Drug Stability and Expiration Dates Quiz
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Questions and Answers

What consequence does a change in the polymorphic form of a drug primarily cause?

  • Physical instability (correct)
  • Greater color variability
  • Increased potency
  • Enhanced chemical stability

    • What is pseudo polymorphism primarily associated with?

  • Increase in particle size
  • Change in the drug’s pH level
  • Loss of crystalline water (correct)
  • Chemical stability

    • Which type of instability does pseudo polymorphism NOT lead to?

  • Physical instability
  • Solubility instability
  • Therapeutic instability
  • Chemical instability (correct)

    • How does the solubility of a drug change when its polymorphic form changes?

    <p>It can either increase or decrease depending on the form.</p> Signup and view all the answers

    What is a consequence of altered drug solubility due to polymorphic changes?

    <p>Altered therapeutic efficacy</p> Signup and view all the answers

    Which of the following is a sign of instability in creams?

    <p>Separation of water droplets</p> Signup and view all the answers

    What effect does polymorphic transformation have on a drug's solubility?

    <p>Decreases bioavailability</p> Signup and view all the answers

    Which phenomenon is associated with the excessive growth of crystals in a suspension?

    <p>Caking</p> Signup and view all the answers

    What is pseudopolymorphism primarily characterized by?

    <p>Loss of crystalline water</p> Signup and view all the answers

    Which of the following is NOT a visible sign of instability in ointments?

    <p>Marginal viscosity decrease</p> Signup and view all the answers

    What can affect the dissolution rate of a drug during processing?

    <p>Humidity levels</p> Signup and view all the answers

    Which of the following is a sign of instability in suspensions?

    <p>Hard sediment formation</p> Signup and view all the answers

    What is a likely consequence of vaporization in drug products with high vapor pressure?

    <p>Loss of content uniformity</p> Signup and view all the answers

    What is a common consequence of a drug changing from an amorphous to a crystalline structure?

    <p>Decreased stability</p> Signup and view all the answers

    What method can help prevent vaporization of volatile drugs?

    <p>Employing tight containers</p> Signup and view all the answers

    Which type of physical instability might lead to the presence of tablet whiskers?

    <p>Pseudopolymorphism</p> Signup and view all the answers

    What is a sign of instability in emulsions?

    <p>Gas formation</p> Signup and view all the answers

    How does aging affect aminophylline suppositories?

    <p>It increases the release time of the drug.</p> Signup and view all the answers

    What is the primary role of a pharmacist in drug formulation?

    <p>To develop formulations with maximum stability</p> Signup and view all the answers

    Which packaging material can lead to the absorption of drugs and preservatives?

    <p>Polyvinyl chloride (PVC)</p> Signup and view all the answers

    Which of the following best describes a typical outcome of increasing levels of humidity during drug processing?

    <p>Increased crystal formation</p> Signup and view all the answers

    Which of the following is a required condition for storing a drug?

    <p>Stored at recommended conditions</p> Signup and view all the answers

    What is the main effect of physical instabilities that are not visually detectable in drug forms?

    <p>Altered bioavailability</p> Signup and view all the answers

    What can cause precipitation in drug solutions?

    <p>Change in pH and dilution of co-solvent</p> Signup and view all the answers

    Which is a common method used to prevent pseudopolymorphism in drug formulations?

    <p>Addition of polymers</p> Signup and view all the answers

    What is a potential effect of using a non-tight container for a drug solution with a co-solvent?

    <p>Loss of co-solvent through evaporation</p> Signup and view all the answers

    What happens to the shelf life of a drug when it is repackaged?

    <p>It becomes shorter</p> Signup and view all the answers

    What is one disadvantage of using crystalline forms compared to amorphous forms of drugs?

    <p>Reduced solubility</p> Signup and view all the answers

    When compounding medications, what must pharmacists determine regarding Beyond Use Dates?

    <p>A new date based on stability testing</p> Signup and view all the answers

    What is a critical factor affecting the stability of an anti-cancer drug in different containers?

    <p>Concentration and container material</p> Signup and view all the answers

    What type of interactions must pharmacists predict when combining drugs?

    <p>Potential drug-excipient incompatibilities</p> Signup and view all the answers

    What characteristics does a hydrophilic polymer contribute to formulations?

    <p>Delays vaporization</p> Signup and view all the answers

    What is one role pharmacists play regarding medication expiration dates?

    <p>Consult patients about appropriate use post-expiration</p> Signup and view all the answers

    What is an example of a mechanism leading to physical instability in drug products?

    <p>Electrolyte interaction</p> Signup and view all the answers

    What must pharmacists do if a drug shows signs of instability?

    <p>Check storage conditions and reassess before making decisions</p> Signup and view all the answers

    Which of the following can change as a result of transforming amorphous drug into crystalline form?

    <p>Bioavailability</p> Signup and view all the answers

    What mechanism is NOT responsible for precipitation in drug formulations?

    <p>Addition of surfactants</p> Signup and view all the answers

    Which statement is true regarding the storage of sensitive drugs?

    <p>They should be labeled with appropriate storage conditions</p> Signup and view all the answers

    Why is it important to observe the expiration date of drugs?

    <p>Increased risk of instability can occur post-expiration</p> Signup and view all the answers

    What is a potential issue when an API gets absorbed in drug packaging?

    <p>Loss of drug strength</p> Signup and view all the answers

    Which of these formulations can experience instability due to environmental factors?

    <p>Both tablet and liquid formulations</p> Signup and view all the answers

    Which condition is crucial for determining the shelf life of a drug?

    <p>Proper storage conditions and stability testing</p> Signup and view all the answers

    What is a common environmental factor that affects drug stability?

    <p>Light exposure</p> Signup and view all the answers

    In relation to drug packaging, what is a pharmacist's responsibility?

    <p>Ensure containers protect against light and moisture when necessary</p> Signup and view all the answers

    What characteristic do compounding pharmacists need to monitor in prepared formulations?

    <p>Signs of instability, even within expiration limits</p> Signup and view all the answers

    Which of the following is a type of chemical instability?

    <p>Loss of potency</p> Signup and view all the answers

    What can negatively affect the effectiveness of a drug even before its expiration date?

    <p>Inadequate storage conditions</p> Signup and view all the answers

    What term describes the physical instability characterized by the separation of water and oil phases in a semisolid dosage form?

    <p>Phase separation</p> Signup and view all the answers

    Which of the following signs indicates physical instability in tablets?

    <p>All of the above</p> Signup and view all the answers

    What is a significant risk associated with toxicological instability?

    <p>Formation of toxic metabolites</p> Signup and view all the answers

    Which drug example is mentioned as converting to a toxic compound?

    <p>Tetracycline</p> Signup and view all the answers

    In which form of dosage is caking particularly noted?

    <p>Suspensions</p> Signup and view all the answers

    Which of the following factors does NOT affect drug stability?

    <p>Suppliers of raw materials</p> Signup and view all the answers

    What is a visible indication of physical instability in capsules?

    <p>Softening or hardening of the shell</p> Signup and view all the answers

    What effect does moisture have on a drug's physical instability?

    <p>Can cause clumping or caking</p> Signup and view all the answers

    Which type of instability is characterized by the drug losing its effect?

    <p>Therapeutic instability</p> Signup and view all the answers

    What can lead to the formation of endotoxins in a drug product?

    <p>Microbial instability</p> Signup and view all the answers

    Which sign might indicate physical instability in powders?

    <p>Clumping or caking</p> Signup and view all the answers

    What does 'meling' refer to in the context of tablet instability?

    <p>Change in uniform color</p> Signup and view all the answers

    What does shelf life refer to in relation to pharmaceutical products?

    <p>The period the drug maintains its chemical and physical properties.</p> Signup and view all the answers

    What is the primary role of pharmacists in regard to drug stability?

    <p>Conduct stability tests for newly synthesized drugs.</p> Signup and view all the answers

    Which factor is NOT typically evaluated during stability testing of drugs?

    <p>The drug’s effectiveness against diseases.</p> Signup and view all the answers

    What aspect must be confirmed by monographs to maintain drug potency?

    <p>The percentage of strength allowed over its shelf life.</p> Signup and view all the answers

    Which of these is not a form of stability testing performed by pharmaceutical companies?

    <p>Market demand analysis.</p> Signup and view all the answers

    What defines an expiration date for a drug?

    <p>The date indicating when the drug loses its effectiveness.</p> Signup and view all the answers

    Which characteristic of a drug is NOT visually assessed for stability?

    <p>The smell of the drug.</p> Signup and view all the answers

    How does drug stability influence the manufacturing process based on storage conditions?

    <p>It determines how long raw materials can be stored before use.</p> Signup and view all the answers

    Which type of stability testing focuses on the drug's relationship with inactive ingredients?

    <p>Stability in dosage forms.</p> Signup and view all the answers

    What is the purpose of conducting stability tests on drugs?

    <p>To ensure drugs remain within specifications over time.</p> Signup and view all the answers

    Why is it impractical for pharmaceutical companies to work with unstable raw materials?

    <p>It leads to potential health risks for patients.</p> Signup and view all the answers

    What is one potential sign of drug instability that can be observed visually?

    <p>The liquid drug changing color.</p> Signup and view all the answers

    What determines the determination of the expiration date of a drug?

    <p>The results from stability testing under specific conditions.</p> Signup and view all the answers

    Which aspect of drug stability involves the measurement of how much active ingredient remains?

    <p>Potency stability.</p> Signup and view all the answers

    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.
    • Factors Affecting Drug Stability:
      • Drug-excipient interactions
      • Environmental factors (light, oxygen, moisture)
      • Packaging materials
    • 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

    • Multiple Phase Dosage Forms: Susceptible to physical instability, e.g., emulsions, semisolids, suspensions.
      • Emulsions: Creaming, aggregation, coalescence.
      • Semisolids: Phase separation.
      • Suspensions: Caking, sedimentation.
    • 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.
    • 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

    • 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

    • 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.
    • 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.
    • 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.
    • 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.
    • 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.
    • 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.
    • 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.

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