1.
Added substance for multiple-dose parenterals
Correct Answer
A. Buffers
Explanation
Antioxidants are added to parenterals to ensure stability of the API, preservatives prevent contamination brought about by multiple withdrawals from the same container, and buffers ensure solubility of the API by maintaining the desired pH.
2.
An inert gas that is usually incorporated into an ampule to prevent API oxidation
Correct Answer
A. Nitrogen
Explanation
Oxygen is responsible for oxidation of API's and must be excluded from parenteral preparations. Hydrogen is not an inert gas and is very reactive while ethylene oxide is not suitable for parenteral preparations, in fact, it is hazardous and is widely used as an industrial gas and healthcare sterilant.
3.
The following are examples of small-volume parenterals, EXCEPT:
Correct Answer
A. Dialysate
Explanation
Dialysate volumes are usually large.
4.
Common uses of LVP solutions without additives include the following, EXCEPT:
Correct Answer
A. Therapeutic agent
Explanation
Only API's require additives like antioxidants, buffers, etc.
5.
Which of the following is not a source of pyrogens in parenterals?
Correct Answer
A. Freshly distilled water
Explanation
freshly distilled water does not contain microorganisms or their endotoxins causing fever in patients.
6.
Products which need to be sterile and pyrogen-free, EXCEPT:
Correct Answer
A. Otic solutions
Explanation
Otic solutions are not required to be sterile and pyrogen-free. Otic solutions are used for ear-related issues, such as ear infections, and do not need to be sterile because the ear is a self-cleaning organ. Additionally, otic solutions are not typically injected into the body, so they do not need to be pyrogen-free, which means free from fever-inducing substances. On the other hand, ophthalmic solutions, irrigating solutions, and injectables need to be sterile and pyrogen-free to ensure safety and prevent infections when used in the eyes, for irrigation, or when injected into the body, respectively.
7.
Composed of 2 security doors that can’t be opened at the same time
Correct Answer
A. Air-lock system
Explanation
An air-lock system is composed of 2 security doors that cannot be opened at the same time. This system is designed to control the flow of air and prevent the entry of contaminants from outside. It is commonly used in environments where contamination control is crucial, such as cleanrooms or laboratories. The air-lock system ensures that there is no direct access between the outside and the controlled environment, maintaining the integrity of the space and protecting it from external pollutants.
8.
Blows pre-filtered air to a controlled area to sweep off contaminants.
Correct Answer
A. HEPA filter
Explanation
A HEPA filter is a type of air filter that is designed to capture very small particles, including contaminants and allergens, from the air. It works by forcing air through a fine mesh that traps these particles, preventing them from circulating in the environment. In the given context, using a HEPA filter would help to remove contaminants from the air by blowing pre-filtered air to a controlled area, ensuring a cleaner and healthier environment.
9.
Why should bacteriostatic water for injection be used at a maximum of 5 ml only?
Correct Answer
A. It contains high conc of preservative.
Explanation
it contains high conc of preservative which already harmful to the patient
10.
Why is it not necessary for single dose parenteral preparations to carry preservatives?
Correct Answer
A. There is no danger of contamination
Explanation
since single-dose parenterals are consumed fully after opening, there is no danger of contamination.
11.
Insulin preparations are usually administered by
Correct Answer
A. SQ
Explanation
Insulin preparations are usually administered subcutaneously (SQ) because this route allows for slow and steady absorption of the insulin into the bloodstream. Subcutaneous injections are given just below the skin, into the fatty tissue, which helps to ensure a more consistent and prolonged effect of the medication. Intramuscular (IM) injections are not commonly used for insulin administration as they can lead to faster absorption and potentially unpredictable blood sugar levels. Intradermal (ID) injections are typically used for skin testing, not for insulin administration. Intravenous (IV) administration of insulin is reserved for emergency situations or in a hospital setting.
12.
The following are methods of sterilization, EXCEPT;
Correct Answer
A. Use of antimicrobials
Explanation
The use of antimicrobials is not a method of sterilization. Antimicrobials are substances that inhibit the growth of microorganisms, but they do not completely eliminate all forms of microbial life. Sterilization, on the other hand, refers to the complete destruction or removal of all forms of microbial life, including bacteria, viruses, and spores. Therefore, the use of antimicrobials cannot be considered a method of sterilization.
13.
The following are examples of non-aqeous parenteral vehicles, EXCEPT:
Correct Answer
A. Magnesium stearate
Explanation
Magnesium stearate is used as lubricant in tablets.
14.
The following are considered as sterile products, EXCEPT:
Correct Answer
A. Syrups
Explanation
Sterility is not required in syrups.
15.
A necessary component particularly for multiple dose parenterals.
Correct Answer
A. Antimicrobials
Explanation
Multiple dose parenterals require antimicrobials due to the possibility of contamination due to multiple withdrawals.
16.
Aerosol component which supplies the necessary force to expel the product from the package
Correct Answer
A. Propellant
Explanation
The propellant supplies the necessary pressure within an aerosol system to expel material from the container and, in combination with other components, to convert the material into the desired physical form.
17.
The following are advantages of aerosols as dosage forms, EXCEPT:
Correct Answer
A. Inexpensive
Explanation
Aerosols are advantageous dosage forms due to their easy application, fine particle size, and freedom from contamination. However, the given answer, "inexpensive," is incorrect because aerosols can often be more expensive compared to other dosage forms. This is because they require specialized packaging and propellant systems, which can increase production costs.
18.
The usual administration site for spinal anesthesia
Correct Answer
A. Intrathecal
Explanation
A spinal anaesthetic delivers drug to the intrathecal space (the CSF), and acts on the spinal cord directly. An epidural delivers drugs outside the dura (outside CSF), and has its main effect on nerve roots leaving the dura at the level of the epidural, rather than on the spinal cord itself.
19.
Factors that can be manipulated to compress or liquefy gases, EXCEPT:
Correct Answer
A. Vapor pressure
Explanation
Vapor pressure is not a factor that can be manipulated to compress or liquefy gases. Vapor pressure is the pressure exerted by a vapor in equilibrium with its liquid or solid phase at a given temperature. Manipulating temperature, volume, and boiling point can all affect the compression or liquefaction of gases.
20.
Aerosol preparations are used to treat problems with the following, EXCEPT:
Correct Answer
A. GIT
Explanation
Aerosol preparations are used to treat problems with the gastrointestinal tract (GIT), respiratory system, and dermal conditions. However, they are not typically used to treat vaginal problems. Vaginal issues are usually addressed with specific medications or treatments designed for that area. Therefore, the correct answer is GIT.
21.
Which is done to prevent sedimentation in preparing ointments using heat?
Correct Answer
A. Continuous stirring while cooling
Explanation
Continuous stirring while cooling is done to prevent sedimentation in preparing ointments using heat. This is because stirring helps to distribute the ingredients evenly throughout the mixture, preventing them from settling at the bottom. By continuously stirring while the ointment is cooling, the ingredients remain suspended and do not separate or form sediment. This ensures a homogeneous and smooth consistency in the final product.
22.
____ is a vegetable dye, used for centuries to impart a red tint to the hair
Correct Answer
A. Henna
Explanation
Henna is a vegetable dye that has been used for centuries to give a red tint to the hair. It is a natural and safe alternative to chemical hair dyes. Henna is derived from the leaves of the henna plant and is known for its conditioning properties as well. It is commonly used in various cultures for body art and hair coloring purposes.
23.
Antiperspirants retard perspiration because their active ingredients have ____ properties
Correct Answer
A. Astringent
Explanation
Antiperspirants retard perspiration because their active ingredients have astringent properties. Astringents are substances that cause the contraction of body tissues, which in this case, would include the sweat ducts. By constricting the sweat ducts, antiperspirants reduce the amount of sweat that is able to reach the skin's surface, thereby reducing perspiration.
24.
Consist of one or more sterile drugs added to an IV fluid
Correct Answer
A. IV admixture
Explanation
An IV admixture refers to a solution that consists of one or more sterile drugs added to an IV fluid. This solution is prepared specifically for intravenous administration to patients. It is commonly used in healthcare settings to deliver medications directly into the bloodstream for immediate effect. IV admixtures are carefully prepared to ensure the correct dosage and combination of drugs, making them a crucial component in patient care.
25.
Enteric coated tablets resist the action of gastric juices but disintegrate in the intestine.
Correct Answer
A. True
Explanation
Enteric coated tablets are designed to resist the action of gastric juices in the stomach. This is because certain medications can be sensitive to the acidic environment of the stomach and may be degraded or inactivated by gastric juices. By having an enteric coating, these tablets are able to pass through the stomach intact and reach the intestine where they disintegrate and release the medication for absorption. Therefore, the statement that enteric coated tablets resist the action of gastric juices but disintegrate in the intestine is true.
26.
Starch can be a diluent a binder and a disintegrator
Correct Answer
A. True
Explanation
Starch can serve multiple purposes in various pharmaceutical formulations. As a diluent, it helps to increase the bulk of the formulation and facilitate the manufacturing process. As a binder, it helps to hold the ingredients together and provide cohesion to the tablet or capsule. Additionally, starch can act as a disintegrator, promoting the breakdown of the dosage form in the gastrointestinal tract for better drug absorption. Therefore, the statement that starch can be a diluent, binder, and disintegrator is true.
27.
Glidants are substances that glue powders together and cause them to form granules
Correct Answer
B. False
Explanation
Glidants are substances that are used to reduce the friction between particles in a powder mixture, allowing them to flow more easily. They do not glue powders together or cause them to form granules. Therefore, the statement that glidants glue powders together and cause them to form granules is incorrect.
28.
Capping is the unequal distribution of color on the surface of the tablet.
Correct Answer
B. False
Explanation
Mottling' is the term used to describe an unequal distribution of colour on a tablet, with light or dark spots standing out in an otherwise uniform surface
29.
Poor flow of the tablet granules may result in incompletely filled dies resulting to thickness variation
Correct Answer
A. True
Explanation
The statement is explaining that if the flow of the tablet granules is poor, it can lead to incomplete filling of the dies, which in turn can cause thickness variation in the tablets. This means that some tablets may be thicker or thinner than others due to the inconsistent filling process. Therefore, the statement is true.
30.
Drugs with narrow therapeutic index do not require geometric dilution once added with diluents
Correct Answer
B. False
Explanation
Geometric dilution is a mixing process that is used when combining two or more ingredients of varying quantities together to achieve a homogeneous mixture
31.
There should be a balance between the amounts of the binder and the lubricant considering the tablet’s release characteristics and maintenance of integrity during handling.
Correct Answer
A. True
Explanation
The statement suggests that in order to achieve the desired release characteristics and maintain the tablet's integrity during handling, it is important to have a balance between the amounts of the binder and the lubricant. This implies that if there is an imbalance between these two components, it could affect the tablet's performance and structural integrity. Therefore, the statement is true.
32.
Disintegration is required as a QC test for tablets because it determines ability of the tablet to be dissolved
Correct Answer
A. True
Explanation
Disintegration is an important quality control test for tablets because it assesses the tablet's ability to dissolve. The test involves placing the tablet in a liquid medium and measuring the time it takes for the tablet to break down into smaller particles. This is crucial because if a tablet does not disintegrate properly, it may not dissolve in the body and therefore may not deliver the intended medication effectively. Therefore, the statement that disintegration is required as a QC test for tablets because it determines the ability of the tablet to be dissolved is true.
33.
The following is a reason for sieving:
Correct Answer
D. All of the choices
Explanation
Sieving is a process used to separate particles based on their size. The reason for sieving can be to reduce agglomerates, which are clumps of particles that can affect the accuracy of measurements or cause problems in processing. Sieving can also prevent stratification, which is the separation of particles based on their size or density. By sieving, particles of different sizes can be mixed together to achieve uniformity of particle size. Therefore, all of the choices - reducing agglomerates, preventing stratification, and achieving uniformity of particle size - are valid reasons for sieving.
34.
The inert substance used to increase the bulk of the tablet
Correct Answer
A. Diluent
Explanation
A diluent is an inert substance that is added to a tablet formulation to increase its bulk. It helps in achieving the desired tablet size and shape. Diluents do not have any therapeutic effect but are necessary for the manufacturing process and to ensure uniformity in tablet weight. They are typically non-reactive and easily compressible, allowing for easy tablet formation. Binders, on the other hand, are used to hold the tablet ingredients together, glidants improve the flow properties of the powder mixture, and granulators are used to form granules from the powdered ingredients.
35.
The equipment/method that can provide the shortest drying time for wet granulations
Correct Answer
B. Fluid bed dryer
Explanation
A fluid bed dryer is the equipment/method that can provide the shortest drying time for wet granulations. This type of dryer uses hot air to fluidize the particles, creating a fluid-like motion that allows for efficient and rapid drying. The hot air is evenly distributed throughout the bed of granules, ensuring uniform drying and minimizing drying time. This makes the fluid bed dryer a preferred choice for industries that require fast and efficient drying of wet granulations.
36.
Examples of primary packaging component, EXCEPT:
Correct Answer
C. Package boxes
Explanation
The question asks for an example of a primary packaging component, excluding package boxes. Primary packaging components are those that come into direct contact with the product and are essential for its protection, storage, and dispensing. Ampules, bottles, and vials are all examples of primary packaging components as they directly hold and protect the product. However, package boxes are not typically considered primary packaging components as they are used for secondary packaging, providing additional protection and branding for the primary packaging components.
37.
The part of the tablet machine used for compacting the materials
Correct Answer
C. Punches
Explanation
The part of the tablet machine used for compacting the materials is called punches. The punches are responsible for exerting pressure on the materials to form them into tablets. They apply force to compress the powder or granules in the die cavity, resulting in the formation of a solid tablet. The punches typically have a specific shape and size that determines the shape and dimensions of the tablet.
38.
The part of sugar coating process employed to round off tablet contours
Correct Answer
B. Subcoating
Explanation
Subcoating is the correct answer because it refers to the part of the sugar coating process that is used to round off tablet contours. In the sugar coating process, subcoating involves applying a layer of syrup or other coating material to the tablet to create a smooth surface. This layer helps to round off any sharp edges or contours on the tablet, resulting in a more polished and finished appearance.
39.
The separation of the tablet into 2 or more layers
Correct Answer
D. Lamination
Explanation
Lamination refers to the separation of a tablet into two or more layers. This can occur when there is an issue with the tablet formulation or manufacturing process, causing the layers to separate. It may result from inadequate compression during tablet production or the use of incompatible excipients. Lamination can affect the integrity and effectiveness of the tablet, leading to potential issues with drug release and absorption.
40.
The following are considered as tablets for solution, EXCEPT:
Correct Answer
D. Sublingual tablet
Explanation
Sublingual tablets are not considered tablets for solution because they are designed to be placed under the tongue and allowed to dissolve, rather than being dissolved in a liquid for consumption. Effervescent tablets are designed to dissolve in water to create a fizzy solution, hypodermic tablets are designed to be dissolved in a liquid for injection, and "none of the choices" implies that all of the options listed are considered tablets for solution. Therefore, the correct answer is sublingual tablet.
41.
The bioavailability of the drug is dependent on tablet
Correct Answer
B. Dissolution
Explanation
The bioavailability of a drug refers to the extent and rate at which it is absorbed into the bloodstream and becomes available for the body to use. In this context, dissolution refers to the process by which the drug dissolves in the gastrointestinal tract. The faster and more completely a drug dissolves, the higher its bioavailability. Therefore, the dissolution of the tablet is a crucial factor in determining the bioavailability of the drug.
42.
The following affect significantly the disintegration time of tablets, EXCEPT:
Correct Answer
A. Diluent
Explanation
The disintegration time of tablets is affected by various factors, such as the type and amount of binder, disintegrant, and lubricant used. However, the diluent does not have a significant impact on the disintegration time. Diluents are used to increase the bulk of the tablet and aid in the manufacturing process, but they do not directly influence the disintegration process. Therefore, the correct answer is diluent.
43.
Colors and dyes in tablet formulations serve these purposes , EXCEPT:
Correct Answer
B. To disguise unpleasant-tasting drugs
Explanation
The purpose of colors and dyes in tablet formulations is to disguise off-colored drugs, provide product identification, and produce more elegant products. However, it is not used to disguise unpleasant-tasting drugs.
44.
The use of too much binder will adversely affect
Correct Answer
D. All of the choices
Explanation
Using too much binder in a formulation can have negative effects on bioavailability, disintegration time, and dissolution rate. Binder is used to hold the ingredients together in a tablet or capsule, but an excessive amount can hinder the release and absorption of the active ingredient. It can slow down the disintegration of the dosage form, making it difficult for the drug to break down and be absorbed by the body. Additionally, an excessive binder can impede the dissolution rate, reducing the drug's ability to dissolve and become available for absorption. Therefore, all of the choices are adversely affected by the excessive use of binder.
45.
Type of tablet not requiring disntegration testing
Correct Answer
A. Chewable tablet
Explanation
Chewable tablets do not require disintegration testing because they are designed to be chewed and dissolved in the mouth rather than swallowed whole. Disintegration testing is conducted to ensure that a tablet breaks down and disperses its active ingredients within a specified time frame. However, chewable tablets are formulated to disintegrate quickly in the mouth, allowing for easy administration and absorption of the medication. Therefore, they do not need to undergo disintegration testing.
46.
The length of time that a drug is within the required specification is defined as
Correct Answer
C. Shelf life
Explanation
The term "shelf life" refers to the length of time that a drug remains stable and maintains its effectiveness while stored under proper conditions. It is the period during which the drug is expected to retain its quality, potency, and safety. The shelf life of a drug is determined through various stability studies and testing, and it is typically indicated by an expiration date on the drug packaging. Therefore, "shelf life" is the correct answer to the question.
47.
The ability of a formulation to remain within its physical, chemical, therapeutic and toxicological specification is termed
Correct Answer
A. Stability
Explanation
Stability refers to the ability of a formulation to maintain its physical, chemical, therapeutic, and toxicological properties within the specified range. It ensures that the formulation remains effective and safe for use over a period of time. Shelf life refers to the duration during which a product can be stored and used without significant deterioration. Expiration date is the date after which a product should not be used as it may no longer be safe or effective. Beyond use date is used in compounding pharmacies and refers to the date after which a compounded product should not be used. Therefore, stability is the most appropriate term to describe the ability of a formulation to maintain its specifications.
48.
The best method to compress two ingredients which are chemically incompatible with each other
Correct Answer
B. Layered compression
Explanation
Layered compression is the best method to compress two ingredients that are chemically incompatible with each other. In layered compression, the two ingredients are compressed separately into individual layers and then combined together. This method ensures that the incompatible ingredients do not come into direct contact with each other, reducing the chances of any chemical reactions or incompatibilities. Layered compression allows for effective compression of the ingredients while maintaining their stability and preventing any undesirable interactions.
49.
The following are mechanisms of disintegrant action, EXCEPT:
Correct Answer
D. All of the choices
Explanation
The correct answer is "all of the choices." This means that all of the given mechanisms, including swelling, air displacement, and effervescence, are not mechanisms of disintegrant action. Disintegrants are substances that help in the breakdown of tablets or capsules into smaller particles, aiding in their dissolution and absorption in the body. However, none of the mechanisms mentioned in the options are associated with this action.
50.
The reason why surfactant is used in the non-aqueous film coat
Correct Answer
C. To quicken spreading of the coat before complete evaporation occurs
Explanation
Surfactants are used in the non-aqueous film coat to quicken the spreading of the coat before complete evaporation occurs. Surfactants are compounds that lower the surface tension of a liquid, allowing it to spread more easily. In the case of a non-aqueous film coat, the surfactant helps to evenly distribute the coat over the surface before it evaporates. This prevents mottling, which is the uneven distribution of the film coat, and also prevents bridging, which is the formation of gaps or unevenness in the coat. By quickening the spreading process, the surfactant ensures a smooth and uniform film coat.