.
Deliquescent drugs should not be formulated into hard gelatin capsules.
Correct Answer
A. True
Explanation
Deliquescent drugs are substances that have a tendency to absorb moisture from the air and dissolve in it. Formulating these drugs into hard gelatin capsules can lead to the capsules becoming soft, deformed, or even dissolving completely due to the moisture absorption. Therefore, it is not recommended to use hard gelatin capsules for deliquescent drugs.
11.
Magnesium stearate and stearic acid are the two most common lubricants utilized by innovator and generic pharmaceutical companies in commercial tablet formulations.
Correct Answer
A. True
Explanation
Magnesium stearate and stearic acid are widely used as lubricants in tablet formulations by both innovator and generic pharmaceutical companies. These substances help to prevent sticking of the tablet material to the manufacturing equipment during the compression process. Therefore, the statement that they are the two most common lubricants used in commercial tablet formulations is true.
12.
Efflorescent granules are typically comprised of citric acid and tartaric acid in combination with sodium bicarbonate.
Correct Answer
B. False
Explanation
should be effervescent.
13.
Drugs with a high therapeutic index will have a low MTC and a high MEC
Correct Answer
B. False
Explanation
drugs with a LOW therapeutic index will have a low Minimum toxicity concentration and a high Minimum effective concentration
14.
A major difference between ANDA and a NDA is that the NDA contains some stability data on the finished product.
Correct Answer
B. False
Explanation
The statement is false because a major difference between ANDA (Abbreviated New Drug Application) and NDA (New Drug Application) is that ANDA does not require stability data on the finished product, while NDA does. Stability data is crucial in assessing the shelf life and quality of a drug product, so it is a requirement for NDA submissions but not for ANDA submissions.
15.
Eutectic formation results when water is absorbed into an excipient resulting in an increase in the number of water molecules in the crystal and increasing the hardness of tablets following compression.
Correct Answer
B. False
Explanation
Eutectic formation occurs when two or more substances mix together to form a new compound with a lower melting point than any of the individual components. It is not related to the absorption of water into an excipient or the increase in the number of water molecules in a crystal. Therefore, the statement is false.
16.
The slugging or recompression method of tablet manufacture can be used to make tablets containing drugs that are unstable in the presence of moisture.
Correct Answer
A. True
Explanation
The slugging or recompression method of tablet manufacture involves compressing a mixture of drug and excipients into large tablets, which are then crushed into granules and compressed again into smaller tablets. This method is suitable for drugs that are unstable in the presence of moisture because it allows for the incorporation of moisture-sensitive drugs into the tablet formulation without exposing them to excessive moisture during the manufacturing process. Therefore, the statement "The slugging or recompression method of tablet manufacture can be used to make tablets containing drugs that are unstable in the presence of moisture" is true.
17.
Sporanox capsules contain coated beads that are not formulated to sustain the release of the active ingredient (Itraconazole).
Correct Answer
A. True
Explanation
The explanation for the given correct answer is that Sporanox capsules do not have a sustained release formulation for the active ingredient, Itraconazole. This means that the coated beads in the capsules do not release the active ingredient slowly over time, but instead release it all at once. Therefore, the statement "Sporanox capsules contain coated beads that are not formulated to sustain the release of the active ingredient (Itraconazole)" is true.
18.
The surface area of a powder increases when the particle size is decreased.
Correct Answer
A. True
Explanation
When the particle size of a powder is decreased, the total surface area of the particles increases. This is because smaller particles have a larger surface area compared to larger particles of the same material. As the particle size decreases, the number of particles increases, resulting in more surface area available for interactions or reactions. Therefore, it is true that the surface area of a powder increases when the particle size is decreased.
19.
A thermolabile drug is one that is unstable to heat. Lamination or capping of a tablet can results from poor bonding between granules in a tablet compact.
Correct Answer
A. True
Explanation
The statement is true because a thermolabile drug is one that is unstable to heat. This means that when exposed to heat, the drug can degrade or become less effective. Lamination or capping of a tablet occurs when there is poor bonding between the granules in the tablet compact. This can happen due to various factors, including the use of a thermolabile drug that becomes unstable and causes the tablet to break apart. Therefore, the statement is true as it correctly states the relationship between thermolabile drugs and the occurrence of lamination or capping in tablets.
20.
The Angle of Repose is a physical property of a powder that is used as a measure of flow. As the Angle of Repose decreases, the flow properties increase.
Correct Answer
A. True
Explanation
The Angle of Repose is a measure of the flow properties of a powder. It refers to the maximum angle at which a pile of powder can maintain its stability without sliding or collapsing. A lower Angle of Repose indicates better flow properties, as it means the powder can flow more easily. Therefore, as the Angle of Repose decreases, the flow properties increase. This statement is true.
21.
Soft gelatin capsules are very useful dosage forms to deliver drugs that are poorly soluble in water. Which one of the following vehicles CANNOT be used in soft gelatin capsules
Correct Answer
C. Purified water
Explanation
Soft gelatin capsules are designed to deliver drugs that are poorly soluble in water. The gelatin shell of the capsule is permeable to lipid-based vehicles, such as Miglyol 812, peanut oil, and castor oil, which can dissolve the drug and facilitate its absorption. Polyethylene glycol can also be used as a vehicle in soft gelatin capsules. However, purified water cannot be used as a vehicle in soft gelatin capsules as it is highly soluble in water and would cause the gelatin shell to dissolve, resulting in the leakage of the drug and loss of its therapeutic effect.
22.
Select the one correct answer
Correct Answer
A. A ball mill may be used to increase the surface area of a solid drug substance
Explanation
A ball mill is a type of grinder that is used to reduce the size of solid materials. By grinding the solid drug substance in a ball mill, it can be broken down into smaller particles, thereby increasing its surface area. This increased surface area can enhance the dissolution rate of the drug substance, as it allows for more efficient interaction with the surrounding medium. This is particularly useful for drugs that have poor solubility, as increasing the surface area can improve their bioavailability and therapeutic effectiveness.
23.
CONI-Snap capsules offer significant advantages over traditional hard gelatin capsules in overcoming problems related to deliquescence.
Correct Answer
B. False
Explanation
The statement suggests that CONI-Snap capsules have advantages over traditional hard gelatin capsules in dealing with deliquescence-related issues. However, the correct answer is false, indicating that CONI-Snap capsules do not offer significant advantages in overcoming these problems.
24.
Ac-Di-Sol is a superdisintegrant for tablets and releases carbon dioxide during the dissolution process.
Correct Answer
B. False
Explanation
Ac-Di-Sol is not a superdisintegrant for tablets. It is actually a binder used in tablet formulations to improve the cohesion and strength of the tablets. It does not release carbon dioxide during the dissolution process. Therefore, the statement is false.
25.
Granules are irregular agglomerates fo small particles which behave as a single large particle.
Correct Answer
A. True
Explanation
Granules are formed when small particles come together and agglomerate, creating irregular shapes. Despite their irregularity, granules often behave as a single large particle due to the cohesive forces between the small particles. This behavior is observed in various industries, such as pharmaceuticals and food processing, where granules are commonly used. Therefore, the statement "Granules are irregular agglomerates of small particles which behave as a single large particle" is true.
26.
The Noyes-Whitney equation is a very effective method to determine the particle size of the drug as a function of temperature
Correct Answer
B. False
Explanation
The Noyes-Whitney equation is not used to determine the particle size of a drug as a function of temperature. Instead, it is an equation that relates the rate of dissolution of a solid drug in a solvent to various factors such as surface area, diffusion coefficient, and concentration gradient. It is commonly used in pharmaceutical sciences to study drug dissolution kinetics. Therefore, the statement that the Noyes-Whitney equation is a very effective method to determine the particle size of the drug as a function of temperature is false.
27.
The primary reason for companies to formulate drugs into granules for reconstitution by the pharmacist is to decrease costs by eliminating water from the product.
Correct Answer
B. False
Explanation
Formulating drugs into granules for reconstitution by the pharmacist is not primarily done to decrease costs by eliminating water from the product. The main reason for this formulation is to increase the stability and shelf life of the drug, as well as to improve its dissolution and absorption in the body. By formulating drugs into granules, they can be stored in a more stable and compact form, and then reconstituted with water when needed. This allows for easier storage, transportation, and administration of the drug.
28.
The drug present in an enteric coated tablet is primarily absorbed in the small intesting following dissolution of the coating in the stomach.
Correct Answer
B. False
Explanation
Enteric coated tablets are designed to bypass the stomach and dissolve in the small intestine. This allows the drug to be absorbed directly into the bloodstream from the small intestine, rather than being exposed to the acidic environment of the stomach. Therefore, the drug present in an enteric coated tablet is primarily absorbed in the small intestine, not the stomach.
29.
Drugs that are not stable in light are said to degrade by a photolytic degradation process.
Correct Answer
A. True
Explanation
Drugs that are not stable in light undergo a process called photolytic degradation, where they break down or degrade when exposed to light. This process can result in changes to the chemical composition and effectiveness of the drug. Therefore, the statement that drugs that are not stable in light degrade by a photolytic degradation process is true.
30.
Drugs classified as BCS I are more soluble than drugs classified as BCS II or BCS IV
Correct Answer
A. True
Explanation
Drugs classified as BCS I are more soluble than drugs classified as BCS II or BCS IV. This means that BCS I drugs have a higher ability to dissolve in a solvent, such as water, compared to BCS II or BCS IV drugs. Solubility is an important factor in drug absorption and bioavailability, as drugs need to dissolve in order to be absorbed into the bloodstream and exert their therapeutic effects. Therefore, this statement is true.
31.
Hydrochloride salts are the most common salts found in commercial drug products.
Correct Answer
A. True
Explanation
Hydrochloride salts are commonly used in commercial drug products due to their stability and solubility properties. They are formed by combining an active pharmaceutical ingredient with hydrochloric acid, resulting in a salt form that is easier to handle and administer. This salt form enhances the drug's bioavailability and allows for better control of dosage. Therefore, it is true that hydrochloride salts are the most common salts found in commercial drug products.
32.
Clarithromycin for Oral Suspension must be reconstituted by the pharmacist before dispensing the product to the patient
Correct Answer
A. True
Explanation
The statement is true because Clarithromycin for Oral Suspension comes in a powder form that needs to be mixed with a specific amount of water before it can be taken by the patient. This reconstitution process ensures that the medication is properly prepared and the correct concentration is achieved. The pharmacist is responsible for accurately measuring and mixing the powder and water to create the suspension, which can then be dispensed to the patient.
33.
The Hatch-Waxman Act sets forth the process by which would-be marketers of generic drugs can file abbreviated new drug applications and seek FDA approval of the generic product
Correct Answer
A. True
Explanation
The statement is true because the Hatch-Waxman Act indeed establishes the procedure for generic drug manufacturers to submit abbreviated new drug applications (ANDAs) to the FDA and obtain approval for their generic products. This act was enacted in 1984 to encourage the production of affordable generic drugs while still protecting the rights of innovator drug companies. It created a streamlined process for generic drug approval, allowing for faster market entry and competition, ultimately benefiting consumers by providing more affordable medication options.
34.
Vegicaps are made from HPMC and contain no animal matter and are suitable for both vegetarians and vegans
Correct Answer
A. True
Explanation
The statement explains that Vegicaps are made from HPMC, which is a plant-based material, and do not contain any animal matter. It further states that Vegicaps are suitable for both vegetarians and vegans. Therefore, the correct answer is true as it aligns with the information provided.
35.
Omeprazole is unstable in acid media
Correct Answer
A. True
Explanation
Omeprazole is unstable in acid media because it is a proton pump inhibitor that works by reducing the production of stomach acid. It is designed to be stable in the neutral pH of the bloodstream, but in the acidic environment of the stomach, it can degrade and lose its effectiveness. This is why omeprazole is typically formulated in enteric-coated tablets, which protect it from the acidic conditions of the stomach and allow it to reach the intestines where it can be absorbed and work effectively.
36.
Which one of the following companies is NOT a generic pharmaceutical company?
Correct Answer
D. Merck
Explanation
Merck is not a generic pharmaceutical company because it primarily focuses on the development and manufacturing of branded prescription drugs. Unlike generic pharmaceutical companies that produce cheaper versions of brand-name drugs once the patent expires, Merck is known for its innovative and patented drugs. Therefore, Merck does not fall under the category of generic pharmaceutical companies.
37.
Prodrug is a term used to describe a compound that requires metabolic biotransformation after administration to produce the pharmacologically active compound
Correct Answer
A. True
Explanation
A prodrug is a compound that is administered in its inactive form and needs to undergo metabolic biotransformation in the body to become the active pharmacologically active compound. This process is necessary for the prodrug to exert its therapeutic effects. Therefore, the statement given in the question is true.
38.
Comminution is a proces that protects the drug from being degraded in the presence of light and moisture
Correct Answer
B. False
Explanation
Comminution is actually a process that involves reducing the size of solid materials into smaller particles. It is commonly used in the pharmaceutical industry to enhance the dissolution rate and bioavailability of drugs. It does not protect the drug from being degraded in the presence of light and moisture. Therefore, the given statement is false.
39.
High molecular weight hypromellose (HPMC) is used in a matrix tablet to retard the dissolution rates of drugs, whereas low molecular weight hypromellose is used to coat immediate relase tablets.
Correct Answer
A. True
Explanation
High molecular weight hypromellose (HPMC) is a polymer that is commonly used in pharmaceutical formulations. In the case of a matrix tablet, HPMC is used to slow down the dissolution rates of drugs. This is because the high molecular weight of HPMC forms a gel layer around the drug, which controls the release of the drug into the body. On the other hand, low molecular weight hypromellose is used to coat immediate release tablets. This coating helps in protecting the drug and controlling its release, allowing for immediate release of the drug upon ingestion. Therefore, the statement is true.
40.
Friability, tablet hardness and tablet weight uniformity are all physical properties of compressed tablets
Correct Answer
A. True
Explanation
Friability, tablet hardness, and tablet weight uniformity are all physical properties that can be measured and evaluated for compressed tablets. Friability refers to the ability of a tablet to withstand mechanical stress and remain intact during handling and packaging. Tablet hardness measures the resistance of a tablet to breakage or crumbling under pressure. Tablet weight uniformity ensures that each tablet in a batch has the same weight, which is important for accurate dosing. Therefore, it is true that these properties are all physical characteristics of compressed tablets.
41.
Recompression or slugging involves more compression and drying steps than direct compression in the manufacture of tablets
Correct Answer
B. False
Explanation
The statement is false because recompression or slugging does not involve more compression and drying steps than direct compression in tablet manufacturing. In fact, direct compression involves fewer steps as it eliminates the need for additional compression and drying processes. Recompression or slugging is a technique where the active ingredients are compressed into tablets after being mixed and dried, whereas direct compression involves directly compressing the blend of active ingredients and excipients into tablets without any prior processing steps.
42.
Levaquin, a fluoroquinolone, is levofloxacin hemihydrate
Correct Answer
A. True
Explanation
Levaquin is indeed a fluoroquinolone antibiotic, and its active ingredient is levofloxacin hemihydrate. Therefore, the statement "Levaquin, a fluoroquinolone, is levofloxacin hemihydrate" is true.
43.
Medicated powders are powders of mixtures of finely divided particles in dry form for either internal or external use
Correct Answer
A. True
Explanation
This statement is true because medicated powders are indeed mixtures of finely divided particles in dry form that can be used both internally and externally. These powders are commonly used in various medical applications, such as treating skin conditions or as a form of medication for respiratory or digestive issues. The finely divided particles allow for easy application and absorption into the body, making them an effective and convenient form of medication.
44.
Lupron contains leuprolide acetate and is used for the treatment of prostate cancer
Correct Answer
A. True
Explanation
Lupron is a medication that contains leuprolide acetate, which is indeed used for the treatment of prostate cancer. Leuprolide acetate is a hormone therapy drug that works by reducing the production of testosterone in the body, which can help slow down the growth of prostate cancer cells. Therefore, the statement is true.
45.
The absorption of doxycycline hyclate is significantly higher in the colon than in the upper small intestine
Correct Answer
B. False
Explanation
The absorption of doxycycline hyclate is not significantly higher in the colon than in the upper small intestine.
46.
Which one of the following drugs is the most stable in gastric juice?
Correct Answer
C. Aspririn
Explanation
Aspirin is the most stable drug in gastric juice. This is because aspirin is an acid-stable drug, meaning it can withstand the acidic environment of the stomach without breaking down or losing its potency. On the other hand, drugs like omeprazole, pantoprazole, and lansoprazole are proton pump inhibitors that work by reducing the production of gastric acid, while insulin is a protein-based drug that can be denatured and lose its effectiveness in the acidic environment of the stomach. Therefore, aspirin is the most stable option in gastric juice.
47.
Which salt of amlodipine is present in Norvasc?
Correct Answer
D. Besylate
Explanation
Norvasc contains the salt form of amlodipine known as besylate. The besylate salt is commonly used in pharmaceutical formulations due to its stability and bioavailability. It helps in improving the solubility and absorption of amlodipine, making it an effective treatment for high blood pressure and angina.
48.
Which of the following ingrediens in a capsule formulation will increase and enhance drug dissolution rate, break up agglomerates and help offset the hydrophobic effects of lubricants
Correct Answer
A. Sodium lauryl sulfate
Explanation
Sodium lauryl sulfate is a surfactant that is commonly used in pharmaceutical formulations to enhance drug dissolution rate. It acts by reducing the surface tension between the drug particles and the dissolution medium, thereby promoting the breakup of agglomerates and increasing the rate at which the drug dissolves. Additionally, sodium lauryl sulfate can offset the hydrophobic effects of lubricants, which can otherwise hinder drug dissolution. Therefore, the presence of sodium lauryl sulfate in a capsule formulation can help improve the dissolution properties of the drug.
49.
Regarding the use of oral liquid vehicles to compound a 30-day supply of Alprazolam (solubility in water is 45 mcg/mL at 25*C and solubility in EtOH is >20 mg/mL at 25*C), if the contents of Alprazolam capsules sufficient to make a 10mg/mL liquid product were emptied into a mortar and comminuted with a pestle to obtain a fine powder and then mixed with Simple Syrup NF, the resulting extemporaneously prepared product is a suspension
Correct Answer
A. True
Explanation
The given answer is true because when the contents of Alprazolam capsules are mixed with Simple Syrup NF, the resulting product is a suspension. This is because Alprazolam has a low solubility in water (45 mcg/mL) and a higher solubility in ethanol (>20 mg/mL), indicating that it does not dissolve completely in water. Therefore, when mixed with Simple Syrup NF, the Alprazolam particles will remain suspended in the liquid, creating a suspension rather than a solution.
50.
For colloidal dispersions, flow is an important property. Glycerin and diluted Simple Syrup NF exhibit Newtonian flow, meaning the rate of shear is linearly related to shearing stress.
Correct Answer
A. True
Explanation
Colloidal dispersions are a type of mixture where small particles are dispersed in a medium. In this case, the medium is either glycerin or diluted Simple Syrup NF. Newtonian flow refers to the property where the rate of shear (deformation) is directly proportional to the shearing stress applied. This means that as more stress is applied, the flow rate increases linearly. The statement suggests that both glycerin and diluted Simple Syrup NF exhibit this type of flow behavior, making the answer true.