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Used in pharmacy and the pharmaceutical sciences to encompass a wide range of
subject areas that are all associated with the steps to which a drug is subjected
towards the end of its development.
Used in pharmacy and the pharmaceutical sciences to encompass a wide range of subject areas that are all associated with the steps to which a drug is subjected towards the end of its development.
PHARMACEUTICS
It encompasses the stages that follow on from the discovery or synthesis of the drug, its isolation
and purification, and its testing for beneficial pharmacological effects and absence of serious
toxicological problems.
It encompasses the stages that follow on from the discovery or synthesis of the drug, its isolation and purification, and its testing for beneficial pharmacological effects and absence of serious toxicological problems.
PHARMACEUTICS
converts a drug into medicine
converts a drug into medicine
PHARMACEUTICS
An agent intended for use in the diagnosis, mitigation,
treatment, cure, or prevention of disease.
An agent intended for use in the diagnosis, mitigation, treatment, cure, or prevention of disease.
A formulation that typically contains the API(s) and excipients
in quantities and physical form design to facilitate the
accurate and efficient administration of the API to the human
or animal patient,
A formulation that typically contains the API(s) and excipients in quantities and physical form design to facilitate the accurate and efficient administration of the API to the human or animal patient,
Modern technology, distributed with or as part of a drug
product that allows for the uniform release or targeting of
drugs to the body.
Modern technology, distributed with or as part of a drug product that allows for the uniform release or targeting of drugs to the body.
refers to the variability in
response to drug therapies in humans
refers to the variability in response to drug therapies in humans
Many genetic and non-genetic factors affect the
way we respond to therapies
Many genetic and non-genetic factors affect the way we respond to therapies
Factors such as cultural, behavioral, and
environmental could have an enormous
impact on the extent of these variations
Factors such as cultural, behavioral, and environmental could have an enormous impact on the extent of these variations
Genetic factors account for up
to ___% in the variations in
response to treatment.
Genetic factors account for up to ___% in the variations in response to treatment.
Need for higher or more frequent doses of drugs
that are acetylated (eg, isoniazid) to produce the
desired therapeutic response
Need for higher or more frequent doses of drugs that are acetylated (eg, isoniazid) to produce the desired therapeutic response
Increased susceptibility to adverse effects of drugs
that are acetylated (eg, with isoniazid, peripheral
neuritis; with hydralazine or procainamide, lupus)
Increased susceptibility to adverse effects of drugs that are acetylated (eg, with isoniazid, peripheral neuritis; with hydralazine or procainamide, lupus)
With alcohol ingestion, marked elevations of blood
acetaldehyde, causing facial flushing, increased
heart rate, diaphoresis, muscle weakness, and
sometimes catecholamine-mediated vasodilation
with euphoria
With alcohol ingestion, marked elevations of blood acetaldehyde, causing facial flushing, increased heart rate, diaphoresis, muscle weakness, and sometimes catecholamine-mediated vasodilation with euphoria
Reduced enzymatic activation of clopidogrel,
resulting in reduced antiplatelet effect and
increased risk of thrombosis in high-risk patients
Reduced enzymatic activation of clopidogrel, resulting in reduced antiplatelet effect and increased risk of thrombosis in high-risk patients
With use of oxidant drugs, such as certain
antimalarials (eg, chloroquine, primaquine),
increased risk of hemolytic anemia
With use of oxidant drugs, such as certain antimalarials (eg, chloroquine, primaquine), increased risk of hemolytic anemia
is an important example
of the field of precision medicine, which aims
to tailor medical treatment to each person or
to a group of people.
is an important example of the field of precision medicine, which aims to tailor medical treatment to each person or to a group of people.
looks at how your DNA affects
the way you respond to
drugs.
looks at how your DNA affects the way you respond to drugs.
can improve your health
by helping you know ahead of time whether a
drug is likely to benefit you and be safe for
you to take.
can improve your health by helping you know ahead of time whether a drug is likely to benefit you and be safe for you to take.
The study of genetic
causes of individual
variations in drug
response
The study of genetic causes of individual variations in drug response
The simultaneous impact of
multiple mutations in the
genome that may determine the
patient’s response to drug
therapy.
The simultaneous impact of multiple mutations in the genome that may determine the patient’s response to drug therapy.
studies use information contained in metabolic profiles (or
metabolome) to inform about how a subject will respond to drug treatment.
studies use information contained in metabolic profiles (or metabolome) to inform about how a subject will respond to drug treatment.
Genome, gut microbiome, sex, nutrition, age, stress, health status, and other factors can impact
the metabolic profile of an individual.
Genome, gut microbiome, sex, nutrition, age, stress, health status, and other factors can impact the metabolic profile of an individual.
Metabolomic profiles obtained prior to, during, or after drug treatment could provide insights
about drug mechanism of action and variation of response to treatment.
Metabolomic profiles obtained prior to, during, or after drug treatment could provide insights about drug mechanism of action and variation of response to treatment.
Build models to predict individual drug pharmacokinetic/pharmacodynamic probabilities
Build models to predict individual drug pharmacokinetic/pharmacodynamic probabilities
Build models based on the actual drug pharmacokinetic/pharmacodynamic response(s) by an individual or group
Build models based on the actual drug pharmacokinetic/pharmacodynamic response(s) by an individual or group
An individual’s metabolic
profile has been referred to
as his or her _________
An individual’s metabolic profile has been referred to as his or her _________
Is a field of science
focusing on studying the effect of biological
rhythms on pharmacotherapy, i.e., a branch of
pharmacology studying the dependencies
between the timing of drug administration and
its effect.
Is a field of science focusing on studying the effect of biological rhythms on pharmacotherapy, i.e., a branch of pharmacology studying the dependencies between the timing of drug administration and its effect.
___________ are self-supporting
oscillations of physiological phenomena generated and controlled by endogenic
“biological clocks”, characterized by repeatability.
___________ are self-supporting oscillations of physiological phenomena generated and controlled by endogenic “biological clocks”, characterized by repeatability.
A self-evident physiological feature of living organisms is the fact that biological
phenomena are not invariable over time, but manifest rhythmicity—at the
systemic, organ, and cellular level.
A self-evident physiological feature of living organisms is the fact that biological phenomena are not invariable over time, but manifest rhythmicity—at the systemic, organ, and cellular level.
Which two substances react to create the pharmaceutical mixture known as ELIXIR?
Which two substances react to create the pharmaceutical mixture known as ELIXIR?
Creation of the ____ is to administer and enforce FD&C ACT of 1938
Creation of the ____ is to administer and enforce FD&C ACT of 1938
Prohibits the distribution and use of any new drug or drug product without the prior filing of a new drug application (NDA) and approval of the FDA.
Prohibits the distribution and use of any new drug or drug product without the prior filing of a new drug application (NDA) and approval of the FDA.
Which law includes the statement: "Caution: Federal Law Prohibits Dispensing Without Prescription."?
Which law includes the statement: "Caution: Federal Law Prohibits Dispensing Without Prescription."?
New drug is required to file an investigational new-drug application (IND) with the
FDA before the drug may be clinically tested on human subjects
New drug is required to file an investigational new-drug application (IND) with the FDA before the drug may be clinically tested on human subjects
What condition is associated with the use of Thalidomide?
What condition is associated with the use of Thalidomide?
New drug is required to file an investigational new-drug application (IND) with the
FDA before the drug may be clinically tested on human subjects
New drug is required to file an investigational new-drug application (IND) with the FDA before the drug may be clinically tested on human subjects
Which federal act serves to consolidate and codify control authority over drugs of abuse into a single statute, is administered by the Drug Enforcement Administration (DEA), and established five schedules with decreasing levels of control?
Which federal act serves to consolidate and codify control authority over drugs of abuse into a single statute, is administered by the Drug Enforcement Administration (DEA), and established five schedules with decreasing levels of control?
Drugs with no accepted medical use, or other substances with a high potential for abuse.
Drugs with no accepted medical use, or other substances with a high potential for abuse.
Drugs with accepted medical uses and a high potential for abuse that if abused may lead to severe psychologic or physical dependence
Drugs with accepted medical uses and a high potential for abuse that if abused may lead to severe psychologic or physical dependence
Drugs with accepted medical uses and a potential for specified quantities of codeine, abuse less than those listed in schedules I and Il that if abused may lead to moderate psychologic or physical dependence.
Drugs with accepted medical uses and a potential for specified quantities of codeine, abuse less than those listed in schedules I and Il that if abused may lead to moderate psychologic or physical dependence.
Drugs with accepted medical uses and low potential for abuse relative to those in Schedule Ill that if abused may lead to limited physical dependence or psychologic dependence relative to drugs in schedule Ill.
Drugs with accepted medical uses and low potential for abuse relative to those in Schedule Ill that if abused may lead to limited physical dependence or psychologic dependence relative to drugs in schedule Ill.
Drugs with accepted medical uses and low potential for abuse relative to those in schedule IV that if abused may lead to limited physical dependence or psychologic dependence relative to drugs in schedule IV.
Drugs with accepted medical uses and low potential for abuse relative to those in schedule IV that if abused may lead to limited physical dependence or psychologic dependence relative to drugs in schedule IV.
The Pregnancy Category 'X' indicates that a drug is contraindicated during pregnancy due to:
The Pregnancy Category 'X' indicates that a drug is contraindicated during pregnancy due to:
The FDA has established _____ categories that can be used to
estimate the potential of a systemically absorbed drug for
causing birth defects.
The FDA has established _____ categories that can be used to estimate the potential of a systemically absorbed drug for causing birth defects.
Appropriate human studies - no risk
Appropriate human studies - no risk
Insufficient human studies, but animal research suggests safety or: Animal studies show issues but human studies show safety
Insufficient human studies, but animal research suggests safety or: Animal studies show issues but human studies show safety
Insufficient human studies, but animal studies show problems or: No animal studies, and insufficient human studies
Insufficient human studies, but animal studies show problems or: No animal studies, and insufficient human studies
Human studies, with/without animal research show fetal risks, but the drug is important to some women to treat their conditions
Human studies, with/without animal research show fetal risks, but the drug is important to some women to treat their conditions
Fetal risks are evident; there are no situations where the risk/benefit justifies use
Fetal risks are evident; there are no situations where the risk/benefit justifies use
Marketed product that presents a threat or a potential threat to consumer safety
Marketed product that presents a threat or a potential threat to consumer safety
Reported problems may include product defects, product adulteration, container leakage, improper labeling, unexpected adverse reactions, and others.
Reported problems may include product defects, product adulteration, container leakage, improper labeling, unexpected adverse reactions, and others.
[Product Recall Classification] There is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death
[Product Recall Classification] There is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death
[Product Recall Classification] The use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or the probability of serious adverse health consequences is remote.
[Product Recall Classification] The use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or the probability of serious adverse health consequences is remote.
[Product Recall Classification] The use of or exposure to a violative product is not likely to cause adverse health consequences.
Unlikely to Cause Any Adverse
Health Reaction
[Product Recall Classification] The use of or exposure to a violative product is not likely to cause adverse health consequences.
Unlikely to Cause Any Adverse Health Reaction
________ are the FDA's strongest labeling requirements for high-risk medicines.
________ are the FDA's strongest labeling requirements for high-risk medicines.
Chloramphenicol is an example of a drug with a black box warning.
Chloramphenicol is an example of a drug with a black box warning.
Advertisements that serve to remind health care professionals of a product's availability (so-called reminder ads) are not allowed for products with "black box" warnings.
Advertisements that serve to remind health care professionals of a product's availability (so-called reminder ads) are not allowed for products with "black box" warnings.
Providing rate-controlled drug action is a common need for dosage forms.
Providing rate-controlled drug action is a common need for dosage forms.
Protecting the drug substance from atmospheric oxygen or humidity is not a reason for the development of dosage forms.
Protecting the drug substance from atmospheric oxygen or humidity is not a reason for the development of dosage forms.
Concealing the bitter, salty, or offensive taste or odor of a drug substance is a common purpose for dosage forms.
Concealing the bitter, salty, or offensive taste or odor of a drug substance is a common purpose for dosage forms.
Insertion of a drug into one of the body's orifices is not a need that justifies the creation of dosage forms.
Insertion of a drug into one of the body's orifices is not a need that justifies the creation of dosage forms.
Providing optimal drug action through inhalation therapy is a primary reason for the development of certain dosage forms.
Providing optimal drug action through inhalation therapy is a primary reason for the development of certain dosage forms.
Is the process of optimizing a drug through
determination and/or definition of those physical and chemical
properties considered important in the formulation of a stable,
effective, and safe dosage forms.
Is the process of optimizing a drug through determination and/or definition of those physical and chemical properties considered important in the formulation of a stable, effective, and safe dosage forms.
It involves parameters such as dissolution, polymorphic forms, and crystal size and shape, pH profile of stability, and drug-excipient interactions, which may have a profound effect on a drug’s physiological availability and physical and chemical stability. This process is known as [blank].
It involves parameters such as dissolution, polymorphic forms, and crystal size and shape, pH profile of stability, and drug-excipient interactions, which may have a profound effect on a drug’s physiological availability and physical and chemical stability. This process is known as [blank].
What effect does decreasing particle size have on drug solubility?
What effect does decreasing particle size have on drug solubility?
How can the purity of a chemical substance be assessed?
How can the purity of a chemical substance be assessed?
Which of the following significantly affects the flow characteristics of a powder drug formulation?
Which of the following significantly affects the flow characteristics of a powder drug formulation?
What does the phase rule help illustrate in drug formulations?
What does the phase rule help illustrate in drug formulations?
Polymorphism in drug substances can lead to variations in which property?
Polymorphism in drug substances can lead to variations in which property?
What is the primary function of a microscopic examination of drug substances?
What is the primary function of a microscopic examination of drug substances?
Which factor primarily influences the solubility of a drug in solution?
Which factor primarily influences the solubility of a drug in solution?
What parameter is crucial for assessing the therapeutic efficacy of a drug?
What parameter is crucial for assessing the therapeutic efficacy of a drug?
Which property indicates a characteristic of pure substances relating to their physical state?
Which property indicates a characteristic of pure substances relating to their physical state?
How does solubility relate to the physicochemical properties of a drug substance?
How does solubility relate to the physicochemical properties of a drug substance?
The oil-water partition coefficient measures a molecule's preference for the _______ phase.
The oil-water partition coefficient measures a molecule's preference for the _______ phase.
To produce a biologic response, the drug molecule must first cross a biologic _______.
To produce a biologic response, the drug molecule must first cross a biologic _______.
The time it takes for the drug to dissolve in fluids at the absorption site is referred to as the _______ rate.
The time it takes for the drug to dissolve in fluids at the absorption site is referred to as the _______ rate.
A drug that is not lipid-soluble typically struggles to pass through the _______ barrier.
A drug that is not lipid-soluble typically struggles to pass through the _______ barrier.
Passive diffusion allows the absorption of _______-soluble substances.
Passive diffusion allows the absorption of _______-soluble substances.
What is primarily responsible for the absorption of lipid-soluble substances across biological membranes?
What is primarily responsible for the absorption of lipid-soluble substances across biological membranes?
What does the dissolution rate refer to in the context of drug absorption?
What does the dissolution rate refer to in the context of drug absorption?
What does the oil-water partition coefficient indicate about a drug molecule?
What does the oil-water partition coefficient indicate about a drug molecule?
Which statement best explains the concept of partition coefficient in pharmacology?
Which statement best explains the concept of partition coefficient in pharmacology?
What is generally regarded as the rate-limiting step in drug absorption?
What is generally regarded as the rate-limiting step in drug absorption?
acts as a
lipid barrier to most drugs
and permits the absorption
of lipid-soluble substances
by passive diffusion.
acts as a lipid barrier to most drugs and permits the absorption of lipid-soluble substances by passive diffusion.
To produce a biologic response,
the drug molecule must first
cross a biologic membrane.
To produce a biologic response, the drug molecule must first cross a biologic membrane.
the time it
takes for the drug to dissolve
in fluids at the absorption
site
the time it takes for the drug to dissolve in fluids at the absorption site
Rate-limiting step in
absorption
Rate-limiting step in absorption
Its preference for hydrophilic or
lipophilic phase.
Its preference for hydrophilic or lipophilic phase.
These type of substance absorb
Moisture from the atmosphere
These type of substance absorb Moisture from the atmosphere
The phenomenon by which substances exposed to air absorb moisture from the atmosphere
The phenomenon by which substances exposed to air absorb moisture from the atmosphere
This is the phenomenon by which substances when exposed to atmosphere loose moisture
This is the phenomenon by which substances when exposed to atmosphere loose moisture
These substances get wet after absorbing moisture.
The hygroscopic liquids get diluted
These substances get wet after absorbing moisture. The hygroscopic liquids get diluted
These substances change their state when they absorb moisture
These substances change their state when they absorb moisture
These loose water and change
from amorphous to crystalline
These loose water and change from amorphous to crystalline
Will tend to absorb moisture
from the air
Will tend to absorb moisture from the air
will absorb moisture from
the air and liquefy
will absorb moisture from the air and liquefy
may give up their water of
crystallization and may become damp or pasty.
may give up their water of crystallization and may become damp or pasty.
Extent of ionization has an important effect on
the formulation and pharmacokinetic parameters
of the drug.
Extent of ionization has an important effect on the formulation and pharmacokinetic parameters of the drug.
In pharmacokinetics, the extent of ionization of a
drug has a strong effect on its extent of
absorption, distribution, an elimination.
In pharmacokinetics, the extent of ionization of a drug has a strong effect on its extent of absorption, distribution, an elimination.
Which statement is true regarding organic salts and their use in drugs?
Which statement is true regarding organic salts and their use in drugs?
Is it correct to say that chloramphenicol has low water solubility, but its succinate ester is formed to increase the water solubility of the drug and facilitate parenteral administration?
Is it correct to say that chloramphenicol has low water solubility, but its succinate ester is formed to increase the water solubility of the drug and facilitate parenteral administration?
What is one of the primary reasons for preparing drugs as esters?
What is one of the primary reasons for preparing drugs as esters?
Which statement accurately describes the use of esters in pharmacy?
Which statement accurately describes the use of esters in pharmacy?
In drug formulation, which form is often used alongside the ester form?
In drug formulation, which form is often used alongside the ester form?
What is one of the advantages of using esters as prodrugs?
What is one of the advantages of using esters as prodrugs?
Which of the following is NOT a reason for preparing a drug in an ester form?
Which of the following is NOT a reason for preparing a drug in an ester form?
“Potency-designated drugs”- the bulk substance, or API, is not 100%
active drug in all cases.
“Potency-designated drugs”- the bulk substance, or API, is not 100% active drug in all cases.
Potency-designated active pharmaceutical ingredients are always 100% active drugs.
Potency-designated active pharmaceutical ingredients are always 100% active drugs.
Proteins are inherently stable molecules that require minimal handling in pharmaceutical preparations.
Proteins are inherently stable molecules that require minimal handling in pharmaceutical preparations.
The bulk of many manufactured protein products may consist of excipients such as buffers and stabilizers.
The bulk of many manufactured protein products may consist of excipients such as buffers and stabilizers.
Complex organic molecules used in pharmaceuticals are primarily carbohydrates.
Complex organic molecules used in pharmaceuticals are primarily carbohydrates.
Understanding the assayed potency designation of an ingredient is crucial for dosing accuracy.
Understanding the assayed potency designation of an ingredient is crucial for dosing accuracy.
What does stability refer to in the context of pharmaceutical products?
What does stability refer to in the context of pharmaceutical products?
Each active ingredient retains its chemical integrity and labeled potency within specified limits.
Each active ingredient retains its chemical integrity and labeled potency within specified limits.
The original physical properties, including appearance, palatability, uniformity, dissolution, and suspendability, are retained.
The original physical properties, including appearance, palatability, uniformity, dissolution, and suspendability, are retained.
Sterility or resistance to microbial growth is retained according to specified requirements. Antimicrobial agents retain effectiveness within specified limits.
Sterility or resistance to microbial growth is retained according to specified requirements. Antimicrobial agents retain effectiveness within specified limits.
The therapeutic effect remains unchanged.
The therapeutic effect remains unchanged.
No significant increase in toxicity occurs.
No significant increase in toxicity occurs.
Long Term Protocol for Drug and/or Drug Product Stability Studies
Long Term Protocol for Drug and/or Drug Product Stability Studies
Intermediate Protocol for Drug and/or Drug Product Stability Studies
Intermediate Protocol for Drug and/or Drug Product Stability Studies
Accelerated Protocol for Drug and/or Drug Product Stability Studies
Accelerated Protocol for Drug and/or Drug Product Stability Studies
Which of the following best describes the purpose of stability testing?
Which of the following best describes the purpose of stability testing?
What is the main goal of accelerated stability studies?
What is the main goal of accelerated stability studies?
The time period during which a drug product is expected to remain within the approved shelf life specification, provided that it is stored under the conditions defined on the container label, is known as what?
The time period during which a drug product is expected to remain within the approved shelf life specification, provided that it is stored under the conditions defined on the container label, is known as what?
What is the term for the date placed on the container label of a drug product designating the time prior to which a batch of product is expected to remain within the approved shelf life specification, provided that it is stored under the conditions defined on the container label?
What is the term for the date placed on the container label of a drug product designating the time prior to which a batch of product is expected to remain within the approved shelf life specification, provided that it is stored under the conditions defined on the container label?
According to the USP, what is defined as "that which holds the article and is or may be in direct contact with the article"?
According to the USP, what is defined as "that which holds the article and is or may be in direct contact with the article"?
What is meant by the term 'immediate container' in pharmacology?
What is meant by the term 'immediate container' in pharmacology?
Which of the following describes a container that holds a quantity of drug intended as a single dose and, when opened, cannot be resealed with assurance that sterility has been maintained?
Which of the following describes a container that holds a quantity of drug intended as a single dose and, when opened, cannot be resealed with assurance that sterility has been maintained?
What is a hermetic container that permits withdrawal of successive portions of the contents without changing the strength or endangering the quality or purity of the remaining portion?
What is a hermetic container that permits withdrawal of successive portions of the contents without changing the strength or endangering the quality or purity of the remaining portion?
Which type of container is impervious to air or any other gas under the ordinary or customary conditions of handling, shipment, storage, and distribution?
Which type of container is impervious to air or any other gas under the ordinary or customary conditions of handling, shipment, storage, and distribution?
Which type of container protects the contents from contamination by extraneous liquids, solids, or vapors; from efflorescence, deliquescence, or evaporation under ordinary or customary conditions of handling, shipment, storage, and distribution, and is capable of tight reclosure?
Which type of container protects the contents from contamination by extraneous liquids, solids, or vapors; from efflorescence, deliquescence, or evaporation under ordinary or customary conditions of handling, shipment, storage, and distribution, and is capable of tight reclosure?
Which type of container protects the contents from extraneous solids and from loss of the article under ordinary conditions of handling, shipment, storage, and distribution?
Which type of container protects the contents from extraneous solids and from loss of the article under ordinary conditions of handling, shipment, storage, and distribution?
What does the Water Attack test measure?
What does the Water Attack test measure?
Highly resistant borosilicate glass
Highly resistant borosilicate glass
Treated soda lime glass
Treated soda lime glass
Soda lime glass
Soda lime glass
General purpose soda lime glass
General purpose soda lime glass
Which material is rigid, has good clarity, but is unsuitable for gamma sterilization?
Which material is rigid, has good clarity, but is unsuitable for gamma sterilization?
Which of the following statements about APET and PETG are true? (Select all that apply)
Which of the following statements about APET and PETG are true? (Select all that apply)
Which substance is known as di-ethyl-hydroxy-phtalat?
Which substance is known as di-ethyl-hydroxy-phtalat?
Leaching can occur in PVC bags used for drug storage.
Leaching can occur in PVC bags used for drug storage.
What drugs are mentioned as examples in the context of PVC bag considerations?
What drugs are mentioned as examples in the context of PVC bag considerations?
Match the following terms related to drug-plastic considerations:
Match the following terms related to drug-plastic considerations:
Which of the following are basic designs of child-resistant containers? (Select all that apply)
Which of the following are basic designs of child-resistant containers? (Select all that apply)
Which of the following factors are associated with non-compliance in medication adherence? (Select all that apply)
Which of the following factors are associated with non-compliance in medication adherence? (Select all that apply)
What is the purpose of oral contraceptive compacts?
What is the purpose of oral contraceptive compacts?
What is the definition of a tamper-evident package?
What is the definition of a tamper-evident package?
What type of packaging is sealed around a product and requires the film to be cut or torn to remove the product?
What type of packaging is sealed around a product and requires the film to be cut or torn to remove the product?
What type of packaging consists of individually sealed dose units where removal requires tearing or breaking the individual compartments?
What type of packaging consists of individually sealed dose units where removal requires tearing or breaking the individual compartments?
What packaging method involves a product and its container being sealed in plastic, usually mounted on a display card, and requires cutting or breaking the plastic to remove the product?
What packaging method involves a product and its container being sealed in plastic, usually mounted on a display card, and requires cutting or breaking the plastic to remove the product?
What type of packaging is described as shrunk by heat or drying to conform to a cap and must be torn to open the package?
What type of packaging is described as shrunk by heat or drying to conform to a cap and must be torn to open the package?
What type of packaging is described as a sealed individual packet that must be torn to reach the product?
What type of packaging is described as a sealed individual packet that must be torn to reach the product?
What is the term for paper or foil sealed to the mouth of a container under the cap that must be torn or broken to reach the product?
What is the term for paper or foil sealed to the mouth of a container under the cap that must be torn or broken to reach the product?
What type of seal is described as paper or foil sealed over a carton flap or bottle cap that must be torn or broken to reach the product?
What type of seal is described as paper or foil sealed over a carton flap or bottle cap that must be torn or broken to reach the product?
What type of container is described as having a plastic or metal tearaway cap that must be broken to remove?
What type of container is described as having a plastic or metal tearaway cap that must be broken to remove?
What type of container has a seal over the mouth that must be punctured to access the product?
What type of container has a seal over the mouth that must be punctured to access the product?
Carton flaps sealed; carton cannot be
opened without damage
Carton flaps sealed; carton cannot be opened without damage
Which of the following options is designed to be tamper-resistant?
Which of the following options is designed to be tamper-resistant?
What is the significance of proper storage conditions for pharmaceutical preparations?
What is the significance of proper storage conditions for pharmaceutical preparations?
What term describes any temperature not exceeding 8°C (46°F)?
What term describes any temperature not exceeding 8°C (46°F)?
What is the ideal storage temperature range for pharmaceuticals in a refrigerator?
What is the ideal storage temperature range for pharmaceuticals in a refrigerator?
What temperature range defines a freezer in Celsius?
What temperature range defines a freezer in Celsius?
What is the temperature range that qualifies as 'cool' for storage purposes?
What is the temperature range that qualifies as 'cool' for storage purposes?
What is the range of room temperature that is considered acceptable in a working area?
What is the range of room temperature that is considered acceptable in a working area?
What is the definition of 'warm' in terms of temperature?
What is the definition of 'warm' in terms of temperature?
Excessive heat is defined as temperatures above 40°C (104°F).
Excessive heat is defined as temperatures above 40°C (104°F).
The addition of flavoring agents to liquid medication can mask the disagreeable taste. What is the purpose of this practice?
The addition of flavoring agents to liquid medication can mask the disagreeable taste. What is the purpose of this practice?
In '________' flavors, one doesn't necessarily know the exact chemical composition.
In '________' flavors, one doesn't necessarily know the exact chemical composition.
Which of the following describes a substance used to impart flavor that is not derived from a spice, fruit or fruit juice, vegetable or vegetable juice, edible yeast, herb, bark, bud, root, leaf or similar plant material, meat, fish, poultry, eggs, dairy products, or fermentation products thereof?
Which of the following describes a substance used to impart flavor that is not derived from a spice, fruit or fruit juice, vegetable or vegetable juice, edible yeast, herb, bark, bud, root, leaf or similar plant material, meat, fish, poultry, eggs, dairy products, or fermentation products thereof?
What term describes any aromatic vegetable substance in whole, broken, or ground form, except substances traditionally regarded as foods, such as onions, garlic, and celery, whose significant function in food is seasoning rather than nutritional, that is true to name, and from which no portion of any volatile oil or other flavoring principle has been removed?
What term describes any aromatic vegetable substance in whole, broken, or ground form, except substances traditionally regarded as foods, such as onions, garlic, and celery, whose significant function in food is seasoning rather than nutritional, that is true to name, and from which no portion of any volatile oil or other flavoring principle has been removed?
Which of the following options are all derived from ABCD? (Select the correct answer)
Which of the following options are all derived from ABCD? (Select the correct answer)
At least one component and artificial-derived from ABCD.
No definition of natural to artificial ratio.
At least one component and artificial-derived from ABCD. No definition of natural to artificial ratio.
All components natural.
At least one component derived from ABCD.
All components natural. At least one component derived from ABCD.
All components natural.
No components derived from ABCD.
All components natural. No components derived from ABCD.
All components are artificial.
All components are artificial.
May contain artificial flavors. No reference point. May only have to
declare in ingredient declaration.
May contain artificial flavors. No reference point. May only have to declare in ingredient declaration.
Which of the following statements about saccharin are true? (Select all that apply)
Which of the following statements about saccharin are true? (Select all that apply)
Cyclamate is metabolized, or processed, in the digestive tract, and its by-products are excreted by the kidneys.
Cyclamate is metabolized, or processed, in the digestive tract, and its by-products are excreted by the kidneys.
ASPARTAME breaks down in the body into three basic components: the amino acids phenylalanine, aspartic acid, and methanol. It is contraindicated in individuals with PKU.
ASPARTAME breaks down in the body into three basic components: the amino acids phenylalanine, aspartic acid, and methanol. It is contraindicated in individuals with PKU.
Acesulfame potassium is structurally similar to saccharin and is excreted unchanged in the urine.
Acesulfame potassium is structurally similar to saccharin and is excreted unchanged in the urine.
Which of the following statements about STEVIA extract from the leaves of the plant Stevia rebaudiana bertoni is correct?
Which of the following statements about STEVIA extract from the leaves of the plant Stevia rebaudiana bertoni is correct?
Which of the following sweetening agents is the most potent?
Which of the following sweetening agents is the most potent?
Which of the following statements about coal tar (pix carbonis) is true?
Which of the following statements about coal tar (pix carbonis) is true?
What is coal tar (pix carbonis) primarily known for in the pharmaceutical industry during the mid-19th century?
What is coal tar (pix carbonis) primarily known for in the pharmaceutical industry during the mid-19th century?
What is typically added to pharmaceutical preparations in the form of diluted solutions?
What is typically added to pharmaceutical preparations in the form of diluted solutions?
Which of the following is commonly used in the form of fine dispersions or suspensions?
Which of the following is commonly used in the form of fine dispersions or suspensions?
What does the FDA regulate under the Federal Food, Drug, and Cosmetic Act of 1938 regarding color additives?
What does the FDA regulate under the Federal Food, Drug, and Cosmetic Act of 1938 regarding color additives?
What is aniline primarily used for in the dye industry?
What is aniline primarily used for in the dye industry?
Which of the following are considered FD&C color additives used in foods, drugs, and cosmetics?
Which of the following are considered FD&C color additives used in foods, drugs, and cosmetics?
Which type of color additives are used in drugs, some cosmetics, and medical devices?
Which type of color additives are used in drugs, some cosmetics, and medical devices?
Which type of color additives is restricted to external parts of the body (not including the lips and other parts that are covered by mucous membrane)?
Which type of color additives is restricted to external parts of the body (not including the lips and other parts that are covered by mucous membrane)?
What is FD&C Red No. 2 also known as, and what was a significant finding related to its safety?
What is FD&C Red No. 2 also known as, and what was a significant finding related to its safety?
What is the current status of FD&C Red No. 4 concerning its use in drugs and cosmetics?
What is the current status of FD&C Red No. 4 concerning its use in drugs and cosmetics?
Which of the following statements about FD&C Yellow No. 5 (Tartrazine) are true? (Select all that apply)
Which of the following statements about FD&C Yellow No. 5 (Tartrazine) are true? (Select all that apply)
Which of the following types of preparations typically require the addition of a chemical preservative? (Select all that apply)
Which of the following types of preparations typically require the addition of a chemical preservative? (Select all that apply)
Which preservative has a concentration range of 0.002% - 0.01%?
Which preservative has a concentration range of 0.002% - 0.01%?
What is the maximum concentration allowed for phenol as a preservative?
What is the maximum concentration allowed for phenol as a preservative?
Which preservative has the lowest acceptable concentration range?
Which preservative has the lowest acceptable concentration range?
What is the concentration range for the combination of methyl & propylparaben as preservatives?
What is the concentration range for the combination of methyl & propylparaben as preservatives?
Which preservative concentration is the highest among the listed substances?
Which preservative concentration is the highest among the listed substances?
Which preservative is primarily used in a concentration range of 0.002% to 0.01%?
Which preservative is primarily used in a concentration range of 0.002% to 0.01%?
What is the purpose of the Summary of Product Characteristics (SPC)?
What is the purpose of the Summary of Product Characteristics (SPC)?
SPC-like Information refers to documents such as package insert and patient information leaflet.
SPC-like Information refers to documents such as package insert and patient information leaflet.
Package Insert (PI) is the document defining information that is supplied with prescription drug products by the MAH. The PI is intended for use by healthcare professionals.
Package Insert (PI) is the document defining information that is supplied with prescription drug products by the MAH. The PI is intended for use by healthcare professionals.
Patient Information Leaflet (PIL) is the
document defining information that is supplied
with non-prescription drug products by the
MAH. The PIL is intended for use by patients
and is written in layman’s language.
Patient Information Leaflet (PIL) is the document defining information that is supplied with non-prescription drug products by the MAH. The PIL is intended for use by patients and is written in layman’s language.
Which of the following correctly describes the labeling for healthcare practitioners and patients in the United States and Europe?
Which of the following correctly describes the labeling for healthcare practitioners and patients in the United States and Europe?
Which components are included in the Physician Labeling Rule (PLR) format of the Prescribing Information?
Which components are included in the Physician Labeling Rule (PLR) format of the Prescribing Information?
Study Notes
Physical Description
- Most drugs are solid materials, either crystalline or amorphous compounds.
- Purity is crucial for identification and evaluation of chemical, physical, and biological properties.
- Drugs can exist as solids, liquids, or gases for therapeutic use.
Microscopic Examination
- Provides insights on particle size and size range of raw materials.
- Photomicrographs help identify formulation processing issues linked to changes in particle or crystal characteristics.
Heat of Vaporization
- Defines the heat absorbed when vaporizing 1 gram of liquid, measured in calories.
- Molecular movement is temperature-dependent.
Melting Point Depression
- A pure substance has a specific melting point/range, used to assess purity and compatibility with other substances.
Phase Rule
- A phase diagram shows the melting point in relation to the composition of two or three-component systems.
- Visualizes solid and liquid phase existence in binary, ternary, and other mixtures.
Particle Size
- Affects dissolution rate, bioavailability, content uniformity, as well as taste, texture, color, and stability.
- Influences flow characteristics and sedimentation rates.
Polymorphism
- Different polymorphic forms can exhibit varying physicochemical properties like melting point and solubility.
Solubility
- A key physicochemical property, crucial for the therapeutic efficacy of a drug.
- A drug must have some aqueous solubility to be effective.
Solubility and Particle Size
- Reducing particle size can lead to increased solubility.
Solubility and pH
- Adjusting pH of the solvent can enhance solubility of the drug substance.
Membrane Permeability
- Drug molecules must traverse biological membranes to elicit a response.
- Biological membranes function as lipid barriers, restricting most drugs while allowing lipid-soluble substances to cross via passive diffusion.
Dissolution
- Dissolution rate refers to how long it takes for a drug to dissolve in fluids at the site of absorption.
- This process is often the rate-limiting step in the drug absorption phase.
Partition Coefficient
- The oil-water partition coefficient quantifies a molecule's lipophilicity, indicating its affinity for either hydrophilic (water-based) or lipophilic (fat-based) environments.
Membrane Permeability
- Drug molecules must traverse biological membranes to elicit a response.
- Biological membranes function as lipid barriers, restricting most drugs while allowing lipid-soluble substances to cross via passive diffusion.
Dissolution
- Dissolution rate refers to how long it takes for a drug to dissolve in fluids at the site of absorption.
- This process is often the rate-limiting step in the drug absorption phase.
Partition Coefficient
- The oil-water partition coefficient quantifies a molecule's lipophilicity, indicating its affinity for either hydrophilic (water-based) or lipophilic (fat-based) environments.
Organic Esters in Pharmacy
- Drugs can exist as either a base form or ester form, with dosage potentially based on either formulation.
- Esters rank as the second most significant acid derivatives in the pharmaceutical industry, following salts.
- Preparation of esters serves various purposes:
- Solubility: Enhances the solubility of drugs in biological fluids.
- Stability: Improves the stability of drug compounds during storage and after administration.
- Resistance to Degradation: Offers protection from breakdown when in the body, ensuring therapeutic effectiveness.
- Prodrug Utilization: Certain esters function as prodrugs, which become active only after metabolism.
Potency-Designated Active Pharmaceutical Ingredients
- Potency-designated drugs refer to bulk substances or active pharmaceutical ingredients (APIs) that are not comprised of 100% active drug.
- Knowing the assayed potency of an ingredient is crucial for making accurate calculations to obtain the correct dosage in formulations.
Complex Organic Molecules
- The majority of complex molecules and biotech products are classified as proteins.
- Proteins are unstable and require special handling to maintain their efficacy and integrity.
- Protein drugs are extremely potent and typically utilized in low concentrations.
- A significant portion of manufactured products and compounded preparations consists of excipients such as vehicles, buffers, and stabilizers, rather than the active drug itself.
Drug-Plastic Interaction
- PVC (polyvinyl chloride) bags are commonly used for drug storage and infusion.
- DEHP (di-ethyl-hexyl-phthalate) is a plasticizer found in PVC that can leach into medications.
Effects of Plastic on Drugs
- Leaching: The process where components of the bag material migrate into the drug solution, potentially altering drug efficacy and safety.
- Adsorption: Some drugs may adhere to the surface of the plastic, leading to reduced drug availability and dosage discrepancies.
- Absorption: Certain drugs may permeate through the plastic wall, further impacting the amount of drug delivered to patients.
Example Drugs Affected
- Diazepam: A commonly used anti-anxiety medication that can interact negatively with PVC bags, compromising its delivery.
- Isosorbide Dinitrate: A medication for angina that is also susceptible to interactions with PVC, potentially affecting its therapeutic effectiveness.
Common Preservatives in Pharmaceuticals
- Benzoic Acid: Utilized at concentrations of 0.1% to 0.2% to prevent microbial growth.
- Sodium Benzoate: Similar to benzoic acid, employed at 0.1% to 0.2% for its antimicrobial properties.
- Alcohol: Effective as a preservative in higher concentrations, typically ranging from 15% to 20%.
- Phenylmercuric Nitrate & Acetate: Rarely used, at very low concentrations of 0.002% to 0.01%, due to potential toxicity.
- Phenol: A commonly used preservative at concentrations varying from 0.1% to 0.5%, known for its antiseptic qualities.
- Cresol: Also serves as a preservative, employed at concentrations of 0.1% to 0.5%, effective against bacteria.
- Chlorobutanol: Used in a set concentration of 0.5% for its preservative effectiveness.
- Benzalkonium Chloride: At very low concentrations (0.002% to 0.01%), it performs as a potent antimicrobial agent.
- Methyl & Propylparaben Combinations: Seen in concentrations of 0.1% to 0.2%, these are used to inhibit a broad spectrum of fungi and bacteria.
Preservative Concentration Overview
- Benzoic Acid: Effective concentration between 0.1% and 0.2%, commonly used for its antimicrobial properties.
- Sodium Benzoate: Similar range to benzoic acid (0.1% - 0.2%); functions as a preservative in acidic foods and beverages.
- Alcohol: Concentration levels range from 15% to 20%; utilized for its antibacterial and antifungal properties.
- Phenylmercuric Nitrate & Acetate: Low concentration range of 0.002% - 0.01%; historically used in some cosmetic and pharmaceutical applications but with declining usage due to safety concerns.
- Phenol: Utilized at concentrations between 0.1% and 0.5%; effective as a disinfectant and preservative.
- Cresol: Similar to phenol, used at 0.1% - 0.5%; provides antiseptic properties and is effective in controlling bacteria and fungi.
- Chlorobutanol: Preservative used at a concentration of 0.5%; known for its effectiveness in topical formulations.
- Benzalkonium Chloride: Utilized at very low concentrations (0.002% - 0.01%); often found in antiseptics and disinfectant formulations.
- Combinations of Methyl & Propylparaben: Effective as a preservative in concentrations of 0.1% - 0.2%; widely used in cosmetics and personal care products due to their antibacterial properties.
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Description
Explore the broad aspects of pharmaceutical sciences in this quiz. It covers the various steps that a drug undergoes during its development, highlighting the key areas essential for pharmacy students and professionals. Test your knowledge and understanding of this critical field.
