Podcast
Questions and Answers
Which of the following best describes transesterification?
Which of the following best describes transesterification?
- A reaction where esters are hydrolyzed into carboxylic acids
- A reaction where esters are converted into amides
- A method to synthesize phenothiazines from polyunsaturated fatty acids
- A process that involves heating esters with an alcohol and an acid catalyst (correct)
What is a common method for mediating oxidation in drug compounds?
What is a common method for mediating oxidation in drug compounds?
- Heating with an amine
- Utilizing UV light exposure
- Reacting with atmospheric oxygen (correct)
- Mixing with hydrolysates of esters
Which of the following drugs is known to be susceptible to photolysis?
Which of the following drugs is known to be susceptible to photolysis?
- Sodium bisulfite
- Butylated hydroxytoluene
- Hydrocortisone (correct)
- Simvastatin
What is the primary function of commonly used antioxidants like ascorbic acid?
What is the primary function of commonly used antioxidants like ascorbic acid?
What method can be employed to protect drug molecules from degradation due to light exposure?
What method can be employed to protect drug molecules from degradation due to light exposure?
What does the half-life ($t_{1/2}$) of a first-order reaction indicate?
What does the half-life ($t_{1/2}$) of a first-order reaction indicate?
In the context of drug stability, what does shelf life refer to?
In the context of drug stability, what does shelf life refer to?
Which statement best defines zero-order kinetics?
Which statement best defines zero-order kinetics?
What is indicated by the correlation coefficient value of 0.846?
What is indicated by the correlation coefficient value of 0.846?
What is the purpose of using a non-parametric procedure like Spearman's rank correlation?
What is the purpose of using a non-parametric procedure like Spearman's rank correlation?
What does the term 'clearance' (Cl) measure in pharmacokinetics?
What does the term 'clearance' (Cl) measure in pharmacokinetics?
Which of the following is NOT a factor influencing the rate of reactions in chemical kinetics?
Which of the following is NOT a factor influencing the rate of reactions in chemical kinetics?
What is the recommended stability testing frequency for a pharmaceutical product after the second year of study?
What is the recommended stability testing frequency for a pharmaceutical product after the second year of study?
What is the significance of an expiration date on a drug preparation?
What is the significance of an expiration date on a drug preparation?
Which storage temperature falls under the category of 'Warm'?
Which storage temperature falls under the category of 'Warm'?
Which of the following factors does NOT affect the stability of a pharmaceutical product?
Which of the following factors does NOT affect the stability of a pharmaceutical product?
What type of stability is primarily concerned with the appearance of a pharmaceutical product?
What type of stability is primarily concerned with the appearance of a pharmaceutical product?
Which of the following is a common catalyst for hydrolytic degradation of drugs?
Which of the following is a common catalyst for hydrolytic degradation of drugs?
Which type of incompatibility may lead to physical changes in the organoleptic properties of a drug?
Which type of incompatibility may lead to physical changes in the organoleptic properties of a drug?
What degradation process are drugs containing ester, amide, lactam, imide or carbamate groups most susceptible to?
What degradation process are drugs containing ester, amide, lactam, imide or carbamate groups most susceptible to?
What is the significance of uniformity in product stability evaluations?
What is the significance of uniformity in product stability evaluations?
What is the effect of excessive heat on drug stability?
What is the effect of excessive heat on drug stability?
Which of the following factors can influence the length of time between handling, manufacture, and usage of a drug?
Which of the following factors can influence the length of time between handling, manufacture, and usage of a drug?
What is the primary purpose of dialysis in the context of colloidal particles?
What is the primary purpose of dialysis in the context of colloidal particles?
Which of the following best describes a dispersed phase in a colloidal system?
Which of the following best describes a dispersed phase in a colloidal system?
What pore size characterizes ultrafiltration membranes used in separation processes?
What pore size characterizes ultrafiltration membranes used in separation processes?
In the context of colloidal dispersions, what does the term 'dispersing medium' refer to?
In the context of colloidal dispersions, what does the term 'dispersing medium' refer to?
When performing ultrafiltration, what type of pressure is typically applied?
When performing ultrafiltration, what type of pressure is typically applied?
Which of the following statements about colloidal particles is true?
Which of the following statements about colloidal particles is true?
What is the effect of dialysis on the concentration of low molecular weight substances in the blood?
What is the effect of dialysis on the concentration of low molecular weight substances in the blood?
What defines a colloidal dispersion?
What defines a colloidal dispersion?
How do small molecules and ions behave in a dialysis process?
How do small molecules and ions behave in a dialysis process?
Which process is used to separate and purify colloidal material?
Which process is used to separate and purify colloidal material?
What does accelerated stability studies primarily aim to achieve?
What does accelerated stability studies primarily aim to achieve?
Which of the following factors is NOT monitored during the stability studies for drug products?
Which of the following factors is NOT monitored during the stability studies for drug products?
What environmental conditions are typically used in long-term stability studies?
What environmental conditions are typically used in long-term stability studies?
Which type of stability testing involves using elevated temperatures in increments?
Which type of stability testing involves using elevated temperatures in increments?
What is the minimum duration for long-term stability studies?
What is the minimum duration for long-term stability studies?
Which climatic zone is characterized by hot and humid conditions?
Which climatic zone is characterized by hot and humid conditions?
What does the retention of physical qualities in cosmetics refer to?
What does the retention of physical qualities in cosmetics refer to?
Which aspect is NOT a goal of accelerated stability studies?
Which aspect is NOT a goal of accelerated stability studies?
What is the common temperature range for conducting accelerated stability studies?
What is the common temperature range for conducting accelerated stability studies?
In long-term stability studies, which factor does NOT change?
In long-term stability studies, which factor does NOT change?
Flashcards
Drug Stability
Drug Stability
The ability of a drug formulation to maintain its intended physical, chemical, microbiological, therapeutic, and toxicological properties over time.
Shelf Life
Shelf Life
The period of time during which a drug preparation is expected to remain stable and retain at least 90% of its labeled potency.
Expiration Date
Expiration Date
The date after which a drug product is no longer guaranteed to meet its quality standards.
Chemical Kinetics
Chemical Kinetics
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Clearance
Clearance
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Half-Life
Half-Life
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Rate Constant
Rate Constant
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Order of Reaction
Order of Reaction
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Drug Stability Testing
Drug Stability Testing
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Stability Testing Schedule
Stability Testing Schedule
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Cold Storage
Cold Storage
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Refrigerator Storage
Refrigerator Storage
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Freezer Storage
Freezer Storage
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Cool Storage
Cool Storage
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Controlled Room Temperature Storage
Controlled Room Temperature Storage
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Warm Storage
Warm Storage
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Excessive Heat Storage
Excessive Heat Storage
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Hydrolysis
Hydrolysis
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Oxidation
Oxidation
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Ester reactions
Ester reactions
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Drugs easily oxidized
Drugs easily oxidized
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Common antioxidants
Common antioxidants
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Photolysis
Photolysis
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Drug Product Stability
Drug Product Stability
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Stability
Stability
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Loss of Potency
Loss of Potency
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Drug Degradation
Drug Degradation
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Accelerated Stability Study (ASS)
Accelerated Stability Study (ASS)
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Long-Term/Real-Time Stability Study
Long-Term/Real-Time Stability Study
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Stress Test
Stress Test
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Climatic Zones
Climatic Zones
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Cosmetic Product Stability
Cosmetic Product Stability
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Loss of Elegance (Cosmetic)
Loss of Elegance (Cosmetic)
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Colloidal Dispersion
Colloidal Dispersion
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Dialysis
Dialysis
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Ultrafiltration
Ultrafiltration
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Electrophoresis
Electrophoresis
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Suspension
Suspension
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Solution
Solution
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Absorption
Absorption
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Adsorption
Adsorption
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Buffering Capacity
Buffering Capacity
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Study Notes
Colloidal Dispersion
- Colloidal dispersions are mixtures with intermediate particle sizes between true solutions and coarse dispersions.
- Dispersed particles (internal phase) are discontinuous.
- Dispersing medium (external phase) is continuous.
- Colloids are categorized as lyophilic (solvent-loving) or lyophobic (solvent-hating).
Classification of Dispersed Systems
- True solutions: homogenous mixtures with dissolved components at a molecular level, particle size <1 nm.
- Colloidal dispersions: particle size intermediate (1 nm - 0.5µm).
- Coarse dispersions: particle size >0.5µm, such as suspensions and emulsions.
Methods for Determining Particle Size
- Microscopy: techniques like optical miscroscopy for particle size measurements to 100 micron.
- Sieving: uses calibrated sieves to determine particle size based on sieving capacity.
- Sedimentation: measurements of the rate of particle settling in appropriate instruments like Andreasen apparatus are methods for determining particle size based on Stokes' Law.
- Particle Volume Measurement: using techniques like Coulter counter (resistance changes as particles pass through).
Stability
- Stability of a drug is defined as a pharmaceutical formulation in a specific container or closure system remaining with its physical, chemical, and toxicological specifications.
- Shelf life is the duration when maintaining the specified potency of the drug.
- Important factors that affect stability are storage conditions, temperature, chemical degradation etc
- Types of stability include chemical, physical, genotoxic, microbiological, toxicological, and therapeutic stability.
Micromertics & Fundamental and Derived Properties of Particles
- Micromertics is the science and technology for determining the properties of small particles.
- Micron or Micrometer is unit for particle size expressed as 10⁻⁶m, 10⁻⁴cm, 10⁻³mm.
- Fundamental properties include particle size and surface area.
- Derived properties include porosity, bulkiness, densities, compressibility, and flow properties.
Important parameters of Drug products
- Loss of activity or potency of the active ingredient
- Amount of degradation product.
- Physical qualities (appearance) of freshly produced products.
- Loss of elegance due to instability in the product.
Types of Stability Studies
- Short-term/Accelerated Stability Studies: performed under exaggerated conditions of temperature, light, humidity, pH, humidity for a shorter time period.
- Long-term/Real Time Stability Studies: determine stability under usual conditions. Assessments of different 'climatic zones' are used.
- Stress Tests: use elevated temperatures to observe physical and chemical degradation of products, lasting 6-12 months.
Rheology
- Rheology is the study of the deformation and flow of matter.
- Types include absolute (poise, centipoise), kinematic (stoke, centistokes), and relative (unitless) units.
- Common classifications include Newtonian and Non-Newtonian fluids, with some Non-Newtonian types including plastic (Bingham body), pseudoplastic (shear thinning), dilatant (shear thickening).
- Thixotropy and antithixotropy describe fluids recovering from shear thinning.
Methods & Equipment For Measuring Viscosity
- Capillary viscometers (Ostwald and Ubbelohde) measure flow rates.
- Falling sphere viscometers measure viscosity through a ball's speed fall within a liquid.
- Cup and Bob viscometers evaluate resistance of fluids to torque using a rotating bob.
- Cone and Plate viscometer measures sample shearing within a narrow gap.
Importance of Rheology in Pharmaceuticals
- Formulation of creams, pastes, lotions, emulsions, suspensions, suppositories, and tablet coatings.
- Fluidity of injection solutions.
- Mixing and flow of materials during packaging.
- Physical stability of disperse systems.
- Spreading and adherence of quasisolids.
- Flow of powders in tabletting or encapsulation.
Product Stability Evaluations
- Physical stability: drug's appearance and uniformity over time in the formulation
- Chemical stability: drug's chemical composition and potential incompatibilities.
- Evaluation tests should include hydrolysis, oxidation, photolysis, isomerization, and polymerization
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Description
Test your knowledge on crucial concepts in pharmaceutical chemistry, including transesterification, oxidation mediation in drug compounds, and the effects of photolysis. This quiz explores the roles of antioxidants and protective methods against light degradation. Challenge yourself and enhance your understanding of drug stability and chemical processes.
