Pharmaceutical Drug Delivery Systems
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Questions and Answers

What does chemical stability ensure in a drug product?

  • The therapeutic effect of the drug product changes over time.
  • The product remains effective against microbial growth.
  • Each active ingredient retains its chemical integrity and potency. (correct)
  • The drug product will maintain its physical appearance.

    • Which factor does NOT affect the stability of a pharmaceutical product?

  • Environmental conditions during storage.
  • The color of the packaging. (correct)
  • The dosage form of the product.
  • The manufacturing process used.

    • What type of stability is indicated by the retention of sterility or resistance to microbial growth?

  • Physical stability
  • Chemical stability
  • Microbiological stability (correct)
  • Toxicological stability

    • Physical stability of a drug product includes retention of which of the following?

    <p>Original physical properties</p> Signup and view all the answers

    Which of these conditions would most likely decrease the chemical stability of a drug?

    <p>Exposure to excessive heat.</p> Signup and view all the answers

    Which of the following statements is true regarding toxicological stability?

    <p>No significant increase in toxicity occurs.</p> Signup and view all the answers

    What two forms of stability evaluations are classically separated in pharmaceutical studies?

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

    Which aspect of drug stability addresses the maintenance of effectiveness of antimicrobial agents?

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

    What is considered an acceptable maximum weight loss during the tablet friability test?

    <p>1%</p> Signup and view all the answers

    What is the primary purpose of conducting a dissolution test?

    <p>To estimate bioavailability</p> Signup and view all the answers

    Which of the following best describes the relationship between dissolution conditions and bioavailability?

    <p>Dissolution conditions must be established clinically to relate to bioavailability.</p> Signup and view all the answers

    Why should the same instrument be used in friability tests throughout a study?

    <p>Different instruments can yield inconsistent results.</p> Signup and view all the answers

    What could cracks, mottling, or tackiness of tablet coating indicate?

    <p>Evidence of instability</p> Signup and view all the answers

    Which method is primarily used to follow color stability of tablets?

    <p>Colorimeter or reflectometer</p> Signup and view all the answers

    What temperature is typically used for dissolution tests?

    <p>37°C</p> Signup and view all the answers

    What test has disintegration been relegated to during the development of pharmaceuticals?

    <p>In-process test</p> Signup and view all the answers

    What effect does a temperature increase have on the rate of oxidation?

    <p>It accelerates the rate of oxidation.</p> Signup and view all the answers

    Which of the following molecular structures is most likely to oxidize?

    <p>Hydroxyl groups bonded to aromatic rings</p> Signup and view all the answers

    Which condition is likely to catalyze oxidation processes?

    <p>pH values higher than optimum</p> Signup and view all the answers

    What happens to the therapeutic activity of products following oxidation?

    <p>It usually lacks therapeutic activity.</p> Signup and view all the answers

    How can the stabilization of penicillin be affected by copper ions?

    <p>As little as 0.2 mg of copper ion per liter considerably reduces stability.</p> Signup and view all the answers

    Which of the following is a recommended method to minimize oxidation in formulations?

    <p>Working in a nitrogen atmosphere</p> Signup and view all the answers

    What role do heavy metal ions play in oxidative reactions?

    <p>They can catalyze oxidation reactions.</p> Signup and view all the answers

    Which agents are commonly added to water to help reduce oxidation due to heavy metals?

    <p>Chelating agents</p> Signup and view all the answers

    What characterizes a Type 1 error in the context of expiration dating?

    <p>The product is labeled with an expiration date that is too early.</p> Signup and view all the answers

    Which statement is true regarding the reasons for studying physical stability in pharmaceuticals?

    <p>To ensure the drug product remains visually appealing over time.</p> Signup and view all the answers

    What is a potential consequence of a physical stability failure in a drug product?

    <p>The active ingredient may not be released properly.</p> Signup and view all the answers

    What is required from manufacturers regarding the prediction of shelf life?

    <p>They should include the statistical approach and error types.</p> Signup and view all the answers

    Which statement regarding simultaneous chemical stability failures is correct?

    <p>It is possible, although remote, for both types to occur in the same product.</p> Signup and view all the answers

    What is a possible outcome of a Type 2 error in pharmaceutical stability studies?

    <p>A degradation product is not detected in time.</p> Signup and view all the answers

    Which of the following describes an intrinsic part of the statistical methodology for stability studies?

    <p>The definition of acceptable levels for change within the product.</p> Signup and view all the answers

    What may indicate a failure related to appearance in drug formulation?

    <p>Loss of elegant appearance but not effectiveness.</p> Signup and view all the answers

    What is a key feature of a transdermal patch regarding its adhesive?

    <p>It must adhere well to both the backing and the patient's skin.</p> Signup and view all the answers

    Which test is NOT typically included in the stability assessment for metered-dose aerosol drug products?

    <p>Drug release per USP</p> Signup and view all the answers

    For which type of inhalation product is it crucial to ensure the emitted particle size is appropriate for lung deposition?

    <p>Dry-powdered inhalation products</p> Signup and view all the answers

    Which factor does NOT influence the shelf life of metered-dose aerosol drug products?

    <p>Particle size of the drug</p> Signup and view all the answers

    What is essential for the appearance of a transdermal patch over its shelf life?

    <p>It should maintain pharmaceutical elegance.</p> Signup and view all the answers

    What is a potential stability concern when using metered-dose inhalation products?

    <p>Leachable from the delivery device</p> Signup and view all the answers

    What must be verified in the stability testing of dry-powdered inhalation products?

    <p>Emitted dose and particle size distribution</p> Signup and view all the answers

    What is a key characteristic of a nasal inhalation product delivery system?

    <p>It must be integrated with the active drug.</p> Signup and view all the answers

    Study Notes

    Transdermal Patches

    • Must deliver drugs as labeled and adhere properly to backing and skin.
    • Should exhibit pharmaceutical elegance throughout shelf life.
    • Release liner must peel easily with minimal adhesive transfer; adhesive should not ooze from patch sides.
    • Stability tests include: appearance, assay, impurities, drug release (per USP), and backing peel force.

    Metered-Dose Aerosols

    • Comprise an aerosol can with propellant, drug, and a mouthpiece for drug delivery.
    • Drug contact components may allow plasticizer leach into the propellant.
    • Stability tests involve: appearance, assay, impurities, plume geometry, emitted dose, particle size distribution, and number of doses.
    • Shelf life may vary based on storage orientation; typically tested upright.

    Dry-Powdered Inhalation Products

    • Consist of drug and excipients in dry powdered form; delivery can be a separate device or integrated.
    • Must reproducibly deliver a specific drug amount at an optimal particle size for lung deposition.
    • Stability tests include: appearance, assay, impurities, emitted dose, particle size distribution, and water content.

    Nasal Inhalation Products

    • Deliver drug with excipients; the delivery system can be separate or integrated.
    • Assigned expiration dates are based on stability study results.

    Types of Stability

    • Chemical Stability: Active ingredients maintain integrity and potency within specified limits.
    • Physical Stability: Original physical properties (appearance, palatability, dissolution) are retained.
    • Microbiological Stability: Sterility and antimicrobial efficacy are preserved according to requirements.
    • Therapeutic Stability: Therapeutic effect remains unchanged.
    • Toxicological Stability: No significant increase in toxicity over time occurs.

    Factors Affecting Stability

    • Intrinsic stability of active ingredient(s) and interactions with inactive ingredients are critical.
    • Manufacturing process, dosage form, container closure system, and environmental conditions can influence stability.
    • Chemical failures may include a decrease in therapeutic activity or formation of toxic degradation products.
    • Physical failures might impact drug release or aesthetic qualities of the product.

    Physical Stability Testing

    • Tablet friability testing assesses durability; acceptable weight loss is typically no more than 1%.
    • Colors are monitored using colorimeters; elevated temperatures can alter degradation mechanisms.

    Dissolution and Drug Release Tests

    • Dissolution tests measure bioavailability; conditions are established during clinical development.
    • Increased temperature accelerates oxidation; storage at 0-5°C may halve oxidation rates.

    Oxidative Stability

    • Compounds with hydroxyl groups on aromatic rings and unsaturated derivatives are prone to oxidation.
    • Oxidation is catalyzed by high pH, certain heavy metals, oxygen exposure, and UV light.
    • Antioxidants and special packaging (e.g., opaque materials) help mitigate oxidation risks.

    Heavy Metal Contamination

    • Trace metals like copper can significantly reduce stability of certain drugs (e.g., penicillin).
    • Proper manufacturing practices should prevent parenteral formulations from contacting heavy metals.

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    Related Documents

    PHA 069 Pharmaceutical Manufacturing with Quality Assurance and cGMP PDF

    Description

    This quiz explores various pharmaceutical drug delivery systems, including transdermal patches, metered-dose aerosols, and dry-powdered inhalation products. Participants will learn about the requirements for each system, stability tests, and delivery methods. Test your knowledge on the intricacies of these essential drug delivery techniques.

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