p.16
Dissolution Testing Apparatus
What is the Cylinder method in dissolution testing?
A method using a cylindrical apparatus to evaluate drug dissolution.
p.9
Controlled Release vs. Immediate Release
What is the significance of the stagnant layer in the dissolution process?
It acts as an interfacial barrier affecting drug release.
p.20
Factors Affecting Drug Solubility
What type of salt is prepared for weakly basic drugs?
A strong acid salt, like hydrochloride or sulfate salts of alkaloidal drugs.
p.5
Dissolution Process and Importance
What is dissolution?
The process by which a solid substance dissolves in a solvent to form a solution.
p.30
Phase Diagrams and Phase Equilibria
What happens outside the range defined by the curve gbhci?
A one-phase system is formed.
p.1
Physicochemical Properties of Drugs
What are physicochemical properties of drugs?
Characteristics that affect the behavior of drugs in biological systems, such as solubility, stability, and permeability.
p.19
Factors Affecting Drug Solubility
What role does solubility play in drug formulation?
It controls dissolution from the dosage form.
p.20
Factors Affecting Drug Solubility
What type of salt is prepared for weakly acidic drugs?
A strong base salt, such as sodium or potassium salts of barbiturates and sulfonamides.
p.26
Quality Control in Drug Manufacturing
What is one application of the information provided?
Extraction of crude drugs.
p.22
Factors Affecting Drug Solubility
What are diluents used for in dosage forms?
To increase the bulk of the formulation.
p.6
Quality Control in Drug Manufacturing
How does dissolution testing help in monitoring drug products?
It monitors drug product stability and the manufacturing process.
p.11
Mathematical Models for Drug Dissolution
What factors are considered in the Noyes-Whitney equation?
Surface area, concentration gradient, and solubility of the drug.
p.6
Dissolution Process and Importance
What does dissolution testing demonstrate about drug release?
That the rate of drug release is uniform from batch to batch.
p.31
Phase Diagrams and Phase Equilibria
What is the formula to calculate degrees of freedom in a three-component system with one phase?
F = C - P + 2, where C is the number of components and P is the number of phases.
p.7
Factors Affecting Drug Solubility
What factors affect drug absorption?
The rate of disintegration of dosage forms, deaggregation of granules, and the dissolution rate of the solid drug.
p.19
Physicochemical Properties of Drugs
How are particle size and effective surface area related?
They are inversely related to each other.
p.4
Dissolution Process and Importance
Why is dissolution important in drug formulation?
It affects the drug's bioavailability and therapeutic effectiveness.
p.23
Factors Affecting Drug Solubility
How does temperature influence solubility?
Temperature can affect the kinetic energy of molecules, influencing how well a solute dissolves in a solvent.
p.11
Mathematical Models for Drug Dissolution
What does the Noyes-Whitney equation help to describe?
The rate of dissolution of a drug from oral formulations.
p.18
Dissolution Testing Apparatus
Why is temperature important in dissolution testing?
It can affect the solubility and dissolution rate of the drug.
What is drug release?
The process by which a drug is released from its dosage form into the body.
p.18
Dissolution Testing Apparatus
What are the factors related to the apparatus in dissolution testing?
Dissolution medium, pH, agitation, and temperature.
p.7
Dissolution Process and Importance
What happens during the dissolution process for drug molecules?
Drug molecules leave the boundary surrounding the dosage form and diffuse into the dissolution media.
p.9
Dissolution Process and Importance
What is the primary focus of the in-vitro dissolution model?
To study the dissolution process of drugs.
p.20
Factors Affecting Drug Solubility
How can the dissolution rate of weak acids and weak bases be enhanced?
By converting them into their salt form.
p.23
Factors Affecting Drug Solubility
What factors affect the solubility of a compound?
Physical and chemical properties of the solute and solvent, including temperature, pressure, and pH.
p.19
Physicochemical Properties of Drugs
What is absolute surface area?
The total surface area of any particle.
p.20
Physicochemical Properties of Drugs
What is the order of dissolution for different solid forms of a drug?
Amorphous > metastable > stable.
p.6
Dissolution Process and Importance
What is the purpose of studying dissolution?
To measure the rate and extent of drug release from a drug product.
p.7
Dissolution Process and Importance
Why is dissolution considered the rate determining step in drug absorption?
Because it is crucial for the absorption of hydrophobic, poorly aqueous soluble drugs.
p.7
Dissolution Process and Importance
Which drugs are examples of poorly aqueous soluble drugs?
Griseofulvin and Spironolactone.
p.7
Dissolution Process and Importance
What is dissolution?
A process in which a solid substance solubilizes in a solvent, involving mass transfer from the solid surface to the liquid phase.
p.28
Phase Diagrams and Phase Equilibria
What does Gibbs' phase rule formula help determine?
The least number of intensive variables to define the state of the system.
p.4
Dissolution Process and Importance
What is dissolution in the context of pharmaceuticals?
The process by which a solid drug dissolves in a solvent to form a solution.
p.6
Dissolution Process and Importance
What does an in vitro test measure in relation to dissolution?
The rate and extent of dissolution or release of drug substance from drug product.
p.8
Dissolution Process and Importance
What are the two consecutive stages in the dissolution of a solid in a liquid?
1. Interfacial reaction 2. Diffusion.
p.16
Dissolution Testing Apparatus
What is Apparatus 6 used for?
It is used for the Cylinder method in dissolution testing.
p.18
Dissolution Testing Apparatus
How does pH affect dissolution testing?
It influences the solubility of the drug.
p.4
Controlled Release vs. Immediate Release
How does drug release differ from dissolution?
Drug release refers to the drug leaving its dosage form, while dissolution is the drug dissolving in a solvent.
p.19
Factors Affecting Drug Solubility
What equation relates to the aqueous solubility of a drug?
The Noyes-Whitney equation.
p.9
Mathematical Models for Drug Dissolution
What does the term 'C_s' refer to in the dissolution model?
The concentration of the solute in the stagnant layer.
p.31
Phase Diagrams and Phase Equilibria
What are the four degrees of freedom in a three-component system?
Temperature, pressure, and the concentrations of two of the three components.
p.17
Dissolution Process and Importance
What are the factors related to the apparatus and test parameters in drug dissolution?
These include the type of dissolution apparatus, stirring speed, temperature, and volume of the dissolution medium.
p.8
Dissolution Process and Importance
What occurs during the interfacial reaction stage of dissolution?
Liberation of solute molecules from the solid phase to the liquid phase.
p.32
Phase Diagrams and Phase Equilibria
What does a phase diagram for a three-component system represent?
The relationships between the phases and compositions of three different components.
p.17
Factors Affecting Drug Solubility
What physicochemical properties of a drug affect its dissolution?
Properties such as solubility, particle size, and polymorphism.
p.8
Dissolution Process and Importance
What is the role of diffusion in the dissolution process?
The solute molecule must migrate through the boundary layer surrounding the crystal to the bulk of the solution.
p.18
Dissolution Testing Apparatus
What role does agitation play in dissolution testing?
It helps to maintain uniformity and enhances the dissolution rate.
p.19
Physicochemical Properties of Drugs
What is effective surface area?
The area of solid surface exposed to the dissolution medium.
p.11
Mathematical Models for Drug Dissolution
What is the Noyes-Whitney equation used for?
It is a mathematical model for drug dissolution.
p.31
Phase Diagrams and Phase Equilibria
How do you determine the concentration of the third component in a three-component system?
By subtracting the sum of the concentrations of the other two components from the total concentration.
p.17
Controlled Release vs. Immediate Release
How do dosage forms influence drug dissolution?
Different dosage forms (e.g., tablets, capsules, solutions) have varying surface areas and release characteristics that affect dissolution rates.
What is drug release?
The process by which a drug is made available for absorption in the body.
p.6
Quality Control in Drug Manufacturing
Why is dissolution an important quality control test?
It is linked to product performance in vivo and ensures equivalence to bioavailable and clinically effective batches.
p.32
Phase Diagrams and Phase Equilibria
What are the key features of a three-component phase diagram?
It includes regions representing different phases, lines indicating phase boundaries, and points showing specific compositions.
p.29
Phase Diagrams and Phase Equilibria
What does the OA curve represent in the phase equilibria of water?
The vapor pressure curve (vapor and liquid in equilibrium).
p.10
Mathematical Models for Drug Dissolution
What does the Noyes-Whitney equation describe?
The rate of release of the drug from its solid state.
p.11
Dissolution Process and Importance
Why is understanding dissolution important for oral drug products?
It affects the bioavailability and therapeutic effectiveness of the drug.
p.8
Dissolution Process and Importance
What happens to solute molecules during the interfacial reaction?
They leave the surface of the solid and move into the liquid.
p.16
Dissolution Testing Apparatus
What does Apparatus 7 refer to in dissolution testing?
The Reciprocating disk method.
p.9
Mathematical Models for Drug Dissolution
What is the 'Double barrier' theory in dissolution?
It refers to the combined effects of the stagnant layer and the interfacial barrier.
p.16
Dissolution Testing Apparatus
What is the purpose of the Reciprocating disk method?
To assess the dissolution rate of pharmaceuticals.
p.23
Dissolution Process and Importance
Why is drug dissolution important?
It determines the bioavailability of a drug, influencing its therapeutic effectiveness.
What should students be able to explain regarding drug release?
The concepts of drug release and dissolution.
p.10
Mathematical Models for Drug Dissolution
What does 'h' represent in the Noyes-Whitney equation?
The diffusion layer thickness.
p.12
Mathematical Models for Drug Dissolution
What does the equation dC/dt = kA (Cs - Cb) represent?
The rate of change of concentration over time in dissolution.
p.15
Dissolution Testing Apparatus
What is the significance of using a dissolution apparatus in drug development?
It helps predict how a drug will behave in the body and ensures quality control.
p.12
Mathematical Models for Drug Dissolution
What is 'A' in the context of the Noyes-Witney equation?
The surface area of the dissolving solid.
p.9
Dissolution Process and Importance
What does the interfacial barrier model describe?
It describes the resistance to mass transfer during dissolution.
p.32
Phase Diagrams and Phase Equilibria
How can a three-component phase diagram be useful?
It helps in understanding the stability and interactions of mixtures of three substances.
p.28
Phase Diagrams and Phase Equilibria
In the phase rule, what does 'C' stand for?
The number of components in the system.
p.25
Partition Coefficient and Its Applications
What is the oil-water partition coefficient a measure of?
A molecule’s lipophilic character and its preference for hydrophilic or lipophilic phases.
p.30
Phase Diagrams and Phase Equilibria
What does the curve gbhci represent in a two-component phenol-water system?
The limits of temperature and concentration within which two liquid phases exist in equilibrium.
p.4
Factors Affecting Drug Solubility
What factors can affect the rate of drug dissolution?
Particle size, temperature, pH of the solvent, and the presence of surfactants.
p.14
Dissolution Testing Apparatus
How many types of dissolution apparatus are commonly used?
There are several types, including the Paddle and Basket methods.
p.22
Factors Affecting Drug Solubility
What function do binders serve in dosage forms?
To hold the ingredients together in a solid form.
p.26
Quality Control in Drug Manufacturing
What is one application of drug extraction from biologic fluids?
Therapeutic drug monitoring.
p.25
Partition Coefficient and Its Applications
What does P_o_w represent?
The ratio of concentration of a solute in octanol (C_o) to its concentration in water (C_w).
p.14
Dissolution Testing Apparatus
What role does the dissolution medium play in testing?
It simulates body fluids to evaluate how a drug will dissolve in the body.
p.10
Mathematical Models for Drug Dissolution
What is 'Cs' in the context of the Noyes-Whitney equation?
The solubility of the drug in the dissolution medium.
p.12
Mathematical Models for Drug Dissolution
What additional factors did Brunner incorporate into the Noyes-Witney equation?
Diffusion coefficient 'D', thickness of stagnant diffusion layer 'h', and volume of dissolution medium 'v'.
p.12
Mathematical Models for Drug Dissolution
What is the significance of the concentration gradient (Cs - Cb) in the equation?
It represents the concentration difference driving the diffusion of the drug.
p.14
Dissolution Testing Apparatus
What is the purpose of dissolution apparatus in pharmaceutical testing?
To measure the rate and extent of drug dissolution in a specific medium.
p.22
Factors Affecting Drug Solubility
What is the role of lubricants in dosage forms?
To reduce friction during the manufacturing process.
p.29
Phase Diagrams and Phase Equilibria
What does the OC curve indicate in the phase equilibria of water?
The melting point curve (liquid and solid in equilibrium).
p.10
Mathematical Models for Drug Dissolution
What does 'M' represent in the Noyes-Whitney equation?
The mass of solute dissolved in time t.
p.22
Factors Affecting Drug Solubility
What is the purpose of colorants in dosage forms?
To enhance the appearance and identify the product.
p.10
Mathematical Models for Drug Dissolution
What does 'S' stand for in the Noyes-Whitney equation?
The surface area of dissolution.
p.23
Dissolution Process and Importance
What is the purpose of dissolution testing?
To evaluate the rate and extent of drug dissolution, which is critical for ensuring consistent drug performance.
p.10
Mathematical Models for Drug Dissolution
What does 'C' represent in the Noyes-Whitney equation?
The concentration of drug in the bulk.
p.28
Phase Diagrams and Phase Equilibria
In the phase rule, what does 'F' represent?
The critical number (number of degrees of freedom).
p.21
Physicochemical Properties of Drugs
What are solvates?
Stoichiometric adducts where solvent molecules are incorporated in the crystal lattice of a solid.
p.5
Dissolution Process and Importance
Why is dissolution important in pharmacology?
It affects the bioavailability of the drug, determining how much of the drug reaches systemic circulation.
p.14
Dissolution Testing Apparatus
What is the Paddle method in dissolution testing?
A method where a paddle stirs the dissolution medium to facilitate drug release.
p.22
Factors Affecting Drug Solubility
What are surfactants used for in dosage forms?
To improve wetting and solubility of the active ingredients.
p.21
Physicochemical Properties of Drugs
How do organic solvates compare to nonsolvates in terms of aqueous solubility?
Organic solvates have greater aqueous solubility than nonsolvates.
p.26
Quality Control in Drug Manufacturing
What study involves the distribution of flavoring oil?
Between oil and water phases of emulsions.
p.15
Dissolution Testing Apparatus
What is the main feature of USP Apparatus 2?
It uses a paddle to stir the liquid and facilitate drug dissolution.
p.2
Factors Affecting Drug Solubility
What factors should students understand that affect drug solubility?
Factors affecting solubility and dissolution.
p.27
Phase Diagrams and Phase Equilibria
What is an example of a three-phase system?
A glass of ice water on a hot summer day (ice, water, and vapor).
p.12
Mathematical Models for Drug Dissolution
What does 'h' represent in the modified equation?
The thickness of the stagnant diffusion layer.
p.29
Phase Diagrams and Phase Equilibria
What is the equilibrium represented by the OB curve?
The sublimation curve (vapor and solid in equilibrium).
p.15
Dissolution Testing Apparatus
What is the purpose of dissolution apparatus in pharmaceutical testing?
To measure the rate at which a drug dissolves in a specific solvent.
p.15
Dissolution Testing Apparatus
How many types of dissolution apparatus are commonly used?
There are several types, including USP Apparatus 1 (basket) and USP Apparatus 2 (paddle).
p.26
Quality Control in Drug Manufacturing
What forms can drugs be absorbed from?
Ointment, suppository, transdermal patch.
p.15
Dissolution Testing Apparatus
What is USP Apparatus 1 used for?
It uses a basket to hold the drug and measure dissolution in a liquid medium.
p.24
Factors Affecting Drug Solubility
What is the definition of solubility according to the United States Pharmacopeia 24?
Parts of solvent required for 1 part of solute.
p.30
Phase Diagrams and Phase Equilibria
What occurs after Point C in the phenol-water system?
Exceeding 63% phenol results in a single phenol-rich liquid phase.
p.27
Phase Diagrams and Phase Equilibria
What happens to the volume of liquid water as ice melts?
The volume of liquid water increases.
p.27
Phase Diagrams and Phase Equilibria
Is equilibrium established in the described ice water system?
No, equilibrium is not established.
p.32
Phase Diagrams and Phase Equilibria
What are the phases typically represented in a three-component phase diagram?
Solid, liquid, and gas phases.
p.23
Factors Affecting Drug Solubility
What role does pressure play in solubility?
Pressure can affect the solubility of gases in liquids, with higher pressure generally increasing solubility.
p.5
Controlled Release vs. Immediate Release
What factors can affect drug release?
Formulation, drug properties, and environmental conditions.
p.23
Factors Affecting Drug Solubility
How does pH affect solubility?
pH can alter the ionization state of a solute, impacting its solubility in a solvent.
p.5
Factors Affecting Drug Solubility
How does the solubility of a drug influence its dissolution rate?
Higher solubility generally leads to a faster dissolution rate.
p.21
Physicochemical Properties of Drugs
Give an example of a solvate with greater water solubility.
Chloroform solvates of griseofulvin are more water soluble than their nonsolvated forms.
p.22
Factors Affecting Drug Solubility
What do disintegrating agents do in dosage forms?
They help the dosage form break down into smaller particles.
p.2
Partition Coefficient and Its Applications
What concept related to drug behavior should students be able to explain?
The concept of partition coefficient and its applications.
p.27
Phase Diagrams and Phase Equilibria
What effect does ice evaporating into vapor have on liquid water volume?
It decreases the volume of liquid water.
p.25
Partition Coefficient and Its Applications
What does the partition coefficient (log P) measure?
The distribution of molecules between two phases.
p.21
Physicochemical Properties of Drugs
What is a hydrate?
A solvate where the solvent associated with the drug is water.
p.14
Dissolution Testing Apparatus
What is the Basket method in dissolution testing?
A method where the drug is placed in a mesh basket submerged in the dissolution medium.
What is a drug substance?
An active ingredient intended to furnish pharmacologic activity.
p.15
Dissolution Testing Apparatus
Why is temperature control important in dissolution testing?
To ensure consistent and accurate results during the dissolution process.
p.12
Mathematical Models for Drug Dissolution
What does 'D' represent in the modified equation?
The diffusion coefficient of the drug.
p.9
Factors Affecting Drug Solubility
What is the concept of 'Limited solvation theory'?
It explains how solvation impacts the dissolution rate of drugs.
p.28
Phase Diagrams and Phase Equilibria
In the phase rule, what does 'P' represent?
The number of phases present.
What is drug release?
The process by which a drug leaves a drug product.
p.28
Phase Diagrams and Phase Equilibria
What are intensive variables in the context of phase equilibria?
Independent variables that do not depend on the volume and size of the phase, such as temperature, pressure, density, and concentration.
p.25
Partition Coefficient and Its Applications
When will P_o_w be less than 1?
When a drug is hydrophilic.
p.27
Phase Diagrams and Phase Equilibria
What factors affect the amount of ice in a glass of water?
Amount of ice, temperature of water, and temperature of surrounding air.
p.32
Phase Diagrams and Phase Equilibria
What is a key aspect to consider when interpreting a three-component phase diagram?
The effect of temperature and pressure on phase stability and transitions.
p.1
Dissolution Process and Importance
What role does dissolution play in drug absorption?
Dissolution is a critical step for drug absorption, as only dissolved drugs can be absorbed into the bloodstream.
p.10
Mathematical Models for Drug Dissolution
What is represented by 'D' in the Noyes-Whitney equation?
The diffusion coefficient.
What is a drug product?
A finished dosage form, such as a tablet or capsule.
p.25
Partition Coefficient and Its Applications
What happens when a solute is added to a mixture of two immiscible liquids?
It distributes between the two phases and reaches an equilibrium at a constant temperature.
p.14
Dissolution Testing Apparatus
Why is temperature control important in dissolution testing?
To ensure consistent conditions that mimic physiological environments.
p.25
Partition Coefficient and Its Applications
When will P_o_w be greater than 1?
When a drug is lipophilic.
p.15
Dissolution Testing Apparatus
What role does the stirring rate play in dissolution testing?
It affects the rate of drug dissolution and the reproducibility of results.
p.10
Mathematical Models for Drug Dissolution
What is 'Kd' in the Noyes-Whitney equation?
The dissolution rate constant.
p.12
Mathematical Models for Drug Dissolution
What does 'V' stand for in the modified Noyes-Witney equation?
The volume of the dissolution medium.
p.1
Dissolution Process and Importance
What is dissolution in the context of pharmaceuticals?
The process by which a solid substance dissolves in a solvent to form a solution.
What is drug release?
The process by which a drug is released from its dosage form into the body.
p.1
Physicochemical Properties of Drugs
What is the significance of active pharmaceutical ingredients (APIs)?
APIs are the biologically active components in a drug that produce its effects.
p.1
Factors Affecting Drug Solubility
How do physicochemical properties influence drug release?
They determine the solubility and stability of the drug, affecting its absorption and therapeutic efficacy.
