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  1. What is a drug product?
    • A finished dosage form
    • Formulated to present as a dosage form
  2. What is a drug product a mixture of?
    • Acitve drug
    • Excipients
    • Organoleptic
  3. What are some example of drug products?
    • ORal: Syrups Elixirs Soltions Tablets Capsules
    • External: Ointments Pastes Creams
    • Parentals: IV, IM, IT, ID, SC, infusions,
  4. T/F The design and formulation of drug products require a thorough understanding of the biopharmaceutic principles of drug delivery
  5. What are the biopharmaceutic properties of the drug molecules that allow for the design and development of drug properties?
    • The physiochemical properties of the drug
    • the Route of administration, including the anatomic and physiologic nature of the application
    • EX: Oral, topical, injectable, implant, transdermal patch
    • The desired pharmacodynamic effect
    • EX: rapid/immediate prolonged sustained extended activity
    • The toxicologic properties
    • The nature and safety of the excipients
    • The expected role/effect of excipients and dosage form on drug delivery
  6. How does the drug product design modulate the bioavailability of the active drug substance?
    • Rapid and complete absorption
    • Slow sustained rate of absorption
    • Virtually no absorption
  7. What does the drug product design depend on?
    Therapeutic objective
  8. What are important in determining the distribution, onset, intensitty and duration of drug action?
    The rate of drug release from the product and extent of drug absorption
  9. Ka the absorption constant is rate limited by what?
    Ka is dissolution rate limited
  10. What are the pharmaceutical factors affecting drug bioavailability?
    • The type of drug product
    • The nature of excipients in the drug product
    • The physiochemical properties of the drug molecule
    • The route drug administration
  11. Disintegration
    • For a drug release from the solid dosage formulation the drug product must disintegrate into smaller particles
    • A pharmaceutical factor affecting drug bioavailability
  12. Dissolution
    defined as the rate or time that a drug takes to dissolve in the fluids at the site of absorption
  13. What is the rate limiting step in absorption?
  14. WHat is the role of excipients?
    Added to the formulation to provide certain functional properties to the drug and dosage form
  15. Do excipient affect the the kinetic of the drug?
    Yes it can alter medium
  16. What should an ideal excipient be?
    Should be phyacodynamically inert
  17. What can the excipient of magnesium sterate do?
    It can repeal water and reduce dissolution rate
  18. What adverse effect of shellac happens when it ages?
    It can crosslink upon aging and decrease the dissolution rate
  19. What happens to the percent dissolve drug when the percent of magnesium stearate is increased?
    The percent dissolved will decrease
  20. What happens to the plasma drug level with an increased level of magnesium stearate?
    The drug plasma levels will decrease
  21. What is the correlation between in vivo and in vitro that should be considered?
    Want to predict the in vivo performance from it in vitro characterisics
  22. What does in vitro testing provide?
    It provides the ability to evaluate the drug product and the ability to redesign it
  23. T/F A pharmaceutical equivalent product may not be bioequivalent
  24. T
  25. When absorption increases in vivo, what happens to dissolution in vitro?
    Absorption in vivo increases so does dissolution in vitro
  26. What happens when solubility in vitro increases what happens to Cmax in vivo?
    Solubility increases in vitro = Cmax in vivo increases
  27. What affect the Cmax vs solubility correlation?
    • Proper/Poor formulation
    • Perfusion/Diffusion limited
  28. What is the correlation between In vitro solubility and in vivo plasma concentration?
    When in vitro solubiltiy increases, in vivo plasma concentration increases
  29. What factors affect the correlation between in vitro solubility and in vivo plasma concentration?
    • Dissolution rate
    • Formulation drug product design
  30. What are pharmacodynamic consideration?
    • Desired therapeutic response
    • Toxic and adverse effects
    • Acute illness need rapid delivery
    • Chronic ilness - sustained / extended delivery
  31. What are the drug product considerations from his slides?
    • Pharmacokinetic of the drug
    • Bioavailability of the drug
    • Dose and potency considerations
    • Frequency of administration / application
  32. What are some pharmacodynamic factors with consideration to the patient
    • Side effects
    • Allergic reaction
  33. When selecting dosage for design, what should you considered?
    • Route of administration
    • Size of the dosage
    • The anatomic and physiologic characterisics of the administration site such as membrane permeability and blood flow
    • The physiochemical properties like pH osmotic pressure and presence of physiologic fluids
    • the site of administration
  34. What is the order of the saftest dosage forms?
    Oral liquids >Suspension > Emulsion > Powders > Capsules > Tablets
  35. What affects pH of the compartment (stomach/digestion?
    • GI motility
    • Presence of food
    • Gastro-intestinal emptying time
    • Hepatic first past effect
    • Irritation
  36. What type of dosage form diffuses and pentrates mucosal membranes?
    • Buccal
    • Cheek
  37. Where does buccal dosage form get absorbed?
    Cheek pouch
  38. Why would buccal dosage form be well absorbed?
    Buccal pouch offers a large surface area for absorption and is well perfused
  39. T/F buccal dosage form can offer rapid deliery or delay release
  40. What dosage form circumvents hepatic first pass effect?
    • Sublingual
    • Inhalation
  41. What is an advantage of nasal dosage form?
    The nsaal mucosa is highly perfused and is ready accessible
  42. What dosage form administerated into the respiratory system?
    Inhalation dosage form
  43. What are the advantages of drugs given by inhalation dosage form?
    • Rapid absorption and rapid onset of activity
    • Avoidance of first pass effects or metabolism prior to systemic absorption
    • Localized drug action at the lungs and minimize systemic toxicity
  44. What dosage form is 100% bioavailable?
  45. What dosage form offers sustained drug delivery?
  46. What time of soluble drug can be readily absorbed in the colon?
  47. What are the physiochemical properties?
    • pka
    • pH profile
    • POlymorphism
    • hydroscopcity
    • partition coefficient
    • excipient interaction

    particle size
Card Set:
2012-03-06 16:42:45

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