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Questions and Answers
What consequence does a change in the polymorphic form of a drug primarily cause?
What consequence does a change in the polymorphic form of a drug primarily cause?
What is pseudo polymorphism primarily associated with?
What is pseudo polymorphism primarily associated with?
Which type of instability does pseudo polymorphism NOT lead to?
Which type of instability does pseudo polymorphism NOT lead to?
How does the solubility of a drug change when its polymorphic form changes?
How does the solubility of a drug change when its polymorphic form changes?
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What is a consequence of altered drug solubility due to polymorphic changes?
What is a consequence of altered drug solubility due to polymorphic changes?
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Which of the following is a sign of instability in creams?
Which of the following is a sign of instability in creams?
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What effect does polymorphic transformation have on a drug's solubility?
What effect does polymorphic transformation have on a drug's solubility?
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Which phenomenon is associated with the excessive growth of crystals in a suspension?
Which phenomenon is associated with the excessive growth of crystals in a suspension?
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What is pseudopolymorphism primarily characterized by?
What is pseudopolymorphism primarily characterized by?
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Which of the following is NOT a visible sign of instability in ointments?
Which of the following is NOT a visible sign of instability in ointments?
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What can affect the dissolution rate of a drug during processing?
What can affect the dissolution rate of a drug during processing?
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Which of the following is a sign of instability in suspensions?
Which of the following is a sign of instability in suspensions?
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What is a likely consequence of vaporization in drug products with high vapor pressure?
What is a likely consequence of vaporization in drug products with high vapor pressure?
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What is a common consequence of a drug changing from an amorphous to a crystalline structure?
What is a common consequence of a drug changing from an amorphous to a crystalline structure?
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What method can help prevent vaporization of volatile drugs?
What method can help prevent vaporization of volatile drugs?
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Which type of physical instability might lead to the presence of tablet whiskers?
Which type of physical instability might lead to the presence of tablet whiskers?
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What is a sign of instability in emulsions?
What is a sign of instability in emulsions?
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How does aging affect aminophylline suppositories?
How does aging affect aminophylline suppositories?
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What is the primary role of a pharmacist in drug formulation?
What is the primary role of a pharmacist in drug formulation?
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Which packaging material can lead to the absorption of drugs and preservatives?
Which packaging material can lead to the absorption of drugs and preservatives?
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Which of the following best describes a typical outcome of increasing levels of humidity during drug processing?
Which of the following best describes a typical outcome of increasing levels of humidity during drug processing?
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Which of the following is a required condition for storing a drug?
Which of the following is a required condition for storing a drug?
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What is the main effect of physical instabilities that are not visually detectable in drug forms?
What is the main effect of physical instabilities that are not visually detectable in drug forms?
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What can cause precipitation in drug solutions?
What can cause precipitation in drug solutions?
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Which is a common method used to prevent pseudopolymorphism in drug formulations?
Which is a common method used to prevent pseudopolymorphism in drug formulations?
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What is a potential effect of using a non-tight container for a drug solution with a co-solvent?
What is a potential effect of using a non-tight container for a drug solution with a co-solvent?
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What happens to the shelf life of a drug when it is repackaged?
What happens to the shelf life of a drug when it is repackaged?
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What is one disadvantage of using crystalline forms compared to amorphous forms of drugs?
What is one disadvantage of using crystalline forms compared to amorphous forms of drugs?
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When compounding medications, what must pharmacists determine regarding Beyond Use Dates?
When compounding medications, what must pharmacists determine regarding Beyond Use Dates?
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What is a critical factor affecting the stability of an anti-cancer drug in different containers?
What is a critical factor affecting the stability of an anti-cancer drug in different containers?
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What type of interactions must pharmacists predict when combining drugs?
What type of interactions must pharmacists predict when combining drugs?
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What characteristics does a hydrophilic polymer contribute to formulations?
What characteristics does a hydrophilic polymer contribute to formulations?
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What is one role pharmacists play regarding medication expiration dates?
What is one role pharmacists play regarding medication expiration dates?
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What is an example of a mechanism leading to physical instability in drug products?
What is an example of a mechanism leading to physical instability in drug products?
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What must pharmacists do if a drug shows signs of instability?
What must pharmacists do if a drug shows signs of instability?
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Which of the following can change as a result of transforming amorphous drug into crystalline form?
Which of the following can change as a result of transforming amorphous drug into crystalline form?
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What mechanism is NOT responsible for precipitation in drug formulations?
What mechanism is NOT responsible for precipitation in drug formulations?
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Which statement is true regarding the storage of sensitive drugs?
Which statement is true regarding the storage of sensitive drugs?
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Why is it important to observe the expiration date of drugs?
Why is it important to observe the expiration date of drugs?
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What is a potential issue when an API gets absorbed in drug packaging?
What is a potential issue when an API gets absorbed in drug packaging?
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Which of these formulations can experience instability due to environmental factors?
Which of these formulations can experience instability due to environmental factors?
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Which condition is crucial for determining the shelf life of a drug?
Which condition is crucial for determining the shelf life of a drug?
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What is a common environmental factor that affects drug stability?
What is a common environmental factor that affects drug stability?
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In relation to drug packaging, what is a pharmacist's responsibility?
In relation to drug packaging, what is a pharmacist's responsibility?
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What characteristic do compounding pharmacists need to monitor in prepared formulations?
What characteristic do compounding pharmacists need to monitor in prepared formulations?
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Which of the following is a type of chemical instability?
Which of the following is a type of chemical instability?
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What can negatively affect the effectiveness of a drug even before its expiration date?
What can negatively affect the effectiveness of a drug even before its expiration date?
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What term describes the physical instability characterized by the separation of water and oil phases in a semisolid dosage form?
What term describes the physical instability characterized by the separation of water and oil phases in a semisolid dosage form?
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Which of the following signs indicates physical instability in tablets?
Which of the following signs indicates physical instability in tablets?
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What is a significant risk associated with toxicological instability?
What is a significant risk associated with toxicological instability?
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Which drug example is mentioned as converting to a toxic compound?
Which drug example is mentioned as converting to a toxic compound?
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In which form of dosage is caking particularly noted?
In which form of dosage is caking particularly noted?
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Which of the following factors does NOT affect drug stability?
Which of the following factors does NOT affect drug stability?
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What is a visible indication of physical instability in capsules?
What is a visible indication of physical instability in capsules?
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What effect does moisture have on a drug's physical instability?
What effect does moisture have on a drug's physical instability?
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Which type of instability is characterized by the drug losing its effect?
Which type of instability is characterized by the drug losing its effect?
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What can lead to the formation of endotoxins in a drug product?
What can lead to the formation of endotoxins in a drug product?
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Which sign might indicate physical instability in powders?
Which sign might indicate physical instability in powders?
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What does 'meling' refer to in the context of tablet instability?
What does 'meling' refer to in the context of tablet instability?
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What does shelf life refer to in relation to pharmaceutical products?
What does shelf life refer to in relation to pharmaceutical products?
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What is the primary role of pharmacists in regard to drug stability?
What is the primary role of pharmacists in regard to drug stability?
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Which factor is NOT typically evaluated during stability testing of drugs?
Which factor is NOT typically evaluated during stability testing of drugs?
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What aspect must be confirmed by monographs to maintain drug potency?
What aspect must be confirmed by monographs to maintain drug potency?
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Which of these is not a form of stability testing performed by pharmaceutical companies?
Which of these is not a form of stability testing performed by pharmaceutical companies?
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What defines an expiration date for a drug?
What defines an expiration date for a drug?
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Which characteristic of a drug is NOT visually assessed for stability?
Which characteristic of a drug is NOT visually assessed for stability?
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How does drug stability influence the manufacturing process based on storage conditions?
How does drug stability influence the manufacturing process based on storage conditions?
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Which type of stability testing focuses on the drug's relationship with inactive ingredients?
Which type of stability testing focuses on the drug's relationship with inactive ingredients?
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What is the purpose of conducting stability tests on drugs?
What is the purpose of conducting stability tests on drugs?
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Why is it impractical for pharmaceutical companies to work with unstable raw materials?
Why is it impractical for pharmaceutical companies to work with unstable raw materials?
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What is one potential sign of drug instability that can be observed visually?
What is one potential sign of drug instability that can be observed visually?
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What determines the determination of the expiration date of a drug?
What determines the determination of the expiration date of a drug?
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Which aspect of drug stability involves the measurement of how much active ingredient remains?
Which aspect of drug stability involves the measurement of how much active ingredient remains?
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Study Notes
Drug Stability and Expiration Dates
- Drug Stability: Ability of a pharmaceutical product to maintain its properties and characteristics during storage and use.
- Shelf life: Time period during which a pharmaceutical product remains within specified parameters.
- Expiration Date: Date after which a drug should not be used and needs to be discarded.
- Drug Instability: Degradation of drug properties and characteristics over time, which can lead to reduced potency or adverse effects.
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Factors Affecting Drug Stability:
- Drug-excipient interactions
- Environmental factors (light, oxygen, moisture)
- Packaging materials
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Types of Drug Instability:
- Physical Instability: Changes in appearance, texture, or physical properties.
- Chemical Instability: Decomposition or reactions leading to changes in potency.
- Microbial Instability: Growth of microbes or formation of endotoxins.
- Therapeutic Instability: Loss of drug effectiveness.
- Toxicological Instability: Conversion to toxic substances.
Physical Drug Instability
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Multiple Phase Dosage Forms: Susceptible to physical instability, e.g., emulsions, semisolids, suspensions.
- Emulsions: Creaming, aggregation, coalescence.
- Semisolids: Phase separation.
- Suspensions: Caking, sedimentation.
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Other Dosage Forms:
- Tablets: Meling, cracking, chipping.
- Capsules: Shell softening or hardening, seal swelling.
- Powders and Granules: Caking, odor/color changes, swelling.
- Liquid Dosage Forms: Loss of homogeneity, microbial growth, turbidity, gas formation.
- Emulsions: Phase separation.
- Suspensions: Caking, excessive crystal growth.
- Semisolids: Discoloration, viscosity change, odor change.
- Creams: Phase separation, shrinkage, greasiness, sandiness, microbial growth.
- Ointments: Bleeding, greasiness, sandiness.
- Suppositories: Softening, oil stains, hardening.
- Sterile Liquids: Cloudiness, particle formation, color change, particulate matter, gas formation, seal integrity loss.
Pharmacist's Role in Drug Stability
- Develop formulations with maximum stability.
- Determine optimum storage conditions.
- Select appropriate container for dispensing.
- Predict shelf life of drug products.
- Establish Beyond Use Dates for compounded products.
- Identify potential drug-excipient interactions and incompatibilities.
- Dispense medication according to oldest stock first principle.
- Inspect medications for signs of instability.
- Ensure appropriate storage conditions are maintained.
- Repackage medications with appropriate Beyond Use Dates.
- Dispense in suitable containers with proper closures.
- Instruct patients on proper storage conditions.
Key Points Regarding Repackaging or Compounding:
- The shelf life of repackaged or compounded drugs is shorter than the original product's shelf life.
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Examples of repackaged products with reduced shelf life:
- Eye drops (1-month use after opening)
- Sterile tablets and capsules compounded into suspensions
- Sterile products repackaged into single-use syringes
Understanding Drug Instability Mechanisms
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Pharmacists' roles:
- Delay or prevent drug instability to maximize shelf life.
- Understand reasons for drug instability to determine expiration dates and provide patient consultation.
- Drug instability mechanisms are covered in detail in later lectures.
Physical Instability
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Polymorphism transformation: The structure of a drug can change between amorphous and crystalline forms, affecting solubility and stability.
- Crystalline structures are generally less soluble than amorphous forms, leading to a change in drug bioavailability and therapeutic effect.
- This transformation can occur during manufacturing, due to heat, pressure and humidity, or during storage.
- It is not visually identifiable.
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Pseudopolymorphism: Crystalline water is lost from a drug's crystalline structure, leading to a hydrated form becoming anhydrous.
- This change can impact a drug's solubility and stability.
- Anhydrous forms typically dissolve better than hydrated forms.
- Examples: Carbamezepine can lose water during storage and may display tablet whiskers - lines developing on the tablet.
- It can be prevented by adding polymers like Pluronic (used in gel formation) to the drug formulation.
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Vaporization: Loss of volatile materials, such as drugs with high vapor pressure (e.g., Trinitroglycerin, flavorings) due to evaporation.
- Can lead to a loss of content uniformity within a batch of tablets, as evaporation can condense back onto tablets unevenly.
- Can be prevented by using tightly sealed containers or including water-soluble polymers like polyethylene oxide, polyvinyl pyrrolidone, or microcrystalline cellulose in the formulation.
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Aging: Physical interactions that can occur over time, affecting a drug's release profile.
- Example: Aminophylline suppositories can interact with the base, increasing the melting point and delaying drug release.
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Drug-Packaging Interaction: Drugs can interact with packing materials like PVC, leading to their absorption.
- API absorption causes a loss of drug strength.
- Preservative absorption can lead to microbial growth within the product.
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Precipitation: Can occur in solutions due to:
- Changes in pH caused by other ingredients or container leaching alkaline metals.
- Loss of cosolvent (e.g., ethanol in acetaminophen syrup).
- Complexation with other ingredients.
- Addition of electrolytes (salting out effect).
- Sometimes, precipitation occurs without a clear cause and needs experience-based approaches.
- Example: Topotecan (anti-cancer drug) solubility is affected by concentration, diluent, and container material.
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Mentimeter Questions
- Polymorphism: The correct answer is Drug Solubility and Bioavailability.
- Pseudo Polymorphism: The correct answers are Physical Instability and Therapeutic Instability.
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Description
Test your knowledge on drug stability and expiration dates with this quiz. Explore key concepts such as shelf life, factors influencing stability, and types of drug instability. Understand the importance of these factors in maintaining pharmaceutical safety and efficacy.
